CLOPIDOGREL TEVA 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Clopidogrel Teva 75 mg Film-Coated Tablets EFG

clopidogrel

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Clopidogrel Teva contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that help it to clot. Antiplatelet agents prevent platelet clumping, reducing the risk of blood clots (a process called thrombosis).

Clopidogrel Teva is given to adults to prevent blood clots (thrombi) in the blood vessels (arteries) that supply the brain and heart, 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 reduce the risk of these serious events because:

• You have a condition that increases the risk of blood clots forming in your blood vessels (arteries), known as atherothrombosis, and
• You have had a heart attack, stroke, or have a condition known as peripheral arterial disease, or
• You have had a severe form of chest pain known as "unstable angina" or "heart attack". For the treatment of this condition, your doctor may also place a stent in the blocked or narrowed artery to restore adequate blood flow. Your doctor may also prescribe aspirin in addition to Clopidogrel Teva.
• you have experienced symptoms of a stroke that have disappeared within a short period of time (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer aspirin during the first 24 hours.
• you have an irregular heartbeat, a condition called "atrial fibrillation", and cannot take medicines known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new clots and prevent the growth of existing clots. You will have been told that "oral anticoagulants" are more effective than aspirin or the combined use of Clopidogrel Teva and aspirin for this condition. Your doctor will have prescribed Clopidogrel Teva plus aspirin if you cannot take "oral anticoagulants" and do not have a high risk of major bleeding.

2. What you need to know before you take Clopidogrel Teva

Do not take Clopidogrel Teva

• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• If you have an active bleeding (such as a stomach ulcer or bleeding in 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 taking Clopidogrel Teva.

Warnings and precautions

Consult your doctor or pharmacist before starting Clopidogrel Teva:

• If you have a risk of bleeding because:

• you have a disease that involves a risk of internal bleeding (such as a stomach ulcer).
• you have a blood disorder that makes you prone to internal bleeding (bleeding in tissues, organs, or joints of the body).
• you have recently had a serious injury.
• you have recently had surgery (including dental surgery).
• you are going to have surgery (including dental surgery) in the next 7 days.

• If you have had a blood clot in an artery of the brain (ischemic stroke) in the last 7 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 had a non-traumatic bleeding in the brain.

While you are taking Clopidogrel Teva:

• Tell your doctor if you are going to have surgery (including dental surgery).
• Also, tell your doctor immediately if you develop a condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bleeding under the skin that can appear as red spots) that may appear with or without unexplained extreme tiredness, confusion, yellow color 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 linked to the way the medicine works, as it prevents the blood from clotting. For small cuts and injuries, e.g. when shaving, this is of no consequence. However, if you are concerned about the bleeding, consult your doctor immediately (see section 4 "Possible side effects").
• Your doctor may ask you to have blood tests.

Children and adolescents

This medicine should not be given to children because 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 of these medicines may affect the use of Clopidogrel Teva or vice versa.

You must tell your doctor if you are taking:

• medicines that may increase the risk of bleeding, such as:

• oral anticoagulants, medicines used to decrease blood clotting,
• non-steroidal anti-inflammatory drugs, medicines used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medicine used to decrease blood clotting,
• ticlopidine, another antiplatelet agent,
• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other medicines of the same type), medicines used to treat depression,
• rifampicin (used for severe infections)
• • omeprazole or esomeprazole, medicines to treat stomach upset,
  • fluconazole or voriconazole, medicines to treat fungal infections,
  • efavirenz, or other antiretroviral medicines (used to treat HIV infections),
  • carbamazepine, a medicine to treat some forms of epilepsy,
  • moclobemide, a medicine for depression,
  • repaglinide, a medicine for diabetes,
  • paclitaxel, a medicine for cancer,
  • opioids: if you are being treated with clopidogrel, you must inform your doctor before any opioid is prescribed to you (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 ischemic attack, or a mild ischemic stroke, you may have been prescribed clopidogrel in combination with aspirin, a substance present in many medicines used to relieve pain and lower fever. An occasional dose of aspirin (not exceeding 1,000 mg in 24 hours) is unlikely to cause any problems, but prolonged use should be discussed with your doctor.

Taking Clopidogrel Teva with food and drinks

Clopidogrel Teva can be taken with or without food.

Pregnancy and breast-feeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. If you become pregnant while taking Clopidogrel Teva, inform your doctor immediately, as it is not recommended to take clopidogrel during pregnancy.

Do not breast-feed while you are taking this medicine.

If you are breast-feeding or plan to breast-feed, inform your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Clopidogrel Teva is unlikely to affect your ability to drive or use machines.

Clopidogrel Teva contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

Clopidogrel Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially, "sodium-free".

