Grepid

Patient Information Leaflet: Information for the User

Grepid 75 mg film-coated tablets

clopidogrel
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4. Contents of this leaflet
  1. What Grepid is and what it is used for
  2. What you need to know before taking Grepid
  3. How to take Grepid
  4. Possible side effects
  5. How to store Grepid
  6. Contents of the pack and other information

1. What Grepid is and what it is used for

Grepid contains clopidogrel and belongs to a group of medicines called platelet aggregation inhibitors. Platelets are microscopic blood components that clump together during blood clotting. By preventing this clumping, platelet aggregation inhibitors reduce the likelihood of blood clots forming (a process known as thrombosis).
Grepid is taken by adults to help prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Your doctor has prescribed Grepid to help prevent blood clots and reduce the risk of these serious events because:

• You have a condition known as hardening of the arteries (also called atherosclerosis), and
• You have previously had a heart attack, stroke, or a condition known as peripheral arterial disease, or
• You have previously experienced severe chest pain known as “unstable angina” or “myocardial infarction” (heart attack). To treat this condition, your doctor may have inserted a stent into the blocked or narrowed artery to restore blood flow. Your doctor may also have prescribed you acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting),
• You have had stroke-like symptoms that disappeared within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also prescribe you acetylsalicylic acid starting within the first 24 hours,
• You have an irregular heartbeat, a condition called “atrial fibrillation”, and you cannot take medicines known as “oral anticoagulants” (vitamin K antagonists), which prevent the formation of new clots and the progression of existing ones. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Grepid and acetylsalicylic acid in treating this condition. If you cannot take “oral anticoagulants” and do not have an increased risk of bleeding, your doctor may have prescribed you Grepid plus acetylsalicylic acid.

2. What you need to know before taking Grepid

Do not take Grepid:

• If you are allergic to clopidogrel or to any of the excipients of this medicine (listed in section 6).
• If you have active bleeding, such as a stomach ulcer or bleeding in the brain.
• If you have severe liver disease.

If you think any of these apply to you, or if you are unsure, consult your doctor before using Grepid.

Warnings and precautions
If any of the following situations apply to you, inform your doctor before taking Grepid:

• if you are at 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 within any tissues, organs, or joints of the body).
  • a recent severe injury.
  • recent surgery (including dental surgery).
  • planned surgery (including dental surgery) within the next 7 days.
• if you have had a blood clot in an artery of the brain (ischaemic stroke) within the last 7 days.
• if you have kidney or liver disease.
• if you have had an allergy or reaction to any medicine used to treat your condition.
• if you have previously had a non-traumatic brain haemorrhage.

While taking Grepid:

• You must inform your doctor if you are scheduled for surgery (including dental surgery).
• You must inform your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) which includes fever and skin bruising appearing as red spots, with or without unexplained extreme fatigue, 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 due to the way the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, such as shaving or minor cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 4 “Possible side effects”).
• Your doctor may prescribe blood tests for you.

Children and adolescents
Do not give this medicine to children, as it is not effective.

Other medicines and Grepid:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Some medicines may affect how Grepid works, or Grepid may affect them.
You must inform your doctor precisely if you are taking:

• medicines that may increase your risk of bleeding such as:
  ✓ oral anticoagulants, medicines used to reduce blood clotting,
  ✓ a non-steroidal anti-inflammatory drug, generally used to treat painful and/or inflammatory conditions of muscles or joints,
  ✓ heparin or any other injectable medicine to reduce blood clotting,
  ✓ ticlopidine or other antiplatelet agents,
  ✓ a selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines usually used to treat depression,
  ✓ rifampicin (used to treat serious infections),

• omeprazole or esomeprazole, medicines used to treat stomach problems,

• fluconazole or voriconazole, medicines used to treat fungal infections,

• efavirenz or other antiretroviral medicines (used to treat HIV infection),

• carbamazepine, a medicine used to treat certain forms of epilepsy,

• moclobemide, a medicine used to treat depression,

• repaglinide, a medicine used to treat diabetes,

• paclitaxel, a medicine used to treat cancer,

• opioids: while being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),

• rosuvastatin (used to lower cholesterol levels).

If you have had severe chest pain (unstable angina or heart attack), a transient ischaemic attack, or a mild ischaemic stroke, you may have been prescribed Grepid in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (not more than 1,000 mg within 24 hours) should generally not cause problems, but prolonged use in other circumstances should be discussed with your doctor.

Grepid with food and drink
Grepid can be taken with or without food.

Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy. If you are pregnant or think you may be pregnant, inform your doctor or pharmacist before taking Grepid. If you become pregnant while taking Grepid, consult your doctor immediately, as Grepid is not recommended during pregnancy. You must not breastfeed while taking this medicine. If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is unlikely that Grepid will affect your ability to drive or use machinery.

Grepid contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars (such as lactose), contact him/her before taking this medicine.

Grepid contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Grepid

Always take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose, including for patients diagnosed with "atrial fibrillation" (an irregular heartbeat), is one 75 mg Grepid tablet daily, taken orally either during or apart from meals, at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe an initial treatment dose of 300 mg or 600 mg of Grepid (4 or 8 tablets of 75 mg) as a single dose.
The recommended maintenance dose is one 75 mg Grepid tablet daily, as described above.

If you have had symptoms of a stroke that resolve within a short period (also known as transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe an initial dose of 300 mg of Grepid (4 tablets of 75 mg) as a single dose. Afterwards, the recommended dose is one 75 mg Grepid tablet daily, as described above, in combination with acetylsalicylic acid for 3 weeks. After this period, your doctor will prescribe either Grepid alone or acetylsalicylic acid alone.

