PACKAGE LEAFLET: INFORMATION FOR THE USER

Irbesartan 75 mg Film-coated Tablets Irbesartan 150 mg Film-coated Tablets Irbesartan 300 mg Film-coated 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 any further questions, ask your doctor or your 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-II receptor antagonists. Angiotensin-II 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 angiotensin-II 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 to

-    treat high blood pressure (essential hypertension)

-    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 other ingredients of Irbesartan

-    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 diarrhea

-    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 and adolescents because the safety and efficacy have not yet been fully established.

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.

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 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.

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 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

The usual dose is 150 mg once a day. The dose may later be increased to 300 mg once daily depending on 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.

Children should not take Irbesartan

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

If you take more Irbesartan than you should

If you accidentally take too many 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, ask your 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 the following convention:

very common: affects more than 1 user in 10

common: affects 1 to 10 users in 100

uncommon: affects 1 to 10 users in 1,000

rare: affects 1 to 10 users in 10,000

very rare: affects less than 1 user in 10,000

not known: Frequency cannot be estimated form the available data

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

Very common: if you suffer from 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 and 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 and 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, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis). Uncommon cases ofjaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

If any of the side effects get 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.

This medicinal product does not require any special storage conditions.

Do not use Irbesartan after the expiry date which is stated on the carton and on the blister. 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 Irbesartan contains The active substance is irbesartan.

Each film-coated tablet contains 75/150/300 mg of irbesartan.

Excipients

Core:

Lactose monohydrate Croscarmellose sodium Povidone K-30 Magnesium stearate

Film-Coat (= Opadry II white 30F58652):

Hypromellose 5 cP Lactose monohydrate Macrogol 4000 Titanium dioxide (E171)

What Irbesartan looks like and contents of the pack

Irbesartan 75 mg Film-coated Tablets:

White to off-white, oval-shaped, biconvex film-coated tablets debossed with “L172” on one side and “75” on the other side.

Irbesartan 150 mg Film-coated Tablets:

White to off-white, oval-shaped, biconvex film-coated tablets debossed with “L173” on one side and “150” on the other side.

Irbesartan 300 mg Film-coated Tablets:

White to off-white, oval-shaped, biconvex film-coated tablets debossed with “L174” on one side and “300” on the other side.

Pack sizes: 28 film-coated tablets

Marketing Authorisation Holder and Manufacturer

Torrent Pharma GmbH Sudwestpark 50, 90449 Nurnberg Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

The Netherlands: Irbesartan Torrent 75/150/300 mg filmomhulde tabletten Germany: Irbesartan Heumann 75/150/300 mg Filmtabletten Lithuania: Irbesartanas Torrent 75/150/300 mg plevele dengtos tabletes Romania: Irbesartan Torrent 75/150/300 mg comprimate filmate United Kingdom: Irbesartan 75/150/300 mg Film-coated Tablets

This leaflet was last approved in October 2011.