Patient Information

Clopidogrel Pharma Combix75 mg Film-Coated Tablets

Read this 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 onlyand should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

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

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

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

• you suffer from a process that produces the hardening of the arteries (also known as arteriosclerosis), and
• you have previously suffered a myocardial infarction, a cerebral infarction, or suffer from a disease known as peripheral arterial disease, or
• you have suffered a severe chest pain, known as “unstable angina” or “myocardial infarction”. Your doctor may have 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),
• you have an irregular heartbeat, a disease known as “atrial fibrillation”, and 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 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 has prescribed clopidogrel in combination with acetylsalicylic acid if you cannot take “oral anticoagulants” and do not have a high risk of severe bleeding.

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 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 this 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 suffered 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.

• You have had a blood clot in an artery of the brain (ischemic cerebral infarction) in the last 7 days.
• You have liver or kidney diseases.

During treatment with 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 bruises (hematomas) 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).
• If you cut or get a wound, bleeding may take longer than usual 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).
• 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

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

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

You must inform your doctor explicitly if you are taking:

• oral anticoagulants, medications used to reduce blood clotting,
• non-steroidal anti-inflammatory medications, medications used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medication used to reduce blood clotting,
• 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 reduce fever. 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.

Use of Clopidogrel Pharma Combix with food and drinks

Clopidogrel Pharma Combix can be taken with and without food.

Pregnancy and breastfeeding

It is preferable not to take this medication during pregnancy.

If you are pregnant or breastfeeding, or think you may be 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 do so, inform your doctor before taking this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Clopidogrel Pharma Combix contains red iron oxide and yellow iron oxide S.

This medication may cause allergic reactions because it contains red iron oxide and yellow iron oxide S.

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

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

If you have experienced severe chest pain (unstable 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 beginning of treatment. Afterwards, the usual dose is one 75 mg Clopidogrel Pharma Combix tablet per day, taken 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 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 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 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 Pharma Combix

Do not stop your treatment unless your doctor tells you to.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 medicines, Clopidogrel Pharma Combix may cause side effects, although not everyone will experience them.

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

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.
• Symptoms 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 hives and itching, blisters on the skin. These may be signs of an allergic reaction.

The most frequent side effect reported with Clopidogrel Pharma Combixisbleeding. Bleeding can occurinthe stomach or intestines, bruises, hematomas (abnormal bleeding or bruises under the skin), nasal bleeding, bloodinurine. 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 Clopidogrel Pharma Combix

If you cut or get a wound, it is possible that bleeding may take a little longer than normaltostop. 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 “Warnings and precautions”).

Other side effects reported with Clopidogrel Pharma Combix are:

Common side effects: diarrhea, abdominal pain, indigestion, or heartburn.

Uncommon side effects: headache, stomach ulcer, vomiting, nausea, constipation, excessive gasinthe stomach or intestines, rashes, itching, dizziness, numbness and tingling.

Rare side effects: vertigo.

Very rare side effects: eosinophilic pneumonia; acquired hemophilia A; jaundice, severe abdominal pain with or without back pain; fever, difficulty breathing,occasionallyassociated with cough; generalized allergic reactions; swelling of the mouth; blistersonthe skin, skin allergy; inflammation of the mucous membrane of the mouth (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in the taste of things.

Unknown frequency: hypersensitivity reactions.

Your doctor may also observe changesinyour blood or urine test results.

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 Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sightand reachof children.

Do notuse this medicationafter the expiration date that appearsonthepackage after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Do not useClopidogrel Pharma Combixif you observe any visible sign of deterioration.

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

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 stearate fumarate, coating agent [hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), talc (E553b), yellow-orange S (E110), Red Allura AC (E129)].

Appearance of the product and content of the container

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

Aluminum/Aluminum blisters with desiccant.

Clopidogrel Pharma Combix is presented in containers of 28, 50, and 84 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: June 2019

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