Ozempic

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  • Heiti vöru:
  • Ozempic
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  • Mannfólk
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  • Allópatísk lyf

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Staðsetning

  • Fáanlegt í:
  • Ozempic
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Drugs used in diabetes,
  • Lækningarsvæði:
  • Diabetes Mellitus
  • Ábendingar:
  • Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;, in addition to other medicinal products for the treatment of diabetes., For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.,
  • Vörulýsing:
  • Revision: 2

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/004174
  • Leyfisdagur:
  • 07-02-2018
  • EMEA númer:
  • EMEA/H/C/004174
  • Síðasta uppfærsla:
  • 24-03-2019

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

EMA/849609/2017

EMEA/H/C/004174

EPAR summary for the public

Ozempic

semaglutide

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

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Ozempic.

For practical information about using Ozempic, patients should read the package leaflet or contact their

doctor or pharmacist.

What is Ozempic and what is it used for?

Ozempic is a diabetes medicine used with diet and exercise to treat adults whose type 2 diabetes is not

satisfactorily controlled.

Ozempic can be used on its own in patients who cannot take metformin (another diabetes medicine). It

can also be used as an ‘add-on’ to other diabetes medicines.

Ozempic contains the active substance semaglutide.

How is Ozempic used?

Ozempic is available as a solution for injection in prefilled pens and can only be obtained with a

prescription. It is injected under the skin of the belly, the thigh or the upper arm.

The starting dose of Ozempic is 0.25 mg once a week. After four weeks, this dose should be increased

to 0.5 mg. If needed, the dose can be further increased up to a maximum of 1 mg once a week. For

further information, see the package leaflet.

Ozempic

EMA/849609/2017

Page 2/3

How does Ozempic work?

The active substance in Ozempic, semaglutide, is a ‘GLP-1 receptor agonist’. It acts in the same way as

GLP-1 (a hormone produced in the gut) by increasing the amount of insulin that the pancreas releases

in response to food. This helps with the control of blood glucose levels.

What benefits of Ozempic have been shown in studies?

Studies showed that Ozempic is effective at lowering blood glucose levels and reducing the risk of

health complications in patients with type 2 diabetes.

Five studies in over 4,000 patients showed that Ozempic lowered levels of HbA1c (a measure of blood

glucose) by between 1.2 and 1.8 percentage points over 10 to 13 months. Ozempic in these studies

compared favourably with other treatments, sitagliptin, exenatide and insulin glargine (which led to

reductions of 0.55, 0.92, 0.83 percentage points respectively) and placebo (reductions of up to 0.09

percentage points). In addition, the results indicated that treatment with Ozempic was associated with

a beneficial fall in body weight.

A further study in over 3,000 diabetes patients at high risk of heart problems showed that overall,

heart attack, stroke or death occurred less frequently in patients treated with Ozempic (6.6%) than

with placebo (8.9%). When looking at the three ‘events’ separately, fewer patients taking Ozempic had

a heart attack or stroke, but rates of death from heart problems were similar in the two groups.

What are the risks associated with Ozempic?

The most common side effects with Ozempic (which may affect more than 1 in 10 people) include

problems with the digestive system, such as diarrhoea, vomiting and nausea (feeling sick). These are

mild or moderate in severity and of short duration. Serious worsening of diabetic retinopathy (damage

to the retina, the light sensitive membrane at the back of the eye) is common (it may affect up to 1 in

10 people).

For the full list of all side effects and restrictions with Ozempic, see the package leaflet.

Why is Ozempic approved?

Ozempic was shown to be effective at controlling blood glucose levels. Treatment with Ozempic also

led to weight loss, which is considered beneficial in patients with diabetes. Ozempic was also shown to

be effective at reducing the occurrence of serious health complications associated with diabetes such

as heart attack and stroke.

Regarding safety, this was considered in line with that of other medicines of the same class. Side

effects affecting the digestive system are considered to be manageable. Worsening of diabetic

retinopathy has also been observed and will be further investigated.

The European Medicines Agency concluded that the benefits of Ozempic seen in studies outweighed its

risk and recommended it be approved for use in the EU.

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

Ozempic?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Ozempic have been included in the summary of product characteristics and the

package leaflet.

Ozempic

EMA/849609/2017

Page 3/3

Other information about Ozempic

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

Ozempic on 8 February 2018.

The full EPAR for Ozempic 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 Ozempic, read the package leaflet (also part of the EPAR) or contact your doctor or

pharmacist.

This summary was last updated in 02-2018.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Ozempic 0.25 mg solution for injection in pre-filled pen

semaglutide

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

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 Ozempic is and what it is used for

What you need to know before you use Ozempic

How to use Ozempic

Possible side effects

How to store Ozempic

Contents of the pack and other information

1.

What Ozempic is and what it is used for

Ozempic contains the active substance semaglutide. It

helps your body reduce your blood sugar level

only when blood sugar is too high and can help prevent heart disease.

Ozempic is used:

on its own – if your blood sugar is not controlled well enough by diet and exercise alone, and

you cannot use metformin (another diabetes medicine) or

with other medicines for diabetes – when they are not enough to control your blood sugar levels.

These other medicines may include: oral antidiabetics (such as metformin, thiazolidinediones,

sulfonylureas) or insulin.

It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or

nurse.

2.

What you need to know before you use Ozempic

Do not use Ozempic:

if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using this medicine.

This medicine is not an insulin and should not be used if:

you have type 1 diabetes – a condition where your body does not produce any insulin

you develop diabetic ketoacidosis – a complication of diabetes with high blood sugar, breathing

difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in

the mouth.

Effects on the digestive system

During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have

diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink

plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk

to your doctor if you have any questions or concerns.

Severe and on-going stomach pain which could be due to acute pancreatitis

If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be

a sign of acute pancreatitis (inflamed pancreas).

