Essential Information for HCPs
Presentation: Movicol sachets containing: 13.125 g macrogol 3350, 0.3507 g sodium chloride, 0.1785 g sodium hydrogen carbonate and 0.0466 g potassium chloride. Indications: Chronic constipation and faecal impaction. Dose: Adults including the elderly and children 12 years and over: Chronic constipation: 1-3 sachets in divided doses adjusted according to individual response. Treatment course should not normally exceed 2 weeks. For extended use the dose can be adjusted down to 1 to 2 sachets daily. Faecal impaction: 8 sachets daily consumed within a 6-hour period. Treatment course should not normally exceed 3 days. Administration: Dissolve each sachet in 125 ml water. For faecal impaction 8 sachets may be dissolved in 1 litre water. Contraindications: Hypersensitivity to the ingredients, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn’s disease and ulcerative colitis and toxic megacolon. Warnings and precautions: Adequate fluid intake must be maintained during treatment (fluid content of Movicol when reconstituted should not replace regular fluid intake). Diagnosis of impaction / faecal loading should be confirmed by physical or radiological examination of the abdomen and rectum. Movicol should be stopped immediately in patients who develop symptoms indicating a change in fluid/electrolytes levels; electrolyte levels should be measured and treated appropriately. Movicol is high in sodium and therefore should be taken into consideration in patients on a low salt diet. Interactions: Absorption of other medicinal products may be transiently reduced whilst taking Movicol due to an increase in gastro- intestinal transit rate, therefore other medicines should not be taken orally for one hour before, during and for one hour after taking Movicol. Macrogol counteracts the thickening effect of starch and therefore the amount of starch-based thickeners may need to be increased in patients with swallowing problems. Pregnancy and breastfeeding: Movicol can be taken during pregnancy and whilst breast-feeding. Adverse reactions: Unknown frequency: allergic reactions including anaphylactic reaction, dyspnoea, and allergic skin reactions (angioedema, urticaria, pruritus, rash, erythema), electrolyte disturbances particularly hyperkalaemia and hypokalaemia, headache, abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anorectal discomfort, peripheral oedema. RRP (ex VAT): 30 £12.33. Legal category: P. Product licence number: PL 00322/0070. Product licence holder: Norgine Limited, Norgine House, Widewater Place, Moorhall Place, Harefield, Uxbridge, UB9 6NS, UK. Further information is available from Norgine Limited, Norgine House, Widewater Place, Moorhall Place, Harefield, Uxbridge, UB9 6NS. Date of preparation: April 2024
MOVICOL PLAIN 13.8G SACHET, POWDER FOR ORAL SOLUTION
Presentation: Movicol Plain sachets containing: 13.125 g macrogol 3350, 0.3508 g sodium chloride, 0.1786 g sodium hydrogen carbonate and 0.0502 g potassium chloride. Indications: Chronic constipation and faecal impaction. Dose: Adults including the elderly and children 12 years and over: Chronic constipation: 1-3 sachets in divided doses adjusted according to individual response. Treatment course should not normally exceed 2 weeks. For extended use the dose can be adjusted down to 1 to 2 sachets daily. Faecal impaction: 8 sachets daily consumed within a 6-hour period. Treatment course should not normally exceed 3 days. Administration: Dissolve each sachet in 125 ml water. For faecal impaction 8 sachets may be dissolved in 1 litre water. Contraindications: Hypersensitivity to the ingredients, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn’s disease and ulcerative colitis and toxic megacolon. Warnings and precautions: Adequate fluid intake must be maintained during treatment (fluid content of Movicol when reconstituted should not replace regular fluid intake). Diagnosis of impaction / faecal loading should be confirmed by physical or radiological examination of the abdomen and rectum. Movicol should be stopped immediately in patients who develop symptoms indicating a change in fluid/electrolytes levels; electrolyte levels should be measured and treated appropriately. Movicol is high in sodium and therefore should be taken into consideration in patients on a low salt diet. Interactions: Absorption of other medicinal products may be transiently reduced whilst taking