CLOPIDOGREL PHARMA COMBIX 75 mg FILM-COATED TABLETS

Introduction

Prospect: Information for the user

Clopidogrel Pharma Combix75 mg film-coated tabletsEFG

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of the prospectus

1. What is Clopidogrel Pharma Combix and what is it used for
2. What you need to know before taking Clopidogrel Pharma Combix
3. How to take Clopidogrel Pharma Combix
4. Possible adverse effects
5. Storage of Clopidogrel Pharma Combix
6. Package contents and additional information

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

Clopidogrel Pharma Combix belongs to a group of medications called antiplatelet agents. Platelets are very small cells found in the blood, and they aggregate when the blood coagulates. Antiplatelet agents, by preventing this aggregation, reduce the possibility of blood clots forming (a process called thrombosis).

Clopidogrel Pharma Combix is administered to prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can cause atherothrombotic events (such as cerebral infarction, myocardial infarction, or death).

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

• You suffer from a process that causes hardening of the arteries (also called arteriosclerosis), and
• You have previously suffered a myocardial infarction, a cerebral infarction, or suffer from a disease called peripheral arterial disease, or
• You have suffered a severe type of 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 also possible that your doctor has prescribed acetylsalicylic acid (a substance present in many medications used to relieve pain and lower fever, as well as to prevent blood clots),
• You have an irregular heartbeat, a disease called "atrial fibrillation", and you cannot take medications known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new clots and prevent the growth of existing clots. You will have been told that "oral anticoagulants" are more effective than acetylsalicylic acid or the combined use of clopidogrel and acetylsalicylic acid for this disease. Your doctor will have prescribed clopidogrel plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a risk of severe 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 any of the other components of this medication (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 affect you, or if you have any doubts, consult your doctor before taking Clopidogrel Pharma Combix:

Warnings and precautions

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

• 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 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 blood clot in an artery of the brain (ischemic cerebral infarction) in the last 7 days.
• If you have liver or kidney disease.

During treatment with Clopidogrel Pharma Combix:

• Tell your doctor if you are scheduled to undergo surgery (including dental surgery).
• Tell 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 that can appear as red spots, accompanied or not by unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4).
• If you cut or injure yourself, bleeding may take longer than usual to stop. This is related to the way the medication works, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cutting yourself while shaving, this is not important. However, if you are concerned about your bleeding, consult your doctor immediately (see section 4).
• Your doctor may ask you to have blood tests.

Children and adolescents

Clopidogrel Pharma Combix should not be administered to children or adolescents.

Use of Clopidogrel Pharma Combix with other medications

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

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

You must explicitly inform your doctor if you are taking:

• oral anticoagulants, medications used to decrease blood coagulation,
• non-steroidal anti-inflammatory medications, medications used to treat pain and/or muscle or joint inflammation,
• heparin, or any other injectable medication used to decrease blood coagulation,
• omeprazole, esomeprazole, or cimetidine, medications to treat stomach discomfort,
• fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medications to treat bacterial and fungal infections,
• fluoxetine, fluvoxamine, or moclobemide, medications to treat depression,
• carbamazepine or oxcarbazepine, medications to treat some forms of epilepsy,
• ticlopidine, another antiplatelet agent,
• antiretrovirals (medications to treat HIV infection).

If you have suffered 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 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.

Use of Clopidogrel Pharma Combix with food and beverages

Clopidogrel Pharma Combix can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medication during pregnancy.

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

You should not breastfeed while taking this medication.

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

Consult your doctor or pharmacist before using any medication.

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

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

3. How to take Clopidogrel Pharma Combix

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

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

If you take more Clopidogrel Pharma Combix than 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 Toxicology Information Service, phone 91 562 04 20, indicating 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 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 missed dose.

If you interrupt treatment with Clopidogrel Pharma Combix

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

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

4. Possible adverse effects

Like all medications, Clopidogrel Pharma Combix can have adverse effects, although not all people experience them.

The frequency of possible adverse effects 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 less than 1 in 10,000 patients)
• frequency unknown (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 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 section 2 "Warnings and precautions").
• 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 adverse effect reported with Clopidogrel Pharma Combixis bleeding. Bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A reduced number of cases of bleeding in the blood vessels of the eyes, intracranial bleeding, pulmonary bleeding, or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel Pharma Combix

If you cut or injure yourself, 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 injuries, such as cutting yourself while shaving, this is not important. 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: diarrhea, abdominal pain, indigestion, or heartburn.

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

Rare adverse effects: vertigo.

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

Frequency unknown: hypersensitivity reactions.

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

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Clopidogrel Pharma Combix

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use Clopidogrel Pharma Combix if you observe any visible signs of deterioration.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Clopidogrel Pharma Combix

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

• 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 package contents

Clopidogrel Pharma Combix 75 mg film-coated tablets are pale pink, round, with beveled edges, smooth on both sides.

Aluminum/Aluminum blisters with desiccant.

Clopidogrel Pharma Combix is available in packages of 28, 50, and 84 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 last revision of this prospectus:June 2019

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