Each sachet of MOVICOL CHOCOLATE contains:

Macrogol 3350 13.125 g
Sodium chloride 350.7 mg
Sodium bicarbonate 178.5 mg
Potassium chloride 31.7 mg
Chocolate flavor and potassium acesulfame as a sweetener.

The content of electrolyte ions per sachet when made up to 125 mL is:

Sodium 65 mmol/L
Potassium 5.4 mmol/L
Chloride 51 mmol/L
Bicarbonate 17 mmol/L

Pharmacology: Macrogol 3350 exerts an osmotic action in the gut, which induces a laxative effect. Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is an improved propulsive colonic transportation of the softened stools and a facilitation of the 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.

Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the gastrointestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine.

The laxative action of macrogol has a time course which will vary according to the severity of the constipation being treated. Faecal Impaction – In a non-comparative study in 27 adult patients, MOVICOL cleared the faecal impaction in 12/27 (44%) after 1 day’s treatment, 23/27 (85%) after 2 day’s treatment and 24/27 (89%) at the end of 3 days. Controlled comparative studies have not been performed with other treatments (eg. enemas).

Indications: For effective relief from constipation, treatment of chronic constipation. MOVICOL Chocolate is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by physical examination of abdomen and rectum.

Contraindications: 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. Known hypersensitivity to the active substances or any of the excipients.

Precautions: Adverse reactions are possible as described under Adverse Reactions. If patients develop any symptoms indicating shifts of fluid/electrolytes (eg. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) MOVICOL Chocolate should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately.

The absorption of other medicinal products could transiently be reduced due to a decrease in gastro- intestinal transit time induced by MOVICOL Chocolate (see interactions with other drugs).

As with all laxatives, prolonged use is not usually recommended and may lead to dependence. Patients should be advised to drink plenty of water and increase fibre in the diet.

Use in pregnancy: There is no experience of the use of MOVICOL Chocolate during pregnancy. MOVICOL Chocolate should only be used if considered essential by the physician.

Use in Lactation: There is no experience of the use of MOVICOL Chocolate in lactation. It is unknown whether macrogol 3350 is excreted in human breast milk. The excretion of macrogol 3350 in milk has not been studied in animals. A decision on whether to continue/discontinue breast feeding or to continue/discontinue therapy with MOVICOL Chocolate should be made taking in account the benefit of breast feeding to the child and the benefit of MOVICOL Chocolate therapy to the woman.

Use in children: MOVICOL paediatric dosages (MOVICOL-Half and MOVICOL Junior) are approved for use in children aged 2 years and above, for chronic constipation and faecal impaction only.

Interactions with other drugs: There is a possibility that the absorption of other medicinal products could be transiently reduced during use with MOVICOL Chocolate (see Precautions). There have been isolated reports of decreased efficacy with some concomitantly administered medicinal products, e.g. anti-epileptics. A theoretical potential also exists for decreased absorption (rate and extent) of drugs which are generally poorly absorbed or are contained in sustained or modified release dosage forms. This is more likely to occur if MOVICOL Chocolate is overdosed to induce watery diarrhoea.

Mutagenicity and carcinogenicity: Preclinical studies show that macrogol 3350 has no significant systemic toxicity potential.

Adverse Reactions: 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 MOVICOL Chocolate. Diarrhoea usually responds to dose reduction.

Dosage:
Constipation: The dose is 1 sachet daily. This may be increased to 2-3 sachets daily, if required.

Faecal Impaction: 8 sachets daily, consumed within 6 hours. A course of treatment for faecal impaction does not normally exceed 3 days.
Patients with impaired cardiovascular function: For the treatment of faecal impaction the dose should be divided so that no more than two sachets are taken in any one hour.

Patients with renal insufficiency: No dosage change is necessary for treatment of either constipation or faecal impaction.

Administration: For oral administration. Each sachet should be dissolved in 125 mL water. For faecal impaction 8 sachets may be dissolved in 1 litre of water. Store solution refrigerated and discard any solution not used within 24 hours.

Overdosage: Severe pain or distention can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances. For information on the management of overdose, contact the Poisons Information Centre on 13 11 26

Presentation: Powder for solution. Boxes of 8 sachets and 30 sachets. Each sachet contains 13.125 g of macrogol 3350.

Storage: Store below 25°C