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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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

•    If you haveanyfurtherquestions, askyour doctoror 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

The name of your medicine is Enalapril Tablets. The active ingredient, enalapril, belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors, which work by widening your blood vessels. This helps reduce blood pressure and also relieves the workload of the heart in patients with heart failure and following a heart attack.

Enalapril Tablets are useful in the treatment of:

•    high blood pressure (hypertension)

•    heart failure. This means that your heart is not working as well as it used to in order to pump blood around your body, leading to tiredness after light exercise, breathlessness and swelling of the ankles and legs.

•    heart muscle damage

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

Do not take Enalapril Tablets if

•    you are allergic (hypersensitive) to enalapril, a similar medicine or any of the other ingredients of Enalapril Tablets (see section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat ortongue.

•    you are more than 3 months pregnant. (It is also better to avoid enalapril in early pregnancy see pregnancy section).

•    you have you a condition called 'aortic stenosis' or 'outflow obstruction'?

•    if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor, pharmacist or nurse 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 pregnancy section)

•    if you have a heart problem.

•    if you have a condition involving the blood vessels in the brain.

•    if you have a blood problem such as low or lack of white blood cells (neutropenia/agranulocytosis), low blood platelet count (thrombocytopenia) or a decreased number of red blood cells (anaemia).

•    ifyouhavealiverproblem.

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

•    if you have kidney disease, had a kidney transplant or are a dialysis patient, check with your doctor before taking enalapril. In addition you should tell your doctor if you suffer from excessive vomiting or diarrhoea.

•    if you need to undergo any surgery or receive anaesthetics (even at the dentist), you should make sure the doctor or dentist treating you is aware that you are taking enalapril.

•    if you are about to have a treatment called LDL apheresis, which is the removal of cholesterol from the body by machine, or you are about to have desensitisation treatment, that is treatment to reduce the effects of an allergy to bee or wasp stings, you should tell your doctor who is treating you that you are taking enalapril.

•    ifyouareover70yearsofage.

•    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 toACE 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 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 breastfeeding (see Breast-feeding section).

•    if you are taking any of the following medicines used to treat high blood pressure:

. an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), 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 Enalapril Tablets”.

You should be aware that Enalapril lowers the blood pressure in black patients less effectively than in nonblack patients.

In addition to measuring your blood pressure your doctor may wish to test that your kidneys are working properly before you start taking the tablets and at intervals during your treatment.

Other medicines and Enalapril Tablets

Tell your doctor or pharmacist if you are taking, have

recently taken or might take any other medicines. Your

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

precautions:

•    other medicines used to treat high blood pressure or heart failure (for example beta-blockers, methyldopa, calcium antagonists, diuretics (water tablets), and adrenergic blocking medicines (such as guanethidine).

•    a medicine called lithium, used to treat a certain kind ofdepression

•    medicines for depression called 'tricyclic antidepressants'.

•    medicines for the treatment of mental disorders such asantipsychotics.

•    narcotics, used to treat moderate and severe pain such as morphine.

•    medicines for the treatment of diabetes such as insulin or oral agents to lower blood sugar.

•    allopurinol, used forthe treatment of gout.

•    medicines forthe treatment of cancer.

•    immunosuppressive agents such as cyclosporins used for the treatment of autoimmune disorders such as rheumatoid arthritis (including gold therapy) or used following transplant surgery.

•    corticosteroids used to treat various conditions including rheumatism, arthritis, allergic conditions, certain skin diseases, asthma or certain blood disorders.

•    procainamide, used to treat abnormal heart rhythms especially rapid heartbeats.

•    non-steroidal antiinflammatory drugs (NSAIDs), including COX-2-inhibitor used to relieve pain, stiffness and inflammation associated with painful conditions, particularly those affecting the muscles, bones and joints.

•    antacids, used forthe relief of indigestion.

•    medicines containing ephedrine, noradrenaline

or adrenaline used for the treatment of hypotension, shock, cardiac failure, asthma or allergies.

•    certain cough and cold medicines and    weight

reducing medicines which contain something called a 'sympathomimetic agent'.

•    aspirin (acetylsalicylic acid).

•    medicines used to dissolve blood    clots

(thrombolytics).

•    alcohol

•    if you are taking an angiotensin II receptor    blocker

(ARB) or aliskiren (see also information under the headings “Do not take Enalapril Tablets” and “Warnings and precautions”).

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

Taking 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, lightheadedness or faintness. You should keep your alcohol intake to a minimum.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

You must tell your doctor if you think 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 than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

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 breastfeeding, compared with other treatments.

Driving and using machines

You should still be able to drive while taking enalapril but do not drive if you feel light-headed, dizzy or tired. Ask yourdoctorfor advice ifyou have these symptoms.

Important information about some of the ingredients of Enalapril Tablets

Enalapril Tablets contains lactose. Ifyou have been told by your doctor that you have an intolerance to some sugars, contact yourdoctor before taking this medicinal product.