Herbion Iceland moss syrup syrup

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

iceland moss thick extract

Available from:

KRKA d.d.

ATC code:

առկա չէ (R05D) բուսական դեղի հաջորդ արտադրատարածք

INN (International Name):

iceland moss thick extract

Dosage:

6mg/ml 150ml glass bottle and measuring spoon

Pharmaceutical form:

syrup

Units in package:

6mg/ml 150ml glass bottle and measuring spoon

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2020-11-30

Summary of Product characteristics

Summary of product characteristics
CONFIDENTIAL
Herbion Iceland moss syrup
MODULE 1
VOL: 1; P: 6 / 47
1.3.1
Iceland moss extract
SPC, Labeling and Package Leaflet
AM
SmPCPIL152630_1
06.07.2020 – Updated: 06.07.2020
Page 1 of 4
1.
NAME OF THE MEDICINAL PRODUCT
Herbion
®
Iceland moss syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of syrup contains 6 mg of Iceland moss soft extract (_Cetraria
islandica_ (L.) Acharius s.l., _tallus_),
which is equivalent to 96 to 108 mg of Iceland moss.
Extraction solvent: water.
Excipients with known effect: sorbitol (E420), ethanol.
1 ml of syrup contains 760 mg sorbitol and 0.6 mg ethanol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup
The syrup is a yellow-brown to brown, slightly opalescent liquid with
specific odour and taste. Slight
sediment typical of natural substances can be noticed.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Herbion Iceland moss syrup is a herbal medicine that is recommended
for:
-
dry, irritating cough,
-
mild inflammations of the upper respiratory tract and irritation of
the oral and pharyngeal
mucosa, hoarseness and sore throat.
Iceland moss extract contains high amounts of water-soluble mucilages,
which are presumed to cover,
protect and moisten the oral and pharyngeal mucosa, thus relieving
irritation and dry cough.
Herbion Iceland moss syrup is indicated in adults and children over
four years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CHILDREN 4 TO 10 YEARS OF AGE: 5 ml of syrup (one dosing spoon) four
times daily.
CHILDREN 10 TO 16 YEARS OF AGE: 10 ml of syrup (2 dosing spoon) four
times daily.
ADULTS AND ADOLESCENTS OVER 16 YEARS OF AGE: 15 ml of syrup (3 dosing
spoons) four times daily.
Herbion Iceland moss syrup is not suitable for children and infants
under four years of age.
Method of administration
Patients should not eat or drink immediately after taking Herbion
Iceland moss syrup because the
medicine could be removed from the oral and pharyngeal mucosa too
soon.
CONFIDENTIAL