CLOPIDOGREL RATIOPHARM

Package leaflet: Information for the user

Clopidogrel ratiopharm 75 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. 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

What this leaflet contains

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

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

Clopidogrel ratiopharm contains 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 ratiopharm 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).
You have been prescribed Clopidogrel ratiopharm 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 suffered from 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 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 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) 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 ratiopharm with 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 Clopidogrel ratiopharm plus acetylsalicylic acid.

2. What you need to know before taking Clopidogrel ratiopharm

Do not take Clopidogrel ratiopharm

• If you are allergic to clopidogrel or to any of the other ingredients of this medicine (listed in section 6)
• If you have another condition causing bleeding, for example a stomach ulcer or bleeding in part of the brain
• If you have severe liver disease.

If you think any of these apply to you, or if you are unsure, consult your doctor before using
Clopidogrel ratiopharm.
Warnings and precautions
Talk to your doctor or pharmacist before taking Clopidogrel ratiopharm:

• if you have a risk of bleeding such as
  • a medical condition that puts you at risk of internal bleeding (such as 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 seven days.
• if you have liver or kidney 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 ratiopharm:

• You must inform your doctor if you are due to have 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 tiredness, 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 how 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 ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may affect the use of Clopidogrel ratiopharm 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 usually used to treat depression,
  o rifampicin (used to treat serious infections),

• omeprazole or esomeprazole, medicines used for stomach problems,

• fluconazole or voriconazole, medicines for treating fungal infections,

• efavirenz or other antiretroviral medicines (used for the treatment of 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 ratiopharm in combination with acetylsalicylic acid, a substance 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.
Clopidogrel ratiopharm with food and drink
Clopidogrel ratiopharm can be taken with or without food.
Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy.
If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking Clopidogrel ratiopharm, consult your doctor immediately, as clopidogrel is not recommended 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
Clopidogrel ratiopharm is unlikely to affect your ability to drive or use machines.
Clopidogrel ratiopharm contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Clopidogrel ratiopharm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".

3. How to take Clopidogrel ratiopharm

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, 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 ratiopharm 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 an initial dose of 300 mg or 600 mg of Clopidogrel ratiopharm (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 ratiopharm 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 an initial dose of 300 mg of Clopidogrel ratiopharm (4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg tablet of Clopidogrel ratiopharm daily, as described above, in combination with acetylsalicylic acid for 3 weeks. After this, your doctor will prescribe either Clopidogrel ratiopharm alone or acetylsalicylic acid alone.
Clopidogrel ratiopharm should be taken for the entire duration prescribed by your doctor.
Please note that instructions on how to remove the tablet from the blister are provided on the outer carton of the blister packs with a peelable film.
If you take more Clopidogrel ratiopharm than you should
Contact your doctor or the nearest hospital emergency department immediately, as there may be an increased risk of bleeding.
If you forget to take Clopidogrel ratiopharm
If you forget to take a dose of Clopidogrel ratiopharm and you remember within 12 hours of your usual time, take the tablet immediately and then take the next tablet 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 the missed tablet.
For the 28x1 tablet pack, you can check the day on which you took the last tablet of Clopidogrel ratiopharm by referring to the calendar printed on the blister.
If you stop taking Clopidogrel ratiopharm
Do not stop treatment unless your doctor has instructed you to do so. 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 decrease 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 Clopidogrel ratiopharm is bleeding.
Bleeding may occur as gastrointestinal bleeding, bruising, haematoma (abnormal bleeding or subcutaneous bruising), nosebleeds, or 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 ratiopharm
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, breathing difficulties sometimes associated with cough; generalized allergic reactions (for example, widespread feeling 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.
In addition, your doctor may have detected 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 Clopidogrel ratiopharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton, bottle, or 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 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 ratiopharm contains

• The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
• The other components are (see section 2 “Clopidogrel ratiopharm contains lactose” and “Clopidogrel ratiopharm contains sodium”):
  • Tablet core: monohydrate lactose, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (Type A), hydrogenated vegetable oil, and sodium lauryl sulfate.
  • Film coating: monohydrate lactose, hypromellose (E464), titanium dioxide (E171), macrogol 4000, red iron oxide (E172), yellow iron oxide (E172), aluminium lake containing indigo carmine (E132).

Description of the appearance of Clopidogrel ratiopharm and package contents

• The film-coated tablets are light pink to pink, film-coated, capsule-shaped tablets. The number “93” is engraved on one side of the tablet and the number “7314” on the other side.
• Clopidogrel ratiopharm is available in single-dose or non-peelable aluminium/aluminium perforated blisters, or in HDPE bottles with a polypropylene closure or child-resistant polypropylene closure with silica gel desiccant. Pack sizes:
  • Perforated aluminium/aluminium blisters with or without peelable film, containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablets
  • Calendar pack with non-peelable blisters containing 28x1 tablets
  • Bottles containing 30 or 100 tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva B.V.,
Swensweg 5,
2031GA Haarlem,
The Netherlands
Manufacturers:
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen,
Hungary
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600,
Bulgaria

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203
България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Тел: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202
Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400
Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117
Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400
Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590
Ελλάδα Österreich
TEVA HELLAS Α.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070
España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300
France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos,
Tél: +33 155917800 Lda.
Tel: +351 214767550
Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524
Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390
Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911
Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900
Κύπρος Sverige
TEVA HELLAS Α.Ε. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000
Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

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