Septolete total spray for local use

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

benzydamine (benzydamine hydrochloride), cetylpyridinium (cetylpyridinium chloride)

Available from:

KRKA d.d.

ATC code:

R02AA20

INN (International Name):

benzydamine (benzydamine hydrochloride), cetylpyridinium (cetylpyridinium chloride)

Dosage:

1,5mg/ml+ 5mg/ml

Pharmaceutical form:

spray for local use

Units in package:

30ml(250 dose) plastic container with pump dispenser

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2016-07-20

Summary of Product characteristics

1.3.1
Benzydamine hydrochloride + Cetylpyridinium
chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL150910_1
28.07.2020 – Updated: 28.07.2020
Page 1 of 6
1.
NAME OF THE MEDICINAL PRODUCT
Septolete
®
total 1.5 mg/5 mg in 1 ml oromucosal spray
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oromucosal spray contains 1.5 mg benzydamine hydrochloride
and 5 mg cetylpyridinium
chloride.
One spray contains 0.1 ml of oromucosal spray, solution, containing
0.15 mg benzydamine
hydrochloride and 0.5 mg cetylpyridinium chloride.
Excipient(s) with known effect:
-
ethanol: 26 mg/one spray
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Clear, colourless to yellowish liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Septolete total oromucosal spray, solution is 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: For a single dose, the spray head should be pressed once to
twice. This may be repeated every
2 hours, 3-5 times a day.
For optimal effect, it is not recommended to use the product
immediately before or after cleaning
teeth.
The stated dose should not be exceeded.
Septolete total can be used for up to 7 days.
Elderly patients
The recommended dose is the same as for adults.
_Paediatric population_
CHILDREN OVER 12 YEARS OF AGE: For a single dose, the spray head
should be pressed once to twice.
This may be repeated every 2 hours, 3-5 times a day.
CONFIDENTIAL
Septolete Total oromucosal spray 1.5 mg/5 mg/ml
VOL: 1; P: 17 / 282
1.3.1
Benzydamine hydrochloride + Cetylpyridinium
chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL150910_1
28.07.2020 – Updated: 28.07.2020
Page 2 of 6
CHILDREN FROM 6 TO 12 YEARS OF AGE: For a single dose, the spray head
should be pressed once. This
may be repeated every 2 hours, 3-5 times a day.
Septole