Clopidogrel / Acetylsalicylic acid Mylan - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Clopidogrel/A­cetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets Clopidogrel/A­cetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets clopidogrel/a­cetylsalicylic a­cid

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.

What is in this leaflet

• 1. What Clopidogrel/A­cetylsalicylic acid Mylan is and what it is used for

• 2. What you need to know before you take Clopidogrel/A­cetylsalicylic acid Mylan

• 3. How to take Clopidogrel/A­cetylsalicylic acid Mylan

• 4. Possible side effects

• 5. How to store Clopidogrel/A­cetylsalicylic acid Mylan

• 6. Contents of the pack and other information

1. What Clopidogrel/Acetylsalicylic acid Mylan is and what it is used for

Clopidogrel/A­cetylsalicylic acid Mylan contains clopidogrel and acetylsalicylic acid (ASA) and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping in some types of blood vessels (called arteries), antiplatelet medicinal products reduce the chances of blood clots forming (a process called atherothrombosis).

Clopidogrel/A­cetylsalicylic acid Mylan is taken by adults to prevent blood clots forming in hardened arteries which can lead to atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed Clopidogrel/A­cetylsalicylic acid Mylan in place of the two separate medicines, clopidogrel and ASA, to help prevent blood clots because you have experienced a severe type of chest pain known as ‘unstable angina’ or heart attack (myocardial infarction). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.

2. What you need to know before you take Clopidogrel/Acetylsalicylic acid Mylan

Do not take Clopidogrel/A­cetylsalicylic acid Mylan

• 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 products called non-steroidal anti-inflammatory products usually 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 polyps (a type of growth in the nose).
• if you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
• if you suffer from severe liver disease.
• if you suffer from severe kidney disease.
• if you are in your last trimester of pregnancy.

Warnings and precautions

If any of the situations mentioned below apply to you, you should tell your doctor before taking

Clopidogrel/A­cetylsalicylic acid Mylan:

• 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 tissues, organs or joints of your body).

• – a recent serious injury.

• – a recent surgery (including dental).

• – a planned surgery (including dental) in the next seven days.

• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred in the last seven days.
• if you have kidney or liver disease.
• if you have a history of asthma or allergic reactions including allergy to any medicine used to treat your disease.
• if you have gout.
• if you drink alcohol, because of the increased risk of bleeding or gastrointestinal injury.
• if you have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency

because of the risk of a particular form of anaemia (low number of red blood cells).

While you are taking Clopidogrel/A­cetylsalicylic acid Mylan

• You should tell your doctor
• if a surgery (including dental) is planned.
• if you have any stomach or abdominal pain or bleeding in the stomach or bowels (red stools

or black stools).

• You should also tell your doctor immediately if you develop a medical condition known as Thrombotic Thrombocytopenic Purpura or TTP that includes fever and bruising 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).
• If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects’).
• Your doctor may order blood tests.

Children and adolescents

Clopidogrel/A­cetylsalicylic acid Mylan is not intended for use in children or adolescents less than 18 years of age. There is a possible association between acetylsalicylic acid (ASA) and Reye’s Syndrome when products containing ASA are given to children or adolescents with a viral infection. Reye’s Syndrome is a very rare disease which can be fatal.

Other medicines and Clopidogrel/A­cetylsalicylic acid Mylan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some other medicines may influence the use of Clopidogrel/A­cetylsalicylic Mylan or vice versa You should specifically tell your doctor if you take

• 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 medicine usually used to treat painful and/or inflammatory conditions of muscle or joints,

• – heparin or any other injectable medicine used to reduce blood clotting,

• – ticlopidine, other antiplatelet agents,

• – a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,

• – rifampicin (used to treat severe infections).

