CLOPIDOGREL ESSETI 75 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel Esseti 75 mg film-coated tablets EFG

Contents of the pack:

1. 1. What is Clopidogrel Esseti and what is it used for.
2. What you need to know before you take Clopidogrel Esseti.
3. How to take Clopidogrel Esseti.
4. Possible side effects.
5. Storage of Clopidogrel Esseti.
6. Contents of the pack and further information.

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

Clopidogrel Esseti contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that help it to clot. Antiplatelet agents prevent platelet clumping, reducing the risk of blood clots (a process called thrombosis).

Clopidogrel is given to adults to prevent blood clots (thrombi) in blood vessels (arteries) that have become hardened, a process 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 that causes hardening of the arteries (also known as atherosclerosis) and
• You have previously had a heart attack, 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". For the treatment of this disease, your doctor may need to place a stent in the obstructed or narrowed artery to restore proper blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found 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 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 condition 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 you take Clopidogrel Esseti

Do not take Clopidogrel Esseti:

• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Esseti (listed in section 6).
• 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 any of these apply to you, or if you are unsure, consult your doctor before taking Clopidogrel Esseti.

Warnings and precautions

• Before starting treatment with Clopidogrel Esseti, inform your doctor 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 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 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 Esseti:

• Tell your doctor if you are scheduled to have surgery (including dental surgery).
• Tell your doctor immediately if you develop a disorder (also known as thrombocytopenic purpura or TTP) that includes fever and bruising (bruises) under the skin that can appear as red spots, accompanied or not by 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 a little longer than usual to stop. This is related to the way the medicine 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 "Warnings and precautions").
• Your doctor may ask you to have blood tests.

Children and adolescents

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

Other medicines and Clopidogrel Esseti

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

Some medicines may affect the use of Clopidogrel Esseti 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, 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 medication used to decrease blood clotting,
• ticlopidine, or other antiplatelet agents,
• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other drugs 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 treatment,
• paclitaxel, a medication for cancer treatment,
• opioids: if you are being treated with clopidogrel, you must inform your doctor before any opioid is prescribed to you (used to treat severe pain),
• rosuvastatin (used to lower 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 Esseti in combination with acetylsalicylic acid, a substance found in many medications used to relieve pain and lower fever. An occasional dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) is not likely to cause any problems, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Esseti with food and drinks

Clopidogrel Esseti can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take 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 Clopidogrel Esseti.

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

You should 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

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

Clopidogrel Esseti contains isomalt and sucrose

This medicine contains isomalt. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Clopidogrel Esseti

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose, even for patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg clopidogrel tablet per day, taken orally with or without food and at the same time each day.

If you have had severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe you 300 mg or 600 mg of clopidogrel (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) to be taken once at the start of treatment. After that, 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 you 300 mg of clopidogrel (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. After that, the recommended dose is one 75 mg clopidogrel tablet per day as described above, with acetylsalicylic acid for 3 weeks. After that, 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 Esseti than you should

Consult 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 5620420 (indicating the medicine and the amount ingested).

If you forget to take Clopidogrel Esseti

If you forget to take a dose of clopidogrel but remember before 12 hours have passed since 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.

You can check the last day you took a Clopidogrel Esseti tablet by looking at the calendar printed on the blister pack.

If you stop taking Clopidogrel Esseti

Do not stop your treatment unless your doctor tells you to.Contact your doctor or pharmacist before stopping this medicine.

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

4. Possible side effects

Like all medicines, Clopidogrel Esseti can cause side effects, although not everybody gets them.

Consult 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), 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 rash and itching, blisters on the skin. These can be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Essetiis 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 from the blood vessels of the eyes, intracranial bleeding, pulmonary or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel Esseti

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 medicine, 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 "Warnings and precautions").

Other side effects include

Common 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 males.

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); low 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 the available data): Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Esseti

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 carton and on the blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions. Store in the original package.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Clopidogrel Esseti

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).

The other ingredients are isomalt (E 953), hydroxypropylcellulose (E 463), low-substituted hydroxypropylcellulose (E 463a), sucrose stearate in the core of the tablets, and hypromellose (E 464), macrogol 400, titanium dioxide (E 171), red iron oxide (E 172) in the tablet coating.

Appearance of the product and pack contents

Clopidogrel Esseti 75 mg tablets are round, biconvex, and pink in color.

They are available in cardboard boxes of 28 tablets in aluminum/aluminum blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder:

ESSETI FARMACEUTICI S.R.L.

Via Raffaele De Cesare, 7

Naples

Postcode: 80132

Italy

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona, Spain

Date of last revision of this leaflet:February 2024