Septolete plus

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cetylpyridinium (cetylpyridinium chloride), benzocaine

Available from:

KRKA d.d.

INN (International Name):

cetylpyridinium (cetylpyridinium chloride), benzocaine

Dosage:

2mg/ml+10mg/ml

Pharmaceutical form:

spray

Prescription type:

OTC

Summary of Product characteristics

Summary of product characteristics
CONFIDENTIAL
1.3.1
Benzocaine + Cetylpyridinium chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL049225_2
– Updated: 02.04.2014
Page 1 of 6
1.
NAME OF THE MEDICINAL PRODUCT
Septolete plus 10 mg/2 mg oromucosal spray
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oromucosal spray contains 10 mg benzocaine and 2 mg
cetylpyridinium chloride.
Excipient:
-
ethanol (96 per cent): 330 mg/ml of spray
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal spray.
Oromucosal spray appears as clear, colourless to yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Septolete plus oromucosal spray is recommended for symptomatic relief
of throat pain:
-
in milder infections in the oral cavity and throat (pharyngitis,
laryngitis),
-
in inflammation of the gums and oral mucous membrane (stomatitis,
gingivitis),
-
in cold and flu.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS OVER 12 YEARS OF AGE: For a single dose, the
spray head should be pressed
TWICE. This may be repeated every 2 to 3 hours, up to 8 times a day.
CHILDREN 6 TO 12 YEARS OF AGE: For a single dose, the spray head
should be pressed ONCE. This may be
repeated every 2 to 3 hours, up to 8 times a day. Children should be
supervised by an adult when using
the spray.
Septolete plus is not recommended for use in children under 6 years of
age due to insufficient data on
safety (please see section 4.4.).
Septolete plus should not be used for more than 7 consecutive days.
METHOD OF ADMINISTRATION
Before the first use of Septolete plus or if Septolete plus has not
been used for a long period of time,
press the spray head several times (5 to 9 times) and release some of
the medicine into the air or sink.
Keep pressing until a fine spray appears.
CONFIDENTIAL
1.3.1
Benzocaine + Cetylpyridinium chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL049225_2
– Updated: 02.04.2014
Page 2 of 6
Remove the plastic cap before
use.
Open your mouth wide, point
the spray noz