MOVICOL WITHOUT AROMA CHILDREN 20BUST

MOVICOL WITHOUT AROMA CHILDREN 20BUST

Therapeutic indications

For the treatment of chronic constipation in children aged 1 to 11 years. For the treatment of fecal impaction in children from the age of 5, defined as refractory constipation with fecal load in the rectum and / or colon.

Dosage and method of use

Dosage Chronic constipationThe usual starting dose in children aged 1 to 6 years is 1 sachet per day, and 2 sachets per day in children aged 7 to 11 years. The dose should be increased or decreased to allow for smooth evacuation of soft stools. If it is necessary to increase the dose, it is best to do it every 2 days. For children under 2 years of age, the maximum recommended dose should not exceed 2 sachets per day. For children between 2 and 11 years of age, the maximum recommended dose needed does not normally exceed 4 sachets per day. Treatment of children with chronic constipation should last for an extended period of time (at least 6-12 months). However, the safety and efficacy of Movicol Bambini Senza Aroma have only been demonstrated for up to 3 months. Treatment should be discontinued gradually and resumed if constipation reappears.FecalomaA course of fecaloma treatment with Movicol Bambini Senza Aroma 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 occlusion has resolved. An indicator of faecal breakdown is the passage of a large amount of stool. After resolution, it is recommended that the child be given an appropriate bowel treatment program to prevent the onset of a new fecal impaction (the dosage to prevent fecal impaction recurrence is that for patients with chronic constipation; see above. ). The use of Movicol Bambini Senza Aroma is not recommended in children under 5 years for the treatment of fecal impaction, or in children under 1 year 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 Bambini Senza Aroma is not recommended for the treatment of fecal impaction in children with impaired cardiovascular function.Patients with renal insufficiency:There are no clinical data for this patient group. Therefore Movicol Bambini Senza Aroma is not recommended for the treatment of fecal impaction in children with impaired renal function. Method of administration Each sachet should be dissolved in 62.5 ml (a quarter of a glass) of water. The correct number of sachets can be reconstituted in advance and the solution stored for up to 24 hours in the refrigerator, covered. For example, for the treatment of fecal impaction, 12 sachets can be dissolved in 750 ml of water.

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. Hypersensitivity to the active ingredients.

Side effects

Reactions related to the gastrointestinal tract occur more commonly. These reactions may appear 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 Bambini Senza Aroma. In the treatment of chronic constipation, diarrhea or loose stools usually improve by reducing the dose. Diarrhea, abdominal distension, anorectal discomfort, and mild vomiting are observed more often during the treatment of fecal impaction. Vomiting may be resolved 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,

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Special warnings

The liquid content of Movicol Bambini Senza Aroma, after reconstitution with water, does not replace the regular intake of liquids, therefore an adequate intake of liquids must be maintained. The diagnosis of fecal impaction / fecal load in the rectum should be confirmed by a physical or radiological examination of the abdomen and rectum. Symptoms indicating fluid / electrolyte exchanges, e.g. edema, shortness of breath, fatigue, dehydration and heart failure, have been reported rarely when using macrogol-containing preparations in adults. If this occurs, the administration of Movicol Bambini Senza Aroma must be stopped immediately, the electrolytes measured and any alterations treated appropriately. When this medicine is used in high doses to treat fecal impaction, it should be administered with caution in patients with impaired swallowing reflex, reflux oesophagitis or reduced levels of consciousness. The reconstituted solution of Movicol Bambini Senza Aroma has no caloric value. Absorption of other medicinal products may be temporarily reduced due to the increase in gastrointestinal transit rate induced by Movicol Bambini Senza Aroma (see section 4.5). Movicol Kids Without Flavor contains 93.4 mg (4.062 mmol) of sodium (main component of table salt) per sachet. This is equivalent to 4.6% of the recommended maximum daily dietary intake for an adult.

Pregnancy and breastfeeding

PregnancyThere are limited data from the use of Movicol in pregnant women. Animal studies have shown indirect reproductive toxicity (see section 5.3). Clinically, macrogol 3350 is not expected to cause effects during pregnancy, since systemic exposure to macrogol 3350 is negligible. Movicol can be used during pregnancy.Feeding timeMacrogol 3350 is not expected to cause effects on newborns / infants, since systemic exposure of lactating women to Macrogol 3350 is negligible. Movicol can be used during breastfeeding.FertilityThere are no data on the effects of Movicol on human fertility. No effects on fertility were observed in studies in male and female rats (see section 5.3).

Expiry and retention

Sachet: this medicine does not require any special storage conditions. Reconstituted solution: Store in a refrigerator (2 ° C - 8 ° C), covered.

Interactions with other drugs

Medicines in solid form taken within one hour of administering large volumes of macrogol-containing preparations (such as those used in the treatment of faecal impaction) may be cleared from the gastrointestinal tract and not absorbed. Macrogol increases the solubility of alcohol-soluble and relatively water-insoluble medicines. There is a possibility that the absorption of other medicinal products may be temporarily reduced while using Movicol Bambini Senza Aroma (see section 4.4). There have been isolated reports of decreased efficacy of some concomitantly administered medicinal products, eg. antiepileptics.

Overdose

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

Active principles

Each sachet of Movicol Bambini Senza Aroma contains the following active ingredients: Macrogol 3350: 6.563 g Sodium chloride: 0.1754 g Sodium hydrogen carbonate: 0.0893 g Potassium chloride: 0.0251 g The content of electrolyte ions per sachet, in the reconstituted solution of 62.5 ml is the following: Sodium: 65 mmol / l Chloride; 53 mmol / l Potassium: 5.4 mmol / l Bicarbonate: 17 mmol / l

Excipients

Nobody.