Package Insert: Information for the User

Clopidogrel Viatris 75 mg Film-Coated Tablets

clopidogrel

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given 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 package insert. See section 4.

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

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

You have been prescribed Clopidogrel Viatris 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 suffer from a disease known as peripheral arterial disease, or
• you have experienced a severe chest pain, known as unstable angina or myocardial infarction (heart attack). 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 Viatris and acetylsalicylic acid for this disease. Your doctor has prescribed Clopidogrel Viatris with acetylsalicylic acid if you cannot take oral anticoagulants and do not have a high risk of severe bleeding.

Do not take Clopidogrel Viatris:

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

Warnings and precautions

Before starting treatment with Clopidogrel Viatris, 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 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 Viatris:

• 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 yourself, 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 Viatris

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 Viatris 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, 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 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 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 they prescribe 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 Viatris in combination with acetylsalicylic acid, a substance present in many medications used to relieve pain and reduce fever. An occasional dose of acetylsalicylic acid (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 Viatris with food and drinks

Clopidogrel Viatris 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 Viatris. If you become pregnant while taking Clopidogrel Viatris, consult your doctor immediately since clopidogrel is not recommended 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 Viatris is unlikely to affect your ability to drive or operate machinery.

Clopidogrel Viatris contains lactose

If your doctor has told you that you have an intolerance to certain sugars (e.g. lactose), consult with him before taking this medication.

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

The recommended dose, also for patients with atrial fibrillation (irregular heartbeat), is one 75 mg Clopidogrel Viatris tablet per day taken orally with or without food 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 Viatris (4 or 8 75 mg tablets) to be taken once at the start of treatment. After that, the recommended dose is one 75 mg Clopidogrel Viatris 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 Viatris (4 tablets of 75 mg) once at the start of treatment. After that, the recommended dose is one 75 mg Clopidogrel Viatris tablet per day, as described above, with acetylsalicylic acid for 3 weeks. After that, your doctor will prescribe either Clopidogrel Viatris alone or acetylsalicylic acid alone.

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

If you take more Clopidogrel Viatris than you should

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

If you forget to take Clopidogrel Viatris

If you forget to take a dose of Clopidogrel Viatris, but remember before 12 hours have passed since the time when 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 missed tablet.

If you interrupt treatment with Clopidogrel Viatris

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 medications, Clopidogrel Viatris may have side effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

• fever, signs of infection, or extreme 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 in the form of red spots and/or confusion (see section 2 “Warnings and precautions”)
• swelling of the mouth or skin problems 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 Viatris 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 Viatris

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.

Rare 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, tingling, and numbness.

Rare side effects (may affect up to 1 in 1,000 people):

dizziness, enlargement of the breasts 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 coughing; 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

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing 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 packaging and on the blister pack, after CAD. The expiration date is the last day of the month indicated.

See storage conditions on the packaging.

Store below 25°C when Clopidogrel Viatris is presented in PVC/PE/PVDC/aluminum blisters.

When Clopidogrel Viatris is presented in any aluminum blister pack, it does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Clopidogrel Viatris Composition

The active ingredient is clopidogrel. Each tablet contains 75 mg of clopidogrel (as besilate).

The other components are as follows (see section 2 "Clopidogrel Viatris contains lactose"):

• Tablet core: hydroxypropylcellulose (E463), mannitol (E421), crospovidone (type A), citric acid monohydrate, microcrystalline cellulose, macrogol 6000, stearic acid, and talc
• Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), iron oxide red (E172), and titanium dioxide (E171).

Appearance of the product and contents of the pack

Clopidogrel Viatris film-coated tablets are pink, round, and biconvex.

They are presented in cartons containing:

• 7, 14, 28, 30, 30 x 1 (unit dose), 50, 50 x 1 (unit dose), 56, 84, 90 or 100 tablets

film-coated in PVC/PE/PVDC/Aluminum blisters, or

• 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets in PA/ALU/PVC/Aluminum blisters.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturers

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park,

Mulhuddart, Dublin 15,

DUBLIN

Ireland

Manufacturers:

Pharmathen S.A.

6 Dervenakion

15351 Pallini Attiki

Greece

Pharmathen International S.A

Industrial Park Sapes

Rodopi Prefecture, Block No 5

Rodopi 69300

Greece

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Date of the last revision of this leaflet {MM/YYYY}.

For detailed information about this medicine, please visit the website of the European Medicines Agency:http://www.ema.europa.eu/