Hypoglycaemia

Combining a sulfonylurea or an insulin with this medicine might increase the risk of getting low blood

sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels.

Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose

of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)

If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your

vision, and this may require treatment. Tell your doctor if you have diabetic eye disease or if you

experience eye problems during treatment with this medicine

.

Children and adolescents

This medicine is not recommended in children and adolescents under 18 years as the safety and

efficacy in this age group have not yet been established.

Other medicines and Ozempic

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

medicines, including herbal medicines or other medicines you bought without a prescription.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the

following:

Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti-

coagulants). Frequent blood testing to determine the ability of your blood to clot may be

required.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask

your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy, as it is not known if it may affect your unborn

child. Therefore, it is recommended to use contraception while using this medicine. If you wish to

become pregnant, you should stop using this medicine at least two months in advance. If you become

pregnant when using this medicine, talk to your doctor right away, as your treatment will need to be

changed.

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.

Driving and using machines

If you use this medicine in combination with a sulphonylurea or insulin, low blood sugar

(hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using

machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for

information on increased risk of low blood sugar and section 4 for the warning signs of low blood

sugar. Talk to your doctor for further information.

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3.

How to use Ozempic

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or

nurse if you are not sure.

How much to use

The starting dose is 0.25 mg once a week for four weeks.

After four weeks your doctor will increase your dose to 0.5 mg once a week.

Your doctor may increase your dose to 1 mg once a week if your blood sugar is not controlled

well enough with a dose of 0.5 mg once a week.

Do not change your dose unless your doctor has told you to.

How Ozempic is given

Ozempic is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or

muscle.

The best places to give the injection are the front of your thighs, the front of your waist

(abdomen), or your upper arm.

Before you use the pen for the first time, your doctor or nurse will show you how to use it.

Detailed instructions for use are on the other side of this leaflet.

When to use Ozempic

You should use this medicine

once a week on the same day each week if possible.

You can give yourself the injection at any time of the day – regardless of meals.

To help you remember to inject this medicine once a week only, it is recommended to note the chosen

weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have

injected it.

If necessary you can change the day of your weekly injection of this medicine as long as it has been at

least 3 days since your last injection of it. After selecting a new dosing day, continue with once a week

dosing.

If you use more Ozempic than you should

If you use more Ozempic than you should, talk to your doctor straight away. You may get side effects

such as feeling sick (nausea).

If you forget to use Ozempic

If you forgot to inject a dose and:

it is 5 days or less since you should have used Ozempic, use it as soon as you remember. Then

inject your next dose as usual on your scheduled day.

it is more than 5 days since you should have used Ozempic, skip the missed dose. Then inject

your next dose as usual on your scheduled day.

Do not take a double dose to make up for a forgotten dose.

If you stop using Ozempic

Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar

levels may increase.

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.

Serious side effects

Common:

may affect up to 1 in 10 people

complications of diabetic eye disease (retinopathy) – you should inform your doctor if you

experience eye problems, such as changes in vision, during treatment with this medicine.

Rare:

may affect up to 1 in 1,000 people

severe allergic reactions (anaphylactic reactions). You should seek immediate medical help and

inform your doctor straight away if you get symptoms such as breathing problems, swelling of

face and throat and a fast heartbeat.

Other side effects

Very common:

may affect more than 1 in 10 people

feeling sick (nausea) – this usually goes away over time

diarrhoea – this usually goes away over time

Common:

may affect up to 1 in 10 people

being sick (vomiting)

low blood sugar (hypoglycaemia) when this medicine

is used with another antidiabetic medicine

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale

skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy

or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.

Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning

signs.

Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may

reduce your dose of these medicines before you start using this medicine.

indigestion

inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being

sick (vomiting)

reflux or heartburn – also called ‘gastro-esophageal reflux disease’ (GERD)

stomach pain

bloating of the stomach

constipation

burping

gall stones

dizziness

tiredness

weight loss

less appetite

gas (flatulence)

increase of pancreatic enzymes (such as lipase and amylase).

Uncommon:

may affect up to 1 in 100 people

change in the way food or drink tastes

fast pulse

injection site reactions – such as bruising, pain, irritation, itching and rash.

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 directly 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.

5.

How to store Ozempic

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 pen label and carton after ’EXP’.

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

Before opening:

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the cooling element. Protect from

light.

During use:

You can keep the pen for 6 weeks when stored at a temperature below 30°C or in a refrigerator

(2°C – 8°C) away from the cooling element. Do not freeze Ozempic and do not use it if it has

been frozen.

When you are not using the pen, keep the pen cap on in order to protect from light.

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.

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 Ozempic contains

The active substance is semaglutide. One ml solution for injection contains 1.34 mg

semaglutide. One pre-filled pen contains 2 mg semaglutide in 1.5 ml solution. Each dose

contains 0.25 mg of semaglutide in 0.19 ml.

The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, water for

injections, sodium hydroxide/hydrochloric acid (for pH adjustment).

What Ozempic looks like and contents of the pack

Ozempic is a clear and colourless or almost colourless solution for injection in a pre-filled pen.

Each pen contains 1.5 ml of solution, delivering 4 doses of 0.25 mg.

Ozempic 0.25 mg solution for injection is available in the following pack size:

1 pen and 4 disposable NovoFine Plus needles.

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 web site:

http://www.ema.europa.eu

Instructions on how to use Ozempic 0.25 mg solution for injection in pre-filled pen

Please read these instructions carefully

before using your

Ozempic pre-filled pen.

Do not use the pen without proper training

from your doctor

or nurse. Only use the medicine in this pen as prescribed.

Start by checking your pen to

make sure that it contains

Ozempic 0.25 mg,

then look at the illustrations below to get to

know the different parts of your pen and needle.

If you are blind or have poor eyesight and cannot read the

dose counter on the pen, do not use this pen without help.

