Patient Information Leaflet

Clopidogrel Aurovitas 75 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine. It contains important information for you.

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

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

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

3.How to take Clopidogrel Aurovitas

4.Possible side effects

5.Storage of Clopidogrel Aurovitas

6.Contents of the pack and additional information

Clopidogrel Aurovitas contains clopidogrel and belongs to a group of medications called antiplatelet agents. Platelets are very small cells found in the blood that aggregate when the blood clots. Antiplatelet agents, by preventing this aggregation, reduce the likelihood of blood clots (a process known as thrombosis) forming.

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

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

• You suffer from a process that produces the hardening of arteries (also known as atherosclerosis), and
• You have previously suffered a myocardial infarction, a cerebral infarction, or suffer from a disease known as peripheral arterial disease, or
• You have suffered a 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 blocked or narrowed artery to restore adequate blood flow. It is possible that your doctor has also prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and reduce fever, as well as to prevent blood clots from forming).
• You have experienced symptoms of a transient ischemic attack 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 and acetylsalicylic acid for this disease. Your doctor has prescribed clopidogrel plus acetylsalicylic acid if you cannot take “oral anticoagulants” and do not have a high risk of severe bleeding.

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, such as a stomach ulcer or brain hemorrhage.
• If you have a severe liver disease.

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

Warnings and precautions

BeforestartingthetreatmentwithClopidogrelAurovitasinformyourdoctorifyoufindyourselfinanyofthefollowingsituationsdescribedbelow:

• 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 suffered a severe injury,
• You have recently undergone surgery (including dental surgery),
• You are scheduled to undergo surgery (including dental surgery) in the next 7 days.

• You have had a clot in a brain artery (ischemic stroke) in the last 7 days.
• You have liver or kidney disease.
• You have had an allergy or reaction to any medication used to treat your disease.
• You have a history of non-traumatic cerebral hemorrhage

During treatment with Clopidogrel Aurovitas:

• Inform your doctor if you have a scheduled 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 get a wound, bleeding may take longer to stop than usual. This is related to the way the medication works, as it prevents the blood from forming clots. For minor cuts or wounds, 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 ask you to have blood tests.

Children and adolescents

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

Other medications and Clopidogrel Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, 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 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,
• 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 reduce blood coagulation,
• 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 certain 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 severe pain),
• Rosuvastatin (used to reduce cholesterol levels).

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

Taking Clopidogrel Aurovitas withfood andbeverages

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 pregnantorthink you may bepregnant,inform your doctor or pharmacist beforetakingClopidogrelAurovitas.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 do so, inform your doctor before taking this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

ClopidogrelAurovitas contains lactose

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

ClopidogrelAurovitas contains hydrogenated ricin oil

ClopidogrelAurovitasmay cause stomach discomfort and diarrhea.

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

The recommended dose, even for patients with a condition called "atrial fibrillation" (an irregular heart rhythm), is one 75 mg clopidogrel 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 mg or 600 mg of clopidogrel (1 or 2 300 mg tablets or 4 or 8 75 mg tablets) to be taken once at the beginning of treatment. After that, the recommended dose is one 75 mg clopidogrel 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 (1 300 mg tablet or 4 75 mg tablets) once at the beginning of treatment. After that, the recommended dose is one 75 mg clopidogrel tablet per day, as described above, with acetylsalicylic acid for 3 weeks. After that, your doctor will prescribe either clopidogrel alone or acetylsalicylic acid alone.

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

IfYouTakeClopidogrelAurovitasMoreThanYouShould
In case of overdose or accidental ingestion, contact your doctor or pharmacist or go to the nearest hospital emergency department, as there is a higher 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 Forgot 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 the missed doses.

If You Interrupt Treatment with Clopidogrel Aurovitas

Do not stop 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,thismedicinecan 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 hives and itching, blisters on the skin. These may be signs of an allergic reaction.

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

If you cut or get a wound, it is possible that bleeding may 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.

Less frequent side effects(may affect up to 1 in 100 people): headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, skin rash, itching, dizziness, 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 general heat with sudden general discomfort until fainting); swelling of the mouth; blisters on the skin, skin allergy; inflammation of the mucous membrane of the mouth (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 levels.

Your doctor may also observe changes in your blood or urine test results.

Reporting side effects

Ifyou experience any type of side effect, consult your doctor orpharmacist, even if it is a possible side effect that does not appearin this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute toproviding more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box, blister pack, and bottle label after CAD. 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.

Medicines should not be disposed of through drains or in the trash. Dispose of containers and unused medicines at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

Clopidogrel Aurovitas Composition

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

Appearance of the product and contents of the package

Film-coated tablet.

Pink, biconvex, beveled-edge, rounded film-coated tablets with the edge “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 perforated PVC/PE/PVdC-Al single-dose blisters containing 28 film-coated tablets.

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

Only some package 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

ThismedicamentisauthorizedinthememberstatesoftheEuropeanEconomicSpacewiththefollowingnames:

Germany:Clopidogrel Aurobindo 75 mg Filmtabletten

Spain:Clopidogrel Aurovitas 75 mg film-coated tablets EFG

France:CLOPIDOGREL ARROW 75 mg, coated tablet

Italy:Clopidogrel Aurobindo

Malta:Clopidogrel Aurobindo 75 mg film-coated tablets

Netherlands:Clopidogrel Aurobindo 75 mg film-coated tablets

Last revision date of this leaflet:August 2022

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).