国: マルタ
言語: 英語
ソース: Medicines Authority
MACROGOL
Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta
A06AD15
MACROGOL 10 g
POWDER FOR ORAL SOLUTION
MACROGOL 10 g
OTC
DRUGS FOR CONSTIPATION
Withdrawn
2016-08-29
D1/MT/PIL/2 DATED 31 MAY 2017 PACKAGE LEAFLET: INFORMATION FOR THE USER DULCOSOFT 10 G POWDER FOR ORAL SOLUTION IN SACHET MACROGOL 4000 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 14 days. WHAT IS IN THIS LEAFLET 1. What Dulcosoft is and what it is used for 2. What you need to know before you take Dulcosoft 3. How to take Dulcosoft 4. Possible side effects 5. How to store Dulcosoft 6. Contents of the pack and other information 1. WHAT DULCOSOFT IS AND WHAT IT IS USED FOR Dulcosoft belongs to a group of medicines called osmotic laxatives. It works by carrying water to your stool, which loosens and increases stool volume, helping to overcome sluggish bowels, working gradually within 24 to 48 hours Dulcosoft is not absorbed into the bloodstream or broken down in the body. It is used for the treatment of constipation in adults and children aged 8 years and above. The treatment of constipation with any medicine should only be in addition to a healthy lifestyle and diet. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DULCOSOFT DO NOT TAKE DULCOSOFT: - if you are allergic to macrogol (polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6). - if you have an existing severe intestinal disease such as: - inflammatory bowel disease (such as ulcerative colitis, Crohn’s disease) or abnormal dilation of the bowel - perforation of the bowel or risk of perforation of the bowel - intestinal obstruction or suspicion of intestinal obstruction or symptomatic 完全なドキュメントを読む
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dulcosoft 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 Dulcosoft 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):_ Dulcosoft is not recommended for use in children below the age of 8 years. Page 2 of 7 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 month 完全なドキュメントを読む