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PACKAGE LEAFLET: INFORMATION FOR THE USER

Indapamide 2.5 mg

Active substance: indapamide

In this leaflet:

1.    What indapamide is and what it is used for

2.    Before you take indapamide tablets

3.    How to take indapamide tablets

4.    Possible side effects

5.    How to store indapamide tablets

6.    Further information

1. What indapamide is and what it is used for

Indapamide is a diuretic (water tablet) which belongs to a group of medicines called sulphonamides. Diuretics increase the amount of water and salts (mostly sodium and chlorides) you pass in your urine. This essentially reduces blood pressure.

Indapamide tablets are used to:

- treat high blood pressure (essential hypertension)

2. Before you take indapamide tablets

Do NOT take indapamide tablets:

-    if you are allergic (hypersensitive) to

-    indapamide

-    sulphonamides (chemically related to indapamide)

-    any of the other ingredients of indapamide tablets (see section 6 “Further information”)

-    if you suffer from

-    severe kidney failure

-    severe impairment of the liver function

-    hepatic encephalopathy

This is a liver disease causing symptoms that affect your central nervous system such as changes in mood, confusion or drowsiness.

-    hypokalaemia (low potassium levels in your blood)

-    if you recently suffered a stroke

Take special care with indapamide tablets:

-    if your liver is not working well, indapamide may cause hepatic encephalopathy. In this case, your doctor will stop your treatment with indapamide tablets.

-    Diuretics may lead to low blood levels of sodium (hypo-natraemia) or potassium (hypokalaemia). Therefore, your doctor will monitor these chemicals in your blood before and during treatment. This is especially important if you:

-    are elderly

-    are malnourished

-    are taking many medicines

-    have liver cirrhosis (a chronic liver disease) with or without swelling (oedema or ascites)

-    have a coronary artery disease or heart failure

-    have certain abnormal patterns on your heart tracing (ECG - electrocardiogram). Hypokalaemia can lead to severe changes in heartbeat, which may sometimes be life-threatening.

-    if you have diabetes, you must check your blood sugar levels regularly. This is especially important if you have low potassium levels in your blood.

-    if you have kidney problems, these can worsen, particularly at the start of treatment. Tell your doctor if your kidneys are not working well before you start taking indapamide tablets.

-    if you have gout, you may experience gout attacks more often.

-    if you suffer from Addison's disease. This can make you feel tired and weak.

-    if you have high levels of calcium in the blood (hypercal-caemia). This may be due to over activity of your parathyroid glands (hyperparathyroidism). If the function of your parathyroid gland is to be examined tell your doctor, who will suspend your treatment with indapamide tablets.

If any of the above applies to you or you have suffered from any of these conditions in the past, tell your doctor before you start treatment.

Indapamide tablets contain an ingredient that may give a positive reaction in doping tests.

A slight weight loss has been reported in some patients taking indapamide.

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.

The following medicines should not be combined with indapamide tablets:

Lithium: It is not recommended to take indapamide tablets during a treatment with lithium. Tell your doctor if you are already taking lithium. Your doctor will take appropriate action.

-    medicines that may cause problems in your heartbeat when taken together with indapamide tablets, such as:

-    halofantrine

-    pentamidine

-    vincamine (IV)

-    terfenadine

-    astemizole

-    erythromycin (IV)

-    sultopride

Please consult your doctor if you are taking:

-    medicines used to treat disorders in your heartbeat, such as:

-    quinidine

-    hydroquinidine

-    disopyramide

-    amiodarone

-    sotalol

-    bretylium

-    some medicines used to treat high blood pressure (angiotensin converting enzyme (ACE) inhibitors, such as captopril, enalapril, lisinopril, ramipril)

-    some neuroleptics (medicines to treat psychosis, a mental illness), such as:

-    phenothiazines (chlorpromazine, thioridazine)

-    certain antidepressants (medicines to treat depression) belonging to the group of imipramines