Movicol due to an increase in gastro- intestinal transit rate, therefore other medicines should not be taken orally for one hour before, during and for one hour after taking Movicol. Macrogol counteracts the thickening effect of starch and therefore the amount of starch-based thickeners may need to be increased in patients with swallowing problems. Pregnancy and breastfeeding: Movicol can be taken during pregnancy and whilst breast-feeding. Adverse reactions: Unknown frequency: allergic reactions including anaphylactic reaction, dyspnoea, and allergic skin reactions (angioedema, urticaria, pruritus, rash, erythema), electrolyte disturbances particularly hyperkalaemia and hypokalaemia, headache, abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anorectal discomfort, peripheral oedema. RRP (ex VAT): 30 £12.33. Legal category: P . Product licence number: PL 20011/0037. Product licence holder: Norgine Pharmaceuticals Ltd., Norgine House, Widewater Place, Moorhall Place, Harefield, Uxbridge, UB9 6NS, UK. Further information is available from Norgine Pharmaceuticals Ltd., Norgine House, Widewater Place, Moorhall Place, Harefield, Uxbridge, UB9 6NS. Date of preparation: April 2024
MOVICOL CHOCOLATE 13.8G SACHET, POWDER FOR ORAL SOLUTION
Presentation: Movicol Chocolate sachets containing: 13.125 g macrogol 3350, 0.3507 g sodium chloride, 0.1785 g sodium hydrogen carbonate and 0.0317 g potassium chloride. Indications: Chronic constipation and faecal impaction. Dose: Adults including the elderly and children 12 years and over: Chronic constipation: 1-3 sachets in divided doses adjusted according to individual response. Treatment course should not normally exceed 2 weeks. For extended use the dose can be adjusted down to 1 to 2 sachets daily. Faecal impaction: 8 sachets daily consumed within a 6-hour period. Treatment course should not normally exceed 3 days. Administration: Dissolve each sachet in 125 ml water. For faecal impaction 8 sachets may be dissolved in 1 litre water. Contraindications: Hypersensitivity to the ingredients, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn’s disease and ulcerative colitis and toxic megacolon. Warnings and precautions: Adequate fluid intake must be maintained during treatment (fluid content of Movicol when reconstituted should not replace regular fluid intake). Diagnosis of impaction / faecal loading should be confirmed by physical or radiological examination of the abdomen and rectum. Movicol should be stopped immediately in patients who develop symptoms indicating a change in fluid/electrolytes levels; electrolyte levels should be measured and treated appropriately. Movicol is high in sodium and therefore should be taken into consideration in patients on a low salt diet. Contains 14.1 mg benzyl alcohol per sachet; benzyl alcohol may cause anaphylactoid reactions. Interactions: Absorption of other medicinal products may be transiently reduced whilst taking Movicol due to an increase in gastro-intestinal transit rate, therefore other medicines should not be taken orally for one hour before, during and for one hour after taking Movicol. Macrogol counteracts the thickening effect of starch and therefore the amount of starch-based thickeners may need to be increased in patients with swallowing problems. Pregnancy and breastfeeding: Movicol can be taken during pregnancy and whilst breast-feeding. Adverse reactions: Unknown frequency: allergic reactions including anaphylactic reaction, dyspnoea, and allergic skin reactions (angioedema, urticaria, pruritus, rash, erythema), electrolyte disturbances particularly hyperkalaemia and hypokalaemia, headache, abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anorectal discomfort, peripheral oedema. RRP (ex VAT): 30 £12.33. Legal category: P . Product licence number: PL 00322/0086. Product licence holder: Norgine Limited, Norgine House, Widewater Place, Moorhall Place, Harefield, Uxbridge, UB9 6NS, UK. Further information is available from Norgine Limited, Norgine House, Widewater Place, Moorhall Place, Harefield, Uxbridge, UB9 6NS. Date of preparation: April 2024
Adverse effects should be reported.
Reporting forms and information can be found at http://www.mhra.gov.uk/yellowcard Adverse events should also be reported to the Medical Information at Norgine Pharmaceuticals Limited on:
Email medinfo@norgine.com Tel. +44 (0) 1895 286606.
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