Herbion cowslip syrup syrup

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

liquid aqueous cowslip root extract, liquid aqueous garden thyme herb extract

제공처:

KRKA d.d.

ATC 코드:

առկա չէ (R05C)

INN (International Name):

liquid aqueous cowslip root extract, liquid aqueous garden thyme herb extract

복용량:

1030mg/5ml+ 2060mg/5ml

약제 형태:

syrup

패키지 단위:

150ml glass bottle and measuring spoon

처방전 유형:

OTC

승인 상태:

Registered

승인 날짜:

2022-03-01

제품 특성 요약

1.3.1
Herbion cowslip syrup
SPC, Labeling and Package Leaflet
AM
SmPCPIL079528_8
06.07.2016 – Updated: 15.02.2017
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Herbion
®
cowslip syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml of syrup (1 measuring spoon) contains:
- 3.08 g liquid aqueous extract of _Primula veris _L.or/and_ Primula
elatior_ (L.) Hill, (Primulae radix),
cowslip root and _Thymus vulgaris_ L. or/and_ Thymus zygis_ L. (Thymi
herba) garden thyme herb,
equivalent to 0.22–0.51 g of Primula root and 0.62 g Thyme.
Extraction solvent: water.
Excipients with known effect: 5 ml of syrup (1 measuring spoon)
contains 3.16 g sucrose and
8.75 mg methyl parahydroxybenzoate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup.
Brown syrup with specific odour and taste. Slight sediment typical of
natural substances can
be noticed.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Herbion cowslip syrup is a herbal drug recommended for easier
expectoration in:
-
respiratory inflammation (bronchitis, pharyngitis) in which
expectoration of thick bronchial
mucus is difficult,
-
in common cold and flu accompanied by cough.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 16 years of age should take 2 measuring
spoons of syrup 3 to 4 times daily.
Children from 4 to 10 years of age should be given 1 measuring spoon
of syrup 3 times daily, and
children from 10 to 16 years of age 1 to 2 measuring spoons of syrup 3
times daily.
It is recommended that the syrup be taken with plenty of tea and warm
beverages.
There is no experience in children under 4 years of age (see section
4.4).
Shake the bottle before use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or any of the excipients.
The syrup should not be taken in inflammation of the gastric mucosa
and gastric ulcer.
A history of acute obstructive laryngitis in children.
Asthma.
Children under 4 years of age.
CONFIDENTIAL
Herbion cowslip syrup
VOL: 1; P: 18 / 184
1.3.1
H