APROVEL 75 mg Tabletki Powlekane

Treść ulotki

1. Aprovel 75 mg tablets
   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. Package contents and other information
2. Aprovel 150 mg tablets
   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. Package contents and other information
3. Aprovel 300 mg tablets
   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. Package contents and other information
4. Aprovel 75 mg film-coated tablets
   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. Package contents and other information
5. Aprovel 150 mg film-coated tablets
   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. Package contents and other information
6. Aprovel 300 mg film-coated tablets
   1. What is Aprovel 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. Package contents and other information

Aprovel 75 mg tablets

irbesartan

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others. It may be harmful for people other than you, even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 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. 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 by the body that binds to receptors in blood vessels
causing them to constrict. This results in an increase in blood pressure.
Aprovel prevents angiotensin-II from binding to these receptors, allowing blood vessels to
dilate and blood pressure to decrease. Aprovel slows the decline of kidney function
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 kidney in hypertensive patients with high blood pressure, type 2 diabetes and with evidence of kidney dysfunction in laboratory tests.

2. What you need to know before taking 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 for more than 3 months(it is best to avoid taking Aprovel even in the early stages of pregnancy - see section Pregnancy)
• if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren

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

• excessive vomiting or diarrhea
• if you suffer from kidney disorders
• if you suffer from heart disorders
• if you are taking Aprovel for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to measure 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 paleness, numbness, fast or pounding heartbeat), especially if you are being treated for diabetes
• if you are to undergo surgeryor receive anesthetics
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren

The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also what is stated in the section "Do not take Aprovel”
You must inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Aprovel is not recommended in early pregnancy and should not be taken
if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (see the section Pregnancy).

Children and adolescents
This medicine should not be used in children and adolescents as safety and
efficacy have not been fully established.

Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is stated in the sections: "Do not take
Aprovel” and "Warnings and precautions”)

You may need blood tests if you are using:

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

If you take some painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.

Aprovel with food and drink
Aprovel 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 starting
a pregnancy); your doctor will usually advise you to stop taking Aprovel before
starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Aprovel. Aprovel is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months as it can
cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Aprovel is not recommended for
women who are breastfeeding and your doctor may choose another treatment if you wish to breastfeed,
especially if the baby is newborn or premature.

Driving and using machines
It is unlikely that Aprovel will affect your ability to drive or operate machinery. However,
occasionally, dizziness or fatigue may occur during treatment for high blood pressure.
If this happens, talk to your doctor before driving or using
machinery.

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

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

3. How to take Aprovel

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.

Method of administration
Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluids (e.g., a
glass of water). You can take Aprovel with or without food. Try to take the medicine every
day at the same time. The treatment should be continued as long as your doctor deems it necessary.

• Patients with high blood pressureThe usual dose is 150 mg once a day (two tablets a day). The dosage may be increased to 300 mg (four tablets a day) once a day depending on the reduction in blood pressure levels.
• Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes, the indicated maintenance dose is 300 mg (four tablets a day) once a day for the treatment of associated kidney disease.

The doctor may decide to use lower doses, especially at the beginning of treatment, in
particular patients such as those in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be reached 4-6 weeks after the start of therapy.
.

Use in children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows some
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 forget to take a dose, continue with therapy as normal. Do not take
a double dose to compensate for the missed dose.
If you have any doubts about 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.
Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (redness, hives) 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 Aprovel 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 for 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 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 an increase in the 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 up from a lying or sitting position, low blood pressure upon standing up from a lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (hemoglobin) have also been reported.
• Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Since the marketing of Aprovel, some side effects have been reported. Side effects with frequency not known are: feeling of spinning, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells (anemia - symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced number of platelets, abnormal liver function, increased potassium levels in the blood, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leucocytoclastic 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 get any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet.
You can also report side effects directly through the national reporting system indicated in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aprovel

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 at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 Aprovel contains

• - The active ingredient is irbesartan. Each Aprovel 75 mg tablet contains 75 mg of irbesartan.
• - The excipients are: microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, hydrated colloidal silica, pregelatinized corn starch and poloxamer 188. See section 2 “Aprovel contains lactose”.

