CLOPIDOGREL KERN PHARMA 75 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel Kern Pharma 75 mg film-coated tablets EFG

Contents of the pack:

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

1. What Clopidogrel Kern Pharma is and what it is used for

Clopidogrel Kern Pharma 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 suffered a heart attack, stroke, 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. 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 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 you take Clopidogrel Kern Pharma

Do not take Clopidogrel Kern Pharma

• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (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 Kern Pharma.

Warnings and precautionsBefore starting treatment with Clopidogrel Kern Pharma, 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 going to have surgery (including dental surgery) in 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 Kern Pharma:

• Tell your doctor if you are going to have surgery (including dental surgery).
• Tell 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 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 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 and injuries, such as cutting yourself while shaving, this is not important. 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

Clopidogrel Kern Pharma should not be given to children as it is not effective.

Taking Clopidogrel Kern Pharma with other medicines

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 Kern Pharma or vice versa.

Tell your doctor or pharmacist if you are using or have recently used or might use other medicines, including those obtained without a prescription.

You must explicitly 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 muscle or joint inflammation,
• heparin, or any other injectable medication used to decrease blood clotting,
• ticlopidine, or other antiplatelet agents,
• 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 (medications for the treatment of HIV infections).
• carbamazepine, a medication to treat some forms of epilepsy,
• moclobemide, medication for depression,
• repaglinide, medication for the treatment of diabetes,
• paclitaxel, medication for the treatment of cancer,
• 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 reduce cholesterol levels).

If you have suffered severe chest pain (unstable angina or myocardial infarction), a transient ischemic attack, or a mild ischemic stroke, you may have been prescribed Clopidogrel Kern Pharma in combination with acetylsalicylic acid, a substance found 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) is generally not a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Kern Pharma with food and drinks

Clopidogrel Kern Pharma can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to use this medicine during pregnancy.

If you are pregnant or think you may be pregnant, you must inform your doctor or pharmacist before taking Clopidogrel Kern Pharma. If you become pregnant while taking Clopidogrel Kern Pharma, consult your doctor immediately, as it is not recommended to take clopidogrel 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 Kern Pharma is unlikely to affect your ability to drive or use machines.

Clopidogrel Kern Pharma contains lactose

If your doctor has told you that you have an intolerance to some sugars (e.g., lactose), consult them before taking this medicine.

3. How to take Clopidogrel Kern Pharma

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

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 suffered severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe you 300 mg or 600 mg of clopidogrel (4 or 8 tablets of 75 mg) to be taken 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 you 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, the 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 Kern Pharma than you should

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20 (indicating the medication and the amount ingested).

Contact your doctor or go to the emergency department of the nearest hospital, as there is a greater risk of bleeding.

If you forget to take Clopidogrel Kern Pharma

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 a forgotten tablet.

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

If you stop taking Clopidogrel Kern Pharma

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 Kern Pharma 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 rashes and itching, blisters on the skin. These can be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Kern Pharmais 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 bleeding, or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel Kern Pharma

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 normally not important. 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, eruptions, itching, dizziness, sensation of tingling and numbness.

Rare side effects (may affect up to 1 in 1,000 people): vertigo, gynecomastia 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., general feeling of heat with sudden general discomfort leading to fainting); swelling of the mouth; blisters on the skin, skin allergy; inflammation of the mucous membrane of the mouth (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 (or cannot be estimated from the available data): hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

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

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use (Website: www.notificaRAM.es).

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

5. Storage of Clopidogrel Kern Pharma

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 after "EXP". The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal.

6. Contents of the pack and other information

Composition of Clopidogrel Kern Pharma

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

The other ingredients are:

• Core of the tablet: anhydrous lactose, microcrystalline cellulose (E-460i), crospovidone, glycerol dibehenate, and talc.
• Coating of the tablet: polyvinyl alcohol, talc, titanium dioxide (E-171), macrogol 3350, soy lecithin, and red iron oxide (E-172).

Appearance of the product and contents of the pack

Round, biconvex, pink film-coated tablets.

It is available in aluminum-aluminum blisters containing 28, 50, or 84 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Polígono. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 – Polígono. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Actavis Limited

BLB015-016 Bulebel Industrial Estate,

ZTN3000, Zejtun

Malta

Date of last revision of this leaflet:March 2024

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