GREPID 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Grepid 75 mg film-coated tablets

clopidogrel

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Grepid and what is it used for.
2. What you need to know before you take Grepid.
3. How to take Grepid.
4. Possible side effects.
5. Storage of Grepid.
6. Contents of the pack and other information.

1. What is Grepid and what is it used for

Grepid contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that help the blood to clot. Antiplatelet agents prevent platelet clumping, reducing the risk of blood clots (a process called thrombosis).

Grepid is given to adults to prevent blood clots (thrombi) in blood vessels (arteries) that have become hardened (a process known as atherothrombosis), which can lead to atherothrombotic events (such as stroke, myocardial infarction, or death).

You have been prescribed Grepid to help prevent blood clots and reduce the risk of these serious events because:

• You have a condition that causes hardening of the arteries (also known as atherosclerosis), and
• You have previously had a heart attack, stroke, or suffer from a disease called peripheral arterial disease, or
• You have had a severe type of chest pain known as "unstable angina" or "myocardial infarction". For the treatment of this disease, your doctor may need to place a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and reduce fever, as well as to prevent blood clots).
• You have experienced symptoms of a stroke that disappear within a short period (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer acetylsalicylic acid to you within the first 24 hours.
• You have an irregular heartbeat, a condition called 'atrial fibrillation', and you cannot take medications known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new clots and prevent the growth of existing clots. You will have been told that "oral anticoagulants" are more effective than acetylsalicylic acid or the combined use of Grepid and acetylsalicylic acid for this disease. Your doctor will have prescribed Grepid plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a risk of severe bleeding.

2. What you need to know before you take 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 have an active bleeding, such as a stomach ulcer or bleeding in the brain;
• If you have a severe liver disease.

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

Warnings and precautions

Before starting treatment with Grepid, inform your doctor if you are in any of the following situations:

• If you are at risk of bleeding (bleeding) because:

• You have a disease that involves a risk of internal bleeding (such as a stomach ulcer).
• You have a blood disorder that predisposes you to internal bleeding (bleeding in tissues, organs, or joints of the body).
• You have recently had a severe injury.
• You have recently undergone surgery (including dental surgery).
• You are scheduled to undergo surgery (including dental surgery) within the next 7 days.

• If you have had a blood clot in an artery of the brain (ischemic stroke) in the last 7 days.
• If you have liver or kidney disease.
• If you have had an allergy or reaction to any medication used to treat your disease.
• If you have had a history of non-traumatic cerebral bleeding.

During treatment with Grepid:

• Tell your doctor if you are scheduled to undergo surgery (including dental surgery).

• Tell your doctor immediately if you develop a disorder (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bruises) under the skin that can appear 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, the bleeding may take longer than usual to stop. This is related to the way the medicine works, as it prevents the blood from forming clots. For minor cuts or injuries, such as cuts while shaving, this is not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 4 "Possible side effects").

• Your doctor may ask you to have blood tests.

Children and adolescents

This medicine should not be given to children as it is not effective.

Taking Grepid with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect the use of Grepid or vice versa.

You must specifically inform your doctor if you are taking:

• medicines that may increase the risk of bleeding, such as:

• oral anticoagulants, medicines used to decrease blood clotting,
• non-steroidal anti-inflammatory drugs, medicines used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medicine used to decrease blood clotting,
• ticlopidine, another antiplatelet agent,
• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other medications of the same type), medicines used to treat depression,
• rifampicin (used for severe infections)

• omeprazole or esomeprazole, medicines used to treat stomach discomfort,
• fluconazole or voriconazole, medicines used to treat fungal infections.
• efavirenz, or other antiretroviral medications (used to treat HIV infections),
• carbamazepine, a medicine used to treat some 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: if you are being treated with clopidogrel, you must inform your doctor before any opioid (used to treat severe pain) is prescribed to you,
• rosuvastatin (used to reduce cholesterol levels).

