Clopidogrel Zentiva

Package leaflet: Information for the user

Clopidogrel Zentiva 75 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Clopidogrel Zentiva is and what it is used for

Clopidogrel Zentiva contains the active substance clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are microscopic components of the blood that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the likelihood of blood clots forming (a process known as thrombosis).
Clopidogrel Zentiva 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).
Clopidogrel Zentiva has been prescribed to you 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 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 had symptoms of stroke that disappear 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 growth of existing ones. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Clopidogrel Zentiva 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 Clopidogrel Zentiva plus acetylsalicylic acid.

2. What you should know before taking Clopidogrel Zentiva

Do not take Clopidogrel Zentiva:

• If you are allergic (hypersensitive) to clopidogrel or to any of the other ingredients 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 apply to you, or if you are unsure, consult your doctor before using Clopidogrel Zentiva.

Warnings and precautions

If any of the conditions listed below apply to you, inform your doctor before taking Clopidogrel Zentiva:

• if you have a risk of bleeding, such as: a medical condition that puts you at risk of internal bleeding (e.g. a stomach ulcer), or a blood disorder that makes you prone to internal bleeding (bleeding within any tissue, organ, or joint of the body), or a recent severe injury, or recent surgery (including dental surgery), or if you are scheduled to have surgery (including dental surgery) within the next 7 days,
• if you have had a blood clot in an artery of the brain (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 Clopidogrel Zentiva:

• You must inform your doctor if you are due to undergo 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 bruising under the skin appearing as small 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 Clopidogrel Zentiva
Tell 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 Clopidogrel Zentiva or vice versa. You must inform your doctor precisely if you are taking:

• medicines that may increase your risk of bleeding such as:
  o oral anticoagulants, medicines used to reduce blood clotting,
  o a non-steroidal anti-inflammatory medicine, generally used to treat painful and/or inflammatory conditions of muscles or joints,
  o heparin or any other injectable medicine used to reduce blood clotting,
  o ticlopidine or other antiplatelet agents,
  o a selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines normally used to treat depression,
  o 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 Clopidogrel Zentiva in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (not 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.

Clopidogrel Zentiva with food and drink
Clopidogrel Zentiva 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 Clopidogrel Zentiva. If you become pregnant while taking Clopidogrel Zentiva, consult your doctor immediately, as it is recommended not to take Clopidogrel Zentiva 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 Clopidogrel Zentiva will affect your ability to drive or use machines.

Clopidogrel Zentiva contains lactose
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

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

3. How to take Clopidogrel Zentiva

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 tablet of Clopidogrel Zentiva 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 an initial dose of 300 mg or 600 mg of Clopidogrel Zentiva (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 tablet of Clopidogrel Zentiva daily, as described above.
If you have experienced stroke symptoms that disappear within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe you an initial dose of 300 mg of Clopidogrel Zentiva (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 tablet of Clopidogrel Zentiva daily, as described above, in combination with acetylsalicylic acid for 3 weeks.
Afterwards, your doctor will prescribe either Clopidogrel Zentiva alone or acetylsalicylic acid alone.
Clopidogrel Zentiva should be taken for as long as your doctor considers it necessary.
If you take more Clopidogrel Zentiva than you should
Contact your doctor or the emergency department of the nearest hospital due to the risk of increased bleeding.
If you forget to take Clopidogrel Zentiva
If you forget to take a dose of Clopidogrel Zentiva 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 regular dose at the usual time. Do not take a double dose to make up for the missed tablet.
If you stop taking Clopidogrel Zentiva
Do not stop treatment unless your doctor has told you to do so. Before stopping, contact your doctor or pharmacist.
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 disorders such as rash, itching, skin blisters. These may be signs of an allergic reaction. The most common side effect reported with Clopidogrel Zentiva is bleeding. Bleeding may occur as gastrointestinal or intestinal bleeding, bruising, haematomas (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine.

