APROVEL 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Aprovel 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 Aprovel is and what it is 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 Aprovel is and what it is used for

Aprovel 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 narrow, leading to an increase in blood pressure. Aprovel prevents angiotensin-II from working, which widens the blood vessels and lowers blood pressure. Aprovel also slows the progression of kidney disease 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 disease.

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 more than 3 months pregnant. (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-lowering medicine containing aliskiren

Warnings and precautions

Tell your doctor before you start taking 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 the levels of potassium in your blood if you have impaired kidney function
• if you have low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing, or paleness), especially if you are being treated for diabetes
• if you are going to have surgery(including dental surgery) or if you are going to be given anesthetics

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

• 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.

Tell your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Aprovel. Your doctor will decide whether to continue treatment. Do not stop taking Aprovel on your own.

See also the information under the heading "Do not take Aprovel".

If you are pregnant, think you may be pregnant, or plan to become pregnant, inform your doctor. Aprovel is not recommended during the first few months of pregnancy and should 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 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 adjust 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 (a type of diuretic)
• lithium-containing medicines
• repaglinide (a medicine used to reduce blood sugar levels)

If you are using a type of painkiller called non-steroidal anti-inflammatory drugs (NSAIDs), 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 may 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 blood pressure-lowering medicine instead. Aprovel is not recommended during the first few months of pregnancy and should not be taken after the third month of pregnancy, as it may harm your baby.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. 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 for high blood pressure, you may occasionally experience dizziness or fatigue. 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 your doctor 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

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Method of administration

Aprovel is taken orally. The tablets should be swallowed with a sufficient amount of liquid (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. 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 disease

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.

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

The maximum blood pressure-lowering effect should be achieved within 4-6 weeks after starting 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 allergic skin reactions (rash, urticaria) and localized swelling (in the face, lips, and/or tongue) have been reported in patients treated with irbesartan. If you think you may have a reaction of this type or experience difficulty breathing, stop taking Aprovel and seek medical attention 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 Aprovel:

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

• 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 disease, dizziness (especially when standing up), low blood pressure (especially when standing up), muscle or joint pain, and decreased levels of a protein 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.

• Rare (may affect up to 1 in 1,000 people): intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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, mainly in the skin (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 300 mg tablet contains 300 mg of irbesartan.

• The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, colloidal silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. See section 2 "Aprovel contains lactose".

Appearance and packaging

Aprovel 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.

Aprovel 300 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, which contain unit-dose blisters for hospital use.

Not all pack sizes may be marketed.

Marketing authorisation 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

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/