Clopidogrel Sun 75 mg film-coated tablets EFG

Patient Information Leaflet

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, as 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 their symptoms are the same as yours.
• If you experience any side effects, inform your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Clopidogrel SUN contains clopidogrel and belongs to a group of medicines called platelet aggregation inhibitors. Platelets are very small cells found in the blood that clump together when blood clots. Platelet aggregation inhibitors reduce the likelihood of blood clots (a process known as thrombosis) by preventing this clumping.

Clopidogrel SUN is given to adults to help prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a condition 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 causing hardening of the arteries (also known as atherosclerosis), and

• you have previously had a myocardial infarction, stroke, or you have a condition called peripheral arterial disease.

• you have experienced symptoms of a stroke that disappear within a short period of time (also known as a transient ischaemic attack) or a mild ischaemic stroke.

  • Your doctor may also have prescribed you acetylsalicylic acid (a substance found in many medicines 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 within a short period of time (also known as a transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also give you acetylsalicylic acid during the first 24 hours.

• you have an irregular heartbeat, a condition called “atrial fibrillation”, and you cannot take medicines known as “oral anticoagulants” (vitamin K antagonists) which prevent the formation of new clots and stop existing clots from growing. You should be aware that “oral anticoagulants” are considered more effective than acetylsalicylic acid or the combination of Clopidogrel SUN and acetylsalicylic acid for this condition. Your doctor will have prescribed Clopidogrel SUN together with acetylsalicylic acid if you are unable to take “oral anticoagulants” and you do not have a high risk of severe bleeding.

2. What you need to know before taking Clopidogrel SUN

Do not take Clopidogrel SUN:

• If you are allergic (hypersensitive) to clopidogrel or to any of the other ingredients of this medicine (listed in section 6);
• If you have a condition that causes bleeding, such as a stomach ulcer or bleeding in the brain;
• If you have severe liver disease.

If you think any of the above may apply to 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 because:

• You have a condition that increases your risk of internal bleeding (such as a stomach ulcer).
• You have a blood disorder that predisposes you to internal bleeding (bleeding into tissues, organs, or joints).
• You have recently suffered 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 a brain artery (ischaemic stroke) within the last 7 days.

??If you have liver or kidney disease.

??If you have had an allergy or reaction to any medicine used to treat your condition.

• If you have a history of non-traumatic intracranial bleeding.

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 bruising (bruises) under the skin which may appear as localized red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).

??If you cut yourself or sustain a wound, bleeding may take longer than normal to stop. This is related to how the medicine works, as it reduces the blood’s ability to form clots. For minor cuts or wounds, such as those occurring during shaving, this is not significant. However, if you are concerned about blood loss, consult your doctor immediately (see section 4 “Possible side effects”).

??Your doctor may ask you to have blood tests.

Children and adolescents

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

Taking Clopidogrel SUN with other medicines

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

Some medicines may affect the use of Clopidogrel SUN 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, medicines used to reduce blood clotting,
• Non-steroidal anti-inflammatory drugs (NSAIDs), medicines generally used to treat pain and/or inflammation of muscles or joints,
• Heparin, or any other injectable medicine used to reduce blood clotting,
• Ticlopidine, or other antiplatelet agents.
• A serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other drugs of the same type), medicines usually used to treat depression,
• Rifampicin (used for serious infections),
• Omeprazole or esomeprazole, medicines used to treat stomach discomfort,
• Fluconazole or voriconazole, medicines used to treat fungal infections,
• Efavirenz, or other antiretroviral medicines (used to treat HIV infections),
• Carbamazepine, a medicine used to treat certain forms of epilepsy,
• Moclobemide, a medicine for depression,
• Repaglinide, a medicine for the treatment of diabetes,
• Paclitaxel, a medicine for the treatment of cancer.
• Opioids: if you are being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain).
  • Rosuvastatin (used to reduce cholesterol levels)

If you have experienced severe chest pain (unstable angina or myocardial infarction), transient ischaemic attack, or mild ischaemic stroke, you may have been prescribed Clopidogrel SUN in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. An occasional dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) generally should not cause problems, but prolonged use under other circumstances should be discussed with your doctor.

Taking Clopidogrel SUN with food and drink

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 must inform your doctor or pharmacist before taking Clopidogrel SUN. If you become pregnant while taking Clopidogrel SUN, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

You must not breastfeed while taking this medicine.

If you are breastfeeding or planning to breastfeed, inform your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Clopidogrel SUN contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Clopidogrel SUN also contains hydrogenated castor oil

This may cause stomach discomfort and diarrhoea.

3. How to take Clopidogrel SUN

Follow exactly the instructions for using Clopidogrel SUN as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

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, at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe 300 or 600 mg of Clopidogrel (4 or 8 tablets of Clopidogrel SUN) to be taken once at the beginning of treatment. After that, 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 of time (also known as a transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe 300 mg of Clopidogrel (4 tablets of Clopidogrel SUN) once at the beginning of treatment. After that, the recommended dose is one 75 mg tablet of Clopidogrel SUN per day, as described above, taken together with acetylsalicylic acid for 3 weeks. After this period, your doctor will prescribe either Clopidogrel SUN alone or acetylsalicylic acid alone.

You should continue taking Clopidogrel SUN for as long as your doctor prescribes it.

If you take more Clopidogrel SUN than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 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 within 12 hours of the scheduled time, take the tablet immediately and take the next dose 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 missed tablet.

If you stop taking Clopidogrel SUN

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

Contact your doctor immediately if you experience:

• fever, signs of infection, or severe tiredness. These symptoms may be due to a rare reduction in certain blood cells.
• signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing 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 may be signs of an allergic reaction.

The most frequently reported adverse effect with Clopidogrel SUN is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases have also been reported of: bleeding from blood vessels in the eyes, intracranial bleeding, pulmonary bleeding, or bleeding into joints.

If you experience prolonged bleeding while taking Clopidogrel SUN

If you cut yourself or sustain a wound, bleeding may take longer than usual to stop. This is related to the mechanism of action of the medicine, as it prevents blood from forming clots. For minor cuts or wounds, such as cutting yourself while shaving, this is usually not a concern. 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)

Diarrhoea, 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 intestines, skin rashes, itching, dizziness, tingling 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 (for example, sensation of warmth with sudden general discomfort up to 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.

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 of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Clopidogrel SUN

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the blister, following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clopidogrel SUN

• The active substance 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 Pink 33K84841 (hypromellose, lactose, titanium dioxide, triacetin, red iron oxide).

Appearance of the product and contents of the pack

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

Clopidogrel SUN is available in cardboard 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 marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The 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 under the following names:

Date of the latest review of this leaflet: September 2023

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