Iscover

Package leaflet: Information for the user

Iscover 75 mg film-coated tablets

clopidogrel
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Iscover is and what it is used for

Iscover contains clopidogrel and belongs to a group of medicines called platelet aggregation inhibitors. Platelets are microscopic blood components that clump together during blood clotting. By preventing this aggregation, platelet aggregation inhibitors reduce the likelihood of blood clots forming (a process known as thrombosis).
Iscover is taken by adults to help prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Your doctor has prescribed Iscover to help prevent blood clots and reduce the risk of these serious events because:

• you have a condition known as hardening of the arteries (also called atherosclerosis), and
• you have previously had a heart attack, stroke, or a condition known as peripheral arterial disease, or
• you have previously experienced severe chest pain known as “unstable angina” or “myocardial infarction” (heart attack). To treat this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting),
• you have had stroke symptoms that disappeared within a short period of time (also known as transient ischemic attack) or a mild ischemic stroke. Your doctor may prescribe acetylsalicylic acid starting within the first 24 hours,
• you have an irregular heartbeat, a condition called “atrial fibrillation”, and you cannot take medicines known as “oral anticoagulants” (vitamin K antagonists), which prevent the formation of new clots and the growth of existing ones. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Iscover and acetylsalicylic acid in treating this condition. If you cannot take “oral anticoagulants” and do not have an increased risk of bleeding, your doctor may have prescribed Iscover plus acetylsalicylic acid.

2. What you should know before taking Iscover

Do not take Iscover

• If you are allergic (hypersensitive) to clopidogrel or to any of the excipients of this medicine (listed in section 6).
• If you have active bleeding, such as a stomach ulcer or bleeding in the brain.
• If you suffer from severe liver disease.
  If you think any of these situations apply to you, or if you are unsure, consult your doctor before using Iscover.

Warnings and precautions
If any of the conditions listed below apply to you, inform your doctor before taking Iscover:

• If you are at risk of bleeding, such as:
  • a medical condition that puts you at risk of internal bleeding (e.g. a stomach ulcer),
  • a blood disorder that makes you prone to internal bleeding (bleeding within any tissue, organ, or joint of the body),
  • a recent serious injury,
  • recent surgery (including dental surgery),
  • planned surgery (including dental surgery) within the next 7 days,
• If you have had a blood clot in an artery of the brain (ischemic stroke) that occurred within the last 7 days,
• If you have kidney or liver disease,
• If you have had an allergy or reaction to any medicine used to treat your condition,
• If you have previously experienced a non-traumatic brain hemorrhage.

While taking Iscover:

• You must inform your doctor if you are scheduled for surgery (including dental procedures).
• You must contact your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) characterized by fever and skin bruising appearing as red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is due to the way the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, such as shaving or minor cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 4 “Possible side effects”).
• Your doctor may prescribe blood tests.

Children and adolescents
Do not give this medicine to children, as it is not effective.

Other medicines and Iscover
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. Some medicines may affect how Iscover works, or Iscover may affect them. You must inform your doctor precisely if you are taking:

• Medicines that may increase your risk of bleeding, such as:
  • oral anticoagulants, medicines used to reduce blood clotting,
  • a non-steroidal anti-inflammatory drug (NSAID), generally used to treat painful and/or inflammatory conditions of muscles or joints,
  • heparin or any other injectable medicine used to reduce blood clotting,
  • ticlopidine, other antiplatelet agents,
• A selective serotonin reuptake inhibitor (SSRI) (including but not limited to fluoxetine or fluvoxamine), medicines usually used to treat depression,
• Rifampicin (used to treat serious infections),
• Omeprazole or esomeprazole, medicines used to treat stomach problems,
• Fluconazole or voriconazole, medicines used to treat fungal infections,
• Efavirenz or other antiretroviral medicines (used to treat HIV infection),
• Carbamazepine, a medicine used to treat certain forms of epilepsy,
• Moclobemide, a medicine used to treat depression,
• Repaglinide, a medicine used to treat diabetes,
• Paclitaxel, a medicine used to treat cancer,
• Opioids: while being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),
• Rosuvastatin (used to lower cholesterol levels).

If you have experienced severe chest pain (unstable angina or heart attack), a transient ischemic attack, or a mild ischemic stroke, you may have been prescribed Iscover in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (not exceeding 1,000 mg within 24 hours) generally should not cause problems, but prolonged use in other circumstances should be discussed with your doctor.