Description of the appearance of Aprovel and package contents
Aprovel 75 mg tablets are white to almost white, biconvex, oval-shaped with a
heart engraved on one side and the number 2771 imprinted on the other side.
Aprovel 75 mg tablets are available in packs of 14, 28, 56 or 98 tablets in blisters. Blister
strips containing 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

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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
sanofi-aventis, s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Genzyme Europe B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
sanofi-aventis Sp. z o.o.
Tel.: +48 22 280 00 00

France
sanofi-aventis France
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/

Aprovel 150 mg tablets

irbesartan

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to people even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 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. 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 by the body that binds to receptors in blood vessels causing them to
constrict. This results in an increase in blood pressure. Aprovel prevents angiotensin-II from binding to
these receptors, allowing blood vessels to dilate and blood pressure to decrease. Aprovel slows the decline
in kidney function in patients with high blood pressure and type 2 diabetes. Aprovel is used in adult
patients

• to treat high blood pressure ( essential arterial hypertension)
• to protect the kidney 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 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 for more than 3 months(it is best to avoid taking Aprovel even in the early stages of pregnancy - see section Pregnancy)
• if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren

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

• excessive vomiting or diarrhea
• if you suffer from kidney problems
• if you suffer from heart problems
• if you are taking Aprovel for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to measure 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 to undergo surgeryor receive anesthetics
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also what is stated under "Do not take Aprovel”
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Aprovel is not recommended in early pregnancy and should not be taken
if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (see the section Pregnancy).

Children and adolescents
This medicine should not be used in children and adolescents as safety and
efficacy have not been fully established.

Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not take
Aprovel” and "Warnings and precautions”)

You may need blood tests if you are using:

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

If you take some painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.

Aprovel with food and drink
Aprovel can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
Tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy); your doctor will usually advise you to stop taking Aprovel before
starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Aprovel. Aprovel is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months as it can
cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Aprovel is not recommended for
women who are breastfeeding and your doctor may choose another treatment if you wish to breastfeed,
especially if the baby is newborn or premature.

Driving and operating machinery
It is unlikely that Aprovel will affect your ability to drive or operate machinery. However,
occasionally, dizziness or fatigue may occur during treatment for high blood pressure.
If this happens, talk to your doctor before driving or using machinery.

Aprovel contains lactose. If you have been diagnosed with 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, i.e. it is essentially ‘sodium-free’.

3. How to take Aprovel

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Method of administration
Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluids (e.g., a
glass of water). You can take Aprovel with or without food. Try to take the medicine every
day at the same time. The treatment should be continued as long as your doctor considers it necessary.

• Patients with high blood pressureThe usual dose is 150 mg once a day. The dosage may be increased to 300 mg (two tablets a day) once a day depending on the reduction in blood pressure levels.
• Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes, the indicated maintenance dose is 300 mg (two tablets a day) once a day for the treatment of associated kidney disease.

The doctor may decide to use lower doses, especially at the beginning of treatment, in
particular patients such as those in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be achieved 4-6 weeks after the start of therapy.

Use in children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows some
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 forget to take a dose, continue normally with the therapy. Do not take
a double dose to make up for the missed dose.
If you have any doubts about 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.
Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (redness, hives) as well as localised
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 Aprovel 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 for 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 disease, blood tests may show high levels of potassium.
• Common (may affect up to 1 in 10 people): dizziness, feeling unwell/vomiting, fatigue and blood
  tests may show an increase in the 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
  when standing up from a lying or sitting position, low blood pressure when standing up 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 relating to sexual performance), chest pain.