Grepid should be taken for as long as your doctor considers it necessary.

If you take more Grepid than you should
Contact your doctor or the nearest emergency department immediately due to the increased risk of bleeding.

If you forget to take Grepid
If you forget to take Grepid but remember within 12 hours of your usual dose time, take one tablet immediately and then take the next dose at the regular time.
If more than 12 hours have passed, skip the missed dose and take your next 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 has told you to do so. Before stopping, consult your doctor or pharmacist.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Contact your doctor immediately if you experience:

• fever, signs of infection, or severe weakness. These effects may be due to a rare reduction in certain blood cells
• signs of liver problems such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red spots, and/or confusion (see section 2 “Warnings and precautions”).
• swelling in the mouth, or skin problems such as rash, itching, or skin blisters. These may be signs of an allergic reaction. The most common side effect reported with Grepid is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (unusual or excessive bruising under the skin), nosebleeds, or blood in the urine. In rare cases, bleeding in the eye, intracranial bleeding, in the lungs, or in the joints has also been reported.

If you experience prolonged bleeding while taking Grepid
If you cut yourself or sustain an injury, it may take longer than usual for the bleeding to stop. This is due to the way the medicine works, as it prevents the formation of blood clots. For minor cuts or injuries, such as shaving or small cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 2 “Warnings and precautions”).

Other side effects include:
Common side effects (may occur in up to 1 in 10 patients):
Diarrhoea, abdominal pain, indigestion or stomach burning.

Uncommon side effects (may occur in up to 1 in 100 patients):
Headache, gastric ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, rash, itching, dizziness, tingling and numbness sensations.

Rare side effects (may occur in up to 1 in 1,000 patients):
Dizziness, breast enlargement in males.

Very rare side effects (may occur in up to 1 in 10,000 patients):
Jaundice; severe abdominal pain with or without back pain; fever, difficulty breathing sometimes associated with cough; generalized allergic reactions (for example, a widespread feeling of warmth with sudden general malaise up to fainting); swelling in the mouth; skin blisters; skin allergy; mouth pain (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes or loss of taste.

Side effects with unknown frequency (frequency cannot be determined from available data): hypersensitivity reactions with chest or abdominal pain, persistent symptoms of hypoglycaemia.

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V.
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 stated on the packaging and on the blister, after
Exp. The expiry date refers to the last day of that month.
Store below 25°C.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Grepid contains

• The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as besylate).
• The other ingredients are (see section 2 “Grepid contains lactose”):
  Tablet core: microcrystalline cellulose, hydroxypropylcellulose (E463), mannitol (E421), crospovidone (type A), citric acid monohydrate, macrogol 6000, stearic acid, sodium stearyl fumarate
  Tablet coating: hypromellose (E464), iron oxide red (E 172), lactose monohydrate, triacetin (E1518), titanium dioxide (E 171)

Description of the appearance of Grepid and package contents
Grepid film-coated tablets are pink, round and biconvex. They are supplied in PVC/PE/PVDC/aluminum blisters in pack sizes of 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

Manufacturer
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 further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Pharmathen S.A. SIA ELVIM
Tél/Tel: +30 210 66 04 300 Tel: +371 67808450

България Luxembourg/Luxemburg
Pharmathen S.A. Pharmathen S.A.
Тел: +30 210 66 04 300 Tel: +30 210 66 04 300

Česká republika Magyarország
Pharmathen S.A. Pharmathen S.A.
Puh/Tel: +30 210 66 04 300 Tel: +30 210 66 04 300

Danmark Malta
Orifarm Generics A/S Pharmathen S.A.
Tlf: +45 63 95 27 00 Tel: +30 210 66 04 300

Deutschland Nederland
Pharmathen S.A. Glenmark Pharmaceuticals B.V.
Tel: +30 210 66 04 300 Tel: +31 (0)8003355533

Eesti Norge
Pharmathen S.A. Orifarm Generics AS
Tel: +30 210 66 04 300 Tlf: +47 21 69 69 10

Ελλάδα Österreich
INNOVIS PHARMA ΑΕΒΕ Pharmathen S.A.
Τηλ: +30 210 6664805-806 Tel: +30 210 66 04 300

España Polska
Pharmathen S.A. Symphar Sp. z o.o.
Tel: +30 210 66 04 300 Tel.: +48 22 822 93 06

France Portugal
Pharmathen S.A. Pharmathen S.A.
Tel: +30 210 66 04 300 Tel: +30 210 66 04 300

Hrvatska România
Pharmathen S.A. Neola Pharma SRL
Tel: +30 210 66 04 300 Tel: +40-(0)21-233 17 81

Ireland Slovenija
Pinewood Healthcare Pharmathen S.A.
Tel: +353 52 6186000 Tel: +30 210 66 04 300

Ísland Slovenská republika
Alvogen ehf. Valeant Slovakia s.r.o.
Sími: +354 522 2900 Tel: +421 2 6920 3921

Italia Suomi/Finland
Pharmathen S.A. Ailon Pharma Oy
Tel: +30 210 66 04 300 Puh/Tel: +358 40 702 4992

Κύπρος Sverige
The Star Medicines Importers Co. Ltd Orifarma Generics AB
Τηλ: +357 25371056 Tel: +46 40 680 02 60

Latvija United Kingdom (Northern Ireland)
SIA ELVIM Athlone Pharmaceuticals
Tel: +371 67808450 Tel: +44 (0) 845 4375565

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