Insulatard

Основна информация

  • Търговско наименование:
  • Insulatard
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Insulatard
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Drugs used in diabetes,
  • Терапевтична област:
  • Diabetes Mellitus
  • Терапевтични показания:
  • Treatment of diabetes mellitus.
  • Каталог на резюме:
  • Revision: 19

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/000441
  • Дата Оторизация:
  • 06-10-2002
  • EMEA код:
  • EMEA/H/C/000441
  • Последна актуализация:
  • 23-09-2019

Доклад обществена оценка

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United Kingdom

An agency of the European Union

Telephone

+44 (0)20 7418 8400

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+44 (0)20 7418 8416

E-mail

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Website

www.ema.europa.eu

© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

EMA/453925/2014

EMEA/H/C/000441

EPAR summary for the public

Insulatard

human insulin

This is a summary of the European public assessment report (EPAR) for Insulatard. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Insulatard.

What is Insulatard?

Insulatard is a suspension for injection that contains the active substance human insulin. It is available

as vials, cartridges (Penfill), or pre-filled pens (InnoLet or FlexPen).

What is Insulatard used for?

Insulatard is used to treat diabetes.

The medicine can only be obtained with a prescription.

How is Insulatard used?

Insulatard is given by injection under the skin in the thigh, the abdominal wall (at the front of the

waist), the gluteal region (buttocks) or the deltoid region (shoulder). The injection site should be

changed for each injection. The patient's blood glucose (sugar) should be tested regularly to find the

lowest effective dose.

Insulatard is a long-acting insulin. It can be given once or twice a day, with or without a fast-acting

insulin (given at meal times), according to the doctor’s recommendation. The usual dose is between

0.3 and 1.0 international units (IU) per kilogram body weight per day.

Insulatard

Page 2/3

How does Insulatard work?

Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose or

when the body is unable to use insulin effectively. Insulatard is a replacement insulin which is very

similar to the insulin made by the pancreas. The active substance in Insulatard, human insulin, is

produced by a method known as ‘recombinant technology’: the insulin is made by yeast cells into

which a gene (DNA) has been introduced, which makes them able to produce insulin.

Insulatard contains insulin mixed with another substance, protamine, in an ‘isophane’ form which is

absorbed much more slowly during the day. This gives Insulatard a longer duration of action. The

replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from

the blood. By controlling the blood glucose, the symptoms and complications of diabetes are reduced.

How has Insulatard been studied?

Insulatard has been studied in four main clinical trials, which included a total of 557 patients with

type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or

type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).

In most patients, Insulatard was compared with other types of human insulin or insulin analogues. The

studies measured the levels of fasting blood glucose or glycosylated haemoglobin (HbA1c, the

haemoglobin in the blood that has glucose attached). HbA1c gives an indication of how well the blood

glucose is controlled. Further studies were also carried out in 225 patients comparing injecting

Insulatard using a syringe, or using a pre-filled pen (InnoLet or FlexPen).

What benefit has Insulatard shown during the studies?

Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been

controlled to a similar level to that seen with other human insulins. Insulatard was effective for both

type 1 and type 2 diabetes, and when using a standard injection or one of the pre-filled pens.

What is the risk associated with Insulatard?

The most common side effect with Insulatard (seen in more than 1 patient in 10) is hypoglycaemia

(low blood glucose levels). For the full list of all side effects and restrictions, see the package leaflet.

Why has Insulatard been approved?

The CHMP decided that Insulatard’s benefits are greater than its risks and recommended that it be

given marketing authorisation.

What measures are being taken to ensure the safe and effective use of

Insulatard?

A risk management plan has been developed to ensure that Insulatard is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

the package leaflet for Insulatard, including the appropriate precautions to be followed by healthcare

professionals and patients.

Other information about Insulatard

The European Commission granted a marketing authorisation valid throughout the European Union for

Insulatard on 7 October 2002.

Insulatard

Page 3/3

The full EPAR for Insulatard can be found on the Agency’s website: ema.europa.eu/Find

medicine/Human medicines/European Public Assessment Reports. For more information about

treatment with Insulatard, read the package leaflet (also part of the EPAR) or contact your doctor or

pharmacist.

This summary was last updated in 11-2013.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Insulatard 40 IU/ml (international units/ml) suspension for injection in vial

human insulin

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

1.

What Insulatard is and what it is used for

Insulatard is human insulin with a gradual onset and long duration of action.

Insulatard is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes).

Diabetes is a disease where your body does not produce enough insulin to control the level of your

blood sugar. Treatment with Insulatard helps to prevent complications from your diabetes.

Insulatard will start to lower your blood sugar about 1½ hours after you inject it, and the effect will

last for approximately 24 hours. Insulatard is often given in combination with fast-acting insulin

preparations.

2.

What you need to know before you use Insulatard

Do not use Insulatard

If you are allergic

to human insulin or any of the other ingredients in this medicine, see section

If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very

common side effects in section 4.

In insulin infusion pumps.

If the protective cap is loose or missing. Each vial has a protective, tamper-proof plastic cap. If

it is not in perfect condition when you get the vial, return the vial to your supplier.

If it has not been stored correctly or if it has been frozen, see section 5.

If the resuspended insulin does not appear uniformly white and cloudy.

If any of these apply, do not use Insulatard. Talk to your doctor, pharmacist or nurse for advice.

Before using Insulatard

Check the label to make sure it is the right type of insulin.

Remove the protective cap.

Always use a new needle for each injection to prevent contamination.

Needles and syringes must not be shared.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you exercise more than usual or if you want to change your usual diet, as this may affect your

blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad, travelling over time zones may affect your insulin needs and the timing

hereof.

Other medicines and Insulatard

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other

medicines.

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change.

Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may fall (hypoglycaemia) if you take:

Other medicines for the treatment of diabetes

Monoamine oxidase inhibitors (MAOI) (used to treat depression)

Beta-blockers (used to treat high blood pressure)

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high

blood pressure)

Salicylates (used to relieve pain and lower fever)

Anabolic steroids (such as testosterone)

Sulfonamides (used to treat infections).

Your blood sugar level may rise (hyperglycaemia) if you take:

Oral contraceptives (birth control pills)

Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)

Thyroid hormone (used to treat thyroid gland disorders)

Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat

asthma)

Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced

influence on the body’s metabolic processes)

Danazol (medicine acting on ovulation).

Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually

occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may

either increase or decrease your blood sugar level.

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning

symptoms which help you to recognise low blood sugar.

Pioglitazone (tablets used for the treatment of type 2 diabetes)

Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were

treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor

as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid

increase in weight or localised swelling (oedema).

If you have taken any of the medicines listed here, tell your doctor, pharmacist or nurse.

Insulatard with alcohol

If you drink alcohol, your need for insulin may change as your blood sugar level may either rise

or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor

for advice before taking this medicine. Insulatard can be used during pregnancy. Your insulin

dose may need to be changed during pregnancy and after delivery. Careful control of your

diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

There are no restrictions on treatment with Insulatard during breast-feeding.

Ask your doctor, pharmacist or nurse for advice before taking this medicine while pregnant or breast-

feeding.

Driving and using machines

Please ask your doctor whether you can drive a car or operate a machine:

If you have frequent hypoglycaemia.

If you find it hard to recognise hypoglycaemia.

If your blood sugar is low or high, it might affect your concentration and ability to react and therefore

also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or

others.

Insulatard contains sodium

Insulatard contains less than 1 mmol sodium (23 mg) per dose, i.e. Insulatard is essentially ‘sodium-

free’.

3.

How to use Insulatard

Dose and when to take your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your

doctor, pharmacist or nurse if you are not sure.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one

type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

Insulatard can be used in children and adolescents.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check

your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

Insulatard is administered by injection under the skin (subcutaneously). You must never inject yourself

directly into a vein (intravenously) or muscle (intramuscularly).

With each injection, change the injection site within the particular area of skin that you use. This may

reduce the risk of developing lumps or skin pitting, see section 4. The best places to give yourself an

injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.

