Company: Galen Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredients: Macrogol 3350 13.125g, sodium chloride 350.7mg, sodium hydrogen carbonate 178.5mg, potassium chloride 46.6mg.
Description: Free flowing white powder for oral solution in a single-dose sachet.
Presentation: 30, €7.68.
Indications: Treatment of chronic constipation. Also effective in resolving faecal impaction.
Pharmacology: Macrogol 3350 induces a laxative effect through its osmotic action in the gut. This product also contains electrolytes to ensure that there is no overall gain or loss of water, potassium or sodium.
Dosage: Adult: Chronic constipation: Dissolve each sachet in 125ml water. 1-3 sachets daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 sachets daily. Faecal impaction: 8 sachets may be dissolved in 1 litre of water, store reconstituted solution covered at 2ºC-8ºC for up to 6 hours. 8 sachets daily within a 6 hour period. Do not exceed 3 days. Impaired cardiovascular function: Divide the dose so that no more than 2 sachets are taken in any 1 hour. Elderly: As per adults. Children: Under 12 years, not recommended. Over 12 years, as per adults.
Contraindications: Hypersensitivity to the active substances or any of the excipients. Intestinal obstruction or perforation caused by functional or structural disorder of the gut wall, ileus and in patients with severe inflammatory conditions of the intestinal tract (e.g. ulcerative colitis, Crohn’s disease, toxic megacolon). Pregnancy and lactation (unless clearly necessary).
Special precautions: Confirm the faecal impaction diagnosis by appropriate physical or radiological examination of the rectum and abdomen. Stop immediately if symptoms indicating shifts of fluids/electrolytes develop (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure); measure electrolytes and treat any abnormality appropriately. Contains glucose and sulphur dioxide.
Drug interactions: No other medicines to be taken orally for 1 hour before and for 1 hour after administration.
Adverse drug reactions: Abdominal distension and pain, borborygmi, nausea, mild diarrhoea.
Full prescribing information and references available from Galen Ltd c/o Allphar. Telephone: (01) 4041600.