Karvea: detailed information

Package leaflet: Information for the patient

Karvea 75 mg tablets

irbesartan
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to others. It may be harmful to others, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Karvea is and what it is used for
What you need to know before taking Karvea
How to take Karvea
Possible side effects
How to store Karvea
Contents of the pack and other information

1. What is Karvea and what is it used for?

Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced by the body that binds to receptors in blood vessels, causing them to constrict. This results in increased blood pressure. Karvea prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease. Karvea slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Karvea is used in adult patients

to treat high blood pressure ( essential arterial hypertension )
to protect the kidneys in hypertensive patients with high blood pressure, type 2 diabetes, and evidence of kidney dysfunction in laboratory tests.

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 (it is better to avoid taking Karvea even in the early stages of pregnancy – see Pregnancy section)
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

Warnings and precautions
Talk to your doctor before taking Karvea if you are in any of the following conditions:

excessive vomiting or diarrhoea
if you have kidney problems
if you have heart problems
if you are taking Karvea for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to monitor serum potassium levels in case of poor kidney function
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or pallor, numbness, rapid and pounding heartbeat), especially if you are being treated for diabetes
if you are due to undergo surgery or receive anaesthetics
if you are taking any of the following medicines used to treat high blood pressure:
an "ACE inhibitor” (e.g. enalapril, lisinopril, ramipril), particularly 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 Karvea".
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Karvea is not recommended during early pregnancy and must not be taken if you are more
than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy).
Children and adolescents
This medicine should not be used in children and adolescents, as its safety and efficacy have not yet been fully established.
Other medicines and Karvea
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may consider it necessary to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take Karvea" and "Warnings and precautions").
You may need blood tests if you are taking:

potassium supplements
potassium-containing salt substitutes
potassium-sparing medicines (such as certain diuretics)
lithium
repaglinide (a medicine used to lower blood sugar levels)

If you take certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), the effectiveness of irbesartan may be reduced.
Karvea with food and drink
Karvea can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Karvea before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Karvea is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Karvea is not recommended for women who are breast-feeding, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
It is unlikely that Karvea will affect your ability to drive or use machines. However, occasionally, dizziness or fatigue may occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or operating machinery.
Karvea contains lactose. If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor 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

Always take this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
Method of administration
Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (for example: a glass of water). You may take Karvea with or without food. Try to take the medicine at the same time each day. Treatment should be continued for as long as your doctor considers it necessary.

Patients with high blood pressure: The usual dose is 150 mg once daily (two tablets daily). The dosage may be increased to 300 mg (four tablets daily) once daily, depending on the reduction in blood pressure levels.
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 is 300 mg (four tablets daily) once daily for the treatment of associated kidney disease.

Your doctor may decide to use lower doses, especially at the beginning of treatment, in particular patients such as those undergoing haemodialysis, or in patients over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting therapy.
Use in children and adolescents
Karvea must not be given to children under 18 years of age. If a child accidentally takes this medicine, 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 forget to take a dose, continue with your next dose as normal. Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use 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 may be serious and may require medical attention.
As with similar medicines, rare cases of skin allergic reactions (redness, rash) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking Karvea and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
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 side effects reported in clinical studies 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 disease, blood tests may show elevated potassium levels.
Common (may affect up to 1 in 10 people): dizziness, feeling unwell/nausea, fatigue, and blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure, type 2 diabetes and kidney disease, dizziness upon standing from a lying or sitting position, low blood pressure upon standing from a lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (haemoglobin) have also been reported.
Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Additional side effects have been reported since Karvea has been marketed. Side effects with unknown frequency include: sensation of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, reduced number of red blood cells (anaemia - symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced platelet count, abnormal liver function, increased potassium levels in the blood, kidney function impairment, inflammation of the small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock). Uncommon 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Karvea

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after Exp.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Karvea contains

The active substance is irbesartan. Each Karvea 75 mg tablet contains 75 mg of irbesartan.
The excipients are: microcrystalline cellulose, cross-linked sodium carboxymethylcellulose, monohydrate lactose, magnesium stearate, colloidal hydrated silica, pregelatinized maize starch and poloxamer 188. See section 2 “Karvea contains lactose”.

Description of the appearance of Karvea and contents of the pack
Karvea 75 mg tablets are white to almost white, biconvex, oval-shaped tablets with a heart-shaped imprint on one side and the number 2771 engraved on the other side.
Karvea 75 mg tablets are available in packs of 14, 28, 56 or 98 tablets in blisters. Single-dose blisters of 56 x 1 tablet for hospital use are also available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Sanofi Belgium Swixx Biopharma UAB
Tél/Tel: +32 (0)2 710 54 00 Tel: +370 5 236 91 40

България Luxembourg/Luxemburg
Swixx Biopharma EOOD Sanofi Belgium
Тел.: +359 (0)2 4942 480 Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika Magyarország
sanofi-aventis, s.r.o. SANOFI-AVENTIS Zrt.
Tel: +420 233 086 111 Tel.: +36 1 505 0050

Danmark Malta
Sanofi A/STlf: +45 45 16 70 00 Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Genzyme Europe B.V.
Tel: 0800 52 52 010 Tel: +31 20 245 4000
Tel. aus dem Ausland: +49 69 305 21 131

Eesti Norge
Swixx Biopharma OÜ sanofi-aventis Norge AS
Tel: +372 640 10 30 Tlf: +47 67 10 71 00

Ελλάδα Österreich
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ sanofi-aventis GmbH
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0

España Polska
sanofi-aventis, S.A. sanofi-aventis Sp. z o.o.
Tel: +34 93 485 94 00 Tel.: +48 22 280 00 00

