PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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 because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, askyour doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even iftheir signs ofillness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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.    How to store Irbesartan

6.    Contents ofthe pack and other information

1.    WHAT IRBESARTAN ISAND WHAT ITISUSEDFOR

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 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.    WHATYOU NEED TO KNOWBEFORE YOU TAKE IRBESARTAN Do not take Irbesartan

•    if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)

•    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).

Warnings and precautions

Tell your doctor or pharmacist ifany ofthe 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 and adolescents because the safety and efficacy has not yet been fully established.

Other medicines and Irbesartan

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

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.

Irbesartan with food and drink

Irbesartan can be taken with or without food. Swallow the tablets with a sufficient amount of fluid or water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you 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.

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 orusemachines.

Important information about some of the ingredients of Irbesartan Irbesartan contains lactose monohydrate (see “Contents of the pack and other information”). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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.

Method ofadministration

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 recommended 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 forthe 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 over the age of 75 years.

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

Ifyou take more Irbesartan than you should

Ifyou accidentally take too many tablets, contact your doctor immediately.

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.

Ifyou forget to take Irbesartan

Ifyou 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 medicine, ask your doctor or pharmacist.

4.    POSSIBLESIDEEFFECTS

Like all medicines, this medicine 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 localized 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: 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 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 but the frequency for them to occur is not known. These undesirable effects 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 of jaundice (yellowing of the skin and/or whites of the eyes) have also beenreported.

If you get any side effects, talk to your doctor or pharmacist. This includes side effects not listed in this leaflet.

5.    HOW TO STORE IRBESARTAN

Keep this medicine out of the sight andreach ofchildren.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after “EXP.” The expiry date refers to the last day ofthat month.

Store in the original package in order to protect from moisture.

This medicine does not require any special temperature storage conditions.

Do not throw away medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    CONTENTS OFTHE PACKAND OTHERINFORMATION

What Irbesartan contains

•    The active substance is irbesartan.

Each film-coated tablet of Irbesartan 75 mg contains 75 mg irbesartan.

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

•    The other ingredients are lactose monohydrate, colloidal anhydrous silica (E551), microcrystalline cellulose (E460), croscarmellose sodium (E468), hypromellose (E464), pregelatinized starch, magnesium stearate (E572), titanium dioxide (E171), macrogol 4000.

What Irbesartan looks like and contents of the pack

•    Irbesartan 75 mg film-coated tablets are white to off-white, oval-shaped, film-coated tablets of 11.0 mm with a “J” debossed on one side and “75” on the other side.

•    Irbesartan 150 mg film-coated tablets are white to off-white, oval-shaped, film-coated tablets of 13.7 mm with a “J” debossed on one side and “150” on the other side.

•    Irbesartan 300 mg film-coated tablets are white to off-white, oval-shaped, film-coated tablets of 17.3 mm with a “J” debossed on one side and “300” on the other side.

•    Irbesartan film-coated tablets are available in blister packs of 28, 56, 84 or 98 tablets.

Not all pack sizes may be marketed.

MarketingAuthorisation Holder and Manufacturer

MarketingAuthorisation Holder:

Jubilant Pharmaceuticals nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium

Manufacturer:

PSI supply nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium

SIA“Unifarma”

Brivibas gatve 414 k-2

Riga

LV-1024

Latvia

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

The Netherlands	Irbesartan Jubilant 75-150-300 mg filmomhulde tabletten
Germany	Irbesartan Jubilant 75-150-300 mg Filmtabletten
Sweden	Irbesartan Jubilant 75-150-300 mg Filmdragerade Tabletter
Denmark	Irbesartan Jubilant
Cyprus	Irbesartan Jubilant 150 mg ErciKaAuppivo pe kercxo npevio SiGKfo
Latvia	Irbesartan Jubilant 150-300 mg apvalkota tablete
Lituania	Irbesartan Jubilant 150-300 mg plevele dengtos tabletes
Estonia	Irbesartan Jubilant 150-300 mg
United Kingdom	Irbesartan Jubilant 75-150-300 mg film-coated tablets

This leaflet was last revised in 09/2012.