PACKAGE LEAFLET: INFORMATION FORTHE USER

IRBESARTAN 75 mg TABLETS IRBESARTAN 150 mg TABLETS IRBESARTAN 300 mg TABLETS

(irbesartan)

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 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 effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Irbesartan is and what it is used for.

2.    Before you take Irbesartan.

3.    How to take Irbesartan.

4.    Possible side effects.

5.    How to store Irbesartan.

6.    Further information.

1.    WHAT IRBESARTAN IS AND WHAT IT IS USED FOR

Irbesartan belongs to a group of medicines known as angiotensin-ll receptor antagonists. Angiotension-ll is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten.This results in an increase in blood pressure. Irbesartan prevents the binding of angiotension-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 adult patients:

•    to treat high blood pressure (essential hypertension)

•    to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

2.    BEFORE YOU TAKE IRBESARTAN Do not take Irbesartan:

•    if you are allergic (hypersensitive) to irbesartan or any of the other ingredients of Irbesartan

•    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).

Take special care with Irbesartan

Tell your doctor if any of the following apply to you:

•    if you get excessive vomiting or diarrhoea

•    if you suffer from kidney problems

•    if you suffer from heart problems

•    if you receive irbesartan for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function

•    if you are going to have an operation (surgery) or be given anaesthetics.

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).

Use in children

This medicinal product should not be used in children or adolescents because the safety and efficacy have not yet been fully established.

Using 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.

Irbesartan does not usually interact with other medicines.

You may need to have blood checks if you take: •

•    potassium supplements

•    salt substitutes containing potassium

•    potassium-sparing medicines (such as certain diuretics)

•    medicines containing lithium.

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Taking Irbesartan with food and drink

Irbesartan can be taken with or without food.

Pregnancy and breast-feeding Pregnancy

You must tell your doctor if you thinkyou are (or might become) pregnant. Your doctor will normally advise you to stop taking Irbesartan before you become pregnant or as soon as you knowyou 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 months of pregnancy.

Breast-feeding

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 born prematurely.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Irbesartan is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during the treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Important information about some of the ingredients of Irbesartan

Irbesartan contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose) contact your doctor before taking this medicine.

3. HOW TO TAKE IRBESARTAN

Always take Irbesartan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Method of administration

Irbesartan is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Irbesartan with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Irbesartan until your doctor tells you otherwise.

Patients with high blood pressure (hypertension)

The usual dose is 150 mg Irbesartan once a day.The dose may later be increased to 300 mg once daily depending on your blood pressure response.

Patients with high blood pressure and type 2 diabetes with kidney disease

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 or those over the age of 75 years.

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

If you take more Irbesartan than you should

If you accidentally take too many tablets, contact your doctor immediately.

Children should not take Irbesartan

Irbesartan should not be given to children under 18years of age. If a child swallows some tablets, contact your doctor immediately.

If you forget to take Irbesartan

If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Irbesartan can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan and contact your doctor immediately.

The frequency of the side effects listed below is defined using following convention:

Very common: at least 1 in 10 patients or more.

Common: at least 1 in 100 and less than 1 in 10 patients. Uncommon: at least 1 in 1000 and less than 1 in 100 patients.

Side effects reported in clinical studies for patients treated with irbesartan were:

Very common:

•    if you sufferfrom high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.

Common:

•    dizziness

•    feeling sick/vomiting

•    fatigue

•    blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme)

•    In patients with high blood pressure and type 2 diabetes with kidney disease:

*    dizziness when getting up from a lying or sitting position

*    low blood pressure when getting up from a lying or sitting position

*    pain in joints or muscles

*    decreased levels of a protein in the red blood cells (haemoglobin) were also reported.

Uncommon:

•    heart rate increased

•    flushing

•    cough

•    diarrhoea

•    indigestion/heartburn

•    sexual dysfunction (problems with sexual performance)

•    chest pain.

Some undesirable effects have been reported since marketing of irbesartan. Undesirable effects where the frequency is not known are:

•    feeling of spinning

•    headache

•    taste disturbance

•    ringing in the ears (tinnitus)

•    muscle cramps

•    pain in joints and muscles

•    abnormal liverfunction

•    increased blood potassium levels

•    impaired kidney function

•    an inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis)

•    uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

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 IRBESARTAN

Keep out of the reach and sight of children.

Do not use Irbesartan after the expiry date which is stated on the carton after 'EXP'.The expiry date refers to the last day of that month. The in-use shelf-life of the product when stored in HDPE bottles is 90 days.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.

6.    FURTHER INFORMATION What Irbesartan contains

The active substance is: irbesartan. Each tablet contains 75 mg 150 mg, 300 mg of irbesartan.The other ingredients are lactose monohydrate, povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate and silica, colloidal anhydrous.

What Irbesartan looks like and contents of the pack

75 mg: Round, White to off-white, biconvex, bevelled edge tablets 'M' on one side, 'INI' on other side

150 mg: Round, White to off-white, biconvex, bevelled edge tablets 'M' on one side, 'IN2' on other side.

300 mg: Oval, White to off white, biconvex, bevelled edge tablets 'M' on one side, 'IN3' on other side.

Irbesartan is available in blister packs of 10,14,28,30,56,57, 58,60,84, 90, 98 and 100, calendar packs of 14,28,56,84 and 98 tablets and HDPE bottles with PP closures of 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Jenson Pharmaceutical Services Limited, Carradine House, 237 Regents Park Road, London, N3 3LF, UK.

Manufacturers

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft., H-2900 Komarom, Mylan utca 1, Hungary.

Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

This leaflet was last revised in: 07/2012

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