If you have had severe chest pain (unstable angina or myocardial infarction), a transient ischemic attack, or a mild ischemic stroke, you may have been prescribed Grepid in combination with acetylsalicylic acid, a substance found in many medications used to relieve pain and reduce fever. A dose of acetylsalicylic acid given occasionally (not exceeding 1,000 mg in 24 hours) is generally not a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Grepid with food and drinks

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, you must inform your doctor or pharmacist before taking Grepid. If you become pregnant while taking Grepid, consult 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 plan to breastfeed, inform your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Grepid contains lactose

If your doctor has told you that you have an intolerance to some sugars (e.g. lactose), consult him before taking this medicine.

3. How to take Grepid

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose, even for patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg Grepid tablet 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 myocardial infarction), your doctor may prescribe you 300 mg or 600 mg of Grepid (4 or 8 tablets of 75 mg) to be taken once at the start of treatment. After that, the recommended dose is one 75 mg Grepid tablet per day as described above.

If you have experienced symptoms of a stroke that disappear within a short period (also known as a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe you 300 mg of Grepid (4 tablets of 75 mg) once at the start of treatment. After that, the recommended dose is one 75 mg Grepid tablet per day as described above, with acetylsalicylic acid for 3 weeks. After that, your doctor will 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 go to the nearest hospital emergency department, as there is a higher risk of bleeding.

If you forget to take Grepid

If you forget to take a dose of Grepid, but remember before 12 hours have passed since the time you should have taken the medication, take the tablet immediately and the next one at the usual time.

If you forget for more than 12 hours, simply take the 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 your treatment unless your doctor tells you to. Contact your doctor or pharmacist before stopping this medicine.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor immediately if you experience:

• Fever, signs of infection, or extreme fatigue. These symptoms may be due to a rare decrease in some blood cells.

• Signs of liver problems: such as yellowing of the skin and/or eyes (jaundice), associated or not with bleeding that appears under the skin as red spots and/or confusion (see section 2 "Warnings and precautions")
• Swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin. These can be signs of an allergic reaction.

The most common side effect reported with Grepid is bleeding.Bleeding may occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases of bleeding from the blood vessels of the eyes, intracranial bleeding, pulmonary bleeding, or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Grepid

If you cut or injure yourself, the bleeding may take a little longer than usual to stop. This is related to the mechanism of action of the medicine, as it prevents the blood from forming clots. For minor cuts or injuries, such as cuts while shaving, this is not a problem. However, if you are concerned about your bleeding, consult 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, excess gas in the stomach or intestine, rash, itching, dizziness, tingling, and numbness.

Rare side effects (may affect up to 1 in 1,000 people):

Dizziness, breast enlargement in men.

Very rare side effects (may affect up to 1 in 10,000 people):

Jaundice; severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions (e.g. general feeling of heat with sudden general discomfort leading to fainting); swelling of the mouth; blisters on the skin, skin allergy; inflammation of the mouth mucosa (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

Side effects with unknown frequency (cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

In addition, your doctor may observe changes in the results of your blood or urine tests.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 blister, after EXP. The expiry date is the last day of the month stated.

See the storage conditions in the carton.

Store below 25°C when Grepid is presented in PVC/PE/PVDC/aluminum blisters.

When Grepid is presented in any aluminum blister, it does not require special storage conditions.

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. This will help protect the environment.

6. Package Contents and Additional Information

Grepid Composition

• The active ingredient is clopidogrel. Each tablet contains 75 mg of clopidogrel (as besylate).

• The other components are as follows (see section 2 "Grepid contains lactose"):

Tablet core:microcrystalline cellulose, hydroxypropylcellulose (E463), mannitol (E421), crospovidone (type A), citric acid monohydrate, macrogol 6000, stearic acid, and talc

Tablet coating:hypromellose (E464), red iron oxide (E172), lactose monohydrate, triacetin (E1518), and titanium dioxide (E171).

Product Appearance and Package Contents

Grepid film-coated tablets are pink, round, and biconvex.

They are available in cardboard boxes containing 10, 14, 28, 30, 50, 84, 90, or 100 film-coated tablets in PVC/PE/PVDC/Aluminum or PA/ALU/PVC/Aluminum blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 further information about this medicinal product, please contact the local representative of the marketing authorization holder.

Date of last revision of this leaflet: July 2022

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