Clopidogrel Vir Pharma 75 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
ClopidogrelVir Pharma 75 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
|
Contents of the leaflet:
- What Clopidogrel Vir Pharma is and what it is used for.
- Before taking Clopidogrel Vir Pharma
- How to take Clopidogrel Vir Pharma
- Possible side effects.
- Storage of Clopidogrel Vir Pharma
- 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 blood components smaller than red or white blood cells, and they clump together when blood clots. Antiplatelet medicines prevent this clumping, thereby reducing the likelihood of blood clots forming (a process known as thrombosis).
Clopidogrel Vir Pharma is used to prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, myocardial infarction, or death).
You have been prescribed Clopidogrel Vir Pharma to help prevent blood clots and reduce the risk of these serious events because:
-
you have a condition causing hardening of the arteries (also known as atherothrombosis), and
-
you have previously had a myocardial infarction, a stroke, or you have a condition called peripheral arterial disease
-
you have experienced a severe type of chest pain known as "unstable angina" or "myocardial infarction." For the treatment of this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed you acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clot formation).
2. Before taking Clopidogrel Vir Pharma
Do not take Clopidogrel Vir Pharma
- If you are allergic (hypersensitive) to clopidogrel or to any of the other components of Clopidogrel Vir Pharma.
- If you have active bleeding, such as a stomach ulcer or bleeding in the brain;
- If you have severe liver disease.
If you think any of these may apply to you, or if you have any doubts, consult your doctor before taking Clopidogrel Vir Pharma.
Take special care with Clopidogrel Vir 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 (haemorrhage) because:
- You have a condition that involves a risk of internal bleeding (such as a stomach ulcer).
- You have a blood disorder that predisposes you to internal bleeding (bleeding into tissues, organs, or joints).
- You have recently suffered a serious injury.
- You have recently undergone surgery (including dental surgery).
- You are scheduled to undergo surgery (including dental surgery) within the next seven days.
- If you have had a blood clot in a brain artery (ischaemic stroke) within the last 7 days.
- If you are taking other types of medicines (see “Use of other medicines”).
- If you have liver or kidney disease.
During treatment with Clopidogrel Vir Pharma:
- Inform your doctor if you have a surgical procedure (including dental surgery) scheduled.
- Inform your doctor immediately if you develop a disorder involving fever and bruising (ecchymosis) under the skin, which may appear as localized red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “POSSIBLE ADVERSE EFFECTS”).
- If you cut yourself or sustain a wound, bleeding may take longer than usual to stop. This is related to how the medicine works, as it prevents blood from forming clots. For minor cuts or injuries, such as during shaving, this is not usually a concern. However, if you are worried about blood loss, 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 notice any adverse effects not listed in section 4 “POSSIBLE ADVERSE EFFECTS” of this leaflet, or if you notice that any adverse effect worsens.
Clopidogrel Vir Pharma must not be given to children or adolescents.
Use of other medicines
Some medicines may affect the use of Clopidogrel Vir Pharma or vice versa.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
The concomitant administration of Clopidogrel Vir Pharma with oral anticoagulants (medicines used to reduce blood clotting) is not recommended.
You must explicitly inform your doctor if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), medicines generally used to treat pain and/or inflammation of muscles or joints, or if you are taking heparin, or any other medicine used to reduce blood clotting, or if you are taking a proton pump inhibitor (e.g. omeprazole) for stomach discomfort.
An occasional dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) should not cause any problems, but prolonged use under other circumstances should be discussed with your doctor.
If you have experienced 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 medicines used to relieve pain and reduce fever. An occasional dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) generally should not cause any problems, but prolonged use under other circumstances should be discussed with your doctor.
You must explicitly inform your doctor if you are taking:
- ticlopidine, another antiplatelet agent.
- antiretrovirals (medicines to treat HIV infection).
Taking Clopidogrel Vir Pharma with food and drink
Clopidogrel Vir Pharma may be taken with or without food.
Pregnancy and breastfeeding
It is preferable not to use this medicine during pregnancy or breastfeeding.
If you are pregnant or think you may be pregnant, inform your doctor or pharmacist before taking Clopidogrel Vir Pharma. If you become pregnant while taking Clopidogrel Vir Pharma, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.
If you are taking Clopidogrel Vir Pharma, consult your doctor about breastfeeding.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
It is unlikely that Clopidogrel Vir Pharma will affect your ability to drive or operate machinery.
Important information about some of the components of Clopidogrel Vir Pharma
This medicine may cause stomach discomfort and diarrhoea because it contains hydrogenated castor oil.
3. How to take Clopidogrel Vir Pharma
Follow exactly the instructions for using Clopidogrel Vir Pharma as given by your doctor. If you have any doubts, consult your doctor or pharmacist.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe you a single initial dose of 300 mg of Clopidogrel Vir Pharma (4 tablets of 75 mg). After this, the usual dose is one 75 mg tablet of Clopidogrel Vir Pharma daily, taken orally, with or without food, and at the same time each day.
The usual dose is one 75 mg tablet of Clopidogrel Vir Pharma daily, taken orally, with or without food, and at the same time each 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 department, as there is an increased risk of bleeding.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20 (indicating the medicine and the amount ingested).
If you forget to take Clopidogrel Vir Pharma
If you forget to take a dose of Clopidogrel Vir Pharma but remember within 12 hours of the time you should have taken it, take the tablet immediately and then take the next dose at your usual time.
If you forget for more than 12 hours, simply take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Clopidogrel Vir Pharma
Do not stop your treatment. Contact your doctor or pharmacist before stopping this medicine.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Clopidogrel Vir Pharma can have adverse effects, although not everyone experiences them.
Contact your doctor immediately if you experience:
- Fever, signs of infection, or severe fatigue. These symptoms may be due to a rare reduction in certain blood cells.
- Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red spots and/or confusion (see "Take special care with Clopidogrel Vir Pharma").
- Swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin. These may be signs of an allergic reaction.
The most frequently reported adverse effect with Clopidogrel Vir Pharma (affecting between 1 and 10 out of every 100 patients) is bleeding. Bleeding may occur in the stomach or intestines, bruising, hematomas (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases have also been reported of: bleeding from blood vessels in the eyes, intracranial bleeding, pulmonary bleeding, or bleeding into joints.
If you experience prolonged bleeding while taking Clopidogrel Vir Pharma.
If you cut yourself or sustain a wound, it may take longer than usual for the bleeding to stop. This is related to the mechanism of action of the medicine, as it prevents blood from forming clots. For minor cuts or wounds, such as those occurring during shaving, this is usually not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Take special care with Clopidogrel Vir Pharma").
Other adverse effects reported with Clopidogrel Vir Pharma are:
Frequent adverse effects (affecting between 1 and 10 out of every 100 patients): Diarrhea, abdominal pain, indigestion or heartburn.
Uncommon adverse effects (affecting between 1 and 10 out of every 1,000 patients): headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, skin eruptions, itching, dizziness, altered sensation.
Rare adverse effects (affecting between 1 and 10 out of every 10,000 patients): dizziness.
Very rare adverse effects (affecting fewer than 1 out of every 10,000 patients): 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 mucous membrane of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances, eosinophilic pneumonia, acquired haemophilia A.
Frequency not known: hypersensitivity reactions.
Additionally, your doctor may observe changes in the results of your blood or urine tests.
If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Conservation of Clopidogrel Vir Pharma
Keep out of the reach and sight of children.
Do not use Clopidogrel Vir Pharma after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.
Store below 30°C.
Do not use Clopidogrel Vir Pharma if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Additional Information
Composition of ClopidogrelVir Pharma
The active substance 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 castor oil, and Opadry (hypromellose, titanium dioxide, polyethylene glycol, yellow iron oxide, and red iron oxide).
Appearance of the medicinal product and contents of the pack
Clopidogrel Vir Pharma tablets are pink-colored, round, and biconvex film-coated tablets.
Each pack contains 28, 30, 50, or 84 film-coated tablets packed in PVC/PVDC/aluminum blisters. The blisters are presented in cardboard packaging.
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
- 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/