The insulin will work more quickly if you inject into the waist (abdomen). You should always

measure your blood sugar regularly.

How to take Insulatard

Insulatard vials are for use with insulin syringes with the corresponding unit scale.

If you only use one type of insulin

Roll the vial between your hands until the liquid is uniformly white and cloudy. Resuspension is

easier when the insulin has reached room temperature. Draw into the syringe the same amount

of air as the dose of insulin you are going to inject. Inject the air into the vial.

Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Pull

the needle out of the vial. Then expel the air from the syringe and check that the dose is correct.

If you have to mix two types of insulin

Just before use, roll the vial of Insulatard between your hands until the liquid is uniformly white

and cloudy. Resuspension is easier when the insulin has reached room temperature.

Draw into the syringe the same amount of air as the dose of Insulatard. Inject the air into the

vial containing Insulatard and pull out the needle.

Draw into the syringe the same amount of air as the dose of fast-acting insulin. Inject the air into

the vial containing fast-acting insulin. Then turn the vial and syringe upside down and draw up

the prescribed dose of fast-acting insulin. Expel any air from the syringe and check that the dose

is correct.

Push the needle into the vial of Insulatard, turn the vial and syringe upside down and draw out

the dose you have been prescribed. Expel any air from the syringe and check that the dose is

correct. Inject the mixture immediately.

Always mix Insulatard and fast-acting insulin in the same sequence.

How to inject Insulatard

Inject the insulin under your skin. Use the injection technique advised by your doctor or nurse.

Keep the needle under your skin for at least 6 seconds to make sure that you have injected all

the insulin.

Discard the needle and syringe after each injection.

If you take more insulin than you should

If you take too much insulin your blood sugar gets too low (hypoglycaemia). See Summary of serious

and very common side effects in section 4.

If you forget to take your insulin

If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See Effects

from diabetes in section 4.

If you stop taking your insulin

Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be

done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See Effects

from diabetes in section 4.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Summary of serious and very common side effects

Low blood sugar

(hypoglycaemia)

is a very common side effect. It may affect more than 1 in 10

people.

Low blood sugar may occur if you:

Inject too much insulin.

Eat too little or miss a meal.

Exercise more than usual.

Drink alcohol, see Insulatard with alcohol in section 2.

Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling

very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness

or tremor; feeling anxious; feeling confused; difficulty in concentrating.

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not

treated, it can cause brain damage (temporary or permanent) and even death. You may recover more

quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how

to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are

conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets,

biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets

or high sugar snacks with you, just in case.

When the symptoms of low blood sugar have disappeared or when your blood sugar level is

stabilised, continue insulin treatment as usual.

If you have such low blood sugar that it makes you pass out, if you have had the need for an

injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a

doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Tell relevant people that you have diabetes and what the consequences may be, including the risk of

passing out (becoming unconscious) due to low blood sugar. Let them know that if you pass out, they

must turn you on your side and get medical help straight away. They must not give you any food or

drink, because you may choke.

Serious allergic reaction

to Insulatard or one of its ingredients (called a systemic allergic reaction) is

a very rare side effect, but it can potentially be life threatening. It may affect less than 1 in 10,000

people.

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

in breathing; have a rapid heartbeat; feel dizzy.

If you notice any of these signs, seek medical advice immediately.

List of other side effects

Uncommon side effects

May affect less than 1 in 100 people.

Signs of allergy:

Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and

itching) at the injection site may occur. These usually disappear after a few weeks of taking your

insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor

immediately. See also Serious allergic reactions above.

Changes at the injection site

(lipodystrophy): The fatty tissue under the skin at the injection site may

shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to

reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the

injection site, tell your doctor or nurse. These reactions can become more severe, or they may change

the absorption of your insulin, if you inject in such a site.

Diabetic retinopathy

(an eye disease related to diabetes which can lead to loss of vision): If you have

diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse.

Ask your doctor about this.

Swollen joints:

When you start taking insulin, water retention may cause swelling around your ankles

and other joints. Normally this soon disappears. If not, talk to your doctor.

Very rare side effects

May affect less than 1 in 10,000 people.

Vision problems:

When you first start your insulin treatment, it may disturb your vision, but the

disturbance is usually temporary.

Painful neuropathy

(pain due to nerve damage): If your blood sugar level improves very fast, you

may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects via the national reporting system listed

in Appendix V. By reporting side effects you can help provide more information on the safety of this

medicine.

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Have not injected enough insulin.

Forget to inject your insulin or stop taking insulin.

Repeatedly inject less insulin than you need.

Get an infection and/or a fever.

Eat more than usual.

Exercise less than usual.

Warning signs of high blood sugar:

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your

appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a

fruity (acetone) smell of the breath.

What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you

can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in

the blood because the body is breaking down fat instead of sugar). If you do not treat it, this

could lead to diabetic coma and eventually death.

5.

How to store Insulatard

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the vial label and carton after ‘EXP’.

The expiry date refers to the last day of that month.

Before opening:

Store in a refrigerator at 2°C – 8°C. Keep away from the cooling element. Do not

freeze.

During use or when carried as a spare:

Do not refrigerate or freeze. You can carry it with you and

keep it at room temperature (below 25°C) for up to 4 weeks.

Always keep the vial in the outer carton when you are not using it, in order to protect from light.

Discard the needle and syringe after each injection.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Insulatard contains

The active substance is human insulin. Insulatard is an isophane (NPH) human insulin

suspension. Each ml contains 40 IU of human insulin. Each vial contains 400 IU of human

insulin in 10 ml suspension for injection.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate

dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

What Insulatard looks like and contents of the pack

Insulatard is presented as a suspension for injection. After resuspension, the liquid should appear

uniformly white and cloudy.

Pack sizes of 1 or 5 vials of 10 ml or a multipack of 5 packs of 1 x 10 ml vial. Not all pack sizes may

be marketed.

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website

http://www.ema.europa.eu

Package leaflet: Information for the user

Insulatard 100 IU/ml (international units/ml) suspension for injection in vial

human insulin

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

1.

What Insulatard is and what it is used for

Insulatard is human insulin with a gradual onset and long duration of action.

Insulatard is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes).

Diabetes is a disease where your body does not produce enough insulin to control the level of your

blood sugar. Treatment with Insulatard helps to prevent complications from your diabetes.

Insulatard will start to lower your blood sugar about 1½ hours after you inject it, and the effect will

last for approximately 24 hours. Insulatard is often given in combination with fast-acting insulin

preparations.

2.

What you need to know before you use Insulatard

Do not use Insulatard

If you are allergic to human insulin or any of the other ingredients in this medicine, see section

If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very

common side effects in section 4.

In insulin infusion pumps.

If the protective cap is loose or missing. Each vial has a protective, tamper-proof plastic cap. If

it is not in perfect condition when you get the vial, return the vial to your supplier.

If it has not been stored correctly or if it has been frozen, see section 5.

If the resuspended insulin does not appear uniformly white and cloudy.

If any of these apply, do not use Insulatard. Talk to your doctor, pharmacist or nurse for advice.

Before using Insulatard

Check the label to make sure it is the right type of insulin.

Remove the protective cap.

Always use a new needle for each injection to prevent contamination.

Needles and syringes must not be shared.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you exercise more than usual or if you want to change your usual diet, as this may affect your

blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad, travelling over time zones may affect your insulin needs and the timing

hereof.

Other medicines and Insulatard

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other

medicines.

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change.

Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may fall (hypoglycaemia) if you take:

Other medicines for the treatment of diabetes

Monoamine oxidase inhibitors (MAOI) (used to treat depression)

Beta-blockers (used to treat high blood pressure)

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high

blood pressure)

Salicylates (used to relieve pain and lower fever)

Anabolic steroids (such as testosterone)

Sulfonamides (used to treat infections).

Your blood sugar level may rise (hyperglycaemia) if you take:

Oral contraceptives (birth control pills)

Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)

Thyroid hormone (used to treat thyroid gland disorders)

Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat

asthma)

Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced

influence on the body’s metabolic processes)

Danazol (medicine acting on ovulation).

Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually

occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may

either increase or decrease your blood sugar level.

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning

symptoms which help you to recognise low blood sugar.

Pioglitazone (tablets used for the treatment of type 2 diabetes)

Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were

treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor

as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid

increase in weight or localised swelling (oedema).

If you have taken any of the medicines listed here, tell your doctor, pharmacist or nurse.

Insulatard with alcohol

If you drink alcohol, your need for insulin may change as your blood sugar level may either rise

or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor

for advice before taking this medicine. Insulatard can be used during pregnancy. Your insulin

dose may need to be changed during pregnancy and after delivery. Careful control of your

diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

There are no restrictions on treatment with Insulatard during breast-feeding.

Ask your doctor, pharmacist or nurse for advice before taking this medicine while pregnant or breast-

feeding.

Driving and using machines

Please ask your doctor whether you can drive a car or operate a machine:

If you have frequent hypoglycaemia.

If you find it hard to recognise hypoglycaemia.

If your blood sugar is low or high, it might affect your concentration and ability to react and therefore

also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or

others.

Insulatard contains sodium

Insulatard contains less than 1 mmol sodium (23 mg) per dose, i.e. Insulatard is essentially ‘sodium-

free’.

3.

How to use Insulatard

Dose and when to take your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your

doctor, pharmacist or nurse if you are not sure.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one

type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

Insulatard can be used in children and adolescents.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check

your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

Insulatard is administered by injection under the skin (subcutaneously). You must never inject yourself

directly into a vein (intravenously) or muscle (intramuscularly).

With each injection, change the injection site within the particular area of skin that you use. This may

reduce the risk of developing lumps or skin pitting, see section 4. The best places to give yourself an

injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.

The insulin will work more quickly if you inject into the waist (abdomen). You should always

measure your blood sugar regularly.

How to take Insulatard

Insulatard vials are for use with insulin syringes with the corresponding unit scale.

If you only use one type of insulin

Roll the vial between your hands until the liquid is uniformly white and cloudy. Resuspension is

easier when the insulin has reached room temperature.

Draw into the syringe the same amount of air as the dose of insulin you are going to inject.

Inject the air into the vial.

Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Pull

the needle out of the vial. Then expel the air from the syringe and check that the dose is correct.

If you have to mix two types of insulin

Just before use, roll the vial of Insulatard between your hands until the liquid is uniformly white

and cloudy. Resuspension is easier when the insulin has reached room temperature.

Draw into the syringe the same amount of air as the dose of Insulatard. Inject the air into the

vial containing Insulatard and pull out the needle.

Draw into the syringe the same amount of air as the dose of fast-acting insulin. Inject the air into

the vial containing fast-acting insulin. Then turn the vial and syringe upside down and draw up

the prescribed dose of fast-acting insulin. Expel any air from the syringe and check that the dose

is correct.

Push the needle into the vial of Insulatard, turn the vial and syringe upside down and draw out

the dose you have been prescribed. Expel any air from the syringe and check that the dose is

correct. Inject the mixture immediately.

Always mix Insulatard and fast-acting insulin in the same sequence.

How to inject Insulatard

Inject the insulin under your skin. Use the injection technique advised by your doctor or nurse.

Keep the needle under your skin for at least 6 seconds to make sure that you have injected all

the insulin.

Discard the needle and syringe after each injection.

If you take more insulin than you should

If you take too much insulin your blood sugar gets too low (hypoglycaemia). See Summary of serious

and very common side effects in section 4.

If you forget to take your insulin

If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See Effects

from diabetes in section 4.

If you stop taking your insulin

Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be

done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See Effects

from diabetes in section 4.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Summary of serious and very common side effects

Low blood sugar

(hypoglycaemia)

is a very common side effect. It may affect more than 1 in 10

people.

Low blood sugar may occur if you:

Inject too much insulin.

Eat too little or miss a meal.

Exercise more than usual.

Drink alcohol, see Insulatard with alcohol in section 2.

Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling

very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness

or tremor; feeling anxious; feeling confused; difficulty in concentrating.

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not

treated, it can cause brain damage (temporary or permanent) and even death. You may recover more

quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how

to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are

conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets,

biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets

or high sugar snacks with you, just in case.

When the symptoms of low blood sugar have disappeared or when your blood sugar level is

stabilised, continue insulin treatment as usual.

If you have such low blood sugar that it makes you pass out, if you have had the need for an

injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a

doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Tell relevant people that you have diabetes and what the consequences may be, including the risk of

passing out (becoming unconscious) due to low blood sugar. Let them know that if you pass out, they

must turn you on your side and get medical help straight away. They must not give you any food or

drink, because you may choke.

Serious allergic reaction

to Insulatard or one of its ingredients (called a systemic allergic reaction) is

a very rare side effect, but it can potentially be life threatening. It may affect less than 1 in 10,000

people.

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

in breathing; have a rapid heartbeat; feel dizzy.

If you notice any of these signs, seek medical advice immediately.

List of other side effects

Uncommon side effects

May affect less than 1 in 100 people.

Signs of allergy:

Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and

itching) at the injection site may occur. These usually disappear after a few weeks of taking your

insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor

immediately. See also Serious allergic reactions above.

Changes at the injection site

(lipodystrophy): The fatty tissue under the skin at the injection site may

shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to

reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the

injection site, tell your doctor or nurse. These reactions can become more severe, or they may change

the absorption of your insulin, if you inject in such a site.

Diabetic retinopathy

(an eye disease related to diabetes which can lead to loss of vision): If you have

diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse.

Ask your doctor about this.

Swollen joints:

When you start taking insulin, water retention may cause swelling around your ankles

and other joints. Normally this soon disappears. If not, talk to your doctor.

Very rare side effects

May affect less than 1 in 10,000 people.

Vision problems:

When you first start your insulin treatment, it may disturb your vision, but the

disturbance is usually temporary.

Painful neuropathy

(pain due to nerve damage): If your blood sugar level improves very fast, you

may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects via the national reporting system listed

in Appendix V. By reporting side effects you can help provide more information on the safety of this

medicine.

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Have not injected enough insulin.

Forget to inject your insulin or stop taking insulin.

Repeatedly inject less insulin than you need.

Get an infection and/or a fever.

Eat more than usual.

Exercise less than usual.

Warning signs of high blood sugar:

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your

appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a

fruity (acetone) smell of the breath.

What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you

can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in

the blood because the body is breaking down fat instead of sugar). If you do not treat it, this

could lead to diabetic coma and eventually death.

5.

How to store Insulatard

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the vial label and carton after ‘EXP’.

The expiry date refers to the last day of that month.

Before opening:

Store in a refrigerator at 2°C – 8°C. Keep away from the cooling element. Do not

freeze.

During use or when carried as a spare:

Do not refrigerate or freeze. You can carry it with you and

keep it at room temperature (below 25°C) for up to 6 weeks.

Always keep the vial in the outer carton when you are not using it, in order to protect from light.

Discard the needle and syringe after each injection.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Insulatard contains

The active substance is human insulin. Insulatard is an isophane (NPH) human insulin

suspension. Each ml contains 100 IU of human insulin. Each vial contains 1,000 IU of human

insulin in 10 ml suspension for injection.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate

dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

What Insulatard looks like and contents of the pack

Insulatard is presented as a suspension for injection. After resuspension, the liquid should appear

uniformly white and cloudy.

Pack sizes of 1 or 5 vials of 10 ml or a multipack of 5 packs of 1 x 10 ml vial. Not all pack sizes may

be marketed.

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

Manufacturer

The manufacturer can be identified by the batch number printed on the slip of the carton and on

the label:

If the second and third characters are S6 or ZF, the manufacturer is Novo Nordisk A/S, Novo

Allé, DK-2880 Bagsværd, Denmark

If the second and third characters are T6, the manufacturer is Novo Nordisk Production SAS, 45

Avenue d’Orléans, F-28000 Chartres, France.

