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VARBIM XL 1.5 mg PROLONGED-RELEASE TABLETS Indapamide

PACKAGE LEAFLET: INFORMATION FORTHE USER

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 get serious, or if you notice

any side effects not listed in this leaflet, please tell your doctor._

IN THIS LEAFLET:

1.    WhatVarbim XL is and what it is used for

2.    Before you take Varbim XL

3.    How to take Varbim XL

4.    Possible side effects

5.    How to store Varbim XL

6.    Further information

O WHATVARBIM XL IS ANDWHAT IT IS USED FOR

Varbim XL 1.5 mg Prolonged-releaseTablets, belong to a class of medicines called "diuretics" which increase urine production by the kidneys.

Varbim XL is used to treat high blood pressure.

BEFOREYOUTAKEVARBIM XL

Do not take Varbim XL if you:

•    are allergic (hypersensitive) to indapamide or any of the other ingredients of this medicine

•    are allergic (hypersensitive) to other medicines in the same chemical class as indapamide ("sulphonamides"), such as trimethoprim or co-trimoxazole

•    have severe liver disease or a condition called hepatic encephalopathy (damage to the brain and nerves which can occur as a complication of liver problems)

•    have severe kidney disease

•    have been told by your doctor that you have low levels of potassium in your blood.

Take special care with Varbim XL Tell your doctor before you start to take this medicine if you suffer from or have previously suffered from any of the following:

•    Heart disease, heart failure or heart rhythm problems

•    Diabetes (please check your blood sugar levels regularly)

•    Gout

•    Kidney problems

•    Liver problems.

Indapamide affects the levels of potassium and sodium in the blood.Your doctor may conduct blood tests to monitor levels of potassium and sodium in your blood before and during your treatment.This is especially important in patients at high risk of developing electrolyte disturbances (such as the elderly, patients taking several other medicines or patients with a poor diet).

Varbim XL may increase the sensitivity of your skin to sunlight. If this happens you should tell your doctor as he/she may decide to stop your treatment. If your doctor decides to restart or continue your treatment you should take measures to protect your skin from the sun and should avoid exposure to artificial UVA (e.g. tanning machines).

If the performance of your parathyroid gland is due to be evaluated, then tell your doctor. Your doctor may advise you to stop taking your tablets in advance of your test. Athletes should be aware that Varbim XL may give a positive reaction in drug tests.

If you think any of these situations may apply to you or you have any questions or doubts about taking your medicine, you should consult your doctor or pharmacist. 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 effects ofVarbim XL may be altered or undesirable effects may occur if you are also taking the following medicines. Talk to your doctor if you are taking any of the following:

• Lithium (used in the treatment of depression): you should not take Varbim XL with lithium due to the

risk of increased levels of lithium in the blood unless your doctor considers it to be absolutely necessary

•    Quinidine, hydroquinidine, disopyrimide, amiodarone, sotalol, dofetilide or ibutilide (used in the treatment of irregular heartbeat)

•    Medicines used in the treatment of schizophrenia such as chlorpromazine, thioridazine, amisulpride or haloperidol

•    Metformin (used in the treatment of diabetes)

•    Baclofen (used in the treatment of muscle spasm)

•    Ciclosporin and tacrolimus (used forthe treatment of auto-immune disorders or to suppress the immune system following a transplant)

•    Erythromycin injection, pentamidine, moxifloxacin, sparfloxacin and amphoteracin B injection (used for treatment of infection)

•    Mizolastine (used in the treatment of allergy)

•    Bepridil (used for the treatment of angina)

•    Cisapride and Diphemanil (used forthe treatment of gastro-intestinal problems)

•    Halofantrine (used for the treatment of malaria)

•    Vincamine injection (used to treat circulatory problems in the brain)

•    Steroids (e.g. prednisolone, hydrocortisone or fludrocortisone) used to treat various conditions including severe asthma and rheumatoid arthritis

•    Stimulant laxatives (e.g. senna)