In rare cases, bleeding into the eye, intracranial bleeding, into the lungs or into the joints has also been reported.
If you experience prolonged bleeding while taking Clopidogrel Zentiva
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 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, 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):
Dizziness, 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 in breathing sometimes associated with cough; generalized allergic reactions (for example, widespread feeling of warmth with sudden general discomfort up to fainting); swelling in the mouth; skin blisters; skin allergy; sore mouth (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.
In addition, your doctor may have identified changes in blood and urine tests.
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 Clopidogrel Zentiva

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 outer packaging and on the
blister, after Exp. The expiry date refers to the last day of the month indicated.
Refer to the storage conditions stated on the outer packaging.
If Clopidogrel Zentiva is supplied in PVC/PVDC/aluminium blisters, store it at a temperature not exceeding
30°C.
If Clopidogrel Zentiva is supplied in aluminium/aluminium blisters, no special storage conditions apply.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines 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 Clopidogrel Zentiva contains
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as
hydrogen sulfate).
The other components are (see section 2 “Clopidogrel Zentiva contains lactose” and “Clopidogrel
Zentiva contains hydrogenated castor oil”):

• Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000, and low-substituted hydroxypropylcellulose,
• Tablet film 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 Clopidogrel Zentiva and pack contents
Clopidogrel Zentiva 75 mg film-coated tablets are round, biconvex, pink-colored tablets, with the number “75” engraved on one side and the number “1171” on the other. Clopidogrel Zentiva is supplied in cardboard boxes containing:

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

Marketing Authorization Holder and Manufacturers:
Marketing Authorization Holder:
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturers:
Sanofi Winthrop Industrie
1, Rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France
Delpharm Dijon
6, Boulevard de l'Europe, F-21800 Quétigny, France
or
S.C. Zentiva S.A.
B-dul Theodor Pallady nr. 50, sector 3, 032266 Bucharest, Romania

For further information on Clopidogrel Zentiva, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Zentiva, k.s. Zentiva, k.s.
Tél/Tel: +32 (78) 700 112 Tel: +370 52152025
[email protected] [email protected]
България Luxembourg/Luxemburg
Zentiva, k.s. Zentiva, k.s.
Тел: + 359 244 17 136 Tél/Tel: +352 208 82330
[email protected] [email protected]
Česká republika Magyarország
Zentiva, k.s. Zentiva Pharma Kft.
Tel: +420 267 241 111 Tel.: +36 1299 1058
[email protected] [email protected]
Danmark Malta
Zentiva Denmark ApS Zentiva, k.s.
Tlf: +45 787 68 400 Tel: +356 2034 1796
[email protected] [email protected]
Deutschland Nederland
Zentiva Pharma GmbH Zentiva, k.s.
Tel: +49 (0) 800 53 53 010 Tel: +31 202 253 638
[email protected] [email protected]
Eesti Norge
Zentiva, k.s. Zentiva Denmark ApS
Tel: +372 52 70308 Tlf: +45 787 68 400
[email protected] [email protected]
Ελλάδα Österreich
Zentiva, k.s. Zentiva, k.s.
Τηλ: +30 211 198 7510 Tel: +43 720 778 877
[email protected] [email protected]
España Polska
Zentiva Spain S.L.U. Zentiva Polska Sp. z o.o.
Tel: +34 671 365 828 Tel: + 48 22 375 92 00
[email protected] [email protected]
France Portugal
Zentiva France Zentiva Portugal, Lda
Tél: +33 (0) 800 089 219 Tel: +351210601360
[email protected] [email protected]
Hrvatska România
Zentiva, d.o.o. ZENTIVA S.A.
Tel: +385 155 17 772 Tel: +4 021.304.7597
[email protected] [email protected]
Ireland Slovenija
Zentiva, k.s. Zentiva, k.s.
Tel: +353 818 882 243 Tel: +386 360 00 408
[email protected] [email protected]
Ísland Slovenská republika
Zentiva Denmark ApS Zentiva, a.s.
Sími: +354 539 5025 Tel: +421 2 3918 3010
[email protected] [email protected]
Italia Suomi/Finland
Zentiva Italia S.r.l. Zentiva Denmark ApS
Tel: +39 800081631 Puh/Tel: +358 942 598 648
[email protected] [email protected]
Κύπρος Sverige
Zentiva, k.s. Zentiva Denmark ApS
Τηλ: +30 211 198 7510 Tel: +46 840 838 822
[email protected] [email protected]
Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]

