Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Macrogol 4000
Ipsen Pharma
A06AD; A06AD15
Macrogol 4000
10 gram(s)
Powder for oral solution
Product subject to prescription which may be renewed (B)
Osmotically acting laxatives; macrogol
Not marketed
2002-02-22
Health Products Regulatory Authority 01 May 2019 CRN008MPX Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Idrolax 10g, powder for oral solution in a sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 10g of macrogol 4000. Excipients: Flavour (orange-grapefruit)*.............................................................. 0.15 g Saccharin sodium................................................................................ 0.017 g Per sachet of 10.17 g *Sorbitol and sulphur dioxide are constituents of orange-grapefruit flavour: Sorbitol (E420) ………………………………………………………1.8 mg per sachet. Sulphur dioxide (E220) ……………………………………………….0.24* x 10 -2 mg per sachet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution in sachet. Almost white powder with an odour and taste of orange-grapefruit. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of constipation in adults and children aged 8 years and above. An organic disorder should have been ruled out before initiation of treatment. IDROLAX 10 g should remain a temporary adjuvant treatment to appropriate lifestyle and dietary management of constipation, with a maximum 3-month treatment course in children. If symptoms persist despite associated dietary measures, an underlying cause should be suspected and treated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. Posology 1 to 2 sachets (10-20 g) per day, preferably taken as a single dose in the morning. The daily dose should be adjusted according to the clinical response and may range from one sachet every other day (especially in children) up to 2 sachets a day. The effect of IDROLAX becomes apparent within 24 to 48 hours after its administration. Paediatric population In children, treatment should not exceed 3 months due to a lack of clinical data for treatment lasting longer than 3 months. Treatment-induced restoration of bowel mo Прочитать полный документ