Septolete total lemon and elderflower lozenges

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:

lozenges

Units in package:

(8/1x8/), (16/2x8/), (24/3x8/), (32/4x8/) and (40/5x8/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2018-08-31

Patient Information leaflet

1.3.1
Benzydamine
hydrochloride
+
Cetylpyridinium
chloride
SPC,
Labeling
and Package
Leaflet
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105029
8
121.12.2017
-
Updated:
02.07.2018
Page
1 of6
1.3.1
Benzydamine
hydrochloride
+
Cetylpyridinium
chloride
SPC,
Labeling
and Package
Leaflet
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Summary of Product characteristics

1.3.1
Benzydamine hydrochloride + Cetylpyridinium
chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL150918_1
28.07.2020 – Updated: 28.07.2020
Page 1 of 6
1.
NAME OF THE MEDICINAL PRODUCT
Septolete
®
total lemon and elderflower 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): 2448.3 mg/lozenge
-
butylated hydroxyanisole (E320): 0.0004 mg/lozenge
-
sodium benzoate (E211): up to 0.00075 mg/lozenge
-
propylene glycol (E1520): 4.8 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 pale green
to green 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
Sewptolete total lemon and elderflower 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: Sewptolete total lemon and
elderflower is contraindicated in
CONFIDENTIAL
Septolete total lemon and elder flower lozenges
VOL: 1; P: 19 / 89
1.3.1
Benzydamine hydrochloride + Cetylpyridinium
chlorid