Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SUPPOSITORY
**Dosage** _Remedol Tablets_ _Adults:_ One to two tablets up to four times a day, as required. _Elderly:_ As for adults but see precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. _Children 6–12 years:_ Half to one tablet up to four times a day. _Remedol Suspension 120mg/5ml_ _Children 1–6 years:_ One to two 5ml spoonfuls (120–240mg). _Children 3 months to 1 year:_ Half to one 5ml spoonful (60–120mg). _Infants under 3 months:_ Half 5ml spoonful is suitable for babies who develop fever following vaccination at 2 months. In other cases to be used only under medical supervision. _Remedol Suspension 250mg/5ml_ _Adults and Children over 12 years:_ Two to four 5ml spoonfuls. _Children 6 to 12 years:_ One to two 5ml spoonfuls (250–500mg). _Children 1 to 6 years:_ Half to one 5ml spoonful (125–250mg). _Infants under 3 months:_ Not recommended. _Remedol Suppositories_ _Infants under 3 months:_ As instructed by the physician. _Children 3 to 6 months:_ One suppository of 125mg, 2–3 times daily. _Children 6 to 12 months:_ One suppository of 125mg, 3–4 times daily. _Children 1 to 5 years:_ One suppository of 250mg repeated every 4–6 hours when necessary (maximum of 4 doses in 24 hours). _Children 6 to 12 years:_ One suppository of 500mg repeated every 4–6 hours when necessary (maximum of 4 doses in 24 hours). Remedol Suppositories may liquefy if stored at temperatures greater than 350C. In such cases cool with cold water or in a refrigerator before opening the plastic container; the quality of the suppositories is not affected at all. These dosages may be repeated as required, but should be given no more frequently than every 4 hours. Not more than 4 doses should be taken in any 24 hours.
RECTAL
Medical Information
**Indications** Remedol tablets are indicated for the treatment of most painful and febrile conditions, for example, headache, toothache, colds, influenza, rheumatic pain and dysmenorrhoea. Remedol suspension is indicated for the treatment of mild to moderate pain (including teething pain), and as antipyretic. Remedol suppositories are indicated for the treatment of conditions associated with fever and pain in children and infants such as tonsillitis, headache, reactions after vaccination, colds, influenza, myalgia and pain following tonsillectomy.
**Contra-indications** Remedol is contra-indicated in patients with known hypersensitivity to Paracetamol.
N02BE01
paracetamol
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
REMEDICA LTD
Active Ingredients
Documents
Package Inserts
Remdol PI.pdf
Approved: December 30, 2022