Naklofen tablets film-coated prolonged-release

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

diclofenac (diclofenac sodium)

Disponible depuis:

KRKA d.d.

Code ATC:

M01AB05

DCI (Dénomination commune internationale):

diclofenac (diclofenac sodium)

Dosage:

100mg

forme pharmaceutique:

tablets film-coated prolonged-release

Unités en paquet:

(20/2x10/) in blister

Type d'ordonnance:

Prescription

Statut de autorisation:

Registered

Date de l'autorisation:

2019-12-12

Résumé des caractéristiques du produit

Summary of product characteristics
CONFIDENTIAL
Diclofenac 100 mg prolonged-release tablet
MODULE 1
VOL: 1; P: 6 / 32
1.3.1
Diclofenac sodium
SPC, Labeling and Package Leaflet
SmPCPIL086776_5
09.01.2017 – Updated: 15.10.2019
Page 1 of 13
1.
NAME OF THE MEDICINAL PRODUCT
Naklofen 100 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 100 mg diclofenac sodium.
Excipients with known effect:
-
sucrose: 105 mg/tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
The prolonged-release tablets are round, biconvex, smooth, red-brown
coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
inflammatory and degenerative rheumatic diseases: rheumatoid
arthritis, ankylosing spondylitis;
arthrosis; extra-articular rheumatism.
-
pain and inflammatory process of on-rheumatic or post-traumatic
origin.
-
symptomatic treatment of primary dysmenorrhea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Naklofen prolonged-release tablets containing 100 mg diclofenac sodium
are mainly intended for
long-term treatment.
The dosage for the initial and maintenance treatment is one tablet
once daily.
If a daily dosage of 150 mg diclofenac sodium is required, Naklofen
prolonged-release tablets can be
combined with a 50 mg Naklofen gastro-resistant tablet or a 50 mg
Naklofen suppository.
If the symptoms occur mostly during the night or in the morning,
Naklofen prolonged-release tablets
should be taken preferably in the evening.
As a general recommendation, the dose should be adjusted individually.
Undesirable effects may be
minimised by using the lowest effective dose for the shortest duration
necessary to control (relieve)
symptoms (see section 4.4).
_Paediatric population_
Naklofen is contraindicated in children and adolescent (see section
4.3).
_Patients with kidney impairment_
Naklofen is contraindicated in patients with renal insufficiency (GFR
<15 ml / min / 1.73 m
2
) (see
section 4.3)
No specific studies h