Clopidogrel Taw Pharma (previously Clopidogrel Mylan) - patient leaflet, side effects, dosage

1. What Clopidogrel Taw Pharma is and what it is used for

Clopidogrel Taw Pharma contains clopidogrel 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, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).

Clopidogrel Taw Pharma is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed Clopidogrel Taw Pharma to help prevent blood clots and reduce the risk of these severe events because:

• - You have a condition of hardening of arteries (also known as atherosclerosis), and

• - You have previously experienced a heart attack, stroke or have a condition known as 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 effective blood flow. You may also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.

• - You have experienced symptoms of a stroke which go away within a short period of time (also

known as transient ischaemic attack) or an ischaemic stroke mild in severity. You may also be given acetylsalicylic acid by your doctor 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 new clots from forming and prevent existing clots from growing. You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid or the combined use of Clopidogrel Taw Pharma and acetylsalicylic acid for this condition. Your doctor should have prescribed Clopidogrel Taw Pharma plus acetylsalicylic acid if you cannot take ‘oral anticoagulants’ and you do not have a risk of major bleeding.

2. What you need to know before you take Clopidogrel Taw Pharma

Do not take Clopidogrel Taw Pharma

• if you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in

section 6);

• 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 think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Taw Pharma.

Warnings and precautions

Talk to your doctor before taking Clopidogrel Taw Pharma if any of the situations mentioned below apply to you:

• 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 within the

last seven days.

• if you have kidney or liver disease.
• if you have had an allergy or reaction to any medicine used to treat your disease.
• if you had a past medical history of non-traumatic brain haemorrhage.

While you are taking Clopidogrel Taw Pharma:

• You should tell your doctor if a surgery (including dental) is planned.
• You should also tell your doctor immediately if you develop a medical condition (also 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 ‘Possible side effects’).

• 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

Do not give this medicine to children because it does not work.

Other medicines and Clopidogrel Taw Pharma

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

Some other medicines may influence the use of Clopidogrel Taw Pharma or vice versa.

You should specifically tell your doctor if you take

• – medicines that may increase your risk of bleeding such as:

o oral anticoagulants, medicines used to reduce blood clotting,

o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints,

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

o ticlopidine, other antiplatelet agent,

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

o rifampicin (used to treat severe infections)

• – omeprazole or esomeprazole, medicines to treat upset stomach,

• – fluconazole or voriconazole, medicines to treat fungal infections,

• – efavirenz, or other anti-retroviral medicines (used to treat HIV infections),

• – carbamazepine, a medicine to treat some forms of epilepsy,

• – moclobemide, medicine to treat depression,

• – repaglinide, medicine to treat diabetes,

• – paclitaxel, medicine to treat cancer,

• – opioids: while you are treated with clopidogrel, you should inform your doctor before being

prescribed any opioid (used to treat severe pain).

If you have experienced severe chest pain (unstable angina or heart attack), transient ischaemic attack or ischaemic stroke in mild severity, you may be prescribed Clopidogrel Taw Pharma in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

Clopidogrel Taw Pharma with food and drink

Clopidogrel Taw Pharma may 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 suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Taw Pharma. If you become pregnant while taking Clopidogrel Taw Pharma, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

You should not breast-feed while taking 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 Taw Pharma is unlikely to affect your ability to drive or to use machines.

Clopidogrel Taw Pharma contains hydrogenated castor oil

This may cause stomach upset or diarrhoea.

3. How to take Clopidogrel Taw Pharma

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, including for patients with a condition called ‘atrial fibrillation’ (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Taw Pharma per day to be taken orally with or without food, and at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg or 600 mg of Clopidogrel Taw Pharma (4 or 8 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel Taw Pharma per day as described above.

If you have experienced symptoms of a stroke which go away within a short period of time (also known as transient ischaemic attack) or an ischaemic stroke mild in severity, your doctor may give you 300 mg of Clopidogrel Taw Pharma (4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel Taw Pharma per day as described above with acetylsalicylic acid for 3 weeks. Then the physician would prescribe either Clopidogrel Taw Pharma alone or acetylsalicylic acid alone.

You should take Clopidogrel Taw Pharma for as long as your doctor continues to prescribe it.

If you take more Clopidogrel Taw Pharma 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 Taw Pharma

If you forget to take a dose of Clopidogrel Taw Pharma, 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.

For the 7, 14, 28, 56, 84 tablets (calendar blister) pack sizes, you can check the day on which you last took a tablet of Clopidogrel Taw Pharma by referring to the calendar printed on the blister

If you stop taking Clopidogrel Taw Pharma

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

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.

The most common side effect reported with Clopidogrel Taw Pharma is bleeding.

Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.

If you experience prolonged bleeding when taking Clopidogrel Taw Pharma

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 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, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.

Rare side effect (may affect up to 1 in 1000 people):

Vertigo, enlarged breasts in males.

Very rare side effects (may affect up to 1 in 10,000 people):

Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of food.

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

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

Reporting of side effects

If you get 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 inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Clopidogrel Taw Pharma

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 refers to the last day of that month.

Store in the original package in order to protect from moisture and light.

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 Taw Pharma contains

The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).

The other ingredients are:

• - Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A),

macrogol 6000, hydrogenated castor oil (see section 2 ‘Clopidogrel Taw Pharma contains hydrogenated castor oil’)

• - Film-coating: polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron

What Clopidogrel Taw Pharma looks like and contents of the pack

The film-coated tablets are pink, round and biconvex.

Boxes of 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in blisters are available.

Boxes of 7, 14, 28, 56, 84 film-coated tablets in calendar blisters are available.

Boxes of 30×1 and 50×1 film-coated tablets in perforated unit dose blisters are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Taw Pharma (Ireland) Limited

104 Lower Baggot Street

Dublin 2

Ireland

Manufacturers

KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-StraBe 5, 27472 Cuxhaven, Germany

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

Belgie/Belgiqu­e/Belgien Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00	Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288
Efcnrapua MannaH EOOfl Ten: +359 2 44 55 400	Luxembourg/Lu­xemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
Ceská republika Mylan Healthcare CZ s.r.o. Tel: + 420 222 004 400	Magyarorszag 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 B.V Tel: + 31 (0)20 426 3300
Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 052	Norge Viatris AS Tel: + 47 66 75 33 00
EXXáSa Generics Pharma Hellas EnE Tql: +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 SAS Tel: +33 4 37 25 75 00	Portugal Mylan, Lda. Tel: + 351 21 412 72 56
Hrvatska	Romania

Mylan Hrvatska d.o.o.

Tel: +385 1 23 50 599

Ireland

Mylan Ireland Limited

Tel: +353 1 8711600

Island

Icepharma hf

Tel: +354 540 8000

BGP Products SRL

Tel: +40 372 579 000

Slovenija

Mylan Healthcare d.o.o.

Tel: + 386 1 23 63 180

Slovenská republika

Mylan s.r.o

Tel: + 421 2 32 199 100

Italia

Mylan Italia S.r.l.

Tel: + 39 02 612 46921

Kúnpog

Varnavas Hadjipanayis Ltd

Tnk + 357 2220 7700

Latvija

Mylan Healthcare SIA

Tel: +371 676 055 80

This leaflet was last revised in MM/YYYY.

Detailed information is available on the European Medicines Agency website:

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