Clopidogrel TAD - patient leaflet, side effects, dosage

1. What Clopidogrel TAD is and what it is used for

Clopidogrel TAD 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 TAD 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 TAD 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 ischemic attack) or an ischemic 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 TAD and acetylsalicylic acid for this condition. Your doctor should have prescribed Clopidogrel TAD 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 TAD

Do not take Clopidogrel TAD

• - If you are allergic (hypersensitive) 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 TAD.

Warnings and precautions

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

• - 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 (ischemic 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 hemorrhage.

While you are taking Clopidogrel TAD:

• - 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 TAD

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 TAD 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,

• – a 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 agent,

• – 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,

• – 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 ischemic attack or ischemic stroke in mild severity, you may be prescribed Clopidogrel TAD 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 1000 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 TAD with food and drink

Clopidogrel TAD 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 TAD. If you become pregnant while taking Clopidogrel TAD, 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 TAD is unlikely to affect your ability to drive or to use machines.

3. How to take Clopidogrel TAD

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 TAD 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 TAD (4 or 8 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel TAD 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 ischemic attack) or an ischemic stroke mild in severity, your doctor may give you 300 mg of Clopidogrel TAD (4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel TAD per day as described above with acetylsalicylic acid for 3 weeks.

Then the physician would prescribe either Clopidogrel TAD alone or acetylsalicylic acid alone.

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

If you take more Clopidogrel TAD 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 TAD

If you forget to take a dose of Clopidogrel TAD, 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 TAD

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 TAD 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 TAD

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 effects (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 in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Clopidogrel TAD

Keep 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 you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Clopidogrel TAD contains

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

hydrochloride).

• - The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone

What Clopidogrel TAD looks like and contents of the pack

The film-coated tablets are pink, round and slightly convex.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

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

Manufacturer

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:

Lietuva

UAB KRKA Lietuva

Tel: + 370 5 236 27 40

Luxembourg/Lu­xemburg

KRKA Belgium, SA.

Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Magyarország

KRKA Magyarország Kereskedelmi Kft.

Tel.: + 36 (1) 355 8490

Malta

EJ Busuttil Ltd

Tel: + 356 21445885

Nederland

KRKA Belgium, SA.

Tel: + 32 (0) 487 50 73 62 (BE)

Norge

KRKA Sverige AB

Tlf: + 46 (0)8 643 67 66 (SE)

Österreich

KRKA Pharma GmbH, Wien

Tel: + 43 (0)1 66 24 300

Polska

KRKA-POLSKA Sp. z o.o.

Tel.: + 48 (0)22 573 7500

Portugal

KRKA Farmacéutica, Sociedade Unipessoal Lda.

Tel: + 351 (0)21 46 43 650

Romania

KRKA Romania S.R.L., Bucharest

Tel: + 4 021 310 66 05

Slovenija

KRKA, d.d., Novo mesto

Tel: + 386 (0) 1 47 51 100

Slovenská republika

KRKA Slovensko, s.r.o.

Tel.: + 421 (0) 2 571 04 501

Suomi/Finland

KRKA Finland Oy

Puh/Tel: + 358 20 754 5330

Sverige

KI.PA. (PHARMACAL) LIMITED

TnX: + 357 (0)24 651 882 (CY)

United Kingdom (Northern Ireland)

KRKA Pharma Dublin, Ltd.

Tel: + 353 1 413 3710

This leaflet was last revised in MM/YYYY.

Detailed information is available on the European Medicines Agency website: .

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Age, Blood pressure, Clinical features, Duration, and Diabetes mellitus diagnosis

National Institutes of Health Stroke Scale