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The product codes for this leaflet are: PL 17780/0076, PL 17780/0079, PL 17780/0078, PL 17780/0077

 

Enalapril Maleate 2.5mg, 5mg, 10mg and 20mg Tablets

Company Details

Zentiva


One Onslow StreetGuildfordSurreyGU1 4YS
Telephone:
Fax:
Medical Information Direct Line:
Medical Information e-mail:UK-medicalinformation@sanofi.com
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ENALAPRIL MALEATE 2.5MG, 5MG, 10MG AND 20MG TABLETS

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, please ask your doctor or your pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
  • Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect.

In this leaflet:

1. What enalapril maleate is and what it is used for
2. Before you take enalapril maleate
3. How to take enalapril maleate
4. Possible side effects
5. Storing enalapril maleate
6. Further information

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1. WHAT ENALAPRIL MALEATE IS AND WHAT IT IS USED FOR

Enalapril belong to a group of medicines known as ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).

Enalapril works by making your blood vessels wider. This helps your blood pressure to fall. It also makes it easier for your heart to pump blood around your body.

Enalapril can be used to treat

  • High blood pressure - also called hypertension
  • Heart failure - where the heart has difficulty pumping blood around your body.
  • Heart muscle damage - there may be no outward signs of this. Enalapril can help stop this causing the symptoms of heart failure.
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2. BEFORE YOU TAKE ENALAPRIL

Do not take enalapril if:

  • You are more than 3 months pregnant. (It is also better to avoid enalapril in early pregnancy- see pregnancy section)
  • You have ever had an allergic (hypersensitivity) reaction to enalapril, any other ACE inhibitor medicine, or any of the ingredients in these tablets (see Section 6: Further Information).
  • Any member of your family has had an allergic reaction to these medicines or you have ever had an allergic reaction for no apparent reason.

Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

If you are not sure about taking enalapril, talk to your doctor.

Take special care and check with your doctor before you take enalapril if you:

  • Have been told to limit the amount of salt in your diet, are having kidney dialysis, or have had severe diarrhoea or sickness
  • Have a narrowed heart valve (mitral valve stenosis) or aorta (aortic stenosis), or have a heart problem known as "hypertrophic cardiomyopathy". These all cause the blood to flow less freely away from the heart.
  • Have kidney problems, including narrowed blood vessels in your kidneys (renal artery stenosis) or a recent kidney transplant
  • Have an inflammatory disease of the skin, muscles or joints (a collagen vascular disease) such as scleroderma, SLE (lupus), rheumatoid arthritis
  • Have ever had "angioneurotic oedema" or "angioedema" after taking other medicines. The signs include itching, red marks on the hands, feet and throat, swelling around the eyes and lips, difficulty breathing.
  • Are having treatment to reduce your reaction to bee and wasp stings
  • Are having treatment of your blood by a machine to lower cholesterol (LDL apheresis)
  • Take extra potassium in your diet or a salt substitute that contains potassium
  • You must tell your doctor if you are (or might become) pregnant. Enalapril is not recommended in early pregnancy, and must not be taken if you are more then 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see pregnancy section).

Please talk to your doctor before taking enalapril if any of the above apply to you, even if they applied only in the past.

Taking enalapril with other medicines

The effect of enalapril may be changed if you take it at the same time as other medicines.

Talk to your doctor before taking enalapril if you are taking any of the following medicines:

  • Water tablets (diuretics) such as spironolactone, triamterene or amiloride. Enalapril may increase the levels of potassium in your blood.
  • Water tablets (diuretics) such as thiazides, frusemide, or other medicines to lower your blood pressure, medicines for chest pain (angina). Taking enalapril at the same time may cause low blood pressure.
  • Lithium (for some types of mental illness)
  • Medicines for depression such as amitriptyline, medicines for serious mental illness such as chlorpromazine, anaesthetics or narcotics such as morphine (for severe pain). Taking these medicines at the same time as enalapril my cause low blood pressure.
  • Non-steroidal anti-inflammatory drugs (NSAlDs), such as indometacin or diclofenac (for pain or inflammation). These medicines may make enalapril work less well.
  • Medicines such as ephedrine, noradrenaline or adrenaline (for low blood pressure, shock, heart failure, asthma or allergies). These medicines may make enalapril work less well.
  • Medicines for diabetes, such as insulin. Enalapril may cause your blood sugar levels to drop even further when taken with these medicines. This is more likely to occur during the first weeks of taking enalapril and in patients with kidney problems. You should check your blood sugar level closely during the first month of taking enalapril.
  • Allopurinol (used to treat gout and kidney stones), procainamide (used to treat heart beat problems), medicines to suppress your immune system (such as ciclosporin after transplant surgery and to treat rheumatoid arthritis).
  • Medicines used to treat stiffness and inflammation of your muscles, bones and joints including gold therapy, such as sodium aurothiomalate, which can lead to flushing of your face, feeling sick (nausea), being sick (vomiting) and low blood pressure

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine - even those not prescribed.

If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking enalapril.

