Septolete total eucalyptus pastilles

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

benzydamine (benzydamine hydrochloride), cetylpyridinium chloride

Tilgængelig fra:

KRKA d.d.

ATC-kode:

R02AA20 վերարտադրված դեղ

INN (International Name):

benzydamine (benzydamine hydrochloride), cetylpyridinium chloride

Dosering:

3mg+ 1mg (8/1x8/), (16/2x8/), (24/3x8/) and (32/4x8/) in blister

Lægemiddelform:

pastilles

Enheder i pakken:

3mg+1mg (8/1x8/), (16/2x8/), (24/3x8/) and (32/4x8/) in blister

Recept type:

OTC

Autorisation status:

Registered

Autorisation dato:

2020-11-18

Produktets egenskaber

1.3.1
Benzydamine hydrochloride + Cetylpyridinium
chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL154478_1
28.07.2020 – Updated: 28.07.2020
Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Septolete
®
total eucalyptus 3 mg/1 mg pastilles
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pastille contains 3 mg benzydamine hydrochloride and 1 mg
cetylpyridinium chloride.
Excipient with known effect:
-
isomalt (E953): 2471.285 mg/pastille
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pastille
Round pastilles with beveled edges and rough surface from light blue
to blue colour.
Allowed white patches, uneven coloring, the presence of air bubbles in
the “hard candy” mass and
small jagged edges.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Septolete total eucalyptus pastilles are indicated in adults and
children over 6 years of age for anti-
inflammatory, analgesic and antiseptic treatment of irritations in the
throat, mouth and gums, in
gingivitis, pharyngitis and laryngitis and before and after tooth
extractions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS: The recommended dosage is 3

4 pastilles a day. The pastille should be slowly dissolved in
the mouth every 3 to 6 hours.
ELDERLY PATIENTS: The recommended dose is the same as for adults.
_Paediatric population_
CHILDREN OVER 12 YEARS OF AGE: The recommended dosage is 3

4 pastilles a day. The pastille should
be slowly dissolved in the mouth every 3 to 6 hours.
CHILDREN AGED FROM 6 TO 12 YEARS OF AGE: The recommended dosage is 3
pastilles a day. The pastille
should be slowly dissolved in the mouth every 3 to 6 hours.
CHILDREN LESS THAN 6 YEARS OF AGE: Septolete total eucalyptus is
contraindicated in children less than 6
years of age.
For optimal effect, it is not recommended to use the product
immediately before or after cleaning
CONFIDENTIAL
VOL: 1; P: 19 / 210
1.3.1
Benzydamine hydrochloride + Cetylpyridinium
chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL154478_1
28.07.2020 – Updated: 28.07.2020