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ENALAPRIL MALEATE 5MG TABLETS

Active substance(s): ENALAPRIL MALEATE

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Innovace® 5mg Tablets
Renitec® 5mg Tablets
Innovace® 20mg Tablets
Renitec 20mg Tablets

1648/1650
27.07.15[13]

(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 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.
The product is available using any 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.
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 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.
- 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
- 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-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 highrisk 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 Xrays)
- 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

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 package.
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 substance is enalapril maleate.
Each tablet contains either 5 mg or 20 mg of enalapril maleate.
- The other ingredients are: lactose monohydrate, magnesium stearate E572,
maize starch, pregelatinised maize starch, sodium bicarbonate E500. The
20mg tablets also contain red iron oxide E172, yellow iron oxide E172.
What Innovace looks like and the contents of the pack
- The 5 mg tablets are white rounded, rectangle-shaped tablets one side
embossed ‘RENITEC’, the other side scored.
- The 20 mg tablets are peach-coloured, rounded, rectangle-shaped tablets
one side embossed ‘RENITEC’, the other side scored and embossed
‘MS’‘DE’.
The 5 mg tablets are available in blister packs of 30 and 60 tablets.
The 20 mg tablets are available in blister packs of 28 tablets.
Manufacturer and Product Licence Holder
Manufactured by Merck Sharp & Dohme, B.V., Waarderweg 39, 2031 BN
Haarlem, The Netherlands. Procured from within the EU by Product Licence
holder: Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

Innovace 5mg Tablets/Renitec 5mg Tablets - PL 20636/1648
Innovace 20mg Tablets/Renitec 20mg Tablets - PL 20636/1650

Leaflet revision and issue date (Ref.) 27.07.15[13]
Innovace and Renitec are trademarks of Merck & Co. Inc.

Enalapril Maleate 5mg Tablets
Enalapril Maleate 20mg Tablets

1648/1650
27.07.15[13]

(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 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.
The product is available using any of the above names but will be
referred to as Enalapril throughout this leaflet.
Enalapril Tablets are also available in other strengths.
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
4. Possible side effects
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).
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 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 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.
- 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.

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 Enalapril:
- 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 Enalapril
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.
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
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
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.
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.
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.

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

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.
- more than 50 kg – 5 mg each day.

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 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.

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.

This medicine is not recommended in newborn babies (first few weeks after
birth) and in children with kidney problems.
If you take more Enalapril than you should
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
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:
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 highrisk 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 Xrays)
- 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

5. HOW TO STORE ENALAPRIL
Keep out of the sight and reach of children.
Do not use Enalapril 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.
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 Enalapril contains:
- The active substance is enalapril maleate. Each tablet contains either 5 mg
or 20 mg of enalapril maleate.
- The other ingredients are: lactose monohydrate, magnesium stearate E572,
maize starch, pregelatinised maize starch, sodium bicarbonate E500. The
20mg tablets also contain red iron oxide E172, yellow iron oxide E172.
What Enalapril looks like and the contents of the pack
- The 5 mg tablets are white rounded, rectangle-shaped tablets one side
embossed ‘RENITEC’, the other side scored.
- The 20 mg tablets are peach-coloured, rounded, rectangle-shaped tablets
one side embossed ‘RENITEC’, the other side scored and embossed
‘MS’‘DE’.
The 5 mg tablets are available in blister packs of 30 and 60 tablets.
The 20 mg tablets are available in blister packs of 28 tablets.
Manufacturer and Product Licence Holder
Manufactured by Merck Sharp & Dohme, B.V., Waarderweg 39, 2031 BN
Haarlem, The Netherlands. Procured from within the EU by Product Licence
holder: Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

Enalapril Maleate 5mg Tablets - PL 20636/1648
Enalapril Maleate 20mg Tablets - PL 20636/1650

Leaflet revision and issue date (Ref.) 27.07.15[13]

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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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