• omeprazole or esomeprazole, medicines to treat upset stomach,
• methotrexate, a medicine used to treat severe joint disease (rheumatoid arthritis) or skin disease (psoriasis),
• acetazolamide, a medicine used to treat glaucoma (increased ocular pressure) or epilepsy or to increase urine flow,
• probenecid, benzbromarone, or sulfinpyrazone, medicines used to treat gout,
• fluconazole or voriconazole, medicines to treat fungal infections,
• anti-retroviral medicines (medicines used to treat HIV infections)
• valproic acid, valproate or carbamazepine, medicines to treat some forms of epilepsy,
• the varicella vaccine, a medicine used to prevent chickenpox or shingles, within 6 weeks of taking Clopidogrel/A­cetylsalicylic acid Mylan, or if you have active chickenpox or shingles infection (see section 2 ‘Children and adolescents’),
• moclobemide, medicine to treat depression,
• repaglinide, medicine to treat diabetes,
• paclitaxel, medicine to treat cancer,
• nicorandil, medicine to treat cardiac chest pain.
• opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioids treatment.

You should stop other clopidogrel treatment while you are taking Clopidogrel/A­cetylsalicylic acid Mylan.

An occasional use of ASA (no more than 1,000 mg in any 24-hour period) should generally not cause a problem, but prolonged use of ASA in other circumstances should be discussed with your doctor or pharmacist.

Metamizole (substance to decrease pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells sticking together and forming a blood clot), when taken concomitantly. Therefore, this combination should be used with caution in patients taking low dose aspirin for cardioprotection.

Pregnancy and breast-feeding

Do not take Clopidogrel/A­cetylsalicylic acid Mylan during third trimester of pregnancy.

It is preferable not to take this medicine during first and second trimesters of pregnancy.

If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel/A­cetylsalicylic acid Mylan. If you become pregnant while taking Clopidogrel/A­cetylsalicylic acid Mylan, consult your doctor immediately as it is recommended not to take Clopidogrel/A­cetylsalicylic acid Mylan while you are pregnant.

You should not breast-feed while using this medicine.

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Clopidogrel/A­cetylsalicylic acid Mylan should not affect your ability to drive or to use machines.

Clopidogrel/A­cetylsalicylic acid Mylan contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Clopidogrel/A­cetylsalicylic acid Mylan contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Clopidogrel/A­cetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets contain Allura Red AC Allura Red AC may cause allergic reactions.

3. How to take Clopidogrel/Acetylsalicylic acid Mylan

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet of Clopidogrel/A­cetylsalicylic acid Mylan per day to be taken orally with a glass of water, with or without food.

You should take your medicine at the same time each day.

Depending on your condition, your doctor will determine the length of time for which you need to take Clopidogrel/A­cetylsalicylic acid Mylan. If you have had a heart attack, it should be prescribed for at least four weeks. In any case, you should take it for as long as your doctor continues to prescribe it.

If you take more Clopidogrel/A­cetylsalicylic acid Mylan than you should

Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.

If you forget to take Clopidogrel/A­cetylsalicylic acid Mylan

If you forget to take a dose of Clopidogrel/A­cetylsalicylic acid Mylan, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.

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

If you stop taking Clopidogrel/A­cetylsalicylic acid Mylan

Do not stop the treatment unless your doctor tells you so. Contact your doctor before stopping or restarting your treatment.

If you have any further questions on 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 extreme tiredness. These may be due to rare decrease of some blood cells.
• signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion (see section 2 ‘Warnings and precautions’).
• swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be the signs of an allergic reaction.

5. How to store Clopidogrel/Acetylsalicylic acid Mylan

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, blister and on the bottle after EXP. The expiry date refers to the last day of that month.

Store below 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Clopidogrel/A­cetylsalicylic acid Mylan contains

Clopidogrel/A­cetylsalicylic acid Mylan 75 mg/75 mg film-coated tablet

The active substances are clopidogrel and acetylsalicylic acid. Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic a­cid.

The other ingredients are:

Tablet core: microcrystalline cellulose, lactose (see section 2 ‘Clopidogrel/A­cetylsalicylic acid Mylan contains lactose’), croscarmellose sodium, hydroxypropyl­cellulose, colloidal anhydrous silica, talc, hydrogenated castor oil, pregelatinized starch, stearic acid, iron oxide yellow (E172).

