Clopidogrel Teva

Package leaflet: Information for the user

Clopidogrel Teva 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. 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Clopidogrel Teva 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 Teva 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).
You have been prescribed Clopidogrel Teva to help prevent blood clots 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, a 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 disappear within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also 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 Teva 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 Teva plus acetylsalicylic acid.

2. What you need to know before taking Clopidogrel Teva

Do not take Clopidogrel Teva

• 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 an area 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 Teva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Clopidogrel Teva:

• 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,
  • a recent surgical procedure (including dental surgery),
  • a surgical procedure (including dental surgery) planned 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 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 Teva

• 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 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 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 Teva
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 Teva 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 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 taking 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 Teva 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 Teva with food and drink
Clopidogrel Teva can be taken with or without food.
Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy.
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. If you become pregnant while taking Clopidogrel Teva, contact 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
It is unlikely that Clopidogrel Teva will affect your ability to drive or use machinery.
Clopidogrel Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Clopidogrel Teva 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 Teva

Take this medicine exactly as your doctor or pharmacist has told you. 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 Teva daily, taken orally at the same time each day, either during or
independent of meals.
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 Teva (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
Teva daily, as described above.
If you have experienced stroke symptoms that disappeared within a short time (also known as transient
ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe an initial dose of 300 mg of
Clopidogrel Teva (4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended
dose is one 75 mg tablet of Clopidogrel Teva daily, as described above, in combination with acetylsalicylic
acid for 3 weeks. After this period, your doctor will prescribe either Clopidogrel Teva alone or acetylsalicylic
acid alone.
Clopidogrel Teva should be taken for as long as prescribed by your doctor.
If you take more Clopidogrel Teva than you should
Contact your doctor or the nearest hospital emergency department immediately, due to the risk of
increased bleeding.
If you forget to take Clopidogrel Teva
If you forget to take a dose of Clopidogrel Teva and remember within 12 hours of the usual time, take the
tablet immediately, 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 a forgotten tablet.
For the 28x1 tablet pack, you can check the day on which you took the last tablet of Clopidogrel Teva by
referring to the calendar printed on the blister.
If you stop taking Clopidogrel Teva
Do not stop treatment unless your doctor tells you to do so. Before stopping, consult 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 small red spots, and/or confusion (see section 2 “Warnings and precautions”),
• Swelling of 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 Teva is bleeding.
Bleeding may occur as gastrointestinal or intestinal bleeding, bruising,
haematoma (abnormal or subcutaneous bleeding), nosebleeds, or blood in the urine. In rare cases, bleeding into the eye, intracranial bleeding, bleeding in the lungs or joints has also been reported.
If you experience prolonged bleeding while taking Clopidogrel Teva
If you cut yourself or are injured, 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 and 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, 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, widespread feeling of warmth with sudden general malaise up to fainting); swelling of 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 determined 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 Teva

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 Teva 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 Teva contains lactose” and “Clopidogrel Teva 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 Teva and package contents

• The film-coated tablets are light pink to pink, film-coated, capsule-shaped tablets. On one side of the tablet the number “93” is engraved. On the other side of the tablet the number “7314” is engraved.
• Clopidogrel Teva is available in:
  • Perforated aluminium/aluminium blisters with a peelable foil, containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablets.
  • Perforated aluminium/aluminium blisters containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablets.
  • HDPE bottles with polypropylene closure or with child-resistant polypropylene closure and silica gel desiccant, containing 30 or 100 tablets.
  • Calendar pack with perforated aluminium/aluminium blisters containing 28x1 tablets.

It is possible that not all pack sizes are marketed.
Please note that instructions on how to remove tablets from the blister strip are provided on the outer carton of peelable foil blisters.

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 TEVA GmbH
Тел: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140208

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
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 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, Lda.
Tél: +33 155917800 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 Finland Oy TEVA Pharmaceuticals Slovakia s.r.o.
Finnland Tel: +421 257267911
Sími: +358 201805900

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 European Medicines Agency website: http://www.ema.europa.eu.