Laxido Orange Oral Powder Sachets SF (30)

Laxido Orange

Medicinal product

Osmotic laxative, sugar-free, oral powder sachets with electrolytes (pack of 30)

Licensed medicinal product in the UK and Ireland with an approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) under the brand name Laxido Orange, powder for oral solution.
Regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA) via the marketing authorisation held by Galen Limited.
Manufactured under Good Manufacturing Practice (GMP) and distributed under Good Distribution Practice (GDP) standards.
Classified as an osmotic laxative containing macrogol 3350 and electrolytes, with sugar Free (SF) formulation using acesulfame potassium as a sweetener.

Licensed medicinal product in the UK and Ireland with an approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) under the brand name Laxido Orange, powder for oral solution.
Regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA) via the marketing authorisation held by Galen Limited.
Manufactured under Good Manufacturing Practice (GMP) and distributed under Good Distribution Practice (GDP) standards.
Classified as an osmotic laxative containing macrogol 3350 and electrolytes, with sugar Free (SF) formulation using acesulfame potassium as a sweetener.

Osmotic laxative, sugar-free, oral powder sachets with electrolytes (pack of 30)

Description

Laxido Orange Oral Powder Sachets SF (30) is a sugar-free osmotic laxative for oral use, formulated as single-dose sachets of orange-flavoured powder that are dissolved in water before administration. Each sachet contains macrogol 3350 and electrolytes (sodium chloride, sodium hydrogen carbonate and potassium chloride), providing effective relief of chronic constipation and faecal impaction in adults, adolescents (aged 12 years and over) and the elderly. Macrogol 3350 works by retaining water in the bowel to soften stools and increase stool volume, making them easier to pass, while the added electrolytes help maintain the body’s normal levels of sodium, potassium and water during treatment. The SF (sugar-free) formulation uses acesulfame potassium as a sweetener and does not contain sugar, making it suitable for patients who need to avoid additional sugar intake.

Bnefits

Treats chronic constipation in adults, adolescents (12+) and the elderly by softening stools and increasing stool volume for easier passage.
Effective in resolving faecal impaction (build-up of hard faeces in the bowel) when diagnosed by a healthcare professional.
Contains macrogol 3350, an osmotic laxative with established efficacy for long-term constipation and faecal impaction.
Formulated with electrolytes (sodium, potassium, hydrogen carbonate, chloride) to help maintain normal electrolyte and fluid balance during treatment.
Sugar-free formulation using acesulfame potassium as a sweetener, suitable for patients who need to avoid added sugars.
Orange-flavoured powder that, once reconstituted with water, provides an easy-to-drink oral solution.
Convenient single-dose sachets allow flexible dosing (1–3 sachets daily for constipation; 8 sachets daily for faecal impaction in adults) as directed by a prescriber.
Can be used in certain patients needing extended treatment for severe or resistant constipation under medical supervision.
Licensed and regulated medicinal product with an approved Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).

Indications

Treatment of chronic constipation in adults, adolescents (aged 12 years and over) and the elderly.
Resolution of faecal impaction (refractory constipation with faecal loading of the rectum and/or colon) in adults, adolescents (aged 12 years and over) and the elderly, after the condition has been confirmed by appropriate clinical examination.
May be used in patients with chronic or resistant constipation secondary to conditions such as multiple sclerosis or Parkinson’s disease, or constipation induced by constipating medications (e.g. opioids, antimuscarinics) when prescribed and supervised by a clinician.

Composition

Active ingredients per sachet (13.8 g powder):
• Macrogol 3350 – 13.125 g
• Sodium chloride – 350.7 mg
• Sodium hydrogen carbonate (sodium bicarbonate) – 178.5 mg
• Potassium chloride – 46.6 mg
Electrolyte content after reconstitution of one sachet in 125 ml water (approximate):
• Sodium – 65 mmol/l
• Chloride – 53 mmol/l
• Hydrogen carbonate (bicarbonate) – 17 mmol/l
• Potassium – 5.4 mmol/l
Excipients:
• Acesulfame potassium (E950, sweetener)
• Orange flavour (containing maltodextrin and propylene glycol (E1520))

Formulation

Pharmaceutical form: Powder for oral solution in single-dose sachets.
Free-flowing white powder with orange taste and smell, sugar-free.
Osmotic laxative based on macrogol 3350 with added electrolytes to support maintenance of normal sodium, potassium and water balance.
Each sachet is designed to be fully dissolved in 125 ml of water prior to oral administration.

Packaging

Carton containing 30 single-dose sachets (commonly supplied as 2 strips of 15 sachets or similar configuration depending on market).
Each sachet contains 13.8 g of sugar-free powder for oral solution.
Outer carton and sachets are labelled with product name (Laxido Orange, sugar free), active ingredients, batch number and expiry date.
Pack size: 30 sachets SF (sugar free), classified as a prescription-only or pharmacy medicine depending on local jurisdiction.

Usage

Laxido Orange SF is for oral use only.
For adults, adolescents (aged 12 years and over) and the elderly, the powder should be prepared by emptying the contents of one sachet into a glass, adding approximately 125 ml of water and stirring until the powder has completely dissolved to form a clear or slightly hazy solution.
The reconstituted solution should be drunk; flavour or temperature (e.g. chilled) may be adjusted within the guidance given in the PIL if preferred.
Chronic constipation (adults, adolescents 12+ and elderly): Usual dose 1–3 sachets per day in divided doses, according to individual response. For extended use, the dose may be reduced to 1–2 sachets daily, as directed by a prescriber. A treatment course normally does not exceed 2 weeks, although it may be repeated if required, under medical advice.
Faecal impaction (adults, adolescents 12+ and elderly): Usual dose 8 sachets daily, all taken within a 6-hour period. Each sachet may be dissolved in 125 ml of water separately, or all 8 sachets may be dissolved together in 1 litre of water and consumed over up to 6 hours. A course for faecal impaction normally does not exceed 3 days.
Patients with impaired cardiovascular function: For faecal impaction, the dose should be divided so that no more than 2 sachets are taken in any one hour.
Children under 12 years: Laxido Orange SF is not recommended unless specifically prescribed; paediatric macrogol formulations should be used instead where appropriate.
The reconstituted solution may be covered and stored in a refrigerator (2–8 °C) and should be used within 6 hours; any unused solution after 6 hours must be discarded.
Adequate fluid intake should be maintained during treatment; the fluid content of the reconstituted product does not replace normal daily fluid requirements.
Patients should always follow the dosage and treatment duration instructions provided by their doctor or pharmacist and read the Patient Information Leaflet before use.

Contraindications

Hypersensitivity to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride or any of the excipients (including acesulfame potassium or components of the orange flavour).
Intestinal perforation or obstruction (bowel obstruction) due to structural or functional disorders of the gut wall.
Ileus (paralytic ileus or suspected ileus).
Severe inflammatory conditions of the intestinal tract such as ulcerative colitis, Crohn’s disease and toxic megacolon.
Gastric retention or uncontrolled peptic ulceration (per some regional product information).
Children under 12 years of age, unless specifically prescribed and supervised by a doctor.
Use in patients with undiagnosed acute abdominal pain, nausea or vomiting where serious abdominal conditions have not been excluded (use only after medical assessment).

Adverse Effects

Very common or common gastrointestinal effects such as abdominal pain, abdominal distension, bloating, flatulence (wind), stomach rumbling, mild diarrhoea, nausea and vomiting.
Soreness or discomfort of the anus (bottom), particularly in association with loose stools or diarrhoea.
Swelling of the abdomen and indigestion.
Allergic reactions including rash, pruritus (itching), urticaria (nettle rash), reddening of the skin, shortness of breath and, rarely, more serious hypersensitivity reactions such as anaphylaxis, angioedema or bronchospasm.
Changes in fluid and electrolyte balance (e.g. oedema, swelling – mainly in the ankles, dehydration, increased thirst, fatigue, headache) which may indicate altered potassium or other electrolyte levels; treatment should be stopped and electrolytes checked if such symptoms occur.
As with other laxatives, excessive doses may cause diarrhoea, abdominal discomfort and electrolyte disturbances, which generally resolve on dose reduction or cessation.

Storage Conditions

Keep out of the sight and reach of children.
Store unopened sachets at or below 25 °C in the original carton to protect from moisture.
Do not use after the expiry date stated on the carton and sachet (expiry refers to the last day of the stated month).
Do not use sachets that are damaged or show signs of deterioration.
After reconstitution, the solution may be covered and stored in a refrigerator between 2–8 °C and must be used within 6 hours; discard any unused solution after 6 hours.
Do not dispose of unused medicine via wastewater or household waste; follow local guidance or ask a pharmacist how to dispose of medicines no longer required.

Duration

For chronic constipation, a course of treatment with Laxido Orange SF typically does not exceed 2 weeks, although courses may be repeated if required under medical supervision; extended use may be needed in some patients with severe chronic or resistant constipation. For faecal impaction, treatment usually does not exceed 3 consecutive days.

Onset

Onset of effect varies between individuals; as an osmotic laxative, macrogol 3350 generally produces softening of stools and relief from constipation over a period of hours to a few days of treatment rather than immediate evacuation.