Each Film coated tablet of Plavised® contains:

• Clopidogrel            75 mg  (As Clopidogrel Hydrogen Sulphate). 

- Acute Coronary Syndrome

• Plavised® is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Plavised® should be administered in conjunction with aspirin.
• Plavised® is also indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Plavised® should be administered in conjunction with aspirin.

- Recent MI, Recent Stroke, or Established Peripheral Arterial Disease

- Atrial Fibrillation

• In patients with atrial fibrillation (AF) who have at least one risk factor forvascular events, who are not suitable for treatment with an anticoagulant and who have a low risk of bleeding, Plavised® in combination with low-dose aspirin is indicated for the prevention of atherothrombotic and thromboembolic events, including stroke.
• In patients with AF at increased risk of vascular events who can take vitamin K antagonist (VKA) therapy, VKA has been shown to result in better clinical benefit than aspirin alone or the combination of Plavised® and aspirin for the reductions of stroke.

-Active Bleeding:

• Plavised® is contraindicated in patients with activepathological bleeding such as peptic ulcer or intracranial hemorrhage.

-Hypersensitivity:

• Plavised® is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel.

-Patients with severe liver disease, or cholestatic jaundice.

• Concomitant use of Plavised® with Proton Pump Inhibitors (PPI) like   omeprazole and esomeprazole results in a reduction of platelets inhibition.Because PPIs inhibits the CYP2C19 liver enyzme that metabolizes Plavised® to its active metabolites.
• Coadministration of opioid agonists delay and reduce the absorption of clopidogrel , presumably because of slowed gastric emptying, resulting in reduced exposure to its metabolites. Consider the use of a parenteral antiplatelet agent in acute coronary syndrome patients requiring coadministration of morphine or other opioid agonists.
• Coadministration of Plavised® and NSAIDs increases the risk of gastrointestinal bleeding.
• Coadministration of Plavised® with warfarin increases the risk of bleeding because of independent effects on hemostasis.
• The concomitant administration of selective serotonin reuptake inhibitors SSRIs (including but not restricted to fluoxetine or fluvoxamine), and SNRIs with clopidogrel may increase the risk of bleeding.
• Avoid concomitant use of repaglinide with Plavised®.

• Available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage. Myocardial infarction and stroke are medical emergencies. Therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of clopidogrel on the fetus. Clopidogrel use during labor or delivery will increase the risk of maternal bleeding and hemorrhage.
• Studies in rats have shown that clopidogrel and/or its metabolites are present in the milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to a nursing woman.

-The most common side effect reported with Plavised® 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

-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.

-Other side effects:

• Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.

Overdose:

• Platelet inhibition by Plavised® is irreversible and will last for the life of the platelet. Overdose following clopidogrel administration may result in bleeding complications. Symptoms of acute toxicity were vomiting, prostration, difficult breathing, and gastrointestinal hemorrhage in animals. 
• Based on biological plausibility, platelet transfusion may restore clotting ability.

-Acute Coronary Syndrome:

• In patients who need an antiplatelet effect within hours, initiate Plavised® with a single 300 mg oral loading dose and then continue at 75 mg once daily.Initiating Plavised® without a loading dose will delay establishment of an antiplatelet effect by several days.

-Recent MI, Recent Stroke, or Established Peripheral Arterial Disease:

• 75 mg once daily orally without a loading dose.

-Atrial Fibrillation:

• The recommended dose of Plavised® is 75 mg once daily, administered in combination with ASA

-Plavised® can be administered with or without food.

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

-You should take Plavised® for as long as your doctor continues to prescribe it.

-If the patient has a risk of bleeding such as:

• a medical condition that puts him/ her at risk of internal bleeding (such as a stomach ulcer).
• a blood disorder that makes him/ her prone to internal bleeding (bleeding inside any tissues, organs or joints of his/ her body).
• a recent serious injury.
• a recent surgery (including dental).
• a planned surgery (including dental) in the next seven days.

-If the patient has had a clot in an artery of his/ her brain (ischaemic stroke) 
  which occurred within the last seven days.

-If the patient has kidney or liver disease.

-If the patient has had an allergy or reaction to any medicine used to treat his/ her disease.

• Plavised® tablet 75mg: (blister of 10 tablets, pack of three blisters). 
   

• Store in a dry place at a temperature 25°C.