Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Chanelle Medical
R05
.
Lozenge
COUGH AND COLD PREPARATIONS
Not marketed
2019-07-19
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 Olvassa el a teljes dokumentumot