MABOCLOP 75 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

MABOCLOP 75 mg film-coated tablets EFG

Clopidogrel

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 think any of the side effects that you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

• If you consider that any of the side effects that you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the pack:

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

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

MABOCLOP 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.

MABOCLOP 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 MABOCLOP to help prevent the formation of blood clots and reduce the risk of these serious events because:

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

• You have previously suffered a myocardial infarction, a stroke, or you are suffering 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. Your doctor may also have prescribed acetylsalicylic acid (a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clots).

2. BEFORE TAKING MABOCLOP 75 mg film-coated tablets

Do not take MABOCLOP

• If you are allergic (hypersensitive) to clopidogrel or any of the other components of MABOCLOP.
• 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 MABOCLOP.

Be careful with MABOCLOP

Before starting treatment with MABOCLOP, 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 going 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 stroke) in the last 7 days.
• If you are using other medications (see "Using other medications").
• If you have liver or kidney disease.

During treatment with MABOCLOP:

• Tell your doctor if you are going to have surgery (including dental surgery).
• Tell your doctor immediately if you develop a disorder that includes fever and bruising (bruises) under the skin that can appear as red spots, with or without unexplained extreme fatigue, confusion, yellow color of 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 way the medicine works, 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 MABOCLOP").
• Your doctor may ask you to have blood tests.
• Tell your doctor or pharmacist if you notice any side effect not mentioned in the section 4 of "POSSIBLE SIDE EFFECTS" of this leaflet or if you notice that any side effect worsens.

MABOCLOP should not be given to children or adolescents.

Using other medications

Some medications may affect the use of MABOCLOP or vice versa.

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

It is not recommended to take MABOCLOP with oral anticoagulants (medications used to decrease blood clotting).

You must explicitly inform your doctor if you are taking non-steroidal anti-inflammatory drugs, medications commonly used to treat pain and/or inflammation of muscles or joints, 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., omeprazole) 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 MABOCLOP with food and drinks

MABOCLOP 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 must inform your doctor or pharmacist before taking MABOCLOP. If you become pregnant while taking MABOCLOP, consult your doctor immediately, as it is not recommended to take clopidogrel during pregnancy.

If you are taking MABOCLOP, consult your doctor about breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Important information about some of the ingredients of MABOCLOP

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

3. HOW TO TAKE MABOCLOP

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

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

You will need to take MABOCLOP for as long as your doctor continues to prescribe it.

If you take more MABOCLOP 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 Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested)

If you forget to take MABOCLOP

If you forget to take a dose of MABOCLOP, but remember before 12 hours have passed since 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 MABOCLOP

Do not stop your treatment. Contact your doctor or pharmacist before stopping this medication.

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

4. Possible side effects

Like all medicines, MABOCLOP can cause side effects, although not everybody 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 MABOCLOP").
• 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 MABOCLOP(affecting between 1 and 10 patients in 100) isbleeding. Bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. There have also been reports of a small number of cases of: bleeding from the blood vessels in the eyes, intracranial bleeding, pulmonary or joint bleeding.

If you experience prolonged bleeding while taking MABOCLOP

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 MABOCLOP").

Other side effects reported with MABOCLOP are:

Common side effects (affecting between 1 and 10 patients in 100): Diarrhea, abdominal pain, indigestion, or heartburn.

Uncommon side effects (affecting between 1 and 10 patients in 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 in 10,000): Vertigo

Very rare side effects (affecting less than 1 patient in 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 the available data): Hypersensitivity reactions.

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

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

5. Storage of MABOCLOP 75 mg film-coated tablets

Store below 30°C.

Keep out of the reach and sight of children.

Do not use MABOCLOP after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Place 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 the containers and medications you no longer need. This will help protect the environment.

6. FURTHER INFORMATION

Composition of MABOCLOP

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

The other ingredients 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 pack contents

MABOCLOP tablets are pink, round, and biconvex.

Each pack contains 28 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