France Portugal
sanofi-aventis France Sanofi - Produtos Farmacêuticos, Lda
Tél: 0 800 222 555 Tel: +351 21 35 89 400
Appel depuis l’étranger : +33 1 57 63 23 23

Hrvatska România
Swixx Biopharma d.o.o. Sanofi Romania SRL
Tel: +385 1 2078 500 Tel: +40 (0) 21 317 31 36

Ireland Slovenija
sanofi-aventis Ireland Ltd.T/A SANOFI Swixx Biopharma d.o.o.
Tel: +353 (0) 1 403 56 00 Tel: +386 1 235 51 00

Ísland Slovenská republika
Vistor hf. Swixx Biopharma s.r.o.
Sími: +354 535 7000 Tel: +421 2 208 33 600

Italia Suomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800 536389 Puh/Tel: +358 (0) 201 200 300

Κύπρος Sverige
C.A. Papaellinas Ltd Sanofi AB
Τηλ: +357 22 741741 Tel: +46 (0)8 634 50 00

Latvija United Kingdom (Northern Ireland)
Swixx Biopharma SIA sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +371 6616 47 50 Tel: +44 (0) 800 035 2525

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/

Patient Information Leaflet: Information for the patient

Karvea 150 mg tablets

irbesartan
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to others. It may be harmful to others, even if their symptoms are the same as yours.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Karvea is and what it is used for
What you need to know before taking Karvea
How to take Karvea
Possible side effects
How to store Karvea
Contents of the pack and other information

1. What Karvea is and what it is used for

to treat high blood pressure ( essential arterial hypertension )
to protect the kidneys in hypertensive patients with high blood pressure, type 2 diabetes, and evidence of kidney dysfunction in laboratory tests.

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 (it is better to avoid taking Karvea even in the early stages of pregnancy – see Pregnancy section)
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

Warnings and precautions
Talk to your doctor before taking Karvea if you are in any of the following conditions:

excessive vomiting or diarrhoea
if you have kidney problems
if you have heart problems
if you are taking Karvea for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to monitor serum potassium levels in case of poor kidney function
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or pallor, numbness, rapid and pounding heartbeat), especially if you are being treated for diabetes
if you are due to have surgery or are taking anaesthetics
if you are taking any of the following medicines used to treat high blood pressure:
an "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.

See also information under the section "Do not take Karvea"
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Karvea is not recommended during early pregnancy and must not be taken if you are more
than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section Pregnancy).
Children and adolescents
This medicine should not be used in children and adolescents, as its safety and efficacy have not yet been fully established.
Other medicines and Karvea
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may consider it necessary to adjust your dose and/or take additional precautions:
If you are taking an ACE inhibitor or aliskiren (see also information under "Do not take Karvea" and "Warnings and precautions")
You may need blood tests if you are taking:

potassium supplements
potassium-containing salt substitutes
potassium-sparing medicines (such as certain diuretics)
medicines containing lithium
repaglinide (a medicine used to lower blood sugar levels).

If you are taking certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs),
the effectiveness of irbesartan may be reduced.
Karvea with food and drink
Karvea can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant); your doctor will usually advise you to stop taking Karvea before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of Karvea. Karvea is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to start breast-feeding. Karvea is not recommended for women who are breast-feeding, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
It is unlikely that Karvea will affect your ability to drive or use machines. However, occasionally, dizziness or fatigue may occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or using machines.
Karvea contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact 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

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Method of administration
Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g.: a glass of water). You may take Karvea with or without food. Try to take the medicine at the same time each day. Treatment should be continued for as long as your doctor considers it necessary.

Patients with high blood pressure: The usual dose is 150 mg once daily. The dosage may be increased to 300 mg (two tablets once daily) depending on the reduction in blood pressure levels.
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 is 300 mg (two tablets once daily) for the treatment of associated kidney disease.

Your doctor may decide to use lower doses, especially at the beginning of treatment, in particular patients such as those undergoing haemodialysis, or in patients over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting therapy.
Use in children and adolescents
Karvea must not be given to children under 18 years of age. If a child accidentally ingests any tablets, contact a 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, continue with your next dose as scheduled. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some of these effects may be serious and may require 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 experience any of these symptoms or have difficulty breathing, stop taking Karvea and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
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 side effects reported in clinical studies 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 disease, blood tests may show high levels of potassium.
Common (may affect up to 1 in 10 people): dizziness, feeling unwell/nausea, fatigue, and blood tests may show increased 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 upon standing from lying or sitting position, low blood pressure upon standing from lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (haemoglobin) have also been reported.
Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Additional side effects have been reported since Karvea has been marketed. Side effects with unknown frequency include: feeling dizzy, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, reduced number of red blood cells (anaemia - symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced platelet count, abnormal liver function, increased blood potassium levels, kidney function disorders, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), and severe allergic reactions (anaphylactic shock). Uncommon 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Karvea

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after Exp.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Karvea contains

The active substance is irbesartan. Each Karvea 150 mg tablet contains 150 mg of irbesartan.
The excipients are: microcrystalline cellulose, cross-linked sodium carboxymethylcellulose, monohydrate lactose, magnesium stearate, hydrated colloidal silica, pregelatinized maize starch and poloxamer 188. See section 2 “Karvea contains lactose”.

Description of the appearance of Karvea and contents of the pack
Karvea 150 mg tablets are white to almost white, biconvex, oval-shaped, with a heart engraved on one side and the number 2772 imprinted on the other side.
Karvea 150 mg tablets are available in packs of 14, 28, 56 or 98 tablets in blisters. Single-dose blisters of 56 x 1 tablet for hospital use are also available.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder: