Summary of content

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.