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Plavix 75 mg film coated tablets, Clopidogrel
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel.
The other ingredients are mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose in the tablet core, and lactose (milk sugar), hypromellose (E464), triacetin (E1518), iron oxide (E172), titanium dioxide (E171) and carnauba wax in the tablet coating.
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WHAT IS PLAVIX
Plavix tablets are round, biconvex, pink, film coated engraved on one side with the number '75' and on the other side with the number '1171'.
Clopidogrel, the active ingredient in Plavix tablets, belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures, smaller than red or white blood cells, which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).
Plavix is taken 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 Plavix 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 atherothrombosis), 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). In this case 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.
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BEFORE TAKING PLAVIX
o If you are hypersensitive (allergic) to clopidogrel or any of the other ingredients of Plavix;
o If you have a medical condition that is currently causing bleeding such as a stomach ulcer;
o If you suffer from severe liver disease;
o If you are breast-feeding.
If you think you may have any of these problems, or if you are in any doubt at all, consult your doctor before taking Plavix.
Take special care with Plavix:
o If any of the situations mentioned below apply to you, you should tell your doctor before taking Plavix:
o If you have a risk of haemorrhage 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 are taking another type of medication (see 'Taking other medicines')
o If you have kidney or liver disease.
Plavix is not intended for use in children or adolescents less than 18 years of age.
Pregnancy
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Plavix. If you become pregnant while taking Plavix, consult your doctor immediately.
Breast-feeding
If you are a mother breast-feeding a baby, you should not take Plavix.
Driving and using machines:
Plavix is unlikely to affect your ability to drive or to use machines.
Taking other medicines:
Some other medicines may influence the use of Plavix or vice versa. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
The use of warfarin (a drug used to reduce blood clotting) with Plavix is not recommended.
You should specifically tell your doctor if you take a non-steroidal anti-inflammatory medicinal product, usually used to treat painful and/or inflammatory conditions of muscles or joints, or if you take heparin, another drug used to reduce blood clotting.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Plavix 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.
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HOW TO TAKE PLAVIX
Always take Plavix exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The usual dose is one 75 mg tablet of Plavix per day to be taken orally with or without food.
You should take your medicine regularly and at the same time each day.
In addition, if you have experienced severe chest pain, your doctor may give you 300 mg of Plavix (4 tablets of 75 mg) at the start of treatment.
If a surgery is planned (including dental), you should tell your doctor that you are taking Plavix.
Duration of treatment
You should take Plavix for as long as your doctor continues to prescribe it.
If you take more Plavix than you should:
Contact your doctor or go to the nearest emergency department because of the increased risk of bleeding.
If you forget to take Plavix:
If you forget to take a dose of Plavix, 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 the forgotten individual doses.
For the 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Plavix by referring to the calendar printed on the blister.
Effects when treatment with Plavix is stopped:
Do not stop the treatment. Contact your doctor or pharmacist before stopping.
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POSSIBLE SIDE EFFECTS
Like all medicines, Plavix can have side effects.
The most common side effect reported with Plavix is bleeding such as bruising, haematoma, nose bleed, blood in the urine, bleeding in the stomach or bowels. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
The other side effects reported with Plavix are:
o Diarrhoea, abdominal pain, constipation, nausea, vomiting, indigestion or heartburn;
o Vertigo, headache, decrease in blood pressure, confusion, hallucinations;
o Skin disorders such as rashes and itching, generalised allergic reactions;
o Joint pain, fever, taste disorders.
Contact your doctor immediately if you experience:
- Fever, signs of infection or extreme tiredness due to rare decrease of some blood cells.
- Jaundice, because there have been reports of very rare liver problems.
If you experience prolonged bleeding when taking Plavix
If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. This is linked to the way your medicine works. For minor cuts and injuries e.g., cutting your self shaving, this is of no concern. However, if you are in any doubt at all, you should contact your doctor straightaway.
If you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist.
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STORAGE OF PLAVIX
Keep out of the reach and sight of children.
There are no special storage instructions.
Store in the original package.
Do not use Plavix after the expiry date stated on the carton and on the blister.
Do not use Plavix if you notice any visible sign of deterioration.
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