Chanelle ivy leaf lozenges

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Fáanlegur frá:

Chanelle Medical

ATC númer:

R05

Skammtar:

.

Lyfjaform:

Lozenge

Lækningarsvæði:

COUGH AND COLD PREPARATIONS

Leyfisstaða:

Not marketed

Leyfisdagur:

2019-07-19

Vara einkenni

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 lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 35 mg dry extract of _Hedera helix L._ folium
(ivy leaf) DER 4-8:1
Extraction solvent: ethanol 30% w/w
Each lozenge contains sorbitol 1.406 g
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Lozenge.
Freckled off-white to beige round flat bevelled edge tablets plain on
both sides.
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
Take 1 lozenge 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 Lozenges a qualified healthcare
professional e.g. a doctor or a pharmacist should be consulted.
Method of administration
For oral short-term use only.
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 exceed 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 Lozenges 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 or purulent sputum occurs, a qualified health care
professional e.g. a do