Nalgesin forte tablets film-coated

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

naproxen (naproxen sodium)

Saatavilla:

KRKA d.d.

ATC-koodi:

M01AE02

INN (Kansainvälinen yleisnimi):

naproxen (naproxen sodium)

Annos:

550mg

Lääkemuoto:

tablets film-coated

Kpl paketissa:

(10/1x10/) in blister, (20/2x10/) in blister

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2016-07-20

Valmisteyhteenveto

1.3.1
Naproxen sodium
SPC, Labeling and Package Leaflet
AM
SmPCPIL157203_1
12.10.2020 – Updated: 12.10.2020
Page 1 of 6
1.
NAME OF THE MEDICINAL PRODUCT
Nalgesin
®
forte 550 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 550 mg naproxen sodium, which is
equivalent to 500 mg naproxen.
Excipient(s) with known effect:
-
sodium: 2.18 mmol (50.16 mg)/tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The tablets are oval, slightly biconvex, one-side scored, blue
film-coated tablets.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Musculoskeletal system disorders (rheumatoid arthritis, psoriatic
arthritis, juvenile chronic
arthritis, ankylosing spondylitis (Bekhterev's disease), gouty
arthritis, rheumatoid damage of
soft tissues, osteoarthrosis of peripheral joints and vertebral column
including that with
radicular syndrome, tendovaginitis, bursitis).
•
Mild or moderate pain syndrome: neuralgia, ossalgia, myalgia,
lumboischialgia, posttraumatic
pain syndrome (sprains and bruises) accompanied with inflammation,
post-surgery pain (in
traumatology, orthopedics, gynecology, maxillofacial surgery),
headache, migraine,
algodismenorrhea, adnexitis, toothache.
•
As a part of complex therapy of infectious inflammatory diseases of
ear, throat, nose with
significant pain syndrome (pharyngitis, tonsillitis, otitis).
•
Feverish syndrome in common cold and infectious diseases.
Nalgesin forte is used for symptomatic treatment (to relieve pain,
inflammation and decrease heat) and
does not affect the course of background disease.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Usual daily dose used to relieve pain is 1 - 2 tablets (550 – 1100
mg).
In case of very severe pain and absence of history of gastrointestinal
diseases, a physician can increase
daily dose up to 3 tablets (1650 mg) but not more than for 2 weeks.
If this medicinal product used as antipyretic, initia