TROGE PARACETAMOL 500mg tablets tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

paracetamol

Available from:

Medopharm

ATC code:

N02BE01

INN (International Name):

paracetamol

Dosage:

500mg

Pharmaceutical form:

tablets

Units in package:

(1000/100x10/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2017-04-25

Summary of Product characteristics

SUMMARY OF PRODUCT
CHARACTERISTICS
for:
TROGE
®
PARACETAMOL
500 mg
Tablets
TROGE
®
Register-Nr. HRB 35614
DEPARTMENT FOR SCIENTIFIC RESEARCH AND PRODUCT DEVELOPMENT
DEPARTMENT FOR INTERNATIONAL REGULATORY AFFAIRS
– March 2017 –
PRODUCT:
PARACETAMOL 500 MG _TABLETS_
SUMMARY OF PRODUCT CHARACTERISTICS
TROGE MEDICAL GMBH · HAMBURG · GERMANY SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1.
NAME OF THE MEDICINAL PRODUCT
TROGE
®
PARACETAMOL 500 mg tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg Paracetamol.
For full list of excipients, see section 6.1._ _
3. PHARMACEUTICAL FORM
Tablets for oral use.
Description:
White tablets, scored, engraved with TROGE® logo and "PARA 500"
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
For the relief of mild to moderate pain including headache, migraine,
neuralgia,
toothache, sore throat and dysmenorrhoea.
For the symptomatic relief of rheumatic and muscular aches and pains,
sciatica,
fibrositis, lumbago, joint swelling and stiffness.
For the symptomatic relief of influenza, feverish colds and
feverishness.
PRODUCT:
PARACETAMOL 500 MG _TABLETS_
SUMMARY OF PRODUCT CHARACTERISTICS
TROGE MEDICAL GMBH · HAMBURG · GERMANY
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
For all indications:
Adults, the elderly and children > 43 kg (> 12 years): One or two
tablets up to
four times a day, as required. The recommended dose of a single dose
is 10 - 15
mg/kg body weight. Maximum daily dose 60 mg/kg body weight should not
be
exceeded
CHILDREN
Children 33 kg – 43 kg (11 - 12 years): One tablet up to four times
a day, as
required.
Children 26 kg – 32 kg (8 – 11 years): Half a tablet up to 2 – 4
times a day, as
required. In exceptional case maximum 3 tablets may be given daily.
Children 17 kg – 25 kg (6 – 8 years): Half a tablet up to 2 – 4
times a day, as
required.
The dose should not be repeated more frequently than every four hours,
and not
more than four doses should be taken in any 24 hour period.
Dosage should not be continued for longer