Maboclop 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

MABOCLOP 75 mg film-coated tablets EFG

Clopidogrel

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 and must not be given to other people, even if

they have the same symptoms, as it may harm them.

• If you consider any of the side effects you experience to be severe, or if you notice any

side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What MABOCLOP 75 mg film-coated tablets are and what they are used for
2. Before taking MABOCLOP 75 mg film-coated tablets
3. How to take MABOCLOP 75 mg film-coated tablets
4. Possible side effects
5. How to store 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 platelet aggregation inhibitors. Platelets are blood components smaller than red or white blood cells, and they clump together when blood clots. Platelet aggregation inhibitors reduce the possibility of blood clots forming (a process known as thrombosis) by preventing this clumping.

MABOCLOP is given to prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, myocardial infarction, or death).

You have been prescribed MABOCLOP 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 myocardial infarction, stroke, or you have a disease called peripheral arterial disease, or

• You have experienced a type of severe chest pain known as “unstable angina” or “myocardial infarction.” 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 clot formation).

2. BEFORE TAKING MABOCLOP 75 mg FILM-COATED TABLETS

Do not take MABOCLOP

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

Take special care 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 (haemorrhage) because:

• You have a disease that involves a risk of internal bleeding (such as a stomach ulcer).

• You have a blood disorder that makes you prone 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 MABOCLOP:

• Inform your doctor if you have a surgical procedure scheduled (including dental surgery).
• Inform your doctor immediately if you develop a disorder involving fever and bruising (bruises) under the skin, which may appear as small red spots, with or without unexplained extreme fatigue, confusion, or 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 how the medicine works, as it prevents blood from forming clots. For minor cuts or wounds, such as those occurring during shaving, this is not usually a concern. 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 effects worsen.

MABOCLOP must not be administered to children or adolescents.

Use of other medicines

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

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

The concomitant administration of MABOCLOP 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 MABOCLOP with food and drinks

MABOCLOP 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 MABOCLOP. If you become pregnant while taking MABOCLOP, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

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

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

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

Important information about some of the components of MABOCLOP

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

3. How to TAKE MABOCLOP

Follow exactly the administration instructions for MABOCLOP 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 300 mg dose of MABOCLOP at the beginning of treatment. Afterwards, the usual dose is one 75 mg MABOCLOP tablet daily, taken orally, with or without food, and at the same time each day.

You should continue taking MABOCLOP for as long as your doctor prescribes it.

If you take more MABOCLOP 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 MABOCLOP

If you forget to take a dose of MABOCLOP 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 interrupt treatment with 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, MABOCLOP 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 MABOCLOP").
• 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 MABOCLOP (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, 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 MABOCLOP

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 those occurring during 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 MABOCLOP").

Other adverse effects reported with MABOCLOP include:

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, pruritus, dizziness, disturbances in touch sensation.

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 mucous membrane of the mouth (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances, eosinophilic pneumonia, acquired haemophilia type A.

Adverse effects with unknown frequency (cannot be estimated from available data): hypersensitivity reactions.

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

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 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 expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of MABOCLOP

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, 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 medicinal product and contents of the pack

MABOCLOP tablets are pink-colored, round, and biconvex film-coated tablets.

Each pack contains 28 film-coated tablets packed in PVC/PVDC/Aluminum blisters. The blisters are presented in cardboard packaging.

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/