ENALAPRIL MALEATE 10 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - ENALAPRIL MALEATE 10 MG TABLETS

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

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Enalapril Tablets are and what they are used for

2. What you need to know before you take Enalapril Tablets

3. How to take Enalapril Tablets

4. Possible side effects

5. How to store Enalapril Tablets

6. Contents of the pack and other information

1. What Enalapril Tablets are and what they are used for

Enalapril Tablets contains an active substance called enalapril maleate. This belongs to the group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).,

Enalapril Tablets are 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 tablets you are allergic to enalapril maleate, or any of the other ingredients of this medicine (listed in section 6).

you have ever had an allergic reaction to a type of medicine similar to this medicine called an ACE inhibitor
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
you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
you are more than 3 months pregnant. (It is also better to avoid Enalapril Tablets in early pregnancy – see Pregnancy section)
you are being treated with sacubitril/valsartan, a medicine for heart failure.

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 Tablets:

if you are (or might become) pregnant. Enalapril 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 section Pregnancy and breast-feeding).
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, potassium-containing salt substitutes, or other drugs that may increase potassium in your blood (e.g., heparin [a medicine used to prevent blood clots], trimethoprim-containing products such as cotrimoxazole [medicines used to treat infections]) 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 are taking an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus: medicines used to treat certain types of cancer or to prevent the body’s immune system from rejecting a transplanted organ) or a medicine containing a neprilysin inhibitor such as sacubitril (available as fixed-dose combination with valsartan), used in patients with heart failure, and racecadotril, used in patients with acute diarrhoea. You may be at increased risk for an allergic reaction called angioedema.
if you have collagen vascular disease (e.g. lupus erythaematosus, 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 breast-feeding or about to start breast-feeding (see Breast-feeding section).
if you are taking any of the following medicines used to treat high blood pressure:

o an angiotensin II receptor blocker (ARBs) (also known as sartans – for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.

o 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 Enalapril Tablets”.

You should be aware that Enalapril 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 Enalapril Tablets:

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 Tablets

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 Tablets can affect the way some medicines work. Also some other medicines can affect the way Enalapril Tablets 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 Tablets” and “Warnings and precautions”)
other medicines to lower blood pressure, such as beta-blocker or water tablets (diuretics)
medicines containing potassium (including dietary salt substitutes) or other drugs that may increase potassium in your blood (e.g., heparin [a medicine used to prevent blood clots], trimethoprim-containing products such as cotrimoxazole [medicines used to treat infections])
medicines for diabetes (including oral antidiabetic medicines and insulin)
lithium (a medicine used to treat a certain kind of depression)
medicines for depression called ‘tricyclic antidepressants’
medicines for mental problems called ‘antipsychotics’
certain cough and cold medicines and weight reducing medicines which contain something called a ‘sympathomimetic agent’
certain pain or arthritis medicines including gold therapy
an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent the body’s immune system from rejecting a transplanted organ). See also information under the heading “Warnings and precautions”
a medicine containing a neprilysin inhibitor such as sacubitril (available as fixed-dose combination with valsartan) and racecadotril. The risk of angioedema (swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing) may be increased. See also information under the headings “Do not take Enalapril Tablets” and “Warnings and precautions”.
non-steroidal anti-inflammatory drugs, including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain)
aspirin (acetylsalicylic acid)
medicines used to dissolve blood clots (thrombolytics)
alcohol.

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

Enalapril Tablets with food and drink

Enalapril Tablets can be taken with or without food. However, if you drink alcohol while taking Enalapril Tablets, it may cause your blood pressure to drop too much and you may experience dizziness, light-headedness or faintness. You should keep your alcohol intake to a minimum.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

Pregnancy

Your doctor will normally advise you to stop taking Enalapril Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Enalapril Tablets. 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 enalapril.

In the case of an older baby your doctor should advise you on the benefits and risks of taking Enalapril whilst breast-feeding, compared with 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 Tablets contain lactose

Enalapril Tablets contain lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Important information about Enalapril Tablets

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take enalapril tablets

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

– It is very important to continue taking this medicine for as long as your doctor prescribes it
– Do not take more tablets than prescribed.
– The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

High blood pressure

– The usual starting dose ranges from 5 to 20 mg taken once a day.
– Some patients may need a lower starting dose.
– The usual long term dose is 20 mg taken once a day.
– The maximal long term dose is 40 mg taken once a day.

