Package leaflet: Information for the user

Clopidogrel Teva Pharma B.V. 75 mg film-coated tablets

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 have any side effects, including any side effects not listed in this leaflet, talk your doctor or pharmacist. See section 4

What is in this leaflet

1. What Clopidogrel Teva Pharma B.V. is and what it is used for

2. What you need to know before you take Clopidogrel Teva Pharma B.V.

3. How to take Clopidogrel Teva Pharma B.V.

4. Possible side effects

5. How to store Clopidogrel Teva Pharma B.V.

6. Contents of the pack and other information

1. What Clopidogrel Teva Pharma B.V. is and what it is used for

   
   

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   Clopidogrel Teva Pharma B.V contains clopidogrel and belongs to a group of medicines called “platelet aggregation inhibitors.” It works by stopping certain particles in your blood (“platelets”) from sticking together to form blood clots which can block blood flow to important parts of your body including your heart and your brain.

   
   

   If you suffer from hardening of the arteries (“atherosclerosis”) there is an increased risk of a blood clot forming in your blood vessels. In adults Clopidogrel Teva Pharma B.V. reduces the risk of blood clots forming which in turn reduces the risk of serious conditions such as heart attack and stroke from occurring.

   
   

   You have been prescribed Clopidogrel Teva Pharma B.V. because:

   
   

   • You have hardening of the arteries and have recently suffered from a heart attack, a stroke or have a condition known as “peripheral arterial disease” (diseases of the blood vessels except those in the brain and heart).

   • You have experienced a severe type of chest pain known as ‘unstable angina’ or ‘myocardial

     infarction’ (heart attack). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You should also be given acetylsalicylic acid (a substance used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.

   • You have an irregular heartbeat, a condition called ‘atrial fibrillation’, and you cannot take

     medicines known as ‘oral anticoagulants’ (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing. You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid or the combined use of Clopidogrel Teva Pharma B.V. and acetylsalicylic acid for this condition. Your doctor should have prescribed Clopidogrel Teva Pharma B.V. plus acetylsalicylic acid if you cannot take ‘oral anticoagulants’ and you do not have a risk of major bleeding.

2. What you need to know before you take Clopidogrel Teva Pharma B.V.

   
   

   Do not take Clopidogrel Teva Pharma B.V.

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

   • If you have severe liver disease.

   • If you are suffering from another condition which is currently causing bleeding such as a stomach ulcer or bleeding within the brain.

   • If you think any of these apply to you, or if you are in any doubt at all, consult your doctor

     before taking Clopidogrel Teva Pharma B.V.

     
     

     Warnings and precautions

     Tell your doctor before you start to take this medicine if:

   • You are at increased risk of bleeding. For example:

     • If you have recently suffered from a serious injury

     • If you have recently undergone surgery or are due to have surgery (including dental

       surgery)

     • If you have any blood disorder which makes internal bleeding (bleeding inside your body) more likely

     • If you suffer from any other illness which makes internal bleeding more likely (e.g. stomach ulcers or wounds inside the eye)

   • You have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days

   • You have liver or kidney disease.

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   • You have had an allergy or reaction to any medicine used to treat your disease.

     
     

     While you are taking Clopidogrel Teva Pharma B.V.:

   • You should tell your doctor if surgery (including dental) is planned

   • You should also tell your doctor immediately if you develop a medical condition (known as Thrombotic Thrombocytopenic Purpura) that includes altered behaviour, headaches, coma, visual disturbances, seizures (fitting), kidney failure, fever, extreme tiredness, weakness or bleeding into the stomach, bowels or skin (including small red spots or large bruised areas) (see section 4 ‘Possible Side Effects’)

   • If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to

     the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries, e.g. cutting yourself shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible Side Effects’)

   • Your doctor may order blood tests

     
     

     Children and adolescents

     Do not give this medicine to children because it does not work.

     
     

     Other medicines and Clopidogrel Teva Pharma B.V.

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

     
     

     Talk to your doctor if you are using or have recently used any of the following medicines:

     
     

   • Oral anticoagulants (oral medicines used to stop blood clotting) such as warfarin. Their use with Clopidogrel Teva Pharma B.V. is not recommended.

