Clopidogrel Viso Farmacéutica 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clopidogrel Viso Farmacéutica 75 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Clopidogrel Viso Farmacéutica is and what it is used for
2. What you need to know before taking Clopidogrel Viso Farmacéutica
3. How to take Clopidogrel Viso Farmacéutica
4. Possible side effects
5. How to store Clopidogrel Viso Farmacéutica
6. Contents of the pack and other information

1. What Clopidogrel Viso Farmacéutica is and what it is used for

Clopidogrel Viso Farmacéutica contains clopidogrel and belongs to a group of medicines called platelet aggregation inhibitors. Platelets are very small cells present in the blood that clump together when blood clots. Platelet aggregation inhibitors prevent this clumping, thereby reducing the likelihood of blood clots (a process known as thrombosis).

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

You have been prescribed clopidogrel 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 atherosclerosis), 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” (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 clot formation).
• You have experienced symptoms of a stroke that resolve within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also prescribe acetylsalicylic acid starting within the first 24 hours.
• You have irregular heartbeats, a condition called "atrial fibrillation", and you cannot take medicines known as “oral anticoagulants” (vitamin K antagonists) to prevent new clots from forming or existing clots from growing. You should be aware that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of clopidogrel and acetylsalicylic acid for this condition. Your doctor should have prescribed clopidogrel plus acetylsalicylic acid only if you cannot take “oral anticoagulants” and you have no risk of severe bleeding.

2. What you need to know before taking Clopidogrel Viso Farmacéutica

Do not take Clopidogrel Viso Farmacéutica

• If you are allergic to clopidogrel or to any of the other ingredients of this medicine (listed in section 6);
• If you have a medical condition causing active bleeding, such as a stomach ulcer or bleeding in the brain;
• If you have severe liver disease.

If you think any of these apply to you, or if you have any doubts, consult your doctor before taking Clopidogrel Viso Farmacéutica.

Warnings and precautions

If you are in any of the following situations, inform your doctor before taking Clopidogrel Viso Farmacéutica:

• If you are at risk of 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 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 have liver or kidney disease.

• If you have had an allergic reaction or hypersensitivity to any medication used to treat your condition.

• If you have a history of non-traumatic intracranial haemorrhage.

During treatment with Clopidogrel Viso Farmacéutica:

• Inform your doctor if you have scheduled surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bruises) under the skin which may appear as localized red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible side 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 from shaving, this is not usually a concern. However, if you are concerned about blood loss, consult your doctor immediately (see section 4 “Possible side effects”).
• Your doctor may request blood tests.

Children and adolescents

Clopidogrel Viso Farmacéutica must not be given to children or adolescents.

Other medicines and Clopidogrel Viso Farmacéutica

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

You must specifically inform your doctor if you are taking:

• Medicines that may increase the risk of bleeding, such as:
  • Oral anticoagulants, medicines used to reduce blood clotting,
  • Non-steroidal anti-inflammatory drugs (NSAIDs), medicines generally used to treat pain and/or inflammation of muscles or joints,
  • Heparin, or any other injectable medicine used to reduce blood clotting,
  • Ticlopidine, or other antiplatelet agents,
  • A selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines generally used to treat depression,
  • Rifampicin (used for serious infections),
  • Omeprazole or esomeprazole, medicines used to treat stomach discomfort,
  • Fluconazole or voriconazole, medicines used to treat fungal infections,
  • Efavirenz, or other antiretroviral medicines (used to treat HIV infection),
  • Moclobemide, a medicine used to treat depression,
  • Carbamazepine, a medicine used to treat certain forms of epilepsy,
  • Repaglinide, a medicine used to treat diabetes,
  • Paclitaxel, a medicine used to treat cancer,
  • Opioids: if you are being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),
  • Rosuvastatin (used to reduce cholesterol levels).