Get help from a person with good eyesight who is trained to use

the Ozempic pre-filled pen.

Your pen is a pre-filled dial-a-dose pen. It contains 2 mg of

semaglutide, and you can only select doses of 0.25 mg. Your

pen is designed to be used with NovoFine and NovoTwist

disposable needles up to a length of 8 mm.

NovoFine Plus needles are included in the pack.

Ozempic pre-filled pen and

needle (example)

Pen cap

Outer

needle cap

Inner

needle cap

Needle

Paper tab

Pen window

Pen label

Dose counter

Dose pointer

Dose selector

Dose button

Flow

check

symbol

1. Prepare your pen with a new needle

Check the name and coloured label

of your pen, to

make sure that it contains Ozempic. This is especially

important if you take more than one type of injectable

medicine. Using the wrong medicine could cause severe

harm to your health.

Pull off the pen cap.

A

Check that the solution in your pen is clear

colourless. Look through the pen window. If the solution

looks cloudy or coloured, do not use the pen.

B

Take a new needle

and tear off the paper tab.

If the paper tab is broken, do not use the needle, as

sterility is not guaranteed.

C

Push the needle straight onto the pen. Turn until it is

on tight.

D

Pull off the outer needle cap and keep it for later.

will need it after the injection, to safely remove the

needle from the pen.

E

Pull off the inner needle cap and throw it away.

If you

try to put it back on, you may accidentally stick yourself

with the needle.

A drop of solution may appear at the needle tip. This is normal,

but you must still check the flow, if you use a new pen for the

first time. See step 2 ‘Check the flow’.

Do not attach a new needle

to your pen until you are ready to

take your injection.

F

Always use a new needle for each injection.

This reduces the risk of blocked needles, contamination, infection and inaccurate dosing.

Never use a bent or damaged needle.

2. Check the flow

Before your first injection with each new pen, check

the flow.

If your pen is already in use, go to step 3 ‘Select

your dose’.

Turn the dose selector

until the dose counter shows the

flow check symbol

A

Flow check

symbol

selected

Hold the pen with the needle pointing up.

Press and hold in the dose button

until the dose counter

returns to 0. The 0 must line up with the dose pointer.

A drop of solution should appear at the needle tip.

B

A small drop may remain at the needle tip, but it will not be injected.

If no drop appears,

repeat step 2 ‘Check the flow’ up to 6 times. If there is still no drop, change the needle

and repeat step 2 ‘Check the flow’ once more.

If a drop still does not appear,

dispose of the pen and use a new one.

Always make sure that a drop appears

at the needle tip before you use a new pen for the first time.

This makes sure that the solution flows.

If no drop appears, you will

not

inject any medicine even though the dose counter may move.

This

may indicate a blocked or damaged needle.

If you do not check the flow before your first injection with each new pen, you may not get the

prescribed dose and the intended effect of Ozempic.

3. Select your dose

Turn the dose selector to select 0.25 mg.

Keep turning until the dose counter stops and shows

0.25 mg.

A

0.25 mg

selected

Only the dose counter and dose pointer will show that 0.25 mg has been selected.

The dose selector clicks differently when turned forwards, backwards or past 0.25 mg. Do not count the pen

clicks.

Always use the dose counter and the dose pointer to see that 0.25 mg has been selected before

injecting this medicine.

Do not count the pen clicks.

0.25 mg in the dose counter must line up precisely with the dose pointer to ensure that you get a

correct dose.

4. Inject your dose

Insert the needle into your skin

as your doctor or nurse

has shown you.

Make sure you can see the dose counter.

Do not cover

it with your fingers. This could interrupt the injection.

A

Press and hold down the dose button until the dose

counter shows 0.

The 0 must line up with the dose

pointer. You may then hear or feel a click.

B

Keep the needle in your skin

after the dose counter has

returned to 0 and

count slowly to 6.

This is to make sure

that you get your full dose.

If the needle is removed earlier, you may see a stream of

solution coming from the needle tip. If so, the full dose

will not be delivered.

C

1-2-3-4-5-6

Count slowly:

Remove the needle from your skin.

If blood appears at

the injection site, press lightly. Do not rub the area.

D

You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your

dose.

Always watch the dose counter to know how many mg you inject.

Hold the dose button down

until the dose counter shows 0.

How to identify a blocked or damaged needle

If 0 does not appear in the dose counter after continuously pressing the dose button, you may

have used a blocked or damaged needle.

In this case, you have

not

received any medicine – even though the dose counter has moved

from the original dose that you have set.

How to handle a blocked needle

Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1

‘Prepare your pen with a new needle’. Make sure you select the full dose you need.

Never touch the dose counter when you inject.

This can interrupt the injection.

5. After your injection

Lead the needle tip into the outer needle cap

on a flat

surface without touching the needle or the outer needle

cap.

A

Once the needle is covered,

carefully push the outer

needle cap completely on.

Unscrew the needle

and dispose of it carefully in

accordance with local guidelines. Ask your doctor, nurse

or pharmacist about sharps disposal.

B

Put the pen cap on

your pen after each use to protect the

solution from light.

C

Always dispose of the needle after each injection

to ensure convenient injections and prevent blocked

needles. If the needle is blocked, you will

not

inject

any

medicine.

When the pen is to be disposed of, do it

without

a needle on as instructed by your doctor, nurse, pharmacist

or local authorities.

Never try to put the inner needle cap back on the needle.

You may stick yourself with the needle.

Always remove the needle from your pen immediately after each injection.

This reduces the risk of blocked needles, contamination, infection, leakage of solution and inaccurate

dosing.

Further important information

Always keep your pen and needles

out of the sight and reach of others,

especially children.

Never share

your pen or your needles with other people.

Caregivers must

be very careful when handling used needles

to prevent needle injury and cross-

infection.

