Septolete total pastilles

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

benzydamine (benzydamine hydrochloride), cetylpyridinium chloride

Available from:

KRKA d.d.

ATC code:

R02AA20

INN (International Name):

benzydamine (benzydamine hydrochloride), cetylpyridinium chloride

Dosage:

3mg+ 1mg

Pharmaceutical form:

pastilles

Units in package:

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

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2016-10-17

Summary of Product characteristics

Summary of Product Characteristics
CONFIDENTIAL
VOL: 1; P: 10 / 49
1.3.1
Benzydamine hydrochloride + Cetylpyridinium
chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL090656_2
22.03.2017 – Updated: 22.03.2017
Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Septolete
®
total 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 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 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: 11 / 49
1.3.1
Benzydamine hydrochloride + Cetylpyridinium
chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL090656_2
22.