CLOPIDOGREL 75 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Clopidogrel Aurovitas, 75 mg, Coated Tablets
   1. Before Taking the Medication, Read the Contents of the Leaflet, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
3. What is Clopidogrel Aurovitas and what is it used for
4. Important information before taking Clopidogrel Aurovitas
   1. When not to take Clopidogrel Aurovitas:
   2. Warnings and precautions
   3. Children and adolescents
   4. Clopidogrel Aurovitas and other medications
   5. Clopidogrel Aurovitas with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Clopidogrel Aurovitas contains lactose
   9. Clopidogrel Aurovitas contains hydrogenated castor oil
5. How to take Clopidogrel Aurovitas
   1. Taking a higher dose of Clopidogrel Aurovitas than recommended
   2. Missing a dose of Clopidogrel Aurovitas
   3. Stopping treatment with Clopidogrel Aurovitas
6. Possible side effects
   1. The patient should immediately contact their doctor if they experience:
   2. The most common side effect reported during treatment with clopidogrel is
   3. If prolonged bleeding occurs while taking Clopidogrel Aurovitas
   4. Other side effects include:
   5. Reporting side effects
7. How to store Clopidogrel Aurovitas
8. Contents of the pack and other information
   1. What Clopidogrel Aurovitas contains
   2. What Clopidogrel Aurovitas looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer/Importer:
   6. This medication is authorized in the Member States of the European Economic Area under the following names:
   7. Clopidogrel Aurovitas is authorized in the following countries:
   8. Date of last revision of the leaflet: 08/2023

Package Leaflet: Information for the Patient

Clopidogrel Aurovitas, 75 mg, Coated Tablets

Clopidogrel

Before Taking the Medication, Read the Contents of the Leaflet, as it Contains Important Information for the Patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Clopidogrel Aurovitas and what is it used for

Clopidogrel Aurovitas contains clopidogrel and belongs to a group of medications called antiplatelet agents. Platelets are very small structures in the blood that clump together during blood clotting. By preventing this clumping, antiplatelet agents reduce the risk of blood clots (a process called thrombosis). Clopidogrel Aurovitas is used in adult patients to prevent the formation of blood clots in hardened, atherosclerotic blood vessels (arteries) that can lead to atherosclerotic events (such as stroke, heart attack, or death). Clopidogrel Aurovitas 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 effective blood flow. The doctor may also prescribe acetylsalicylic acid (a substance found in many medications, used to relieve pain and reduce fever, as well as to prevent blood clotting).
• The patient has had symptoms of a stroke that resolve quickly (called a transient ischemic attack) or a mild ischemic stroke. The doctor may also prescribe acetylsalicylic acid within the first 24 hours.
• The patient has an irregular heartbeat, known as "atrial fibrillation," and the patient cannot take medications called "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new blood clots and the growth of existing ones.

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

2. Important information before taking Clopidogrel Aurovitas

When not to take Clopidogrel Aurovitas:

• if the patient is hypersensitive (allergic) to clopidogrel or any of the other ingredients of this medication (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 thinks they may be affected by any of these conditions or has any other doubts, they should consult their doctor before taking Clopidogrel Aurovitas.

Warnings and precautions

If any of the following situations apply to the patient, they should discuss it with their doctor, pharmacist, or nurse before starting Clopidogrel Aurovitas:

• if there is a risk of bleeding, such as:
• a condition that increases the risk of internal bleeding (such as a stomach ulcer).
• a blood disorder that predisposes to internal bleeding (bleeding into tissues, organs, or joints).
• 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 medication used to treat this condition.
• if the patient has had a non-traumatic brain hemorrhage in the past.

During treatment with Clopidogrel Aurovitas:

• 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 or TTP), characterized by fever and purple spots on the skin, which may appear with or without unexplained extreme fatigue, confusion, jaundice (yellowing of the skin and eyes), or other symptoms (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 medication works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts and injuries, such as cuts while shaving. Nevertheless, if bleeding occurs, the patient should immediately contact their doctor (see section 2 "Warnings and precautions").
• The doctor may order blood tests.

Children and adolescents

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

Clopidogrel Aurovitas and other medications

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

• medications that may increase the risk of bleeding, such as:
• oral anticoagulants, medications used to prevent blood clotting,
• non-steroidal anti-inflammatory medications, usually used to treat painful and/or inflammatory conditions of muscles or joints,
• heparin or other injectable medications used to reduce blood clotting,
• ticlopidine or other antiplatelet agents,
• selective serotonin reuptake inhibitors (including fluoxetine and fluvoxamine), medications usually used to treat depression,
• rifampicin (used to treat severe infections),
• omeprazole or esomeprazole, medications used to treat stomach disorders,
• fluconazole or voriconazole, medications used to treat fungal infections,
• efavirenz or other antiretroviral medications (used to treat HIV infection),
• carbamazepine, a medication used to treat certain types of epilepsy,
• moclobemide, a medication used to treat depression,
• repaglinide, a medication used to treat diabetes,
• paclitaxel, a medication used to treat cancer,
• opioids: during treatment with clopidogrel, the patient should inform their doctor before prescribing any opioid (medications used to treat severe pain),
• rosuvastatin (used to lower cholesterol levels).

