75 mg film-coated tablets
clopidogrel
1. What Grepid is and what it is used for
Grepid contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood, which form clots when the blood coagulates (clots). By preventing this clot formation, platelet inhibitors reduce the risk of blood clots forming (a process called thrombosis or blood clot formation).
Grepid is used by adults to prevent blood clots ( thrombosis s) in hardened blood vessels ( artery s), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke ( stroke ), heart attack, or death).
You have been given Grepid to prevent the formation of blood clots and to reduce the risk of these serious events due to:
- You suffer from atherosclerosis (also known as atherosclerosis), and
- You have previously had a heart attack, stroke or are suffering from something called peripheral arterial disease or
- You have had a severe angina ( unstable angina ) or heart attack (heart attack). To treat this condition, your doctor may have placed a stent in the blocked or narrowed blood vessel to restore effective blood flow. You can also get acetylsalicylic acid (a substance found in many medicines used to relieve pain and lower fever and also to prevent the formation of blood clots) from your doctor.
- You have had signs of a stroke that disappears within a shorter period of time (also called a transient ischemic attack, TIA attack / mini- stroke ) or a mild stroke . You can also get acetylsalicylic acid from your doctor within the first 24 hours.
- You have an irregular heartbeat, something called atrial fibrillation, and you cannot take blood-thinning drugs that are taken orally ( vitamin K antagonists ) that prevent new blood clots from forming and prevent existing blood clots from growing. You should have learned that blood-thinning drugs taken orally are more effective than acetylsalicylic acid or the combination of Grepid and acetylsalicylic acid for this disease. Your doctor should have given you Grepid and acetylsalicylic acid if you are unable to take blood-thinning medicines orally and you are not at risk of heavy bleeding.
2. What you need to know before taking Grepid
Do not take Grepid
- If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6)
- If you suffer from any disease that causes you to have active bleeding, such as gastric ulcer or bleeding in the brain,
- If you have severe liver disease.
If you think any of these are suitable for you, or if you have any doubts, talk to your doctor before starting Grepid.
Warnings and cautions
If any of the following conditions apply to you, you should inform your doctor before taking Grepid:
- if you are at risk of bleeding such as:
- a disease that puts you at risk for internal bleeding (such as stomach ulcers ).
- a blood disease that puts you at risk of internal bleeding (in the body’s tissues , organs or joints).
- a recent serious injury.
- a recent surgery (including dental surgery).
- a planned operation (including dental operations) within the next week.
- if you have had a blockage in an artery in your brain (ischemic stroke ) that occurred in the last week.
- if you have kidney or liver disease.
- if you have had an allergy or reaction to other medicines to treat your illness.
- if you are allergic to other thienopyridines (eg prasugrel, ticlopidine).
- if you have previously had non-traumatic cerebral haemorrhage (ie not caused by external influences such as severe violence to the head)
While taking Grepid:
- You should inform your doctor if surgery (including dental surgery) is planned.
- You should also inform 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 occur as red pin-sized dots, with or without unexplained severe weakness, 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 the bleeding to stop. This is linked to how your medicine works because it prevents the formation of blood clots. This normally has no significance for minor cuts and injuries such as. if you cut yourself when shaving. However, if you are concerned about your bleeding, contact your doctor immediately (see section 4)”Possible side effects”).
- Your doctor may order blood tests.
Children and young people
Do not give this medicine to children as it does not help.
Other medicines and Grepid
Tell your doctor or pharmacist if you have recently taken or might be taking any other medicines, including medicines obtained without a prescription.
Some other medicines may affect the use of Grepid or vice versa.
You must tell your doctor if you are taking
– medicines that may increase your risk of bleeding such as:
- blood-thinning drugs taken orally, drugs used to reduce the formation of blood clots
- non-steroidal anti-inflammatory drugs ( NSAIDs ), which are commonly used in the treatment of painful and / or inflammatory conditions in muscles and joints,
- heparin or any other medicine that is injected to reduce the formation of blood clots
- ticlopidine, another antiplatelet agent
- selective serotonin reuptake inhibitors (including but not limited to fluoxetine or fluvoxamine), medicines commonly used to treat depression
- rifampicin (used to treat severe infections )
omeprazole or esomeprazole, medicines used to treat stomach problems
– fluconazole or voriconazole, drugs used to treat fungal infections
efavirenz or other antiretroviral medicines (used to treat HIV (human immunodeficiency virus infections )
– carbamazepine, a drug used to treat various forms of epilepsy
moclobemide, is a medicine used to treat depression.
repaglinide, a medicine used to treat diabetes
paclitaxel, a medicine used to treat cancer
– opioids: when you are being treated with clopidogrel, you should inform your doctor before receiving treatment with opioids (used to treat severe pain).
