Panadol Actifast Soluble Tablets/Panadol Soluble 500mg Tablets
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
04-05-2024
Summary of Product characteristics
(SPC)
04-05-2024
Active ingredient:
paracetamol 500 mg
Available from:
SmithKline Beecham (SWG) Limited
ATC code:
N02BE01
INN (International Name):
paracetamol
Pharmaceutical form:
effervescent tablet
Authorization status:
Authorised
Authorization date:
2006-10-31
Summary of Product characteristics
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Panadol ActiFast Soluble Tablets
Or
Panadol Soluble 500 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol Ph.Eur. 500.0 mg
3.
PHARMACEUTICAL FORM
Effervescent tablet (Tablets).
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of
most painful and febrile conditions, for example, headache including migraine and tension
headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat,
and for relieving the fever, aches and pains of colds and flu.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and the elderly:
1 -2 tablets in at least half a tumbler of water, up to 4 times daily as required.
Children:
6 - 12 years: ½ - 1 tablet dissolved in water up to 4 times daily. Not recommended for
children under the age of 6 years.
Doses of paracetamol should not be given more frequently than every 4 hours, and not more
than 4 doses should be given in any 24 hour period.
Children should not be given paracetamol for more than 3 days without consulting a doctor.
Oral administration only.
Page 2 of 6
4.3.
CONTRAINDICATIONS
Hypersensitivity to paracetamol or any of the other constituents.
4.4.
SPECIAL WARNINGS OR PRECAUTIONS FOR USE
Care is advised in the administration of paracetamol to patients with renal or hepatic
impairment. The hazard of overdose is greater in those with no
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