Innovace 2.5mg tablets

Main information

  • Trade name:
  • Innovace 2.5mg tablets
  • Dosage:
  • 2.5mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Innovace 2.5mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02050501; GTIN: 5013945194005

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 00025/0220; PL 00025/0194; PL 00025/0195; PL 00025/0196; PL 00025/0220; PL 00025/0194; PL 00025/0195; PL 00025/0196
  • Last update:
  • 29-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Package leaflet: Information for the user

Innovace® 2.5 mg, 5 mg, 10 mg or 20 mg tablets

enalapril maleate

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

contains important information for you.

-

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

-

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

-

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 or pharmacist. This includes any

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

What is in this leaflet

What Innovace is and what it is used for

What you need to know before you take Innovace

How to take Innovace

Possible side effects

How to store Innovace

Contents of the pack and other information

1.

What Innovace is and what it is used for

Innovace contains an active substance called enalapril maleate. This belongs to the

group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).

Innovace is used:

to treat high blood pressure (hypertension)

to treat heart failure (weakening of heart function). It can lower the need to go

to hospital and can help some patients live longer

to prevent the signs of heart failure. The signs include: shortness of breath,

tiredness after light physical activity such as walking, or swelling of the ankles

and feet.

This medicine works by

widening

your blood vessels. This lowers your blood

pressure. The medicine usually starts to work within an hour, and the effect lasts for at

least 24 hours. Some people will require several weeks of treatment until the best

effect on your blood pressure is seen.

2.

What you need to know before you take Innovace

Do not take Innovace

if you are allergic to enalapril maleate or any of the other ingredients of this

medicine (listed in section 6)

if you have ever had an allergic reaction to a type of medicine similar to this

medicine called an ACE inhibitor

if you have ever had swelling of your face, lips, mouth, tongue or throat which

caused difficulty in swallowing or breathing (angioedema) when the reason

why was not known or it was inherited

if you have diabetes or impaired kidney function and you are treated with a

blood pressure lowering medicine containing aliskiren

if you are more than 3 months pregnant. (It is also better to avoid Innovace in

early pregnancy – see Pregnancy section).

Do not take this medicine if any of the above apply to you. If you are not sure, talk

your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Innovace:

if you have a heart problem

if you have a condition involving the blood vessels in the brain

if you have a blood problem such as low or lack of white blood cells

(neutropenia/agranulocytosis), low blood platelet count (thrombocytopenia) or

a decreased number of red blood cells (anaemia)

if you have a liver problem

if you have a kidney problem (including kidney transplantation). These may

lead to higher levels of potassium in your blood which can be serious. Your

doctor may need to adjust your dose of Innovace or monitor your blood level

of potassium

if you are having dialysis

if you have been very sick (excessive vomiting) or had bad diarrhoea recently

salt-restricted

diet,

taking

potassium

supplements,

potassium-sparing agents, or potassium-containing salt substitutes

if you are over 70 years of age

if you have diabetes. You should monitor your blood for low blood glucose

levels, especially during the first month of treatment. The level of potassium in

your blood can also be higher

if you have ever had an allergic reaction with swelling of the face, lips, tongue

or throat with difficulty in swallowing or breathing. You should be aware that

black

patients

increased

risk

these

types

reactions

inhibitors

if you have low blood pressure (you may notice this as faintness or dizziness,

especially when standing)

if you have collagen vascular disease (e.g., lupus erythematosus, rheumatoid

arthritis or scleroderma), are on therapy that suppresses your immune system,

are taking the drugs allopurinol or procainamide, or any combinations of these

if you are taking an mTOR inhibitor (e.g., temsirolimus, sirolimus,

everolimus: medicines used to treat certain types of cancer or to prevent the

body’s immune system from rejecting a transplanted organ). You may be at

increased risk for an allergic reaction called angioedema

if you are taking any of the following medicines used to treat high blood

pressure:

- an angiotensin II receptor blocker (ARB) (also known as sartans - for

example valsartan, telmisartan, irbesartan, etc.), in particular if you have

diabetes-related kidney problems.

- aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of

electrolytes (e.g., potassium) in your blood at regular intervals.

See also information under the heading “Do not take Innovace.”

