APROVEL 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Aprovel 75 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 Package Leaflet

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

1. What is Aprovel and what is it used for

Aprovel belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that constricts blood vessels, leading to an increase in blood pressure. Aprovel prevents angiotensin-II from binding to its receptors, relaxing blood vessels and reducing blood pressure. Aprovel slows down the progression of kidney damage in patients with high blood pressure and type 2 diabetes.

Aprovel 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 Aprovel

Do not take Aprovel

• 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 diseaseand are being treated with a blood pressure medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before starting to take Aprovel 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 Aprovel 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 have low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or pallor, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes
• if you are going to have surgery(surgical procedure) or if you are going to be givenanesthetics

• if you are taking any of the following medicines used to treat high blood pressure:

• 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 Aprovel".

If you are pregnant, think you might be pregnant, or plan to become pregnant, inform your doctor. Aprovel is not recommended during the first three months of pregnancy and should not be used after the third month of pregnancy as it may cause serious harm to 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 Aprovel 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 Aprovel" and "Warnings and precautions").

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

• potassium supplements
• potassium-sparing diuretics (certain water tablets)
• medicines containing lithium
• repaglinide (a medicine used to reduce blood sugar levels).

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

Taking Aprovel with food and drink

Aprovel can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead. Aprovel should not be used during the first few months of pregnancy and should not be used after the third month of pregnancy as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Aprovel while breastfeeding, and your doctor may prescribe a different treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

Aprovel is unlikely to affect your ability to drive or use machines. However, during treatment with blood pressure medicines, dizziness or fatigue may occasionally occur. If you experience these symptoms, talk to your doctor before driving or using machines.

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

Aprovel contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Aprovel

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Method of administration

Aprovel is taken by mouth. The tablets should be swallowed with a sufficient amount of water (e.g. a glass of water). Aprovel 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 (two tablets a day). Depending on the response to blood pressure, this dose may be increased to 300 mg once daily (four tablets a day).

• 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 disease is 300 mg once daily (four tablets a day).

Your doctor may advise a lower dose, especially when starting treatment, in certain patients such as those on hemodialysis or those over 75 years of age.

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

Use in children and adolescents

Aprovel 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 Aprovel than you should

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

If you forget to take Aprovel

If you accidentally miss a dose, simply 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.

However, some of these side effects can be serious and may require medical attention.

As with similar medicines, rare cases of skin reactions (rash, urticaria) and localized swelling (e.g. 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 Aprovel and see a doctor 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 have been reported in clinical trials in patients treated with Aprovel:

• 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 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 problems), and chest pain.

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

Frequency not known: cannot be estimated from the available data

The following side effects have been reported: feeling dizzy, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, decreased number of red blood cells (anemia - symptoms may include tiredness, headaches, difficulty breathing when exercising, dizziness, and paleness), reduced number of platelets, abnormal liver function, high levels of potassium in the blood, kidney failure, inflammation of small blood vessels (a condition known as leucocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Rare cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects

If you experience 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 Aprovel

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 the month shown.

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 Aprovel contains

• The active substance is irbesartan. Each Aprovel 75 mg tablet contains 75 mg of irbesartan.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, colloidal silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, and carnauba wax. See section 2 "Aprovel contains lactose".

Appearance and packaging

Aprovel 75 mg film-coated tablets are white or almost white, biconvex, and oval-shaped with a heart-shaped indentation on one side and the number 2871 engraved on the other side.

Aprovel 75 mg 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 authorization holder:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer:

SANOFI WINTHROP INDUSTRIE1, rue de la ViergeAmbarès & LagraveF‑33565 Carbon Blanc Cedex – France

SANOFI WINTHROP INDUSTRIE30-36 Avenue Gustave Eiffel, BP 7166F-37071 Tours Cedex 2 – France

For further information on this medicine, contact the local representative of the marketing authorization 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/