CLOPIDOGREL TEVA 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Clopidogrel Teva 75 mg Film-Coated Tablets EFG

clopidogrel

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Clopidogrel Teva and what is it 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 further information

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

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 likelihood of blood clots (a process called thrombosis) forming.

Clopidogrel Teva is administered to adults to prevent the formation of blood clots (thrombi) in blood vessels (arteries) that have become hardened, a process known as atherothrombosis, which can cause atherothrombotic events (such as stroke, myocardial infarction, or death).

You have been prescribed Clopidogrel Teva to help prevent the formation of blood clots and reduce the risk of these serious events, as:

• You suffer from a process that causes hardening of the arteries (also known as atherothrombosis), and
• You have previously suffered a myocardial infarction, a stroke, or suffer from a disease called peripheral arterial disease, or
• You have suffered a type of severe 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 obstructed or narrowed artery to restore adequate blood flow. It is also possible that your doctor has prescribed acetylsalicylic acid (a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clots).
• you have experienced symptoms of a stroke that disappear within a short period (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 called "atrial fibrillation", and you 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 will 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 will have prescribed Clopidogrel Teva plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a risk of severe bleeding.

2. What you need to know before taking Clopidogrel Teva

Do not take Clopidogrel Teva:

• If you are allergic (hypersensitive) to clopidogrel or any of the other components of this medication (listed in section 6).
• If you have an active bleeding disorder, such as a stomach ulcer or bleeding in the brain.
• If you have a severe liver disease.

If you think any of these cases apply to you, or if you have any doubts, 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 have a risk of bleeding (bleeding) 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 had a severe 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 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 medication used to treat your disease.
• If you have had a non-traumatic cerebral hemorrhage.

While you are being treated with Clopidogrel Teva:

• Inform your doctor if you are going 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 bruising (bruises) under the skin that can appear as red spots, with or without unexplained extreme fatigue, confusion, yellow color of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• If you cut or injure yourself, the 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, e.g., when shaving, this is not important. 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 medication should not be administered to children as it is not effective.

Taking Clopidogrel Teva with other medications

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

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

You must explicitly inform your doctor if you are taking:

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

• oral anticoagulants, medications used to decrease blood clotting,
• non-steroidal anti-inflammatory drugs, medications used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medication used to decrease blood clotting,
• ticlopidine, another antiplatelet agent,
• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other medications of the same type), medications used to treat depression,
• rifampicin (used for severe infections)

• omeprazole or esomeprazole, medications to treat stomach discomfort,
• fluconazole or voriconazole, medications to treat fungal infections,
• efavirenz, or other antiretroviral medications (used to treat HIV infections),
• carbamazepine, a medication to treat some forms of epilepsy,
• moclobemide, a medication for depression,
• repaglinide, a medication for the treatment of diabetes,
• paclitaxel, a medication for the treatment of cancer,
• opioids: if you are being treated with clopidogrel, you should inform your doctor before being prescribed any opioid (used to treat severe pain),
• rosuvastatin (used to reduce cholesterol levels).

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

If you are breastfeeding or plan to breastfeed, inform your doctor before taking this medication.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

It is unlikely that Clopidogrel Teva will affect your ability to drive or operate machines.

Clopidogrel Teva contains lactose.

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

3. How to take Clopidogrel Teva

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

If you have suffered severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg or 600 mg of clopidogrel (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) for you to take once at the start of treatment. Afterward, the recommended dose is one 75 mg tablet of Clopidogrel Teva per day, as described above.

If you have experienced symptoms of a stroke that disappear within a short period (also known as a 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 start of treatment. Afterward, the recommended dose is one 75 mg tablet of Clopidogrel Teva per day, as described above, with acetylsalicylic acid for 3 weeks. Afterward, the doctor will prescribe either Clopidogrel Teva alone or acetylsalicylic acid 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 emergency department of the nearest hospital, 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 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 make up 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 calendar printed on the blister pack.

If you stop taking Clopidogrel Teva

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

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

4. Possible side effects

Like all medications, this medication 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 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 can 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, the bleeding may take a little longer than usual to stop. This is related to the mechanism of action of the medication, as it prevents the blood from forming clots. For minor cuts or injuries (such as when shaving), this is not important. However, if you have any doubts, the bleeding worsens, or 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 stomach upset

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); 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 the available data): Hypersensitivity reactions with chest or abdominal pain.

In addition, your doctor may observe changes in the results of your blood or urine tests.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Clopidogrel Teva

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

Do not use this medication after the expiration date stated on the packaging, bottle, or blister after EXP. 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 wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications that are no longer needed. This will help protect the environment.

6. Packaging 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"):
  • 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 indigo carmine lacquer (E132).

Product Appearance and Packaging 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 pack sizes may be marketed.
  • Calendar blisters aluminum/aluminum packaging containing 28 x 1 tablets

Only certain pack sizes may be marketed.

• Please note that the instructions for removing the tablet from the peelable blister are found on the outside of the box of peelable blisters.

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 any information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

This leaflet was approved in {Month/year}

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