CLOPIDOGREL AUROVITAS 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Clopidogrel Aurovitas 75 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Clopidogrel Aurovitas and what is it used for
2. What you need to know before taking Clopidogrel Aurovitas
3. How to take Clopidogrel Aurovitas
4. Possible side effects
5. Storage of Clopidogrel Aurovitas
6. Package Contents and Additional Information

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

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

Clopidogrel is administered to adults to prevent the formation of blood clots (thrombi) in blood vessels (arteries) that have hardened, a process known as atherothrombosis, which can cause atherothrombotic events (such as stroke, myocardial infarction, or death).

You have been prescribed clopidogrel to help prevent the formation of blood clots and reduce the risk of these serious events, as:

• You suffer from a process that causes the hardening of the arteries (also called atherosclerosis), and
• You have previously suffered a myocardial infarction, a stroke, or suffer from a disease called peripheral arterial disease, or
• You have suffered a type of severe 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. It is also possible that your doctor has prescribed acetylsalicylic acid (a substance present 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 in 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 taking Clopidogrel Aurovitas

Do not take Clopidogrel Aurovitas

• If you are allergic (hypersensitive) to clopidogrel or any of the other components of this medication (listed in section 6).
• If you have an active bleeding disorder, such as a stomach ulcer or bleeding in the brain.
• If you have a severe liver disease.

If you think any of these may apply to you, or if you have any doubts, consult your doctor before taking Clopidogrel Aurovitas.

Warnings and Precautions

Before starting treatment with Clopidogrel Aurovitas, inform your doctor if you are in any of the following situations:

• 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 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 7 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 a history of non-traumatic cerebral hemorrhage

During treatment with Clopidogrel Aurovitas:

• Inform your doctor if you are scheduled to undergo 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 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 medication 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 medication should not be given to children as it is not effective.

Other Medications and Clopidogrel Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

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

You must explicitly inform your doctor if you are taking:

• medications 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 injectable medication used to decrease blood clotting,
• ticlopidine, another antiplatelet agent,
• 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 (for the treatment of HIV infections),
• carbamazepine, a medication to treat some forms of epilepsy,
• moclobemide, a medication for depression,
• repaglinide, a medication for the treatment of diabetes,
• paclitaxel, a medication for the treatment of 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 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 in combination with acetylsalicylic acid, a substance present 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 Aurovitas with Food and Drinks

Clopidogrel Aurovitas 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 pregnant, you should inform your doctor or pharmacist before taking Clopidogrel Aurovitas. If you become pregnant while taking Clopidogrel Aurovitas, 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 breastfeed, inform your doctor before taking this medication.

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

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

Clopidogrel Aurovitas contains Lactose

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

Clopidogrel Aurovitas contains Hydrogenated Castor Oil

Clopidogrel Aurovitas may cause stomach upset and diarrhea.

3. How to take Clopidogrel Aurovitas

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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 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. 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 in a short period (also known as a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe 300 mg of clopidogrel (1 tablet of 300 mg or 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 Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist or go to the emergency department of the nearest hospital, as there is a greater risk of bleeding. You can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Clopidogrel Aurovitas

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 forgotten doses.

If you stop taking Clopidogrel Aurovitas

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

Consult 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.

4. Possible Side Effects

Like all medications, this medication can cause 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 rashes and itching, blisters on the skin. These can be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Aurovitas is 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 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 Aurovitas:

If you cut or injure yourself, the bleeding may take 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 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:

Frequent 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, skin rash, 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., 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); decrease in 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 levels.

Your doctor may also 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 side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Clopidogrel Aurovitas

Keep this medication out of sight and reach of children.

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

Store below 30°C.

Bottle: use within 6 months after first opening the bottle.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

Clopidogrel Aurovitas Composition

• The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as clopidogrel bisulfate).
• The other ingredients are: microcrystalline cellulose (Grade 133), mannitol, low-substituted hydroxypropylcellulose, crospovidone (Type A), macrogol 6000, hydrogenated castor oil, lactose monohydrate (see section 2 "Clopidogrel Aurovitas contains lactose"), hypromellose (15 cp), titanium dioxide (E171), triacetin, and red iron oxide (E172).

Product Appearance and Packaging Content

Film-coated tablet.

Pink, biconvex, film-coated tablets with a beveled edge, rounded and marked with "E" on one face and "34" on the other face of the tablet.

Clopidogrel Aurovitas is available in blisters containing 14, 28, 30, 50, 56, 84, 100, and 500 film-coated tablets, and in transparent PVC/PE/PVdC-Al unit-dose blisters containing 28 film-coated tablets.

Bottles containing 30, 100, and 500 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

ThismedicinalproductisauthorizedintheMemberStatesoftheEuropeanEconomicAreawiththefollowingnames:

Germany: Clopidogrel Aurobindo 75 mg Filmtabletten

Spain: Clopidogrel Aurovitas 75 mg film-coated tablets EFG

France: CLOPIDOGREL ARROW 75 mg, film-coated tablet

Italy: Clopidogrel Aurobindo

Malta: Clopidogrel Aurobindo 75 mg film-coated tablets

Netherlands: Clopidogrel Aurobindo 75 mg film-coated tablets

Date of the last revision of this leaflet:August 2022

Detailed 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).