Abridged prescribing information

Composition: MOVICOL®  Liquid: Each 25 ml of solution contains: Macrogol 3350 (Polyethylene Glycol) BP : 13.125g, Sodium Chloride BP : 350.7 mg, Sodium Bicardonate BP : 178.5 mg, Potassium Chloride BP : 46.6 mg, Aq. Base q.s. The concentration of electrolyte icons present when a 25 ml dose is made up to 125 ml of solution with 100 ml of water, is as follows: Sodium : 65 mmol/l, Chloride : 53 mmol/l, Bicarbonate : 17 mmol/l, Potassium : 5.4 mmol/l.

THERAPEUTIC INDICATIONS: For the treatment of constipation. Effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon.

DOSE AND METHOD OF ADMINISTRATION: MOVICOL®  Liquid: Constipation: 25 ml diluted in 100 ml of water 1-3 times daily, in divided doses,, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 doses per day of 25 ml diluted in 100 ml of water. A course of treatment for constipation with MOVICOL® Liquid does not normally exceed 2 weeks, although this can be repeated if required. As for all laxatives, prolonged use is not usually recommended. Extended use may be necessary in the case of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson’ Disease, or induced by regular constipating medication in perticular opioids and antimuscarinics. Faecal Impaction : 4×25 ml doses, each dose (25ml) diluted in 100 ml of water, twice daily. A course of treatment dose not normally exceed 3 days. 

SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Not recommended for children below 12 years. Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum. If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) MOVICOL® 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 an increase in gastro-intestinal transit rate induced by MOVICOL®. Patients with impaired cardiovascular function: For the treatment of faecal impaction the dose should be divided so that no more than two doses are taken in any one hour. Patients with renal insufficiency: No dosage change is necessary for treatment of either constipation or faecal impaction.

CONTRAINDICATIONS: Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn’s disease and ulcerative colitis and toxic megacolon. Hypersensitivity to the active ingredients or to any of the excipients.

FERTILITY, PREGNANCY AND LACTATION: Pregnancy: There is limited amount of data from the use of MOVICOL® in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or post-natal development.  No effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible. MOVICOL® can be used during pregnancy.  Breast-feeding: No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to macrogol 3350 is negligible. MOVICOL® can be used during breast-feeding.  Fertility: There are no data on the effects of MOVICOL® on fertility in humans. 

UNDESIRABLE EFFECTS:  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®. Diarrhoea usually responds to dose reduction. The frequency of the adverse effects is not known as it cannot be estimated from the available data. Immune system disorders: Allergic reactions, including anaphylaxis, angiooedema, dyspnoea, rash, urticaria, and pruritus. Skin and Soft tissue disorders: Erythema. Metabolism and nutrition disorders: Electrolyte disturbances, particularly hyperkalemia and hypokalemia. Nervous system disorders: Headache.  Gastrointestinal disorders: Abdominal pain, diarrhoea, vomiting, nausea, dyspepsia, abdominal distension, borborygmi, flatulence, anal discomfort.

PHARMACOLOGICAL PROPERTIES: Macrogol 3350 acts by virtue of its 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 defecation. 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.

STORAGE: Store protected from moisture at a temperature not exceeding 30°C. Keep out of reach of children.

PRESENTATION: MOVICOL® Liquid 200 ml PET bottle, provided with dosing cup.