Clopidogrel Viatris 75 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Clopidogrel Viatris 75 mg Film-coated Tablets

clopidogrel

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, 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 you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Clopidogrel Viatris is and what it is used for.
2. What you need to know before taking Clopidogrel Viatris.
3. How to take Clopidogrel Viatris.
4. Possible side effects.
5. How to store 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 platelet aggregation inhibitors. Platelets are very small cells found in the blood that clump together when blood clots. Platelet aggregation inhibitors prevent this clumping, thereby reducing the likelihood of blood clots (a process known as thrombosis).

Clopidogrel Viatris 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 Viatris 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 heart attack, stroke, or you have a condition called peripheral arterial disease, or
• you have experienced a severe type of chest pain known as “unstable angina” or “myocardial infarction” (heart attack). For the treatment of this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore proper blood flow. 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).
• you have experienced symptoms of a stroke that disappear within a short period of time (also known as 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 will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Clopidogrel Viatris with acetylsalicylic acid for this condition. Your doctor will have prescribed Clopidogrel Viatris plus acetylsalicylic acid if you cannot take “oral anticoagulants” and you do not have a high risk of serious bleeding.

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

Do not take Clopidogrel Viatris:

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

Warnings and precautions

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

• If you are at risk of bleeding because:
  • you have a condition that involves a 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 medication used to treat your condition.
• If you have a history of non-traumatic intracranial haemorrhage.

During treatment with Clopidogrel Viatris:

• 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 usual to stop. This is related to how the medicine works, as it prevents blood from forming clots. For minor cuts or injuries, such as shaving cuts, 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.

Other medicines and Clopidogrel Viatris

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 Viatris 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, another antiplatelet agent,
  • 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 used to treat diabetes,
• paclitaxel, a medicine used to treat 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 lower 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 Viatris in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. A single dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) should not cause any problems, but prolonged use under 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 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 Viatris. If you become pregnant while taking Clopidogrel Viatris, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

You must not breastfeed while taking this medicine.

If you are breastfeeding or plan 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 Viatris will affect your ability to drive or operate machinery.

Clopidogrel Viatris contains lactose

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

3. How to take Clopidogrel Viatris

Follow exactly the instructions for use of this medicine given 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 tablet of Clopidogrel Viatris taken orally once daily, with or without food, at the same time every day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe 300 mg or 600 mg of Clopidogrel Viatris (4 or 8 tablets of 75 mg) to be taken as a single dose at the beginning of treatment. After this, the recommended dose is one 75 mg tablet of Clopidogrel Viatris daily, as described above.

If you have experienced symptoms of a stroke that disappear within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe 300 mg of Clopidogrel Viatris (4 tablets of 75 mg) as a single dose at the beginning of treatment. After this, the recommended dose is one 75 mg tablet of Clopidogrel Viatris daily, as described above, taken together with acetylsalicylic acid for 3 weeks. After this period, 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 an increased risk of bleeding.

If you forget to take Clopidogrel Viatris

If you forget to take a dose of Clopidogrel Viatris but remember within 12 hours of the scheduled time, take the tablet immediately and then take the next dose at your usual time.

If you remember more than 12 hours after the scheduled time, simply take the next dose at your usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Clopidogrel Viatris

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 adverse effects

Like all medicines, Clopidogrel Viatris can have adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

• fever, signs of infection, or extreme 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 commonly reported adverse effect with Clopidogrel Viatris is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, or blood in the 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 Viatris

If you cut yourself or sustain a wound, bleeding may take longer than usual to stop. This is related to the medicine’s mechanism of action, as it prevents blood from forming clots. For minor cuts or wounds, such as those occurring during 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 adverse effects include:

Frequent adverse effects (may affect up to 1 in 10 people):

diarrhoea, abdominal pain, indigestion, or heartburn.

Uncommon adverse 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 or numbness sensations.

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

dizziness, enlargement of the breasts in men.

Very rare adverse 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, a sensation of generalized warmth with sudden general discomfort up to fainting); swelling of the mouth; blisters on the skin, skin allergy; inflammation of the mouth lining (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste.

Adverse effects with unknown frequency (cannot be estimated from available data): Hypersensitivity reactions with chest or abdominal pain, symptoms of persistent low blood sugar levels.

In addition, your doctor may observe changes in your blood or urine test results.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Viatris

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

Do not use this medicine after the expiry date stated on the packaging and on the blister, after EXP. The expiry date refers to 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, no special storage conditions are required.

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

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

6. Contents of the pack and other information

Composition of Clopidogrel Viatris

The active substance 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), 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 cardboard packs 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/Aluminium blisters, or

• 7, 14, 28, 30, 50, 56, 84, 90 or 100 film-coated tablets

in PA/ALU/PVC/Aluminium blisters.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation 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

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorisation Holder.

Date of last review of this leaflet {MM/YYYY}.

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