Kenyan Health Patient Information Leaflet
Non-opioid analgesic / antipyretic
Headache, migraine, backache, toothache, rheumatic pain, and dysmenorrhoea. Clinical selection for Paracetamol 500mg / caffeine 65 mg should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC. Class context: Non-opioid analgesic / antipyretic. Confirm site-specific dose, duration and monitoring before prescribing.
Adults and children aged 16 years: 2 tablets up to QID (Max. 8 tabs per day). Children aged 12-15 years: 1 tablet up to QID (Max. 4 tablets per day). Not recommended for children under 12 years.
[Paracetamol] Rare at therapeutic doses. Serious: acute liver failure in overdose, rare severe skin reactions (SJS/TEN/AGEP). [caffeine] Adverse reactions vary by agent. Counsel on common predictable effects and serious warning symptoms (allergy, severe rash, jaundice, unusual bleeding, severe GI symptoms, neurological changes). Report suspected ADRs via national pharmacovigilance channels.
Store as labelled. Keep out of reach of children.