If you have had severe chest pain ( unstable angina or heart attack), transient ischemic attack ( TIA attack/mini-stroke), or mild stroke, you can be prescribed Grepid in combination with acetylsalicylic acid, a substance found in many medicines used to relieve pain and lower fever.
Temporary use of acetylsalicylic acid (not more than 1000 mg for 24 hours) is not generally considered a problem, but long-term use in other conditions should be discussed with your doctor.
Pregnancy and breastfeeding
This medicine should preferably not be taken during pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking Grepid, contact your doctor immediately as it is not recommended to take Grepid during pregnancy.
You should not breastfeed while taking this medicine.
If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine.
Consult a doctor or pharmacist before taking any medicine.
Driving and using machines
Grepid is unlikely to affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Grepid contains lactose
If you have been told by your doctor that you have an intolerance to some sugars (eg 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. Ask your doctor or pharmacist if you are unsure.
The recommended dose, including for patients with a condition called atrial fibrillation (irregular heartbeat), is a 75 mg tablet of Grepid per day taken orally, with or without food, and at the same time each day.
If you have had severe chest pain ( unstable angina or heart attack), your doctor may give you Grepid 300 mg (4 tablets of 75 mg) to start treatment.
After this, the recommended dose is one of 75 mg Grepid per day as described above.
If you have had a sign of a stroke that disappears within a short period (also called a transient ischemic attack, TIA attack/mini-stroke) or a mild stroke, your doctor may give you Grepid 300 mg (4 tablets of 75 mg) as a starting dose. . Thereafter, the recommended dose is one Grepid 75 mg tablet daily with acetylsalicylic acid for 3 weeks, as described above.
After that, your doctor may prescribe either Grepid alone or acetylsalicylic acid alone.
You should take Grepid for as long as your doctor prescribes it.
If you take more Grepid than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
Contact your doctor or the nearest hospital emergency department due to the increased risk of bleeding.
If you forget to take Grepid
If you forget to take a dose of Grepid and discover it within 12 hours, take the tablet as soon as you notice and take the next tablet at the usual time.
If it takes more than 12 hours before you discover it, simply take the next daily 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 treatment unless your doctor tells you to. Contact a doctor or pharmacist before stopping treatment.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Contact your doctor immediately if you have:
- fever, signs of infection or severe weakness. This may be due to a rare decrease in certain blood cells .
- signs of liver problems such as yellowing of the skin and / or eyes (jaundice), with or without concomitant small spotty bleeding under the skin (visible as red dots) and / or confusion (see section 2 “Warnings and Precautions”).
- swelling of the mouth or skin problems such as rash and itching , blisters on the skin. This may be a sign of an allergic reaction .
The most common side effect reported with Grepid is bleeding.
Bleeding can occur as bleeding in the stomach or intestines, bruising, hematoma (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. In a few cases, bleeding in the eye, internal bleeding in the head, lungs or joints have also been reported.
If you experience prolonged bleeding while taking Grepid
If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is linked to how your medicine works because it prevents the formation of blood clots. This normally has no significance for minor cuts and injuries such as. if you cut yourself when shaving. However, if you are concerned about your bleeding, contact your doctor immediately (see section 2 “Warnings and precautions”).
Other side effects include:
Common side effects (may affect up to 1 in 10 people): Diarrhea, abdominal pain, indigestion or heartburn.
Uncommon side effects (may affect up to 1 in 100 people):
Headache, stomach ulcer , vomiting, nausea, constipation, increased gas formation in the stomach or intestines, rash, itching , dizziness, feeling of tingling and numbness.
Rare side effects (may affect up to 1 in 1,000 people): Dizziness, enlarged breasts in men.
