Grepid 75 mg film-coated tablets

Grepid 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).

Grepid 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 Grepid 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 Grepid

• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Grepid
• 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 Grepid.

Take special care with Grepid

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

• 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 Grepid:

• 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 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 Grepid or vice versa.

You should specially 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 muscles 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 (not more than 1000 mg in 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Grepid with food and drink

Grepid 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 pharmacist before taking Grepid. If you become pregnant while taking Grepid, 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

Grepid is unlikely to affect your ability to drive or to use machines.

Important information about some of the ingredients of Grepid

Grepid contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact you doctor before taking this medicine.

Always take Grepid 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 Grepid per day to be taken orally with or without food and at the same time each day.

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

If you take more Grepid than you should

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

If you forget to take Grepid

If you forget to take a dose of Grepid, 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 the forgotten individual doses.

If you stop taking Grepid
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, Grepid 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 Grepid?).
• 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 Grepid 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 Grepid

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 ?Take special care with Grepid?).

Other side effects reported with Grepid 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 effects: 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 Grepid after the expiry date which is stated on the carton and on the blister, after EXP.

This medicinal product does not require any special storage conditions.

Do not use Grepid if you notice any visible sign of deterioration.

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 Grepid contains

• The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
• The other ingredients are: Tablet core: Microcrystalline cellulose,hydroxypropylcellulose (E463) , mannitol (E421) , crospovidone (type A) , citric acid monohydrate , macrogol 6000 , stearic acid , talc Tablet coating: Hypromellose (E464) , iron oxide red (E172) , lactose monohydrate , triacetin (E1518) , titanium dioxide (E171)

What Grepid looks like and contents of the pack

Grepid film-coated tablets are pink, round and biconvex.
They are supplied in PVC/PE/PVDC/Alu blisters or in PA/ALL/PVC-Alu blisters packed in cartons containing 10, 14, 28, 30, 50, 84, 90 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Pharmathen S.A.,
6 Dervenakion
15351 Pallini Attiki
Greece

Manufacturers

Pharmathen S.A.,
6 Dervenakion
15351 Pallini Attiki
Greece
Or
Pharmathen International S.A
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300, Greece
or
Orifarm Generics A/S
Energivej 15
5260 Odense S, Denmark

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

BelgiëBelgiqueBelgien Pharmathen S.A. TélTel 30 210 66 65 067 LuxembourgLuxemburg Portfarma ehf. Tel 354 534 4030

Pharmathen S.A. Te. 30 210 66 65 067 Magyarország Pharmathen S.A. Tel. 30 210 66 65 067

eská republika Pharmathen S.A. PuhTel 30 210 66 65 067 Malta Pharmathen S.A. Tel 30 210 66 65 067

Danmark Orifarm Generics AS Tlf 45 63 95 27 00 Nederland Combiphar Europe B.V. Tel 31 33 258 02 06

Deutschland LESS Pharma GmbH Tel 49 6039 939 71 32 Norge Orifarm Generics AS Tlf 47 21 52 00 30

Eesti Estonia Portfarma ehf. Österreich Kwizda Pharma GmbH

Tel 354 534 4030 Tel 43059977 30-0

Pharmathen S.A. 30 210 66 65 067 Polska Celon Pharma Sp. z o.o. Tel. 48 22 751 59 33

España LABORATORIOS NORMON, S.A. Tel 34 918065240 Portugal Pharmathen S.A. Tel 30 210 66 65 067

France Pharmathen S.A. Tél 33 0 237494040 România Pharmathen S.A. Tel 30 210 66 65 067

Ireland Pinewood Healthcare Tel 353 52 6186000 Slovenija Pharmathen S.A. Tel 30 210 66 65 067

Ísland Portfarma ehf. Sími 354 534 4030 Slovenská republika Pharmathen S.A. PuhTel 30 210 66 65 067

Italia DOC GENERICI S.R.L. Tel39 02655341 SuomiFinland Pharmathen S.A. PuhTel 30 210 66 65 067

Pharmathen S.A. 357 25372425 Sverige Orifarm Generics AB Tel 40 680 02 30

Latvija Portfarma ehf. Tel 354 534 4030 United Kingdom Beacon Pharmaceuticals Ltd Tel 44 0 1892 506958

Lietuva

Portfarma ehf.
Tel: +354 534 4030

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