Heart failure

– The usual starting dose is 2.5 mg taken once a day.
– Your doctor will raise this amount step by step until the dose that is right for you has been achieved.
– The usual long term dose is 20 mg each day, taken in one or two doses.
– The maximal long term dose is 40 mg each day, divided in two doses.

Use in 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.

Use in 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 Tablets 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 once a day.
more than 50 kg – 5 mg once a 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 50kg.

Enalapril Tablets are not recommended in newborn babies (first few weeks after birth) and in children with kidney problems.

If you take more Enalapril Tablets than you should

If you have taken one extra dose this is unlikely to cause problems. If you or someone else has taken more than one extra dose or a large overdose of Enalapril Tablets, contact your doctor or local hospital accident and emergency department immediately. The following effects may happen: feeling of light-headed or dizzy, coughing, feeling anxious, feeling your heart beat, slower heartbeat, faster heartbeat, kidney problems.

If you forget to take Enalapril Tablets

If you forgot to take your tablet, skip the missed dose. Take the next one as normal. Do not take a double dose to make up for a forgotten dose.

If you stop taking Enalapril Tablets

Do not stop taking your medicine unless our 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 Tablets 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)
■ 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)
■ 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)

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 Tablets 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)
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)

blushing
sudden fall in blood pressure
fast or uneven heart beats (palpitations)
stroke (possibly due to very low blood pressure in high-risk patients)
decreased number of red blood cells
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 hoarse Voice
asthma-associated tightness in chest
slow movement of food through your intestine (ileus), inflammation of your pancreas
being sick (vomiting), indigestion, constipation, loss of appetite
irritated stomach (gastric irritations), dry mouth, stomach ulcer
muscle cramps
impaired kidney function, kidney failure
increased sweating
itching or nettle rash
hair loss
generally feeling unwell (malaise), high temperature (fever)
erectile dysfunction
high level of proteins in your urine (measured in a test)
low level of blood sugar or sodium, high level of blood urea (all measured in a blood test).

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

‘Raynaud’s phenomenon’ where your hands and feet may become very cold and white due to low blood flow
changes in blood values such as a lower number of white and red blood cells, lower

haemoglobin, lower number of blood platelets

bone marrow depression
swollen glands in neck, armpit or groin
autoimmune diseases
strange dreams or sleep problems
accumulation of fluid or other substances in the lungs (as seen on X-rays)
inflammation of your nose
inflammation of the lungs causing difficulty breathing (pneumonia)
inflammation of the cheeks, gums, tongue, lips, throat
reduced amount of urine
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)
mouth ulcers.

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store enalapril tablets

Do not take this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Any out of date medicines should be returned to your pharmacist.

Do not store Enalapril Tablets above 25 °C.

Keep this medicine out of the sight and reach of children.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationthe active substance is enalapril maleate. each tablet contains either 2.5 mg or 5 mg or 10 mg or 20 mg of enalapril maleate.

The other ingredients are croscarmellose sodium, lactose monohydrate, magnesium stearate, iron oxide (10 and 20mg tablets only) (E172), pregelatinised maize starch and sodium bicarbonate.

What Enalapril Tablets looks like and contents of the pack

Enalapril 2.5 mg, 5 mg, 10 mg and 20 mg Tablets are available in packs of 28.

2.5mg tablets are white, circular, flat, market ‘E 2.5’ on one face.

5mg tablets are white, circular, flat, market with score on one side and marked ‘E 5’ on the reverse side.

10mg tablets are peach, circular, flat, market with score on one side and marked ‘E 10’ on the reverse side.

20mg tablets are orange, circular, flat, market with score on one side and marked ‘E 20’ on the reverse side.

Marketing Authorisation Holder:

Morningside Healthcare Ltd

Morningside Healthcare Ltd.

Unit C, Harcourt Way

Leicester, LE19 1WP, UK

Manufacturer:

Actavis hf

Reykjavikurvegi 78

PO Box 420

IS-222 Hafnarfjordur

Iceland

This leaflet was last revised in July 2020.