ENALAPRIL MALEATE 20MG TABLETS

Active substance: ENALAPRIL MALEATE

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S1615 LEAFLET Innovace 20140715

PACKAGE LEAFLET: INFORMATION FOR THE USER

INNOVACE® 20mg TABLETS
(enalapril maleate)

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).

The name of your medicine is Innovace 20mg Tablets but will be
referred to as Innovace throughout the following leaflet.

You should be aware that this medicine lowers the blood pressure
in black patients less effectively than in non-black patients.

Please note that information regarding other strengths of Innovace
is also present in the below leaflet.

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before taking this medicine.

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, please ask your doctor or
pharmacist.





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).



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.

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 you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.

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

What is in this leaflet:

Other medicines and Innovace

1. What Innovace is and what it is used for

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:

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

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).

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).



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



to treat heart failure (weakening of heart function). It can lower
the need to go to hospital and can help some patients live
longer.



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-2inhibitors (medicines that reduce inflammation, and can be used
to help relieve pain).



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.



aspirin (acetylsalicylic acid).

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
INNOVACE



medicines used to dissolve blood clots (thrombolytics).



alcohol.

Do not take Innovace

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

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



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.

Pregnancy and breast-feeding

 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).

Innovace with food and drink

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 breastfeeding. 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.



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.

Innovace contains lactose



if you are having dialysis.

3. HOW TO TAKE INNOVACE



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

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.



if you are on a salt-restricted diet, are taking potassium
supplements, potassium-sparing agents, or potassiumcontaining salt substitutes.



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





Do not take more tablets than prescribed.

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.



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



Some patients may need a lower starting dose.



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.



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



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



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.

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.

High Blood Pressure

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



runny nose, sore throat or hoarseness.

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



asthma.



slow movement of food through your intestine, inflammation of
your pancreas.



moderate kidney problems - 5 mg to 10 mg each day.



severe kidney problems - 2.5 mg each day.



being sick (vomiting), indigestion, constipation, anorexia.



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.



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).

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.

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



more than 50 kg – 5 mg each day.



‘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.

If you take more Innovace than you should



pulmonary infiltrates.

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.



inflammation of your nose.



pneumonia.



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

If you forget to take Innovace



lower amount of urine produced.



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



erythema multiforme.



Take the next dose as usual.





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

‘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.



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

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.

4. POSSIBLE SIDE EFFECTS

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

Like all medicines, this medicine can cause side effects, although
not everybody gets them. The following side effects may happen
with this medicine:



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

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

swelling in your intestine (intestinal angioedema).

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.



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



swelling of your hands, feet or ankles.

By reporting side effects, you can help provide more information on
the safety of this medicine.



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

5. HOW TO STORE INNOVACE

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:



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C. Store in the original package in order
to protect from moisture.



Do not use Innovace after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

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
high-risk 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).



feeling your skin prickling or being numb.



ringing in your ears (tinnitus).



The active ingredient is enalapril maleate. Each tablet contains
20mg of enalapril maleate.



Other ingredients are: sodium bicarbonate, maize starch,
magnesium stearate, lactose monohydrate, iron oxide (E172).

What Innovace looks like and contents of the pack
Innovace is a peach, triangle shaped tablet with all three corners
rounded. The one side is scored and the other marked ‘MSD 714’.
Innovace is available as all-aluminum blister packs containing 28
tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Merck Sharpe & Dohme BV,
Waarderweg 39, Haarlem, The Netherlands.

vertigo.



What Innovace contains

confusion, sleeplessness or sleepiness, nervousness.



6. CONTENTS OF THE PACK AND OTHER INFORMATION

POM

PL: 19488/1615

Leaflet revision date: 15 July 2014
S1615 LEAFLET Innovace 20140715

S1615 LEAFLET Enalapril 20140715

PACKAGE LEAFLET: INFORMATION FOR THE USER

ENALAPRIL MALEATE 20mg TABLETS

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).

The name of your medicine is Enalapril Maleate 20mg Tablets but
will be referred to as Enalapril throughout the following leaflet.

You should be aware that this medicine lowers the blood pressure
in black patients less effectively than in non-black patients.

Please note that information regarding other strengths of Enalapril
is also present in the below leaflet.

If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist before taking this medicine.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

If you are about to have a procedure



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



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





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


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



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.

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 you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.

