Movicol Chocolate 13.9g Powder
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of chronic constipation.
Dosage (summary)
Adults: 1-3 sachets daily; Elderly: 1 sachet daily.
Pregnancy & Breastfeeding
Safety in pregnancy not established.
Key Drug Interactions
- Theoretical reduction in absorption of alcohol-soluble drugs.
Contraindications
- Intestinal perforation or obstruction
- Hypersensitivity to ingredients
- Not for children under 12
Common side effects
- Abdominal distension
- Nausea
- Mild diarrhoea
- Vomiting
- Anal irritation
Counselling Points
- Reconstitute each sachet in 125 ml water.
- Do not exceed recommended dosage.
- Discontinue if rectal bleeding occurs.
Serious warnings
- Do not use with abdominal pain, nausea, or vomiting.
- Risk of dependence with prolonged use.
- Consult doctor for sudden change in bowel habits.
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
For the treatment of chronic constipation.
4.2 Posology and method of administration
Adults: 1 to 3 sachets daily in divided doses, according to individual response, each sachet reconstituted in 125 ml water and taken orally.
Elderly: Initially, one sachet daily is recommended. No dosage change is needed to be made for patients with renal insufficiency. A course of treatment with MOVICOL CHOCOLATE 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.
4.3 Contraindications
- 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 and ulcerative colitis and toxic megacolon.
- Hypersensitivity to the active ingredients or to any of the excipients.
- Not recommended for children under 12 years of age.
4.4 Special warnings and precautions for use
MOVICOL CHOCOLATE should not be used in the presence of abdominal pain, nausea or vomiting. MOVICOL CHOCOLATE 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. If patients develop any symptoms indicating shifts of fluid/electrolytes (e.g. 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. If there is a sudden change in bowel habits that has persisted for a period greater than two weeks, a medical practitioner should be consulted. Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition. MOVICOL CHOCOLATE should be discontinued and medical advice obtained.
4.5 Interactions with other medicines
No clinical interactions with other medicinal products have been reported. Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water. There is therefore a theoretical possibility that the absorption of such medicinal products could be transiently reduced.
4.6 Fertility, pregnancy and lactation
Safety in pregnancy has not been established.
4.7 Effects on ability to drive and use machines
No specific information available.
4.8 Undesirable effects
Abdominal distension, pain, borborygmi, nausea, abdominal cramps, mild diarrhoea which usually responds to dose reduction, vomiting and anal irritation may occur. Urticaria and allergic reactions, including anaphylaxis to macrogol (polyethylene glycol) have been reported.
4.9 Overdose
Symptoms: Severe pain or distension, diarrhoea or vomiting is associated with overdosage.
Treatment: Severe pain or distension, associated with overdosage, can be treated by nasogastric aspiration. In the case of gross accidental overdosage, extensive fluid loss by diarrhoea or vomiting may require correction with generous amounts of fluid and electrolytes.