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Package leaflet: information for the user

Clopidogrel 75mg 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 your 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 have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

What is in this leaflet:

1.    What Clopidogrel is and what it is used for

2.    What you need to know before you take Clopidogrel

3.    How to take Clopidogrel

4.    Possible side effects

5.    How to store Clopidogrel

6.    Contents of the pack and other information

1.    What Clopidogrel is and what it is used for

Clopidogrel 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 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 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 should also be given aspirin (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 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 aspirin or the combined use of Clopidogrel and aspirin for this condition. Your doctor should have prescribed Clopidogrel plus aspirin 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

Do not take Clopidogrel

•    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.

Warnings and precautions

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

•    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

-    recent surgery (including dental procedures)

-    planned surgery (including dental procedures). You will need to stop taking Clopidogrel tablets seven days before any planned surgery

•    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 medicines used to treat your disease.

While you are taking Clopidogrel:

•    You should tell your doctor if you are to have surgery (including dental procedures).

•    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

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 or vice versa.

You should especially tell your doctor if you take:

-    oral anticoagulants, medicines used to reduce blood clotting,

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

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

-    omeprazole, esomeprazole or cimetidine, medicines to reduce excess stomach acid,

-    fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections,

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

-    moclobemide, medicine to treat depression,

-    carbamazepine, or oxcarbazepine, medicines to treat some forms of epilepsy,

-    ticlopidine, other antiplatelet agent.

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

Clopidogrel with food and drink Clopidogrel may be taken with or without food.

Pregnancy and breast-feeding

It is preferable not to take this product during pregnancy.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking Clopidogrel, 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.

Driving and using machines

Clopidogrel is unlikely to affect your ability to drive or to use machines.

Clopidogrel 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.

3.    How to take Clopidogrel

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

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300mg of Clopidogrel (4 tablets of 75mg) once at the start of treatment. Then, the recommended dose for adults, including the elderly, is one 75mg tablet of Clopidogrel per day to be taken orally with or without food, and at the same time each day.

Clopidogrel is not intended for use in children or adolescents.

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

If you take more Clopidogrel than you should

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

If you forget to take Clopidogrel

If you forget to take a dose of Clopidogrel, 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

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 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

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 may 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.

-    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 the taste of food.

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 Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Clopidogrel

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 on the blister, after EXP. The expiry date refers to the last day of that month. Refer to the storage conditions on the carton.

If Clopidogrel is supplied in PVC/PE/PVDC/aluminium blisters, store below 25°C.

If Clopidogrel is supplied in PA/ALL/PVC/aluminium blisters, it does not require any special storage conditions.

Do not use this medicine if you notice any visible signs of deterioration.

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 contains

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

The other ingredients are (see section 2 'Clopidogrel contains lactose'): Microcrystalline cellulose, Mannitol, Hydroxypropylcellulose, Crospovidone (Type A), Citric acid monohydrate, Macrogol 6000, Stearic acid, Talc in the tablet core, and Hypromellose (E464), Lactose monohydrate, Iron oxide red (E172), Triacetin (E1518), Titanium dioxide (E171) in the tablet coating.

What Clopidogrel looks like and contents of the pack

Clopidogrel film-coated tablets are pink, round, biconvex. They are supplied in PVC/PE/PVDC/Aluminium blisters or in PA/Al/PVC - Aluminium foil (Alu-Alu) blisters packed in cartons containing 14, 28, 30, 50, 56, 84, 90, 98, 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

Aspire Pharma Ltd. Bellamy House, Winton Road, Petersfield, Hampshire, GU32 3HA, United Kingdom Manufacturer:

Pharmathen S.A. 6 Dervenakion, Pallini Attiki, 15351 Greece Alternative manufacturer:

Pharmathen International S.A. Industrial Park, Sapes Rodopi prefecture, Block No 5, 69300 Rodopi, Greece This leaflet was last revised in 05/2016

ASPIRE’

1010016-P8.3F    Pharma