Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Macrogol 4000
Sanofi-Aventis Ireland Limited T/A SANOFI
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
2015-01-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Macrosoft 10 g Powder for Oral Solution in Sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 10 g macrogol 4000. Excipient with known effect: Each sachet contains 0.2 mg sorbitol (contained in lemon-grapefruit flavour). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution in sachet. White powder, free of large agglomerates, with an odour and taste of lemon, packed in a sachet for the preparation of an oral solution. 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 with Macrosoft. Macrosoft should remain a temporary adjuvant treatment to appropriate lifestyle and dietary management of constipation, with a maximum 3- months 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 Posology It is generally recommended to consider healthy lifestyle measures such as adequate hydration, physical activity, and increased natural fibre intake. In case the symptoms persist or get worse, a physician should be consulted. _Adults_ 1 to 2 sachets (10 to 20 g macrogol 4000) per day, preferably taken as a single dose in the morning. _Paediatric population_ ~_ CHILDREN_ _8 YEARS AND ADOLESCENTS:_ 1 to 2 sachets (10 to 20 g macrogol 4000) per day, preferably taken as a single dose in the morning. ~_ CHILDREN (<8 YEARS):_ Macrosoft is not recommended for use in children below the age of 8 years. The daily dose should be adapted as required to produce regular soft stools and may range from one sachet every other day (especially in children) up to 2 sachets a day. If administered regularly, the frequency of bowel movements tends to be one movement per day. In children, treatment should not exceed 3 months due to a lack o Baca dokumen lengkapnya