PACKAGE LEAFLET: INFORMATION FOR THE USER INNOZIDE® 20/12.5mg Tablets ENALAPRIL MALEATE 20mg and HYDROCHLOROTHIAZIDE 12.5mg Tablets (enalapril maleate / hydrochlorothiazide)

This product will be referred to as Innozide throughout the remainder of this leaflet.

Read all of this leaflet carefully before you start taking this

medicine.

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

•    If you have any further questions, ask your doctor or 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Innozide is and what it is used for

2.    Before you take Innozide

3.    How to take Innozide

4.    Possible side effects

5.    How to store Innozide

6.    Further information

Innozide contains enalapril maleate and hydrocholorothaizide:

•    enalapril belongs to a group of medicines known as ACE inhibitors, which work by widening your blood vessels

•    hydrochlorothiazide belongs to a group of medicines known as water tablets (diuretics), which increase the volume of urine you produce.

The effect of these medicines is to lower your blood pressure. Innozide is used to treat high blood pressure (hypertension). Taking both medicines that Innozide contains can increase their effect compared to taking just one.

Do not take Innozide if:

•    you have ever had an allergic reaction to Innozide, a similar medicine or to any of the ingredients (listed in Section 6). The signs may have been itching, nettle rash, wheezing or swelling of your hands, throat, mouth or eyelids

•    you are allergic to a type of medicine called 'sulphonamides'

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

•    you are not passing urine

•    you have a condition know as renal artery stenosis (narrowing of the arteries that supply the blood to your kidneys).

•    you have severe kidney or liver problems

Do not take Innozide if any of the above apply to you. If you are not

sure, talk to your doctor or pharmacist before taking Innozide.

Take special care with Innozide

Check with your doctor or pharmacist before taking your medicine if:

•    you have kidney problems, have had a recent kidney transplantation, are a dialysis patient, or are taking water tablets (diuretics)

•    you have blood disorders or liver problems

•    you are on a salt restricted diet, or have suffered from excessive vomiting or diarrhoea recently

•    you have a heart condition called 'aortic stenosis', 'hypertrophic cardiomyopathy' or 'outflow obstruction'

•    you have collagen vascular disease, are taking immunosuppressant therapy (used for the treatment of autoimmune disorders such as rheumatoid arthritis or following transplant surgery)

•    you are taking allopurinol, (used for the treatment of gout), or procainamide, (used to treat abnormal heart rhythms). If you develop an infection (symptoms may be high temperature or fever), you should let your doctor know immediately. Your doctor may take a blood sample from time to time to check your white blood cell count

•    you have a history of 'angioedema' while taking other medicines. The signs may have been itching, nettle rash, wheezing or swelling of your hands, throat, mouth or eyelids

•    you have diabetes and are taking antidiabetic medicines, including insulin to control your diabetes (you should monitor your blood for low blood glucose levels, especially during the first month of treatment)

•    you are taking potassium supplements or potassium containing salt substitutes

•    you are taking lithium, used for the treatment of some psychiatric illnesses

•    you have been told by your doctor that you have an intolerance to some sugars.

•    You must tell your doctor if you think you are (or might become) pregnant. 'Innozide' 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 are about to have any of the following procedures, you should tell your doctor who is treating you that you are taking Innozide:

•    any surgery or receive anaesthetics (even at the dentist)

•    a treatment called LDL apheresis, to remove cholesterol from your blood using a machine

•    desensitisation treatment, to reduce the effect of an allergy to bee or wasp stings.

Routine tests

When you first start to take Innozide, your doctor will monitor your blood pressure frequently to ensure you have been given the correct dose. In addition, for some patients the doctor may want to do some tests to measure your potassium, sodium, magnesium, creatinine and liver enzyme levels.

Tell you doctor if you have or will take an anti-doping test since this medication can produce a positive result.

Children

Innozide is not recommended for use in children.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have

recently taken any other medicines, including medicines obtained

without a prescription as some drugs may affect each other's action.

This includes herbal medicines. Also some other medicines can

affect the way Innozide works:

•    potassium sparing water tablets (diuretics) such as spironolactone, eplerenone, triamterene or amiloride, potassium supplements, or potassium-containing salt substitutes. 'Innozide' may increase the levels of potassium in your blood leading to high potassium levels. This causes few signs and is usually seen by a test.

•    water tablets (diuretics) such as thiazides, furosemide, bumetanide

•    other medicines that lower blood pressure, such as nitroglycerine, nitrates, and vasodilators

•    lithium, used for the treatment of some psychiatric illnesses. Innozide should not be taken with this drug

•    barbiturates (sedatives used for sleeplessness or epilepsy)

•    tricyclic antidepressants such as amitriptyline, used for depression, antipsychotics such as phenothiazines, used for severe anxiety

•    pain killers such as morphine or anaesthetics, because your blood pressure may become too low

•    cholestyramine or colestipol (used to help control cholesterol levels)

•    medicines used for, stiffness and inflammation associated with painful conditions, particularly those affecting your muscles, bones and joints:

-    including gold therapy which can lead to flushing of your face, feeling sick (nausea), vomiting and low blood pressure, when taken with Innozide, and

-    non-steroidal anti-inflammatory drugs (NSAIDs), for example diflunisal or diclofenac. They may prevent your blood pressure from being well controlled and may increase the level of potassium in your blood

•    medicines such as ephedrine, used in some cough and cold remedies, or noradrenaline and adrenaline used for low blood pressure, shock, cardiac failure, asthma or allergies. If used with Innozide these drugs may keep your blood pressure high

•    ACTH (to test whether your adrenal glands are working properly)

•    Corticosteroids (used to treat certain conditions such as rheumatism, arthritis, allergic conditions, asthma or certain blood disorders)

•    Allopurinol (used to treat gout)

•    Ciclosporins (immunosuppressive agents used for autoimmune disorders)

•    Medicines for the treatment of cancer

•    Antacids (used for indigestion relief)

•    Procainamide, amiodarone or sotalol (used to treat abnormal heart rhythms)

•    Digitalis (used to treat heart rhythm problems)

•    Carbenoxalone (used to treat stomach ulcers)

•    Excessive use of laxatives

•    antidiabetic medicines such as insulin. Innozide may cause your blood sugar levels to drop even further if you take it with antidiabetics.

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

Taking Innozide with food and drink

Innozide can be taken with or without food. However, if you drink alcohol while taking Innozide, 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 Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Innozide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Innozide. Innozide is not recommended during 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

T ell your doctor if you are breast-feeding or about to start breast-feeding. Innozide is not recommended for mothers who are breast-feeding.

Driving and using machines

Certain side effects, such as dizziness and weariness, have been reported with Innozide which may affect some patients' ability to drive or operate machinery.

Important information about some of the ingredients of Innozide

Innozide contains lactose, which is a type of sugar. It is important to tell your doctor if you suffer from lactose intolerance.

Rare (affects less than 1 in 1,000 people)

•    strange dreams, sleeping problems

•    decreases in your white blood cells, red blood cells, platelets, bone marrow depression (all are usually detected by tests)

•    swollen glands, autoimmune diseases, low blood flow to your fingers and toes causing redness and pain (Raynaud's), fluid on your lungs, runny or sore nose

•    eosinophilic pneumonia (signs may be cough, high temperature and difficulty breathing)