Clopidogrel genoptim

Clopidogrel Genoptim, 75 mg, coated tablets
Clopidogrelum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual and must not be passed on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Clopidogrel Genoptim is and what it is 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 CLOPIDOGREL GENOPTIM IS AND WHAT IT IS USED FOR

Clopidogrel Genoptim contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small components in the blood that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the risk of blood clots (a process known as thrombosis).

Clopidogrel Genoptim is prescribed for adults to prevent blood clots (thrombi) in hardened and narrowed blood vessels (arteries) due to atherosclerosis, a condition that may lead to atherothrombotic events (such as stroke, heart attack, or death).

Clopidogrel Genoptim is prescribed to prevent blood clots and reduce the risk of such serious events because:

• the patient has atherosclerosis (also known as atherosclerotic vascular disease), and
• the patient has previously had a heart attack, stroke, or has peripheral arterial disease, or
• the patient has experienced severe chest pain known as "unstable angina" or "myocardial infarction" (heart attack). To treat this condition, the doctor may have inserted a stent into a blocked or narrowed artery to restore effective blood flow. The treating physician should also prescribe acetylsalicylic acid (a substance found in many medicines used both for pain relief and fever reduction, as well as for preventing blood clotting).
• the patient has an irregular heartbeat known as "atrial fibrillation" and cannot take medicines called "oral anticoagulants" (vitamin K antagonists), which prevent the formation of new clots and the growth of existing ones. The treating physician should inform the patient that oral anticoagulants are more effective in such cases than acetylsalicylic acid alone, or the combination of acetylsalicylic acid with Clopidogrel Genoptim. If oral anticoagulants cannot be used and there is no high risk of severe bleeding, the doctor should prescribe Clopidogrel Genoptim together with acetylsalicylic acid.

2. IMPORTANT INFORMATION BEFORE USING CLOPIDOGREL CLOPIDOGREL GENOPTIM

GENOPTIM
When not to use Clopidogrel Genoptim

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

If the patient thinks any of these situations apply, or has any other
doubts, they should consult their doctor before taking Clopidogrel
Genoptim.
Warnings and precautions
If any of the situations listed below apply to the patient, they should inform their doctor before taking
Clopidogrel Genoptim:

• if there is a risk of bleeding, such as:
  • a medical condition that increases the risk of internal bleeding (e.g. stomach ulcer)
  • a blood disorder that predisposes to internal bleeding (bleeding into tissues, organs or joints)
  • recent severe injury
  • recent surgical procedure (including dental surgery)
  • planned surgical procedure (including dental surgery) within the next seven days
• if the patient has been diagnosed with a blood clot in the brain (ischaemic stroke) that occurred within the last seven days
• if the patient has kidney or liver disease
• if the patient has previously had an allergic reaction 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 scheduled for a surgical procedure (including dental surgery).
• The patient should also inform their doctor immediately if they develop a medical condition (called thrombotic thrombocytopenic purpura), characterized by fever and small red or purple spots under the skin (resembling bruises), with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• In case of cuts or injuries, the time it takes for bleeding to stop may be slightly longer than usual. This is due to the way the medicine works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts or injuries, for example, small cuts while shaving. However, if bleeding occurs, the patient should contact their doctor immediately (see section 4 “Possible side effects”).
• 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
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those obtained without a prescription.
Some other medicines may affect the action of Clopidogrel Genoptim and vice versa.
In particular, inform the doctor if the patient is taking:

• medicines that may increase the risk of bleeding, such as:
  • oral anticoagulants, medicines used to inhibit blood clotting,
  • non-steroidal anti-inflammatory drugs (NSAIDs), usually used to treat pain and/or inflammation of muscles or joints,
  • heparin or other injectable medicines used to reduce blood clotting,
  • ticlopidine and other antiplatelet medicines,
  • selective serotonin reuptake inhibitors (SSRIs) (including but not limited to fluoxetine and fluvoxamine), medicines usually used to treat depression,
• omeprazole or esomeprazole, medicines used to treat stomach problems,
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz, a medicine used to treat HIV (human immunodeficiency virus) infection,
• 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 in HIV infection).

