PROSPECTO: INFORMATION FOR THE USER

ClopidogrelVir Pharma75 mg film-coated tablets

ClopidogrelVir Pharmabelongs to a group of medications known as antiplatelet agents. Platelets are the smallest elements of blood, smaller than red or white blood cells, and they aggregate when blood coagulates. Antiplatelet agents, by preventing this aggregation, reduce the likelihood of blood clots (a process known as thrombosis) forming.

ClopidogrelVir Pharmais administered to prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can cause atherothrombotic effects (such as cerebral infarction, myocardial infarction, or death).

You have been prescribed ClopidogrelVir Pharmato help prevent blood clots from forming and reduce the risk of these serious events because:

• you suffer from a process that causes artery hardening (also known as atherothrombosis), and

• you have previously experienced a myocardial infarction, a cerebral infarction, or suffer from a condition known as peripheral arterial disease

• you have experienced severe 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 obstructed or narrowed artery to restore adequate blood flow. It is possible that your doctor has also prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and reduce fever, as well as to prevent blood clots from forming),

Do not take ClopidogrelVir Pharma

• If you are allergic (hypersensitive) to clopidogrel or to any of the other components of Clopidogrel Vir Pharma.
• 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 this may affect you, or if you have any doubts, consult your doctor before taking ClopidogrelVir Pharma.

Be especially careful with ClopidogrelVir Pharma

Before starting treatment with ClopidogrelVir Pharmainform your doctor if you are in any of the following situations:

• If you have a 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 suffered a severe injury.
  • You have recently undergone surgery (including dental surgery).
  • You are scheduled to undergo surgery (including dental surgery) in the next seven days.
• If you have had a clot in an artery of the brain (ischemic cerebral infarction) in the last 7 days.
• If you are using another type of medication (see “Use of other medications”).
• If you have liver or kidney diseases.

During treatment with ClopidogrelVir Pharma:

• Inform your doctor if you have a scheduled surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder that includes fever and hematomas (bruises) under the skin that may appear as localized red spots, accompanied or not by extreme fatigue, confusion, yellow color in the skin or eyes (jaundice) (see section 4 “Possible Adverse Effects”).
• If you cut or get a wound, bleeding may take longer to stop. This is related to the way the medication works, as it prevents the blood from forming clots. For minor cuts or wounds, such as cutting during shaving, this is not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 4 “Possible Adverse Effects”).
• Your doctor may ask you to have blood tests.
• Inform your doctor or pharmacist if you observe any adverse effect not mentioned in section 4 of “Possible Adverse Effects” of this prospectus or if you observe that some adverse effect worsens.

ClopidogrelVir Pharmashould not be administered to children or adolescents.

Use of other medications

Some medications may affect the use of ClopidogrelVir Pharmaor vice versa.

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

The concomitant administration of ClopidogrelVir Pharmawith oral anticoagulants (medications used to reduce blood coagulation) is not recommended.

You must inform your doctor explicitly if you are taking nonsteroidal anti-inflammatory drugs, medications used to treat pain and/or inflammation of muscles or joints, or if you are taking heparin, or any other medication used to reduce blood coagulation, or if you are taking a proton pump inhibitor (e.g. omeprazole) for stomach discomfort.

A dose of acetylsalicylic acid administered sporadically (not exceeding 1,000 mg in 24 hours) should not cause any problems, but prolonged use in other circumstances should be consulted with your doctor.

If you have suffered severe chest pain (unstable angina or myocardial infarction), you may have been prescribed Clopidogrel Vir Pharma in combination with acetylsalicylic acid, a substance present in many medications used to relieve pain and reduce fever. A dose of acetylsalicylic acid administered sporadically (not exceeding 1,000 mg in 24 hours) should generally not cause any problems, but prolonged use in other circumstances should be consulted with your doctor.

You must inform your doctor explicitly if you are taking:

• ticlopidine, another antiplatelet agent.
• antiretrovirals (medications used to treat HIV infection).

Taking ClopidogrelVir Pharmawith food and drinks

ClopidogrelVir Pharmacan be taken with and without food.

Pregnancy and breastfeeding

It is preferable not to use this medication during pregnancy and breastfeeding.

If you are pregnant or think you may be, you must inform your doctor or pharmacist before taking ClopidogrelVir PharmaIf you become pregnant while taking ClopidogrelVir Pharma, consult your doctor immediately since clopidogrel is not recommended during pregnancy.

