MOVICOL

What it is

MOVICOL contains macrogol 3350 and electrolytes (sodium chloride, sodium bicarbonate, potassium chloride). It is a powder for oral solution.

Approved indications

— Effective relief of constipation in adults. — Treatment of chronic constipation in adults and children aged 2 years and older. — Resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum, or the rectum and colon, confirmed by physical examination of abdomen and rectum, in adults and children aged 2 years and older. — Prevention of recurrence of faecal impaction in children aged 2 years and older.

Dosing overview

Each sachet should be dissolved in 62.5 mL (about ¼ cup) of water. Use in children aged 2 years and older should be limited to 12 weeks except under medical supervision.

Key safety warnings

The fluid content of MOVICOL when reconstituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. If patients develop symptoms indicating shifts of fluid and electrolytes (such as oedema, shortness of breath, increasing fatigue, dehydration, or cardiac failure), MOVICOL should be stopped immediately and electrolytes measured, with any abnormality treated appropriately. MOVICOL contains 93.4 mg of sodium per sachet; the maximum daily dose for constipation is equivalent to 28% of the WHO recommended maximum daily intake for sodium and the product is considered high in sodium. This should be particularly taken into account for those on a low salt diet. Benzyl alcohol may cause anaphylactoid reactions; MOVICOL contains 7.0 mg benzyl alcohol per sachet and should be used with caution and only if necessary in pregnancy, lactation, liver or kidney impairment because of the risk of benzoic acid accumulation and toxicity. The absorption of other medicines could transiently be reduced due to a decrease in gastro-intestinal transit time induced by MOVICOL. Prolonged use is not usually recommended and may lead to dependence; if prolonged use is necessary, it should only be under medical supervision.

Contraindications

MOVICOL is contraindicated in intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus and severe inflammatory conditions of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic megacolon. It is also contraindicated in known hypersensitivity to macrogol or any of the ingredients.

Regulatory history

MOVICOL Lemon-Lime Flavour was first listed on the ARTG on 21 August 1997. MOVICOL Junior Lemon-Lime Flavour was registered on 23 September 2004, followed by MOVICOL Junior Flavour Free on 18 March 2009. MOVICOL Chocolate Flavour and MOVICOL Flavour Free were both registered on 4 April 2011. MOVICOL Junior Chocolate Flavour was registered on 3 April 2013, with MOVICOL Liquid Orange Flavour and MOVICOL Ready to Take following in 2013 and 2016 respectively.