Laxido Orange Prescribing Information and Adverse Event Reporting

Laxido Orange, powder for oral solution solution (macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride): Please refer to the Summary of Product Characteristics (SPC) before prescribing.

Abbreviated Prescribing Information.

Presentation: Single-dose sachet, each containing a free flowing white powder composed of: Macrogol 3350 13.125g, sodium chloride 350.7mg, sodium hydrogen carbonate 178.5mg, and potassium chloride 46.6mg. Indications: Treatment of chronic constipation and faecal impaction. Dosage: Chronic constipation: A course of treatment for chronic constipation with Laxido Orange does not normally exceed 2 weeks, although this can be repeated if required. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson’s Disease, or induced by regular constipating medication in particular opioids and antimuscarinics. Adults, adolescents and the elderly: 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. Children below 12 years old: Not recommended. Faecal Impaction: A course of treatment for faecal impaction with Laxido Orange does not normally exceed 3 days. Adults, adolescents and the elderly: 8 sachets daily, all of which should be consumed within a 6 hour period. Children below 12 years old: Not recommended. Patients with impaired cardiovascular function: For the treatment of faecal impaction the dose should be divided so that not more than 2 sachets are taken in any one hour. Administration: Each sachet should be dissolved in 125 ml water. For use in faecal impaction, 8 sachets may be dissolved in 1 litre of water. The reconstituted solution should be stored covered in a refrigerator (2°C to 8°C), for up to six hours. Contraindications: 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 and toxic megacolon). Hypersensitivity to the active substances or any of the excipients contained in Laxido Orange. Warnings and Precautions: The fluid content of Laxido Orange when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. The faecal impaction diagnosis should be confirmed by appropriate physical or radiological examination of the rectum and abdomen. If patients develop any symptoms indicating shifts of fluids/electrolytes, Laxido Orange should be stopped immediately. The absorption of other medicinal products could transiently be reduced due to an increase in gastrointestinal transit induced by Laxido Orange. This medicinal product contains 187mg of sodium per sachet, equivalent to approximately 9% of the WHO recommended maximum daily intake of 2g sodium for an adult. When used to treat chronic constipation the maximum daily dose of this product is equivalent to approximately 28% of the WHO recommended maximum daily intake for sodium. Laxido Orange is considered high in sodium. This should be particularly taken into account for those on a low salt diet. In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered. Interactions: It is a theoretical possibility that absorption of other medicinal products could be reduced transiently during concomitant use with Laxido Orange. There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products e.g. anti-epileptics. Therefore, other medicines should not be taken orally for one hour before and for one hour after taking Laxido Orange. Laxido Orange may result in a potential interactive effect if used with starch-based food thickeners. The macrogol ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems. Fertility, pregnancy and lactation: Studies in animals have shown indirect reproductive toxicity. There are limited data from the use of Laxido Orange in pregnant women. Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible. Laxido Orange can be used during pregnancy. Laxido Orange can be used during breast-feeding. There are no data on the effects of Laxido Orange on fertility in humans. Effects on ability to drive and use machines: Laxido Orange has no influence on the ability to drive and use machines. Undesirable effects: Reactions related to the gastrointestinal tract are the most common and include: abdominal pain, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence and anorectal discomfort. Diarrhoea may also occur, mild cases of which usually respond to dose reduction. Allergic reactions including anaphylaxis, angioedema, dyspnoea and skin reactions can occur. Other effects can include electrolyte disturbances, headache and peripheral oedema. Overdose: Refer to SPC. Legal Category: P. NHS Price: Cartons of 20 sachets: £3.85; 30 sachets: £5.50. MA Number: PL 27827/0026. Full prescribing information available from the MA Holder: Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, United Kingdom. Date of Preparation: April 2024.