Movicol children 6.9g - against constipation powder for oral solution chocolate flavoured 20 sachets

Product Description

Treatment of chronic constipation in children aged 2 to 11 years.

Indications

Movicol Children 6.9 g Powder For Oral Solution Chocolate Flavour for the treatment of fecal impaction in children from the age of 5 years, defined as refractory constipation with fecal loading in the rectum and/or colon.

Composition

Active ingredients

Each sachet of Movicol Children contains the following active ingredients:

The content of electrolyte ions per sachet, in the reconstituted solution of 62.5 ml is as follows: Sodium 65 mmol/l Chloride 51 mmol/l Bicarbonate 17 mmol/l Potassium 5.4 mmol/l.

Excipients

Acesulfame potassium (E950) Chocolate flavouring * (*Chocolate flavouring consists of maltodextrin, acacia gum E414, vegetable oils and fats, propylene glycol E1520 and ethyl alcohol.)

Directions for use and Dosage

Chronic constipation The usual starting dose for children aged 2 to 6 years is one sachet per day, and two sachets per day for children aged 7 to 11 years.
The dose should be increased or decreased to allow regular evacuation of soft stools.
If it is necessary to increase the dose, it is best to do so every 2 days.
The maximum dose required does not normally exceed 4 sachets per day.
Treatment of children with chronic constipation should continue for a prolonged period of time.
However, the safety and efficacy of Movicol Paediatric have only been demonstrated for a period of up to 3 months.
Treatment should be discontinued gradually and restarted if constipation recurs.
A course of treatment for faecal impaction with Movicol Paediatric for up to 7 days is as follows: Daily dosage regimen:

The daily number of sachets should be taken in divided doses, all consumed within a 12-hour period. The above dosing schedule should be discontinued once the impaction has resolved.
An indicator of faecal disimpaction is the passage of a large amount of stool.
After resolution, it is recommended that the child be placed on an appropriate bowel management program to prevent the onset of new faecal impaction (the dosage to prevent recurrence of faecal impaction is that for patients with chronic constipation, see above).
The use of Movicol Paediatric is not recommended in children under five years of age for the treatment of faecal impaction, or in children under two years of age for the treatment of chronic constipation.
For patients aged 12 years and over, the use of Movicol is recommended.
Patients with impaired cardiovascular function: There are no clinical data for this patient group. Therefore, Movicol Paediatric is not recommended for the treatment of faecal impaction in children with impaired cardiovascular function.
Patients with renal insufficiency: There are no clinical data for this patient group. Therefore, Movicol Paediatric is not recommended for the treatment of faecal impaction in children with impaired renal function. Administration Each sachet should be dissolved in 62.5 ml (one quarter of a glass) of water.
The correct number of sachets may vary. The solution can be reconstituted in advance and stored covered in the refrigerator for up to 24 hours.
For example, for the treatment of faecal impaction, 12 sachets can be dissolved in 750 ml of water.

Warnings

The diagnosis of faecal impaction/fecal loading in the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.
Symptoms indicating fluid/electrolyte shifts, such as oedema, shortness of breath, fatigue, dehydration and cardiac failure, have been reported rarely when using macrogol-containing preparations in adults.
If this occurs, Movicol Paediatric should be stopped immediately, electrolytes should be measured and any abnormalities should be treated appropriately.
When this medicine is used in high doses to treat faecal impaction, it should be administered with caution in patients with impaired swallowing reflex, reflux esophagitis, or reduced levels of consciousness.
The reconstituted Movicol Paediatric solution has no caloric value.
The absorption of other medicinal products may be temporarily reduced due to the increase in gastrointestinal transit rate induced by Movicol Paediatric.

Contraindications

Intestinal perforation or obstruction due to structural or functional disorders of the intestinal wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic megacolon.

Interactions

Solid medicinal products taken within one hour of administration of large volumes of macrogol-containing preparations (such as those used in the treatment of faecal impaction) may be eliminated from the gastrointestinal tract and not absorbed.
Macrogol increases the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water.
There is a possibility that the absorption of other medicinal products may be temporarily reduced during the use of Movicol Paediatric.
Isolated cases of reduced efficacy of some concomitantly administered medicinal products, e.g. antiepileptics, have been reported.

Undesirable effects

Gastrointestinal tract-related reactions occur most commonly.
These reactions may occur as a consequence of the expansion of the contents of the gastrointestinal tract and the increase in motility due to the pharmacological effects of Movicol Paediatric.
In the treatment of chronic constipation, diarrhoea or loose stools usually improves with dose reduction. Diarrhoea, abdominal distension, anorectal discomfort and mild vomiting are more often observed during the treatment of faecal impaction.
Vomiting may resolve if the dose is reduced or delayed.
The frequency of 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);
• very rare (<1/10,000);
• not known (cannot be estimated from the available data).

Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

Severe abdominal pain or distension may be treated by nasogastric aspiration.
Extensive fluid losses with diarrhea or vomiting may require correction of electrolyte disturbances.

Pregnancy and breastfeeding

Data on the use of the drug in pregnant women are limited.
Studies in animals have shown indirect reproductive toxicity.
Clinically, macrogol 3350 is not expected to cause effects during pregnancy, since systemic exposure to macrogol 3350 is negligible.
The drug can be used during pregnancy.
Macrogol 3350 is not expected to cause effects on newborns/infants, since systemic exposure to Macrogol 3350 in breastfeeding women is negligible.
The medicinal product can be used during pregnancy.
Macrogol 3350 is not expected to cause effects on newborns/infants, since systemic exposure to Macrogol 3350 in breastfeeding women is negligible.
The medicinal product can be used during pregnancy. be used during breastfeeding.
There are no data on the effects of the product on fertility in humans.
No effects on fertility were observed in studies on male and female rats.

Storage

Sachet: do not store above 25 degrees C.

Format

20 sachets