Clopidogrel Teva 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clopidogrel Teva 75 mg film-coated tablets EFG

clopidogrel

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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 very small cells in the blood that clump together when blood clots. Antiplatelet medicines prevent this clumping and thereby reduce the possibility of blood clots (a process known as thrombosis).

Clopidogrel Teva is given to adults to help prevent blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, myocardial infarction, or death).

Your doctor has prescribed Clopidogrel Teva to help prevent blood clots and reduce the risk of these serious events because:

• You have a condition causing hardening of the arteries (also known as atherothrombosis), and
• You have previously had a myocardial infarction, stroke, or you have a condition called peripheral arterial disease, or
• You have experienced a severe type of chest pain known as “unstable angina” or “myocardial infarction.” For the treatment of this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore proper 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 clots).
• 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 also administer acetylsalicylic acid 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 clots. You have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Clopidogrel Teva and acetylsalicylic acid for this condition. Your doctor has prescribed Clopidogrel Teva plus acetylsalicylic acid if you are unable to take “oral anticoagulants” and do not have a high risk of serious bleeding.

2. What you need to know before taking Clopidogrel Teva

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 active bleeding, such as a stomach ulcer or bleeding in the brain.
• If you have severe liver disease.

If you think any of these situations 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 are at risk of bleeding because:
  • you have a condition that involves a risk of internal bleeding (such as a stomach ulcer).
  • you have a blood disorder that predisposes you to internal bleeding (bleeding into tissues, organs, or joints).
  • 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 brain artery (ischaemic stroke) within 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 a history of non-traumatic brain haemorrhage.

While being treated with Clopidogrel Teva:

• Inform your doctor if you are scheduled for 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 which may appear as localized red spots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• If you get a cut or injury, bleeding may take longer than normal to stop. This is related to how the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, e.g., while shaving, this is not usually a concern. However, if you are worried 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 given to children because it is not effective.

Taking Clopidogrel Teva with other medicines

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

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

You must specifically inform your doctor 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 (NSAIDs), medicines generally 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 fluvoxetine and other drugs of this type), medicines generally used to treat depression,

• rifampicin (used for serious infections),

• omeprazole or esomeprazole, medicines used to treat stomach discomfort,

• fluconazole or voriconazole, medicines used to treat fungal infections,

• efavirenz, or other antiretroviral medicines (used to treat HIV infections),

• carbamazepine, a medicine used to treat certain forms of epilepsy,

• moclobemide, a medicine for depression,

• repaglinide, a medicine used to treat diabetes,

• paclitaxel, a medicine used to treat cancer,

• opioids: if you are being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),

• rosuvastatin (used to reduce cholesterol levels).

If you have suffered from severe chest pain (unstable angina or myocardial infarction), a transient ischaemic attack, or mild ischaemic 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 (not exceeding 1,000 mg in 24 hours) generally 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 medicine during pregnancy.

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

You must not breastfeed while taking this medicine.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Clopidogrel Teva contains lactose.

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

3. How to take Clopidogrel Teva

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose, even for patients with a condition called “atrial fibrillation” (an irregular heartbeat), is one 75 mg Clopidogrel Teva tablet daily, taken orally with or without food, at the same time each day.

If you have experienced 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) as a single dose at the beginning of treatment. Afterwards, the recommended dose is one 75 mg Clopidogrel Teva tablet 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 you 300 mg of Clopidogrel Teva (4 tablets of 75 mg) as a single dose at the beginning of treatment. Afterwards, the recommended dose is one 75 mg Clopidogrel Teva tablet daily as described above, taken together with acetylsalicylic acid for 3 weeks. After this, your 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 nearest hospital emergency department, 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 within 12 hours of the time you should have taken it, take the tablet immediately and then take the next dose at the usual time.

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

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

If you stop taking Clopidogrel Teva

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

• Fever or signs of infection or extreme tiredness. These symptoms may be due to a decrease in certain blood cells.

• Signs of liver problems, such as yellowing of the skin and/or the whites of the eyes (jaundice), with or without bleeding appearing under the skin as 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 may be signs of an allergic reaction.

The most frequently reported adverse effect with Clopidogrel Teva is bleeding.

Bleeding may occur in the stomach or intestines, bruising, haematomas (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, or joints.

If you experience prolonged bleeding while taking Clopidogrel Teva

If you cut yourself or sustain a wound, bleeding may take longer than usual to stop. This is related to the medicine's mechanism of action, as it prevents blood from forming clots. For minor cuts or wounds (such as during shaving), this is usually not a concern. However, if you have any doubts, if bleeding worsens, or if unexpected bleeding occurs in unusual parts of your body, contact your doctor immediately (see section 2 “Warnings and precautions”).

Other adverse effects include:

Frequent adverse effects (may affect up to 1 in 10 people):

Diarrhoea, abdominal pain, stomach ulcer, indigestion or heartburn

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

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

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

Dizziness, breast enlargement in men.

Very rare adverse 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 coughing; generalized allergic reactions (for example, a sensation of warmth with sudden general discomfort up to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mouth lining (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste.

Adverse effects with unknown frequency (cannot be estimated from 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 of adverse effects

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

5. Storage of Clopidogrel Teva

Keep this medicine out of sight and reach of children.

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

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clopidogrel Teva:

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

Appearance of the product and contents of the pack:

• The film-coated tablets are light pink to pink, film-coated, capsule-shaped tablets. One side of the tablet is marked with the number “93”. The other side of the tablet is marked with the number “7314”.
• Clopidogrel Teva is available in:
  • Perforated aluminium/aluminium blisters with 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 child-resistant closure and silica gel desiccant containing 30 or 100 tablets. Only certain pack sizes may be commercially available.
  • Calendar packs of aluminium/aluminium blisters containing 28 x 1 tablets.

Only certain pack sizes may be commercially available.

• Please note that instructions on how to remove the tablet from the blister with peelable foil are printed on the outer box of the peelable foil blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Teva B.V.

Swensweg 5

2031GA Haarlem

The 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 Gödöllő, 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 Authorisation Holder.

This patient information leaflet was approved in {Month/Year}

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