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

Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy.
If you are pregnant or think you may be pregnant, inform your doctor or pharmacist before taking Iscover. If you become pregnant while taking Iscover, consult your doctor immediately, as it is recommended not to take Iscover during pregnancy.
You must not breastfeed while taking this medicine.
If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is unlikely that Iscover will affect your ability to drive or operate machinery.

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

Iscover contains hydrogenated castor oil
This may cause stomach discomfort or diarrhea.

3. How to take Iscover

Always take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose, including for patients diagnosed with "atrial fibrillation" (an irregular heartbeat),
is one 75 mg Iscover tablet daily, taken orally during or apart from meals, at the same time each day.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe
you an initial dose of 300 mg or 600 mg of Iscover (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg)
once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg Iscover tablet daily,
as described above.
If you have experienced symptoms of a stroke that disappear within a short period of time (also known as
transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe 300 mg of Iscover
(1 tablet of 300 mg or 4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended
dose is one 75 mg Iscover tablet daily, as described above, in combination with acetylsalicylic acid for
3 weeks. After this period, your doctor will prescribe either Iscover alone or acetylsalicylic acid alone.
Iscover should be taken for as long as your doctor considers it necessary.
If you take more Iscover than you should
Contact your doctor or go to the nearest hospital emergency department due to the risk of increased
bleeding.
If you forget to take Iscover
If you forget to take a dose but remember within 12 hours of your usual time, take one tablet immediately
and then take the next dose at your usual time.
If more than 12 hours have passed, simply take your next dose at the usual time. Do not take a double
dose to make up for a forgotten tablet.
For packs containing 7, 14, 28, and 84 tablets, you can check the day on which the last Iscover tablet
was taken by looking at the calendar printed on the blister pack.
If you stop taking Iscover
Do not stop treatment unless instructed by your doctor. Before stopping, contact your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience:

• fever, signs of infection, or severe weakness. These effects may be due to a rare reduction in certain blood cells,
• signs of liver problems such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red spots, and/or confusion (see section 2 "Warnings and precautions"),
• swelling in the mouth or skin disorders such as rash, itching, or skin blisters. These may be signs of an allergic reaction.

The most common side effect reported with Iscover is bleeding. Bleeding may occur
in the stomach or intestines, bruising, haematomas (unusual bleeding or subcutaneous bruising), nosebleeds, or blood in the urine. In rare cases, bleeding in the eye, intracranial bleeding, in the lungs, or in the joints has also been reported.
If you experience prolonged bleeding while taking Iscover
If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is due to the way the medicine works, as it prevents the formation of blood clots. For minor cuts or injuries, such as shaving or small cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 2 "Warnings and precautions").
Other side effects include:
Common side effects (may occur in up to 1 in 10 patients):
Diarrhoea, abdominal pain, indigestion or stomach burning.
Uncommon side effects (may occur in up to 1 in 100 patients):
Headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, tingling and numbness sensations.
Rare side effects (may occur in up to 1 in 1,000 patients):
Vertigo, breast enlargement in males.
Very rare side effects (may occur in up to 1 in 10,000 patients):
Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalized allergic reactions (for example, widespread sensation of warmth with sudden general malaise up to fainting); swelling in the mouth; skin blisters; skin allergy; mouth pain (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste.
Side effects with unknown frequency (frequency cannot be determined from available data): hypersensitivity reactions with chest or abdominal pain, persistent symptoms of hypoglycaemia.
Additionally, your doctor may have identified changes in blood and urine test results.
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 Iscover

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the
blister after Exp. The expiry date refers to the last day of that month.
Refer to the storage conditions indicated on the outer packaging.
If Iscover is supplied in PVC/PVDC/aluminium blisters, store it below 30°C.
If Iscover is supplied in aluminium/aluminium blisters, no special storage conditions
are required for this medicine.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Iscover contains
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as
hydrogen sulfate).
The other components are (see section 2 “Iscover contains lactose” and “Iscover contains hydrogenated castor oil”):

• Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000, low-substituted hydroxypropylcellulose,
• Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E 172), titanium dioxide (E 171),
• Polishing agent: carnauba wax.

Description of the appearance of Iscover and contents of the pack
Iscover 75 mg film-coated tablets are round, biconvex, pink in colour, with the number “75” engraved on one side and “1171” on the other. Iscover is supplied in cardboard boxes containing:

• 7, 14, 28, 30, 84, 90 and 100 tablets in PVC/PVDC/aluminium blisters or aluminium/aluminium blisters,
• 50x1 tablets in PVC/PVDC/aluminium blisters or single-dose aluminium blisters.
  Not all pack sizes may be marketed.