Since marketing of Aprovel, some side effects have been reported. Side effects with frequency not
known are: feeling of spinning, headache, taste disturbances, ringing in the ears, muscle cramps,
joint and muscle pain, decreased number of red blood cells (anaemia - symptoms may include fatigue,
headache, shortness of breath during physical activity, dizziness and pale appearance), reduced
number of platelets, abnormal liver function, increased levels of potassium in the blood, kidney
function disorders, inflammation of small blood vessels mainly affecting the skin (a condition known as
leucocytoclastic vasculitis), severe allergic reactions (anaphylactic shock). Cases of jaundice
(yellowing of the skin and/or whites of the eyes) have also been reported uncommonly.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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. How to store Aprovel

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 at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 Aprovel contains

• - The active ingredient is irbesartan. Each Aprovel 150 mg tablet contains 150 mg of irbesartan.
• - The excipients are: microcrystalline cellulose, sodium carboxymethyl cellulose, lactose monohydrate, magnesium stearate, hydrated colloidal silica, pregelatinized corn starch and poloxamer 188. See section 2 “Aprovel contains lactose”.

Description of the appearance of Aprovel and package contents
Aprovel 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.
Aprovel 150 mg tablets are available in packs of 14, 28, 56 or 98 tablets in blisters. Also
available are single-dose blisters of 56 x 1 tablet 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 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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
sanofi-aventis, s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/STlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Genzyme Europe B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
sanofi-aventis Sp. z o.o.
Tel.: +48 22 280 00 00

France
sanofi-aventis France
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6616 47 50

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/

Aprovel 300 mg tablets

irbesartan

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others. It may be harmful to people even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 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. 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 by the body that binds to receptors in blood vessels,
causing them to constrict. This results in an increase in blood pressure.
Aprovel prevents angiotensin-II from binding to these receptors, allowing blood vessels to
dilate and blood pressure to decrease. Aprovel slows the decline of kidney function
in patients with high blood pressure and type 2 diabetes.
Aprovel is used in adult patients

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

2. What you need to know before taking 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 for more than 3 months(it is best to avoid taking Aprovel even in the early stages of pregnancy - see section Pregnancy)
• if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren

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

• excessive vomiting or diarrhea
• if you suffer from kidney problems
• if you suffer from heart problems
• if you are taking Aprovel for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to measure 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, fast or pounding heartbeat), especially if you are being treated for diabetes
• if you are to undergo surgeryor receive anesthesia
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also what is stated under "Do not take Aprovel”
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Aprovel is not recommended in the early stages of pregnancy and should not be taken
if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (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.

Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not take
Aprovel” and "Warnings and precautions”)

You may need blood tests if you are using:

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

If you take certain painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.

Aprovel with food and drink
Aprovel can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
Tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy); your doctor will usually advise you to stop taking Aprovel before
starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Aprovel. Aprovel is not recommended in the early
stages of pregnancy and should not be taken if you are pregnant for more than 3 months as it can
cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Aprovel is not recommended for
women who are breastfeeding and your doctor may choose another treatment if you wish to breastfeed,
especially if the baby is newborn or premature.

Driving and operating machinery
It is unlikely that Aprovel will affect your ability to drive or operate machinery. However,
occasionally, dizziness or fatigue may occur during treatment for high blood pressure.
If this happens, talk to your doctor before driving or using machinery.

Aprovel contains lactose. If you have been diagnosed with intolerance to some sugars, lo
contact your doctor before taking this medicine.

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

3. How to take Aprovel

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Method of administration
Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluids (e.g., a
glass of water). You can take Aprovel with or without food. Try to take the medicine every
day at the same time. The treatment should be continued as long as your doctor considers it necessary.

• Patients with high blood pressureThe usual dose is 150 mg once a day. The dosage may be increased to 300 mg once a day depending on the reduction in blood pressure levels.
• Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes, the indicated maintenance dose is 300 mg once a day for the treatment of associated kidney disease.

The doctor may decide to use lower doses, especially at the beginning of treatment, in
particular patients such as those in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be reached 4-6 weeks after the start of therapy.

