ENALAPRIL MALEATE 10MG TABLETS

Active substance: ENALAPRIL MALEATE

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Innovace® 5mg Tablets /
Enalapril Maleate 5mg Tablets
Innovace® 10mg Tablets /
Enalapril Maleate 10mg Tablets

2156/2157
13.03.14[8]

(enalapril maleate)
PATIENT INFORMATION LEAFLET
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 any 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.
The product is available using one of the above names but will be
referred to as Innovace throughout this leaflet.
Innovace tablets are also available in other strengths.
What is in this leaflet:
1. What Innovace is and what it is used for
2. What you need to know before you take Innovace
3. How to take Innovace
4. Possible side effects
5. How to store Innovace
6. 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.
Innovace 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
(angiooedema) when the reason why was not known or it was
inherited.
- if you have diabetes or kidney problems and are taking a medicine
containing aliskiren to reduce blood pressure
- 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 to your doctor or pharmacist before taking this medicine.
Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine
- 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.
- if you are on a salt-restricted diet, are 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 are at increased risk of these types of
reactions to ACE 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 erthematosus,
rheumatoid arthritis or scleroderma), are on therapy that suppresses
your immune system, are taking the drugs allopurinol or procainamide,
or any combinations of these.
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:
In particular tell your doctor or pharmacist if you are taking any of the following
medicines:
- other medicines to lower blood pressure, such as beta-blockers,
angiotensin-receptor-blockers, water tablets (diuretics), or a medicine called
aliskiren.
- 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.
- 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.
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 is.
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-headed 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)
- low blood pressure, changes in heart rhythm, fast heartbeat, angina or
chest pain.
- headache, fainting (syncope).
- change in sense of taste, shortness of breath.
- diarrhoea or abdominal pain, rash.
- tiredness (fatigue), depression.
- allergic reactions with swelling of the face, lips, tongue or throat with
difficulty in swallowing or breathing.
- increased blood potassium level, increased levels of creatinine in your
blood (both are usually detected by a test).
Uncommon (may affect up to 1 in 100 people)
- sudden fall in blood pressure.
- fast or uneven heart beats (palpitations).
- heart attack (possibly due to very low blood pressure in certain highrisk patients, including those with blood flow problems of the heart or
brain).
- anaemia (including aplastic and haemolytic).
- stroke (possibly due to very low blood pressure in high-risk patients).
- confusion, sleeplessness or sleepiness, nervousness.
- feeling your skin prickling or being numb.
- vertigo.
- ringing in your ears (tinnitus).
- runny nose, sore throat or hoarseness.
- asthma.
- slow movement of food through your intestine, inflammation of your
pancreas.
- being sick (vomiting), indigestion, constipation, anorexia.
- irritated stomach (gastric irritations), dry mouth, ulcer, impaired kidney
function, kidney failure.
- increased perspiration.
- itching or nettle rash.
- loss of hair.
- muscle cramps, flushing, 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.
- autoimmune diseases.
- strange dreams or sleep problems.
- pulmonary infiltrates.
- inflammation of your nose.
- pneumonia.
- inflammation of the cheeks, gums, tongue, lips, throat.
- lower amount of urine produced.
- erythema multiforme.
- ‘Stevens-Johnson syndrome’ a serious skin condition where you have
reddening and scaling of your skin, blistering or raw sores, or
detachment of the top layer of skin from bottom layers.
- liver problems such as lower liver function, inflammation of your liver,
jaundice (yellowing of the skin or eyes), higher levels of liver enzymes
or bilirubin (measured in a blood test).
- enlargement of the mammary glands in males.
Very Rare (may affect up to 1 in 10,000 people)
- swelling in your intestine (intestinal angiooedema).
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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE INNOVACE
Keep out of the sight and reach of children.
Do not use Innovace 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 container.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Innovace contains:
The active ingredient in Innovace Tablets is enalapril maleate. Each
tablet contains either 5mg or 10mg of the active ingredient enalapril
maleate.
The other ingredients in Innovace are lactose monohydrate, maize
starch, pregelatinised maize starch, sodium hydrogen carbonate,
magnesium stearate. Innovace 10mg Tablets also contain red iron oxide
E172.

What Innovace looks like and the contents of the pack
Innovace 5mg Tablets are white rounded, triangle-shaped marked 'MSD 712'
one side and scored on the other side.
Innovace 10mg Tablets are rust-red coloured rounded, triangle-shaped tablets
marked 'MSD 713' on one side and scored on the other side.
Innovace Tablets are available in blister packs containing 28 tablets.
Manufacturer and Product Licence holder
Manufactured by: Merck Sharp & Dohme B. V., Haarlem, Holland and
procured from within the EU by Product Licence holder Tenolol Ltd,
5 Sandridge Close, Harrow, HA1 1XD. Repackaged by Servipharm Ltd.

POM

Innovace 5mg Tablets – PL 30900/2156
Innovace 10mg Tablets – PL 30900/2157

Leaflet revision and issue date (Ref.) 13.03.14[8]
Innovace is a registered trademark of Merck & Co. Inc.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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