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

Manufacturers:
Sanofi Winthrop Industrie
1, Rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France
or
Delpharm Dijon
6, Boulevard de l'Europe, F-21800 Quétigny, France
or
Sanofi S.r.l.
Strada Statale 17, Km 22
67019 Scoppito (AQ) - Italy

For further information on Iscover, please 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

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

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: 800 536 389

Suomi/Finland
SanofiOy
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 medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

Package leaflet: Information for the user

Iscover 300 mg film-coated tablets

clopidogrel
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Iscover is and what it is used for

Iscover contains clopidogrel and belongs to a group of medicines called platelet aggregation inhibitors. Platelets are microscopic components of the blood that clump together during blood clotting. By preventing this aggregation, platelet aggregation inhibitors reduce the likelihood of blood clot formation (a process known as thrombosis).

Iscover is taken by adults to prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

Iscover has been prescribed to you to help prevent blood clot formation and to reduce the risk of these serious events because:

• you have a condition known as hardening of the arteries (also called atherosclerosis), and
• you have previously had a heart attack, stroke, or a condition known as peripheral arterial disease, or
• you have previously experienced severe chest pain known as "unstable angina" or "myocardial infarction" (heart attack). To treat this condition, your doctor may have inserted a stent into the blocked or narrowed artery to restore blood flow. Your doctor may also have prescribed you acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting),
• you have experienced stroke symptoms that disappeared within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may prescribe you acetylsalicylic acid starting within the first 24 hours,
• you have an irregular heartbeat, a condition called "atrial fibrillation", and you cannot take medicines known as "oral anticoagulants" (vitamin K antagonists) which prevent the formation of new clots and the progression of existing ones. You will have been informed that "oral anticoagulants" are more effective than acetylsalicylic acid or the combination of Iscover and acetylsalicylic acid in treating this condition. If you cannot take "oral anticoagulants" and do not have an increased risk of bleeding, your doctor may have prescribed you Iscover plus acetylsalicylic acid.

2. What you need to know before taking Iscover

Do not take Iscover:

• If you are allergic (hypersensitive) to clopidogrel or to any of the excipients of this medicine (listed in section 6).
• If you have active bleeding, such as a stomach ulcer or bleeding in any part of the brain.
• If you suffer from severe liver disease. If you think any of these cases apply to you, or if you are unsure, consult your doctor before using Iscover.

Warnings and precautions
Inform your doctor before taking Iscover if you have any of the following conditions:

• If you are at risk of bleeding, such as:
  • a medical condition that puts you at risk of internal bleeding (e.g. a stomach ulcer),
  • a blood disorder that makes you prone to internal bleeding (bleeding within any tissue, organ, or joint of the body),
  • a recent serious injury,
  • recent surgery (including dental surgery),
  • planned surgery (including dental surgery) within the next 7 days,
• If you have had a blood clot in a brain artery (ischaemic stroke) that occurred within the last 7 days,
• If you have kidney or liver disease,
• If you have had an allergy or reaction to any medicine used to treat your condition,
• If you have previously had a non-traumatic brain haemorrhage.

While taking Iscover:

• You must inform your doctor if you are scheduled for surgery (including dental surgery).
• You must inform your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) which includes fever and skin bruising appearing as red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is due to the way the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, such as shaving or minor cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 4 “Possible side effects”).
• Your doctor may prescribe blood tests for you.

Children and adolescents
Do not give this medicine to children, as it is not effective.

Other medicines and Iscover
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Some medicines may affect the use of Iscover or vice versa. You must inform your doctor precisely if you are taking:

• Medicines that may increase your risk of bleeding, such as:
  • oral anticoagulants, medicines used to reduce blood clotting,
  • a non-steroidal anti-inflammatory medicine, generally used to treat painful and/or inflammatory conditions of muscles or joints,
  • heparin or any other injectable medicine used to reduce blood clotting,
• ticlopidine, other antiplatelet agents,
• a selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines normally used to treat depression,
• rifampicin (used to treat serious infections),
• omeprazole or esomeprazole, medicines used to treat stomach problems,
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz or other antiretroviral medicines (used to treat HIV infection),
• carbamazepine, a medicine used to treat certain forms of epilepsy,
• moclobemide, a medicine used to treat depression,
• repaglinide, a medicine used to treat diabetes,
• paclitaxel, a medicine used to treat cancer,
• opioids: while being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),
• rosuvastatin (used to lower cholesterol levels).

If you have had severe chest pain (unstable angina or heart attack), a transient ischaemic attack, or a mild ischaemic stroke, you may have been prescribed Iscover in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (no more than 1,000 mg within 24 hours) should generally not cause problems, but prolonged use in other circumstances should be discussed with your doctor.

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

Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy. If you are pregnant or think you may be pregnant, inform your doctor or pharmacist before taking Iscover. If you become pregnant while taking Iscover, consult your doctor immediately, as it is recommended not to take Iscover during pregnancy. You must not breastfeed while taking this medicine. If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is unlikely that Iscover will affect your ability to drive or use machinery.

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

Iscover contains hydrogenated castor oil
This may cause stomach upset or diarrhoea.

3. How to take Iscover

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose, including for patients diagnosed with "atrial fibrillation" (an irregular heartbeat),
is one 75 mg Iscover tablet daily, taken orally either during or apart from meals, at the same time each day.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe you
300 mg or 600 mg of Iscover (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) as a single dose at the
beginning of treatment. Afterwards, the recommended dose is one 75 mg Iscover tablet daily as described
above.
If you have experienced symptoms of a stroke that disappear within a short period of time (also known as
transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe 300 mg of Iscover
(1 tablet of 300 mg or 4 tablets of 75 mg) as a single dose at the beginning of treatment. Afterwards,
the recommended dose is one 75 mg Iscover tablet daily, as described above, in combination with
acetylsalicylic acid for 3 weeks. Afterwards, your doctor will prescribe either Iscover alone or
acetylsalicylic acid alone.
Iscover should be taken for as long as your doctor considers it necessary.
If you take more Iscover than you should
Contact your doctor or go to the nearest hospital emergency department due to the risk of increased
bleeding.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience:

• fever, signs of infection or severe weakness. These effects may be due to a rare reduction in certain blood cells
• signs of liver problems such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red spots, and/or confusion (see section 2 "Warnings and precautions")
• swelling in the mouth or skin problems such as rash, itching, skin blisters. These may be signs of an allergic reaction. The most common side effect reported with Iscover is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (unusual or subcutaneous bleeding or bruising), nosebleeds, blood in the urine. In rare cases, bleeding in the eye, intracranial bleeding, in the lungs or in the joints has also been reported. If you experience prolonged bleeding while taking Iscover If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is due to the way the medicine works, as it prevents blood clots from forming. For minor cuts and injuries, such as self-inflicted cuts or shaving, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 2 "Warnings and precautions"). Other side effects include: Common side effects (may occur in up to 1 in 10 patients): Diarrhoea, abdominal pain, indigestion or stomach burning. Uncommon side effects (may occur in up to 1 in 100 patients): Headache, gastric ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, rash, itching, dizziness, tingling and numbness sensations. Rare side effects (may occur in up to 1 in 1,000 patients): Vertigo, breast enlargement in males. Very rare side effects (may occur in up to 1 in 10,000 patients): Jaundice, severe abdominal pain with or without back pain, fever, difficulty breathing sometimes associated with cough, generalized allergic reactions (for example, widespread sensation of warmth with sudden general malaise up to fainting), swelling in the mouth, skin blisters, skin allergy, mouth pain (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes or loss of taste. Side effects with unknown frequency (frequency cannot be estimated from the available data): hypersensitivity reactions with chest or abdominal pain, persistent symptoms of hypoglycaemia. Additionally, your doctor may have identified changes in blood and urine test results. Reporting of side effects If you experience any side effects, 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 ISCOVER

Keep this medicine out of the sight and reach of children.
Do not use Iscover after the expiry date stated on the outer packaging and on the blister.
After Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
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 Iscover contains
The active substance is clopidogrel. Each tablet contains 300 mg of clopidogrel (as hydrogen sulfate).
The other components are (see section 2 “Iscover contains lactose” and “Iscover contains hydrogenated castor oil”):

• Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000, and low-substituted hydroxypropylcellulose,
• Tablet coating: monohydrate lactose (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E 172), titanium dioxide (E 171)
• Polishing agent: carnauba wax.

Description of the appearance of Iscover and pack contents
The film-coated tablets of Iscover 300 mg are oblong, pink in colour, with the number “300” engraved on one side and the number “1332” on the other. Iscover is supplied in cardboard boxes containing 4 x 1, 10 x 1, 30 x 1 and 100 x 1 tablets in single-dose aluminum blisters. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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

For further information on Iscover, 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/S Sanofi S.r.l.
Tlf: +45 45 16 70 00 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: 800 536 389 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 6 616 47 50 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/