Use in children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows some
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 forget to take a dose, continue with therapy as normal. Do not take
a double dose to make up for a missed dose.
If you have any doubts about 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.
Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (redness, hives) 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 Aprovel 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 for patients treated with Aprovel were:

• Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show elevated levels of potassium.
• Common (may affect up to 1 in 10 people): dizziness, feeling unwell/vomiting, fatigue and blood tests may show an increase in the 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 when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (hemoglobin) have also been reported.
• Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Since the marketing of Aprovel, some side effects have been reported. Side effects with unknown frequency are: feeling of spinning, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells (anemia - symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced number of platelets, abnormal liver function, increased levels of potassium in the blood, kidney function disorders, inflammation of small blood vessels mainly affecting the skin (a condition known as leucocytoclastic 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 get any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet.
You can also report side effects directly through the national reporting system detailed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aprovel

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 at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Aprovel contains

• - The active ingredient is irbesartan. Each Aprovel 300 mg tablet contains 300 mg of irbesartan.
• - The excipients are: microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, magnesium stearate, hydrated colloidal silica, pregelatinized maize starch and poloxamer 188. See section 2 “Aprovel contains lactose”.

Description of the appearance of Aprovel and package contents
Aprovel 300 mg tablets are white to almost white, biconvex, oval-shaped with a
heart engraved on one side and the number 2773 imprinted on the other side.
Aprovel 300 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

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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
sanofi-aventis, s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Genzyme Europe B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
sanofi-aventis Sp. z o.o.
Tel.: +48 22 280 00 00

France
sanofi-aventis France
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6616 47 50

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/

Aprovel 75 mg film-coated tablets

irbesartan

Read this leaflet carefully before you start to take 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 pass it on to others. It may be harmful for people other than you, even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 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. 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 by the body that binds to receptors in blood vessels,
causing them to constrict. This results in an increase in blood pressure.
Aprovel prevents angiotensin-II from binding to these receptors, allowing blood vessels to
dilate and blood pressure to decrease. Aprovel slows the decline of kidney function
in patients with high blood pressure and type 2 diabetes.
Aprovel is used in adult patients

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

2. What you need to know before taking 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 for more than 3 months(it is best to avoid taking Aprovel even in the early stages of pregnancy - see section Pregnancy)
• if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren

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

• - excessive vomiting or diarrhoea
• - if you suffer from kidney disorders
• - if you suffer from heart disorders
• if you are taking Aprovel for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to measure serum potassium levels if you have poor kidney function
• if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, fast or pounding heartbeat), especially if you are being treated for diabetes
• - if you are to undergo surgery(surgical) or receive anaesthetics
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also what is stated under "Do not take Aprovel”
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Aprovel is not recommended in early pregnancy and should not be taken
if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (see section Pregnancy).

Children and adolescents
This medicine should not be used in children and adolescents as safety and
efficacy have not been fully established.

Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your doctor may need to adjust the dose and / or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also "Do not take
Aprovel” and "Warnings and precautions”).

You may need blood tests if you are using:

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

If you take some painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.

Aprovel with food and drink
Aprovel can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy); your doctor will usually advise you to stop taking Aprovel before
becoming pregnant or as soon as you find out you are pregnant and will advise
you to take another medicine instead of Aprovel. Aprovel is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months as it can cause
serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Aprovel is not recommended for
women who are breastfeeding and your doctor may choose another treatment if you wish to breastfeed,
especially if the baby is newborn or premature.

Driving and using machines:
It is unlikely that Aprovel will affect your ability to drive or operate machinery. However,
occasionally, dizziness or fatigue may occur during treatment for high blood pressure.
If this happens, talk to your doctor before driving or using
machinery.

Aprovel contains lactose.If you have been diagnosed with 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, i.e. it is essentially ‘sodium-free’.

3. How to take Aprovel

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult
your doctor or pharmacist.

Method of administration
Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluids (e.g., a
glass of water). You can take Aprovel with or without food. Try to take the medicine every
day at the same time. The treatment should be continued as long as your doctor considers it necessary.