Caring for your pen

Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might

not get the intended effect of this medicine.

Do not inject Ozempic which has been frozen.

If you do that, you might not get the intended effect

of this medicine.

Do not inject Ozempic which has been exposed to direct sunlight.

If you do that, you might not

get the intended effect of this medicine.

Do not expose your pen to dust, dirt or liquid.

Do not wash, soak or lubricate your pen.

If necessary, clean it with a mild detergent on a moistened

cloth.

Do not drop your pen

or knock it against hard surfaces. If you drop it or suspect a problem, attach a

new needle and check the flow before you inject.

Do not try to refill your pen.

Do not try to repair your pen

or pull it apart.

Package leaflet: Information for the patient

Ozempic 0.5 mg solution for injection in pre-filled pen

semaglutide

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

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 Ozempic is and what it is used for

What you need to know before you use Ozempic

How to use Ozempic

Possible side effects

How to store Ozempic

Contents of the pack and other information

1.

What Ozempic is and what it is used for

Ozempic contains the active substance semaglutide. It

helps your body reduce your blood sugar level

only when blood sugar is too high and can help prevent heart disease.

Ozempic is used:

on its own – if your blood sugar is not controlled well enough by diet and exercise alone, and

you cannot use metformin (another diabetes medicine) or

with other medicines for diabetes – when they are not enough to control your blood sugar levels.

These other medicines may include: oral antidiabetics (such as metformin, thiazolidinediones,

sulfonylureas) or insulin.

It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or

nurse.

2.

What you need to know before you use Ozempic

Do not use Ozempic:

if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using this medicine.

This medicine is not an insulin and should not be used if:

you have type 1 diabetes – a condition where your body does not produce any insulin

you develop diabetic ketoacidosis – a complication of diabetes with high blood sugar, breathing

difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in

the mouth.

Effects on the digestive system

During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have

diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink

plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk

to your doctor if you have any questions or concerns.

Severe and on-going stomach pain which could be due to acute pancreatitis

If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be

a sign of acute pancreatitis (inflamed pancreas).

Hypoglycaemia

Combining a sulfonylurea or an insulin with this medicine might increase the risk of getting low blood

sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels.

Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose

of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)

If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your

vision, and this may require treatment. Tell your doctor if you have diabetic eye disease or if you

experience eye problems during treatment with this medicine.

Children and adolescents

This medicine is not recommended in children and adolescents under 18 years as the safety and

efficacy in this age group have not yet been established.

Other medicines and Ozempic

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

medicines, including herbal medicines or other medicines you bought without a prescription.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the

following:

Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti-

coagulants). Frequent blood testing to determine the ability of your blood to clot may be

required.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask

your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy, as it is not known if it may affect your unborn

child. Therefore, it is recommended to use contraception while using this medicine. If you wish to

become pregnant, you should stop using this medicine at least two months in advance. If you become

pregnant when using this medicine, talk to your doctor right away, as your treatment will need to be

changed.

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.

Driving and using machines

If you use this medicine in combination with a sulphonylurea or insulin, low blood sugar

(hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using

machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for

information on increased risk of low blood sugar and section 4 for the warning signs of low blood

sugar. Talk to your doctor for further information.

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3.

How to use Ozempic

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or

nurse if you are not sure.

How much to use

The starting dose is 0.25 mg once a week for four weeks.

After four weeks your doctor will increase your dose to 0.5 mg once a week.

Your doctor may increase your dose to 1 mg once a week if your blood sugar is not controlled

well enough with a dose of 0.5 mg once a week.

Do not change your dose unless your doctor has told you to.

How Ozempic is given

Ozempic is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or

muscle.

The best places to give the injection are the front of your thighs, the front of your waist

(abdomen), or your upper arm.

Before you use the pen for the first time, your doctor or nurse will show you how to use it.

Detailed instructions for use are on the other side of this leaflet.

When to use Ozempic

You should use this medicine

once a week on the same day each week if possible.

You can give yourself the injection at any time of the day – regardless of meals.

To help you remember to inject this medicine once a week only, it is recommended to note the chosen

weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have

injected it.

If necessary you can change the day of your weekly injection of this medicine as long as it has been at

least 3 days since your last injection of it. After selecting a new dosing day, continue with once a week

dosing.

If you use more Ozempic than you should

If you use more Ozempic than you should, talk to your doctor straight away. You may get side effects

such as feeling sick (nausea).

If you forget to use Ozempic

If you forgot to inject a dose and:

it is 5 days or less since you should have used Ozempic, use it as soon as you remember. Then

inject your next dose as usual on your scheduled day.

it is more than 5 days since you should have used Ozempic, skip the missed dose. Then inject

your next dose as usual on your scheduled day.

Do not take a double dose to make up for a forgotten dose.

If you stop using Ozempic

Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar

levels may increase.

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.

Serious side effects

Common

: may affect up to 1 in 10 people

complications of diabetic eye disease (retinopathy) – you should inform your doctor if you

experience eye problems, such as changes in vision, during treatment with this medicine.

Rare:

may affect up to 1 in 1,000 people

severe allergic reactions (anaphylactic reactions). You should seek immediate medical help and

inform your doctor straight away if you get symptoms such as breathing problems, swelling of

face and throat and a fast heartbeat.

Other side effects

Very common:

may affect more than 1 in 10 people

feeling sick (nausea) – this usually goes away over time

diarrhoea – this usually goes away over time

Common:

may affect up to 1 in 10 people

being sick (vomiting)

low blood sugar (hypoglycaemia) when this medicine

is used with another antidiabetic medicine

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale

skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy

or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.

Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning

signs.

Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may

reduce your dose of these medicines before you start using this medicine.

indigestion

inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being

sick (vomiting)

reflux or heartburn – also called ‘gastro-esophageal reflux disease’ (GERD)

stomach pain

bloating of the stomach

constipation

burping

gall stones

dizziness

tiredness

weight loss

less appetite

gas (flatulence)

increase of pancreatic enzymes (such as lipase and amylase).

Uncommon:

may affect up to 1 in 100 people

change in the way food or drink tastes

fast pulse

injection site reactions – such as bruising, pain, irritation, itching and rash.

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 directly 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.

5.

How to store Ozempic

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 pen label and carton after ’EXP’.

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

Before opening:

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the cooling element. Protect from

light.

During use:

You can keep the pen for 6 weeks when stored at a temperature below 30°C or in a refrigerator

(2°C – 8°C) away from the cooling element. Do not freeze Ozempic and do not use it if it has

been frozen.

When you are not using the pen, keep the pen cap on in order to protect from light.

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.

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 Ozempic contains

The active substance is semaglutide. One ml solution for injection contains 1.34 mg

semaglutide. One pre-filled pen contains 2 mg semaglutide in 1.5 ml solution. Each dose

contains 0.5 mg of semaglutide in 0.37 ml.

The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, water for

injections, sodium hydroxide/hydrochloric acid (for pH adjustment).

What Ozempic looks like and contents of the pack

Ozempic is a clear and colourless or almost colourless solution for injection in a pre-filled pen.

Each pen contains 1.5 ml of solution, delivering 4 doses of 0.5 mg.

Ozempic 0.5 mg solution for injection is available in the following pack sizes:

1 pen and 4 disposable NovoFine Plus needles.

3 pens and 12 disposable NovoFine Plus needles.

Not all pack sizes may be marketed.

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 web site:

http://www.ema.europa.eu

Instructions on how to use Ozempic 0.5 mg solution for injection in pre-filled pen

Please read these instructions carefully

before using your

Ozempic pre-filled pen.

Do not use the pen without proper training

from your doctor

or nurse.

Start by checking your pen to

make sure that it contains

Ozempic 0.5 mg,

then look at the illustrations below to get to

know the different parts of your pen and needle.

If you are blind or have poor eyesight and cannot read the

dose counter on the pen, do not use this pen without help.

Get help from a person with good eyesight who is trained to use

the Ozempic pre-filled pen.

Your pen is a pre-filled dial-a-dose pen. It contains 2 mg of

semaglutide, and you can only select doses of 0.5 mg. Your pen

is designed to be used with NovoFine and NovoTwist

disposable needles up to a length of 8 mm.

NovoFine Plus needles are included in the pack.

Ozempic pre-filled pen and

needle (example)

Pen cap

Outer

needle cap

Inner

needle cap

Needle

Paper tab

Pen window

Pen label

Dose counter

Dose pointer

Dose selector

Dose button

Flow

check

symbol

1. Prepare your pen with a new needle

Check the name and coloured label

of your pen, to

make sure that it contains Ozempic. This is especially

important if you take more than one type of injectable

medicine. Using the wrong medicine could cause severe

harm to your health.

Pull off the pen cap.

A

Check that the solution in your pen is clear

colourless. Look through the pen window. If the solution

looks cloudy or coloured, do not use the pen.

B

Take a new needle

and tear off the paper tab.

If the paper tab is broken, do not use the needle, as

sterility is not guaranteed.

C

Push the needle straight onto the pen. Turn until it is

on tight.

D

Pull off the outer needle cap and keep it for later.

will need it after the injection, to safely remove the

needle from the pen.

E

Pull off the inner needle cap and throw it away.

If you

try to put it back on, you may accidentally stick yourself

with the needle.

A drop of solution may appear at the needle tip. This is normal,

but you must still check the flow, if you use a new pen for the

first time. See step 2 ‘Check the flow’.

Do not attach a new needle

to your pen until you are ready to

take your injection.

F

Always use a new needle for each injection.

This reduces the risk of blocked needles, contamination, infection and inaccurate dosing.

Never use a bent or damaged needle.

2. Check the flow

Before your first injection with each new pen, check

the flow.

If your pen is already in use, go to step 3

‘Select your dose’.

Turn the dose selector

until the dose counter shows the

flow check symbol

A

Flow check

symbol

selected

Hold the pen with the needle pointing up.

Press and hold in the dose button

until the dose counter

returns to 0. The 0 must line up with the dose pointer.

A drop of solution should appear at the needle tip.

B

A small drop may remain at the needle tip, but it will not be injected.

If no drop appears,

repeat step 2 ‘Check the flow’ up to 6 times. If there is still no drop, change the needle

and repeat step 2 ‘Check the flow’ once more.

If a drop still does not appear,

dispose of the pen and use a new one.

Always make sure that a drop appears

at the needle tip before you use a new pen for the first time.

This makes sure that the solution flows.

If no drop appears, you will

not

inject any medicine even though the dose counter may move.

This

may indicate a blocked or damaged needle.

If you do not check the flow before your first injection with each new pen, you may not get the

prescribed dose and the intended effect of Ozempic.

3. Select your dose

Turn the dose selector to select 0.5 mg.

Keep turning until the dose counter stops and shows

0.5 mg.

0.5 mg

selected

A

Only the dose counter and dose pointer will show that 0.5 mg has been selected.

The dose selector clicks differently when turned forwards, backwards or past 0.5 mg. Do not count the pen

clicks.

Always use the dose counter and the dose pointer to see that 0.5 mg has been selected before

injecting this medicine.

Do not count the pen clicks.

0.5 mg in the dose counter must line up precisely with the dose pointer to ensure that you get a

correct dose.

How much solution is left

To see how much solution is left

, use the dose counter:

Turn the dose selector until the

dose counter stops.

If it

shows 0.5,

at least 0.5 mg

is left in your pen.

If the

dose counter stops before 0.5 mg,

there is not

enough solution left for a full dose of 0.5 mg.