Very rare side effects (may affect up to 1 in 10,000 patients):
Jaundice, severe abdominal pain with or without back pain, fever, difficulty breathing sometimes while coughing, generalized (widespread) allergic reactions (eg a feeling of warmth with sudden discomfort until fainting), swelling in the mouth, blisters on the skin, skin allergy , sore mouth ( stomatitis ), decrease in blood pressure , confusion, hallucinations, joint pain, muscle aches, taste changes, loss of taste.
Adverse reactions that have been reported (occurring in an unknown number of users):
Hypersensitivity reaction you with chest pain or abdominal pain, signs of persistent low blood sugar.
In addition, your doctor may detect changes in your blood or urine tests.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Grepid
Keep out of 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 expiration date is the last day of the specified month.
See storage instructions on the box.
Store below 25 ° C if Grepid is sold in PVC / PE / PVDC / aluminum blisters. No special storage instructions for Grepid are sold in blisters of aluminum only.
Do not use this medicine if you notice any visible signs 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.
6. Contents of the packaging and other information
Content declaration
– The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as sealed).
– Other ingredients (see section 2 “Grepid contains lactose”):
Tablet core: microcrystalline cellulose, hydroxypropyl cellulose (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 the medicine looks like and contents of the pack
Grepid film-coated tablets are round, pink and biconvex.
They are supplied in PVC / PE / PVDC / aluminum blisters or in PA / ALL / PVC aluminum blisters packaged in cartons containing 10, 14, 28, 30, 50, 84, 90 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Marketing Authorisation Holder
Pharmathen SA,
6 Dervenakion
15351 Pallini Attiki
Greece
Manufacturer
Pharmathen SA,
6 Dervenakion
15351 Pallini Attiki
Greece
Or
Pharmathen International SA Industrial Park Sapes,
Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Or
Orifarm Generics A / S Energivej 15
5260 Odense S, Denmark
Further information on this medicine can be obtained from the representative of the marketing authorization holder:
| Belgium / Belgique / BelgienPharmathen SATel: +30 210 66 04 300 | LithuaniaSIA ELVIMTel: +371 67808450 |
| Bulgaria Pharmathen SATel: +30 210 66 04 300 | Luxembourg / LuxemburgPharmathen SATel: +30 210 66 04 300 |
| Czech RepublicPharmathen SAPuh / Tel: +30 210 66 04 300 | Hungary Pharmathen SATel .: +30 210 66 04 300 |
| Dan markOrifarm Generics A / STel: +45 63 95 27 00 | MaltaPharmathen SATel: +30 210 66 04 300 |
| GermanyGlenmark Arzneimittel GmbHTel: +49 8142 44392 0 | The NetherlandsGlenmark Pharmaceuticals BVTel: +31 (0) 20 561 6127 |
| Estonia (Estonia)Pharmathen SATel: +30 210 66 04 300 | Nor geOrifarm Generics ASTel: + 47 21 69 69 10 |
| GreeceINNOVIS PHARMA ΑΕΒΕ:Ηλ: +30 210 6664805-806 | Austria Pharmathen SATel: +30 210 66 04 300 |
| SpainPharmathen SATel: +30 210 66 04 300 | PolandSymphar Sp. z oo Tel .: +48 22 822 93 06 |
| CroatiaPharmathen SATel: +30 210 66 04 300 | Port ugalPharmathen SATel: +30 210 66 04 300 |
| FrancePharmathen SATel: +30 210 66 04 300 | RomaniaNeola Pharma SRLTel : + 40- (0) 21-233 17 81 |
| IrelandPinewood HealthcareTel: + 353 52 618 6000 | SloveniaPharmathen SATel: +30 210 66 04 300 |
| IcelandAlvogen ehf.Phone: +354 522 2900 | Slovak RepublicValeant Slovakia sroTel: + 421 2 6920 3921 |
| ItalyPharmathen SATel: +30 210 66 04 300 | Finland / FinlandPharmathen SAPuh / Tel: +30 210 66 04 300 |
| ΚύπροςThe Star Medicines Importers Co. Ltd. :Ηλ: +357 25371056 | Sweden Orifarm Generics ABTel: +46 40 680 02 60 |
| Latvia SIA ELVIMTel: +371 67808450 | U nited KingdomKent Pharmaceuticals LtdTel: +44 (0) 1233 506500 |