Clopidogrel and acetylsalicylic acid Viatri: detailed information

Package leaflet: Information for the patient

Clopidogrel and Acetylsalicylic Acid Viatris 75 mg/75 mg film-coated tablets, mg/100 mg film-coated tablets

clopidogrel/acetylsalicylic acid
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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 other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Clopidogrel and Acetylsalicylic Acid Viatris is and what it is used for
What you need to know before taking Clopidogrel and Acetylsalicylic Acid Viatris
How to take Clopidogrel and Acetylsalicylic Acid Viatris
Possible side effects
How to store Clopidogrel and Acetylsalicylic Acid Viatris
Contents of the pack and other information

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

Clopidogrel and Acetylsalicylic Acid Viatris contains clopidogrel and acetylsalicylic acid (ASA), and
belongs to a group of medicines called antiplatelet agents. Platelets are microscopic components of
blood that clump together during blood clotting.
By preventing this clumping in certain types of blood vessels (called arteries), antiplatelet agents
reduce the likelihood of blood clots forming (a process known as atherothrombosis).
Clopidogrel and Acetylsalicylic Acid Viatris is taken by adults to prevent the formation of
blood clots in hardened arteries, which can cause atherothrombotic events (such as stroke,
heart attack, or death).
Clopidogrel and Acetylsalicylic Acid Viatris has been prescribed to you instead of two separate medicines,
clopidogrel and ASA, to help prevent blood clots because you have previously suffered from a severe type of chest pain known as “unstable angina” or a heart attack (myocardial infarction). To treat this condition, your doctor may have inserted a stent into the blocked or narrowed artery to restore blood flow.

2. What you should know before taking Clopidogrel and Acetylsalicylic Acid Viatris

Do not take Clopidogrel and Acetylsalicylic Acid Viatris

If you are allergic to clopidogrel, acetylsalicylic acid (ASA), or any of the other ingredients of this medicine (listed in section 6).
If you are allergic to other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), generally used to treat painful and/or inflammatory conditions of muscles or joints.
If you have a medical condition that includes the combination of asthma, nasal discharge (runny nose), and nasal polyps (a type of growth in the nose).
If you have active bleeding, such as a stomach ulcer or bleeding in an area of the brain.
If you have severe liver disease.
If you have severe kidney disease.
If you are in the last trimester of pregnancy.

Warnings and precautions
If you have any of the conditions listed below, inform your doctor before taking
Clopidogrel and Acetylsalicylic Acid Viatris:

if you have a risk of bleeding such as:
- a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer),
- a blood disorder that makes you prone to internal bleeding (bleeding inside any tissue, organ, or joint of the body),
- a recent serious injury,
- a recent surgical procedure (including dental surgery),
- a planned surgical procedure (including dental surgery) within the next 7 days,
if you have had a blood clot in an artery of the brain (ischaemic stroke) within the last 7 days,
if you have kidney or liver disease,
if you have previously suffered from asthma or have had allergic reactions including a reaction to any medicine used to treat your condition,
if you have gout,
if you drink alcohol, due to an increased risk of gastrointestinal bleeding or injury,
if you have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency, due to the risk of a particular type of anaemia (low red blood cell count).

While taking Clopidogrel and Acetylsalicylic Acid Viatris:

You must inform your doctor
- if you need to undergo surgery (including dental surgery),
- if you experience stomach or abdominal pain or bleeding in the stomach or intestines (red or black stools).
You must inform your doctor immediately if you develop a medical condition known as Thrombotic Thrombocytopenic Purpura (TTP), which includes fever and bruising under the skin appearing as red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4).
If you cut or injure yourself, 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 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.
Inform your doctor immediately if you develop symptoms or signs of drug reaction with eosinophilia and systemic symptoms (DRESS), which may include flu-like symptoms and a skin rash with fever, swollen lymph nodes, and an increase in a type of white blood cells (eosinophilia). Other abnormal blood test results may include (but are not limited to) increased levels of liver enzymes (see section 4 “Possible side effects”).

Children and adolescents
The use of Clopidogrel and Acetylsalicylic Acid Viatris is not recommended in children and adolescents under 18 years of age. There is a possible association between acetylsalicylic acid (ASA) and Reye's syndrome when medicines containing ASA are taken by children or adolescents with a viral infection. Reye's syndrome is a very rare disease that can be fatal.