A

Dose counter

stopped:

0.5 mg left

If there is not enough solution left in your pen for a full dose, do not use it. Use a new Ozempic® pen.

4. Inject your dose

Insert the needle into your skin

as your doctor or nurse

has shown you.

Make sure you can see the dose counter.

Do not cover

it with your fingers. This could interrupt the injection.

A

Press and hold down the dose button until the dose

counter shows 0.

The 0 must line up with the dose

pointer. You may then hear or feel a click.

B

Keep the needle in your skin

after the dose counter has

returned to 0 and

count slowly to 6.

This is to make sure

that you get your full dose.

If the needle is removed earlier, you may see a stream of

solution coming from the needle tip. If so, the full dose

will not be delivered.

C

1-2-3-4-5-6

Count slowly:

Remove the needle from your skin.

If blood appears at

the injection site, press lightly. Do not rub the area.

D

You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your

dose.

Always watch the dose counter to know how many mg you inject.

Hold the dose button down

until the dose counter shows 0.

How to identify a blocked or damaged needle

If 0 does not appear in the dose counter after continuously pressing the dose button, you may

have used a blocked or damaged needle.

In this case, you have

not

received any medicine – even though the dose counter has moved

from the original dose that you have set.

How to handle a blocked needle

Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1

‘Prepare your pen with a new needle’. Make sure you select the full dose you need.

Never touch the dose counter when you inject.

This can interrupt the injection.

5. After your injection

Lead the needle tip into the outer needle cap

on a flat

surface without touching the needle or the outer needle

cap.

A

Once the needle is covered,

carefully push the outer

needle cap completely on.

Unscrew the needle

and dispose of it carefully in

accordance with local guidelines. Ask your doctor, nurse

or pharmacist about sharps disposal.

B

Put the pen cap on

your pen after each use to protect the

solution from light.

C

Always dispose of the needle after each injection

to ensure convenient injections and prevent blocked

needles. If the needle is blocked, you will

not

inject

any

medicine.

When the pen is empty, throw it away

without

a needle on as instructed by your doctor, nurse, pharmacist

or local authorities.

Never try to put the inner needle cap back on the needle.

You may stick yourself with the needle.

Always remove the needle from your pen immediately after each injection.

This reduces the risk of blocked needles, contamination, infection, leakage of solution and inaccurate

dosing.

Further important information

Always keep your pen and needles

out of the sight and reach of others,

especially children.

Never share

your pen or your needles with other people.

Caregivers must

be very careful when handling used needles

to prevent needle injury and cross-

infection.

Caring for your pen

Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might

not get the intended effect of this medicine.

Do not inject Ozempic which has been frozen.

If you do that, you might not get the intended effect

of this medicine.

Do not inject Ozempic which has been exposed to direct sunlight.

If you do that, you might not

get the intended effect of this medicine.

Do not expose your pen to dust, dirt or liquid.

Do not wash, soak or lubricate your pen.

If necessary, clean it with a mild detergent on a moistened

cloth.

Do not drop your pen

or knock it against hard surfaces. If you drop it or suspect a problem, attach a

new needle and check the flow before you inject.

Do not try to refill your pen.

Once empty, it must be disposed of.

Do not try to repair your pen

or pull it apart.

Package leaflet: Information for the patient

Ozempic 1 mg solution for injection in pre-filled pen

semaglutide

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

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 Ozempic is and what it is used for

What you need to know before you use Ozempic

How to use Ozempic

Possible side effects

How to store Ozempic

Contents of the pack and other information

1.

What Ozempic is and what it is used for

Ozempic contains the active substance semaglutide. It

helps your body reduce your blood sugar level

only when blood sugar is too high and can help prevent heart disease.

Ozempic is used:

on its own – if your blood sugar is not controlled well enough by diet and exercise alone, and

you cannot use metformin (another diabetes medicine) or

with other medicines for diabetes – when they are not enough to control your blood sugar levels.

These other medicines may include: oral antidiabetics (such as metformin, thiazolidinediones,

sulfonylureas) or insulin.

It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or

nurse.

2.

What you need to know before you use Ozempic

Do not use Ozempic:

if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using this medicine.

This medicine is not an insulin and should not be used if:

you have type 1 diabetes – a condition where your body does not produce any insulin

you develop diabetic ketoacidosis – a complication of diabetes with high blood sugar, breathing

difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in

the mouth.

Effects on the digestive system

During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have

diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink

plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk

to your doctor if you have any questions or concerns.

Severe and on-going stomach pain which could be due to acute pancreatitis

If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be

a sign of acute pancreatitis (inflamed pancreas).

Hypoglycaemia

Combining a sulfonylurea or an insulin with this medicine might increase the risk of getting low blood

sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels.

Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose

of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar.

Diabetic eye disease (retinopathy)

If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your

vision, and this may require treatment. Tell your doctor if you have diabetic eye disease or if you

experience eye problems during treatment with this medicine.

Children and adolescents

This medicine is not recommended in children and adolescents under 18 years as the safety and

efficacy in this age group have not yet been established.

Other medicines and Ozempic

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

medicines, including herbal medicines or other medicines you bought without a prescription.

In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the

following:

Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti-

coagulants). Frequent blood testing to determine the ability of your blood to clot may be

required.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask

your doctor for advice before taking this medicine.

This medicine should not be used during pregnancy, as it is not known if it may affect your unborn

child. Therefore, it is recommended to use contraception while using this medicine. If you wish to

become pregnant, you should stop using this medicine at least two months in advance. If you become

pregnant when using this medicine, talk to your doctor right away, as your treatment will need to be

changed.

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.

Driving and using machines

If you use this medicine in combination with a sulphonylurea or insulin, low blood sugar

(hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using

machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for

information on increased risk of low blood sugar and section 4 for the warning signs of low blood

sugar. Talk to your doctor for further information.