Taking enalapril with food and drink

  • You can take enalapril with or without food.
  • If you drink alcohol while taking enalapril you may feel dizzy, light-headed or faint. Take care with the amount of alcohol you drink.

Pregnancy and Breast-feeding

You must tell your doctor if you are ( or might become) pregnant. 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. Enalapril is not recommended in early pregnancy, and must not be taken when more then 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

  • Do not take enalapril during weeks 13 to 40 of your pregnancy. This is because your baby may be harmed. If you have taken enalapril during this period, it is best to have an ultrasound (scan) check of the baby's kidneys and skull. Also, when your baby is born, it should be closely monitored for any signs of low blood pressure (hypotension).

Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding newborn babies (first few weeks after birth), 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

Enalapril may make you feel tired or dizzy. If this happens do not drive or use any tools or machines.

Important information about some of the ingredients in enalapril tablets

Enalapril tablets contain lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking enalapril.

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3. HOW TO TAKE ENALAPRIL

Always take enalapril exactly as your doctor has told you. The dose of enalapril will depend on the condition being treated and any other medicines you are taking. This leaflet gives the usual dose but you should read the amount prescribed for you on the medicine label. You should check with your doctor or pharmacist if you are not sure.

Taking enalapril tablets

  • Swallow the tablets with water. You can take them with or without food.
  • Take your tablet at about the same time each day. Take the enalapril tablet marked for the correct day on the blister pack. This will help you remember whether you have taken it.
  • Take your medicine until your doctor tells you to stop. If you feel better, do not stop taking the tablets. If you stop them, your condition may get worse.

The first enalapril tablets you take might make you feel dizzy or light-headed. This is because the first dose may make your blood pressure fall by more than doses you take after that. It may help to lie down until you feel better.

If you are concerned talk to your doctor or pharmacist.

Your doctor may ask to see you more frequently when you start taking the medicine or when your dose is changed to monitor how you are responding to taking enalapril. You should not skip these visits even if you feel well.

Adults with high blood pressure (hypertension)

  • The starting dose is usually 5 to 10mg each day. This may be increased gradually to a maintenance dose (the dose you will stay on) of 20mg daily. The maximum daily dose is 40mg.
    The actual dose, decided by your doctor, will depend on your blood pressure and other medical conditions.

If you are taking a high dose of water tablets (diuretics), your doctor may ask you to stop taking them for 2 to 3 days before you start taking enalapril

Adults with heart failure

  • The starting dose is usually 2.5mg each day.
  • The dose may be increased to 20mg each day. The doctor will decide on this over 2 to 4 weeks depending on how your condition changes with enalapril. The 20mg may be given as one dose or split into two doses of 10mg.
  • The maximum daily dose is 40mg, split into two doses of 20mg.

People with kidney problems

  • If you have kidney problems, the doctor will alter the amount of enalapril you take depending on how well your kidneys are working
  • If you are on kidney dialysis your dosage will vary day by day. Your doctor will let you know what your dose should be.

Older People

  • Your dose will be decided by your doctor. It will depend on how well your kidneys are working.

Children

  • The dose will depend on the child's weight and how their blood pressure changes after taking enalapril. The doctor will decide on the dose.
  • Children with kidney problems should not have enalapril.
  • Very young babies (neonates) should not have enalapril.

If you take more enalapril than you should

Contact your doctor or go to the nearest hospital casualty department straight away. Remember to take any tablets with you.

If you forget to take enalapril

If you miss a dose do not worry. Take your normal dose when it is next due. Do not take a double dose to make up for a forgotten tablet.

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4. POSSIBLE SIDE EFFECTS

Like all medicines, enalapril can cause side effects, although not everybody gets them.

Stop taking enalapril and see a doctor or go to a hospital straightaway if:

  • You get swelling of the hands, feet, ankle, face, lips or throat which may cause difficulty in swallowing or breathing, itching of the skin and nettle rash.
  • You get red, swollen or scalded skin with blisters on the lips, eyes, mouth, nose and/or genitals. You may also have a high temperature, swollen glands or joint pain.

This may mean you are having an allergic reaction to enalapril.

Talk to your doctor straight away if you notice any of the following serious side-effects.

These are uncommon or rare (affect less than 1 person in 100):

  • You may get a bloating feeling and cramping pain in the stomach (abdomen), be sick (vomiting), have indigestion, heartburn, upset stomach, constipation, loss of appetite, dry mouth. This could be caused by an obstruction or blockage of the bowel (ileus).
  • Severe stomach pains which may reach through to your back. This could be a sign of pancreatitis
  • Blood disorders including bone marrow problems and anaemia. Symptoms include bruising more easily, bleeding longer after injury, bleeding from the gums or elsewhere, purple spots or blotching on the skin (caused by damage to small blood vessels), a greater chance of infection.
  • Lung problems including inflammation of the lungs. You may feel unwell or less hungry, or get high temperature (fever) lasting 2 to 3 days, difficulty breathing, shortness of breath, cough.
  • High temperature, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of the skin or eyes (jaundice) and liver failure. These are symptoms of hepatitis (inflammation of the liver).
  • A condition which may include some or all of the following: high temperature, inflamed blood vessels, painful inflamed muscles and joints, blood problems detected by a blood test, rash, being very sensitive to sunlight, other effects of the skin. This could be a condition called Stevens-Johnson syndrome.

