Clopidogrel Genoptim

PATIENT INFORMATION LEAFLET: USER INFORMATION

Clopidogrel Genoptim, 75 mg, film-coated tablets

Clopidogrel

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Clopidogrel Genoptim and what is it used for
• 2. Important information before taking Clopidogrel Genoptim
• 3. How to take Clopidogrel Genoptim
• 4. Possible side effects
• 5. How to store Clopidogrel Genoptim
• 6. Contents of the pack and other information

1. WHAT IS CLOPIDOGREL GENOPTIM AND WHAT IS IT USED FOR

Clopidogrel Genoptim contains clopidogrel and belongs to a group of medicines called antiplatelet medicines. Platelets are very small blood cells that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the chance of blood clots (a process known as thrombosis).
Clopidogrel Genoptim is given to adults to prevent blood clots (thrombi) in hardened arteries (atherosclerosis) that can lead to events related to atherosclerosis (such as stroke, heart attack, or death).
Clopidogrel Genoptim is prescribed to prevent blood clots and reduce the risk of these serious events, because:

• the patient has atherosclerotic hardening of the arteries (also known as atherosclerosis) and
• the patient has previously had a heart attack, stroke, or has a condition known as peripheral arterial disease, or
• the patient has had severe chest pain known as "unstable angina" or "myocardial infarction" (heart attack). To treat this condition, the doctor may place a stent in the blocked or narrowed artery to restore blood flow. The attending physician should also prescribe acetylsalicylic acid (a substance present in many medicines, used to relieve pain and reduce fever, as well as to prevent blood clotting).
• the patient has an irregular heartbeat, known as "atrial fibrillation", and the patient cannot take medicines called "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new and existing blood clots. The attending physician should inform the patient that oral anticoagulants are more effective in such cases than acetylsalicylic acid, or the simultaneous use of acetylsalicylic acid with Clopidogrel Genoptim. In the absence of the possibility of using oral anticoagulants and the absence of a risk of severe bleeding, the doctor should prescribe Clopidogrel Genoptim with acetylsalicylic acid.

2. IMPORTANT INFORMATION BEFORE TAKING CLOPIDOGREL GENOPTIM

GENOPTIM

When not to take Clopidogrel Genoptim

• if the patient is hypersensitive to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• if the patient has a condition that causes bleeding, such as a stomach ulcer or bleeding in the brain.
• if the patient has severe liver disease.

If the patient thinks that any of these problems apply to them, or has any other doubts, they should consult their doctor before taking Clopidogrel Genoptim.

Warnings and precautions

If any of the following situations apply to the patient, they should inform their doctor before taking Clopidogrel Genoptim:

• if there is a risk of bleeding, such as:
• a condition that increases the risk of internal bleeding (e.g. stomach ulcer)
• a blood disorder that increases the risk of internal bleeding (bleeding into tissues, organs, or joints)
• a recent severe injury
• a recent surgical procedure (including dental)
• a planned surgical procedure (including dental) within the next seven days
• if the patient has had a blood clot in the brain (ischemic stroke) within the last seven days
• if the patient has kidney or liver disease
• if the patient has had an allergy or hypersensitivity to any of the medicines used to treat this condition.

While taking Clopidogrel Genoptim:

• The patient should inform their doctor if they are planning to have surgery (including dental).
• The patient should also immediately inform their doctor if they experience a condition known as thrombotic thrombocytopenic purpura (TTP), characterized by fever and purple spots on the skin, which may appear as red, pinpoint spots with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• In the event of injury or trauma, the time it takes for bleeding to stop may be slightly longer than usual. This is related to the way the medicine works, as it prevents blood clots from forming. This usually does not cause problems with minor injuries and trauma, such as cuts while shaving. Nevertheless, in the event of bleeding, the patient should immediately contact their doctor (see section 2 "Warnings and precautions").
• The doctor may order blood tests.

Children and adolescents

This medicine should not be used in children, as it has not been shown to be effective in this patient group.

Clopidogrel Genoptim and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, and about medicines they plan to take, including those available without a prescription.
Some other medicines may affect the action of Clopidogrel Genoptim and vice versa.
In particular, the patient should inform their doctor if they are taking:

• medicines that may increase the risk of bleeding, such as:
• oral anticoagulants, medicines used to prevent blood clotting,
• non-steroidal anti-inflammatory medicines, usually used to treat painful and/or inflammatory conditions of the muscles or joints,
• heparin or other injectable medicines used to reduce blood clotting,
• ticlopidine and other antiplatelet medicines,
• selective inhibitors of serotonin reuptake (including fluoxetine and fluvoxamine), medicines usually used to treat depression,
• omeprazole or esomeprazole, medicines used to treat stomach disorders,
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz, a medicine used to treat HIV infection (human immunodeficiency virus),
• carbamazepine, a medicine used to treat certain types of epilepsy,
• moclobemide, a medicine used to treat depression,
• repaglinide, a medicine used to treat diabetes,
• paclitaxel, a medicine used to treat cancer,
• antiretroviral medicines (medicines used to treat HIV infection).

Patients who have had severe chest pain (unstable angina or heart attack) may be prescribed Clopidogrel Genoptim in combination with acetylsalicylic acid, a substance present in many medicines, used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (no more than 1000 mg in 24 hours) should not usually cause a problem, but long-term use in other circumstances should be discussed with the doctor.

Clopidogrel Genoptim with food and drink

Clopidogrel Genoptim can be taken with or without food.