• Patients with high blood pressureThe usual dose is 150 mg once a day (two tablets a day). The dosage may then be increased to 300 mg (four tablets a day) once a day depending on the reduction of blood pressure levels.
• Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes, the indicated maintenance dose is 300 mg (four tablets a day) once a day for the treatment of associated kidney disease.

The doctor may decide to use lower doses, especially at the beginning of treatment, in
particular patients such as those in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be reached 4-6 weeks after the start of therapy.

Use in children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows some
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 forget to take a dose, continue normally with the therapy. Do not take
a double dose to compensate for the missed dose.
If you have any doubts about 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.
Some of these effects can be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (redness, hives) have been reported in patients treated with irbesartan, as well as localized swelling of the face, lips and/or tongue. If you experience any of these symptoms or have difficulty breathing, stop taking Aprovel 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 for patients treated with Aprovel were:

• Very common (may affect more than 1 in 10 people): if you suffer from 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/vomiting, fatigue and blood tests may show an increase in the 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 when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (hemoglobin) have also been reported.
• Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Since Aprovel was marketed, some side effects have been reported. Side effects with unknown frequency are: feeling of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells (anemia - symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and pale appearance), reduced number of platelets, abnormal liver function, increased potassium levels in the blood, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leucocytoclastic 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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist .
You can also report side effects directly through the national reporting system detailed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aprovel

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 at a temperature above 30°C.
Do not dispose of any medicine in 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 Aprovel contains

• - The active ingredient is irbesartan. Each Aprovel 75 mg tablet contains 75 mg of irbesartan.
• - The excipients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. See section 2 “Aprovel contains lactose”.

Description of the appearance of Aprovel and package contents
Aprovel 75 mg film-coated tablets are white to almost white, biconvex, oval-shaped with a heart engraved on one side and the number 2871 imprinted on the other side.
Aprovel 75 mg film-coated tablets are available in packs of 14, 28, 30, 56, 84, 90 and
98 film-coated tablets in blisters. Unit-dose blisters of
56 x 1 film-coated 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

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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
sanofi-aventis, s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/STlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Genzyme Europe B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
sanofi-aventis Sp. z o.o.
Tel.: +48 22 280 00 00

France
sanofi-aventis France
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6616 47 50

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44

• (0) 800 035 2525

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

Aprovel 150 mg film-coated tablets

irbesartan

Read 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 questions, ask your doctor or pharmacist.
• - This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful for people other than you, even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 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. 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 by the body that binds to receptors in blood vessels causing them
to constrict. This results in an increase in blood pressure. Aprovel prevents angiotensin-II from binding
to these receptors, allowing blood vessels to dilate and blood pressure to decrease. Aprovel slows the
decline of kidney function 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 kidney in hypertensive patients with high blood pressure, type 2 diabetes and with evidence of
  kidney dysfunction in laboratory tests.

2. What you need to know before taking 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 for more than 3 months(it is best to avoid taking Aprovel even in the early stages of pregnancy - see section Pregnancy)
• if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren

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

• - excessive vomiting or diarrhea
• - if you suffer from kidney disorders
• - if you suffer from heart disorders
• if you take Aprovel for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to measure 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 to undergo surgery(surgical) or receive anesthetics
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also what is stated under "Do not take Aprovel”
You should inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Aprovel is not recommended in early pregnancy and should not be taken
if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (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.

Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your doctor may need to adjust the dose and / or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not take
Aprovel” and "Warnings and precautions”)

You may need blood tests if you are using:

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

If you take some painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.

Aprovel with food and drink
Aprovel can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You should inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy); your doctor will usually advise you to stop taking Aprovel before
starting pregnancy or as soon as you find out you are pregnant and will advise you
to take another medicine instead of Aprovel. Aprovel is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months as it can cause
serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Aprovel is not recommended for
women who are breastfeeding and your doctor may choose another treatment if you wish to breastfeed,
especially if the baby is newborn or premature.

Driving and using machines:
It is unlikely that Aprovel will affect your ability to drive or operate machinery. However,
occasionally, dizziness or fatigue may occur during treatment for high blood pressure.
If this happens, talk to your doctor before driving or using machinery.

