| a) Generic Name |
Paracetamol BP & Caffeine BP
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| b) Trade/Brand Name |
To be submitted at the time of inclusion.
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| a) Presentation |
Tablet
Each tablet contains Paracetamol BP 500 mg & Caffeine BP 65 mg
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| b) Indications |
Paracetamol is an analgesic and antipyretic formulated to give extra pain relief. The tablet is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, backache, toothache, neuralgia, rheumatic pain and dysmenorrhoea, and relief of the symptoms of colds, influenza and sore throat.
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| c) Dosage & Administration |
Adults, including the elderly and children 12 years and over:2 tablets every 4 hours as required. Do not take more than 8 tablets in 24 hours. Do not give to children under 12 years of age.
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| d) Side effects
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Adverse effects are rare but hypersensitivity including skin rash may occur. There have been very rare reports of blood dyscrasis including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.
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| e) Precautions and
Warnings
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Use with caution in alcoholism, decreased kidney function and liver disease.
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| f) Contraindications |
Transient stinging may occur when drops are instilled. Hypersensitivity may occur e.g. conjunctivitis. As with any mydriatic, caution should be used when intraocular pressure is high or unknown or when anterior chamber is shallow.
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| i) Drug Interactions |
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
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| k) Storage Conditions |
• Store in a cool and dry place, protect from light.
• Keep out of the reach of children.
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| l) Package Quantity |
To be submitted at the time of inclusion.
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