CLOPIDOGREL VIVANTA 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for thepatient

Clopidogrel Vivanta 75 mgfilm-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 only, and you should not give it 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 side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Clopidogrel Vivanta and what is it used for
2. What you need to know before taking Clopidogrel Vivanta
3. How to take Clopidogrel Vivanta
4. Possible side effects
5. Storage of Clopidogrel Vivanta
6. Package contents and additional information

1. What is Clopidogrel Vivanta and what is it used for

Clopidogrel Vivanta 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 used in adults 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 have a condition that causes hardening of the arteries (also known as atherothrombosis), and
• you have previously had a myocardial infarction, stroke, or suffer from a disease called peripheral arterial disease, or
• you have had a severe type of 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. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and reduce fever, as well as to prevent blood clots),
• you have experienced symptoms of a stroke that disappear within a short period (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer acetylsalicylic acid to you during the first 24 hours.
• you have an irregular heartbeat, a disease called "atrial fibrillation", and you cannot take medications known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new clots and prevent the growth of existing clots. You will have been told that "oral anticoagulants" are more effective than acetylsalicylic acid or the combined use of clopidogrel and acetylsalicylic acid for this disease. Your doctor will 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 Vivanta

Do not take Clopidogrel Vivanta

• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medication (listed in section 6).
• If you have a medical condition that is currently 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 may apply to you, or if you are unsure, consult your doctor before taking Clopidogrel Vivanta.

Warnings and precautions

Consult your doctor before starting to take Clopidogrel Vivanta if you are in any of the following situations:

• 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 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 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 Vivanta:

• You must inform 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 of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• If you cut or injure yourself, 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 cuts while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and precautions").
• Your doctor may ask you to have blood tests.

Children and adolescents

This medication should not be given to children as it is not effective.

Other medications and Clopidogrel Vivanta

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

Some medications may affect the use of Clopidogrel Vivanta 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, another antiplatelet agent,
• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other medications of the same type), medications 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 to treat HIV infections),
• carbamazepine, a medication to treat some forms of epilepsy,
• moclobemide, a medication for depression,
• repaglinide, a medication for diabetes,
• paclitaxel, a medication for cancer,
• opioids: while 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 had severe chest pain (unstable angina or myocardial infarction), a transient ischemic attack, or a mild ischemic stroke, you may have been prescribed clopidogrel in combination with acetylsalicylic acid, a substance found in many medications used to relieve pain and reduce fever. A dose of acetylsalicylic acid administered occasionally (not exceeding 1,000 mg in 24 hours) is generally not a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Vivanta with food and drinks

Clopidogrel Vivanta can be taken with or without food.

Pregnancy and breastfeeding

This medication should not be used during pregnancy.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication. If you become pregnant while taking Clopidogrel Vivanta, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

You should not breastfeed while taking this medication.

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

Clopidogrel Vivanta is unlikely to affect your ability to drive or use machines.

Clopidogrel Vivanta contains hydrogenated castor oil

It may cause stomach upset and diarrhea.

Clopidogrel Vivanta contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

3. How to take Clopidogrel Vivanta

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in 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 clopidogrel tablet per day, administered orally with or without food and at the same time every day.

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

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

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

If you take more Clopidogrel Vivanta 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Clopidogrel Vivanta

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 missed doses.

For pack sizes of 7, 14, 28, 56, 84, and 112 tablets, you can check the day you last took a Clopidogrel Vivanta tablet by consulting the calendar printed on the blister pack.

If you stop taking Clopidogrel Vivanta

Do not stop your treatment unless your doctor tells you to.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 have side effects, although not everyone gets them.

Contact your doctor immediately if you experience:

• fever, signs of infection, or extreme 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), with or without 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 is 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 bleeding, pulmonary or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel Vivanta

If you cut or injure yourself, it is possible that 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 cuts while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and precautions").

Other side effects include:

Frequent side effects (may affect up to 1 in 10 people):

diarrhea, abdominal pain, indigestion, or heartburn.

Uncommon side effects (may affect up to 1 in 100 people):

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

Rare side effects (may affect up to 1 in 1,000 people):

dizziness, breast enlargement in men.

Very rare side effects (may affect up to 1 in 10,000 people):

jaundice; severe abdominal pain with or without back pain; fever; difficulty breathing, sometimes associated with cough; generalized allergic reactions (e.g., feeling of heat with sudden general discomfort leading to fainting); 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.

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 side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Clopidogrel Vivanta

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

Do not use this medication after the expiration date stated on the carton and on the blister pack after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

Clopidogrel Vivanta Composition:

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

The other components are:

• Tablet core: mannitol (E421), microcrystalline cellulose (PH 112), macrogol, hydrated colloidal silica, low-substituted hydroxypropylcellulose, hydrogenated ricin oil.
• Tablet coating: lactose monohydrate, hypromellose 2910, titanium dioxide, triacetin, red iron oxide, black iron oxide.

See section 2 "Clopidogrel Vivanta contains hydrogenated ricin oil" and "Clopidogrel Vivanta contains lactose".

Product Appearance and Packaging Content

Round, pink, film-coated tablets, engraved with "MC 5" on one side and smooth on the other.

The film-coated tablets are available in boxes containing:

• 7, 14, 28, 30, 50, 56, 60, 84, 90, 100, 112, and 120 film-coated tablets in blisters (with or without calendar blister);
• 50x1 film-coated tablets in unit-dose blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Vivanta Generics s.r.o.

Trtinova 260/1, Cakovice,

19600, Prague 9

Czech Republic.

Manufacturer

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Estate, Paola, PLA3000, Malta

Or

MSN Labs Europe Limited,

KW20A Corradino Park, Paola, PLA3000, Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Clopidogrel Vivanta 75 mg Filmtabletten

Spain: Clopidogrel Vivanta 75 mg film-coated tablets EFG

Ireland: Clopidogrel MSN 75 mg film-coated tablets

Netherlands: Clopidogrel Vivanta 75 mg filmomhulde tabletten

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/