3. How to take Clopidogrel Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, check with your doctor or pharmacist.

The recommended dose, even for patients with a condition known as "atrial fibrillation" (an irregular heartbeat), is one 75 mg Clopidogrel Teva tablet per day, to be taken orally with or without food, and at the same time each day.

If you have had severe chest pain (unstable angina or heart attack), your doctor may prescribe you 300 mg or 600 mg of clopidogrel (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) to be taken once at the start of treatment. After that, the recommended dose is one 75 mg Clopidogrel Teva tablet per day as described above.

If you have experienced symptoms of a stroke that have disappeared within a short period of time (also known as a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe you 300 mg of Clopidogrel Teva (4 tablets of 75 mg) once at the start of treatment. After that, the recommended dose is one 75 mg Clopidogrel Teva tablet per day as described above, with aspirin for 3 weeks. After that, your doctor will prescribe either Clopidogrel Teva alone or aspirin alone.

You should take Clopidogrel Teva for as long as your doctor continues to prescribe it.

If you take more Clopidogrel Teva than you should

Contact your doctor or go to the nearest hospital emergency department immediately, as there is an increased risk of bleeding.

If you forget to take Clopidogrel Teva

If you forget to take a dose of Clopidogrel Teva, but remember before it has been more than 12 hours since the time you should have taken it, take the tablet immediately and the next one at the usual time.

If you forget for more than 12 hours, simply take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

In the 28x1 tablet format, you can check the last day you took a Clopidogrel Teva tablet by looking at the calendar printed on the blister pack.

If you stop taking Clopidogrel Teva

Do not stop taking your treatment unless your doctor tells you to.Consult your doctor or pharmacist before stopping treatment with this medicine.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek medical help immediately if you experience:

• Fever or signs of infection or extreme tiredness. These symptoms may be due to a decrease in some blood cells.
• Signs of liver problems, such as yellowing of the skin and/or the whites of the eyes (jaundice), associated or not with bleeding that appears under the skin in the form of red spots and/or confusion (see section 2 "Warnings and precautions").

• Swelling of the mouth or skin disorders such as rashes, itching, and blisters on the skin. These can be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Teva is bleeding.

Bleeding may occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, or blood in the urine. In a small number of cases, bleeding in the eye, inside the head, abdomen, lungs, and joints.

If you experience prolonged bleeding while taking Clopidogrel Teva

If you cut or injure yourself, it may take a little longer than usual for the bleeding to stop. This is linked to the way the medicine works, as it prevents the blood from clotting. For minor cuts and injuries (such as when shaving), this is usually of no consequence. However, if you have any doubts, if the bleeding worsens, or if you experience unexpected bleeding in unusual parts of your body, you should contact your doctor immediately (see section 2 "Warnings and precautions").

Other side effects include:

Common side effects (may affect up to 1 in 10 people):

Diarrhea, abdominal pain, indigestion, or heartburn

Uncommon side effects (may affect up to 1 in 100 people)

Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine, rash, itching, dizziness, tingling, and numbness.

Rare side effects (may affect up to 1 in 1,000 people):

Dizziness, breast enlargement in men.

Very rare side effects (may affect up to 1 in 10,000 people):

Jaundice; severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions (e.g., feeling of heat with sudden general discomfort leading to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mouth mucosa (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

Side effects of unknown frequency (cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

Your doctor may also observe changes in the results of your blood or urine tests.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, bottle, or blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Clopidogrel Teva Composition

• The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
• The other ingredients are (see section 2 "Clopidogrel Teva contains lactose" and "Clopidogrel Teva contains sodium"):

• Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (type A), hydrogenated vegetable oil, and sodium lauryl sulfate
• Tablet coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, red iron oxide (E172), yellow iron oxide (E172), aluminum lake indigo carmine (E132).

Product Appearance and Package Contents

• The film-coated tablets are light pink to pink, film-coated, capsule-shaped tablets. One side of the tablet is engraved with the number "93". The other side of the tablet is engraved with the number "7314".
• Clopidogrel Teva is available in

• Perforated aluminum/aluminum blisters with a peelable lid containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1, or 100x1 tablets;
• Perforated aluminum/aluminum blisters containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1, or 100x1 tablets
• HDPE bottles with a polypropylene cap or a safety cap and a desiccant silica gel containing 30 or 100 tablets. Only certain package sizes may be marketed.
• Calendar blisters of aluminum/aluminum containing 28 x 1 tablets

Only certain package sizes may be marketed.

• Please note that the instructions for removing the tablet from the blister pack with a peelable lid are found on the outside of the box of blister packs with a peelable lid.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturer:

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13,

4042 Debrecen,

Hungary

TEVA Pharmaceutical Works Private Limited Company

Táncsics Mihály út 82,

2100 Gödöllo,

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 Authorization Holder:

Date of Last Revision of this Leaflet:{MM/AAAA}.

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