IRBESARTAN ZENTIVA 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan Zentiva 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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. See section 4.

Contents of the pack

1. What is Irbesartan Zentiva and what is it used for
2. What you need to know before you take Irbesartan Zentiva
3. How to take Irbesartan Zentiva
4. Possible side effects
5. Storage of Irbesartan Zentiva
6. Contents of the pack and other information

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

Irbesartan Zentiva belongs to a group of medicines called angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that causes blood vessels to constrict. This constriction increases blood pressure.

Irbesartan Zentiva prevents angiotensin-II from binding to its receptors, relaxing blood vessels and lowering blood pressure. Irbesartan Zentiva slows the progression of kidney damage in patients with high blood pressure and type 2 diabetes.

Irbesartan Zentiva is used in adult patients

• to treat high blood pressure (essential hypertension)
• to protect the kidneys in patients with high blood pressure, type 2 diabetes, and evidence of kidney damage.

2. What you need to know before you take Irbesartan Zentiva

Do not take Irbesartan Zentiva

• if you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant more than 3 months. (In any case, it is better to avoid taking this medicine during the first few months of pregnancy – see section Pregnancy)
• if you have diabetes or kidney problemsand are being treated with a blood pressure medicine containing aliskiren.

Warnings and precautions

Consult your doctor before taking Irbesartan Zentiva and if any of the following apply to you:

• if you have excessive vomiting or diarrhea
• if you have kidney problems
• if you have heart problems
• if you are taking Irbesartan Zentiva for diabetic kidney disease. In this case, your doctor may regularly perform blood tests, especially to measure potassium levels in case of impaired kidney function

• if you are going to have surgery(surgical procedure) or if you are going to be given anesthetics
• • if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• a medicine called an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Irbesartan Zentiva”.

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. It is not recommended to take Irbesartan Zentiva during the first few months of pregnancy (first trimester), and it must not be taken after the third month of pregnancy, as it may harm your baby (see section Pregnancy).

Children and adolescents

This medicine should not be used in children and adolescents as the safety and efficacy have not been fully established.

Taking Irbesartan Zentiva with other medicines

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

Your doctor may need to change your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Irbesartan Zentiva” and “Warnings and precautions”).

You may need to have blood tests if you are taking:

• potassium supplements
• potassium-sparing diuretics (a type of diuretic)
• lithium-containing medicines

If you are using a type of painkiller called non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Taking Irbesartan Zentiva with food and drink

Irbesartan Zentiva can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Irbesartan Zentiva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead. It is not recommended to take Irbesartan Zentiva during the first few months of pregnancy and it must not be taken after the third month of pregnancy, as it may harm your baby.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding, as it is not recommended to take Irbesartan Zentiva during this period. Your doctor may decide to give you a different treatment that is more suitable, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

It is unlikely that Irbesartan Zentiva will affect your ability to drive or use machines. However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, consult your doctor before driving or using machines.

Irbesartan Zentiva contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Irbesartan Zentiva

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

Method of administration

Irbesartan Zentiva is taken orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Irbesartan Zentiva can be taken with or without food. Try to take your daily dose at the same time each day. It is important to continue taking this medicine until your doctor tells you to stop.

• Patients with high blood pressure

The usual dose is 150 mg once daily. Depending on the response to blood pressure, this dose may be increased to 300 mg once daily.

• Patients with high blood pressure and type 2 diabetes with kidney damage

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

Your doctor may recommend a lower dose, especially when starting treatment, in certain patients, such as those on hemodialysisor aged 75 years or older.

The maximum blood pressure-lowering effect should be achieved after 4-6 weeks of treatment.

Use in children and adolescents

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

If you take more Irbesartan Zentiva than you should

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

If you forget to take Irbesartan Zentiva

If you accidentally miss a dose, just take your normal dose when it is due. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some of these side effects can be serious and may need medical attention.

As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips, and/or tongue have been reported in patients treated with irbesartan. If you think you have had an allergic reaction, stop taking Irbesartan Zentiva and contact a doctor or hospital immediately.

The following side effects have been reported:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

The following side effects were reported in clinical trials in patients treated with Irbesartan Zentiva:

• Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney damage, blood tests may show high potassium levels.

• Common (may affect up to 1 in 10 people): dizziness, nausea/vomiting, fatigue, and blood tests may show high levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure and type 2 diabetes with kidney damage, dizziness (especially when standing up), low blood pressure (especially when standing up), muscle pain or joint pain, and decreased levels of a protein present in red blood cells (hemoglobin)

• Uncommon (may affect up to 1 in 100 people): rapid heartbeat, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (sexual function disorders), and chest pain.

Since the marketing of Irbesartan Zentiva, the following side effects have been reported:

Frequency not known: cannot be estimated from the available data

The following side effects have been reported: dizziness, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, reduced platelet count, abnormal liver function, high potassium levels in the blood, impaired kidney function, inflammation of small blood vessels, mainly in the skin (a condition known as leucocytoclastic vasculitis), and severe allergic reactions (anaphylactic shock). Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Irbesartan Zentiva

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

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 protect the environment.

6. Contents of the pack and other information

What Irbesartan Zentiva contains

• The active substance is irbesartan. Each film-coated tablet contains 300 mg of irbesartan.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, colloidal silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, and carnauba wax. See section 2 “Irbesartan Zentiva contains lactose”.

Appearance and packaging

Irbesartan Zentiva 300 mg film-coated tablets are white or almost white, biconvex, and oval-shaped, with a heart-shaped indentation on one side and the number 2873 engraved on the other side.

Irbesartan Zentiva 300 mg film-coated tablets are available in blister packs of 14, 28, 30, 56, 84, 90, or 98 film-coated tablets. They are also available in packs of 56 x 1 film-coated tablet containing unit-dose blisters for hospital use.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer:

SANOFI WINTHROP INDUSTRIE

1, rue de la Vierge

Ambarès & Lagrave

F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE

30-36 Avenue Gustave Eiffel, BP 7166

F-37071 Tours Cedex 2 – France

CHINOIN PRIVATE CO. LTD.

Lévai u.5.

2112 Veresegyház - Hungary

Sanofi-Aventis, S.A.

Ctra. C-35 (La Batlloria-Hostalric), km. 63.09

17404 Riells i Viabrea (Girona)

Spain

For further information on this medicine, contact the local representative of the Marketing Authorisation Holder.

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.