PATIENT INFORMATION LEAFLET

Clopidogrel SUN 75 mg Film-Coated Tablets

Clopidogrel

Read this 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 questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you. Do not give it to others. It may harm them, even if they have the same symptoms as you.

- If you experience any side effects, tell your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Clopidogrel SUN.

3. How to take Clopidogrel SUN

4. Possible side effects.

5. Storage of Clopidogrel SUN.

6. Contents of the pack and additional information.

Clopidogrel SUN contains clopidogrel and belongs to a group of medications called antiplatelet agents. Platelets are very small cells that are 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 known as thrombosis) forming.

Clopidogrel SUN is administered to adults to prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can cause atherothrombotic effects (such as cerebral infarction, myocardial infarction, or death).

You have been prescribed Clopidogrel SUN to help prevent blood clots from forming and reduce the risk of these serious events because:

- you have a process that produces the hardening of the arteries (also known as atherosclerosis), and

- you have previously experienced a myocardial infarction, a cerebral infarction, or have a disease known as peripheral arterial disease.

- you have experienced symptoms of a stroke that disappear in a short period of time (also known as a transient ischemic attack) or a mild ischemic stroke

• . It is possible that your doctor has also prescribed acetylsalicylic acid (a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clots) during the first 24 hours.

• .
• you have experienced symptoms of a stroke that disappear in a short period of time (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer acetylsalicylic acid during the first 24 hours.

- you have an irregular heartbeat, a disease known as “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 have been told that “oral anticoagulants” are more effective than acetylsalicylic acid or the combined use of Clopidogrel SUN and acetylsalicylic acid for this disease. Your doctor has prescribed Clopidogrel SUN plus acetylsalicylic acid if you cannot take “oral anticoagulants” and do not have a high risk of severe bleeding.

Do not take Clopidogrel SUN:

- If you are hypersensitive or allergic to any of the components of this medication (listed in section 6);

- If you have a disease that causes bleeding, such as a stomach ulcer or brain hemorrhage;

- If you have a severe liver disease.

If you think any of this may affect you, or if you have any doubts, consult your doctor before taking Clopidogrel SUN.

Warnings and precautions

If you are in any of the situations described below, inform your doctor before starting to take Clopidogrel SUN

?? If you are at risk of bleeding (bleeding) because:

- You have a disease that involves an increased 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 suffered a serious injury.

- You have recently undergone surgery (including dental surgery).

- You are scheduled to undergo surgery (including dental surgery) in the next seven days.

?? If you have had a blood clot in a cerebral artery (ischemic stroke) in the last 7 days.

?? If you have liver or kidney diseases.

?? If you have had an allergy or reaction to any medication used to treat your disease.

• If you have a history of non-traumatic cerebral hemorrhage.

During treatment with Clopidogrel SUN:

?? Inform your doctor if you are scheduled for 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 hematomas (bruises) under the skin that may appear as localized red spots, accompanied or not by extreme fatigue, confusion, yellow discoloration 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 from forming clots. For minor cuts or injuries, such as cutting during shaving, this is not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 4 "Possible side effects").

?? Your doctor may request blood tests.

Children and adolescents

This medication should not be administered to children because it is not effective.

Use of Clopidogrel SUN with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to take other medications, including those purchased without a prescription.

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

You must inform your doctor explicitly if you are taking:

- Medications that may increase the risk of bleeding, such as:

- Oral anticoagulants, medications used to reduce blood coagulation,

- Nonsteroidal anti-inflammatory drugs, medications used to treat pain and/or inflammation of muscles or joints,

- Heparin, or any other injectable medication used to reduce blood coagulation,

- 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 to treat serious 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 to treat diabetes,

- Paclitaxel, a medication to treat cancer.

- Opioids: If you are taking clopidogrel, inform your doctor before being prescribed any opioid (used to treat intense pain).

• Rosuvastatin (used to reduce cholesterol levels)

If you have had severe chest pain (unstable angina or myocardial infarction), transient ischemic attack, or mild ischemic stroke, you may have been prescribed Clopidogrel SUN in combination with acetylsalicylic acid, a substance present in many medications used to relieve pain and reduce fever. A dose of acetylsalicylic acid administered sporadically (not exceeding 1,000 mg in 24 hours) generally should not cause any problems, but prolonged use in other circumstances should be consulted 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 medication during pregnancy.

If you are pregnant or think you may be, 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 medication.

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Clopidogrel SUN is unlikely to affect your ability to drive or operate machinery.

Clopidogrel SUN contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with him before taking this medication.

Clopidogrel SUN also contains hydrogenated ricin oil

This may cause stomach discomfort and diarrhea.

Follow exactly the administration instructions for Clopidogrel SUN 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 heart rhythm), is one 75 mg Clopidogrel SUN tablet per day, taken 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 or 600 mg of Clopidogrel (4 or 8 Clopidogrel SUN tablets) to be taken once at the beginning of treatment. After that, the recommended dose is one 75 mg Clopidogrel SUN tablet per day as described above.

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

You should take Clopidogrel SUN for the time your doctor continues to prescribe it.

If you take moreClopidogrel SUNthan 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, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeClopidogrel 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 compensate for a missed tablet.

If you interrupt treatment withClopidogrel SUN

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.

Like all medicines, this medicine can have side effects, although not everyone will experience 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 hives and itching, blisters on the skin. These may be signs of an allergic reaction.

The most frequent side effect reported with Clopidogrel SUNis bleeding. Bleeding can occur in the stomach or intestines, bruises, hematomas (abnormal bleeding or bruises under the skin), nasal bleeding, blood in urine. Also, a reduced number of cases of: bleeding of the blood vessels of the eyes, intracranial, pulmonary, or joint bleeding have been reported.

If you experience prolonged bleeding while taking Clopidogrel SUN

If you cut or get a wound, it is possible that bleeding will 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 wounds, such as cutting during shaving, this usually does not matter. 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.

Poorly frequent side effects(may affect up to 1 in 100 people)

Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, rashes, itching, dizziness, numbness, and tingling.

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., generalized feeling of heat with sudden general discomfort until fainting); swelling of the mouth; blisters on the skin, skin allergy; mouth pain (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

Side effects of 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 your blood or urine test results.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the carton and in the Blister, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you do not need. In this way, you will help protect the environment.

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-substitution hydroxypropyl cellulose.

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

Product Appearance and Packaging Content

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

Clopidogrel SUN is presented in carton packs containing:

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

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Responsible 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

Phone: + 34 93 342 78 90

This medicine is authorized in the following member states, with the following names:

Last reviewed date of this leaflet: September 2023

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/