Septolete total lemon and honey lozenges

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

benzydamine (benzyadamine hydrochloride), cetylpyridinium chloride

Доступна с:

KRKA d.d.

код АТС:

R02AA20

ИНН (Международная Имя):

benzydamine (benzyadamine hydrochloride), cetylpyridinium chloride

дозировка:

3mg+ 1mg

Фармацевтическая форма:

lozenges

Штук в упаковке:

16(2x8) in blister

Тип рецепта:

OTC

Статус Авторизация:

Registered

Дата Авторизация:

2018-09-26

тонкая брошюра

1.3.1
Benzydamine
hydrochloride
+
Cetylpyridinium
chloride
SPC.
Labeling
and Package
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SmPCPILI05028
8
I
21.12.2017
-
Updated:
02.07.2018
I
Page
1
of6
1.3.1
Benzydamine
hydrochloride
+
Cetylpyridinium
chloride
SPC,
Labeling
and Package
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Характеристики продукта

1.3.1
Benzydamine hydrochloride + Cetylpyridinium
chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL150916_1
28.07.2020 – Updated: 28.07.2020
Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Septolete
®
total lemon and honey 3 mg/1 mg lozenges
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 3 mg benzydamine hydrochloride and 1 mg
cetylpyridinium chloride.
Excipient with known effect:
-
isomalt (E953): 2452.8 mg/lozenge
-
sodium benzoate (E211): up to 0.0009 mg/lozenge
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lozenge
Round lozenges with bevelled edges and rough surface from light yellow
to yellow colour. Allowed
white patches, uneven colouring, the presence of air bubbles in the
“hard candy” mass and small
jagged edges.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Septolete total lemon and honey is indicated in adults, adolescents
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 lozenges a day. The lozenge 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_
ADOLESCENTS OVER 12 YEARS OF AGE: The recommended dosage is 3

4 lozenges a day. The lozenge
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
lozenges a day. The lozenge
should be slowly dissolved in the mouth every 3 to 6 hours.
CHILDREN LESS THAN 6 YEARS OF AGE: Septolete total lemon and honey is
contraindicated in children less
than 6 years of age.
CONFIDENTIAL
Septolete total lemon and honey lozenges
VOL: 1; P: 19 / 84
1.3.1
Benzydamine hydrochloride + Cetylpyridinium
chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL150916_1
28.07.2020 – Updated: 28.07.2