MOVICOL PAEDIATRIC CHOCOLATE FLAVOUR

Posology Chronic constipation The usual starting dose is 1 sachet daily for children aged 2 to 6 years, and 2 sachets daily for children aged 7 to 11 years. The dose should be adjusted up or down as required to produce regular soft stools.

If the dose needs increasing this is best done every second day. The maximum dose needed does not normally exceed 4 sachets a day. Treatment of children with chronic constipation needs to be for a prolonged period (at least 6-12 months).

However safety and efficacy of Movicol Paediatric Chocolate flavour has only been proved for a period of up to three months. Treatment should be stopped gradually and resumed if constipation recurs. Faecal impaction A course of treatment for faecal impaction with Movicol Paediatric Chocolate flavour is for up to 7 days as follows: Daily dosage regimen: Number of MOVICOL Paediatric Chocolate flavour sachets Age (years) Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 5-11 4 6 8 10 12 12 12 The daily number of sachets should be taken in divided doses, all consumed within a 12 hour period.

The above dosage regimen should be stopped once disimpaction has occurred. An indicator of disimpaction is the passage of a large volume of stools. After disimpaction it is recommended that the child follows an appropriate bowel management program to prevent reimpaction (dosing for prevention of re-impaction should be as for patients with chronic constipation; see above) Movicol Paediatric Chocolate flavour is not recommended for children below five years of age for the treatment of faecal impaction, or in children below two years of age for the treatment of chronic constipation.

For patients of 12 years and older it is recommended to use Movicol.

Patients with impaired cardiovascular function:

There are no clinical data for this group of patients. Therefore Movicol Paediatric Chocolate flavour is not recommended for treating faecal impaction in children with impaired cardiovascular function.

Patients with renal insufficiency:

There are no clinical data for this group of patients. 4 for warning about excipients). 5mL (quarter of a glass) of water. The correct number of sachets may be reconstituted in advance and kept covered and refrigerated for up to 6 hours.

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 Paediatric Chocolate flavour.

In the treatment of chronic constipation, diarrhoea or loose stools normally respond to a reduction in dose. Diarrhoea, abdominal distension, anorectal discomfort and mild vomiting are more often observed during the treatment for faecal impaction.

Vomiting may be resolved if the dose is reduced or delayed. The frequency of the adverse reactions listed below is defined using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1000); and very rare (<1/10,000); not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse event Rare Allergic reactions including anaphylactic reaction Immune system disorders Not known Dyspnoea, and skin reactions (see below) Skin and subcutaneous tissue disorders Not Known Allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema.

Metabolism and nutrition disorders Not known Electrolyte disturbances, particularly hyperkalaemia and hypokalaemia. Nervous system disorders Not known Headache. Very common Abdominal pain, borborygmi. Common Diarrhoea, vomiting, nausea and anorectal discomfort.

Uncommon Abdominal distension, flatulence. Gastrointestinal disorders Not known Dyspepsia and peri-anal inflammation. General disorders and administration site conditions Not known Peripheral oedema. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

The fluid content of Movicol Paediatric Chocolate Flavour when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. Diagnosis of faecal impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.

g. oedema, shortness of breath, increasing fatigue, dehydration and cardiac failure have been reported in adults when using preparations containing macrogol. If this occurs Movicol Paediatric Chocolate flavour should be stopped immediately, electrolytes measured and any abnormality should be treated appropriately.

When used in high doses to treat faecal impaction this medicinal product should be administered with caution to patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness. Movicol Paediatric Chocolate flavour solution when reconstituted has no calorific value.

5). 0 mg benzyl alcohol per sachet. Benzyl alcohol may cause anaphylactoid reactions. High volumes of benzyl alcohol should be used with caution and only if necessary, especially in subjects with kidney or liver impairment because of the risk of accumulation and toxicity (metabolic acidosis) of benzyl alcohol.

If used for more than a week in children less than 3 years old, medical advice should be provided due to increased risk of accumulation of benzyl alcohol. 062 mmol) sodium (main component of cooking /table salt) per sachet. 6% of the recommended maximum daily dietary intake of sodium for an adult.

5.

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. 1.