Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLYCEROL 85%
Bausch & Lomb UK Limited
1.8 Grams
Rectal Solution
2010-11-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Babylax 1.8 g Rectal Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Glycerol (85%) 1.8 g per applicator. Excipients: Each applicator contains 0.36mg of benzalkonium chloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Rectal solution. Clear, colourless, rectal solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of constipation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For rectal use only. Under 3 months: ½ to 1 applicator. Over 3 months up to 6 years: 1 applicator. Children over 6 years: 1 - 2 applicators. Adults and elderly: 1 - 2 applicators. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If constipation persists, consult your doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.6 FERTILITY, PREGNANCY AND LACTATION None. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/11/2010_ _CRN 2090792_ _page number: 1_ None. 4.8 UNDESIRABLE EFFECTS Prolonged use may lead to irritation of the anal canal. 4.9 OVERDOSE None. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Glycerol is a trivalent alcohol. When glycerol is given rectally, it promotes peristalsis and evacuation of the lower bowel by virtue of its irritant action, so that defecation stimulus is increased. 5.2 PHARMACOKINETIC PROPERTIES There is a slight absorption of glycerol from the rectum. The elimination of absorbed glycerol is via the kidneys. 5.3 PRECLINICAL SAFETY DATA (Registry of toxic Effects of Chemical Substances 1987) 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Benzalkonium chloride Mac Read the complete document