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website

http://www.ema.europa.eu

Package leaflet: Information for the user

Insulatard Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge

human insulin

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Insulatard is and what it is used for

What you need to know before you use Insulatard

How to use Insulatard

Possible side effects

How to store Insulatard

Contents of the pack and other information

1.

What Insulatard is and what it is used for

Insulatard is human insulin with a gradual onset and long duration of action.

Insulatard is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes).

Diabetes is a disease where your body does not produce enough insulin to control the level of your

blood sugar. Treatment with Insulatard helps to prevent complications from your diabetes.

Insulatard will start to lower your blood sugar about 1½ hours after you inject it, and the effect will

last for approximately 24 hours. Insulatard is often given in combination with fast-acting insulin

preparations.

2.

What you need to know before you use Insulatard

Do not use Insulatard

If you are allergic

to human insulin or any of the other ingredients in this medicine, see section

If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very

common side effects in section 4.

In insulin infusion pumps.

If the cartridge or the device containing the cartridge is dropped, damaged or crushed.

If it has not been stored correctly or if it has been frozen, see section 5.

If the resuspended insulin does not appear uniformly white and cloudy.

If any of these apply, do not use Insulatard. Talk to your doctor, pharmacist or nurse for advice.

Before using Insulatard

Check the label to make sure it is the right type of insulin.

Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not

use it if any damage is seen or if the rubber plunger has been drawn above the white label band

at the bottom of the cartridge. This could be the result of an insulin leakage. If you suspect that

the cartridge is damaged, take it back to your supplier. See your pen manual for further

instructions.

Always use a new needle for each injection to prevent contamination.

Needles and Insulatard Penfill must not be shared.

Insulatard Penfill is only suitable for injecting under the skin using a reusable pen. Speak to

your doctor if you need to inject your insulin by another method.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you exercise more than usual or if you want to change your usual diet, as this may affect your

blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad, travelling over time zones may affect your insulin needs and the timing

hereof.

Other medicines and Insulatard

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other

medicines.

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change.

Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may fall (hypoglycaemia) if you take:

Other medicines for the treatment of diabetes

Monoamine oxidase inhibitors (MAOI) (used to treat depression)

Beta-blockers (used to treat high blood pressure)

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high

blood pressure)

Salicylates (used to relieve pain and lower fever)

Anabolic steroids (such as testosterone)

Sulfonamides (used to treat infections).

Your blood sugar level may rise (hyperglycaemia) if you take:

Oral contraceptives (birth control pills)

Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)

Thyroid hormone (used to treat thyroid gland disorders)

Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat

asthma)

Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced

influence on the body’s metabolic processes)

Danazol (medicine acting on ovulation).

Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually

occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may

either increase or decrease your blood sugar level.

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning

symptoms which help you to recognise low blood sugar.

Pioglitazone (tablets used for the treatment of type 2 diabetes)

Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were

treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor

as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid

increase in weight or localised swelling (oedema).

If you have taken any of the medicines listed here, tell your doctor, pharmacist or nurse.

Insulatard with alcohol

If you drink alcohol, your need for insulin may change as your blood sugar level may either rise

or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor

for advice before taking this medicine. Insulatard can be used during pregnancy. Your insulin

dose may need to be changed during pregnancy and after delivery. Careful control of your

diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

There are no restrictions on treatment with Insulatard during breast-feeding.

Ask your doctor, pharmacist or nurse for advice before taking this medicine while pregnant or breast-

feeding.

Driving and using machines

Please ask your doctor whether you can drive a car or operate a machine:

If you have frequent hypoglycaemia.

If you find it hard to recognise hypoglycaemia.

If your blood sugar is low or high, it might affect your concentration and ability to react and therefore

also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or

others.

Insulatard contains sodium

Insulatard contains less than 1 mmol sodium (23 mg) per dose, i.e. Insulatard is essentially ‘sodium-

free’.

3.

How to use Insulatard

Dose and when to take your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your

doctor, pharmacist or nurse if you are not sure.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one

type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

Insulatard can be used in children and adolescents.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check

your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

Insulatard is administered by injection under the skin (subcutaneously). You must never inject yourself

directly into a vein (intravenously) or muscle (intramuscularly). Insulatard Penfill is only suitable for

injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by

another method.

With each injection, change the injection site within the particular area of skin that you use. This may

reduce the risk of developing lumps or skin pitting, see section 4. The best places to give yourself an

injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.

The insulin will work more quickly if you inject into the waist (abdomen). You should always

measure your blood sugar regularly.

Do not refill the cartridge. Once empty, it must be disposed of.

Insulatard Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems

and NovoFine or NovoTwist needles.

If you are treated with Insulatard Penfill and another insulin Penfill cartridge, you should use

two insulin delivery systems, one for each type of insulin.

Always carry a spare Penfill cartridge in case the one in use is lost or damaged.

Resuspension of Insulatard

Always check if there is enough insulin left (at least 12 units) in the cartridge to allow even

resuspension. If there is not enough insulin left, use a new one. See your pen manual for further

instructions.

Every time you use a new Insulatard Penfill

(before you put the cartridge into the insulin

delivery system).

Let the insulin reach room temperature before you use it. This makes it easier to resuspend.

Move the cartridge up and down between positions

a

b

and back (see the picture) so that the

glass ball moves from one end of the cartridge to the other at least 20 times.

Repeat this movement at least 10 times before each injection.

The movement must always be repeated until the liquid appears uniformly white and cloudy.

Complete the other stages of injection without delay.

How to inject Insulatard

Inject the insulin

under your skin.

Use the injection technique advised by your doctor or nurse

and as described in your pen manual.

Keep the needle under your skin

for at least 6 seconds. Keep the push-button fully depressed

until the needle has been withdrawn from the skin. This will ensure correct delivery and limit

possible flow of blood into the needle or insulin reservoir.

After each injection, be sure to remove and discard the needle and store Insulatard without the

needle attached. Otherwise the liquid may leak out, which can cause inaccurate dosing.

If you take more insulin than you should

If you take too much insulin your blood sugar gets too low (hypoglycaemia). See Summary of serious

and very common side effects in section 4.

If you forget to take your insulin

If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See Effects

from diabetes in section 4.

If you stop taking your insulin

Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be

done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See Effects

from diabetes in section 4.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Summary of serious and very common side effects

Low blood sugar

(hypoglycaemia)

is a very common side effect. It may affect more than 1 in 10

people.

Low blood sugar may occur if you:

Inject too much insulin.

Eat too little or miss a meal.

Exercise more than usual.

Drink alcohol, see Insulatard with alcohol in section 2.

Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling

very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness

or tremor; feeling anxious; feeling confused; difficulty in concentrating.

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not

treated, it can cause brain damage (temporary or permanent) and even death. You may recover more

quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how

to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are

conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets,

biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets

or high sugar snacks with you, just in case.

When the symptoms of low blood sugar have disappeared or when your blood sugar level is

stabilised, continue insulin treatment as usual.

If you have such low blood sugar that it makes you pass out, if you have had the need for an

injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a

doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Tell relevant people that you have diabetes and what the consequences may be, including the risk of

passing out (becoming unconscious) due to low blood sugar. Let them know that if you pass out, they

must turn you on your side and get medical help straight away. They must not give you any food or

drink, because you may choke.

Serious allergic reaction

to Insulatard or one of its ingredients (called a systemic allergic reaction) is

a very rare side effect, but it can potentially be life threatening. It may affect less than 1 in 10,000

people.

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

in breathing; have a rapid heartbeat; feel dizzy.

If you notice any of these signs, seek medical advice immediately.

List of other side effects

Uncommon side effects

May affect less than 1 in 100 people.

Signs of allergy:

Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and

itching) at the injection site may occur. These usually disappear after a few weeks of taking your

insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor

immediately. See also Serious allergic reactions above.

Changes at the injection site

(lipodystrophy): The fatty tissue under the skin at the injection site may

shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to

reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the

injection site, tell your doctor or nurse. These reactions can become more severe, or they may change

the absorption of your insulin, if you inject in such a site.

Diabetic retinopathy

(an eye disease related to diabetes which can lead to loss of vision): If you have

diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse.

Ask your doctor about this.

Swollen joints:

When you start taking insulin, water retention may cause swelling around your ankles

and other joints. Normally this soon disappears. If not, talk to your doctor.

Very rare side effects

May affect less than 1 in 10,000 people.

Vision problems:

When you first start your insulin treatment, it may disturb your vision, but the

disturbance is usually temporary.

Painful neuropathy

(pain due to nerve damage): If your blood sugar level improves very fast, you

may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects via the national reporting system listed

in Appendix V. By reporting side effects you can help provide more information on the safety of this

medicine.

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Have not injected enough insulin.

Forget to inject your insulin or stop taking insulin.

Repeatedly inject less insulin than you need.

Get an infection and/or a fever.

Eat more than usual.

Exercise less than usual.

Warning signs of high blood sugar:

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your

appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a

fruity (acetone) smell of the breath.

What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you

can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in

the blood because the body is breaking down fat instead of sugar). If you do not treat it, this

could lead to diabetic coma and eventually death.

5.

How to store Insulatard

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the cartridge label and carton after

‘EXP’. The expiry date refers to the last day of that month.

Before opening:

Store in a refrigerator at 2°C – 8°C. Keep away from the cooling element. Do not

freeze.

During use or when carried as a spare:

Do not refrigerate or freeze. You can carry it with you and

keep it at room temperature (below 30°C) for up to 6 weeks.

Always keep the cartridge in the outer carton when you are not using it, in order to protect from light.

Discard the needle after each injection.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Insulatard contains

The active substance is human insulin. Insulatard is an isophane (NPH) human insulin

suspension. Each ml contains 100 IU of human insulin. Each cartridge contains 300 IU of

human insulin in 3 ml suspension for injection.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate

dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

What Insulatard looks like and contents of the pack

Insulatard is presented as a suspension for injection. After resuspension, the liquid should appear

uniformly white and cloudy.

Pack sizes of 1, 5 and 10 cartridges of 3 ml. Not all pack sizes may be marketed.

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

Manufacturer

The manufacturer can be identified by the batch number printed on the slip of the carton and on the

label:

If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo

Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.

If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production

SAS, 45 Avenue d’Orléans, F-28000 Chartres, France.

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website

http://www.ema.europa.eu

Package leaflet: Information for the user

Insulatard InnoLet 100 IU/ml (international units/ml) suspension for injection in pre-filled pen

human insulin

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Insulatard is and what it is used for

What you need to know before you use Insulatard

How to use Insulatard

Possible side effects

How to store Insulatard

Contents of the pack and other information

1.

What Insulatard is and what it is used for

Insulatard is human insulin with a gradual onset and long duration of action.

Insulatard is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes).

Diabetes is a disease where your body does not produce enough insulin to control the level of your

blood sugar. Treatment with Insulatard helps to prevent complications from your diabetes.

Insulatard will start to lower your blood sugar about 1½ hours after you inject it, and the effect will

last for approximately 24 hours. Insulatard is often given in combination with fast-acting insulin

preparations.

2.

What you need to know before you use Insulatard

Do not use Insulatard

If you are allergic to human insulin or any of the other ingredients in this medicine, see section

If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very

common side effects in section 4.

In insulin infusion pumps.

If InnoLet is dropped, damaged or crushed.

If it has not been stored correctly or if it has been frozen, see section 5.

If the resuspended insulin does not appear uniformly white and cloudy.

If any of these apply, do not use Insulatard. Talk to your doctor, pharmacist or nurse for advice.

Before using Insulatard

Check the label to make sure it is the right type of insulin.

Always use a new needle for each injection to prevent contamination.

Needles and Insulatard InnoLet must not be shared.

Insulatard InnoLet is only suitable for injecting under the skin. Speak to your doctor if you need

to inject your insulin by another method.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you exercise more than usual or if you want to change your usual diet, as this may affect your

blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad, travelling over time zones may affect your insulin needs and the timing

hereof.

Other medicines and Insulatard

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other

medicines.

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change.

Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may fall (hypoglycaemia) if you take:

Other medicines for the treatment of diabetes

Monoamine oxidase inhibitors (MAOI) (used to treat depression)

Beta-blockers (used to treat high blood pressure)

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high

blood pressure)

Salicylates (used to relieve pain and lower fever)

Anabolic steroids (such as testosterone)

Sulfonamides (used to treat infections).

Your blood sugar level may rise (hyperglycaemia) if you take:

Oral contraceptives (birth control pills)

Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)

Thyroid hormone (used to treat thyroid gland disorders)

Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat

asthma)

Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced

influence on the body’s metabolic processes)

Danazol (medicine acting on ovulation).

Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually

occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may

either increase or decrease your blood sugar level.

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning

symptoms which help you to recognise low blood sugar.

Pioglitazone (tablets used for the treatment of type 2 diabetes)

Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were

treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor

as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid

increase in weight or localised swelling (oedema).

If you have taken any of the medicines listed here, tell your doctor, pharmacist or nurse.

Insulatard with alcohol

If you drink alcohol, your need for insulin may change as your blood sugar level may either rise

or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor

for advice before taking this medicine.

Insulatard can be used during pregnancy. Your insulin dose may need to be changed during

pregnancy and after delivery. Careful control of your diabetes, particularly prevention of

hypoglycaemia, is important for the health of your baby.

There are no restrictions on treatment with Insulatard during breast-feeding.

Ask your doctor, pharmacist or nurse for advice before taking this medicine while pregnant or breast-

feeding.

Driving and using machines

Please ask your doctor whether you can drive a car or operate a machine:

If you have frequent hypoglycaemia.

If you find it hard to recognise hypoglycaemia.

If your blood sugar is low or high, it might affect your concentration and ability to react and therefore

also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or

others.

Insulatard contains sodium

Insulatard contains less than 1 mmol sodium (23 mg) per dose, i.e. Insulatard is essentially ‘sodium-

free’.

3.

How to use Insulatard

Dose and when to take your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your

doctor, pharmacist or nurse if you are not sure.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one

type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

Insulatard can be used in children and adolescents.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check

your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

Insulatard is administered by injection under the skin

(subcutaneously). You must never inject yourself

directly into a vein (intravenously) or muscle (intramuscularly). Insulatard InnoLet is only suitable for

injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

With each injection, change the injection site within the particular area of skin that you use. This may

reduce the risk of developing lumps or skin pitting, see section 4. The best places to give yourself an

injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.

The insulin will work more quickly if you inject into the waist (abdomen). You should always

measure your blood sugar regularly.

How to handle Insulatard InnoLet

Insulatard InnoLet is a pre-filled disposable pen containing human insulin as isophane (NPH).

Read carefully the Instructions on how to use Insulatard InnoLet included in this package leaflet. You

must use the pen as described in the Instructions on how to use Insulatard InnoLet.

Always ensure you use the correct pen before you inject your insulin.

If you take more insulin than you should

If you take too much insulin your blood sugar gets too low (hypoglycaemia). See Summary of serious

and very common side effects in section 4.

If you forget to take your insulin

If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See Effects

from diabetes in section 4.

If you stop taking your insulin

Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be

done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See Effects

from diabetes in section 4.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Summary of serious and very common side effects

Low blood sugar

(hypoglycaemia)

is a very common side effect. It may affect more than 1 in 10

people.

Low blood sugar may occur if you:

Inject too much insulin.

Eat too little or miss a meal.

Exercise more than usual.

Drink alcohol, see Insulatard with alcohol in section 2.

Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling

very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness

or tremor; feeling anxious; feeling confused; difficulty in concentrating.

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not

treated, it can cause brain damage (temporary or permanent) and even death. You may recover more

quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how

to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are

conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets,

biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets

or high sugar snacks with you, just in case.