Tell your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days. Also do this if you notice any side effects not listed in the leaflet.

Very common (affects more than 1 person in 10):

  • blurred vision or problems with eyesight
  • dizziness
  • cough
  • feeling sick (nausea)
  • lack or loss of strength (weakness).

Common (affects less than 1 person in 10):

  • headache, depression (low mood)
  • feeling faint or light-headed when standing up quickly. This could be due to low blood pressure
  • fainting
  • heart problems including increased heart rate, uneven heart beat and chest pain
  • difficulty breathing or shortness of breath
  • diarrhoea, stomach pains, change in the way things taste
  • tiredness.
  • high levels of potassium in the blood (hyperkalaemia). This can cause an irregular or unusual heart beat.

Uncommon (affects less than 1 person in 100):

  • low blood sugar levels (hypoglycaemia). You may feel a sense of nervousness, shaky or sweaty.
  • feeling confused, drowsy or sleepy, difficulty sleeping (insomnia), feeling more nervous than usual, unusual skin sensations such as numbness, tingling, pricking, burning, or creeping on the skin (paraesthesia).
  • balance problems. dizziness (vertigo) or feeling faint and light-headed. especially when getting up
  • very fast, uneven or forceful heart beat (palpitations)
  • serious conditions including heart attack and stroke
  • runny nose, sore or hoarse throat, difficulty breathing, wheezing, tightness in the chest
  • being sick (vomiting), indigestion, constipation, loss of appetite (anorexia), dry mouth
  • ulcer in your stomach or gut. Symptoms may be a burning, aching pain with an empty feeling and hunger
  • sweating
  • itching, lumpy rash
  • hair loss or balding
  • kidney problems including kidney failure
  • difficulty in getting an erection or ejaculating (impotence)
  • muscle cramps, flushing, ringing in the ears, feeling unwell, high temperature.

Rare (affects less than 1 person in 1,000):

  • abnormal or strange dreams, sleep problems
  • Raynaud's phenomenon. Symptoms include toes or fingers that change colour when exposed to the cold or when pressure is put on them, pain in the fingers or toes when cold, tingling or pain on warming
  • runny nose, itching, sneezing and stuffy nose (rhinitis)
  • inflammed mouth or tongue, or ulcers in the mouth
  • passing less urine than usual over the day
  • breast enlargement in men.

Very rare (affects less than 1 person in 10,000):

  • a condition called "intestinal angioedema" has been reported in patients taking this type of medicine (ACE inhibitors). Symptoms are stomach pain with or without feeling sick (nausea) or being sick (vomiting).

Frequency not known (cannot be estimated from available data):

  • Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called 'syndrome of inappropriate anti-diuretic hormone secretion' (SIADH).

Blood Tests

Taking enalapril may affect the results of some blood tests. These include tests on: the blood cells or other parts of it, potassium levels, creatine or urea, sodium, liver enzymes or bilirubin.

If you are going to have a blood test, it is important to tell your doctor that you are taking enalapril.

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5. HOW TO STORE ENALAPRIL

  • Keep your medicine in a safe place out of the reach and sight of children.
  • Store in the original package.
  • Do not store above 30°C.
  • Do not use this medicine after the expiry date shown on the pack.
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6. FURTHER INFORMATION

What enalapril contains

The name of this medicine is Enalapril Maleate 2.5mg. 5mg, 10mg or 20mg Tablets (called enalapril throughout this leaflet).

Each tablet contains 2.5mg, 5mg, 10mg or 20mg of enalapril maleate as the active substance.

Other ingredients are lactose monohydrate, maize starch, crospovidone, pregelatinised starch, maleic acid and magnesium stearate. The 10mg and 20mg tablets also contain iron oxide (E172).

What enalapril looks like and contents of the pack

Enalapril Maleate 2.5mg Tablets are white, round, bevel edged tablets marked S105 on one side.

Enalapril Maleate 5mg Tablets are white or off-white, oblong, biconvex bevel edged tablets with a break-line on one side

Enalapril Maleate 10mg Tablets are pink, round, bevel edged tablets marked S107 on one side.

Enalapril Maleate 20mg Tablets are mottled mustard, oblong, biconvex bevel edged tablets with a break-line engraved on one side.

They are supplied in blister packs of 10, 14, 28, 30, 50, 56, 60, 98 and 100 tablets. Not all pack sizes may be marketed.

The Marketing Authorisation Holder is:

Zentiva
One Onslow Street
Guildford
Surrey
GUI 4YS
UK

The Manufacturer is:

Chinoin Pharmaceutical and Chemical Works Co Ltd
H-2112 Veresegyház
Lévai u. 5
Hungary
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This leaflet was last revised in September 2011

'Zentiva' is a registered trademark. © 2011 Zentiva

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