•    Non-steroidal anti-inflammatory drugs (sometimes called N.S.A.I.D's) used in the treatment of pain and inflammation (e.g. ibuprofen, diclofenac and indometacin) and cyclo-oxygenase-2 (COX-2) inhibitors (such as celecoxib and etoricoxib)

•    High doses of aspirin (3 g or more a day)

•    ACE inhibitors used to treat high blood pressure and heart failure (e.g. captopril, enalapril, perindopril)

•    Some medicines used to treat heart failure (e.g. digoxin, digitoxin)

•    Some potassium-sparing diuretics (water tablets) such as amiloride, spironolactone, triamterene

•    Certain water tablets which may cause a decrease in the levels of potassium in your blood such as bendroflumethiazide, furosemide, piretanide, bumetanide and xipamide

•    Some antidepressants (e.g. imipramine) and neuroleptics (used to treat mental disorders)

•    Some iodine containing medicines (used in the diagnosis of some illnesses)

•    Tetracosactide (used in the diagnosis of some illnesses and treatment of gastro-intestinal problems)

•    Medicines containing calcium.

Taking Varbim XL with food and drink

Food and drink have no impact on the way that your medicine works. You may take it with or after food or on an empty stomach.

Pregnancy and breast-feeding

The use ofVarbim XL is not recommended if you are pregnant, breast-feeding or trying to have a baby. Consult your doctor if any of these situations apply to you. Driving and using machines

Varbim XL lowers blood pressure which may make you feel light-headed and dizzy, especially at the start of treatment or when another medicine to reduce or control high blood pressure is added to your treatment. If affected do not drive or operate heavy machinery. Important information about some of the ingredients ofVarbim XL

Your medicine contains the sugar lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

HOWTO TAKE VARBIM XL

Always take Varbim XL exactly as your doctor has told you. You should check with your doctor if you are not sure. The usual dose is 1 tablet per day which should preferably be taken in the morning. Your tablets should be swallowed whole with a sufficient amount of water. Do not crush or chew the tablets.

Patients with kidney problems

Patients with severe kidney problems should not take Varbim XL (see section 2 "DO NOTTAKE"). Varbim XL are fully effective only when your kidneys work properly or are only slightly impaired. Ask your doctor if unsure. Patients with liver problems

Patients with severe liver problems should not take Varbim XL (see section 2 "DO NOTTAKE").

Elderly

Elderly patients can be treated with Varbim XL provided that your kidneys are healthy or are only slightly impaired. Children and adolescents

Varbim XL is not recommended for use in children and

adolescents due to a limited experience in these age groups.

Duration of treatment

Your doctor will decide the duration of treatment.

Do not change the dose, even if you think yourVarbim XL is not working properly. If this is the case, consult your doctor.

If you take more Varbim XL than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Symptoms of an overdose may include nausea, vomiting, low blood pressure (leading to lightheadedness), cramps, dizziness, drowsiness, confusion, excessive production of urine or low production of urine. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Varbim XL

If you forget to take a tablet then take it as soon as you remember. However, do not take a double dose to make up for a forgotten dose.

If you stop taking Varbim XL Treatment for high blood pressure is normally life-long. You should not stop taking your medicine without discussing it with your doctor first.

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

POSSIBLE SIDE EFFECTS

Like all medicines, Varbim XL can cause side effects, although not everybody gets them.

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    An allergic reaction (swelling of the face, lips, tongue, throat or airways leading to severe difficulty in breathing; skin rash or hives)

•    An allergic reaction with flu like symptoms, blistering of the skin, mouth, eyes and genital organs (toxic epidermic necrolysis or Steven Johnson syndrome).

These are very serious but rare side effects.You may need urgent medical attention or hospitalisation.

The following side effects have been reported at the approximate frequencies shown:

Common (affecting fewer than one person in 10 but more than one person in 100):

•    Low levels of potassium in the blood which may cause muscle weakness.Your doctor may monitor these levels via blood tests (see above - "Take Special Care with Varbim XL")

•    Allergic reaction (especially in people who are prone to allergic reactions and asthma attacks) leading to skin rashes with macules (flat discoloured area) and papules (small raised lumps).

Uncommon (affecting fewer than one person in 100 but more than one person in 1,000):

•    Vomiting

•    Allergic reaction (especially in people who are prone to allergic reactions and asthma attacks) leading to purple spots or patches on the skin.

Rare (affecting fewer than one person in 1,000 but more than one person in 10,000):

•    Dizziness (vertigo)

•    Tiredness

•    Headache

•    Pins and needles (paresthesia)

•    Nausea (feeling sick)

•    Constipation (infrequent bowel movements; hard, dry stools)

•    Dry mouth.

Very rare (affecting fewer than one person in 10,000):

•    Reduction in blood platelets, which increases risk of bleeding or bruising

•    Reduction in the number of white blood cells (leucopenia), which makes infections more likely and may be serious (agranulocytosis) or bone marrow suppression (aplastic anaemia). If you suffer from unexplained fever, soreness of the throat or other flu-like symptoms then contact your doctor straight away as this could indicate that levels of white blood cells in your blood are too low

•    Reduction in levels of red blood cells (anaemia) which can cause weakness, paleness, a fast heartbeat and breathlessness

•    Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis)

•    Irregular heart beat

•    Low blood pressure, which may cause lightheadedness

•    Kidney problems

•    Liver problems (detected by blood tests)

•    Increases in the levels of calcium in your blood

•    Serious allergic reactions (angioedema, especially in people who are prone to allergic reactions and asthma attacks) with swelling of the face, lips, tongue, throat or airways and nettle rash.The swelling of the throat or airways may cause shortness of breath or difficulty in swallowing. If this occurs, contact your doctor immediately

•    Serious allergic reaction with flu like symptoms, blistering of the skin, mouth, eyes and genital organs (toxic epidermic necrolysis or Steven Johnson syndrome). If this occurs, contact your doctor immediately.

The following side effects may also occur. However, based on available data it is not possible to give an indication of how common these are:

•    Varbim XL may cause low levels of sodium and potassium in your blood.Your doctor may monitor these levels via blood tests (see above - "Take Special Care with Varbim XL")

•    Varbim XL may cause a decrease in your blood volume (hypovolaemia) with a loss of water and a fall in the blood pressure on standing up (orthostatic hypotension)

•    Varbim XL may cause low levels of chloride in your blood, which may lead to a metabolic alkalosis (low acidity of the blood)

•    Varbim XL may increase the levels of sugar in your blood

•    If you have existing liver problems, taking Varbim XL may cause a condition called hepatic encephalopathy (damage to the brain and nerves which can occur as a complication of liver disease)

•    If you suffer from a condition called "acute disseminated lupus erythmatosus" (rare, widespread inflammatory disease), taking Varbim XL may worsen the disease

•    Taking Varbim XL may make your skin more sensitive to UV light (see "Take Special Care with Varbim XL" above)

•    Varbim XL may cause high levels of uric acid in your blood leading to gout attacks (painful swelling and redness in the joints, most commonly in the big toe).

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

HOWTO STORE VARBIM XL

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use Varbim XL after the expiry date that is stated on the carton.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.

FURTHER INFORMATION

WhatVarbim XL contains:

•    The active substance is indapamide. Each tablet contains 1.5 mg indapamide

•    The other ingredients are: lactose monohydrate, pregelatinised starch, hypromellose, colloidal silicon dioxide, magnesium stearate, macrogol 6000, titanium dioxide.

WhatVarbim XL looks like and contents of the pack:

•    White to off-white, round shaped, prolonged-release, film-coated tablets

•    The tablets are packed in blister packs of 14, 15, 28, 30, 50, 60, 90, 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder:TEVA UK Limited, Eastbourne, BN22 9AG.

Manufacturer: IVAX Pharmaceuticals s.r.o, Ostravska 29/305, 747 70 Opava-Komarov, Czech Republic.

This leaflet was last revised: April 2008. PL 00289/1038

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TEVA UK LIMITED