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3.

How to use Ozempic

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or

nurse if you are not sure.

How much to use

The starting dose is 0.25 mg once a week for four weeks.

After four weeks your doctor will increase your dose to 0.5 mg once a week.

Your doctor may increase your dose to 1 mg once a week if your blood sugar is not controlled

well enough with a dose of 0.5 mg once a week.

Do not change your dose unless your doctor has told you to.

How Ozempic is given

Ozempic is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or

muscle.

The best places to give the injection are the front of your thighs, the front of your waist

(abdomen), or your upper arm.

Before you use the pen for the first time, your doctor or nurse will show you how to use it.

Detailed instructions for use are on the other side of this leaflet.

When to use Ozempic

You should use this medicine

once a week on the same day each week if possible.

You can give yourself the injection at any time of the day – regardless of meals.

To help you remember to inject this medicine once a week only, it is recommended to note the chosen

weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have

injected it.

If necessary you can change the day of your weekly injection of this medicine as long as it has been at

least 3 days since your last injection of it. After selecting a new dosing day, continue with once a week

dosing.

If you use more Ozempic than you should

If you use more Ozempic than you should, talk to your doctor straight away. You may get side effects

such as feeling sick (nausea).

If you forget to use Ozempic

If you forgot to inject a dose and:

it is 5 days or less since you should have used Ozempic, use it as soon as you remember. Then

inject your next dose as usual on your scheduled day.

it is more than 5 days since you should have used Ozempic, skip the missed dose. Then inject

your next dose as usual on your scheduled day.

Do not take a double dose to make up for a forgotten dose.

If you stop using Ozempic

Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar

levels may increase.

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.

Serious side effects

Common:

may affect up to 1 in 10 people

complications of diabetic eye disease (retinopathy) – you should inform your doctor if you

experience eye problems, such as changes in vision, during treatment with this medicine.

Rare:

may affect up to 1 in 1,000 people

severe allergic reactions (anaphylactic reactions). You should seek immediate medical help and

inform your doctor straight away if you get symptoms such as breathing problems, swelling of

face and throat and a fast heartbeat.

Other side effects

Very common:

may affect more than 1 in 10 people

feeling sick (nausea) – this usually goes away over time

diarrhoea – this usually goes away over time

Common:

may affect up to 1 in 10 people

being sick (vomiting)

low blood sugar (hypoglycaemia) when this medicine

is used with another antidiabetic medicine

The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale

skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy

or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.

Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning

signs.

Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may

reduce your dose of these medicines before you start using this medicine.

indigestion

inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being

sick (vomiting)

reflux or heartburn – also called ‘gastro-esophageal reflux disease’ (GERD)

stomach pain

bloating of the stomach

constipation

burping

gall stones

dizziness

tiredness

weight loss

less appetite

gas (flatulence)

increase of pancreatic enzymes (such as lipase and amylase).

Uncommon:

may affect up to 1 in 100 people

change in the way food or drink tastes

fast pulse

injection site reactions – such as bruising, pain, irritation, itching and rash.

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 directly 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.

5.

How to store Ozempic

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 pen label and carton after ’EXP’.

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

Before opening:

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the cooling element. Protect from

light.

During use:

You can keep the pen for 6 weeks when stored at a temperature below 30°C or in a refrigerator

(2°C – 8°C) away from the cooling element. Do not freeze Ozempic and do not use it if it has

been frozen.

When you are not using the pen, keep the pen cap on in order to protect from light.

Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless.

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 Ozempic contains

The active substance is semaglutide.

One ml solution for injection contains 1.34 mg

semaglutide. One pre-filled pen contains 4 mg semaglutide in 3 ml solution. Each dose contains

1 mg of semaglutide in 0.74 ml.

The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, water for

injections, sodium hydroxide/hydrochloric acid (for pH adjustment).

What Ozempic looks like and contents of the pack

Ozempic is a clear and colourless or almost colourless solution for injection in a pre-filled pen.

Each pen contains 3 ml solution, delivering 4 doses of 1 mg.

Ozempic 1 mg solution for injection is available in the following pack sizes:

1 pen and 4 disposable NovoFine Plus needles.

3 pens and 12 disposable NovoFine Plus needles.

Not all pack sizes may be marketed.

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 web site:

http://www.ema.europa.eu

Instructions on how to use Ozempic 1 mg solution for injection in pre-filled pen

Please read these instructions carefully

before using your

Ozempic pre-filled pen.

Do not use the pen without proper training

from your doctor

or nurse.

Start by checking your pen to

make sure that it contains

Ozempic 1 mg,

then look at the illustrations below to get to

know the different parts of your pen and needle.

If you are blind or have poor eyesight and cannot read the

dose counter on the pen, do not use this pen without help.

Get help from a person with good eyesight who is trained to use

the Ozempic pre-filled pen.

Your pen is a pre-filled dial-a-dose pen. It contains 4 mg of

semaglutide, and you can only select doses of 1 mg. Your pen is

designed to be used with NovoFine and NovoTwist disposable

needles up to a length of 8 mm.

NovoFine Plus needles are included in the pack.

Ozempic pre-filled pen and

needle (example)

Pen cap

Outer

needle cap

Inner

needle cap

Needle

Paper tab

Pen window

Pen label

Dose counter

Dose pointer

Dose selector

Dose button

Flow

check

symbol

1. Prepare your pen with a new needle

Check the name and coloured label

of your pen, to

make sure that it contains Ozempic. This is especially

important if you take more than one type of injectable

medicine. Using the wrong medicine could cause severe

harm to your health.

Pull off the pen cap.

A

Check that the solution in your pen is clear

colourless. Look through the pen window. If the solution

looks cloudy or coloured, do not use the pen.

B

Take a new needle

and tear off the paper tab.