You must tell your doctor if you think you are (or might become) pregnant. This

medicine is not recommended in early pregnancy, and must not be taken if you are

more than 3 months pregnant, as it may cause serious harm to your baby if used at

that stage (see Pregnancy section).

You should be aware that this medicine lowers the blood pressure in black patients

less effectively than in non-black patients.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist

before taking this medicine.

If you are about to have a procedure

If you are about to have any of the following, tell your doctor that you are taking

Innovace:

any surgery or receive anaesthetics (even at the dentist).

a treatment to remove cholesterol from your blood called ‘LDL apheresis’.

a desensitisation treatment, to lower the effect of an allergy to bee or wasp

stings.

If any of the above applies to you, talk to your doctor or dentist before the procedure.

Other medicines and Innovace

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

other medicines. This includes herbal medicines. This is because Innovace can affect

the way some medicines work. Also some other medicines can affect the way

Innovace works. Your doctor may need to change your dose and/or to take other

precautions.

In particular tell your doctor or pharmacist if you are taking any of the following

medicines:

an angiotensin II receptor blocker (ARB) or aliskiren (see also information

under the headings “Do not take Innovace” and “Warnings and precautions”)

other medicines to lower blood pressure, such as beta-blockers or water tablets

(diuretics)

medicines containing potassium (including dietary salt substitutes)

medicines for diabetes (including oral antidiabetic medicines and insulin)

lithium (a medicine used to treat a certain kind of depression)

medicines for depression called ‘tricyclic antidepressants’

medicines for mental problems called ‘antipsychotics’

certain cough and cold medicines and weight reducing medicines which contain

something called a ‘sympathomimetic agent’

certain pain or arthritis medicines including gold therapy

an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus; medicines used

to treat certain types of cancer or to prevent the body’s immune system from

rejecting a transplanted organ). See also information under the heading

“Warnings and precautions”

non-steroidal anti-inflammatory drugs, including COX-2-inhibitors (medicines

that reduce inflammation, and can be used to help relieve pain)

aspirin (acetylsalicylic acid)

medicines used to dissolve blood clots (thrombolytics)

alcohol.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist

before taking Innovace.

Innovace with food and drink

Innovace can be taken with or without food. Most people take Innovace with a drink

of water.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to

have a baby, ask your doctor for advice before taking this medicine. Your doctor will

normally advise you to stop taking Innovace before you become pregnant or as soon as

you know you are pregnant and will advise you to take another medicine instead of

Innovace. This medicine is not recommended in early pregnancy, and must not be taken

when more than 3 months pregnant, as it may cause serious harm to your baby if used

after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-

feeding newborn babies (first few weeks after birth), and especially premature babies,

is not recommended whilst taking this medicine. In the case of an older baby your

doctor should advise you on the benefits and risks of taking this medicine whilst

breast-feeding, compared to other treatments.

Driving and using machines

You may feel dizzy or sleepy while taking this medicine. If this happens, do not drive

or use any tools or machines.

Innovace contains lactose

Innovace contains lactose, which is a type of sugar. If you have been told by your

doctor that you have intolerance to some sugars, talk to your doctor before taking this

medicine.

3.

How to take Innovace

Always take this medicine exactly as your doctor or pharmacist has told you. Check

with your doctor or pharmacist if you are not sure.

It is very important to continue taking this medicine for as long as your doctor

prescribes it.

Do not take more tablets than prescribed.

The score line is only there to help you break the tablet if you have difficulty

swallowing it whole.

High Blood Pressure

The usual starting dose ranges from 5 to 20 mg taken once a day.

Some patients may need a lower starting dose.

The usual long term dose is 20 mg taken once a day.

The maximal long term dose is 40 mg taken once a day.

Heart Failure

The usual starting dose is 2.5 mg taken once a day.

Your doctor will raise this amount step by step until the dose that is right for

you has been achieved.

The usual long term dose is 20 mg each day, taken in one or two doses.

The maximal long term dose is 40 mg each day, divided in two doses.

Patients with kidney problems

Your dose of medicine will be changed depending on how well your kidneys are

working:

moderate kidney problems - 5 mg to 10 mg each day

severe kidney problems - 2.5 mg each day

if you are having dialysis - 2.5 mg each day. On days you are not having

dialysis, your dose may be changed depending on how low your blood pressure

Elderly patients

Your dose will be decided by your doctor and will be based on how well your kidneys

are working.

