Septolete Neo

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cetylpyridinium chloride (cetylpyridinium chloride monohydrate)

Available from:

KRKA d.d.

INN (International Name):

cetylpyridinium chloride (cetylpyridinium chloride monohydrate)

Dosage:

1,2mg

Pharmaceutical form:

lozenges with cherry flavour

Prescription type:

OTC

Summary of Product characteristics

1.3.1
Cetylpyridinium chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL045437_1
06.12.2013 – Updated: 06.12.2013
Page 1 of 5
1.
NAME OF THE MEDICINAL PRODUCT
Septolete Neo Cherry lozenges 1.2 mg
Septolete Neo Apple lozenges 1.2 mg
Septolete Neo Lemon lozenges 1.2 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 1.2 mg cetylpyridinium chloride.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lozenges.
Septolete Neo Cherry: violet, round, slightly biconvex lozenges.
Septolete Neo Apple: green, round, slightly biconvex lozenges.
Septolete Neo Lemon: yellow, round, slightly biconvex lozenges.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Septolete Neo lozenges are recommended in infectious-inflammatory
diseases of the mouth
and throat:
- pharyngitis, laryngitis, beginning of angina,
- inflammation of the gums and oral mucous membrane (gingivitis,
stomatitis).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dosage for adults and children over 12 years of age is
up to 8 lozenges a
day. Dissolve 1 lozenge in the mouth every 2 to 3 hours.
For children over 4 years of age, up to 4 lozenges a day are
recommended while for children
from 10 to 12 years of age, up to 6 lozenges a day. Dissolve 1 lozenge
in the mouth every 3 to
4 hours.
The lozenges should not be taken immediately before or during meals.
4.3
CONTRAINDICATIONS
Hypersensitivity to cetylpyridinium chloride or to any of the
excipients.
Children under 4 years of age.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
1.3.1
Cetylpyridinium chloride
SPC, Labeling and Package Leaflet
AM
SmPCPIL045437_1
06.12.2013 – Updated: 06.12.2013
Page 2 of 5
The lozenges should not be taken in open wounds in the mouth because
cetylpyridinium
chloride slows the healing of wounds.
In severe infections accompanied by high fever, headache and vomiting,
a physician should
be consulted, especially if the condition does not improve in three
days.
Diabetic patients should bear in mind that each lozenge contains
around 1 g of maltitol