Panadol 500mg tablets film-coated

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

paracetamol

Commercializzato da:

S.C. Europharm S.A.

Codice ATC:

N02BE01

INN (Nome Internazionale):

paracetamol

Dosaggio:

500mg

Forma farmaceutica:

tablets film-coated

Confezione:

(12/1x12/) blister

Tipo di ricetta:

OTC

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2015-05-15

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Panadol Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500.0 mg
3.
PHARMACEUTICAL FORM
Film-coated tablets
White, film-coated and capsule-shaped tablets with flat edges with
PANADOL embossed
on one side and a break line on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic therapy of pain: headache (including migraine and tension
headache,
toothache, sore throat, backache, muscle and rheumatic pains,
dysmennorhoea, and for
relieving the fever (as antipyretic). In case of increased body’s
temperature associated with
cold and flu. Medicine is intended for pain decrease at the time of
using and has no
influence for progressive disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration only.
Adults (including the elderly) and children over 12 years aged: 1-2
tablets taken every
4 to 6 hours as required. Minimum dosing interval: 4 hours. Maximum
daily dose: 8 tablets
(4000 mg).
Children, 6 to 12 years: ½-1 tablet taken every 4 to 6 hours as
required. Minimum dosing
interval: 4 hours. Maximum daily dose: 4 tablets. Maximum daily dose:
60mg/kg presented
in divided doses of 10 – 15 mg/kg throughout the 24 hour period.
Maximum duration of continued use without medical advice: 3 days.
4.3
CONTRAINDICATIONS

Hypersensitivity to paracetamol or any of the other constituents;

Children under the age of 6 years.
Care is advised in the administration of paracetamol to patients with
renal or hepatic failure,
benign hyperbilirubinemia (including Gilber’s syndrome), virus
hepatitis, hereditary
absence of glucose-6-phosphate dehydrogenase, alcohol-induced liver
failure, alcohol
dependence, the elderly age, during pregnancy and lactation.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients who have been diagnosed with liver or kidney impairment must
seek medical
advice before taking this medication.
Do not exceed the stated dose.
Do not take with any other paracetamol - containing