Chanelle ivy leaf syrup

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Disponibbli minn:

Chanelle Medical

Kodiċi ATC:

R05

Dożaġġ:

.

Għamla farmaċewtika:

Syrup

Żona terapewtika:

COUGH AND COLD PREPARATIONS

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2019-07-19

Karatteristiċi tal-prodott

Health Products Regulatory Authority
26 July 2019
CRN008LH3
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Chanelle ivy leaf syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of syrup contain 35 mg of extract (as dry extract) from
_Hedera helix _L.., folium (ivy leaf) (4 – 8: 1). Extraction
solvent:
Ethanol 30 % w/w.
Each 5 ml of Syrup contain 2.49 g of Sorbitol and 6.7 mg of Potassium
sorbate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
Colourless to pale yellow syrup with the odour and flavour of cherry.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used as an expectorant in case
of productive cough exclusively based on long-standing
use.
This product is indicated for use in adults and adolescents over 12
years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and adolescents over 12 years
5 ml 3 times daily.
The use is not recommended in children under 12 years of age (see 4.4
special warnings and precautions for use)
Duration of use
If symptoms persist, worsen or do not improve after 7 days of use of
Chanelle Ivy Leaf Syrup a qualified healthcare professional
e.g. a doctor or a pharmacist should be consulted.
Method of administration
For oral short-term use only. Shake bottle well before each use.
4.3 CONTRAINDICATIONS
Hypersensitivity to ivy preparations or any of the excipients listed
in section 6.1 or to any other plant belonging to the family
Araliaceae.
Pregnancy and lactation (see section 4.6 ‘Fertility, pregnancy and
lactation’).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceeed stated dose.
The use is not recommended in children under 12 years of age because
no data on safety is available.
If symptoms persist, worsen or do not improve after 7 days of use of
Chanelle Ivy Leaf
Syrup a qualified healthcare professional e.g. a doctor or a
pharmacist should be consulted.
Health Products Regulatory Authority
26 July 2019
CRN008LH3
Page 2 of 3
If dyspnoea, fever