Use in children

Experience in the use of Innovace in children with high blood pressure is limited. If

the child can swallow tablets, the dose will be worked out using the child’s weight

and blood pressure. The usual starting doses are:

between 20 kg and 50 kg – 2.5 mg each day

more than 50 kg – 5 mg each day.

The dose can be changed according to the needs of the child:

a maximum of 20 mg daily can be used in children who are between 20 kg and

50 kg

a maximum of 40 mg daily can be used in children who are more than 50 kg.

This medicine is not recommended in newborn babies (first few weeks after birth) and

in children with kidney problems.

If you take more Innovace than you should

If you take more Innovace than you should, talk to your doctor or go to a hospital

straight away. Take the medicine pack with you. The following effects may happen:

feeling of light-headedness or dizziness. This is due to a sudden or excessive drop in

blood pressure.

If you forget to take Innovace

If you forget to take a tablet, skip the missed dose.

Take the next dose as usual.

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

If you stop taking Innovace

Do not stop taking your medicine unless your doctor tells you to.

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

pharmacist.

4.

Possible side effects

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

them. The following side effects may happen with this medicine:

Stop taking Innovace and talk to a doctor straight away, if you notice any of the

following:

swelling of your face, lips, tongue or throat which may cause difficulty in

breathing or swallowing

swelling of your hands, feet or ankles

if you develop a raised red skin rash (hives).

You should be aware that black patients are at increased risk of these types of

reactions. If any of the above happen, stop taking Innovace and talk to a doctor

straight away.

When you start taking this medicine you may feel faint or dizzy. If this happens, it

will help to lie down. This is caused by your blood pressure lowering. It should

improve as you continue to take the medicine. If you are worried, please talk to your

doctor.

Other side effects include:

Very Common

(may affect more than 1 in 10 people)

feeling dizzy, weak or sick

blurred vision

cough.

Common

(may affect up to 1 in 10 people)

light-headedness due to low blood pressure, changes in heart rhythm, fast

heartbeat, angina or chest pain

headache, depression, fainting (syncope), change in sense of taste

shortness of breath

diarrhoea, abdominal pain

tiredness (fatigue)

rash, allergic reactions with swelling of the face, lips, tongue or throat with

difficulty in swallowing or breathing

high levels of potassium in the blood, increased levels of creatinine in your

blood (both are usually detected by a test).

Uncommon

(may affect up to 1 in 100 people)

flushing

sudden fall in blood pressure

fast or uneven heart beats (palpitations)

heart attack (possibly due to very low blood pressure in certain high-risk

patients, including those with blood flow problems of the heart or brain)

stroke (possibly due to very low blood pressure in high-risk patients)

anaemia (including aplastic and haemolytic)

confusion, sleeplessness or sleepiness, nervousness

feeling your skin prickling or being numb

vertigo (spinning sensation)

ringing in your ears (tinnitus)

runny nose, sore throat or hoarseness

asthma-associated tightness in chest

slow movement of food through your intestine (ileus), inflammation of your

pancreas

being sick (vomiting), indigestion, constipation, anorexia

irritated stomach (gastric irritations), dry mouth, ulcer

muscle cramps

impaired kidney function, kidney failure

increased sweating

itching or nettle rash

hair loss

generally feeling unwell (malaise), high temperature (fever)

impotence

high level of proteins in your urine (measured in a test)

low level of blood sugar or sodium, high level of blood urea (all measured in a

blood test).

Rare

(may affect up to 1 in 1,000 people)

‘Raynaud’s phenomenon’ where your hands and feet may become very cold and

white due to low blood flow

changes in blood values such as a lower number of white and red blood cells,

lower haemoglobin, lower number of blood platelets

bone marrow depression

swollen glands in neck, armpit or groin

autoimmune diseases

strange dreams or sleep problems

accumulation of fluid or other substances in the lungs (as seen on X-rays)

inflammation of your nose

inflammation of the lungs causing difficulty breathing (pneumonia)

inflammation of the cheeks, gums, tongue, lips, throat

reduced amount of urine

rash that looks like targets (erythema multiforme)

‘Stevens-Johnson syndrome’ and ‘toxic epidermal necrolysis’ (serious skin

conditions where you have reddening and scaling of your skin, blistering or raw

sores), exfoliative dermatitis/erythroderma (severe skin rash with flaking or

peeling of the skin), pemphigus (small fluid-filled bumps on the skin)

liver or gallbladder problems such as lower liver function, inflammation of your

liver, jaundice (yellowing of the skin or eyes), high levels of liver enzymes or

bilirubin (measured in a blood test)

enlargement of breasts in males (gynaecomastia).