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

Package leaflet: Information for the user

Clopidogrel Zentiva 300 mg film-coated tablets

clopidogrel
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
  Contents of this leaflet:

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

1. What Clopidogrel Zentiva is and what it is used for

Clopidogrel Zentiva contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are microscopic blood components that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the likelihood of blood clots forming (a process known as thrombosis).
Clopidogrel Zentiva 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).
Clopidogrel Zentiva has been prescribed to you 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 inserted a stent into 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 disappear within a short period of time (also known as transient ischaemic attack) or mild ischaemic stroke. Your doctor may also 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) that 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 Clopidogrel Zentiva 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 Clopidogrel Zentiva plus acetylsalicylic acid.

2. What you need to know before taking Clopidogrel Zentiva

Do not take Clopidogrel Zentiva:

• If you are allergic (hypersensitive) to clopidogrel or to any of the other ingredients 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 apply to you, or if you are unsure, consult your doctor before using Clopidogrel Zentiva.

Warnings and precautions
Inform your doctor before taking Clopidogrel Zentiva 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), or a blood disorder that makes you prone to internal bleeding (bleeding within any tissue, organ, or joint of the body), or a recent severe injury, or recent surgery (including dental surgery), or if you are scheduled to undergo 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 Clopidogrel Zentiva:

• Inform your doctor if you need to undergo surgery (including dental surgery).
• 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 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 Clopidogrel Zentiva
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 the use of Clopidogrel Zentiva or vice versa. You must inform your doctor precisely if you are taking:

• Medicines that may increase your risk of bleeding, such as:
  o oral anticoagulants, medicines used to reduce blood clotting,
  o a non-steroidal anti-inflammatory drug, generally used to treat painful and/or inflammatory conditions of muscles or joints,
  o heparin or any other injectable medicine used to reduce blood clotting,
  o ticlopidine or other antiplatelet agents,
  o a selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines normally used to treat depression,
  o 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 Clopidogrel Zentiva in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (not 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.

Clopidogrel Zentiva with food and drink
Clopidogrel Zentiva can be taken with or without food.

Pregnancy and breastfeeding
It is preferable not to take this product during pregnancy.
If you are pregnant or think you may be pregnant, inform your doctor or pharmacist before taking Clopidogrel Zentiva. If you become pregnant while taking Clopidogrel Zentiva, consult your doctor immediately, as it is recommended not to take Clopidogrel Zentiva 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 Clopidogrel Zentiva will affect your ability to drive or use machinery.

Clopidogrel Zentiva contains lactose
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

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

3. How to take Clopidogrel Zentiva

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 tablet of Clopidogrel Zentiva daily, taken orally either during or apart from meals, and at the same time each day.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe an initial dose of 300 mg or 600 mg of Clopidogrel Zentiva (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 tablet of Clopidogrel Zentiva daily, as described above.
If you have experienced stroke-like symptoms that disappear within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe an initial dose of 300 mg of Clopidogrel Zentiva (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 tablet of Clopidogrel Zentiva daily, as described above, in combination with acetylsalicylic acid for 3 weeks.
Afterwards, your doctor will prescribe either Clopidogrel Zentiva alone or acetylsalicylic acid alone.
Clopidogrel Zentiva should be taken for as long as your doctor considers it necessary.
If you take more Clopidogrel Zentiva 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 will get 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 Clopidogrel Zentiva is bleeding. Bleeding may occur as bleeding in the stomach or intestines, bruising, haematomas (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. In rare cases, bleeding into the eye, intracranial bleeding, bleeding in the lungs and joints has also been reported. If you experience prolonged bleeding while taking Clopidogrel Zentiva 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 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):
Dizziness, 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, a widespread feeling of warmth with sudden general malaise up to fainting), swelling in the mouth, skin blisters, skin allergy, sore mouth (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.
In addition, 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 Clopidogrel Zentiva

