Clopidogrel ratiopharm GmbH - patient leaflet, side effects, dosage

2. What you need to know before you take Clopidogrel ratiopharm GmbH

Do not take Clopidogrel ratiopharm GmbH

• 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 ratiopharm GmbH.

Warnings and precautions

Talk to your doctor or pharmacist before taking Clopidogrel ratiopharm GmbH:

• 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 stroke) which occurred w last seven days

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 ratiopharm GmbH:

• 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 l for bleeding to stop. This is linked to the way your medicine works as it prevents ility of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, s 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 childre

Other medicines and Clopidogrel ratiopharm GmbH

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some other medicines may influence the use of Clopidogrel ratiopharm GmbH or vice versa.

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You should specifically tell your doctor if you take

• – medi hat may increase your risk of bleeding such as:

o ticoagulants, medicines used to reduce blood clotting,

o -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,

• – anti-retroviral medicines (medicines to treat HIV 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 ratiopharm GmbH 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.

Clopidogrel ratiopharm GmbH with food and drink

Clopidogrel ratiopharm GmbH may be taken with or without food.

Pregnancy and breast-feeding

It is preferable not to take this product during pregnancy.

If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel ratiopharm GmbH. If you become pregnant while taking Clopidogrel ratiopharm GmbH, 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 ratiopharm GmbH is unlikely to affect your ability to dri

Clopidogrel ratiopharm GmbH contains hydrogenated castor oil

This may cause stomach upset or diarrhoea.

3. How to take Clopidogrel ratiopharm GmbH

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

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel ratiopharm GmbH (4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel ratiopharm GmbH per day to be taken orally with or without food, and at the same time each day.

You should take Clopidogrel ratiopharm GmbH for as long as your doctor continues to prescribe it.

If you take more Clopidogrel ratiopharm GmbH 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 ratiopharm GmbH

If you forget to take a dose of Clopidogrel ratiopharm GmbH, but remember within 12 hours of your usual time, take your tablet straight away 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.

If you stop taking Clopidogrel ratiopharm GmbH

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 decrease of some blood cells.

• – signs of liver problems such as yellowing of the skin and/or 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 and itching, blisters o These may be the signs of an allergic reaction.

The most common side effect reported with clopidogrel 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 the urine. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.

If you experience prolonged bleeding when taking Clopidogrel ratiopharm GmbH.

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 t e.g., cutting yourself, shaving, this is usually of no concern. Ho bleeding, you should contact your doctor straightaway (see s

Other side effects are : -Common side effects (may affect up to 1 in 10 p Diarrhoea, abdominal pain, indigestion or heartbu

-Uncommon side effects (may affect up Headache, stomach ulcer, vomiting, rashes, itching, dizziness, sensation

• – Rare side effect (may affect up to 1 in 1,000 people):

Vertigo, enlarged breasts in males.

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

5. How to store Clopidogrel ratiopharm GmbH

Do not store above 30 °C.

Store in the original blister in order to protect from moisture.

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.

Do not use Clopidogrel ratiopharm GmbH if you notice any visible sign of damage of blister or film-coated tablets.

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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 ratiopharm GmbH contains

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as besilate).

The other ingredients are (see section 2 ‘Clopidogrel ratiopha oil’):

Tablet core:

Macrogol 6000

Cellulose, microcrystalline (E460)

Crospovidone type A

Castor oil, hydrogenated

Film-coating:

Macrogol 6000

Ethylcellulose (E462)

Titanium dioxide (E 171)

What Clopidogrel ratiopharm GmbH looks like and contents of the pack

Clopidogrel ratiopharm GmbH 75 mg film-coated tablets are white to off-white, marbled, round and biconvex. They are supplied in cardboard cartons containing 7, 14, 28, 30, 50, 84, 90 and 100 tablets

Archie Samuel s.r.o.

Slunná 16

61700 Brno Czech Republic

Manufacturer

Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany

Puh/Tel: +358 20 180 5900

Kûnpoç

Teva EXXaç A.E., EXXaSa

Tql: +30 211 880 5000

Latvija

UAB Sicor Biotech filiale Latvijâ

Tel: +371 67 323 666

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