When the symptoms of low blood sugar have disappeared or when your blood sugar level is

stabilised, continue insulin treatment as usual.

If you have such low blood sugar that it makes you pass out, if you have had the need for an

injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a

doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Tell relevant people that you have diabetes and what the consequences may be, including the risk of

passing out (becoming unconscious) due to low blood sugar. Let them know that if you pass out, they

must turn you on your side and get medical help straight away. They must not give you any food or

drink, because you may choke.

Serious allergic reaction

to Insulatard or one of its ingredients (called a systemic allergic reaction) is

a very rare side effect, but it can potentially be life threatening. It may affect less than 1 in 10,000

people.

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

in breathing; have a rapid heartbeat; feel dizzy.

If you notice any of these signs, seek medical advice immediately.

List of other side effects

Uncommon side effects

May affect less than 1 in 100 people.

Signs of allergy:

Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and

itching) at the injection site may occur. These usually disappear after a few weeks of taking your

insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor

immediately. See also Serious allergic reactions above.

Changes at the injection site

(lipodystrophy): The fatty tissue under the skin at the injection site may

shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to

reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the

injection site, tell your doctor or nurse. These reactions can become more severe, or they may change

the absorption of your insulin, if you inject in such a site.

Diabetic retinopathy

(an eye disease related to diabetes which can lead to loss of vision): If you have

diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse.

Ask your doctor about this.

Swollen joints:

When you start taking insulin, water retention may cause swelling around your ankles

and other joints. Normally this soon disappears. If not, talk to your doctor.

Very rare side effects

May affect less than 1 in 10,000 people.

Vision problems:

When you first start your insulin treatment, it may disturb your vision, but the

disturbance is usually temporary.

Painful neuropathy

(pain due to nerve damage): If your blood sugar level improves very fast, you

may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects via the national reporting system listed

in Appendix V. By reporting side effects you can help provide more information on the safety of this

medicine.

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Have not injected enough insulin.

Forget to inject your insulin or stop taking insulin.

Repeatedly inject less insulin than you need.

Get an infection and/or a fever.

Eat more than usual.

Exercise less than usual.

Warning signs of high blood sugar:

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your

appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a

fruity (acetone) smell of the breath.

What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you

can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in

the blood because the body is breaking down fat instead of sugar). If you do not treat it, this

could lead to diabetic coma and eventually death.

5.

How to store Insulatard

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the InnoLet label and carton after

‘EXP’. The expiry date refers to the last day of that month.

Before opening:

Store in a refrigerator at 2°C – 8°C. Keep away from the cooling element. Do not

freeze.

During use or when carried as a spare:

Do not refrigerate or freeze. You can carry it with you and

keep it at room temperature (below 30°C) for up to 6 weeks.

Always keep the pen cap on your InnoLet when you are not using it, in order to protect from light.

Discard the needle after each injection.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Insulatard contains

The active substance is human insulin. Insulatard is an isophane (NPH) human insulin

suspension. Each ml contains 100 IU of human insulin. Each pre-filled pen contains 300 IU of

human insulin in 3 ml suspension for injection.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate

dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

What Insulatard looks like and contents of the pack

Insulatard is presented as a suspension for injection. After resuspension, the liquid should appear

uniformly white and cloudy.

Pack sizes of 1, 5 and 10 pre-filled pens of 3 ml. Not all pack sizes may be marketed.

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder and Manufacturer

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website

http://www.ema.europa.eu

Now turn over for information on how to use your

InnoLet.

Instructions on how to use Insulatard suspension for injection in InnoLet

Read the instructions carefully before using your InnoLet.

If you do not follow the instructions

carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar

level.

Your InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.

InnoLet is designed to be used with NovoFine or NovoTwist disposable needles up to a length of

8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet

is lost or damaged.

Push-button

Dose

selector

Pen cap

Compartment

for needles

Residual

scale

Insulin cartridge

Glass ball

Paper tab

Needle

Inner needle

Big outer

needle cap

Disposable needle (example)

Dose scale

Getting started

Check the name and coloured label

of your InnoLet to make sure that it contains the correct type of

insulin. This is especially important if you take more than one type of insulin. If you take the wrong

type of insulin, your blood sugar level may get too high or too low. Take off the pen cap.

Resuspending is easier when the insulin has reached room temperature.

Resuspending the insulin

Before every injection:

Check there are at least 12 units

of insulin left in the cartridge to allow even resuspension. If

there are less than 12 units left, use a new InnoLet.

Move the pen up and down

between positions A and B and back so that the glass ball moves

from one end of the cartridge to the other (picture

1A

) at least 20 times. Repeat this movement

at least 10 times before each injection. The movement must always be repeated until the liquid

appears uniformly white and cloudy.

Always make sure that you have resuspended the insulin prior to each injection. If you do not

resuspend the insulin, this may cause inaccurate dosing, which can lead to too high or too low

blood sugar level.

After resuspending, complete all of the following stages of injection

without delay.

1A

Attaching the needle

Always use a new needle

for each injection. This reduces the risk of contamination, infection,

leakage of insulin, blocked needles and inaccurate dosing.

Be careful not to bend or damage the needle before use.

Remove the paper tab

from a new disposable needle.

Screw the needle straight and tightly

onto your InnoLet (picture

1B

Pull off the big outer needle cap and the inner needle cap.

You may want to store the big

outer needle cap in the compartment.

Never try to put the inner needle cap back on the needle. You may stick yourself with the

needle.

1B

Priming to expel air prior to each injection

Small amounts of air may collect in the needle and cartridge during normal use.

To avoid injection of air and ensure proper dosing:

Dial 2 units

by turning the dose selector clockwise.

Hold your InnoLet with the needle upwards and tap the cartridge gently

with your finger a

few times (picture

1C

to make any air bubbles collect at the top of the cartridge.

Keeping the needle upwards, press the push-button

and the dose selector returns to 0.

Always make sure that a drop appears at the needle tip

before injection (picture

1C

). This

makes sure the insulin flows. If not, change the needle and repeat the procedure no more than

6 times.

If a drop of insulin still does not appear, the device is defective and must not be used.

If no drop appears, you will not inject any insulin, even though the dose selector may move.

This may indicate a blocked or damaged needle.

Always prime InnoLet before you inject. If you do not prime InnoLet, you may get too little

insulin or no insulin at all. This may lead to too high blood sugar level.

1C

Setting the dose

Always check that the push-button is fully depressed and the dose selector is set to 0.

Dial the number of units required

by turning the dose selector clockwise (picture

2

You will hear a click for every single unit dialled.

The dose can be corrected by turning the

dial either way. Make sure not to turn the dial or correct the dose when the needle is inserted in

the skin. This may lead to inaccurate dosing that can make your blood sugar level too high or

too low.

Always use the dose scale and the dose selector to see how many units you have selected before

injecting the insulin. Do not count the pen clicks. If you select and inject the wrong dose, your

blood sugar level may get too high or too low. Do not use the residual scale, it only shows

approximately how much insulin is left in your pen.

You cannot set a dose larger than the number of units remaining in the cartridge.

2

Injecting the insulin

Insert the needle into your skin.

Use the injection technique advised by your doctor.

Deliver the dose by pressing the push-button fully down

(picture

3

You will hear clicks as

the dose selector returns to 0.

After the injection, the needle should remain under the skin for at least 6 seconds

to ensure

that the full dose has been delivered.

Make sure not to block the dose selector while injecting,

as the dose selector must be allowed

to return to 0 when you press the push-button. Always make sure that the dose selector returns

to 0 after the injection. If the dose selector stops before it returns to 0, the full dose has not been

delivered, which may result in too high blood sugar level.

Discard the needle after each injection.

3

Removing the needle

Replace the big outer needle cap and unscrew the needle

(picture

4

Dispose of it carefully.

Put the pen cap back on your InnoLet to protect the insulin from light.

4

Always use a new needle for each injection.