Aprovel contains lactose.If your doctor has diagnosed you with intolerance to some sugars, contact
him/her before taking this medicine.

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

3. How to take Aprovel

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.

Method of administration
Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluids (e.g., a
glass of water). You can take Aprovel with or without food. Try to take the medicine every
day at the same time. The treatment should be continued as long as your doctor deems necessary.

• Patients with high blood pressureThe usual dose is 150 mg once a day. The dosage may then be increased to 300 mg (two tablets a day) once a day depending on the reduction in blood pressure levels.
• Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes, the indicated maintenance dose is 300 mg (two tablets a day) once a day for the treatment of associated kidney disease.

The doctor may decide to use lower doses, especially at the beginning of treatment, in
particular patients such as those in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be reached 4-6 weeks after the start of therapy.

Use in children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows some
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 forget to take a dose, continue normally with the therapy. Do not take
a double dose to compensate for the missed dose.
If you have any doubts about 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.
Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of allergic skin reactions (redness, hives) 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 Aprovel 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 for patients treated with Aprovel were:

• Very common (may affect more than 1 in 10 people): if you suffer from 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/vomiting, fatigue and blood tests may show an increase in the 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 when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, joint or muscle pain and a decrease in the levels of a protein in red blood cells (hemoglobin) have also been reported.
• Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Since Aprovel was marketed, some side effects have been reported. Side effects with unknown frequency are: feeling of spinning, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, reduced number of platelets, abnormal liver function, increased levels of potassium in the blood, decreased number of red blood cells (anemia - symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and pale appearance), kidney function disorders, inflammation of small blood vessels mainly affecting the skin (a condition known as leucocytoclastic 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 get any side effects, talk to your doctor or pharmacist .
You can also report side effects directly through 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 Aprovel

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 at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 Aprovel contains

• - The active ingredient is irbesartan. Each Aprovel 150 mg tablet contains 150 mg of irbesartan.
• - The excipients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. See section 2 “Aprovel contains lactose”. Description of the appearance of Aprovel and package contentsAprovel 150 mg film-coated tablets are from white to almost white, biconvex, oval-shaped with a heart engraved on one side and the number 2872 imprinted on the other side.

Aprovel 150 mg film-coated tablets are available in packs of 14, 28, 30, 56, 84, 90 and
98 film-coated tablets in blisters. Unit-dose blisters of
56 x 1 film-coated 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

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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
sanofi-aventis, s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/STlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Genzyme Europe B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
sanofi-aventis Sp. z o.o.
Tel.: +48 22 280 00 00

France
sanofi-aventis France
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6616 47 50

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/

Aprovel 300 mg film-coated tablets

irbesartan

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others. It may be harmful for people other than you, even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 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. How to store Aprovel
• 6. Contents of the pack and other information

1. What is Aprovel 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 by the body that binds to receptors in blood vessels causing them to constrict. This results in an increase in blood pressure. Aprovel prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease. Aprovel slows the decline of kidney function in patients with high blood pressure and type 2 diabetes. Aprovel is used in adult patients

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

2. What you need to know before taking 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 for more than 3 months(it is best to avoid taking Aprovel even in the early stages of pregnancy - see section Pregnancy)
• if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren

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

• - excessive vomiting or diarrhea
• - if you suffer from kidney disorders
• - if you suffer from heart disorders
• if you are taking Aprovel for diabetic kidney disorders. In this case, your doctor may prescribe regular blood tests, especially to measure 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, fast and pounding heartbeat), especially if you are being treated for diabetes
• - if you are to undergo surgeryor receive anesthetics
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also what is stated under "Do not take Aprovel”
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Aprovel is not recommended in early pregnancy and should not be taken
if you are pregnant for more than 3 months, as it can cause serious harm to the baby if taken in
this period (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.

Other medicines and Aprovel
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not take
Aprovel” and "Warnings and precautions”).