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

What is in this leaflet:

Other medicines and Enalapril

1. What Enalapril is and what it is used for

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 Enalapril can affect the way some medicines work.
Also some other medicines can affect the way Enalapril works:

2. What you need to know before you take Enalapril
3. How to take Enalapril
4. Possible side effects
5. How to store Enalapril

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

6. Contents of the pack and other information



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).

1. WHAT ENALAPRIL IS AND WHAT IT IS USED FOR
Enalapril contains an active substance called enalapril maleate.
This belongs to the group of medicines called ACE inhibitors
(angiotensin converting enzyme inhibitors).
Enalapril 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.



medicines for depression called 'tricyclic antidepressants'.



medicines for mental problems called ‘antipsychotics'.

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.



certain cough and cold medicines and weight reducing
medicines which contain something called a ‘sympathomimetic
agent'.

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.



certain pain or arthritis medicines including gold therapy.



non-steroidal anti-inflammatory drugs, including COX-2inhibitors (medicines that reduce inflammation, and can be used
to help relieve pain).



aspirin (acetylsalicylic acid).



medicines used to dissolve blood clots (thrombolytics).



alcohol.



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
ENALAPRIL
Do not take Enalapril


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 are not sure if any of the above applies to you, talk to your
doctor or pharmacist before taking Enalapril.
Enalapril with food and drink
Enalapril can be taken with or without food. Most people take
Enalapril with a drink of water.
Pregnancy and breast-feeding
Pregnancy

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.

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 Enalapril before you become pregnant or as soon as you
know you are pregnant and will advise you to take another medicine
instead of Enalapril. 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.

Warnings and Precautions

Breast-feeding

Talk to your doctor or pharmacist before taking this medicine

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

• 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 Enalapril in early pregnancy – see Pregnancy section).



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 Enalapril 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 potassiumcontaining salt substitutes.



if you are over 70 years of age.

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.
Enalapril contains lactose
Enalapril 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 ENALAPRIL
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.

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.

High Blood Pressure



Some patients may need a lower starting dose.

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.



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



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



if you have low blood pressure (you may notice this as faintness
or dizziness, especially when standing).



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





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.

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.







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

Heart Failure

Patients with kidney problems



runny nose, sore throat or hoarseness.

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



asthma.



slow movement of food through your intestine, inflammation of
your pancreas.



moderate kidney problems - 5 mg to 10 mg each day.



severe kidney problems - 2.5 mg each day.



being sick (vomiting), indigestion, constipation, anorexia.



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.



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).

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 Enalapril 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.

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



more than 50 kg – 5 mg each day.



‘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.

If you take more Enalapril than you should



pulmonary infiltrates.

If you take more Enalapril 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.



inflammation of your nose.



pneumonia.



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

If you forget to take Enalapril



lower amount of urine produced.

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 forget to take a tablet, skip the missed dose.



erythema multiforme.



Take the next dose as usual.





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

‘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.



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

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.

4. POSSIBLE SIDE EFFECTS

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

Like all medicines, this medicine can cause side effects, although
not everybody gets them. The following side effects may happen
with this medicine:



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

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

swelling in your intestine (intestinal angioedema).

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.



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



swelling of your hands, feet or ankles.

By reporting side effects, you can help provide more information on
the safety of this medicine.



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

5. HOW TO STORE ENALAPRIL

You should be aware that black patients are at increased risk of
these types of reactions. If any of the above happen, stop taking
Enalapril 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:



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C. Store in the original package in order
to protect from moisture.



Do not use Enalapril after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

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
high-risk 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).



feeling your skin prickling or being numb.



ringing in your ears (tinnitus).



The active ingredient is enalapril maleate. Each tablet contains
20mg of enalapril maleate.



Other ingredients are: sodium bicarbonate, maize starch,
magnesium stearate, lactose monohydrate, iron oxide (E172).

What Enalapril looks like and contents of the pack
Enalapril is a peach, triangle shaped tablet with all three corners
rounded. The one side is scored and the other marked ‘MSD 714’.
Enalapril is available as all-aluminum blister packs containing 28
tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Merck Sharpe & Dohme BV,
Waarderweg 39, Haarlem, The Netherlands.

vertigo.



What Enalapril contains

confusion, sleeplessness or sleepiness, nervousness.



6. CONTENTS OF THE PACK AND OTHER INFORMATION

POM

PL: 19488/1615

Leaflet revision date: 15 July 2014
S1615 LEAFLET Enalapril 20140715

Expand view ⇕

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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