CLOPIDOGREL VIR PHARMA 75 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

ClopidogrelVir Pharma75 mg film-coated tablets EFG

Contents of the pack:

1. What Clopidogrel Vir Pharma is and what it is used for.
2. Before taking Clopidogrel Vir Pharma.
3. How to take Clopidogrel Vir Pharma.
4. Possible side effects.
5. Storage of Clopidogrel Vir Pharma.
6. Further information.

1. What Clopidogrel Vir Pharma is and what it is used for

Clopidogrel Vir Pharma belongs to a group of medicines called antiplatelet agents. Platelets are small elements in the blood that are smaller than red or white blood cells, and they clump together when the blood clots. Antiplatelet agents prevent this clumping, reducing the risk of blood clots (a process called thrombosis).

Clopidogrel Vir Pharma is given to prevent the formation of blood clots (thrombi) in blood vessels (arteries) that have become hardened, a process known as atherothrombosis, which can cause atherothrombotic events (such as stroke, myocardial infarction, or death).

You have been prescribed Clopidogrel Vir Pharma to help prevent the formation of blood clots and reduce the risk of these serious events because:

• you have a condition that causes hardening of the arteries (also known as atherothrombosis), and

• you have previously had a myocardial infarction, a stroke, or suffer from a disease called peripheral arterial disease.

• you have had a severe type of chest pain, known as "unstable angina" or "myocardial infarction". For the treatment of this disease, your doctor may have placed a stent in the obstructed or narrowed artery to restore adequate blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance present in many medications used to relieve pain and lower fever, as well as to prevent blood clots),

2. Before taking Clopidogrel Vir Pharma

Do not take ClopidogrelVir Pharma

• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients 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 any of these apply to you, or if you are unsure, consult your doctor before taking Clopidogrel Vir Pharma.

Be careful with ClopidogrelVir Pharma

Before starting treatment with Clopidogrel Vir Pharma, inform your doctor if you are in any of the following situations:

• if you are at 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 had a serious 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 blood clot in an artery of the brain (ischemic stroke) in the last 7 days.
• if you are using other medications (see "Using other medications").
• if you have liver or kidney disease.

During treatment with Clopidogrel Vir Pharma:

• tell your doctor if you are scheduled to have surgery (including dental surgery).
• tell your doctor immediately if you develop a disorder that includes fever and bruising (bruises) under the skin that can appear as red spots, accompanied or not by extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "POSSIBLE SIDE EFFECTS")
• if you cut or injure yourself, the bleeding may take a little longer to stop. This is related to the way the medicine works, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cutting yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Be careful with Clopidogrel Vir Pharma").
• your doctor may ask you to have blood tests.
• tell your doctor or pharmacist if you notice any side effects not mentioned in this leaflet or if you notice that any side effect gets worse.

Clopidogrel Vir Pharma should not be given to children or adolescents.

Using other medications

Some medications may affect the use of Clopidogrel Vir Pharma or vice versa.

tell your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

it is not recommended to take Clopidogrel Vir Pharma with oral anticoagulants (medications used to decrease blood clotting).

you must explicitly inform your doctor if you are taking non-steroidal anti-inflammatory drugs, medications commonly used to treat pain and/or inflammation of muscles or joints, or if you are taking heparin, or any other medication used to decrease blood clotting or if you are taking a proton pump inhibitor (e.g., omeprazole) for stomach upset.

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

if you have had 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 lower fever. A dose of acetylsalicylic acid administered occasionally (not exceeding 1,000 mg in 24 hours) should not cause any problems, but prolonged use in other circumstances should be discussed with your doctor.

you must explicitly inform your doctor if you are taking:

• ticlopidine, another antiplatelet agent.
• antiretrovirals (medications for treating HIV infection).

Taking ClopidogrelVir Pharmawith food and drinks

Clopidogrel Vir Pharma can be taken with or 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 pregnant, you should inform your doctor or pharmacist before taking Clopidogrel Vir Pharma. If you become pregnant while taking Clopidogrel Vir Pharma, consult your doctor immediately, as it is not recommended to take clopidogrel during pregnancy.

if you are taking Clopidogrel Vir Pharma, consult your doctor about breastfeeding.

consult your doctor or pharmacist before using any medication.

