Valsts: Nīderlande
Valoda: holandiešu
Klimata pārmaiņas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
MACROGOL 4000
sanofi-aventis Netherlands B.V.
A06AD15
MACROGOL 4000
Poeder voor drank
ACESULFAAM KALIUM (E 950) ; CALCIUMCITRAAT 0-WATER ; CITROEN-GRAPEFRUIT FLAVOUR, Code 154 ; CITROENOLIE ; CITROENZUUR 0-WATER (E 330) ; FRAMBOZENSMAAKSTOF ; GLUCONOLACTON (E 575) ; GRAPEFRUITSMAAKSTOF ; KALIUMCHLORIDE ; MAGNESIUMCITRAAT 0-WATER ; MANNITOL (D-) (E 421) ; MARACUJA SMAAKSTOF ; SILICIUMDIOXIDE (E 551) ; SORBITOL (D-)(E 420),
Oraal gebruik
Macrogol
Hulpstoffen: ACESULFAAM KALIUM (E 950); CALCIUMCITRAAT 0-WATER; CITROEN-GRAPEFRUIT FLAVOUR, Code 154; CITROENOLIE; CITROENZUUR 0-WATER (E 330); FRAMBOZENSMAAKSTOF; GLUCONOLACTON (E 575); GRAPEFRUITSMAAKSTOF; KALIUMCHLORIDE; MAGNESIUMCITRAAT 0-WATER; MANNITOL (D-) (E 421); MARACUJA SMAAKSTOF; SILICIUMDIOXIDE (E 551); SORBITOL (D-)(E 420);
2016-12-16
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DULCOSOFT 10 G, POEDER VOOR DRANK 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 narrowing of the bowel - painful Izlasiet visu dokumentu
1 1. NAME OF THE MEDICINAL PRODUCT Dulcosoft 10 g, poeder voor drank 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. 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, 2 treatment should not exceed 3 months due to a lack of clinical data for treatment lasting longe Izlasiet visu dokumentu