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PATIENT INFORMATION LEAFLET

INDAPAMIDE 2.5 mg TABLETS

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

•    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 personally and you should not pass it on to others. It may harm them even if their symptoms are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Indapamide is one of a group of medicines called anti-hypertensives. Indapamide is a diuretic. It acts on the kidneys to remove more water from the body, thereby increasing the volume of urine. It reduces blood pressure by reducing the volume of the blood and the work required by the heart.

Indapamide is used to treat high blood pressure (hypertension).

Do not take Indapamide 2.5mg Tablets if you:

•    have an allergy (hypersensitive) to indapamide or any of the other ingredients of Indapamide 2.5mg Tablets.

•    are allergic (hypersensitive) to sulphonamides (e.g.co-trimoxazole, used to treat infections)

•    have severe kidney disease

•    have severe liver disease or suffer from a condition called hepatic encephalopathy (liver problems which affect the brain and central nervous system)

•    have been told that you have low levels of potassium in your blood (hypokalaemia) which may cause muscle weakness or paralysis

Warnings and precautions

Talk to your doctor or pharmacist before using Indapamide 2.5mg Tablets if you:

•    have recently suffered a stroke

•    are pregnant, planning to become pregnant or are breast-feeding

•    are diabetic

•    suffer from gout

•    have very low levels of sodium in your blood, which may be caused by excessive sweating, vomiting or reaction to another drug.

•    have liver problems

•    need to have a test to check how well your parathyroid gland is working

•    have any heart rhythm problems such as irregular heartbeat.

You should tell your doctor if you have had photosensitivity reactions or are to expose your skin to UVA light or the sun.

You should visit your doctor regularly while you are taking this medicine, as he/she may wish to carry out some tests to check for low sodium or potassium levels or high calcium levels

Athletes: This drug contains an active ingredient that may give a positive reaction in doping tests. Other medicines and Indapamide:

Please tell your doctor if you have taken or are taking any other medicines, even those obtained without a prescription or herbal medicines.

You should NOT take Indapamide with Lithium used to treat depression due to the risk of increased levels of lithium in the blood.

You should consult your doctor BEFORE taking any other medicines, especially the following:

•    Medicines used to treat an abnormal heartbeat such as quinidine or cardioglycosides (e.g. digoxin, soltalol, hydroquinidine, disopyramide, amiodarone, ibutilide, dofetilide).

•    Digitalis preparations (e.g. digoxin, digitoxin) used to treat heart failure

•    ACE Inhibitors, angiotensin converting enzyme inhibitors e.g. captopril used in the treatment of high blood pressure

•    Potassium sparing diuretics (e.g. amiloride, spironolactone, triamterene), which increase the flow of urine without excessive loss of potassium

•    Bepridil, used to treat angina pectoris, a condition causing chest pain

•    Cisapride, used to treat reduced movement of the gullet and stomach and bowel constipation.

•    Carbenoxolone, diphemanil, used in the treatment of ulcers

•    Diuretics (e.g. bumetanide, furosemide, piretanide, thiazides or xipamide) that are used to increase the flow of urine.

•    Astemizol, terfenadine or mizolastine (anti-histamines), intravenous erythromycin, sparfloxacin,moxifloxacin (antibiotics), halofantrine (anti-malarial drug)

•    Pentamidine used to treat certain types of pneumonia

•    Baclofen, to treat muscle stiffness occurring in diseases such as multiple sclerosis

•    NSAIDs-non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen), used in the management of arthritis.

•    Amphotericin B, used to treat fungal infections

•    Stimulant laxatives, which are used for constipation.

•    Metformin -used in the treatment of diabetes

•    Anti-depressants and neuroleptics e.g. sultopride, tricyclic antidepressants, antipsychotic drugs used to treat mental disorders such as depression, anxiety, schizophrenia

•    Calcium tablets or supplements.

•    Ciclosporin, tacrolimus or other medicines to depress the immune system after organ transplantation, to treat autoimmune diseases or severe rheumatic or skin diseases

•    Corticosteroids used to reduce inflammation, treatment in severe asthma and rheumatoid arthritis

•    Tetracosactide to treat Crohn’s disease

Tell your doctor if you need to have tests requiring administration of iodinated contrast media. Pregnancy, breast-feeding and fertility

Do not take this medicine without consulting with your doctor if you are pregnant, planning to become pregnant or are breast-feeding. This medicine is not recommended during pregnancy or while breastfeeding.

Driving and using machines

As this medicine may make you feel dizzy or cause other symptoms; you should not drive or operate machinery until you know how the drug affects you.

Important information about some of the ingredients of Indapamide

Indapamide 2.5mg Tablets contain Lactose Monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take Indapamide 2.5mg Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults only

The usual dose is one tablet to be taken in the morning.

Use in children and adolescents (<18 years of age)

Indapamide 2.5mg tablets are not recommended for use in children or adolescents.

How to take Indapamide 2.5mg tablets

You should take your tablets in the morning before breakfast. The tablets should be swallowed with water.

If you take more Indapamide 2.5mg Tablets than you should

If you or anybody else has taken too many tablets you should contact your nearest hospital casualty department or doctor immediately. A very large dose of Indapamide 2.5mg Tablets can cause nausea (feeling sick), vomiting, low blood pressure, cramps, dizziness, drowsiness, confusion and changes in the amount of urine produced by the kidneys.

If you forget to take Indapamide 2.5mg Tablets

If you forget to take a dose, take the next dose as soon as you remember, then go on as before. If you miss a day, do not take a double dose the following day, but continue as prescribed by your doctor. Do not take a double dose to make up for the forgotten dose.

