Clopidogrel Pharma Combix 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clopidogrel Pharma Combix 75 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Clopidogrel Pharma Combix is and what it is used for
2. What you need to know before taking Clopidogrel Pharma Combix
3. How to take Clopidogrel Pharma Combix
4. Possible side effects
5. How to store Clopidogrel Pharma Combix
6. Contents of the pack and other information

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

Clopidogrel Pharma Combix belongs to a group of medicines called antiplatelet agents. Platelets are very small blood cells that clump together when blood clots. Antiplatelet medicines prevent this clumping, thereby reducing the likelihood of blood clots (a process known as thrombosis).

Clopidogrel Pharma Combix is given 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, heart attack, or death).

You have been prescribed Clopidogrel Pharma Combix 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 atherosclerosis), and
• you have previously had a heart attack, stroke, or you have a disease called peripheral arterial disease, or
• you have experienced a severe type of chest pain known as “unstable angina” or “heart attack.” 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, reduce fever, and prevent blood clot formation),
• you have an irregular heartbeat, a condition called “atrial fibrillation,” and you cannot take medicines known as “oral anticoagulants” (vitamin K antagonists), which prevent the formation of new clots and stop existing clots from growing. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of clopidogrel and acetylsalicylic acid for this condition. Your doctor will have prescribed clopidogrel plus acetylsalicylic acid if you cannot take “oral anticoagulants” and do not have a high risk of serious bleeding.

2. What you need to know before taking Clopidogrel Pharma Combix

Do not take Clopidogrel Pharma Combix

• if you are allergic to clopidogrel or to any of the other ingredients of this medicine (listed in section 6).
• 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 Pharma Combix:

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Clopidogrel Pharma Combix

• If you are at risk of bleeding because:

• You have a disease that involves a risk of internal bleeding (such as a stomach ulcer).

• You have a blood disorder that makes you prone 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 have liver or kidney disease.

While taking Clopidogrel Pharma Combix:

• Inform your doctor if you have scheduled surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bruises) under the skin which may appear as localized red spots, with or without unexplained extreme tiredness, confusion, or yellowing of the skin or eyes (jaundice) (see section 4).
• If you cut yourself or sustain an injury, 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 shaving cuts, this is not significant. However, if you are concerned about blood loss, consult your doctor immediately (see section 4).
• Your doctor may ask you to have blood tests.

Children and adolescents

Clopidogrel Pharma Combix must not be given to children or adolescents.

Taking Clopidogrel Pharma Combix with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may affect the use of Clopidogrel Pharma Combix, or vice versa.

You must specifically inform your doctor if you are taking:

• oral anticoagulants, medicines used to reduce blood clotting,
• non-steroidal anti-inflammatory drugs (NSAIDs), medicines generally used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medicine used to reduce blood clotting,
• omeprazole, esomeprazole, or cimetidine, medicines used to treat stomach discomfort,
• fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines used to treat bacterial and fungal infections,
• fluoxetine, fluvoxamine, or moclobemide, medicines used to treat depression,
• carbamazepine or oxcarbazepine, medicines used to treat certain forms of epilepsy,
• ticlopidine, another antiplatelet agent,
• antiretrovirals (medicines used to treat HIV infection).

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

Taking Clopidogrel Pharma Combix with food and drink

Clopidogrel Pharma Combix can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine, as clopidogrel is not recommended during pregnancy.

You must not breastfeed while taking this medicine.

If you are breastfeeding or plan to breastfeed, inform your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is unlikely that Clopidogrel Pharma Combix will affect your ability to drive or operate machinery.

Clopidogrel Pharma Combix contains Allura Red and Orange Yellow S.

This medicine may cause allergic reactions because it contains Allura Red and Orange Yellow S.

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Clopidogrel Pharma Combix

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

If you have suffered from severe chest pain (unstable angina or heart attack), your doctor may prescribe a single initial dose of 300 mg of Clopidogrel Pharma Combix (4 tablets of 75 mg). After this, the usual dose is one 75 mg tablet of Clopidogrel Pharma Combix daily, taken orally, with or without food, at the same time each day.

You should continue taking Clopidogrel Pharma Combix for as long as your doctor prescribes it.

If you take more Clopidogrel Pharma Combix 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 91 562 04 20, stating the medication and the amount ingested.

If you forget to take Clopidogrel Pharma Combix

If you forget to take a dose of Clopidogrel Pharma Combix but remember within 12 hours of the time you were supposed to take it, take the tablet immediately and then take the next dose 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 missed dose.

If you stop taking Clopidogrel Pharma Combix

Do not stop your treatment unless your doctor tells you to. Contact your doctor or pharmacist before stopping this medicine.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Clopidogrel Pharma Combix can have adverse effects, although not everyone experiences them.

The frequency of possible adverse effects listed below is defined using the following convention:

• very common (may affect more than 1 in 10 patients)
• common (may affect between 1 and 10 in 100 patients)
• uncommon (may affect between 1 and 10 in 1,000 patients)
• rare (may affect between 1 and 10 in 10,000 patients)
• very rare (may affect fewer than 1 in 10,000 patients)
• frequency not known (cannot be estimated from available data)

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 section 2 “Warnings and precautions”).
• 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 Pharma Combix is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (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 joint bleeding.

If you experience prolonged bleeding while taking Clopidogrel Pharma Combix

If you cut yourself or sustain a wound, bleeding may take slightly longer than usual to stop. This is related to the mechanism of action of the medicine, as it prevents blood from forming clots. For minor cuts or injuries, 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 “Warnings and precautions”).

Other adverse effects reported with Clopidogrel Pharma Combix are:

Common adverse effects: diarrhoea, abdominal pain, indigestion or heartburn.

Uncommon adverse effects: headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, skin rashes, itching, dizziness, tingling and numbness.

Rare adverse effects: vertigo.

Very rare adverse effects: eosinophilic pneumonia; acquired haemophilia A; 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); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste.

Frequency not known: hypersensitivity reactions.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Pharma Combix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use Clopidogrel Pharma Combix 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 the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Clopidogrel Pharma Combix

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

• The other components (excipients) are: butylhydroxyanisole (E320), butylhydroxytoluene (E321), mannitol (E421), crospovidone, polyethylene glycol (E1521), microcrystalline cellulose (E460i), sodium stearyl fumarate, coating agent [hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), talc (E553b), orange yellow S (E110), Allura Red AC (E129)].

Appearance of the product and contents of the pack

Clopidogrel Pharma Combix 75 mg film-coated tablets are pale pink, round, bevelled-edge tablets, smooth on both sides.

Aluminium/Aluminium blisters with desiccant.

Clopidogrel Pharma Combix is available in packs containing 28, 50 and 84 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d’activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of the most recent review of this leaflet: June 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) www.aemps.gob.es.