Pregnancy and breastfeeding

This medicine should not be used during pregnancy.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
If the patient becomes pregnant while taking Clopidogrel Genoptim, they should immediately consult their doctor, as the use of clopidogrel during pregnancy is not recommended.
This medicine should not be used during breastfeeding.
If the patient is breastfeeding or plans to breastfeed, they should consult their doctor before taking this medicine.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Clopidogrel Genoptim is unlikely to affect the ability to drive or use machines.

Clopidogrel Genoptim contains lactose

If the doctor has previously informed the patient that they have an intolerance to some sugars, the patient should consult their doctor before taking this medicine.

3. HOW TO TAKE CLOPIDOGREL GENOPTIM

Clopidogrel Genoptim should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist again.
The recommended dose of Clopidogrel Genoptim is 75 mg once daily, taken orally at the same time each day, with or without food. This dosage also applies to patients with a condition known as "atrial fibrillation" (irregular heartbeat).
If the patient has had severe chest pain (unstable angina or heart attack), the doctor may prescribe an initial dose of 300 mg of Clopidogrel Genoptim (4 tablets of 75 mg). Then, the recommended dose is one 75 mg tablet of Clopidogrel Genoptim once daily, taken orally (as above).
Clopidogrel Genoptim should be taken for as long as prescribed by the doctor.

Taking a higher dose of Clopidogrel Genoptim than recommended

The patient should contact their doctor or the nearest emergency department due to an increased risk of bleeding.

Missing a dose of Clopidogrel Genoptim

If the patient forgets to take a dose of Clopidogrel Genoptim, but remembers within 12 hours of the usual time, they should take the tablet immediately, and then take the next tablet at the usual time.
If the patient forgets for more than 12 hours, they should simply take the next single dose at the usual time. The patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Clopidogrel Genoptim

The patient should not stop treatment unless advised by their doctor.Before stopping, the patient should consult their doctor or pharmacist.
In case of doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

The patient should immediately contact their doctor if they experience:

• fever, signs of infection, or extreme fatigue. This may be due to a rare decrease in the number of certain blood cells.
• signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding, which may appear as red, pinpoint spots under the skin and/or confusion (see section 2 "Warnings and precautions").
• swelling of the mouth or skin disorders, such as rash and itching, blisters. These may be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Genoptim is

bleeding.
Bleeding may occur as stomach or intestinal bleeding, bruising, hematoma (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. There have also been reports of a small number of cases of bleeding in the eye, into the brain, lungs, or joints.

If prolonged bleeding occurs while taking Clopidogrel Genoptim

In the event of injury or trauma, the time it takes for bleeding to stop may be slightly longer than usual. This is related to the way the medicine works, as it prevents blood clots from forming. This usually does not cause problems with minor injuries and trauma, such as cuts while shaving. Nevertheless, in the event of bleeding, the patient should immediately contact their doctor (see section 2 "Warnings and precautions").

Other side effects include:

Common side effects (may affect up to 1 in 10 people): diarrhea, stomach pain, indigestion or heartburn.
Uncommon side effects (may affect up to 1 in 100 people): headache, stomach ulcer, vomiting, nausea, constipation, gas in the stomach or intestines, rash, itching, dizziness, feeling of numbness or tingling.
Rare side effects (may affect up to 1 in 1,000 people): vertigo of labyrinthine origin, gynecomastia in men.
Very rare side effects (may affect up to 1 in 10,000 people): jaundice, severe stomach pain with or without back pain, fever, breathing difficulties sometimes associated with cough, generalized allergic reactions (e.g. general feeling of heat with sudden general malaise leading to fainting), swelling of the mouth, blisters, skin allergy, oral pain (stomatitis), low blood pressure, confusion, hallucinations, joint pain, muscle pain, taste disturbances.
Side effects with unknown frequency (frequency cannot be estimated from the available data): hypersensitivity reactions with chest pain or stomach pain, persistent symptoms of low blood sugar.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, the patient can help provide more information on the safety of this medicine.

5. HOW TO STORE CLOPIDOGREL GENOPTIM

This medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP" and on the blister after "EXP". The expiry date refers to the last day of the month.
See storage conditions on the carton.
If Clopidogrel Genoptim is packaged in PVC/PE/PVDC/Aluminum blisters, store below 25°C.
If Clopidogrel Genoptim is packaged in PA/Aluminum/PVC/Aluminum blisters, there are no special storage precautions.
Do not use this medicine if signs of deterioration are visible.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Clopidogrel Genoptim contains

The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Other ingredients are:
Core: microcrystalline cellulose, mannitol (E421), hydroxypropylcellulose, crospovidone, citric acid monohydrate, macrogol 6000, stearic acid, talc.
Coating: hypromellose, lactose monohydrate, iron oxide red (E172), triacetin, titanium dioxide (E171).

What Clopidogrel Genoptim looks like and contents of the pack

Clopidogrel Genoptim film-coated tablets are pink, round, and biconvex. They are packaged in cartons containing 28 or 84 film-coated tablets in PVC/PE/PVDC/Aluminum blisters or in PA/Aluminum/PVC/Aluminum blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer

Pharmathen S.A.
6, Dervenakion str.
15351 Pallini, Attiki
Greece
Pharmathen International S.A.
Industrial Park
Sapes Rodopi prefecture, Block No 5
69300 Rodopi
Greece
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Trogran
Poland:
Clopidogrel Genoptim
Romania:
Trogran 75 mg

Date of last revision of the leaflet: