Laxido Orange 125 ml Powder for oral solution

LAXIDO ORANGE is indicated in adults and adolescents for the treatment of chronic constipation.

Posology
Adults, adolescents and the elderly: 1 to 3 sachets daily in divided doses, according to individual response, each sachet reconstituted in 125 ml water and taken orally. No dosage change is needed to be made for patients with renal insufficiency. A course of treatment with LAXIDO ORANGE does not normally exceed two 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 Parkinsonu2019s disease, or induced by regular constipating medication, in particular opioids and antimuscarinics. For extended use, the dose can be adjusted down to 1 or 2 sachets daily, in divided doses, each reconstituted with 125 ml water and taken orally.
Paediatric population
Not recommended for use in children under 12 years of age (see section 4.3)
Method of administration
For oral administration. Each sachet should be dissolved in 125 ml water.

• Hypersensitivity to macrogol (PEG), sodium hydrogen carbonate, sodium chloride, potassium chloride or to any of the excipients of LAXIDO ORANGE listed in section 6.1.
• Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, gastric retention, peptic ulceration, and severe inflammatory conditions of the intestinal tract, such as Crohnu2019s disease, ulcerative colitis and toxic megacolon.
• Children under 12 years of age.

The fluid content of LAXIDO ORANGE when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. LAXIDO ORANGE should not be used in the presence of abdominal pain, nausea or vomiting. LAXIDO ORANGE should not be used continuously unless directed by a doctor. Frequent or prolonged use of laxatives may result in dependence and loss of normal bowel function. Mild adverse drug reactions are possible as indicated in section 4.8. If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) LAXIDO ORANGE should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately. If there is a sudden change in bowel habits that has persisted for a period greater than 2 weeks, a medical practitioner should be consulted. Rectal bleeding or failure to have a bowel movement after use of LAXIDO ORANGE may indicate a serious condition. LAXIDO ORANGE should be discontinued, and medical advice obtained. The absorption of other medicines could transiently be reduced due to an increase in gastrointestinal transit rate induced by LAXIDO ORANGE (see section 4.5). Reactions related to the gastrointestinal tract occur most commonly. These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of LAXIDO ORANGE (see section 4.8). Diarrhoea usually responds to dose reduction. LAXIDO ORANGE contains 187 mg of sodium per sachet, equivalent to approximately 9 % of the WHO recommended maximum daily intake of 2 g 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.

Macrogol 3350 raises the solubility of medicines that are soluble in alcohol and mainly insoluble in water. There is a possibility that the absorption of other medicines could be transiently reduced during use with LAXIDO ORANGE (see section 4.4). There have been reports of decreased efficacy with some concomitantly administered medicines, e.g. anti-epileptics.

Pregnancy
There is limited amount of 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.
Breastfeeding
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to macrogol 3350 is negligible. LAXIDO ORANGE can be used during breastfeeding.
Fertility
There are no data on the effects of LAXIDO ORANGE on fertility in humans. There were no effects on fertility in studies in male and female rats.

LAXIDO ORANGE has no influence on the ability to drive and use machines. Patients should not drive, use machinery or perform any tasks that require concentration until they are certain that LAXIDO ORANGE does not adversely affect their ability to do so safely (see section 4.8).

Reactions related to the gastrointestinal tract occur most commonly. These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and an increase in motility due to the pharmacologic effects of LAXIDO ORANGE. Mild diarrhoea usually responds to dose reduction. The frequency of the adverse effects is not known as it cannot be estimated from the available data.
System Organ Class Adverse Event
Immune system disorders Allergic reactions, including anaphylaxis, angioedema, dyspnoea, rash, urticaria and pruritus
Skin and subcutaneous tissue disorders Erythema.
Metabolism and nutrition disorders Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia.
Nervous system disorders Headache.
Gastrointestinal disorders Abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anorectal discomfort.
General disorders and administration site conditions Peripheral oedema.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Severe abdominal pain or distension can be treated using nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.