Tablet coating: hypromellose, triacetin, talc, poly (vinyl alcohol) (partially hydrolysed), titanium dioxide (E171), glycerol monocaprylocaprate (E422), sodium lauril sulfate, iron oxide yellow

(E172)

Clopidogrel/A­cetylsalicylic acid Mylan 75 mg/100 mg film-coated tablet

The active substances are clopidogrel and acetylsalicylic acid. Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic a­cid.

The other ingredients are:

Tablet core : microcrystalline cellulose, lactose (see section 2 ‘Clopidogrel/A­cetylsalicylic acid Mylan contains lactose’), croscarmellose sodium, hydroxypropyl­cellulose, colloidal anhydrous silica, talc, hydrogenated castor oil, pregelatinized starch, stearic acid, iron oxide yellow (E172).

Tablet coating : hypromellose, triacetin, talc, poly (vinyl alcohol) (partially hydrolysed), titanium dioxide (E171), glycerol monocaprylocaprate (E422), sodium lauril sulfate, Allura Red AC (E129) (see section 2 ‘Clopidogrel/A­cetylsalicylic acid Mylan contains Allura Red AC’)

What Clopidogrel/Acetylsalicylic acid Mylan looks like and contents of the pack

Clopidogrel/A­cetylsalicylic acid Mylan 75 mg/75 mg film-coated tablets are yellow, oval shaped biconvex tablets imprinted with CA2 on one side of the tablet and M on the other side.

Clopidogrel/A­cetylsalicylic acid Mylan 75 mg/100 mg film-coated tablets are pink, oval-shaped biconvex, tablets imprinted with CA3 on one side of the tablet and M on the other side.

The tablets are provided in blister packs of 28 or 30 tablets or perforated unit dose blister packs of 28 or 30 tablets or plastic bottles of 100 tablets. The bottles contain a desiccant. The desiccant should not be eaten.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Pharmaceuticals Limited

Damastown Industrial Park,

Mulhuddart, Dublin 15,

DUBLIN

Ireland

Manufacturers

McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00	Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288
E'b.ii'apusi Maä.iaH EOOfl Tea: +359 2 44 55 400	Luxembourg/Lu­xemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
Česká republika Mylan Healthcare CZ s.r.o. Tel: + 420 222 004 400	Magyarország Mylan EPD Kft Tel: + 36 1 465 2100
Danmark Viatris ApS Tlf: +45 28 11 69 32	Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74

Deutschland Mylan Healthcare GmbH Tel: +49 800 0700 800	Nederland Mylan BV Tel: +31 (0)20 426 3300
Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 052	Norge Mylan Healthcare Norge AS Tel: + 47 66 75 33 00
EZZáóa Generics Pharma Hellas EnE TnÀ: +30 210 993 6410	Österreich Arcana Arzneimittel GmbH Tel: +43 1 416 2418
España Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712	Polska Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 00

France Mylan S.A.S Tel: +33 4 37 25 75 00	Portugal Mylan, Lda. Tel: + 351 21 412 72 56
Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599	România BGP Products SRL Tel: +40 372 579 000
Ireland Mylan Ireland Limited Tel: +353 1 8711600	Slovenija Mylan Healthcare d.o.o Tel: + 386 1 23 63 180
Ísland Icepharma hf Símí: +354 540 8000	Slovenská republika Mylan s.r.o. Tel: +421 2 32 199 100
Italia Mylan Italia S.r.l. Tel: + 39 02 612 46921	Suomi/Finland Mylan Finland OY Puh/Tel: +358 20 720 9555
Kúnpo^ Varnavas Hadiipanavis Ltd Tn^: + 357 2220 7700	Sverige Mylan AB Tel: + 46 855 522 750
Latvija Mylan Healthcare SIA Tel: +371 676 055 80	United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711600

This leaflet was last revised in {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency web site:

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