Leaflet: information for the user

Clopidogrel Teva 75 mg film-coated tablets

clopidogrel

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

• Keep this leaflet, as 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 others, even if they have the same symptoms as you, as it may harm them.

•If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Clopidogrel Teva 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. Storage of Clopidogrel Teva

6. Contents of the pack and additional information

Clopidogrel Teva contains clopidogrel and belongs to a group of medications called antiplatelet agents. Platelets are very small cells that are found in the blood, and they aggregate when the blood clots. Antiplatelet agents, by preventing this aggregation, reduce the possibility of blood clots (a process known as thrombosis) forming.

Clopidogrel Teva is administered to adults to prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a process known as atherothrombosis, and which may cause atherothrombotic effects (such as cerebral infarction, myocardial infarction, or death).

You have been prescribed Clopidogrel Teva to help prevent blood clots from forming and reduce the risk of these serious events because:

• You suffer from a process that produces the hardening of the arteries (also known as atherothrombosis), and
• You have previously suffered a myocardial infarction, a cerebral infarction, or suffer from a disease known as peripheral arterial disease, or
• You have suffered a severe type of chest pain, known as “unstable angina” or “myocardial infarction”. For the treatment of this disease, your doctor may need to place a stent in the blocked or narrowed artery to restore adequate blood flow. It is possible that your doctor has also prescribed acetylsalicylic acid (a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clots from forming).
• You have experienced symptoms of a stroke that disappear in a short period of time (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer acetylsalicylic acid during the first 24 hours.You have an irregular heartbeat, a disease known as “atrial fibrillation”, and cannot take medications known as “oral anticoagulants” (vitamin K antagonists) that prevent the formation of new clots and prevent the growth of existing clots. You have been told that “oral anticoagulants” are more effective than acetylsalicylic acid or the combined use of Clopidogrel Teva and acetylsalicylic acid for this disease. Your doctor has prescribed Clopidogrel Teva plus acetylsalicylic acid if you cannot take “oral anticoagulants” and do not have a high risk of severe bleeding.

Do not take Clopidogrel Teva:

•If you are allergic (hypersensitive) to clopidogrel or to any of the other ingredients of this medicine (listed in section 6).

•If you have an active bleeding, such as a stomach ulcer or brain hemorrhage.

•If you have a severe liver disease.

If you think any of these cases apply to you, or if you are unsure, consult your doctor before taking Clopidogrel Teva.

Warnings and precautions

Before starting treatment with Clopidogrel Teva, inform your doctor if you are in any of the following situations:

• If you are at risk of bleeding (hemorrhage) because:
• • You have a disease that involves a risk of internal bleeding (such as a stomach ulcer).
  • You have a blood disorder that predisposes you to internal bleeding (bleeding in tissues, organs, or joints of the body).
  • You have recently suffered a serious injury.
  • You have recently undergone surgery (including dental surgery).
  • You are scheduled to undergo surgery (including dental surgery) within the next seven days.
• If you have had a blood clot in a cerebral artery (ischemic stroke) in the last 7 days.
• If you have liver or kidney diseases.
• If you have had an allergy or reaction to any medication used to treat your condition.
• If you have a history of non-traumatic cerebral hemorrhage.

While taking Clopidogrel Teva:

•Inform your doctor if you are to undergo surgery (including dental surgery).

•Also inform your doctor immediately if you develop a condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and hematomas (bruises) under the skin that may appear as localized red spots, with or without extreme fatigue, confusion, yellow discoloration of the skin or eyes (jaundice) (see section 4 “Possible side effects”).

•If you suffer a cut or injury, bleeding may take longer than usual to stop. This is related to the way the medication works, as it prevents the formation of blood clots. For small cuts and injuries, such as shaving, this is not a concern. However, if you are concerned about 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 administered to children because it is not effective.

Taking Clopidogrel Teva with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription.

Some of these medicines may affect the use of Clopidogrel Teva or vice versa.

You must inform your doctor specifically if you are taking:

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

• Oral anticoagulants, medicines used to reduce 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 reduce 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 to treat serious infections)

• Omeprazole or esomeprazole, medicines to treat stomach discomfort,
• 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 to treat depression,
• Repaglinide, a medicine to treat diabetes,
• Paclitaxel, a medicine to treat cancer,
• Opioids: If you are taking clopidogrel, inform your doctor before being prescribed any opioid (used to treat intense pain),
• Rosuvastatin (used to reduce cholesterol levels).