If you stop taking Indapamide 2.5mg Tablets

As the treatment for high blood pressure is usually life-long, you should discuss with your doctor before stopping this medicinal product.

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

Like all medicines, Indapamide 2.5mg Tablets can cause side effects, although not everybody gets them.

Stop taking Indapamide immediately and see your doctor or go to a hospital straight away if:

•    You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You may also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Indapamide tablets.

•    You get a severe blistering rash where layers of skin peel off leaving scalded skin. You may also have a fever. This could be an indicator for an illness called ‘Toxic Epidermal Necrolysis’

•    You get a skin rash with dark circles and pale centres, red patches, blistering or peeling. You may also have a fever. This could be indicator for an illness called ‘Erythema multiforme’ or ‘Steven-Johnson syndrome’.

Tell your doctor as soon as possible if you have any of the following side-effects:

•    You feel tired, weak, confused and have muscles that ache, are stiff or do not work well. This may be due to low sodium levels in your blood (hyponatraemia).

•    You feel irritable and your muscles twitch. This may be due to an imbalance in your blood called metabolic acidosis.

•    Itchy, lumpy rash. You may also have a high temperature, sore throat, headache or diarrhoea.

•    You get more infections than usual or bruise more easily. This could be caused by problems with your blood.

•    You get increased thirst, hunger and weight loss. This could be a sign of diabetes.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet:

Common (may affect up to 1 in 10 people):

•    Low potassium in the blood, which may cause muscle weakness, red raised skin rash.

Uncommon (may affect up to 1 in 100 people):

• Vomiting, red or purple spots beneath the skin (purpura).

Rare (may affect up to 1 in 1,000 people):

•    Nausea (feeling sick), constipation, dry mouth, vertigo (dizziness due to an imbalance in the ear), tiredness and headache.

•    Pins and needles or tingling sensation of the skin

•    Increased risk of dehydration in the elderly and in patients suffering from heart failure

•    Feeling of the heart pounding (palpitations)

Very rare (may affect up to 1 in 10,000 people):

•    An increase in uric acid or glucose in the blood. A slight reduction in glucose tolerance in patients with diabetes.

•    A change in acidity of the blood.

•    Irregular heart rhythm, low blood pressure.

•    Kidney disorders- causing symptoms of tiredness, increased need to urinate, itchy skin, feeling sick, swollen extremities.

•    Pancreatitis, an inflammation of the pancreas, usually marked by abdominal pain, often radiating to the back, nausea and vomiting.

•    Abnormal liver function with yellowing of the skin (symptoms such as tiredness, loss of appetite, feeling or being sick, swollen extremities). Changes in blood cells, such as thrombocytopenia (decrease in the number of platelets which causes easy bruising and nasal bleeding), leucopenia

and agranulocytosis (decrease of white blood cells which may cause unexplained fever, soreness of the throat or other flu like symptoms)

•    Anaemia (decrease in red blood cells)

•    Angioedema and/or urticaria, with swelling of the skin around the eyes, lips, hands or feet. It may cause swelling of the throat, tongue and airways resulting in shortness of breath or difficulty in swallowing.

•    A severe blistering rash where layers of skin peel off leaving scalded skin. You may also have a fever. This could be an illness called ‘Toxic Epidermal Necrolysis’

•    A skin rash with dark circles and pale centres, red patches, blistering or peeling. You may also have a fever. This could be an illness called ‘Erythema multiforme’ or ‘Steven-Johnson syndrome’.

Not known (frequency cannot be estimated from the available data):

•    If you suffer from systemic lupus erythematosus (a disorder of the immune system leading to inflammation and damage to the joints, tendons and organs), this might get worse. Cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been reported.

•    Abnormal ECG heart tracing

•    Life-threatening irregular beat (Torsades de Pointes)

•    In cases of liver failure, there is a possibility of getting hepatic encephalopathy (liver problems which affect the brain and central nervous system)

•    Hepatitis

•    Fainting

Some changes to your blood may occur. Your doctor may want to give you a blood test to check your condition. The following changes in your blood test results may occur:

•    Low potassium in the blood

•    Low sodium in the blood that may lead to dehydration and low blood pressure

•    Increase in uric acid, a substance that may cause or worsen gout (painful joints especially in the feet)

•    Increase in blood glucose levels in diabetic patients

•    Increase in calcium levels in the blood

•    Increased levels of liver enzymes

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

Store below 25^o C in the original package to protect from moisture.

Do not use after the expiry date shown on the label.

Return any left over tablets to your pharmacist. Only keep them if your doctor tells you to. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

What Indapamide 2.5mg Tablets contain

Indapamide 2.5mg tablets contain the active ingredient Indapamide (as hemihydrate)

The tablet core also contains lactose monohydrate, maize starch, povidone, magnesium stearate. The tablet coating contains Opaseal varnish, purified talc, calcium carbonate, acacia, sucrose, titanium dioxide (E171), Opaglos 6000P

What Indapamide 2.5mg Tablets look like and contents of the pack

Indapamide 2.5mg tablets are white, circular, coated tablets printed “I”. Each tablet contains 2.5mg of indapamide equivalent to 2.5mg indapamide hemihydrate, the active ingredient.

Pack sizes: 28, 30, 50, 56, 60, 100, 120 and 250 tablets.

Not all pack sizes may be marketed.

Product Licence Holder:

Athlone Pharmaceuticals Limited, Ballymurray, Co.Roscommon, Ireland.

Distributed by:

Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL, U.K PL 30464/0030

This leaflet was last revised: October 2014