Patient Information Leaflet

INNOZIDE® 20/12.5 mg Tablets

(enalapril maleate and hydrochlorothiazide)

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE, EVEN IF YOU HAVE JUST REFILLED YOUR PRESCRIPTION. SOME OF THE INFORMATION IN THE PREVIOUS LEAFLET MAY HAVE CHANGED.

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

WHAT IS IN YOUR TABLETS?

HOW DO YOUR TABLETS WORK?

'Innozide' contains two active ingredients, enalapril maleate and hydrochlorothiazide. Enalapril belongs to a group of medicines known as ACE inhibitors, which work by widening your blood vessels to make it easier for your heart to pump blood through them. Hydrochlorothiazide belongs to a group of medicines known as diuretics, which increase the volume of urine you produce. In this way the water content of your blood is reduced and hence the volume of blood circulating in your body is reduced.

Enalapril maleate or hydrochlorothiazide taken alone will lower high blood pressure. However, taking both together, as in 'Innozide', can increase the effect of either drug taken separately.

WHY DO YOU NEED TO TAKE THESE TABLETS?

Your doctor has prescribed 'Innozide' because you have a condition known as hypertension, or high blood pressure.

Blood pressure is the term given to the pressure produced by your heart pumping blood to all parts of your body. Your blood pressure is measured by two numbers, e.g. 120/80 mm Hg. The first number measures the pressure while your heart beats and the second number measures the pressure between heartbeats.

Normal blood pressure is part of good health. High blood pressure is caused when the blood vessels tighten and the measurement goes above the normal range for your age. There are usually no symptoms of high blood pressure and you will only know you have it if you have had your blood pressure measured.

Although you might feel quite well, if your high blood pressure is not treated, it can damage your heart and kidneys, and in some cases lead to stroke, heart attack, heart and/or kidney failure, or blindness.

High blood pressure can be treated and controlled with medicines such as 'Innozide'. Your doctor may also recommend that you make some changes to your lifestyle to help lower your blood pressure, such as losing weight, keeping alcohol intake to a moderate level or avoiding it altogether, stopping smoking, and reducing the amount of salt in your diet. Your doctor may also encourage you to take more mild exercise.

WHAT ELSE SHOULD YOU KNOW BEFORE TAKING YOUR TABLETS?

You should check with your doctor before taking 'Innozide' if:

• you have kidney problems or are on dialysis.
• you have liver problems.
• you are taking medication for diabetes.
• you have a heart problem called 'aortic stenosis', 'hypertrophic cardiomyopathy' or an 'outflow obstruction'.
• you suffer from gout.
• you know that you may have high levels of uric acid in your blood.
• you have been taking diuretic tablets.
• you have had an allergic reaction to lactose, because lactose is one of the inactive ingredients in 'Innozide' Tablets.
• you have a condition known as systemic lupus erythematosus.

While taking 'Innozide' you should be aware of the following:

• If you are about to have a treatment called LDL apheresis, which is removal of cholesterol from your blood by a machine, you should tell the doctor who is treating you that you are taking 'Innozide'.
• If you undergo any surgery or receive anaesthetics (even at the dentist) you should make the doctor or dentist treating you aware that you are taking 'Innozide'.
• If 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 the doctor who is treating you that you are taking 'Innozide'.
• If you are about to have a test to check if your parathyroid glands are working properly (these are glands in your neck which control the level of calcium in your blood), you should tell the doctor who is treating you that you are taking 'Innozide'.
• You should tell your doctor if you have suffered from excessive vomiting and/or diarrhoea.
• In addition to measuring your blood pressure, your doctor may wish you to have a blood test to check that your kidneys are working properly before you start taking 'Innozide' and at intervals during your treatment.
• If you have angina and this gets worse while taking 'Innozide' you should tell your doctor.

HOW SHOULD YOU TAKE 'INNOZIDE'?

You should take your tablets by mouth exactly as advised by your doctor or pharmacist. The number of tablets you take each day will depend upon your condition. For many people this is one tablet, once a day. If necessary the dosage may be increased to two tablets, once a day. Do not take more or less than your doctor has prescribed.

If you are currently taking other diuretic tablets (water tablets) discuss with your doctor before starting to take 'Innozide'.

