Karvea 300 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Karvea 300 mg film-coated tablets

Irbesartan

Read the entire leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Karvea is and what it is used for

Karvea 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. Karvea prevents angiotensin-II from binding to these receptors, relaxing the blood vessels and thereby reducing blood pressure. Karvea slows the decline of kidney function in patients with high blood pressure and type 2 diabetes.

Karvea 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 clinical evidence of impaired kidney function.

2. What you need to know before taking Karvea

Do not take Karvea

• 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 also during early pregnancy – 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 taking Karvea 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 Karvea for diabetic kidney disease. In this case, your doctor may carry out regular 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 paleness, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes

• if you are going to have surgery or if you are to be given anaesthetics

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

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. 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 Karvea. Your doctor will decide whether to continue treatment. Do not stop taking Karvea monotherapy without medical advice.

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of Karvea 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 established.

Taking Karvea 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 inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Karvea” 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 taking a type of painkiller known as non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Taking Karvea with food and drink

Karvea 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. Generally, your doctor will advise you to stop taking Karvea before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive treatment. Use of Karvea is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

Breast-feeding

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

Driving and using machines

It is unlikely that Karvea will affect your ability to drive or operate machinery. However, during treatment for high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, discuss them with your doctor before driving or operating machinery.

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

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

3. How to take Karvea

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Method of administration

Karvea is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). Karvea 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 unless your doctor advises you otherwise.

• Patients with high blood pressure

The usual dose is 150 mg once daily. Subsequently, and 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 the treatment of associated kidney impairment is 300 mg once daily.

Your doctor may recommend a lower dose, especially at the beginning of treatment, in certain patients, such as patients on haemodialysis or patients 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

Karvea 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 Karvea than you should

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

If you forget to take Karvea

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 the missed dose.

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 experiences 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) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you think you may be experiencing such a reaction or have difficulty breathing, stop taking Karvea 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 Karvea 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 measuring 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 (sexual function disorders), 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.

Since the marketing of Karvea, some adverse effects have been reported. 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, reduction in the number of red blood cells (anaemia - symptoms may include tiredness, headaches, shortness of breath during exercise, dizziness, and paleness), reduction in the number of platelets, 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 included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Karvea

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Karvea

• The active substance is irbesartan. Each Karvea 300 mg tablet contains 300 mg of irbesartan.
• The other components are monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, colloidal anhydrous silica, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. See section 2 “Karvea contains lactose”.

Appearance of the product and contents of the pack

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

Karvea 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 x 1 film-coated tablet, containing single-dose blisters intended for hospital supply.

Only certain pack sizes may be marketed.

Marketing Authorization 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 from the local representative of the Marketing Authorization 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/