Other medicines and Clopidogrel and Acetylsalicylic Acid Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the use of Clopidogrel and Acetylsalicylic Acid Viatris or vice versa.
You must especially inform your doctor if you are taking:

medicines that may increase your risk of bleeding such as:
- oral anticoagulants, medicines used to reduce blood clotting,
- ASA or another non-steroidal anti-inflammatory drug (NSAID), generally used to treat painful and/or inflammatory conditions of muscles or joints,
- heparin or any other injectable medicine used to reduce blood clotting,
- ticlopidine or other antiplatelet agents,
- a selective serotonin reuptake inhibitor (including, but not limited to, fluoxetine or fluvoxamine), medicines normally used to treat depression,
- rifampicin (used to treat serious infections),
omeprazole or esomeprazole, medicines used to treat stomach problems,
methotrexate, a medicine used to treat a serious joint disease (rheumatoid arthritis) or a skin condition (psoriasis),
acetazolamide, a medicine used to treat glaucoma (increased eye pressure) or epilepsy or to increase urine flow,
probenecid, benzbromarone or sulfinpyrazone, medicines used to treat gout,
fluconazole or voriconazole, medicines used to treat fungal infections,
efavirenz or tenofovir, or other antiretroviral medicines (used for HIV infections),
valproic acid, valproate or carbamazepine, medicines used to treat certain forms of epilepsy,
the varicella vaccine, a medicine used to prevent chickenpox or shingles, within 6 weeks of taking Clopidogrel and Acetylsalicylic Acid Viatris, or if you currently have an infection caused by chickenpox or herpes zoster (see section 2 “Children and adolescents”),
moclobemide, a medicine used to treat depression,
repaglinide, a medicine used to treat diabetes,
paclitaxel, a medicine used to treat cancer,
nicorandil, a medicine used to treat heart-related chest pain,
opioids: while being treated with clopidogrel, inform your doctor before they prescribe any opioid (used to treat severe pain),
rosuvastatin (used to lower cholesterol levels).

While taking Clopidogrel and Acetylsalicylic Acid Viatris, you must stop any other treatment containing clopidogrel.
Occasional use of ASA (not exceeding 1,000 mg in 24 hours) generally should not cause problems, but prolonged use of ASA under other circumstances should be discussed with your doctor or pharmacist.
Metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that clump together to form a blood clot) when taken simultaneously. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection.

Pregnancy and breastfeeding
Do not use Clopidogrel and Acetylsalicylic Acid Viatris during the third trimester of pregnancy.
It is preferable not to use this medicine during the first and second trimesters of pregnancy.
If you are pregnant or suspect you may be pregnant, inform your doctor or pharmacist before taking Clopidogrel and Acetylsalicylic Acid Viatris. If you become pregnant while taking Clopidogrel and Acetylsalicylic Acid Viatris, consult your doctor immediately, as it is recommended not to take Clopidogrel and Acetylsalicylic Acid Viatris during pregnancy.
You must not breastfeed while using 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 and Acetylsalicylic Acid Viatris will affect your ability to drive or use machines.

Clopidogrel and Acetylsalicylic Acid Viatris contains lactose
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Clopidogrel and Acetylsalicylic Acid Viatris contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

Clopidogrel and Acetylsalicylic Acid Viatris 75 mg/100 mg film-coated tablets contain red allura AC
Red allura AC may cause allergic reactions.

3. How to take Clopidogrel and Acetylsalicylic Acid Viatris

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one tablet of Clopidogrel and Acetylsalicylic Acid Viatris daily, taken orally with a glass of water, either during or independent of meals.
You should take the medicine at the same time each day.
Depending on your condition, your doctor will determine how long you need to take Clopidogrel and Acetylsalicylic Acid Viatris. If you have had a heart attack, the medicine should be prescribed for at least 4 weeks. In any case, Clopidogrel and Acetylsalicylic Acid Viatris should be taken for as long as your doctor considers necessary.

If you take more Clopidogrel and Acetylsalicylic Acid Viatris than you should
Contact your doctor or the nearest hospital emergency department, as there is an increased risk of bleeding.

If you forget to take Clopidogrel and Acetylsalicylic Acid Viatris
If you forget to take a dose of Clopidogrel and Acetylsalicylic Acid Viatris but remember within 12 hours of your usual time, take one tablet immediately and then take the next dose at your usual time.
If more than 12 hours have passed, simply take the next dose at your regular time.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Clopidogrel and Acetylsalicylic Acid Viatris
Do not stop treatment unless your doctor tells you to. Before stopping or restarting treatment, contact your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience:

fever, signs of infection or severe tiredness. 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 in the mouth or skin problems such as rash, itching, blisters. These may be signs of an allergic reaction,
a serious reaction affecting the skin, blood and internal organs (DRESS) (see section 2 “Warnings and precautions”).

