Clopidogrel Mabo 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel MABO 75 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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 it may harm them.
• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Clopidogrel MABO 75 mg film-coated tablets is and what it is 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. How to store 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 blood components smaller than red or white blood cells, and they clump together when blood clots. Antiplatelet medicines prevent this clumping, thereby reducing the likelihood of blood clots forming (a process known as thrombosis).

Clopidogrel MABO is used to help prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a condition known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

Your doctor has prescribed Clopidogrel MABO 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 atherothrombosis), and

• You have previously had a heart attack, a stroke, or you have a condition 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 and reduce 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 to any of the other components of Clopidogrel MABO.
• 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 MABO.

Take special care 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 (haemorrhage) 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 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 are taking other types of medicines (see “Use of other medicines”).

• If you have liver or kidney disease.

During treatment with Clopidogrel MABO:

• Inform your doctor if you have scheduled surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder including fever and bruising (bruises) under the skin which may appear as localized red spots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 “POSSIBLE ADVERSE EFFECTS”).
• If you cut yourself or sustain a wound, bleeding may take longer than usual to stop. This is related to the way the medicine works, as it reduces the blood’s ability to form clots. For minor cuts or wounds, such as those occurring during shaving, this is not significant. However, if you are concerned about blood loss, consult your doctor immediately (see section 4 “POSSIBLE ADVERSE EFFECTS”).
• Your doctor may request blood tests.
• Inform your doctor or pharmacist if you notice any adverse effects not listed in section 4 “POSSIBLE ADVERSE EFFECTS” of this leaflet, or if you notice that any adverse effect worsens.

Clopidogrel MABO must not be given to children or adolescents.

Use of other medicines

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

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

The concomitant administration of Clopidogrel MABO with oral anticoagulants (medicines used to reduce blood clotting) is not recommended.

You must specifically inform your doctor if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), medicines generally used to treat pain and/or inflammation of muscles or joints, if you are taking heparin, or any other medicine used to reduce 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, or antiretrovirals (medicines to treat HIV infection).

An occasional dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) should not cause any problems, but prolonged use under other circumstances should be discussed with your doctor.

Taking Clopidogrel MABO with food and drink

Clopidogrel MABO can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to use this medicine during pregnancy and breastfeeding.

If you are pregnant or think you may be pregnant, you must inform your doctor or pharmacist before taking Clopidogrel MABO. If you become pregnant while taking Clopidogrel MABO, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

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

Consult your doctor or pharmacist before using any medicine.

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 medicine may cause stomach discomfort and diarrhoea because it contains hydrogenated castor oil.

3. How to TAKE Clopidogrel MABO

Follow exactly the administration instructions for Clopidogrel MABO given by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe a single initial dose of 300 mg of Clopidogrel MABO. Afterwards, the usual dose is one 75 mg Clopidogrel MABO tablet per day, taken orally, with or without food, at the same time each 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 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 telephone number 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 within 12 hours of the scheduled time, 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 MABO

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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Clopidogrel MABO may have adverse effects, although not everyone experiences 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 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 “Take special care with Clopidogrel MABO”).
• 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 MABO (affecting between 1 and 10 out of every 100 patients) is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, or blood in the urine. A small number of cases have also been reported of: bleeding from blood vessels in the eyes, intracranial bleeding, pulmonary bleeding, or bleeding into joints.

If you experience prolonged bleeding while taking Clopidogrel MABO

If you cut yourself or sustain a wound, it may take longer than usual for the bleeding to stop. This is related to the mechanism of action of the medicine, as it prevents blood from forming clots. For minor cuts or wounds, such as cutting yourself while shaving, this is usually not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Take special care with Clopidogrel MABO”).

Other adverse effects reported with Clopidogrel MABO are:

Frequent adverse effects (affecting between 1 and 10 out of every 100 patients): Diarrhoea, abdominal pain, indigestion or heartburn.

Uncommon adverse effects (affecting between 1 and 10 out of every 1,000 patients): headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, skin rashes, itching, dizziness, altered sense of touch.

Rare adverse effects (affecting between 1 and 10 out of every 10,000 patients): vertigo.

Very rare adverse effects (affecting fewer than 1 in 10,000 patients): 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 haemophilia type A.

Adverse effects with 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 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 MABO 75 mg film-coated tablets

Store below 30°C.

Keep out of the reach and sight of children.

Do not use Clopidogrel MABO after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection 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. ADDITIONAL INFORMATION

Composition of Clopidogrel MABO

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

The other components are: microcrystalline cellulose, mannitol (E421), hydroxypropyl cellulose, anhydrous colloidal silica, polyethylene glycol, hydrogenated castor oil, and Opadry (hypromellose, titanium dioxide, polyethylene glycol, yellow iron oxide, and red iron oxide).

Appearance of the medicinal product and contents of the container

Clopidogrel MABO tablets are pink-colored, round, biconvex tablets.

Each pack contains 28, 50, or 84 film-coated tablets, packed in PVC/PVDC/Aluminum blisters. The blisters are presented in cardboard packs.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/