Company: Galen Ltd.
Legal category: Prescription. GMS reimbursable. Sport permitted.
Active ingredients: Macrogol 3350 6.563g, sodium chloride 175.4mg, sodium hydrogen carbonate 89.3mg, potassium chloride 25.1mg.
Description: Powder for oral solution in single-dose sachet.
Presentation: 30, €5.71.
Indications: Treatment of chronic constipation, faecal impaction.
Pharmacology: Macrogol 3350 acts by osmotic action in the gut, which induces a laxative effect. It increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of softened stools and facilitation of defaecation. Electrolytes combined with macrogol 3350 are exchanged across the intestinal barrier (mucosa) with serum electrolytes and excreted in faecal water without net gain or loss of sodium, potassium and water.
Dosage: Children: 12 years and older, use Laxido Orange. Dissolve each sachet in 62.5ml water. Chronic constipation: 2 to 6 years, 1 sachet daily; 7 to 11 years, 2 sachets daily. Adjust as required. Maximum dose needed does not normally exceed 4 sachets a day. Withdraw gradually. Under 2 years, not recommended. Faecal impaction: Take in divided doses within a 12 hour period for up to 7 days. 5 to 11 years, Days 1, 2, 3 and 4 take 4, 6, 8 or 10 sachets daily respectively, Days 5-7 take 12 sachets daily. Under 5 years, not recommended.
Contraindications: Hypersensitivity to the active substances. Intestinal obstruction or perforation caused by functional or structural disorder of the gut wall, ileus. Severe inflammatory conditions of intestinal tract.
Special precautions: Confirm faecal impaction diagnosis by appropriate physical/ radiological rectum and abdomen examination. 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. Not recommended for faecal impaction in cardiovascular or renal impairment. Caution: High doses in patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness.
Drug interactions: Other medicines (see SPC). Medicines in solid dose form within one hour (faecal impaction).
Adverse drug reactions: Abdominal pain, borborygmi, nausea, diarrhoea, vomiting, anal discomfort.
Full prescribing information and references available from Galen Ltd. Telephone: +44 (0)28 3833 4974. Fax: +44 (0)28 3835 0206. E-mail: customer.services@galen-pharma.com