Paracetamol
Visa No.: 893100551124
Product: Tatanol
API: Paracetamol
Product Category: Pain Relief
Version approved leaflet: 20228e_03/06/2025
INDICATIONS
Paracetamol is widely used for the treatment of mild to moderate pain and fever.
Pain: headache, musculoskeletal pain, toothache, sore throat, dysmenorrhea, post-vaccination pain.
Fever: reduces body temperature in febrile patients but does not reduce normal body temperature.
DOSAGE AND ADMINISTRATION
Method of administration: Oral use
Do not use paracetamol for self-treatment of pain for more than 10 days in adults or 5 days in children unless directed by a physician.
Do not use paracetamol to self-treat high fever (>39.5°C), persistent fever (>3 days), or recurrent fever without medical consultation, as these may indicate serious illness.
Dosage:
Adults and children ≥ 12 years old: 1–2 tablets per dose, every 4–6 hours as needed. Maximum: 8 tablets/day.
Children > 6 years old: ½ tablet - 1 tablet per dose, , every 4–6 hours as needed. Maximum: 4 doses/day.
Renal impairment
Children: For creatinine clearance (CrCl) < 10 mL/min, the dosing interval should be every 8 hours.
Adult: For CrCl 10–50 mL/min, the dosing interval should be every 6 hours.
For CrCl < 10 mL/min, the dosing interval should be every 8 hours.
Hepatic impairment: Use with caution; lower doses recommended. Avoid prolonged use.
CONTRAINDICATIONS
Hypersensitivity to paracetamol or any excipient
Severe hepatic impairment
WARNINGS AND PRECAUTIONS
Read the instructions carefully before use.
If further information is required, consult a physician or pharmacist.
Keep out of reach of children.