CLOPIDOGREL MABO 75 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel MABO 75 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

• If you experience any of the side effects, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Contents of the pack:

1. What Clopidogrel MABO 75 mg film-coated tablets are and what they are used for
2. Before you take Clopidogrel MABO 75 mg film-coated tablets
3. How to take Clopidogrel MABO 75 mg film-coated tablets
4. Possible side effects
5. Storage of Clopidogrel MABO 75 mg film-coated tablets
6. Further information.

1. What Clopidogrel MABO 75 mg film-coated tablets are and what they are used for

Clopidogrel MABO 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 chance of blood clots (a process called thrombosis) forming.

Clopidogrel MABO 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 MABO to help prevent the formation of blood clots and reduce the risk of these serious events, since:

• You suffer from a process that causes hardening of the arteries (also called atherothrombosis), and

• You have previously suffered a myocardial infarction, a stroke, or suffer from a disease called peripheral arterial disease, or

• You have suffered a type of severe 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).

2. Before taking Clopidogrel MABO 75 mg film-coated tablets

Do not take Clopidogrel MABO

• If you are allergic (hypersensitive) to clopidogrel or any of the other components of Clopidogrel MABO.
• 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 may apply to you, or if you are in doubt, consult your doctor before taking Clopidogrel MABO.

Be careful with Clopidogrel MABO

Before starting treatment with Clopidogrel MABO, 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) within the next seven days.

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

During treatment with Clopidogrel MABO:

• Inform your doctor if you are scheduled to undergo surgery (including dental surgery).
• Inform 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 unexplained extreme fatigue, confusion, yellow color in the skin or eyes (jaundice) (see section 4 "POSSIBLE SIDE EFFECTS").
• If you cut or injure yourself, the 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 usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Be careful with Clopidogrel MABO").
• Your doctor may ask you to have blood tests.
• Inform your doctor or pharmacist if you notice any side effects not mentioned in section 4 of "POSSIBLE SIDE EFFECTS" of this leaflet or if you notice that any side effect worsens.

Clopidogrel MABO should not be given to children or adolescents.

Using other medications

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

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those obtained without a prescription.

Concomitant administration of Clopidogrel MABO with oral anticoagulants (medications used to decrease blood clotting) is not recommended.

You must explicitly inform your doctor if you are taking non-steroidal anti-inflammatory drugs, medications commonly used to treat pain and/or muscle or joint inflammation, if you are taking heparin, or any other medication used to decrease blood clotting, if you are taking ticlopidine, another antiplatelet agent, or if you are taking a proton pump inhibitor (e.g., omeprazol) for stomach discomfort, antiretrovirals (medications for treating HIV infection).

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 consulted with your doctor.

Taking Clopidogrel MABO with food and drinks

Clopidogrel MABO 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 MABO. If you become pregnant while taking Clopidogrel MABO, consult your doctor immediately, as it is not recommended to take clopidogrel during pregnancy.

If you are taking Clopidogrel MABO, consult your doctor about breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Important information about some of the components of Clopidogrel MABO

This medication may cause stomach discomfort and diarrhea because it contains hydrogenated castor oil.

3. How to take Clopidogrel MABO

Follow the instructions for taking Clopidogrel MABO exactly as indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

If you have suffered severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg of Clopidogrel MABO for you to take once at the start of treatment. After that, the normal dose is one 75 mg tablet of Clopidogrel MABO per day, taken orally, with or without food, and at the same time every day.

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

If you take more Clopidogrel MABO 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 MABO

If you forget to take a dose of Clopidogrel MABO, 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 Clopidogrel MABO

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 MABOcan 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 MABO").
• 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 Clopidogrel MABO(affecting between 1 and 10 patients out of 100) isbleeding. Bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases of bleeding in the blood vessels of the eyes, intracranial bleeding, pulmonary or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel MABO

If you cut or injure yourself, the 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 usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Be careful with Clopidogrel MABO").

Other side effects reported with Clopidogrel MABO are:

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 sense of 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); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; altered taste, eosinophilic pneumonia, acquired hemophilia A.

Side effects of unknown frequency (cannot be estimated from available data: hypersensitivity reactions.

Your doctor may also observe changes in the results of your blood or urine tests.

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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Clopidogrel MABO 75 mg film-coated tablets

Keep below 30°C.

Keep out of the reach and sight of children.

Do not use Clopidogrel MABO after the expiration date that appears on the carton and blister after EXP. The expiration date is the last day of the month indicated.

Do not use Clopidogrel MABO if you notice any visible signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Clopidogrel MABO

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

The other components 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

Clopidogrel MABO tablets are pink, round, and biconvex.

Each pack contains 28, 50, and 84 film-coated tablets packaged in PVC/PVDC/Aluminum blisters, which are presented in cardboard boxes.

Marketing authorization holder and manufacturer

Marketing authorization holder

MABO-FARMA S.A.

Vía de los Poblados 3,

Building 6, 28033, Madrid,

Spain.

Manufacturer

Tedec-Meiji Farma, S.A.

Carretera M-300 Km 30,500

1. Alcalá de Henares

Madrid.

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923 Alcorcón. Madrid

This leaflet was approved in September 2019.

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