Driving and using machines

it is unlikely that Clopidogrel Vir Pharma will affect your ability to drive or use machines.

Important information about some of the ingredients of ClopidogrelVir Pharma.

this medication may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

3. How to take Clopidogrel Vir Pharma

follow the instructions for taking Clopidogrel Vir Pharma exactly as indicated by your doctor. consult your doctor or pharmacist if you have any doubts.

if you have had 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 start of treatment. afterwards, the usual 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 usual 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 ClopidogrelVir Pharmathan you should

contact your doctor or go to the emergency department of the nearest hospital, as there is a greater 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 forget to take ClopidogrelVir Pharma.

if you forget to take a dose of Clopidogrel Vir Pharma, but remember before 12 hours have passed since the time 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 make up for the forgotten dose.

If you stop taking ClopidogrelVir Pharma

do not stop 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.

4. Possible side effects

like all medications, Clopidogrel Vir Pharma can have side effects, although not everyone gets 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 careful with Clopidogrel Vir Pharma").
• swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin. these can be signs of an allergic reaction.

The most common side effect reported with ClopidogrelVir Pharma(affecting between 1 and 10 patients out of 100) is bleeding. bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in the urine. a small number of cases of bleeding from the blood vessels of the eyes, intracranial bleeding, pulmonary or joint bleeding have also been reported.

If you experience prolonged bleeding while taking ClopidogrelVir Pharma.

if you cut or injure yourself, the bleeding may take a little longer 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 injuries, such as cutting yourself while shaving, this is usually not a problem. however, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Be careful with Clopidogrel Vir Pharma").

Other side effects reported with ClopidogrelVir Pharmaare:

common side effects (affecting between 1 and 10 patients out of 100): diarrhea, abdominal pain, indigestion or heartburn.

uncommon side effects (affecting between 1 and 10 patients out of 1,000): headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine, rash, itching, dizziness, altered touch.

rare side effects (affecting between 1 and 10 patients out of 10,000): vertigo

very rare side effects (affecting less than 1 patient out of 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; blisters on the skin, skin allergy; inflammation of the mouth mucosa (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; altered taste, eosinophilic pneumonia, acquired hemophilia A.

frequency unknown: hypersensitivity reactions

in addition, your doctor may observe changes in the results of your blood or urine tests.

if you think any of the side effects you are suffering from is serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting 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 Pharmacovigilance System for Human Use Medicines: www.notificaram.es. by reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Clopidogrel Vir Pharma

keep out of the reach and sight of children.

do not use Clopidogrel Vir Pharma after the expiration date that appears on the carton and blister after EXP. the expiration date is the last day of the month indicated.

store below 30°C.

do not use Clopidogrel Vir Pharma if you observe any visible signs of deterioration.

medications should not be thrown down the drain or into the trash. deposit the containers and medications you no longer need in the SIGRE collection point at the pharmacy. if you have any doubts, ask your pharmacist how to dispose of the containers and medications you no longer need. this way, you will help protect the environment.

6. Further information

Composition of ClopidogrelVir Pharma

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

the other ingredients are: microcrystalline cellulose, mannitol (E421), hydroxypropyl cellulose, colloidal anhydrous silica, polyethylene glycol, hydrogenated castor oil, and opadry (hypromellose, titanium dioxide, polyethylene glycol, yellow iron oxide, and red iron oxide).

Appearance of the product and packaging contents

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

each pack contains 28, 30, 50, or 84 film-coated tablets, packaged in PVC/PVDC/aluminum blisters, which are presented in cardboard boxes.

Marketing authorization holder and manufacturer

marketing authorization holder:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923 (Alcorcón) Madrid

Spain

manufacturer:

Tedec-Meiji Farma, S.A

Carretera M-300 Km 30,500

1. 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.

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