   • Glycoprotein IIb/IIIa inhibitors (medicines used to stop blood clotting). E.g. abciximab,

     eptifibatide or tirofiban.

   • Heparin (medicine used to prevent blood clotting).

   • Medicines used to break down blood clots (e.g. alteplase and streptokinase).

   • Non-steroidal anti-inflammatory medicines (used to treat painful inflammatory conditions of the joints or muscles). E.g. ibuprofen, diclofenac and meloxicam.

   • Omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach.

   • Fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections.

   • Carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy.

   • Ticlopidine, other antiplatelet agent.

   • a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,

   • moclobemide, medicine to treat depression.

     
     

     Taking these medicines in combination with Clopidogrel Teva Pharma B.V. could result in an increased risk of bleeding.

     
     

     If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed clopidogrel in combination with acetylsalicylic acid, a substance used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

     
     

     Clopidogrel Teva Pharma B.V. with food and drink

     You can take Clopidogrel Teva Pharma B.V. with or without food.

     
     

     Pregnancy and breast-feeding

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     It is preferable not to use this medicine during pregnancy.

     
     

     If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Teva Pharma B.V. If you become pregnant while taking Clopidogrel Teva Pharma B.V., consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

     
     

     You should not breastfeed while taking this medicine.

     If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.

     Driving and using machines

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

     
     

     Clopidogrel Teva Pharma B.V. contains lactose

     If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

     
     

     Clopidogrel Teva Pharma B.V. contains hydrogenated castor oil. This may cause stomach upset and diarrhoea.

     
     

3. How to take Clopidogrel Teva Pharma B.V.

   
   

   Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

   The recommended dose is one 75 mg tablet per day which should be swallowed with water or another liquid. You should take your medicine regularly at the same time each day. You can take it with or without food.

   
   

   If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Pharma B.V. once at the start of treatment. Then, the usual dose is one 75-mg tablet of Clopidogrel Teva Pharma B.V. per day

   
   

   You should continue taking Clopidogrel Teva Pharma B.V. for as long as your doctor has told you to take it.

   
   

   If you take more Clopidogrel Teva Pharma B.V. than you should

   If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause an increased risk of bleeding. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

   
   

   If you forget to take Clopidogrel Teva Pharma B.V.

   If you forget to take a dose of Clopidogrel Teva Pharma B.V., but remember within 12 hours of the missed dose, take your tablet straight away and then take your next tablet at the usual time.

   
   

   If you forget to take a dose of Clopidogrel Teva Pharma B.V., but don’t remember within 12 hours of the missed dose, skip the missed dose and take the next tablet at the usual time. Do not take a double dose to make up for a forgotten tablet.

   
   

   If you stop taking Clopidogrel Teva Pharma B.V.

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   Do not stop taking Clopidogrel Teva Pharma B.V. without discussing it with your doctor first. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

   
   

4. Possible side effects

   
   

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

   
   

   Some of the side effects may be serious. If you suffer from any of the following symptoms you should contact your doctor immediately:

   
   

   • Fever, signs of infection (e.g. sore throat), pale skin or extreme tiredness. These may be due to a decrease of some blood cells

   • Altered behaviour, headaches, coma, visual disturbances, seizures (fitting), kidney failure, fever,

     extreme tiredness, weakness or bleeding into the stomach, bowels or skin (including small red spots or large bruised areas). This could indicate that you are suffering from a serious condition called thrombotic thrombocytic purpura (rare disorder of the blood clotting system which causes multiple blood clots to form around the body)

   • Signs of liver problems such as yellowing of the skin and whites of the eyes (jaundice), whether

     or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions’)

   • Swelling in the mouth or skin disorders such as rashes, itching and blistering of the skin. These

     may be the signs of an allergic reaction.

     
     

     Bleeding

     The most common side effect (affects 1 to 10 users in 100) reported for medicines containing clopidogrel is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleeds or blood in the urine. In a small

     number of cases, bleeding in the eye, inside the head, the abdomen, the lung and the joints have also been reported.

     
     

     If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. This is linked to the way that your medicine works. For minor cuts and injuries (e.g. shaving cuts) you should not worry. However, if you are in any doubt, bleeding becomes serious or you experience unexpected bleeding from unusual parts of your body you should contact your doctor straight away (see section 2 ‘Warnings and precautions’).

     
     

     The following side effects have been reported. Common side effects (may affect up to 1 in 10 people):

   • Bruising, haematoma (unusual bleeding under the skin), nose bleeds, bleeding in the stomach or

     bowels, increased bleeding at the site of a puncture wound

   • Diarrhoea, abdominal pain, indigestion or heartburn

   
   

   Uncommon side effects (may affect up to 1 in 100 people): Headache and dizziness

   Prolonged bleeding, bleeding inside the head, bleeding in the eye, blood in the urine and/or purpura (red spots on the skin caused by bleeding underneath the skin)

   Rashes, itching, abnormal touch sensation

   Ulcers in the stomach and small intestine, nausea, vomiting, constipation, flatulence (wind) and inflammation of the stomach leading to sickness, loss of appetite and discomfort after eating Reduction in blood platelets which makes bleeding or bruising more likely

   Blood disorders including a reduction in the number of white blood cells which makes infections more likely.

   
   

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   Rare side effects (may affect up to 1 in 1000 people):

   Reduced levels of certain white blood cells which increases the risk of infection (neutropenia) Vertigo (dizziness accompanied by a whirling sensation)

   Bleeding inside the abdomen

   
   

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

   A serious condition called thrombotic thrombocytic purpura (rare disorder of the blood clotting system which causes multiple blood clots to form around the body). Symptoms may include altered behaviour, headaches, coma, visual disturbances, seizures (fitting), kidney failure, fever, extreme tiredness, weakness, or bleeding into the stomach, bowels or skin (including small red spots or large bruised areas)

   Severe reduction in certain blood cells leading to increased risk of bleeding or bruising, increased risk of infections, pale skin and extreme tiredness

   Generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); breathing difficulties, swelling or inflammation of the mouth, skin allergy, blisters on the skin

   Confusion or hallucinations Taste disorders

   Sore mouth (stomatitis)

   Inflammation of the blood vessels, decrease in blood pressure Yellowing of the skin and whites of the eyes (jaundice)

   Bleeding in the lungs, throat, stomach or bowels, abdomen or joints Bleeding of post-operative wounds or other serious bleeds

   Severe abdominal pain with or without back pain, pain in the joints and muscular pain Diarrhoea

   Fever

   Changes in levels of certain substances in your blood or urine. This may be detectable via blood or urine tests.

   Reporting of side effects

   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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. How to store Clopidogrel Teva Pharma B.V.

   
   

   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 outer carton, bottle or blister after EXP. The expiry date refers to the last day of that month.

   Do not store above 25°C. Store in the original package to protect from light. 30 tablets HDPE bottles:

   Discard any remaining tablets 30 days after first opening of the bottle.

   
   

   100 tablets HDPE bottles:

   Discard any remaining tablets 100 days after first opening of the bottle.

   
   

   Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

   
   

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6. Contents of the pack and other information What Clopidogrel Teva Pharma B.V. contains

The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrobromide).

The other ingredients in the tablet core are (see section 2 ‘Clopidogrel Teva Pharma B.V. contains lactose’ and ‘Clopidogrel Teva Pharma B.V. contains hydrogenated castor oil’) lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (type A), hydrogenated castor oil and sodium laurilsulfate, and in the film-coating are lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172), indigo carmine aluminium lake (E132).

What Clopidogrel Teva Pharma B.V. looks like 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 debossed with “C75”. The other side of the tablet is plain.

Clopidogrel Teva Pharma B.V. is supplied in peelable perforated blisters of aluminium/ aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablet; perforated blisters of

aluminium/ aluminium containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablet or HDPE bottles with polypropylene closures or child resistant polypropylene closures and silica gel desiccant containing 30 or 100 tablets.

Not all pack sizes may be marketed.

Please note that instructions on how to remove the tablet from the blister strip are given on the outer carton of the peelable blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma B.V.,

Computerweg 10,

3542 DR Utrecht, The Netherlands

Manufacturer:

TEVA Pharmaceutical Works Private Limited Company Pallagi út 13,

4042 Debrecen, Hungary

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TEVA Santé SA, Rue Bellocier, 89107 Sens, France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Medicinal product no longer authorised

This leaflet was last revised in: <Month YYYY>

Detailed information is available on the European Medicines Agency website: .