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PACKAGE LEAFLET: INFORMATION FOR THE USER

Indapamide 2.5mg Tablets

Indapamide

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need 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 gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

1. WHAT INDAPAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Indapamide 2.5mg Tablets. They contain the active ingredient called Indapamide.

Indapamide Tablets belong to a group of medicines called anti-hypertensives. This medicine is used to treat high blood pressure and works by causing the kidneys to get rid of unneeded water and salt from the body into the urine.

2. BEFORE YOU TAKE INDAPAMIDE TABLETS

Do not take Indapamide Tablets if you:

♦    are allergic (hypersensitive) to Indapamide or any of the other ingredients of Indapamide Tablets. See section 6.

♦    have or ever had severe kidney failure

♦    have or ever had severe liver problems

♦    have or ever had any serious allergic reaction to sulphonamides (e.g. co-trimoxazole)

Take special care with Indapamide Tablets if you:

Tell your doctor before you start to take this medicine if you:

♦    have or have ever had liver problems

♦    have or have ever had kidney problems

♦    have or have ever had heart rhythm problems

♦    have diabetes

♦    suffer from porphyria (abnormalities in the chemical steps that lead to the production of heme, a component of your blood and bone marrow)

♦    have or ever had severe pain and swelling in the joints

♦    have or ever had thyroid, or parathyroid disease (which causes too low/high calcium levels in the bloodstream)

♦    have been told by your doctor that you have low levels of potassium in your blood (hypokalaemia)

Taking Indapamide Tablets with food or drink Follow your doctor's directions. They may include a daily exercise program and a low-sodium or low-salt diet, potassium supplements, and increased amounts of potassium-rich foods (e.g., bananas, prunes, raisins, and orange juice) in your diet.

Effects on laboratory tests

♦    Indapamide Tablets may lower potassium levels and your doctor may monitor this by means of blood tests

♦    Blood calcium levels may need to be monitored in those patients suffering from overactivity of the parathyroid gland

*    Blood glucose levels may need to be monitored as this medicine may affect them

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly, and blood tests should be done occasionally.

Athletes - This drug contains the active ingredient that may give a positive reaction in the doping tests.

Taking other medicines

You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with your Indapamide Tablets.

Examples of medicines that can affect Indapamide Tablets are:

*    carbenoxolone, which is used in the treatment of ulcers)

*    diuretics or "water tablets”, such as bumetanide, furosemide, thiazides and xipamide

*    diuretics or "water tablets” such as amiloride, spironolactone and triamterene which increase the flow of urine without excessive loss of potassium.

*    Lithium, an antidepressant

*    quinidine or cardioglycosides, such as digoxin, disopyramide, amiodarone and sotalol, which are used to treat abnormal heart beat

*    lidocaine, flecainide and mexiletine, which are used to treat irregular heart beat

*    Intravenous erythromycin, an antibiotic

*    pentamidine, which is used in the treatment of protozoal infections

*    prazosin, which is used to treat high blood pressure

*    antiepileptics such as oxcarbazepine

*    anti-psychotics such as pimozide and sertindole, which are used to treat some mental disorders

*    baclofen, which is a muscle relaxant

*    ACE inhibitors (angiotensin converting enzyme inhibitors) such as e.g. captopril, which are used in the treatment of high blood pressure

*    NSAIDs (non- steroidal anti-inflammatory drugs) such as aspirin and Ibuprofen, which are used in the management of arthritis

*    amphotericin B, which is used to treat fungal infections

*    tetracosactide, which is used to assess adrenal gland function

*    stimulant laxatives, which are used for constipation

*    metformin, which is used in the treatment of diabetes

*    anti-depressants and neuroleptics, which are used to treat mental disorders

*    calcium salts

*    ciclosporin and tacrolimus, which are used in patients who have had an organ transplant

*    tetracosactide or corticosteroids, which are used to reduce inflammation

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Pregnancy and Breast-feeding

Tell your doctor if you are pregnant, planning to become pregnant or if you are breast - feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Indapamide Tablets may cause dizziness. Do not drive a car or operate machinery in such a case.

Important information about some of the ingredients of Indapamide Tablets

This medicinal product contains Lactose 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 or pharmacist if you are not sure.

Dosage - You should swallow the tablet whole with a glass of water.

Adults and Elderly: The normal dosage is one tablet (2.5mg) each day which should be swallowed with a glass of water It is advised that the tablet be taken in the morning before breakfast. Treatment for high blood pressure is usually life-long. Your doctor may prescribe this medicine with other blood pressure lowering agents. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Children: Not recommended for children.

If you take more Indapamide Tablets than you should

If you take more Indapamide Tablets than you should, contact your doctor or nearest hospital emergency department immediately. Take the pack and remaining tablets with you.

If you forget to take Indapamide Tablets

If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Indapamide Tablets

Do not stop taking Indapamide Tablets without talking to your doctor, even if you feel better. It is important that you take the full course of Indapamide prescribed by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Very serious side effects - If any of the following happens, stop taking IndapamideTablets and tell your doctor immediately or go to the nearest hospital emergency department:

♦    Rare allergic (Hypersensitive) reactions such as difficulty of breafh-ing, swelling of your face, throat or tongue, skin rash, itching or nettle rash.

Common (occurring in less than 1 in 10 patients)

♦    felling sick

♦    constipation

♦    dry mouth

♦    dizziness

♦    fainting

♦    impotence

♦    problems in seeing long distant objects

♦    musclecramps

♦    headache

♦    lower than normal level of potassium in the blood, rarely leading to palpitations (feeling your heart beat).

♦    lower than normal level of sodium in the blood with a drop in the blood volume leading to dehydration and low blood pressure on standing.

♦    an increase in uric acid or glucose in the blood.

♦    a slight reduction in glucosefolerance in patients with diabetes.

♦    metabolic acidosis (excess of acid in your blood)

♦    kidneydamage

Rare (occurring in less than 1 in 1,000 patients)

♦    blood disorders (including effects on blood clotting, ability to flight infections and anaemia).

♦    an increase in the level of calcium in the blood.

Very rare (occurring in less than 1 in 10,000 patients)

♦    diabetes mellifus

♦    acute hepatitis (a liver disorder)

♦    pancreatitis (Inflammation of the pancreas), which causessevere pain in the abdomen and back)

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.

5. HOW TO STORE INDAPAMIDE TABLETS

Keep out of the reach and sight of children.

Do not store the tablets above 25°C. Store in the original container (in case of Tablet containers) or in the original package (in case of blisters). Keep them in the original pack. Do not use these tablets after the expiry date shown on the pack. The expiry date refers to the last day of that month.

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.

6. FURTHER INFORMATION

What Indapamide Tablets contains:

The active substance is Indapamide. The other ingredients are Lactose monohydrate, Maize Starch, Povidone, Magnesium Stearate, Polyvinyl Acetate Phthalate, Stearic acid, Purified Talc, Calcium Carbonate, Acacia, Sucrose, Opaseal, Opaglos 6000 P, Industrial Methylated Spirit, Ethyl Acetate, Titanium Dioxide E171 and Opacode S-1-8152HV

What Indapamide Tablets looks like and contents of the pack:

Indapamide 2.5 mg tablets are white, biconvex, sugar-coated tablet. Pack sizes:

28, 30, 50, 56, 60 and 100 tablets in blisters and 30, 50, 60, 100 and 250 in containers.

Not all pack sizes may be marketed.

Marketing Authorisation Holder: Special Concept Development (UK) Ltd. Unit 1-7 Colonial Way, Watford, Heardfordshire, WD24 4YR. UK. Manufacturer:

LPC Medical (UK) Limited, 30 Chaul End Lane, Luton, Bedfordshire, LU4 8EZ, U.K. This leaflet was last revised in: February 2014