Clopidogrel Teva Pharma (previously Clopidogrel HCS) - patient leaflet, side effects, dosage

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

Do not take Clopidogrel Teva Pharma

• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
• If you suffer from severe liver disease.

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.

Warnings and precautions

If any of the situations mentioned below apply to you, you should tell your doctor before taking

Clopidogrel Teva Pharma:

• if you have a risk of bleeding such as

• – a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer)

• – a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).

• – a recent serious injury.

• – a recent surgery (including dental).

• – a planned surgery (including dental) in the next seven days. if you have had a clot in an artery of your brain (ischaemic stro last seven days.

  occurred within the

  
  

if you have kidney or liver disease.

if you have had an allergy or reaction to any medicine used to treat your disease.

While you are taking Clopidogrel Teva Pharma:

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

• You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing 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 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

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

Some other medicines may influence the use of Clopidogrel Teva Pharma or vice versa.

You should specifically tell your doctor if you take

• – medicines that may increase your risk of bleeding such as:

o oral anticoagulants, medicines used to reduce blood clotting,

o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints,

o heparin or any other injectable medicine used to reduce blood clotting,

o ticlopidine, other antiplatelet agent,

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

• – omeprazole or esomeprazole, medicines to treat upset stomach,

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

• – efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections,

• – carbamazepine, a medicine to treat some forms of epilepsy,

• – moclobemide, medicine to treat depression,

• – repaglinide, medicine to treat diabetes,

• – paclitaxel, medicine to treat cancer.

If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Teva Pharma in combination with acetylsalicylic acid, a substance present in many medicines 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.

Pregnancy and breast-feeding

It is preferable not to take 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. If you become pregnant while taking Clopidogrel Teva Pharma, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

You should not breast-feed while taking this medicine.

If you are breast-feeding or planning to breast-feed, 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 is unlikely to affect your ability to drive or to use machines.

Clopidogrel Teva Pharma contains hydrogenated castor oil This may cause stomach upset or diarrhoea.

3. How to take Clopidogrel Teva Pharma

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, including for patients with a condition called ‘atrial fibrillation’ (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Teva Pharma per day to be taken orally with or without food, and at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Teva Pharma (4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel Teva Pharma per day as described above.

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

If you take more Clopidogrel Teva Pharma than you should

Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.

If you forget to take Clopidogrel Teva Pharma

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

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

For the 28×1 tablets pack size, you can check the day on which you last took the tablet by referring to the calendar printed on the blister.

If you stop taking Clopidogrel Teva Pharma

Do not stop the treatment unless your doctor tells you so. Contact your doctor or pharmacist before stopping.

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.

Contact your doctor immediately if you experience :

• - fever, signs of infection or extreme tiredness. These may be due to rare cells.

  
  

  aundice), whether or not nt dots and/or confusion

  
  

signs of liver problems such as yellowing of the skin and/or the e associated with bleeding which appears under the skin as red pi (see section 2 ‘Warnings and precautions’).

• - swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be the signs of an allergic reaction.

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

Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in th eye, inside the head, the lung or the joints has also been reported.

If you experience prolonged bleeding when taking Clopidogrel Teva Pharma

If you cut or injure yourself, it may take slightly 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

t your doctor straightaway (see section 2 ‘Warnings and

e:

Common side effects (may affect up to 1 in 10 people): Diarrhoea, abdominal pain, indigestion or heartburn.

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

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

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

Vertigo, enlarged breasts in males.

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

Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste of food.

In addition, your doctor may identify changes in your blood or urine test results.

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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Clopidogrel Teva Pharma

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 and on the blister, after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture and light.

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.

6. Contents of the pack and other information

What Clopidogrel Teva Pharma contains

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

The other ingredients are (see section 2 ‘Clopidogrel Teva Pharma contains hydrogenated castor oil’):

• Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000 and hydrogenated castor oil
• Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.

What Clopidogrel Teva Pharma looks like and contents of the pack

The film-coated tablets are pink, round and slightly convex.

Boxes of 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in blisters or boxes of 28×1 and 50×1 film-coated tablets in perforated unit dose blisters are available.

kCT

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V. Swensweg 5 2031GA Haarlem The Netherlands

Manufacturers

KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-StraBe 5, 27472 Cuxhaven, Germany

Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Hol­der

Tel:+ 385 1 37 20 000

Tel: +4021 230 65 24

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Slovenská republika

Teva Pharmaceuticals Slovakia s.r.o.

Tel: +(421) 2 5726 7911

Suomi/Finland

ratiopharm Oy

Puh/Tel: +358 20 180 5900

Kûnpoç

Teva EXXaç A.E.

EXXaSa

Tql: +30 210 72 79 099

Latvija

UAB Sicor Biotech filiale Latvija

Tel: +371 67 323 666

This leaflet was last revised in.

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

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