Patients who have experienced 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 (not more than 1000 mg within 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 may be taken with or without food.
Pregnancy and breastfeeding
Use of this medicine during pregnancy is not recommended.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.
If the patient becomes pregnant while taking Clopidogrel Genoptim, she should consult her doctor immediately, as use of clopidogrel during pregnancy is not recommended.
This medicine should not be used during breastfeeding.
If the patient is breastfeeding or planning to breastfeed, she should consult her doctor before taking this medicine.
Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
Clopidogrel Genoptim is unlikely to affect the ability to drive or operate machinery.
Clopidogrel Genoptim contains lactose
If the doctor has previously informed the patient of an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. HOW TO USE CLOPIDOGREL GENOPTIM

Clopidogrel Genoptim should always be taken exactly as directed by the physician or
pharmacist. In case of doubt, please consult your 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 dose also applies to patients with a condition known as
"atrial fibrillation" (irregular heartbeat).
If a patient has experienced severe chest pain (unstable angina or heart attack), the physician may
prescribe an initial loading dose of 300 mg of Clopidogrel Genoptim (4 tablets of 75 mg) to be taken
immediately. Afterwards, the recommended dose is one 75 mg tablet of Clopidogrel Genoptim daily,
taken orally (as described above).
Clopidogrel Genoptim should be taken for as long as directed by the physician.
Taking more Clopidogrel Genoptim than recommended
Contact your physician or the nearest emergency department immediately due to increased risk
of bleeding.
Missing a dose of Clopidogrel Genoptim
If a 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 dose at the regular time.
If more than 12 hours have passed, the patient should simply take the next single dose at the
regular time. Do not take a double dose to make up for the missed tablet.
Stopping Clopidogrel Genoptim
Do not stop treatment unless advised by your doctor. Before stopping, consult your physician or
pharmacist.
If you have any doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact the treating physician immediately if the patient experiences:

• fever, signs of infection, or feeling extremely tired. This may be due to a rare reduction in the number of certain blood cells.
• symptoms of liver dysfunction, such as yellowing of the skin and (or) eyes (jaundice), occurring with or without bleeding appearing under the skin as red pinpoint spots and (or) confusion (see section 2 "Warnings and precautions").
• swelling of the lips or skin disorders such as rash and itching, or skin blisters. These may be symptoms of allergic reactions.

The most common adverse reaction reported during treatment with Clopidogrel Genoptim is bleeding.
Bleeding may occur as gastrointestinal bleeding, bruising, haematoma (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. There have also been a small number of reports of bleeding in the eye, brain, lungs, or joints.
If prolonged bleeding occurs while taking Clopidogrel Genoptim
After a cut or injury, 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 cuts or injuries, for example, small cuts during shaving. However, if bleeding occurs, you should contact the treating physician immediately (see section 2 "Warnings and precautions").
Other adverse reactions include:
Common adverse reactions (may affect up to 1 in 10 people): diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon adverse reactions (may affect up to 1 in 100 people): headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, tingling or numbness.
Rare adverse reactions (may affect up to 1 in 1,000 people): vertigo, gynaecomastia in men.
Very rare adverse reactions (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 (e.g. general feeling of warmth with sudden general malaise up to fainting), swelling of the lips, skin blisters, skin allergy, mouth pain (stomatitis), low blood pressure, confusion, hallucinations, joint pain, muscle pain, disturbances or loss of taste.
Adverse reactions with unknown frequency (frequency cannot be estimated from the available data): hypersensitivity reactions with chest pain or abdominal pain, persistent symptoms of low blood sugar.
In addition, the treating physician may detect changes in blood or urine test results.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 2-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. HOW TO STORE CLOPIDOGREL GENOPTIM

This medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)" and on the blister after "EXP". The expiry date refers to the last day of the stated month.
See storage conditions on the cardboard carton.
If Clopidogrel Genoptim is packed in PVC/PE/PVDC/Aluminium blisters, store below 25°C.
If Clopidogrel Genoptim is packed in PA/Aluminium/PVC/Aluminium blisters, there are no special storage instructions.
Do not use this medicine if signs of deterioration are visible.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Clopidogrel Genoptim contains
The active substance is clopidogrel. Each coated tablet contains 75 mg of clopidogrel (as clopidogrel bisulfate).
Other ingredients are:
Tablet core: microcrystalline cellulose, mannitol (E421), hydroxypropylcellulose, crospovidone, monohydrate citric acid, polyethylene glycol 6000, stearic acid, talc.
Tablet coating: hypromellose, lactose monohydrate, iron oxide red (E172), triacetin, titanium dioxide (E171).

What Clopidogrel Genoptim looks like and contents of the pack
Clopidogrel Genoptim coated tablets are pink, round, biconvex tablets. They are packed in cardboard boxes containing 28 or 84 coated tablets in blisters made of PVC/PE/PVDC/Aluminium or in blisters PA/Aluminium/PVC/Aluminium.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Poland

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 Vysoke Myto
Czech Republic
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland

This medicinal product is authorised in the European Economic Area under the following names:
Denmark: Trogran
Poland: Clopidogrel Genoptim
Romania: Trogran 75 mg