CLOPIDIX 75 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Clopidix, 75 mg, film-coated tablets
   1. You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Clopidix and what is it used for
4. Important information before taking Clopidix
   1. When not to take Clopidix:
   2. Warnings and precautions:
   3. While taking Clopidix:
   4. Children and adolescents:
   5. Clopidix and other medicines:
   6. Clopidix with food and drink
   7. Pregnancy and breastfeeding:
   8. Driving and using machines
   9. Clopidix contains lactose
   10. Clopidix contains soybean oil
5. How to take Clopidix
   1. Taking a higher dose of Clopidix than recommended
   2. Missing a dose of Clopidix:
   3. Stopping treatment with Clopidix
6. Possible side effects
   1. If prolonged bleeding occurs while taking Clopidix
   2. Reporting side effects
7. How to store Clopidix
8. Contents of the packaging and other information
   1. What Clopidix contains
   2. What Clopidix looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet accompanying the packaging: information for the user

Clopidix, 75 mg, film-coated tablets

Clopidogrel

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Clopidix and what is it used for

Clopidix contains clopidogrel and belongs to a group of medicines called antiplatelet medicines. Platelets are very small bodies in the blood that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the risk of blood clots (a process called thrombosis). Clopidix is used in adults to prevent the formation of blood clots (thrombi) in hardened, atherosclerotic blood vessels (arteries) that can lead to atherosclerotic events such as stroke, heart attack, or death. Clopidix is prescribed to prevent blood clots and reduce the risk of these serious events because the patient has atherosclerotic disease (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 effective blood flow. The doctor may also prescribe acetylsalicylic acid (a substance found in many medicines, used to relieve pain and reduce fever, as well as to prevent blood clotting).

• the patient has atherosclerotic disease (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 effective blood flow. The doctor may also prescribe acetylsalicylic acid (a substance found 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), which prevent the formation of new and the growth of existing blood clots.

Blood. The doctor should inform the patient that oral anticoagulants are more effective in such cases than acetylsalicylic acid or the simultaneous use of acetylsalicylic acid with Clopidix. In the absence of the possibility of using oral anticoagulants and the absence of a risk of severe bleeding, the doctor should prescribe Clopidix with acetylsalicylic acid.

2. Important information before taking Clopidix

When not to take Clopidix:

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

If the patient believes that any of these disorders apply to them or has any other doubts, they should consult their doctor before taking Clopidix.

Warnings and precautions:

If any of the situations listed below apply to the patient, they should inform their doctor before taking Clopidix:

• if there is a risk of bleeding, such as:
• a condition that causes a risk of internal bleeding (e.g. stomach ulcer),
• a blood disorder that predisposes to internal bleeding (bleeding into tissues, organs, or joints of the body),
• a recent severe injury,
• a recent surgical procedure (including dental surgery),
• a planned surgical procedure (including dental surgery) 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;
• if the patient has had a non-traumatic brain hemorrhage in the past.

While taking Clopidix:

• The patient should inform their doctor if they are planning to have surgery (including dental surgery).
• The patient should also immediately inform their doctor if they experience a condition (called thrombotic thrombocytopenic purpura, TTP), characterized by fever and subcutaneous bleeding spots with a red, punctate appearance, with or without unexplained extreme fatigue, disorientation, jaundice (yellowing of the skin or eyes), (see section 4 "Possible side effects").
• In the event of a cut or injury, the time it takes for the bleeding to stop may be slightly longer than usual. This is related to the way the medicine works, as it prevents the formation of blood clots. This usually does not cause problems with minor cuts and injuries, e.g. cuts while shaving. Nevertheless, in the event of bleeding, the patient should immediately contact their doctor (see section 4 "Possible side effects").

Blood. The doctor may order blood tests.

• The doctor may order blood tests.

Children and adolescents:

This medicine should not be used in children, as it does not have a therapeutic effect in this group of patients.

Clopidix and other medicines:

The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription. Some other medicines may affect the action of Clopidix 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 inhibit the blood clotting process,
• non-steroidal anti-inflammatory medicines, usually used to treat painful and/or inflammatory conditions of the muscles or joints,
• heparin or other medicines given by injection, used to reduce blood clotting,
• ticlopidine and other antiplatelet medicines,
• selective serotonin reuptake inhibitors (including, but not limited to, fluoxetine or fluvoxamine), medicines usually used to treat depression,
• rifampicin (used to treat severe infections),
• omeprazole or esomeprazole, medicines used to treat stomach disorders,
• 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 types of epilepsy,
• moclobemide, a medicine used to treat depression,
• repaglinide, a medicine used to treat diabetes,
• paclitaxel, a medicine used to treat cancer,
• opioids: during treatment with clopidogrel, the patient should inform their doctor before prescribing any opioid (medicines used to treat severe pain),
• rosuvastatin (a medicine used to reduce cholesterol levels).

