Plavix
(Clopidogrel Bisulfate)
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What Plavix is and what it is used for
Plavix 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)Plavix 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 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 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 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 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 Plavix and acetylsalicylic acid for this
condition. Your doctor should have prescribed
Plavix plus acetylsalicylic acid if you cannot take
‘oral anticoagulants’ and you do not have a risk of
major bleeding.
How to take Plavix
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 Plavix 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
of Plavix (1 tablet of 300 mg or 4 tablets of 75 mg)
once at the start of treatment. Then, the
recommended dose is one 75 mg tablet of Plavix per
day as described above.
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 the nearest hospital emergency
department because of the increased risk of bleeding.
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If you have any further questions on the use of this
medicine, ask your doctor or pharmacist
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 Plavix
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 Plavix
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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
United Kingdom
You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard or
search for MHRA Yellow Card in the Google Play or
Apple App Store.
Ireland
You can also report side effects directly via HPRA
Pharmacovigilance, Earlsfort Terrace, IRL
•Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517. Website:
www.hpra.ie; E-mail: [email protected]
Malta
You can also report side effects directly via ADR
Reporting www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provid e more
information on the safety of this medicine.
How to Store Plavix
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. This medicinal product does not require any special storage conditions. Do not use this medicine if you notice any visible sign 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 to protect the environment.
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