The most common side effect reported with Clopidogrel and Acetylsalicylic Acid Viatris is
bleeding. Bleeding may present as bleeding in the stomach or intestines,
bruising, haematomas (unusual or extensive bruising under the skin), nosebleeds,
blood in the urine. In rare cases, bleeding in the eye, intracranial
(especially in the elderly), in the lungs and in the joints has also been reported.
If you experience prolonged bleeding while taking Clopidogrel and Acetylsalicylic Acid Viatris
If you cut or injure yourself, it may take longer than usual for the
bleeding to stop. This is due to the way the medicine works, as it prevents the
formation of blood clots. For minor cuts and 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 patients):
Diarrhoea, abdominal pain, indigestion and stomach burning.
Uncommon side effects (may occur in up to 1 in 100 patients):
Headache, gastric ulcer, vomiting, nausea, constipation, excessive gas in the stomach or
intestine, skin rash, itching, dizziness, tingling and numbness sensations.
Rare side effects (may occur in up to 1 in 1,000 patients):
Dizziness, breast enlargement in males.
Very rare side effects (may occur in up to 1 in 10,000 patients):
Jaundice (yellowing of the skin and/or eyes); burning sensation in the stomach and/or oesophagus (throat), 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 in the mouth; skin blisters; skin allergy; mouth burning (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste, inflammation of small arteries.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
Perforated ulcer, ringing in the ears, hearing loss, sudden life-threatening allergic reactions or hypersensitivity reactions with abdominal or chest pain, nephropathy, hypoglycaemia, gout (a condition characterised by joint pain and swelling caused by uric acid crystals), worsening of food allergies, and a particular type of anaemia (low number of red blood cells in the blood) (see section 2 “Warnings and precautions”), swelling.
In addition, your doctor may detect changes in blood or urine tests.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clopidogrel and Acetylsalicylic Acid Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and bottle 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Clopidogrel and Acetylsalicylic Acid Viatris contains
Clopidogrel and Acetylsalicylic Acid Viatris 75 mg/75 mg film-coated tablet
The active substances are clopidogrel and acetylsalicylic acid. Each tablet contains 75 mg of
clopidogrel (as hydrogen sulfate) and 75 mg of acetylsalicylic acid.
The other components are:

tablet core: microcrystalline cellulose, lactose (see section 2 “Clopidogrel and Acetylsalicylic Acid Viatris contains lactose”), sodium croscarmellose, hydroxypropylcellulose, anhydrous colloidal silica, talc, hydrogenated castor oil, pregelatinized starch, stearic acid, yellow iron oxide (E172).
tablet coating: hypromellose, triacetin, talc, poly(vinyl alcohol) (partially hydrolysed), titanium dioxide (E171), glycerol monocaprylocaprate (E422), sodium lauryl sulfate, yellow iron oxide (E172)

Clopidogrel and Acetylsalicylic Acid Viatris 75 mg/100 mg film-coated tablet
The active substances are clopidogrel and acetylsalicylic acid. Each tablet contains 75 mg of
clopidogrel (as hydrogen sulfate) and 100 mg of acetylsalicylic acid.
The other components are:

tablet core: microcrystalline cellulose, lactose (see section 2 “Clopidogrel and Acetylsalicylic Acid Viatris contains lactose”), sodium croscarmellose, hydroxypropylcellulose, anhydrous colloidal silica, talc, hydrogenated castor oil, pregelatinized starch, stearic acid, yellow iron oxide (E172).
tablet coating: hypromellose, triacetin, talc, poly(vinyl alcohol) (partially hydrolysed), titanium dioxide (E171), glycerol monocaprylocaprate (E422), sodium lauryl sulfate,
allura red AC (E129) (see section 2 “Clopidogrel and Acetylsalicylic Acid Viatris
contains allura red AC”)

Description of the appearance of Clopidogrel and Acetylsalicylic Acid Viatris and contents of the
pack
The film-coated tablets of Clopidogrel and Acetylsalicylic Acid Viatris 75 mg/75 mg are yellow, oval-shaped, biconvex, with “CA2” printed on one side and “M” on the other side of the tablet.
The film-coated tablets of Clopidogrel and Acetylsalicylic Acid Viatris 75 mg/100 mg are pink, oval-shaped, biconvex, with “CA3” printed on one side and “M” on the other side of the tablet.
The tablets are supplied in blisters of 28 or 30 tablets, or in perforated unit dose blisters of 28 or 30 tablets, or in plastic bottles containing 100 tablets. The bottles contain a desiccant.
The desiccant must not be ingested.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturers:
McDermott Laboratories Limited, operating as Gerard Laboratories, operating as Mylan Dublin, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary.

For further information about this medicinal product, 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 Arcana Arzneimittel GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 416 2418

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 21 412 72 00

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Mylan Ireland 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.
Simi: +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

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