If you have had severe chest pain (unstable angina or myocardial infarction), transient ischemic attack, or mild ischemic stroke, you may have been prescribed clopidogrel in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. A single dose of acetylsalicylic acid administered occasionally (not exceeding 1,000 mg in 24 hours) generally should not cause any problems, but prolonged use in other circumstances should be consulted with your doctor.

Taking Clopidogrel Teva with food and drinks

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

You should not breastfeed while taking this medicine.

If you are breastfeeding or plan to do so, inform your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Clopidogrel Teva is unlikely to affect your ability to drive or operate machinery.

Clopidogrel Teva contains lactose.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose, even for patients with a condition called "atrial fibrillation" (an irregular heart beat), is one 75 mg Clopidogrel Teva tablet per day, administered orally with or without food and at the same time every day.

If you have experienced severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg or 600 mg of clopidogrel (1 or 2 300 mg tablets or 4 or 8 75 mg tablets) to be taken once at the beginning 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 disappear in a short period of time (also known as transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe 300 mg of Clopidogrel Teva (4 tablets of 75 mg) once at the beginning of treatment. After that, the recommended dose is one 75 mg Clopidogrel Teva tablet per day as described above with acetylsalicylic acid for 3 weeks. After that, your doctor will prescribe either Clopidogrel Teva alone or acetylsalicylic acid alone.

You should take Clopidogrel Teva for the time 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, as there is a higher risk of bleeding.

If you forget to take Clopidogrel Teva

If you forget to take a dose of Clopidogrel Teva, but remember before 12 hours have passed since the time you should have taken the medication, 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 compensate for a missed tablet.

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

If you interrupt treatment with Clopidogrel Teva

Do not interrupt your treatment unless your doctor tells you to. Contact your doctor or pharmacist before stopping taking this medication.

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

Like all medicines, this medicine can have side effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

•Fever or signs of infection or extreme fatigue. 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 white part 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 hives, itching, and blisters on the skin.

These may be signs of an allergic reaction.

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

Bleeding can occur in the stomach or intestine, bruises, hematomas (abnormal bleeding or bruises under the skin) nasal bleeding or blood in 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 get a wound, it is possible that bleeding will take a little longer to stop than normal. This is related to the mechanism of action of the medication, as it prevents the blood's ability to form clots. For minor cuts or wounds (such as cutting during shaving), this usually does not matter. However, if you have any doubts, bleeding worsens or unexpected bleeding occurs in unusual parts of your body, you should contact your doctor immediately (see section 2 "Warnings and precautions").

Other side effects include:

Frequent side effects (can affect up to 1 in 10 people):

Diarrhea, abdominal pain, indigestion, or heartburn

Rare side effects (can affect up to 1 in 100 people)

Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, rashes, itching, dizziness, tingling, and numbness.

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

Dizziness, breast enlargement in men.

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

Jaundice; severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with coughing; generalized allergic reactions (for example, feeling of general heat with sudden general discomfort until fainting); swelling of the mouth; skin blisters, skin allergy; inflammation of the mucous membrane of the mouth (stomatitis); decreased 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 available data): Hypersensitivity reactions with chest or abdominal pain.

Your doctor may also observe changes in your blood or urine test results.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. Mediante the reporting of side effects you can contribute to providing more information about the safety of this medicine

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

Do not use this medication after the expiration date that appears on the packaging, bottle or blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. Do not use this medication if you observe any visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Clopidogrel Teva:

•The active ingredient 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”):

−Core tablet: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (type A), hydrogenated vegetable oil, and sodium lauryl sulfate

−Coating tablet: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172), and aluminium lake indigo carmine (E132).

Appearance of the product and contents of the package:

•The film-coated tablets are pinkish 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

− Blister packs of aluminum/aluminum with a peelable lid containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1, or 100x1 tablets;

−Blister packs of aluminum/aluminum containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1, or 100x1 tablets

−HDPE bottles with a polypropylene cap or a safety cap and silica gel desiccant containing 30 or 100 tablets. Only some package sizes may be marketed.

− Calendar blister packs of aluminum/aluminum containing 28 x 1 tablets

Only some package sizes may be marketed.

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

Marketing authorization holder and manufacturer responsible:

Marketing authorization holder: Teva B.V.

Swensweg 5

2031GA Haarlem

Holland

Manufacturer responsible:

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 any information about this medicine, please contact the local representative of the marketing authorization holder

This leaflet was approved in {Month/year}

The detailed information about this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu