Patient leaflet - Grepid
1. What Grepid is and what it is used for
Grepid contains clopidogrel and 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 by adults 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:
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– You have a condition of hardening of arteries (also known as atherosclerosis), and
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– You have previously experienced a heart attack, stroke or have a condition known as peripheral
arterial disease, or
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– 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 may also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
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– You have experienced symptoms of a stroke which go away within a short period of time (also
known as transient ischemic attack) or an ischemic stroke mild in severity. You may also be given acetylsalicylic acid by your doctor starting within the first 24 hours.
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– 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 Grepid and acetylsalicylic acid for this condition. Your doctor should have prescribed Grepid 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 Grepid
Do not take Grepid
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– if you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in
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section 6).
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– if you have a medical condition that is currently causing bleeding such as a stomach ulcer or
bleeding within the brain.
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– 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.
Warnings and precautions
If any of the situations mentioned below apply to you, you should tell your doctor before taking Grepid:
- if you have a risk of bleeding, such as
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– a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
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– a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
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– a recent serious injury.
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– a recent surgery (including dental).
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– a planned surgery (including dental) in the next seven days.
- if you have had a clot in an artery of your brain (ischemic stroke) which occurred within the 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.
- if you are allergic to other thienopyridines (such as prasugrel, ticlopidine).
- if you had a past medical history of non-traumatic brain hemorrhage.
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.
Children and adolescents
Do not give this medicine to children because it does not work.
Other medicines and Grepid
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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:
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– 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 muscles 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
o rifampicin (used to treat severe infections)
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– omeprazole or esomeprazole, medicines to treat upset stomach
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– fluconazole or voriconazole, medicines to treat fungal infections
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– efavirenz, or other anti-retroviral medicines (used to treat HIV infections)
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– carbamazepine, a medicine to treat some forms of epilepsy
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– moclobemide, medicine to treat depression
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– repaglinide, medicine to treat diabetes
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– paclitaxel, medicine to treat cancer
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– opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioid (used to treat severe pain)
If you have experienced severe chest pain (unstable angina or heart attack), transient ischemic attack or ischemic stroke in mild severity, you may be prescribed Grepid in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (not more than 1 000 mg in 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 pharmacist before taking Grepid. If you become pregnant while taking Grepid, consult your doctor immediately as it is recommended not to take Grepid 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
Grepid is unlikely to affect your ability to drive or to use machines.
Grepid contains lactose
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
3. How to take Grepid
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 Grepid 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 or 600 mg of Grepid (4 or 8 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Grepid per day as described above.
If you have experienced symptoms of a stroke which go away within a short period of time (also known as transient ischemic attack) or an ischemic stroke mild in severity, your doctor may give you 300 mg of Grepid (4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Grepid per day as described above with acetylsalicylic acid for 3 weeks. Then the physician would prescribe either Grepid alone or acetylsalicylic acid alone.
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 a forgotten tablet.
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 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:
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– fever, signs of infection or extreme tiredness. These may be due to rare decrease of some blood
cells.
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– 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’).
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– 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 section 2 ‘Warnings and precautions’).
Other side effects include :
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 effects (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):
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 or loss of taste of food.
Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.
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 Grepid
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.
Refer to the storage conditions on the carton.
If Grepid is supplied in PVC/PE/PVDC/aluminium blisters, store below 25°C.
If Grepid is supplied in all aluminium blisters, it does not require any special storage conditions.
Do not use this medicine if you notice any visible sign of deterioration.
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 protect the environment.
6. Contents of the pack and other information
What Grepid contains
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– The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as
besilate).
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– The other ingredients are (see section 2 ‘Grepid contains lactose’):
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:
| Belgie/Belgique/Belgien Pharmathen S.A. Tél/Tel: +30 210 66 04 300 | Lietuva SIA ELVIM Tel: +371 67808450 |
| Etnrapua Pharmathen S.A. Ten.: +30 210 66 04 300 | Luxembourg/Luxemburg Pharmathen S.A. Tel: +30 210 66 04 300 |
| Česká republika Pharmathen S.A. Puh/Tel: +30 210 66 04 300 | Magyarorszag Pharmathen S.A. Tel.: +30 210 66 04 300 |
| Danmark Orifarm Generics A/S Tlf: +45 63 95 27 00 | Malta Pharmathen S.A. Tel: +30 210 66 04 300 |
| Deutschland Glenmark Arzneimittel GmbH Tel: +49 8142 44392 0 | Nederland Glenmark Pharmaceuticals B.V. Tel: +31 (0)8003355533 |
| Eesti (Estonia) Pharmathen S.A. Tel: +30 210 66 04 300 | Norge Orifarm Generics AS Tlf: + 47 21 69 69 10 |
| EZZáSa INNOVIS PHARMA AEBE Tnk +30 210 6664805–806 | Österreich Pharmathen S.A. Tel: +30 210 66 04 300 |
| España Pharmathen S.A. Tel: +30 210 66 04 300 | Polska Symphar Sp. z o.o. Tel.: +48 22 822 93 06 |
| France Pharmathen S.A. Tel: +30 210 66 04 300 | Portugal Pharmathen S.A. Tel: +30 210 66 04 300 |
| Hrvatska Pharmathen S.A. Tel: +30 210 66 04 300 | Romania Neola Pharma SRL Tel: +40-(0)21–233 17 81 |
| Ireland Pinewood Healthcare Tel: + 353 52 6186000 | Slovenija Pharmathen S.A. Tel: +30 210 66 04 300 |
| island Alvogen ehf. Simi: +354 522 2900 | Slovenská republika Valeant Slovakia s.r.o. Tel: + 421 2 6920 3921 |
| Italia Pharmathen S.A. Tel:+30 210 66 04 300 | Suomi/Finland Ailon Pharma Oy Puh/Tel: +358 40 702 4992 |
| Kvnpog The Star Medicines Importers Co. Ltd TnX: +357 25371056 | Sverige Orifarm Generics AB Tel: +46 40 680 02 60 |
| Latvija SIA ELVIM Tel: +371 67808450 | United Kingdom (Northern Ireland) Athlone Pharmaceuticals Tel: +44 (0) 845 4375565 |
This leaflet was last revised in <Month YYYY>.
Detailed information on this medicine is available on the European Medicines Agency website:
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Age, Blood pressure, Clinical features, Duration, and Diabetes mellitus diagnosis
National Institutes of Health Stroke Scale