1. Name of the midicinal product-MOVICOL® Paediatric Plain 6.9 g sachet, powder for oral solution.
4.1 Therapeutic indications- deletion of confirmed by physical or radiological examination of the abdomen and rectum. For the prevention of the recurrence of faecal impaction in children.
4.2 Posology and method of administration- Chronic constipation and prevention of re-impaction
The usual starting dose is 1 sachet daily for children aged 2 to 6 years, and 2 sachets daily for children aged 7 – 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 or a prolonged period (a least 6 – 12 months). However, safety and efficacy of MOVICOL Paediatric Plain 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 Plain is for up to 7 days as follows:
Daily dosage regimen:
Number of MOVICOL Paediatric Plain sachets
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Age (years)
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Day 1
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Day 2
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Day 3
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Day 4
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Day 5
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Day 6
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Day 7
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5 - 11
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4
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6
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8
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10
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12
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12
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12
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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).
The dosage regimen for faecal impaction is based on one clinical trial.
4.3 Contraindications- Known Hypersensitivity to any of the ingredients active substances.
4.4 Special warnings and precautions for use -
Diagnosis of faecal impaction/faecal loading of the rectum should be confirmed by the physical or radiological examination of the abdomen and rectum.
Mild adverse drug reactions are possible as indicated in Section 4.8. Rarely symptoms indicating shifts of fluid/electrolytes e.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 Plain 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 solution when reconstituted has no calorific value.
4.5 Interactions with other medicinal products and other forms of interaction- Change from Medication Medicinal products
4.7. Effects on ability to drive and use mechines-There is no effect on the MOVICOL Paediatric Plain has no influence on the
4.8 Undesirable effects-
Abdominal distension and pain, borborygmi and nausea can occur. Diarrhoea or loose stools usually respond to reduction in dose. In children who are being treated for faecal impaction, mild vomiting is very common (approximately 20%) and this may be resolved if the subsequent dose is reduced or delayed. Other reported undesirable effects include perianal inflammation and soreness. Allergic reactions are a possibility.
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, <1/1,000); and very rare ( <1/10,000).
Chronic Constipation Indication:
Gastrointestinal disorders:
Very common: abdominal pain, borborygmi, diarrhoea or loose stools which normally respond to a reduction in dose.
Common: nausea, mild vomiting, abdominal distension, flatulence, perianal inflammation and soreness.
Immune system disorders:
Rare: allergic reactions
Faecal Impaction Indication:
Gastrointestinal disorders:
Very common: mild vomiting, abdominal distension and pain which are attributable to the expansion of the contents of the intestinal tract, perianal inflammation and soreness.
Vomiting may be resolved if the dose is reduced or delayed.
Common: borborygmi, nausea and mild diarrhoea.
Immune system disorders:
Rare: allergic reactions.
5.1 Pharmacodynamic properties-In an open study of MOVICOL (Paediatric Plain) in chronic constipation, weekly defaecation frequency was increased from 1.3 at baseline to 7.7 6.7, 7.2 and 7.1 at weeks 2, 4 and 12 respectively. In a study comparing MOVICOL (Paediatric Plain)
6.3 Shelflife-
6.4 Special precautions for use.
The shelf life of the sachets is 3 years.
Discard any solution not used within 24 hours.
Reconstituted solution: 24 hours
6.5 Nature and contents of container-6.9g sachets contained in Pack sizes:
6.6 Instruction for use, handling and disposal-
None. Any unused solution should be discarded within 24 hours.
10 Date of revison of the text- from 30 March 2005 to - Date aapproved 21 July 2006
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