Always remove and discard the needle after each injection and store your InnoLet without the needle

attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles and

inaccurate dosing.

Further important information

Caregivers must be very careful when handling used needles – to reduce the risk of needle sticks and

cross-infection.

Dispose of your used InnoLet carefully without the needle attached.

Never share your pen or your needles with other people. It might lead to cross-infection.

Never share your pen with other people. Your medicine might be harmful to their health.

Always keep your InnoLet and needles out of sight and reach of others, especially children.

Caring for your pen

Your InnoLet is designed to work accurately and safely. It must be handled with care. If it is dropped,

damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate dosing, which can

lead to too high or too low blood sugar level.

You can clean your InnoLet by wiping it with a medicinal swab. Do not soak, wash or lubricate it.

This may damage the mechanism and may cause inaccurate dosing, which can lead to too high or too

low blood sugar level.

Do not refill your InnoLet. Once empty, it must be disposed of.

Package leaflet: Information for the user

Insulatard FlexPen 100 IU/ml (international units/ml) suspension for injection in pre-filled pen

human insulin

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Insulatard is and what it is used for

What you need to know before you use Insulatard

How to use Insulatard

Possible side effects

How to store Insulatard

Contents of the pack and other information

1.

What Insulatard is and what it is used for

Insulatard is human insulin with a gradual onset and long duration of action.

Insulatard is used to reduce the high blood sugar level in patients with diabetes mellitus (diabetes).

Diabetes is a disease where your body does not produce enough insulin to control the level of your

blood sugar. Treatment with Insulatard helps to prevent complications from your diabetes.

Insulatard will start to lower your blood sugar about 1½ hours after you inject it, and the effect will

last for approximately 24 hours. Insulatard is often given in combination with fast-acting insulin

preparations.

2.

What you need to know before you use Insulatard

Do not use Insulatard

If you are allergic to human insulin or any of the other ingredients in this medicine, see section

If you suspect hypoglycaemia (low blood sugar) is starting, see Summary of serious and very

common side effects in section 4.

In insulin infusion pumps.

If FlexPen is dropped, damaged or crushed.

If it has not been stored correctly or if it has been frozen, see section 5.

If the resuspended insulin does not appear uniformly white and cloudy.

If any of these apply, do not use Insulatard. Talk to your doctor, pharmacist or nurse for advice.

Before using Insulatard

Check the label to make sure it is the right type of insulin.

Always use a new needle for each injection to prevent contamination.

Needles and Insulatard FlexPen must not be shared.

Insulatard FlexPen is only suitable for injecting under the skin. Speak to your doctor if you need

to inject your insulin by another method.

Warnings and precautions

Some conditions and activities can affect your need for insulin. Consult your doctor:

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.

If you exercise more than usual or if you want to change your usual diet, as this may affect your

blood sugar level.

If you are ill, carry on taking your insulin and consult your doctor.

If you are going abroad, travelling over time zones may affect your insulin needs and the timing

hereof.

Other medicines and Insulatard

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other

medicines.

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change.

Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may fall (hypoglycaemia) if you take:

Other medicines for the treatment of diabetes

Monoamine oxidase inhibitors (MAOI) (used to treat depression)

Beta-blockers (used to treat high blood pressure)

Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high

blood pressure)

Salicylates (used to relieve pain and lower fever)

Anabolic steroids (such as testosterone)

Sulfonamides (used to treat infections).

Your blood sugar level may rise (hyperglycaemia) if you take:

Oral contraceptives (birth control pills)

Thiazides (used to treat high blood pressure or excessive fluid retention)

Glucocorticoids (such as ‘cortisone’ used to treat inflammation)

Thyroid hormone (used to treat thyroid gland disorders)

Sympathomimetics (such as epinephrine [adrenaline], salbutamol or terbutaline used to treat

asthma)

Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced

influence on the body’s metabolic processes)

Danazol (medicine acting on ovulation).

Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually

occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may

either increase or decrease your blood sugar level.

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning

symptoms which help you to recognise low blood sugar.

Pioglitazone (tablets used for the treatment of type 2 diabetes)

Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were

treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor

as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid

increase in weight or localised swelling (oedema).

If you have taken any of the medicines listed here, tell your doctor, pharmacist or nurse.

Insulatard with alcohol

If you drink alcohol, your need for insulin may change as your blood sugar level may either rise

or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor

for advice before taking this medicine. Insulatard can be used during pregnancy. Your insulin

dose may need to be changed during pregnancy and after delivery. Careful control of your

diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

There are no restrictions on treatment with Insulatard during breast-feeding.

Ask your doctor, pharmacist or nurse for advice before taking this medicine while pregnant or breast-

feeding.

Driving and using machines

Please ask your doctor whether you can drive a car or operate a machine:

If you have frequent hypoglycaemia.

If you find it hard to recognise hypoglycaemia.

If your blood sugar is low or high, it might affect your concentration and ability to react and therefore

also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or

others.

Insulatard contains sodium

Insulatard contains less than 1 mmol sodium (23 mg) per dose, i.e. Insulatard is essentially ‘sodium-

free’.

3.

How to use Insulatard

Dose and when to take your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your

doctor, pharmacist or nurse if you are not sure.

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one

type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

Insulatard can be used in children and adolescents.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check

your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

Insulatard is administered by injection under the skin (subcutaneously). You must never inject yourself

directly into a vein (intravenously) or muscle (intramuscularly). Insulatard FlexPen is only suitable for

injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

With each injection, change the injection site within the particular area of skin that you use. This may

reduce the risk of developing lumps or skin pitting, see section 4. The best places to give yourself an

injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.

The insulin will work more quickly if you inject into the waist (abdomen). You should always

measure your blood sugar regularly.

How to handle Insulatard FlexPen

Insulatard FlexPen is a pre-filled disposable pen containing human insulin as isophane (NPH).

Read carefully the Instructions on how to use Insulatard FlexPen included in this package leaflet. You

must use the pen as described in the Instructions on how to use Insulatard FlexPen.

Always ensure you use the correct pen before you inject your insulin.

If you take more insulin than you should

If you take too much insulin your blood sugar gets too low (hypoglycaemia). See Summary of serious

and very common side effects in section 4.

If you forget to take your insulin

If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See Effects

from diabetes in section 4.

If you stop taking your insulin

Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be

done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See Effects

from diabetes in section 4.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Summary of serious and very common side effects

Low blood sugar

(hypoglycaemia)

is a very common side effect. It may affect more than 1 in 10

people.

Low blood sugar may occur if you:

Inject too much insulin.

Eat too little or miss a meal.

Exercise more than usual.

Drink alcohol, see Insulatard with alcohol in section 2.

Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling

very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness

or tremor; feeling anxious; feeling confused; difficulty in concentrating.

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not

treated, it can cause brain damage (temporary or permanent) and even death. You may recover more

quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how

to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are

conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets,

biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets

or high sugar snacks with you, just in case.

When the symptoms of low blood sugar have disappeared or when your blood sugar level is

stabilised, continue insulin treatment as usual.

If you have such low blood sugar that it makes you pass out, if you have had the need for an

injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a

doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Tell relevant people that you have diabetes and what the consequences may be, including the risk of

passing out (becoming unconscious) due to low blood sugar. Let them know that if you pass out, they

must turn you on your side and get medical help straight away. They must not give you any food or

drink, because you may choke.

Serious allergic reaction

to Insulatard or one of its ingredients (called a systemic allergic reaction) is

a very rare side effect, but it can potentially be life threatening. It may affect less than 1 in 10,000

people.

Seek medical advice immediately:

If signs of allergy spread to other parts of your body.

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty

in breathing; have a rapid heartbeat; feel dizzy.

If you notice any of these signs, seek medical advice immediately.

List of other side effects

Uncommon side effects

May affect less than 1 in 100 people.

Signs of allergy:

Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and

itching) at the injection site may occur. These usually disappear after a few weeks of taking your

insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor

immediately. See also Serious allergic reactions above.