Patients who have had severe chest pain (unstable angina or heart attack) may be prescribed Clopidogrel Aurovitas in combination with acetylsalicylic acid, a substance found in many medications, 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 Aurovitas with food and drink

Clopidogrel Aurovitas can be taken with or without food.

Pregnancy and breastfeeding

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

Driving and using machines

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

Clopidogrel Aurovitas contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medication.

Clopidogrel Aurovitas contains hydrogenated castor oil

This may cause indigestion or diarrhea.

3. How to take Clopidogrel Aurovitas

This medication should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted. The recommended dose of Clopidogrel Aurovitas 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 Clopidogrel Aurovitas (4 or 8 tablets of 75 mg). Then, the recommended dose of Clopidogrel Aurovitas is one 75 mg tablet per day (as above). If the patient has had symptoms of a stroke that resolve quickly (also known as a transient ischemic attack) or a mild ischemic stroke, the doctor may prescribe a single dose of 300 mg of Clopidogrel Aurovitas (4 tablets of 75 mg) at the start of treatment. Then, the recommended dose is one Clopidogrel Aurovitas tablet, 75 mg per day, as described above, with acetylsalicylic acid for 3 weeks. Then, the doctor may prescribe clopidogrel or acetylsalicylic acid separately. Clopidogrel Aurovitas should be taken for as long as prescribed by the doctor.

Taking a higher dose of Clopidogrel Aurovitas than recommended

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

Missing a dose of Clopidogrel Aurovitas

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

Stopping treatment with Clopidogrel Aurovitas

The patient should not stop treatment unless their doctor advises them to do so.Before stopping treatment, the patient should contact their doctor or pharmacist. If the patient has any further doubts about taking this medication, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Clopidogrel Aurovitas 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 caused by a rare decrease in the number of certain blood cells.
• symptoms of liver dysfunction, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding, which may appear with or without unexplained extreme fatigue, confusion, or other symptoms (see section 2 "Warnings and precautions").
• swelling of the mouth or skin disorders, such as rashes and itching, blisters. These may be symptoms of an allergic reaction.

The most common side effect reported during treatment with clopidogrel 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 Aurovitas

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 medication works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts and injuries, such as cuts while shaving. Nevertheless, if bleeding occurs, the patient should immediately contact their doctor (see section 2 "Warnings and precautions").

Other side effects include:

Frequent side effects (in no more than 1 in 10 people):
Diarrhea, stomach pain, indigestion, or heartburn.
Uncommon side effects (in no more than 1 in 100 people):
Headache, stomach ulcers, vomiting, nausea, constipation, gas in the stomach or intestines, rashes, itching, dizziness, tingling or numbness.
Rare side effects (in no more than 1 in 1,000 people):
Vertigo of labyrinthine origin, breast enlargement in men.
Very rare side effects (in no more than 1 in 10,000 people):
Jaundice, severe stomach 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 malaise up to fainting); swelling of the mouth; blistering skin; skin allergy; oral mucositis (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disorders or loss of taste.
Side effects of unknown frequency (frequency cannot be estimated from 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 or pharmacist. 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, phone: +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 medication.

5. How to store Clopidogrel Aurovitas

The medication should be stored out of sight and reach of children. This medication should not be used after the expiration date stated on the carton and blister after: EXP. The expiration date refers to the last day of the specified month. Store at a temperature below 30°C. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Clopidogrel Aurovitas contains

• The active substance of the medication is clopidogrel. Each coated tablet contains 97.875 mg of clopidogrel hydrogen sulfate (equivalent to 75 mg of clopidogrel).
• Other ingredients are: Core:microcrystalline cellulose (grade 113), mannitol, low-substituted hydroxypropylcellulose (grade 21 and grade 11), crospovidone (type A), macrogol 6000, hydrogenated castor oil. Coating:lactose monohydrate, hypromellose 2910/15 cp, titanium dioxide (E 171), triacetin, iron oxide red (E 172).

What Clopidogrel Aurovitas looks like and contents of the pack

Coated tablet. Pink, round, biconvex coated tablets with beveled edges, with "E" embossed on one side and "34" on the other. Clopidogrel Aurovitas, 75 mg, coated tablets are available in blisters in a cardboard box. Pack sizes: Blisters: 28, 30, 56, 60, 84, 90, 98, 100, 112, 120, and 180 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Ltd. HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta Generis Farmacêutica, S.A. Rua João de Deus 19, Venda Nova 2700-487 Amadora Portugal

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

Clopidogrel Aurovitas is authorized in the following countries:

Belgium: Clopidogrel AB 75 mg film-coated tablets / coated tablets / film tablets Poland: Clopidogrel Aurovitas Portugal: Clopidogrel Generis

Date of last revision of the leaflet: 08/2023