Clopidogrel Viatris

Patient Information Leaflet

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 be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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
antiplatelet agents. Platelets are microscopic blood components that clump together during blood
clotting. By preventing this clumping, antiplatelet medicines reduce the likelihood of blood clot
formation (a process known as thrombosis).
Clopidogrel Viatris is taken by adults to prevent the formation of blood clots (thrombi) in hardened
blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic
events (such as stroke, heart attack, or death).
Clopidogrel Viatris has been prescribed to you to help prevent blood clots and to reduce the risk of
these serious events because:

• you have a condition known as hardening of the arteries (also called atherosclerosis), and
• you have previously had a heart attack, stroke, or a condition known as peripheral arterial disease, or
• you have previously suffered from a severe type of chest pain known as “unstable angina” or “myocardial infarction” (heart attack). To treat this condition, your doctor may have inserted a stent into the blocked or narrowed artery to restore 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 clotting),
• you have experienced stroke symptoms that disappeared within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may prescribe you acetylsalicylic acid starting within 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 the progression of existing ones. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Clopidogrel Viatris and acetylsalicylic acid in treating this condition. If you cannot take “oral anticoagulants” and do not have an increased risk of bleeding, your doctor may have prescribed you Clopidogrel Viatris plus acetylsalicylic acid.

2. What you need to know before taking Clopidogrel Viatris

Do not take Clopidogrel Viatris:

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

If you think any of these situations apply to you, or if you are unsure, consult your doctor before taking Clopidogrel Viatris.
Warnings and precautions
If any of the conditions listed below apply to you, inform your doctor before taking Clopidogrel Viatris:

• if you have an increased risk of bleeding, such as:
• a medical condition that puts you at risk of internal bleeding (e.g. gastric ulcer)
• a blood disorder that makes you prone to internal bleeding (bleeding within any tissue, organ, or joint of the body)
• a recent severe injury
• a recent surgical procedure (including dental surgery)
• a planned surgical procedure (including dental surgery) within the next seven days
• if you have had a blood clot in a brain artery (ischemic stroke) within the last 7 days
• if you have kidney or liver disease
• if you have had an allergy or reaction to any medicine used to treat your condition
• if you have previously had a non-traumatic brain hemorrhage.

While taking Clopidogrel Viatris:

• You must inform your doctor if you are scheduled for surgery (including dental surgery)
• You must inform your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and skin bruising appearing as small red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”)
• If you get a cut or injury, it may take longer than usual for the bleeding to stop. This is due to how the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, such as shaving or minor cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 4 “Possible side effects”)
• Your doctor may prescribe blood tests for you

Children and adolescents
Do not give this medicine to children as it is not effective.
Other medicines and Clopidogrel Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Some medicines may affect the use of Clopidogrel Viatris or vice versa.
You must inform your doctor precisely if you are taking:

• medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, or a non-steroidal anti-inflammatory drug, generally used to treat painful and/or inflammatory conditions of muscles or joints, or heparin or any other injectable medicine used to reduce blood clotting, or ticlopidine or other antiplatelet agents, or a selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines usually used to treat depression, or rifampicin (used to treat serious infections),
• omeprazole or esomeprazole, medicines used to treat stomach problems,
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz or other antiretroviral medicines (used to treat HIV infection), carbamazepine, a medicine used to treat certain 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: while taking 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 had severe chest pain (unstable angina or heart attack), a transient ischemic attack, or a mild ischemic 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. Occasional use of acetylsalicylic acid (not more than 1,000 mg within 24 hours) should generally not cause problems, but prolonged use in other circumstances should be discussed with your doctor.
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 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 recommended not to take Clopidogrel Viatris during pregnancy.
You must not breastfeed while taking this medicine.
If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that Clopidogrel Viatris will affect your ability to drive or use machinery.
Clopidogrel Viatris contains lactose:
If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), consult your doctor before taking this medicine.
Clopidogrel Viatris contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Clopidogrel Viatris

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose, including for patients with a condition called “atrial fibrillation”
(irregular heartbeat), is one 75 mg tablet of Clopidogrel Viatris per day, 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 an initial dose of 300 mg or 600 mg of Clopidogrel Viatris (4 or 8 tablets of 75 mg) once at the beginning of treatment.
Afterwards, the recommended dose is one 75 mg tablet of Clopidogrel Viatris per day, as described previously.
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 you an initial dose of 300 mg of Clopidogrel Viatris (4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg tablet of Clopidogrel Viatris per day, as described above, in combination with acetylsalicylic acid for 3 weeks. Afterwards, your doctor will prescribe either Clopidogrel Viatris alone or acetylsalicylic acid alone.
Clopidogrel Viatris should be taken for as long as your doctor considers it necessary.
If you take more Clopidogrel Viatris than you should
Contact your doctor or the nearest emergency department due to the 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 usual time, take one tablet immediately and then take the next dose at the usual time.
If more than 12 hours have passed, simply take the usual single dose at the regular 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 has told you to do so. Before stopping, contact your doctor or pharmacist.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any of the following occur, contact your doctor immediately:

• fever, signs of infection, or severe weakness. These effects 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 rash, itching, skin blisters. These may be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Viatris is bleeding.
Bleeding may present as gastrointestinal bleeding (in the stomach or intestines), easy bruising, haematomas (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. In rare cases, bleeding in the eye, intracranial bleeding, in the lungs or in the joints has also been reported.
If you experience prolonged bleeding while taking Clopidogrel Viatris
If you cut yourself or are injured, it may take longer than usual for the bleeding to stop. This is due to the way the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, such as shaving cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 2 “Warnings and precautions”).
Other side effects include:
Common side effects (may occur in up to 1 in 10 people):
Diarrhoea, abdominal pain, indigestion or stomach burning.
Uncommon side effects (may occur in up to 1 in 100 people):
Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, skin rash, itching, dizziness, tingling and numbness sensations.
Rare side effects (may occur in up to 1 in 1,000 people):
Vertigo, breast enlargement in men.
Very rare side effects (may occur in 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, widespread feeling of warmth with sudden general malaise up to fainting), swelling of the mouth, skin blisters, skin allergy, mouth pain (stomatitis), decreased blood pressure, confusion, hallucinations, joint pain; muscle pain; taste disturbances or loss of taste.
Side effects with unknown frequency (frequency cannot be estimated from the available data): hypersensitivity reactions with chest or abdominal pain, persistent symptoms of hypoglycaemia.
In addition, your doctor may have detected changes in blood or urine test results.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. This includes any possible side effect not listed in this patient information leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 outer packaging and on the
blister, after Exp. The expiry date refers to the last day of that month.
Store below 25°C.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine 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 other information

What Clopidogrel Viatris contains
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as besylate).
The other components are (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, sodium stearyl fumarate
• Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), iron oxide red (E172), titanium dioxide (E171).

Description of the appearance of Clopidogrel Viatris and pack sizes
Clopidogrel Viatris film-coated tablets are pink, round and biconvex.
They are supplied in:

• PVC/PE/PVDC/aluminium blisters in 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

Not all 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
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288
България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)
Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100
Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74
Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300
Eesti* Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00
Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 210 0 100 002 Tel: +43 1 86390
España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z.o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00
France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 214 127 200
Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000
Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180
Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100
Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0)2 612 46921 Puh/Tel: +358 20 720 9555
Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: + 46 (0)8 630 19 00
Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

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