Skip to Content

UK Edition. Click here for US version.

ENALAPRIL MALEATE 20MG TABLETS

Active substance(s): ENALAPRIL MALEATE

View full screen / Print PDF » Download PDF ⇩
Transcript
S1615 LEAFLET Innovace 20151016

PACKAGE LEAFLET: INFORMATION FOR THE USER

INNOVACE® 20mg TABLETS
(enalapril maleate)
The name of your medicine is Innovace 20mg Tablets but will be
referred to as Innovace throughout the following leaflet.
Please note that information regarding other strengths of Innovace is
also present in the below leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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.



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



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 have further questions, ask your doctor or pharmacist.



If you are about to have a procedure

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



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.



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.

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

Other medicines and Innovace

4. Possible side effects

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.

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).

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



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

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 to 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 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



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.

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 are having dialysis

Driving and using machines



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

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



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

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.



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

3. HOW TO TAKE INNOVACE

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



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 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 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.

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

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.



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

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



muscle cramps



impaired kidney function, kidney failure

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



increased sweating



itching or nettle rash



hair loss



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

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.




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



impotence



severe kidney problems - 2.5 mg each day



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



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.



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)

Elderly patients



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

‘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

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:



bone marrow depression



swollen glands in neck, armpit or groin



autoimmune diseases



between 20 kg and 50 kg – 2.5 mg each day



strange dreams or sleep problems



more than 50 kg – 5 mg each day.



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)

Use in children

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.

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



If you stop taking Innovace



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

Not known (frequency cannot be estimated from the available data)

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



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.

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.

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 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.

Other side effects include:
Very Common (may affect more than 1 in 10 people)


feeling dizzy, weak or sick



blurred vision



cough.

swelling in your intestine (intestinal angioedema)

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION



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

What Innovace contains



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

What Innovace looks like and contents of the pack



high levels of potassium in the blood, increased levels of creatinine
in your blood (both are usually detected by a test).

Innovace is a peach, triangle shaped tablet with all three corners
rounded. The one side is scored and the other marked ‘MSD 714’.

Uncommon (may affect up to 1 in 100 people)



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



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



flushing

Innovace is available as all-aluminum blister packs containing 28
tablets.



sudden fall in blood pressure

Product Licence holder



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)

Procured from within the EU and repackaged by the Product Licence
holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.



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

Manufacturer
This product is manufactured by Merck Sharpe & Dohme BV,
Waarderweg 39, Haarlem, The Netherlands.
POM

PL 19488/1615

Leaflet revision date: 16 October 2015
S1615 LEAFLET Innovace 20151016

S1615 LEAFLET Enalapril 20151016

PACKAGE LEAFLET: INFORMATION FOR THE USER

ENALAPRIL MALEATE 20mg TABLETS
(enalapril maleate)
The name of your medicine is Enalapril Maleate 20mg Tablets but will
be referred to as Enalapril throughout the following leaflet.
Please note that information regarding other strengths of Enalapril is
also present in the below leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

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 Enalapril.”
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.



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



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 have further questions, ask your doctor or pharmacist.



If you are about to have a procedure

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



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.



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.

What is in this leaflet
1. What Enalapril is and what it is used for
2. What you need to know before you take Enalapril
3. How to take Enalapril

Other medicines and Enalapril

4. Possible side effects

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

5. How to store Enalapril
6. Contents of the pack and other information
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).

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 Enalapril” 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



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

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



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 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
(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
Enalapril 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 Enalapril:


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 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
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.
Breast-feeding



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.

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 are having dialysis

Driving and using machines



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

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



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

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.



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

3. HOW TO TAKE ENALAPRIL

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



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 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 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.

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

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.





impaired kidney function, kidney failure



increased sweating

Patients with kidney problems



itching or nettle rash

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



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)

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



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

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

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



‘Raynaud’s phenomenon’ where your hands and feet may become
very cold and white due to low blood flow

Use in children



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)

a maximum of 20 mg daily can be used in children who are
between 20 kg and 50 kg



inflammation of your nose

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



inflammation of the lungs causing difficulty breathing (pneumonia)



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

This medicine is not recommended in newborn babies (first few weeks
after birth) and in children with kidney problems.



reduced amount of urine



rash that looks like targets (erythema multiforme)

If you take more Enalapril than you should



‘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)

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



more than 50 kg – 5 mg each day.

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



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‑headedness or dizziness. This is
due to a sudden or excessive drop in blood pressure.
If you forget to take Enalapril


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 Enalapril
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

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



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.

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 Enalapril 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 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:

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 ENALAPRIL


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)


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

swelling in your intestine (intestinal angioedema)

Not known (frequency cannot be estimated from the available data)

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Enalapril contains


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



Other ingredients are: lactose monohydrate, sodium bicarbonate,
maize starch, pregelatinized starch, magnesium stearate, red iron
oxide (E172) and yellow 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.
POM

PL 19488/1615

Leaflet revision date: 16 October 2015
S1615 LEAFLET Enalapril 20151016

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.

Hide