Keep this medicine out of 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 the month indicated.
This medicine requires no special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines 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 Clopidogrel Zentiva contains
The active substance is clopidogrel. Each tablet contains 300 mg of clopidogrel (as
hydrogen sulfate).
The other components are (see section 2 “Clopidogrel Zentiva contains lactose” and “Clopidogrel
Zentiva 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), iron oxide red (E 172), titanium dioxide (E 171),
• Polishing agent: carnauba wax.

Description of the appearance of Clopidogrel Zentiva and the contents of the pack
Film-coated tablets (tablets) of Clopidogrel Zentiva 300 mg are oblong, pink in colour, with the number “300” engraved on one side and the number “1332” on the other. Clopidogrel Zentiva is supplied in cardboard boxes containing 4 x 1, 10 x 1, 30 x 1 and 100 x 1 tablets in perforated aluminium unit dose blisters. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer:
Sanofi Winthrop Industrie
1, Rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France

For further information on Clopidogrel Zentiva, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Zentiva, k.s. Zentiva, k.s.
Tél/Tel: +32 (78) 700 112 Tel: +370 52152025
[email protected] [email protected]

България Luxembourg/Luxemburg
Zentiva, k.s. Zentiva, k.s.
Тел: + 359244 17 136 Tél/Tel: +352 208 82330
[email protected] [email protected]

Česká republika Magyarország
Zentiva, k.s. Zentiva Pharma Kft.
Tel: +420 267 241 111 Tel.: +36 11299 1058
[email protected] [email protected]

Danmark Malta
Zentiva Denmark ApS Zentiva, k.s.
Tlf: +45 787 68 400 Tel: +356 2034 1796
[email protected] [email protected]

Deutschland Nederland
Zentiva Pharma GmbH Zentiva, k.s.
Tel: +49 (0) 800 53 53 010 Tel: +31 202 253 638
[email protected] [email protected]

Eesti Norge
Zentiva, k.s. Zentiva Denmark ApS.
Tel: +372 52 70308 Tlf: +45 787 68 400
[email protected] [email protected]

Ελλάδα Österreich
Zentiva, k.s. Zentiva, k.s.
Τηλ: +30 211 198 7510 Tel: +43 720 778 877
[email protected] [email protected]

España Polska
Zentiva Spain S.L.U. Zentiva Polska Sp. z o.o.
Tel: +34 671 365 828 Tel: + 48 22 375 92 00
[email protected] [email protected]

France Portugal
Zentiva France Zentiva Portugal, Lda
Tél: +33 (0) 800 089 219 Tel: +351210601360
[email protected] [email protected]

Hrvatska România
Zentiva, d.o.o. ZENTIVA S.A.
Tel: +385 155 17 772 Tel: +4 021.304.7597
[email protected] [email protected]

Ireland Slovenija
Zentiva, k.s. Zentiva, k.s.
Tel: +353 818 882 243 Tel: +386 360 00 408
[email protected] [email protected]

Ísland Slovenská republika
Zentiva Denmark ApS Zentiva, a.s.
Sími: +354 539 5025 Tel: +421 2 3918 3010
[email protected] [email protected]

Italia Suomi/Finland
Zentiva Italia S.r.l. Zentiva Denmark ApS
Tel: +39 800081631 Puh/Tel: +358 942 598 648
[email protected] [email protected]

Κύπρος Sverige
Zentiva, k.s. Zentiva Denmark ApS.
Τηλ: +30 211 198 7510 Tel: +46 840 838 822
[email protected] [email protected]

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]

More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu