CLOPIDOGREL SUN 75 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel SUN 75 mg film-coated tablets EFG

clopidogrel

Read the entire 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, tell your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

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

Clopidogrel SUN contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that clump together to form blood clots. Antiplatelet agents prevent this clumping, reducing the risk of blood clots (a process called thrombosis).

Clopidogrel SUN 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 SUN 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.

has 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 have prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and lower fever, as well as to prevent blood clots) during the first 24 hours.

• has 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 during the first 24 hours.

• has an irregular heartbeat, a condition called "atrial fibrillation", and 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 SUN and acetylsalicylic acid for this condition. Your doctor will have prescribed Clopidogrel SUN 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 SUN

Do not take Clopidogrel SUN:

• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
• If you have a disease that causes 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 are unsure, consult your doctor before taking Clopidogrel SUN.

Warnings and precautions

If you are in any of the following situations, tell your doctor before starting treatment with Clopidogrel SUN

If you have a 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 makes you prone 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 have 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 non-traumatic brain hemorrhage.

During treatment with Clopidogrel SUN:

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 Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bruises) under the skin that can appear as 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, 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 or injuries, such as cuts during 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.

Using Clopidogrel SUN with other medicines

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

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

You must specifically tell your doctor if you are taking:

• medicines that may increase the risk of bleeding, such as:
• oral anticoagulants, medicines used to decrease blood clotting,

non-steroidal anti-inflammatory drugs, medicines used to treat pain and/or inflammation of muscles or joints,

• heparin, or any other injectable medicine 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), medicines used to treat depression,

rifampicin (used for severe infections),

• omeprazole or esomeprazole, medicines used to treat stomach upset,
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz, or other antiretroviral medications (used to treat HIV infections),
• carbamazepine, a medicine used to treat some forms of epilepsy,
• moclobemide, a medicine used to treat depression,
• repaglinide, a medicine used to treat diabetes,
• paclitaxel, a medicine used to treat cancer.
• opioids: if you are being treated with clopidogrel, you should inform your doctor before being prescribed any opioid (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 SUN 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) should not cause any problems, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel SUN with food and drinks

Clopidogrel SUN can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or think you may be pregnant, you should inform your doctor or pharmacist before taking Clopidogrel SUN. If you become pregnant while taking Clopidogrel SUN, 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 SUN is unlikely to affect your ability to drive or use machines.

Clopidogrel SUN contains lactose

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

Clopidogrel SUN also contains hydrogenated castor oil

This may cause stomach upset and diarrhea.

3. How to take Clopidogrel SUN

Follow the instructions for taking Clopidogrel SUN exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended dose, even for patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg tablet of Clopidogrel SUN 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 300 or 600 mg of clopidogrel (4 or 8 tablets of Clopidogrel SUN) to be taken once at the start of treatment. Afterward, the recommended dose is one 75 mg tablet of Clopidogrel SUN 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 Clopidogrel SUN) once at the start of treatment. Afterward, the recommended dose is one 75 mg tablet of Clopidogrel SUN per day, as described above, with acetylsalicylic acid for 3 weeks. Afterward, the doctor will prescribe either Clopidogrel SUN alone or acetylsalicylic acid alone.

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

If you take more Clopidogrel SUN than you should

Contact 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Clopidogrel SUN

If you forget to take a dose of Clopidogrel SUN, 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.

If you stop taking Clopidogrel SUN

Do not stop treatment unless your doctor tells you to. 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 side effects

Like all medicines, this medicine can have side effects, although not everyone gets them.

Consult 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 SUN is bleeding. Bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in the urine. A small number of cases of bleeding in 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 SUN

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 cuts during 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, 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; mouth pain (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste.

Side effects with unknown frequency (cannot be estimated from 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 side effects

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

5. Storage of Clopidogrel SUN

Keep out of sight and reach of children.

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

This medicine does not require special storage conditions.

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

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

6. Container Content and Additional Information

Clopidogrel SUN Composition

• The active ingredient is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
• The other components are:

Tablet core: mannitol, microcrystalline cellulose, macrogol 6000, hydrogenated castor oil, and low-substituted hydroxypropylcellulose.

Tablet coating: Opadry II Rosa 33K84841 (hypromellose, lactose, titanium dioxide, triacetin, red iron oxide.

Product Appearance and Container Content

Clopidogrel SUN 75 mg are film-coated tablets, round, pink, biconvex, and smooth on both sides.

Clopidogrel SUN is presented in cardboard boxes containing:

7, 10, 14, 20, 25, 28, 30, 50, 55, 56, 60, 84, 90, 98, 100, and 200 tablets in Cold form Aluminum/PA/PVC/Aluminum blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

or

Terapia SA

124 Fabricii Street

Cluj-Napoca, 400632

Romania

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007- Barcelona

Spain

Tel.: + 34 93 342 78 90

This medicinal product is authorized in the following Member States with the following names:

Date of the Last Revision of this Leaflet: September 2023

Detailed and updated 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/