-    pain-relieving medicines (non-steroidal anti-inflammatory drugs, also known as NSAIDs, e.g. aspirin and ibuprofen) or high doses of salicylic acid

-    medicines to treat infections: amphotericin B (IV)

-    steroids (corticosteroids such as prednisolone, cortisol and tetracosactide) and steroid inducing hormones

-    certain water tablets (diuretics such as amiloride, spironolactone, triamterene, furosemide, piretanide, bumeta-nide, thiazides and xipamide)

-    digitalis preparations (heart medication, such as digoxin)

-    metformin (tablets to treat diabetes)

-    baclofen (a muscle relaxing drug)

-    laxatives (medicines to treat constipation)

-    medicines that suppress the immune system (ciclosporin)

-    calcium supplements

-    iodinated contrast media (used to help in examinations such as X-rays)

- carbenoxolone (medicine to treat oesophageal ulceration) Taking indapamide tablets with food and drink:

As far as it is known, indapamide tablets are not influenced by food and drink.

Pregnancy and breast-feeding:

Do not take indapamide tablets if you are pregnant. It may harm the unborn child. Tell your doctor if you are pregnant, think you might be pregnant or if you intend to become pregnant.

Do not take indapamide tablets while breast-feeding. Inda-pamide is passed to your baby through your breast milk. If you have to continue treatment with indapamide tablets, you should stop breast-feeding.

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

Driving and using machines:

Indapamide may have little effect on the ability to drive or to use machines. Especially at the start of treatment dizziness may occur. Do not drive or use machines if you are affected.

Important information about some of the ingredients of indapamide tablets:

This medicine contains lactose (milk sugar) and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take indapamide tablets

Always take indapamide tablets exactly as your doctor has told you. You should check with your doctor if you are not sure.

The usual dose is one tablet daily, taken in the morning. Swallow the tablets with water.

Do not increase the dose if you think indapamide tablets are not working properly. If this is the case, consult your doctor. At higher doses the blood pressure reducing effect is not enhanced, but the excretion of salt in urine is increased.

If you take more indapamide tablets than you should:

Tell your doctor or pharmacist or telephone your nearest casualty department. Remember to take the pack and any remaining tablets with you.

If you forget to take indapamide tablets:

If you forget to take a dose of indapamide tablets, do not worry. Just take the next dose at the usual time. Do not try to make up for the missed dose.

If you stop using indapamide tablets:

Do not stop or change your treatment before talking to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

tations), irregular heart rate (arrhythmia). These could be signs of dehydration. Severe dehydration can also lead to blood clots or ‘gout'.

- Photosensitivity reaction (an excessive sensitivity of the skin to sunlight, increasing the risk of sunburn)

Common:

-    low levels of potassium in the blood (hypokalaemia) Rare:

-    feeling of pins and needles (paraesthesia)

-    nausea (feeling sick)

-    constipation (infrequent bowel movements; hard, dry stools)

-    diarrhoea

-    indigestion

-    loss of appetite

-    dry mouth

-    reversible short sightedness

-    kidney problems (renal insufficiency)

Very rare:

-    high levels of calcium in the blood (hypercalcaemia)

-    low blood pressure (hypotension)

-    changes in your blood counts, such as

-    low levels of platelets (thrombocytopenia)

-    low levels of white blood cells (leucopenia), which may be severe (agranulocytosis)

-    aplastic anaemia (a bone marrow depression)

-    haemolytic anaemia (anaemia caused by an abnormal breakdown of red blood cells)

-    inflammation of the pancreas

-    abnormal liver function (detected by blood tests) Unknown frequency:

-    low levels of sodium in the blood (hyponatraemia)

-    decreased blood volume (hypovolaemia) with

-    dehydration

-    orthostatic hypotension (fall in the blood pressure on standing up)

-    low levels of chloride in the blood, which may lead to

-    metabolic alkalosis (low acidity of the blood)

-    increased blood sugar levels

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.