Aprovel 300 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aprovel 300 mg film-coated tablets

Irbesartan

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Aprovel is and what it is used for
2. What you need to know before taking Aprovel
3. How to take Aprovel
4. Possible side effects
5. How to store 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 known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors, causing blood vessels to constrict. This leads to an increase in blood pressure. Aprovel prevents angiotensin-II from binding to these receptors, relaxing the blood vessels and thereby lowering blood pressure. Aprovel slows 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 clinical evidence of impaired kidney function.

2. What you need to know before taking Aprovel

Do not take Aprovel

• if you are allergic to irbesartan or to 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 early pregnancy as well – see section “Pregnancy”)

• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering 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 diarrhoea

• 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 carry out regular blood tests, especially to monitor 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 paleness, numbness, rapid and strong heartbeat)

• if you are going to have surgery (a surgical procedure) or if you are going to be given anaesthetics

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

• an angiotensin-converting enzyme (ACE) inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

• aliskiren.

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

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Aprovel. Your doctor will decide whether to continue treatment. Do not stop taking Aprovel when used as monotherapy.

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of Aprovel is not recommended during early pregnancy (first 3 months), and must not be used from the third month of pregnancy onwards, 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 safety and efficacy have not yet been fully established.

Taking Aprovel with other medicines

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

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

If you are taking an angiotensin-converting enzyme (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
• salt substitutes containing potassium
• potassium-sparing medicines (such as certain diuretics)
• medicines containing lithium
• repaglinide (a medicine used to lower blood sugar levels).

If you are using a type of painkiller known as 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, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Aprovel before becoming pregnant or as soon as you become pregnant, and will recommend another antihypertensive medicine instead. The use of Aprovel is not recommended during early pregnancy, and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Aprovel is not recommended for women during this period. Your doctor may decide to prescribe a treatment that is more suitable if you wish to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

It is unlikely that Aprovel will affect your ability to drive or use machines. However, during treatment for hypertension, dizziness or fatigue may occasionally occur. If you experience these symptoms, discuss them with your doctor before driving or operating machinery.

Aprovel contains lactose. If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), consult with him before taking this medicine.

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

3. How to take Aprovel

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Method of administration

Aprovel is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Aprovel may be taken with or without food. You should try to take your daily dose at the same time each day. It is important that you continue taking this medicine until your doctor advises you otherwise.

• Patients with high blood pressure

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

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

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

Your doctor may recommend a lower dose, particularly at the start of treatment, in certain patients such as those undergoing haemodialysis or those 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 must 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 next dose at the usual time. Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

However, some of these adverse effects may be serious and may require immediate medical attention.

As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) and localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you think you may be experiencing a reaction of this type or have shortness of breath, stop taking Aprovely and seek immediate medical attention.

The adverse effects listed below are grouped according to their frequency as follows:

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

Adverse effects reported in clinical trials conducted in patients treated with Aprovel were:

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

• Common (may affect up to 1 in 10 people): dizziness, nausea/vomiting, fatigue, and blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney impairment: 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 (haemoglobin).

• Uncommon (may affect up to 1 in 100 people): tachycardia, skin redness, cough, diarrhoea, indigestion/acid reflux, sexual dysfunction (disturbances in sexual function), and chest pain.

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

Additional adverse effects have been reported since Aprovel was marketed. Adverse effects observed with unknown frequency include: sensation of spinning (vertigo), headache, taste disturbances, tinnitus (ringing in the ears), muscle cramps, muscle and joint pain, reduced number of red blood cells (anaemia - symptoms may include tiredness, headaches, shortness of breath on exertion, dizziness and pallor), reduced platelet count, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels, mainly in the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock), and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of any unused medicine and its container. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aprovel

• The active substance is irbesartan. Each Aprovel 300 mg tablet contains 300 mg of irbesartan.

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

Appearance of the product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder:

Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

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

Sanofi-Aventis, S.A.
Ctra. C-35 (La Batlloria-Hostalric), km. 63.09
17404 Riells i Viabrea (Girona)
Spain

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this leaflet:

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