Changes at the injection site

(lipodystrophy): The fatty tissue under the skin at the injection site may

shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to

reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the

injection site, tell your doctor or nurse. These reactions can become more severe, or they may change

the absorption of your insulin, if you inject in such a site.

Diabetic retinopathy

(an eye disease related to diabetes which can lead to loss of vision): If you have

diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse.

Ask your doctor about this.

Swollen joints:

When you start taking insulin, water retention may cause swelling around your ankles

and other joints. Normally this soon disappears. If not, talk to your doctor.

Very rare side effects

May affect less than 1 in 10,000 people.

Vision problems:

When you first start your insulin treatment, it may disturb your vision, but the

disturbance is usually temporary.

Painful neuropathy

(pain due to nerve damage): If your blood sugar level improves very fast, you

may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects via the national reporting system listed

in Appendix V. By reporting side effects you can help provide more information on the safety of this

medicine.

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

Have not injected enough insulin.

Forget to inject your insulin or stop taking insulin.

Repeatedly inject less insulin than you need.

Get an infection and/or a fever.

Eat more than usual.

Exercise less than usual.

Warning signs of high blood sugar:

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your

appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a

fruity (acetone) smell of the breath.

What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you

can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in

the blood because the body is breaking down fat instead of sugar). If you do not treat it, this

could lead to diabetic coma and eventually death.

5.

How to store Insulatard

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the FlexPen label and carton after

‘EXP’. The expiry date refers to the last day of that month.

Before opening:

Store in a refrigerator at 2°C – 8°C. Keep away from the cooling element. Do not

freeze.

During use or when carried as a spare:

Do not refrigerate or freeze. You can carry it with you and

keep it at room temperature (below 30°C) for up to 6 weeks.

Always keep the pen cap on your FlexPen when you are not using it, in order to protect from light.

Discard the needle after each injection.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Insulatard contains

The active substance is human insulin. Insulatard is an isophane (NPH) human insulin

suspension. Each ml contains 100 IU of human insulin. Each pre-filled pen contains 300 IU of

human insulin in 3 ml suspension for injection.

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate

dihydrate, sodium hydroxide, hydrochloric acid, protamine sulfate and water for injections.

What Insulatard looks like and contents of the pack

Insulatard is presented as a suspension for injection. After resuspension, the liquid should appear

uniformly white and cloudy.

Pack sizes of 1, 5 and 10 pre-filled pens of 3 ml. Not all pack sizes may be marketed.

The suspension is cloudy, white and aqueous.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

Manufacturer

The manufacturer can be identified by the batch number printed on the slip of the carton and on the

label:

If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo

Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.

If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production

SAS, 45 Avenue d’Orléans, F-28000 Chartres, France.

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website

http://www.ema.europa.eu

Now turn over for information on how to use your

FlexPen.

Instructions on how to use Insulatard suspension for injection in FlexPen

Read the following instructions carefully before using your FlexPen.

If you do not follow the

instructions carefully, you may get too little or too much insulin, which can lead to too high or too low

blood sugar level.

Your FlexPen is a pre-filled dial-a-dose insulin pen. You can select doses from 1 to 60 units in

increments of 1 unit. FlexPen is designed to be used with NovoFine or NovoTwist disposable needles

up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in

case your FlexPen is lost or damaged.

Insulatard FlexPen

Pen cap

Cartridge

Residual

scale

Pointer

Dose

selector

Push-

button

Big outer

needle cap

Needle

Paper tab

Inner

needle cap

Needle (example)

Glass

ball

12 units

Caring for your pen

Your FlexPen must be handled with care.

If it is dropped, damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate

dosing, which can lead to too high or too low blood sugar level.

You can clean the exterior of your FlexPen by wiping it with a medicinal swab. Do not soak it, wash

or lubricate it as it may damage the pen.

Do not refill your FlexPen. Once empty, it must be disposed of.

Preparing your Insulatard FlexPen

A

Check the name and coloured label of your pen to make sure that it contains the correct type of

insulin.

This is especially important if you take more than one type of insulin. If you take the wrong

type of insulin,

your blood sugar level may get too high or too low.

Every time you use a new pen

Let the insulin reach room temperature before you use it.

This makes it easier to resuspend. Pull off the pen cap (see

A

A

B

Before your first injection with a new FlexPen, you must resuspend the insulin:

Move the pen up and down twenty times between the two positions as shown, so the glass ball moves

from one end of the cartridge to the other. Repeat until the liquid appears uniformly white and cloudy.

For every following injection,

move the pen up and down between the two positions at least 10 times

until the liquid appears uniformly white and cloudy.

Always make sure that you have resuspended the insulin prior to each injection. This reduces the risk

of too high or too low blood sugar level. After you have resuspended the insulin, complete all the

following steps of injection without delay.

B

Always check there are at least 12 units of insulin left in the cartridge to allow resuspension. If

there are less than 12 units left, use a new FlexPen. 12 units are marked on the residual scale.

See the big picture on top of this instruction.

Do not use the pen if the

resuspended

insulin does not look

uniformly white and cloudy.

Attaching the needle

C

Remove the paper tab from a new disposable needle.

Screw the needle straight and tightly onto your FlexPen.

C

D

Pull off the big outer needle cap and keep it for later.

D

E

Pull off the inner needle cap and dispose of it.

Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.

E

Always use a new needle for each injection. This reduces the risk of contamination, infection,

leakage of insulin, blocked needles and inaccurate dosing.

Be careful not to bend or damage the needle before use.

Checking the insulin flow

F

Prior to each injection small amounts of air may collect in the cartridge during normal use. To

avoid injection of air and ensure proper dosing:

Turn the dose selector to select 2 units.

F

2 units

selected

G

Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a

few times to make any air bubbles collect at the top of the cartridge.

G

H

Keeping the needle upwards, press the push-button all the way in. The dose selector returns to 0.

A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no

more than 6 times.

If a drop of insulin still does not appear, the pen is defective, and you must use a new one.

H

Always make sure that a drop appears at the needle tip before you inject. This makes sure that

the insulin flows. If no drop appears, you will not inject any insulin, even though the dose

selector may move. This may indicate a blocked or damaged needle.

Always check the flow before you inject. If you do not check the flow, you may get too little

insulin or no insulin at all. This may lead to too high blood sugar level.

Selecting your dose

I

Check that the dose selector is set at 0.

Turn the dose selector to select the number of units you need to inject.

The dose can be corrected either up or down by turning the dose selector in either direction until the

correct dose lines up with the pointer. When turning the dose selector, be careful not to push the push-

button as insulin will come out.

You cannot select a dose larger than the number of units left in the cartridge.

I

5 units

selected

24 units

selected

Always use the dose selector and the pointer to see how many units you have selected before

injecting the insulin.

Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may

get too high or too low. Do not use the residual scale, it only shows approximately how much

insulin is left in your pen.

Making the injection

J

Insert the needle into your skin. Use the injection technique shown by your doctor or nurse.

Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful

only to push the push-button when injecting.

Turning the dose selector will not inject insulin.

J

K

Keep the push-button fully depressed and let the needle remain under the skin for at least 6 seconds.

This will make sure you get the full dose.

Withdraw the needle from the skin then release the pressure on the push-button.

Always make sure that the dose selector returns to 0 after the injection. If the dose selector stops

before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar

level.

K

L

Lead the needle into the big outer needle cap without touching it. When the needle is covered,

carefully push the big outer needle cap completely on and then unscrew the needle.

Dispose of it carefully and put the pen cap back on.

L

Always remove the needle after each injection and store your FlexPen without the needle

attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles

and inaccurate dosing.

Further important information

Caregivers must be very careful when handling used needles – to reduce the risk of needle sticks

and cross-infection.

Dispose of your used FlexPen carefully without the needle attached.

Never share your pen or your needles with other people. It might lead to cross-infection.

Never share your pen with other people. Your medicine might be harmful to their health.

Always keep your pen and needles out of sight and reach of others, especially children.