CLOPIDOGREL VISO FARMACÉUTICA 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Clopidogrel Viso Farmacéutica 75 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Clopidogrel Viso Farmacéutica and what is it 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. Storage of Clopidogrel Viso Farmacéutica
6. Package Contents and Additional Information

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

Clopidogrel Viso Farmacéutica contains clopidogrel and belongs to a group of medications called antiplatelet agents. Platelets are very small cells found in the blood, and they aggregate when the blood clots. Antiplatelet agents, by preventing this aggregation, reduce the likelihood of blood clots (a process called thrombosis) forming.

Clopidogrel is administered 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 clopidogrel to help prevent the formation of blood clots and reduce the risk of these serious events because:

• You suffer from a process that causes the hardening of the arteries (also called atherosclerosis), and
• You have previously suffered a myocardial infarction, stroke, or suffer from 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 disease, your doctor may need to place a stent in the obstructed or narrowed artery to restore adequate blood flow. It is also possible that your doctor has prescribed acetylsalicylic acid (a substance present in many medications used to relieve pain and lower fever, as well as to prevent blood clots).
• You have experienced symptoms of a stroke that disappear in a short period (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer acetylsalicylic acid from the first 24 hours.
• You have irregular heartbeats, a disease called "atrial fibrillation", and you cannot take medications known as "oral anticoagulants" (vitamin K antagonists) that prevent new clots from forming, from the formation of new ones to the prevention of the growth of existing ones. You should know that "oral anticoagulants" are more effective than acetylsalicylic acid or the combined use of clopidogrel and acetylsalicylic acid for this condition. Your doctor should have prescribed clopidogrel plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a 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 any of the other components of this medication (listed in section 6);
• If you have a medical condition that is causing 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 affect 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 situations described below, inform your doctor before taking Clopidogrel Viso Farmacéutica:

• 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 severe 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 clot in an artery of the brain (ischemic stroke) in the last 7 days.
• If you have liver or kidney disease.
• If you have had an allergy or reaction to any medication used to treat your disease
• If you have had a history of non-traumatic cerebral hemorrhage.

During treatment with Clopidogrel Viso Farmacéutica:

• Tell your doctor if you are scheduled to undergo 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 that can appear as localized red spots, with or without unexplained extreme fatigue, confusion, yellow color in the skin or eyes (jaundice) (see section 4 "Possible side effects").
• If you cut or injure yourself, the bleeding may take longer than usual 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 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 Clopidogrel Viso Farmacéutica").
• Your doctor may ask you to have blood tests.

Children and Adolescents

Clopidogrel Viso Farmacéutica should not be administered to children or adolescents.

Other Medications and Clopidogrel Viso Farmacéutica

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

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

You must explicitly inform your doctor if you are taking:

• medications that may increase the risk of bleeding, such as
• • oral anticoagulants, medications used to decrease blood clotting,
  • non-steroidal anti-inflammatory drugs, medications used to treat pain and/or inflammation of muscles or joints,
  • heparin, or any other injectable medication used to decrease blood clotting,
  • ticlopidine, or other antiplatelet agents,
  • a selective serotonin reuptake inhibitor (which includes but is not limited to fluoxetine or fluvoxamine), medications that are generally used to treat depression,
  • rifampicin (used for severe infections)
  • omeprazole or esomeprazole, medications to treat stomach discomfort,
  • fluconazole or voriconazole, medications to treat fungal infections.
  • efavirenz, or other antiretroviral medications (used for the treatment of HIV infections),
  • moclobemide, medication to treat depression,
  • carbamazepine, medication to treat some forms of epilepsy,
  • repaglinide, medication to treat diabetes,
  • paclitaxel, medication to treat cancer.
  • opioids: if you are being treated with clopidogrel, you must inform your doctor before any opioid (used to treat severe pain) is prescribed to you.
  • rosuvastatin (used to reduce cholesterol levels).

If you have experienced severe chest pain (unstable angina or myocardial infarction), transient ischemic attack, or mild ischemic stroke, you should be prescribed Clopidogrel Viso Farmacéutica in combination with acetylsalicylic acid, a substance present in many medications used to relieve pain and lower fever. 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 discussed with your doctor.

Using Clopidogrel Viso Farmacéutica with Food and Drinks

Clopidogrel Viso Farmacéutica can be taken with or without food.

Pregnancy and Breastfeeding

It is preferable not to take this medication during pregnancy and breastfeeding.

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

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

You should not breastfeed while taking this medication.

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

Consult your doctor or pharmacist before using any medication.

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 told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Clopidogrel Viso Farmacéutica

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose, even for patients with a disease called "atrial fibrillation" (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Viso Farmacéutica per day, administered orally with or without food and at the same time every day.

If you have experienced severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg or 600 mg of clopidogrel (4 or 8 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of clopidogrel per day.

If you have experienced symptoms of a stroke that disappear in a short period (also known as a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe 300 mg of Clopidogrel Viso Farmacéutica (4 tablets of 75 mg) once at the start of treatment. Afterward, the recommended dose is one 75 mg tablet of Clopidogrel Viso Farmacéutica per day, as described above, with acetylsalicylic acid for 3 weeks. Afterward, the 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 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 Clopidogrel Viso Farmacéutica

If you forget to take a dose of clopidogrel, but remember before 12 hours have passed since the time 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 interrupt treatment with Clopidogrel Viso Farmacéutica

Do not interrupt your treatment unless your doctor tells you to do so.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.

4. Possible Side Effects

Like all medications, this medication can cause side 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 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 section 2 "Warnings and Precautions").
• 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 Clopidogrel Viso Farmacéuticais bleeding.

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

If you experience prolonged bleeding while taking Clopidogrel Viso Farmacéutica

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 Clopidogrel Viso Farmacéutica").

Other side effects include:

Common side effects (affect more than 1 patient in 10):

Diarrhea, abdominal pain, indigestion, or heartburn.

Uncommon side effects (affect more than 1 patient in 100):

Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine, rash, itching, dizziness, sensation of tingling and numbness.

Rare side effects (affect more than 1 patient in 1,000):

Dizziness, breast enlargement in men.

Very rare side effects (affect 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); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

Side effects with unknown frequency (cannot be estimated from available data):

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

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Clopidogrel Viso Farmacéutica

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

Do not use this medication after the expiration date that appears on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

See the storage conditions on the packaging.

Store below 25 ºC.

Do not use this medication if you observe any visible signs of deterioration.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Clopidogrel Viso Farmacéutica

• The active ingredient 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, red iron oxide (E172), triacetin (E1518), titanium dioxide (E171).

Appearance of the Product and Container Content

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

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

Only some 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 Member States of 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 Clopidogrel 75 mg film-coated tablets

(Northern Ireland)

Date of the last revision of this leaflet:November 2023

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