国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Glycerol
Ethypharm
A06AX; A06AX01
Glycerol
1 gram(s)
Suppository
Other drugs for constipation; glycerol
Marketed
1993-02-25
Health Products Regulatory Authority 11 June 2019 CRN008YGJ Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glycerol 1g Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains: 700mg Glycerol For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Suppository Amber coloured suppository, of nominal weight 1 g. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For occasional use as a stimulant laxative used for the treatment of constipation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Suppositories for rectal insertion. Infants One suppository, to aid insertion the suppository tip should be moistened with water before use. 4.3 CONTRAINDICATIONS § The product is contraindicated if there is intestinal obstruction or blockage. § Hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The product is intended for occasional use only. Prolonged use is not recommended as it can cause diarrhoea. Use of this product may interfere with glucose control in diabetic patients. If symptoms persist consult a doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None stated. 4.6 FERTILITY, PREGNANCY AND LACTATION No evidence of harmful effects available. However, best avoided during the first trimester of pregnancy. May be used during breast feeding. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None stated. 4.8 UNDESIRABLE EFFECTS Use of the product may cause abdominal cramps. Glycerol can cause irritation when given rectally. Health Products Regulatory Authority 11 June 2019 CRN008YGJ Page 2 of 3 REPORTING OF SUSPECTED ADVERSE REACTIONS Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 67 完全なドキュメントを読む