You may need blood tests if you are using:

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

If you take some painkillers, called non-steroidal anti-inflammatory drugs,
the effectiveness of irbesartan may be reduced.

Aprovel with food and drink
Aprovel can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy); your doctor will usually advise you to stop taking Aprovel before
starting a pregnancy or as soon as you find out you are pregnant and will advise
you to take another medicine instead of Aprovel. Aprovel is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months as it can cause
serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Aprovel is not recommended for
women who are breastfeeding and your doctor may choose another treatment if you wish to breastfeed,
especially if the baby is newborn or premature.

Driving and operating machinery:
It is unlikely that Aprovel will affect your ability to drive or operate machinery. However,
occasionally, dizziness or fatigue may occur during treatment for high blood pressure.
If this happens, talk to your doctor before driving or using
machinery.

Aprovel contains lactose.If you have been diagnosed with intolerance to some sugars, lo
contact your doctor before taking this medicine.

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

3. How to take Aprovel

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Method of administration
Aprovel is for oral use. Swallow the tablets with a sufficient amount of fluids (e.g., a
glass of water). You can take Aprovel with or without food. Try to take the medicine every
day at the same time. The treatment should be continued as long as your doctor considers it necessary.

• Patients with high blood pressureThe usual dose is 150 mg once a day. The dosage may subsequently be increased to 300 mg once a day depending on the reduction in blood pressure levels.
• Patients with high blood pressure and type 2 diabetes with kidney diseaseIn patients with high blood pressure and type 2 diabetes, the indicated maintenance dose is 300 mg once a day for the treatment of associated kidney disease.

The doctor may decide to use lower doses, especially at the beginning of treatment, in
particular patients such as those in hemodialysis, or in patients over 75 years of age.
The maximum antihypertensive effect should be achieved 4-6 weeks after the start of therapy.

Use in children and adolescents
Aprovel should not be given to children under 18 years of age. If a child swallows some
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 forget to take a dose, continue with the therapy as normal. Do not take
a double dose to compensate for the missed dose.
If you have any doubts about 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 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 (redness, hives) have been reported in patients treated with irbesartan, as well as localized swelling of the face, lips and/or tongue. If you experience any of these symptoms or have difficulty breathing, stop taking Aprovel 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 for patients treated with Aprovel were:

• Very common (may affect more than 1 in 10 people): if you suffer from 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/vomiting, fatigue and blood tests may show an increase in the 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 when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, joint or muscle pain, and a decrease in the levels of a protein in red blood cells (hemoglobin) have also been reported.
• Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Since the marketing of Aprovel, some side effects have been reported. Side effects with unknown frequency are: feeling of spinning, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, decreased number of red blood cells (anemia - symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and paleness), reduced number of platelets, abnormal liver function, increased potassium levels in the blood, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leucocytoclastic vasculitis), severe allergic reactions (anaphylactic shock). Cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported uncommonly.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist .
You can also report side effects directly through the national reporting system detailed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aprovel

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 at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 Aprovel contains

• - The active ingredient is irbesartan. Each Aprovel 300 mg tablet contains 300 mg of irbesartan.
• - The excipients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax. See section 2 “Aprovel contains lactose”.

Description of the appearance of Aprovel and package contents
Aprovel 300 mg film-coated tablets are white to almost white, biconvex, oval shaped with a heart engraved on one side and the number 2873 imprinted on the other side.
Aprovel 300 mg film-coated tablets are available in packs of 14, 28, 30, 56, 84, 90 and
98 film-coated tablets in blisters. Unit-dose blisters of
56 x 1 film-coated 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

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
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
sanofi-aventis, s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/STlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275

Deutschland
Sanofi-Aventis Deutschland GmbH
Tel: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Genzyme Europe B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη ΑΕΒΕ
Τηλ: +30 210 900 16 00

Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
sanofi-aventis Sp. z o.o.
Tel.: +48 22 280 00 00

France
sanofi-aventis France
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800 536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6616 47 50

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +44 (0) 800 035 2525
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu/