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What is in this leaflet:

1.    What Irbesartan is and what it is used for

2.    What you need to know before you take Irbesartan

3.    How to take Irbesartan

4.    Possible side effects

5.    HowtostoreIrbesartan

6.    Contents of the pack and other information.

1.    What Irbesartan is and what it is used for

Irbesartan belongs to a group of medicines known as angiotensin-ll receptor blocker. Angiotensin-ll is a substance produced in the body which binds to receptors in blood vessels causing narrowing of blood vessels. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-ll to these receptors, causing the blood vessels to relax and the blood pressure to lower. Irbesartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Irbesartan is used in adults for the treatment of high blood pressure (essential hypertension) and for the protection of the kidney in hypertensive patients, type 2 diabetic patients and laboratory evidence of impaired kidney function.

2.    What you need to know before you take

Irbesartan_

Do not take Irbesartan

if you are allergic to irbesartan or any of the other ingredients of Irbesartan this medicine (listed in section 6). An allergic reaction may include rash, itching, swelling of face, lips, or hands/feet, or breathing difficulties.

•    if you are more than 3 months pregnant (It is also better to avoid irbesartan in early pregnancy-see pregnancy section).

Irbesartan should not be given to children and adolescents (under 18 years)

Ask your doctor if you are not sure whether you can take Irbesartan.

If you think this apply to you, do not take the tablets, talktoyourdoctor and follow the advice given.

Warnings and precautions

Talk to your doctor or pharmacist before taking Irbesartan

•    if you suffer from excessive vomiting or diarrhoea.

•    if you are on diuretic (watertablet) therapy or on restricted dietary salt intake.

•    if you suffer from renovascular hypertension

[hypertension due to narrowing of kidney blood vessels (renal artery stenosis)], use of irbesartan may cause severe decrease in your blood pressure and kidney insufficiency.

•    if you suffer from kidney disease: In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels and creatinine levels in case of poor kidney function.

•    if you have an aortic, mitral valve stenosis (narrowing of heart valves) or obstructive hypertrophic cardiomyopathy (disease of the muscle of the heart in which a portion of the muscle is thickened).

•    if you are suffering from primary aldosteronism (a syndrome associated with increased secretion of a hormone called aldosterone by the adrenal gland characterised by high blood pressure, headache, and muscle weakness): Irbesartan may not decrease blood pressure.

•    if you are hypertensive and have diabetic kidney disease, therapeutic effects of Irbesartan may vary.

•    if you are suffering from severe heart failure or kidney disease, treatment with Irbesartan may cause acute fall in blood pressure, increase in blood urea and creatinine, kidney failure and decrease in production of urine.

•    If you are going to have an operation (surgery) or need an anaesthetic, tell the doctor about your medicine.

•    You must tell your doctor if you think you are (or might become) pregnant. Irbesartan is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section)

Please consult your doctor, even if these statements were applicable to you at any time in the past.

Other medicines and Irbesartan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important to inform your doctor if you are taking any of the following medicines:

•    Diuretics (water tablets) and other antihypertensive (blood pressure lowering medicines) drugs: These drugs may increase the blood pressure lowering effects of irbesartan

•    Potassium supplements and potassiumsparing diuretics: use at the same time may increase blood potassium levels.

•    Lithium: increase in blood lithium levels and toxicity may occur if lithium is administered at the same time as Irbesartan.

•    Non steroidal anti inflammatory drugs (medicines used to treat pain and fever): decrease in blood pressure lowering effect may occur; may lead to an increased risk of worsening of kidney function, including possible kidney failure, and an increase in blood potassium. Caution should be exercised if you are elderly.

Irbesartan with food and drink

Irbesartan can be taken with orwithout food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan. Irbesartan is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was bom prematurely.

Fertility

In animal studies Irbesartan had no effect on fertility.

Driving and using machines

Irbesartan is unlikely to affect your ability to drive and use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, you should consult your doctor before attempting such activities.

Irbesartan contains 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.

3. How to take Irbesartan_

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended initial and maintenance dose is 150 mg once a day. Your doctor may increase your dose to 300 mg once daily depending on blood pressure response.

In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, orthose overthe age of 75 years.

If you have liver disease your doctor would decide appropriate dosage for you.

The maximal blood pressure lowering effect should be reached 4 to 6 weeks after beginning treatment.

Irbesartan is for oral use. The film-coated tablets should be swallowed with sufficient amount of water. To help you remember to take your medicine,