Very Rare

(may affect up to 1 in 10,000 people)

swelling in your intestine (intestinal angioedema).

Not known

(frequency cannot be estimated from the available data)

overproduction of antidiuretic hormone, which causes fluid retention, resulting

in weakness, tiredness or confusion

A symptom complex has been reported which may include some or all of the

following: fever, inflammation of the blood vessels (serositis/vasculitis), muscle

pain (myalgia/myositis), joint pain (arthralgia/arthritis). Rash, photosensitivity

or other skin manifestations may occur.

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

(see details below). By reporting side effects you can help provide more information

on the safety of this medicine.

United Kingdom:

Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search

for MHRA Yellow Card in the Google Play or Apple App Store

Ireland:

HPRA

Pharmacovigilance,

Earlsfort

Terrace,

Dublin

Tel:

+353 1 6764971; Fax:

+353

6762517.

Website:

www.hpra.ie;

e-mail:

medsafety@hpra.ie.

5.

How to store Innovace

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 blister and the

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

Do not store above 25°C. Store in the original package in order to protect from

moisture.

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 Innovace contains

The active substance is enalapril maleate (either 2.5 mg, 5 mg, 10 mg, or 20

mg).

The other ingredients are lactose monohydrate, sodium hydrogen carbonate,

maize starch, pregelatinised starch, magnesium stearate. The 10 mg tablet also

contains iron oxide red (E172) and the 20 mg tablet also contains iron oxide red

(E172) and iron oxide yellow (E172).

What Innovace looks like and contents of the pack

Innovace tablets are available in 4 strengths.

The white round shaped tablet, one side marked ‘MSD 14’, the other side plain,

contain 2.5 mg of enalapril maleate.

The white, rounded triangle shaped tablet, one side scored* and the other side marked

‘MSD 712’ contain 5 mg enalapril maleate.

The rust-red, rounded triangle shaped tablet, one side scored*, the other side marked

‘MSD 713’ contain 10 mg enalapril maleate.

The peach, rounded triangle shaped tablet, one side scored*, the other marked ‘MSD

714’ contain 20 mg enalapril maleate.

*The scoreline is only to facilitate breaking for ease of swallowing and not to divide

into equal doses.

Innovace is supplied in the following pack sizes:

Innovace 2.5 mg – All-aluminium blister packages containing 2, 11, 20, 28, 30, 40, 49

x 1, 50, or 100 tablets.

Innovace 5 mg - All-aluminium blister packages containing 2, 14, 20, 28, 28 x 1, 30,

49 x 1, 50, 60, 98, or 100 tablets.

Innovace 10 mg - All-aluminium blister packages containing 28, 49 x 1, 30, 50, 98 or

100 tablets.

Innovace 20 mg - All-aluminium blister packages containing 10, 14, 20, 28, 28 x 1,

30, 49 x 1, 50, 56, 60, 84, 90, 98, 100 or 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The holder of the Marketing Authorisation is:

MAH (UK)

Merck Sharp & Dohme Limited,

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK

MAH (Ireland)

Merck Sharp & Dohme Ireland (Human Health) Limited,

Red Oak North, South County Business Park, Leopardstown,

Dublin 18, Ireland

The product is manufactured by Merck Manufacturing Division, Merck Sharp &

Dohme Limited, Shotton Lane, Cramlington, Northumberland NE23 3JU, UK.

This medicinal product is authorised in the Member States of the EEA under the

following names:

Austria,

Belgium,

Finland,

France,

Greece,

Luxembourg,

Netherlands,

Portugal,

Spain, Sweden:

RENITEC

Germany:

XANEF

Italy:

ENAPREN

UK, Ireland:

INNOVACE

This leaflet was last revised in October 2017.

© Merck Sharp & Dohme Limited, 2017. All rights reserved.

PIL.RNT.17.UK.6140.IB-039-G