Patients who have had severe chest pain (unstable angina or heart attack) may be prescribed Clopidix in combination with acetylsalicylic acid, a substance found 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 prolonged use in other circumstances should be discussed with the doctor.

Clopidix with food and drink

Clopidix can be taken with or without food.

Pregnancy and breastfeeding:

The use of this medicine is not recommended during pregnancy. If the patient is pregnant or thinks they may be pregnant, or is planning to have a baby, they should consult their doctor or pharmacist before taking Clopidix. If the patient becomes pregnant while taking Clopidix, 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

Clopidix should not affect the patient's ability to drive or use machines.

Clopidix contains lactose

If the patient has been diagnosed with an intolerance to some sugars (e.g. lactose), they should contact their doctor before taking the medicine.

Clopidix contains soybean oil

The medicine contains soybean oil. It should not be used in case of a known hypersensitivity to peanuts or soy.

3. How to take Clopidix

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The recommended dose of Clopidix is 75 mg per day, taken orally at the same time every 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 or 600 mg of Clopidix (4 or 8 tablets of 75 mg). Then, the recommended dose of Clopidix is one 75 mg tablet per day (as above). Clopidix should be taken for as long as the doctor recommends.

Taking a higher dose of Clopidix than recommended

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

Missing a dose of Clopidix:

If the patient forgets to take a dose of Clopidix, but remembers within 12 hours of the time they usually take it, they should take the tablet immediately, and the next tablet should be taken 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 Clopidix

Treatment should not be stopped unless the doctor recommends it. Before stopping the medicine, the patient should contact their doctor or pharmacist. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Clopidix 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 dysfunction, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding, which appears under the skin in the form of red, punctate spots and/or disorientation (see section 2 "Warnings and precautions");
• swelling of the lips or skin disorders, such as rashes and itching, blisters. This may be a sign of an allergic reaction. The most common side effect reported during treatment with Clopidix 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, brain, lungs, or joints.

If prolonged bleeding occurs while taking Clopidix

In the event of a cut or injury, the time it takes for the bleeding to stop may be slightly longer than usual. This is related to the way the medicine works, as it prevents the formation of blood clots. This usually does not cause problems with minor cuts and injuries, e.g. 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 reported during treatment with clopidogrel include: Common(may affect 1 to 10 patients): diarrhea, stomach pain, indigestion or heartburn. Uncommon(may affect 1 to 100 patients): headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rashes, itching, dizziness, feeling of numbness or tingling. Rare(may affect 1 to 1000 patients): vertigo of labyrinthine origin, gynecomastia in men. Very rare(may affect 1 in 10,000 patients): jaundice, severe stomach pain with or without back pain, fever, difficulty breathing, sometimes accompanied by cough, generalized allergic reactions (e.g. general feeling of heat with sudden general malaise up to fainting), swelling of the lips, blisters, skin allergy, oral mucosa inflammation (stomatitis), low blood pressure, disorientation, hallucinations, joint pain, muscle pain, taste disorders or loss of taste. Frequency not known(frequency cannot be estimated from the available data): hypersensitivity reactions with chest pain or stomach pain, persistent symptoms of low blood sugar. Additionally, changes in blood or urine test results may occur.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Clopidix

Store in a place inaccessible and invisible to children. Do not use Clopidix after the expiry date stated on the carton and blister. Store at a temperature not exceeding 25°C, protect from moisture. 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 packaging and other information

What Clopidix contains

The active substance of Clopidix is clopidogrel. Each tablet contains 75 mg of clopidogrel (in the form of hydrogen sulfate). The other ingredients are: in the tablet core: stearic acid, hydrogenated vegetable oil, gelatinized starch 1500, colloidal silica anhydrous, mannitol 200SD, in the Opadry II White coating: hypromellose, lactose monohydrate, macrogol 3350, titanium dioxide, triacetin.

What Clopidix looks like and what the pack contains

Clopidix 75 mg tablets are film-coated, round, biconvex, with a smooth surface, without spots or damage, white to cream-colored. The blisters (OPA/Aluminum/PVC/Aluminum) are packed together with the leaflet in a cardboard box. The pack contains 28 film-coated tablets.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd., ul. Ostrzykowizna 14 A, 05-170 Zakroczym, tel.: +(48) (22) 785 27 60, fax: +(48) (22) 785 27 60 ext. 106

Date of last revision of the leaflet:

• 26.09.2023