Clopidogrel Krka 75 mg film-coated tablets

Clopidogrel Krka belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood, which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).

Clopidogrel Krka is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed Clopidogrel Krka to help prevent blood clots and reduce the risk of these severe events because:

• You have a condition of hardening of arteries (also known as atherosclerosis), and
• You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease.

Do not take Clopidogrel Krka
- if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Krka;
- 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 Krka.

Take special care with Clopidogrel Krka

If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Krka:
- 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 within the last seven days - if you have kidney or liver disease.

While you are taking Clopidogrel Krka:
- 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.

Clopidogrel Krka is not intended for use in children or adolescents.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some other medicines may influence the use of Clopidogrel Krka or vice versa.

You should specifically tell your doctor if you take

• oral anticoagulants, medicines used to reduce blood clotting,
• a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints,
• heparin or any other injectable medicine used to reduce blood clotting,
• omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach,
• fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections,
• fluoxetine, fluvoxamine, or moclobemide, medicines to treat depression,
• carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy,
• ticlopidine, other antiplatelet agent.

An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period), a substance present in many medicines used to relieve pain and lower fever, should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Krka with food and drink
Clopidogrel Krka 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 Krka. If you become pregnant while taking Clopidogrel Krka, 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 Krka is unlikely to affect your ability to drive or to use machines.

Important information about some of the ingredients of Clopidogrel Krka

Clopidogrel Krka contains hydrogenated castor oil which may cause stomach upset and diarrhoea.

Always take Clopidogrel Krka exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is one 75 mg tablet of Clopidogrel Krka per day to be taken orally with or without food, and at the same time each day.

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

If you take more Clopidogrel Krka than you should:
Contact your doctor or the nearest emergency department because of the increased risk of bleeding.

If you forget to take Clopidogrel Krka:
If you forget to take a dose of Clopidogrel Krka, 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 dose.

If you stop taking Clopidogrel Krka:

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 product, ask your doctor or pharmacist.

Like all medicines, Clopidogrel Krka can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention: - very common (affects more than 1 user in 10)
- common (affects 1 to 10 users in 100)
- uncommon (affects 1 to 10 users in 1,000)
- rare (affects 1 to 10 users in 10,000)
- very rare (affects less than 1 user in 10,000)
- not known (frequency cannot be estimated from the available data)

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 ?Take special care with Clopidogrel Krka?).
• 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 effectis 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 Krka

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 of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ?Take special care with Clopidogrel Krka?).

Other side effects reported are
Common side effects: Diarrhoea, abdominal pain, indigestion or heartburn.

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

Rare side effect: Vertigo.

Very rare side effects: jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste.

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.
Do not use Clopidogrel Krka after the expiry date which is stated on the carton and 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Clopidogrel Krka contains

• The active substance is clopidogrel. Each film-coated tabletcontains 75 mg of clopidogrel (as hydrochloride).
• The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil in the tablet core and hydroxypropylcellulose (E463), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol in the film-coating.

What Clopidogrel Krka 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, 60, 84, 90, 100 and 120 film-coated tablets in blisters are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, ?marje?ka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, ?marje?ka cesta 6, 8501 Novo mesto, Slovenia

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

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

BelgiëBelgiqueBelgien KRKA, d.d., Novo mesto TélTel 32 03 321 63 52 LuxembourgLuxemburg KRKA, d.d., Novo mesto TélTel 32 03 321 63 52

KRKA Te. 359 02 962 34 50 Magyarország KRKA Magyarország Kereskedelmi Kft. Tel. 361 0 355 8490

eská republika KRKA R, s.r.o. Tel 420 0 221 115 150 Malta KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66

Danmark KRKA Sverige AB Tlf 46 08 643 67 66 SE Nederland KRKA, d.d., Novo mesto Tel 32 3 321 63 52 BE

Deutschland TAD Pharma GmbH Tel 49 0 4721 6060 Norge KRKA Sverige AB Tlf 46 08 643 67 66 SE

Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel 372 06 671 658 Österreich KRKA Pharma GmbH, Wien Tel 43 01 66 24 300

SIEGER PHARMA S.A. T. 30 210 60 39 336-8 Polska KRKA-POLSKA Sp. z o.o. Tel. 48 022 573 7500

España KRKA, d.d., Novo mesto Tel 34 061 5089 809 Portugal KRKA Farmacêutica, Unipessoal Lda. Tel 351 021 46 43 650

France KRKA, d.d., Novo mesto Tél 32 3 321 63 52 BE România KRKA Romania S.R.L., Bucharest Tel 402 01 310 66 05

Ireland KRKA Pharma Dublin, Ltd. Tel 46 8 643 67 66 Slovenija KRKA, d.d., Novo mesto Tel 386 0 1 47 51 100

Ísland Slovenská republika

KRKA Sverige AB Sími 46 08 643 67 66 SE KRKA Slovensko, s.r.o., Tel 421 0 2 571 04 501

Italia KRKA, d.d., Novo mesto Tel 39 069448827 SuomiFinland KRKA Sverige AB PuhTel 46 08 643 67 66 SE

Kipa Pharmacal Ltd. 357 24 651 882 Sverige KRKA Sverige AB Tel 46 08 643 67 66 SE

Latvija KRKA, d.d., Novo mesto Tel 371 6 733 86 10 United Kingdom Consilient Health UK Ltd. Tel 44 02089562310

Lietuva

UAB KRKA Lietuva
Tel: + 370 5 236 27 40

This leaflet was last approved in MM/YYYY.

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