If you have experienced severe chest pain (unstable angina or myocardial infarction), transient ischaemic attack, or mild ischaemic stroke, you should be prescribed Clopidogrel Viso Farmacéutica in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. A single dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) should not cause problems, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Viso Farmacéutica with food and drink

Clopidogrel Viso Farmacéutica can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy or breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

You must not breastfeed while taking this medicine.

If you are breastfeeding or plan to breastfeed, inform your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Clopidogrel Viso Farmacéutica contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Clopidogrel Viso Farmacéutica

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose, including for patients with a condition called “atrial fibrillation” (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Viso Farmacéutica daily, taken orally with or without food, at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe an initial dose of 300 mg or 600 mg of clopidogrel (4 or 8 tablets of 75 mg) once at the beginning of treatment. After that, the recommended dose is one 75 mg clopidogrel tablet daily.

If you have experienced symptoms of a stroke that disappear within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe an initial dose of 300 mg of Clopidogrel Viso Farmacéutica (4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg tablet of Clopidogrel Viso Farmacéutica daily, as described above, together with acetylsalicylic acid for 3 weeks. After this period, your doctor will prescribe either Clopidogrel Viso Farmacéutica alone or acetylsalicylic acid alone.

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

If you take more Clopidogrel Viso Farmacéutica 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 medicine and the amount ingested).

If you forget to take Clopidogrel Viso Farmacéutica

If you forget to take a dose of clopidogrel but remember within 12 hours of the time you should have taken it, take the tablet immediately and 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 Viso Farmacéutica

Do not stop your treatment unless instructed by your doctor. Contact your doctor or pharmacist before stopping this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause 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 reduction 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 section 2 Warnings and precautions).
• 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 Viso Farmacéutica is bleeding.

Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases have also been reported: bleeding from blood vessels in the eyes, intracranial, pulmonary or joint bleeding.

If you experience prolonged bleeding while taking Clopidogrel Viso Farmacéutica

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

Other adverse effects include:

Frequent adverse effects (affect more than 1 in 10 patients):

Diarrhoea, abdominal pain, indigestion or heartburn.

Uncommon adverse effects (affect more than 1 in 100 patients):

Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rashes, pruritus, dizziness, tingling and numbness.

Rare adverse effects (affect more than 1 in 1,000 patients):

Dizziness, breast enlargement in men.

Very rare adverse effects (affect less 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; changes in taste or loss of taste.

Adverse effects with frequency not known (cannot be estimated from available data):

Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

In addition, your doctor may observe changes in your blood or urine test results.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Clopidogrel Viso Farmacéutica

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

See storage conditions on the packaging.

Store below 25 °C.

Do not use this medicine 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 containers at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clopidogrel Viso Farmacéutica

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

• The other components are:

Tablet core: microcrystalline cellulose (E460), mannitol (E421), hydroxypropylcellulose (E463), crospovidone (E1202), citric acid monohydrate (E330), macrogol 6000 (E1521), stearic acid (E570), talc (E553b)

Tablet coating: hypromellose (E464), lactose monohydrate, iron oxide red (E172), triacetin (E1518), titanium dioxide (E171).

Appearance of the product and contents of the pack

Clopidogrel Viso Farmacéutica tablets are pink, round, biconvex, film-coated tablets. They are supplied in PVC/PE/PVDC/Aluminum blisters packed in cardboard containers containing:

14, 28, 30, 50, 56, 84, 90, 98, 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Pharmathen S.A

6 Dervenakion

Pallini Attiki

15351 Greece

Alternative Manufacturer:

Pharmathen International S.A.

Industrial Park Sapes

Rodopi Prefecture

Block No 5, Rodopi

69300, Greece

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Clopidogrel Pharmaten

Italy: CLOPIDOGREL Doc Generici

Spain: Clopidogrel Viso Farmacéutica 75 mg film-coated tablets EFG

United Kingdom (Northern Ireland): Clopidogrel 75 mg film-coated tablets

Date of the most recent review of this leaflet: November 2023

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