If the paper tab is broken, do not use the needle, as

sterility is not guaranteed.

C

Push the needle straight onto the pen. Turn until it is

on tight.

D

Pull off the outer needle cap and keep it for later.

will need it after the injection, to safely remove the needle

from the pen.

E

Pull off the inner needle cap and throw it away.

If you

try to put it back on, you may accidentally stick yourself

with the needle.

A drop of solution may appear at the needle tip. This is normal,

but you must still check the flow, if you use a new pen for the

first time. See step 2 ‘Check the flow’.

Do not attach a new needle

to your pen until you are ready to

take your injection.

F

Always use a new needle for each injection.

This reduces the risk of blocked needles, contamination, infection and inaccurate dosing.

Never use a bent or damaged needle.

2. Check the flow

Before your first injection with each new pen, check

the flow.

If your pen is already in use, go to step 3 ‘Select

your dose’.

Turn the dose selector

until the dose counter shows the

flow check symbol

A

Flow check

symbol

selected

Hold the pen with the needle pointing up.

Press and hold in the dose button

until the dose counter

returns to 0. The 0 must line up with the dose pointer.

A drop of solution should appear at the needle tip.

B

A small drop may remain at the needle tip, but it will not be injected.

If no drop appears,

repeat step 2 ‘Check the flow’ up to 6 times. If there is still no drop, change the needle

and repeat step 2 ‘Check the flow’ once more.

If a drop still does not appear,

dispose of the pen and use a new one.

Always make sure that a drop appears

at the needle tip before you use a new pen for the first time.

This makes sure that the solution flows.

If no drop appears, you will

not

inject any medicine even though the dose counter may move.

This

may indicate a blocked or damaged needle.

If you do not check the flow before your first injection with each new pen, you may not get the

prescribed dose and the intended effect of Ozempic.

3. Select your dose

Turn the dose selector to select 1 mg.

Keep turning until the dose counter stops and shows 1 mg.

1 mg

selected

A

Only the dose counter and dose pointer will show that 1 mg has been selected.

The dose selector clicks differently when turned forwards, backwards or past 1 mg. Do not count the pen

clicks.

Always use the dose counter and the dose pointer to see that 1

mg has been selected before

injecting this medicine.

Do not count the pen clicks.

mg in the dose counter must line up precisely with the dose pointer to ensure that you get a correct

dose.

How much solution is left

To see how much solution is left,

use the dose counter:

Turn the dose selector until the

dose counter stops.

If it shows 1,

at least 1

mg

is left in your pen.

If the

dose counter stops before 1

mg,

there is not

enough solution left for a full dose of 1 mg.

A

Dose counter

stopped:

1 mg left

If there is not enough solution left in your pen for a full dose, do not use it. Use a new Ozempic pen.

4. Inject your dose

Insert the needle into your skin

as your doctor or nurse

has shown you.

Make sure you can see the dose counter.

Do not cover it

with your fingers. This could interrupt the injection.

A

Press and hold down the dose button until the dose

counter shows

0.

The 0 must line up with the dose

pointer. You may then hear or feel a click.

B

Keep the needle in your skin

after the dose counter has

returned to 0 and

count slowly to

6.

This is to make sure

that you get your full dose.

If the needle is removed earlier, you may see a stream of

solution coming from the needle tip. If so, the full dose

will not be delivered.

C

1-2-3-4-5-6

Count slowly:

Remove the needle from your skin.

If blood appears at

the injection site, press lightly. Do not rub the area.

D

You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your

dose.

Always watch the dose counter to know how many mg you inject.

Hold the dose button down

until the dose counter shows 0.

How to identify a blocked or damaged needle

If 0 does not appear in the dose counter after continuously pressing the dose button, you may

have used a blocked or damaged needle.

In this case, you have

not

received any

medicine – even though the dose counter has moved

from the original dose that you have set.

How to handle a blocked needle

Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1

‘Prepare your pen with a new needle’. Make sure you select the full dose you need.

Never touch the dose counter when you inject.

This can interrupt the injection.

5. After your injection

Lead the needle tip into the outer needle cap

on a flat

surface without touching the needle or the outer needle

cap.

A

Once the needle is covered,

carefully push the outer

needle cap completely on.

Unscrew the needle

and dispose of it carefully in

accordance with local guidelines. Ask your doctor, nurse

or pharmacist about sharps disposal.

B

Put the pen cap on

your pen after each use to protect the

solution from light.

C

Always dispose of the needle after each injection

to ensure convenient injections and prevent blocked

needles. If the needle is blocked, you will

not

inject

any

medicine.

When the pen is empty, throw it away

without

a needle on as instructed by your doctor, nurse, pharmacist

or local authorities.

Never try to put the inner needle cap back on the needle.

You may stick yourself with the needle.

Always remove the needle from your pen immediately after each injection.

This reduces the risk of blocked needles, contamination, infection, leakage of solution and inaccurate

dosing.

Further important information

Always keep your pen and needles

out of the sight and reach of others,

especially children.

Never share

your pen or your needles with other people.

Caregivers must

be very careful when handling used needles

to prevent needle injury and cross-

infection.

Caring for your pen

Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might

not get the intended effect of this medicine.

Do not inject Ozempic which has been frozen.

If you do that, you might not get the intended effect

of this medicine.

Do not inject Ozempic which has been exposed to direct sunlight.

If you do that, you might not

get the intended effect of this medicine.

Do not expose your pen to dust, dirt or liquid.

Do not wash, soak or lubricate your pen.

If necessary, clean it with a mild detergent on a moistened

cloth.

Do not drop your pen

or knock it against hard surfaces. If you drop it or suspect a problem, attach a

new needle and check the flow before you inject.

Do not try to refill your pen.

Once empty, it must be disposed of.

Do not try to repair your pen

or pull it apart.