Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
HUMULUS LUPULUS, AVENA SATIVA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, COFFEE PREPARED
Weleda (UK) Limited
HUMULUS LUPULUS, AVENA SATIVA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, COFFEE PREPARED
100 Millilitre
Oral Drops Solution
Product not subject to medical prescription
Authorised
1991-10-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Avena sativa comp oral drops solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Total content of ethanol: 45% v/v For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral drops, solution. A clear to slightly turbid amber-brown liquid, fine suspended particles may be present. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Traditionally used for relief of symptoms of restlessness, promoting relaxation and natural sleep at night. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Over 12 years: Daytime use: 15-20 drops to be taken in water three times daily. Night-time use: 20-40 drops to be taken in water half an hour before retiring. Elderly: The adult dose is appropriate. Children: Not to be used in children under 12 years unless under the guidance of a medical practitioner. 4.3 CONTRAINDICATIONS None known. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Consult your doctor or pharmacist if you are taking any other medication. 100 ml contains the ethanolic tinctures of: Avena sativa L., Herba (1=2 in 30% w/w alcohol) 25.0 ml Humulus lupulus L., Fruct. (1=10 in 86% w/w alcohol) 4.0 ml Passiflora incarnata L., Herba (1=3 in 62% w/w alcohol) 7.5 ml Valeriana officinalis L., Radix decoct. (1=10 in 43% w/w alcohol) 30.0 ml IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/04/2011_ _CRN 2098605_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy: There is no evidence of the safety of the product in human pregnancy, nor is there any evidence from animal studies. Although no adverse reactions have been observed, the read_full_document