If you are taking ClopidogrelVir Pharma, consult your doctor about breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

It is unlikely that ClopidogrelVir Pharmawill alter your ability to drive or operate machinery.

Important information about some of the components of ClopidogrelVir Pharma.

This medication may cause stomach discomfort and diarrhea because it contains hydrogenated ricin oil.

Follow exactly the administration instructions for Clopidogrel Vir Pharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you have experienced severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg of Clopidogrel Vir Pharma (4 tablets of 75 mg) to be taken once at the beginning of treatment. After that, the normal dose is one 75 mg tablet of Clopidogrel Vir Pharma per day, taken orally, with or without food, and at the same time every day.

The normal dose is one 75 mg tablet of Clopidogrel Vir Pharma per day, taken orally, with or without food, and at the same time every day.

You should take Clopidogrel Vir Pharma for as long as your doctor continues to prescribe it.

If you take more Clopidogrel Vir Pharma than you should

Contact your doctor or go to the nearest hospital emergency service, as there is a higher risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested)

If you forgot to take Clopidogrel Vir Pharma

If you forget to take a dose of Clopidogrel Vir Pharma, but remember before 12 hours have passed since the time when 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 compensate for the missed dose.

If you interrupt treatment with Clopidogrel Vir Pharma

Do not interrupt your treatment. Contact your doctor or pharmacist before stopping this medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, ClopidogrelVir Pharmamay have side effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

• Fever, signs of infection, or severe 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 “Be especially careful with ClopidogrelVir Pharma”).
• Swelling of the mouth or skin disorders such as hives and itching, blisters on the skin. These may be signs of an allergic reaction.

The most frequent side effect reported with ClopidogrelVir Pharma(affecting between 1 and 10 patients in every 100)is bleeding. Bleeding may appear in the stomach or intestine, bruises, hematomas (abnormal bleeding or bruises under the skin), nasal bleeding, blood in urine. Also, a reduced number of cases of: bleeding of the blood vessels of the eyes, intracranial, pulmonary, or joint bleeding have been reported.

If you experience prolonged bleeding while taking ClopidogrelVir Pharma.

If you cut or get a wound, it is possible that bleeding may take a little longer than usual to stop. This is related to the mechanism of action of the medication, as it prevents the blood's ability to form clots. For minor cuts or wounds, such as cutting during shaving, this usually does not matter. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Be especially careful with ClopidogrelVir Pharma”).

Other side effects reported with ClopidogrelVir Pharmaare:

Frequent side effects (affecting between 1 and 10 patients in every 100): Diarrhea, abdominal pain, indigestion, or heartburn.

Infrequent side effects (affecting between 1 and 10 patients in every 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestine, rashes, itching, dizziness, altered sensation.

Rare side effects (affecting between 1 and 10 patients in every 10,000): Dizziness

Very rare side effects (affecting fewer than 1 patient in every 10,000): Jaundice, severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions; swelling of the mouth; blisterson the skin, skin allergy; inflammation of the mucous membrane of the mouth (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; altered taste, eosinophilic pneumonia, acquired hemophilia A.

Unknown frequency: Hypersensitivity reactions

Your doctor may also observe changes in your blood or urine test results.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication

Keep out of reach and sight of children.

Do not use ClopidogrelVir Pharmaafter the expiration date that appears on the carton and on the blister after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Do not use ClopidogrelVir Pharmaif you observe any visible sign of deterioration.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Clopidogrel Composition Vir Pharma

The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulfate)

The other components are: Microcrystalline cellulose, mannitol (E421), hydroxypropyl cellulose, anhydrous colloidal silica, polyethylene glycol, hydrogenated ricin oil, and opadry (hypromellose, titanium dioxide, polyethylene glycol, yellow iron oxide, and red iron oxide).

Product Appearance and Packaging Contents

Clopidogrel Vir Pharma tablets are pink, round, and biconvex tablets.

Each package contains 28, 30, 50, or 84 film-coated tablets in PVC/PVDC/Aluminum blisters, which are presented in cardboard boxes.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-68-70. Polígono Industrial Urtinsa II.

28923 (Alcorcón) Madrid

Spain

Responsible Manufacturer:

Tedec-Meiji Farma, S.A

Carretera M-300 Km 30,500

28802. Alcalá de Henares

Madrid

Spain

and

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial URTINSA II.

28923 (Alcorcón) Madrid

Spain

This leaflet was approved in May 2024.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/