Maboclop 75 mg comprimidos recubiertos con pelicula efg

PROSPECTO: INFORMATION FOR THE USER

MABOCLOP 75 mg film-coated tablets EFG

Clopidogrel

Read this prospectus carefully before starting to take the medicine.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

-If you consider that any of the adverse effects you are experiencing are serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

1.What isMABOCLOP 75 mg film-coated tabletsand for what it is used

2.Before takingMABOCLOP 75 mg film-coated tablets

3.How to takeMABOCLOP 75 mg film-coated tablets

4.Possible adverse effects

5.Storage ofMABOCLOP 75 mg film-coated tablets

6.Additional information.

MABOCLOPbelongs to a group of medicines called antiplatelet agents. Platelets are small blood elements smaller than red or white blood cells, and they aggregate when blood clots.Antiplatelet agents, by preventing this aggregation, reduce the likelihood of blood clots (a process called thrombosis) forming.

MABOCLOPis administered to prevent blood clots (thrombi)inblood vessels (arteries) hardened, a process known as atherothrombosis, and which may cause atherothrombotic effects (such as cerebral infarction, myocardial infarction, or death).

You have been prescribedMABOCLOPto help prevent blood clots from forming and reduce the risk of these serious events because:

-You suffer from a process that produces artery hardening (also known as atherothrombosis), and

-You have previously suffered a myocardial infarction, a cerebral infarction, or suffer from a disease called peripheral arterial disease, or

-You have suffered a severe type of 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 possible that your doctor has also prescribed acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clots from forming).

Do not take MABOCLOP

• If you are allergic (hypersensitive) to clopidogrel or to 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 this may affect you, or if you have any doubts, consult your doctor before taking MABOCLOP.

Be especially careful with MABOCLOP

Before starting treatment with MABOCLOP, inform your doctor if you are in any of the following situations:

• If you have a 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 clot in an artery of the brain (ischemic cerebral infarction) in the last 7 days.
• You are using another type of medication (see "Use of other medications").
• You have liver or kidney diseases.

During treatment with MABOCLOP:

• Inform your doctor if you have scheduled surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder that includes fever and hematomas (bruises) 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 "Possible Adverse Effects").
• If you cut or get a wound, bleeding may take longer to stop. This is related to the way the medication works, as it prevents the blood's ability to form clots. For minor cuts or wounds, such as cutting during shaving, this is not a problem.However, if you are concerned about your blood loss, consult your doctor immediately (see section 4 "Possible Adverse Effects").
• Your doctor may ask you to have blood tests.
• Inform your doctor or pharmacist if you observe any adverse effect not mentioned in section 4 "Possible Adverse Effects" of this prospectus or if you observe that some adverse effect worsens.

MABOCLOP should not be administered to children or adolescents.

Use of other medications

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

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

The concomitant administration of MABOCLOP with oral anticoagulants (medications used to reduce blood coagulation) is not recommended.

You must inform your doctor explicitly if you are taking nonsteroidal anti-inflammatory drugs, medications used to treat pain and/or inflammation of muscles or joints, if you are taking heparin, or any other medication used to reduce blood coagulation, 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 to treat HIV infection).

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.

Taking MABOCLOP with food and beverages

MABOCLOP can be taken with and without food.

Pregnancy and breastfeeding

It is preferable not to use this medication during pregnancy and lactation.

If you are pregnant or think you may be, 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 operating machinery

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

Important information about some of the components of MABOCLOP

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

Follow exactly the administration instructions forMABOCLOPprescribed by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

You should takeMABOCLOPfor as long as your doctor continues to prescribe it.

If you take more MABOCLOP than you should

Contact your doctor or go to the nearest hospital emergency department, 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 MABOCLOP

If you forget to take a dose ofMABOCLOP, but remember before 12 hours have passed since the timewhenyou were supposed to take 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 missed dose.

If you interrupt treatment with MABOCLOP

Do not interrupt 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.

Like all medicines,MABOCLOPmay cause side effects, although not everyone will experience 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 especially careful withMABOCLOP”).
• Swelling of the mouth or skin disorders such as hives and itching, blistersonthe skin.Thesemay be signs of an allergic reaction.

The most frequent side effect reported with MABOCLOP(affecting between 1 and 10 patients in every 100)isbleeding.Thebleeding may appearinthe stomach or intestine, 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 MABOCLOP

If you cut or get a wound, it is possible that the bleeding may take a little longer than usualtostop. 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 “Be especially careful withMABOCLOP”).

Other side effects reported with MABOCLOP are:

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

Rare side effects (affecting between 1 and 10 patients in every 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gasinthe stomach or intestine, rashes, itching, dizziness, alteration of sensation.

Rare side effects (affecting between 1 and 10 patients in every 10,000): Dizziness

Very rare side effects (affecting fewer than 1 patient in every 10,000): Jaundice, severe abdominal pain with or without back pain; fever, difficulty breathing,occasionally associated 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; alteration of taste, eosinophilic pneumonia, acquired hemophilia type A.

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

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

Ifyou experience any type ofside effect, consultyour doctor,pharmacistor 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.

Store below30ºC.

Keep out of the reach and sight of children.

Do not useMABOCLOPafter the expiration date that appearsonthe carton andonthe blister pack after CAD. The expiration date is the last day of the month indicated.

Do not useMABOCLOPif you observe any visible sign of deterioration.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging andthe medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and the medicines you no longer need. In this way, you will help protect the environment.

Composition ofMABOCLOP

The active ingredient is clopidogrel. Each coated tabletcontains 75 mg of clopidogrel(as hydrogen sulfate).

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

Appearance of the product and contents of the package

The MABOCLOPtablets arepink, round, and biconvextablets.

Each package contains 28 coated tablets in PVC/PVDC/Aluminum blisters, theblistersare presented in cardboard packages.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821 Coslada

Madrid

Spain

Responsible for manufacturing

Tedec-Meiji Farma, S.A.

Carretera M-300 Km30,500

28802. Alcalá de Henares

Madrid.

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923 Alcorcón. Madrid

This leaflet was approvedinSeptember 2019

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