CLOPIDOGREL VIATRIS 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Clopidogrel Viatris 75 mg Film-Coated Tablets

clopidogrel

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Clopidogrel Viatris contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that help it to clot. Antiplatelet agents prevent platelet clumping, reducing the risk of blood clots (a process called thrombosis).

Clopidogrel Viatris is given to adults to prevent blood clots (thrombi) in the blood vessels (arteries) that supply the brain and heart, a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

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

• a condition that leads to hardening of the arteries (also known as atherosclerosis),
• and you have previously experienced a heart attack, stroke, or suffer from a condition known as peripheral arterial disease, or
• you have experienced a severe form of chest pain known as "unstable angina" or "heart attack" (myocardial infarction). For the treatment of this condition, your doctor may need to insert a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed aspirin for you.
• you have experienced symptoms of a stroke that have disappeared within a short period (also known as a transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also administer aspirin to you 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) that prevent the formation of new clots and prevent existing clots from growing. You would have been told that "oral anticoagulants" are more effective than aspirin or the combined use of Clopidogrel Viatris and aspirin for this condition. Your doctor would have prescribed Clopidogrel Viatris plus aspirin for you if you cannot take "oral anticoagulants" and do not have a high risk of major bleeding.

2. What you need to know before you take Clopidogrel Viatris

Do not take Clopidogrel Viatris:

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

If you think any of these apply to you, or if you are in any doubt, consult your doctor before taking Clopidogrel Viatris.

Warnings and precautions

Before starting treatment with Clopidogrel Viatris, inform your doctor if you:

• have a risk of bleeding because:
• • you have a disease that involves a risk of internal bleeding (such as a stomach ulcer)
  • you have a blood disorder that makes you prone to internal bleeding (bleeding in tissues, organs, or joints of the body)
  • you have recently had a serious injury
  • you have recently had surgery (including dental surgery)
  • you are going to have surgery (including dental surgery) in the next seven days
• have had a clot in an artery of the brain (ischaemic stroke) in the last seven days
• suffer from liver or kidney disease
• have had an allergy or reaction to any medicine used to treat your condition
• have had a non-traumatic bleeding in the brain

During treatment with Clopidogrel Viatris:

• tell your doctor if you are going to have surgery (including dental surgery)
• tell your doctor immediately if you develop a disorder (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bleeding under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice)) (see section 4 "Possible side effects")
• if you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is linked to the way the medicine works, as it prevents the blood from clotting. For minor cuts or injuries, such as a cut while shaving, this is of no concern. 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 medicine should not be given to children because it is not effective.

Other medicines and Clopidogrel Viatris

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

Some medicines may influence the use of Clopidogrel Viatris or vice versa.

You should specifically tell 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, medicines used to treat pain and/or inflammation of muscles or joints
  • heparin, or any other injectable medicine used to reduce blood clotting
  • ticlopidine, another antiplatelet agent
  • a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other medicines of the same type), medicines used to treat depression
  • rifampicin (used for severe infections)
• omeprazole or esomeprazole, medicines used to treat stomach upset
• 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 some forms of epilepsy
• moclobemide, a medicine used to treat depression
• repaglinide, a medicine used to treat diabetes
• paclitaxel, a medicine used to treat 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 lower cholesterol levels)

If you have experienced severe chest pain (unstable angina or heart attack), a transient ischaemic attack, or a mild ischaemic stroke, you may have been prescribed Clopidogrel Viatris in combination with aspirin. A dose of aspirin given 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 Viatris with food and drink

Clopidogrel Viatris can be taken with or without food.

Pregnancy and breast-feeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or think you may be pregnant, inform your doctor or pharmacist before taking Clopidogrel Viatris. If you become pregnant while taking Clopidogrel Viatris, consult your doctor immediately, as it is not recommended to take clopidogrel during pregnancy.

Do not breast-feed while taking this medicine.

If you are breast-feeding or plan to breast-feed, inform your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Clopidogrel Viatris is unlikely to affect your ability to drive or use machines.

Clopidogrel Viatris contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Clopidogrel Viatris

Follow the exact instructions for administration of this medicine as indicated by your doctor or pharmacist. If you are 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, to be 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 you 300 mg or 600 mg of Clopidogrel Viatris (4 or 8 tablets of 75 mg) 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 stroke that have disappeared within a short period (also known as a transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe you 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 aspirin for 3 weeks. After that, your doctor will prescribe either Clopidogrel Viatris alone or aspirin alone.

You should take Clopidogrel Viatris for as long as your doctor prescribes it for you.

If you take more Clopidogrel Viatris than you should

Contact your doctor or go to the nearest hospital emergency department immediately, 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 you should have taken the medicine, 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 forgotten tablet.

If you stop taking Clopidogrel Viatris

Do not stop treatment unless your doctor tells you to. Contact your doctor or pharmacist before stopping treatment with this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clopidogrel Viatris can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience:

• fever, signs of infection, or extreme tiredness. 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 pinpoint dots 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 common side effect reported with Clopidogrel Viatris 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 of bleeding in the eyes, brain, lungs, or joints have also been reported.

If you experience prolonged bleeding while taking Clopidogrel Viatris

If you cut or injure yourself, it may take a little longer than usual for the bleeding to stop. This is linked to the way the medicine works, as it prevents the blood from clotting. For minor cuts or injuries, such as a cut while shaving, this is of no 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, rash, itching, dizziness, feeling of tingling and numbness.

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; generalised allergic reactions (for example, a feeling of heat with general discomfort and dizziness); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mouth mucosa (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

Side effects with frequency not known (cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, symptoms of low blood sugar levels that persist.

Your doctor may also observe changes in the results of your blood or urine tests.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Clopidogrel Viatris

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

Do not use this medicine after the expiry date which is stated on the carton and blister, after EXP. The expiry date is the last day of the month stated.

See the storage conditions in the carton.

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

When Clopidogrel Viatris is presented in any aluminium blister, no special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Clopidogrel Viatris Composition

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

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), red iron oxide (E172), and titanium dioxide (E171).

Product Appearance and Package Contents

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

They are available in cardboard boxes containing:

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

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

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder.

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

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/