WHAT UNWANTED EFFECTS COULD YOUR TABLETS HAVE?

Like all medicines, 'Innozide' may occasionally cause side effects in some patients. These are usually mild and in most instances therapy does not need to be stopped.

The most common side effects reported are dizziness and tiredness, which generally respond to dosage reduction and seldom require discontinuation of treatment.

Other side effects are: muscle cramps; nausea; weakness; low-blood-pressure symptoms which may be dizziness or light-headedness, particularly when standing; headache; cough; and inability to achieve or maintain erection in men.

Less common side effects reported are:

• effects on the circulatory system such as faintness; palpitations; increased heart rate; chest pain; difficulty in breathing
• intestinal disorders such as inflammation of the pancreas (an organ lying below and behind the stomach), diarrhoea, vomiting, indigestion, abdominal pain, wind, constipation
• effects on the nervous system such as sleeping disorders, pins and needles, giddiness, vertigo, nervousness.

Other effects are: kidney disorders, kidney failure, dry mouth, gout, ringing sounds in the ears, reduced sexual drive, fever, inflammation of blood vessels, pain and inflammation of muscles and joints, blood disorders affecting the components of the blood and usually detected by blood tests (symptoms may be tiredness, paleness of skin, prolonged bruising after injury), rashes, sensitivity of the skin to light or other skin disorders, excessive sweating.

It is very important that you stop taking 'Innozide' immediately and see your doctor if you have severe dizziness or light-headedness (especially at the start of treatment or when the dose is increased or when you stand up).

It is vital to stop taking 'Innozide' and seek medical attention immediately if you begin to itch, get short of breath or wheezy, develop severe skin rashes and develop swelling of the hands, mouth, throat, face or eyes. If you are a black person you should be aware that black patients are more likely to suffer from these types of reaction.

Additional side effects reported with either enalapril or hydrochlorothiazide are:

Enalapril maleate: an obstruction in the intestine causing abdominal swelling; liver disorders such as inflammation of the liver, flu-like symptoms, jaundice (symptoms may be yellowing of the skin and/or whites of the eyes); depression, confusion; dream abnormalities; abnormal accumulation of substances in the lungs; wheezing; dry cough; nasal discharge; sore throat and hoarseness; effects on the heart and circulation such as chest pain (which may occur after exercise); heart attack; abnormal heart rhythm; stroke; coldness of the hands and feet; hair loss; flushing; taste alteration; loss of appetite; blurred vision; nettle rash; inflammation of the mouth and/or tongue; reduction of urine output; severe skin rashes and sensitivity of the skin to sunlight.

Hydrochlorothiazide: loss of appetite, stomach upset, jaundice (symptoms may be yellowing of the skin and/or whites of the eyes), inflammation of the salivary gland, blood disorders which may only be detected by blood tests (symptoms may be tiredness and/or paleness of skin, bruising of the skin), sensitivity of the skin to sunlight, fever, inflammation of the blood vessels, inflammation of the lungs and fluid on the lungs, allergic type reactions, a severe skin reaction called toxic epidermal necrolysis; presence of sugar in the urine (usually detected by a simple test), changes in the levels in the body of salts (potassium and sodium) which are usually detected by a blood test, nettle rash, inflammation of the kidneys, restlessness, temporary blurred vision and visual changes which can make a colourless object look tinged with yellow.

Whilst you are taking this medicine it may affect tests your doctor may perform on blood and urine samples. Please remind your doctor that you are taking 'Innozide' if ever he/she wants to carry out such a test.

If any of these side effects happen, or you have any other unusual symptoms or feelings, stop taking the tablets and contact your doctor.

HOW SHOULD YOUR TABLETS BE KEPT?

Keep your tablets out of the reach and sight of children.

Do not store above 25°C. Store in the original container.

Do not put them into another container as they might get mixed up.

If you have any tablets left over when your doctor tells you to stop taking them, return them to the pharmacist. Do not take them past the expiry date which is clearly marked on the pack.

REMEMBER: this medicine is for you. Do not share it with anyone else. It may not suit them.

HOW CAN YOU OBTAIN MORE INFORMATION ABOUT 'INNOZIDE'?

This leaflet gives you only the most important patient information about 'Innozide'. If you have any questions after you have read it, ask your doctor or pharmacist, who will give you further information.