MOVICOL IT'S CALLED BB 20BUST

MOVICOL CHILDREN 6,9 G, POLVER FOR ORAL FUTURE, WITHOUT AROM

active ingredients

Each bag of Movicol Children Without Aroma contains the following active ingredients: Macrogol 3350 6,563 g Sodium chloride 0.1754 g Sodium hydrogencarbonate 0.0893 g Potassium chloride 0.0251 g The content of electrolyte ions per sachet, in the reconstituted solution of 62.5 ml is as follows: Sodium 65 mmoli/l Chloride 53 mmoli/l Potassium 5,4 mmoli/l Bicarbonate 17 mmoli/l

Excellent

Not present.

Therapeutic indications

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

Contraindications

Perforation or intestinal obstruction due to structural or functional disorders of the intestinal wall, ileum, severe inflammatory states of the intestinal tract, such as Crohn's disease, ulcerative colitis and toxic megacolon. Hypersensitivity to active ingredients.

Population

Population Chronic stipsis The usual initial dose in children from 1 to 6 years is 1 sachet per day, and 2 sachets per day in children from 7 to 11 years. The dose must be increased or decreased so as to allow a regular evacuation of soft feces. If you need to increase the dose, it is better to do it every 2 days. For children under 2 years of age, the recommended maximum dose should not exceed 2 sachets per day. For children aged between 2 and 11 years the recommended maximum dose does not normally exceed 4 sachets per day. Treatment of children with chronic constipation must last for a prolonged period of time (at least 6-12 months). However, the safety and effectiveness of Movicol Children Without Aroma have only been demonstrated for a period of up to 3 months. Treatment should be stopped gradually and resumed if the stipsi reappears. Fecaloma A fecaloma treatment cycle with Movicol Children Without Aroma up to 7 days is as follows: Daily Posological Regime:

Number of bags of Movicol Children Without Aroma
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 must be taken divided into doses, all consumed within a period of 12 hours. The above-mentioned posological scheme must be interrupted once the occlusion has been resolved. An indicator of fecal impact is the passage of a large amount of feces. After the resolution, it is recommended to have the child follow an appropriate treatment program for the intestine, to prevent the occurrence of a new fecaloma (the dose to prevent relapse of the fecaloma is that for patients with chronic constipation; see above). The use of Movicol Children Without Aroma is not recommended in children under 5 years for the treatment of fecaloma, or in children under 1 year for the treatment of chronic constipation. For patients aged 12 and over, Movicol is recommended. Patients with impaired cardiovascular function: There are no clinical data for this group of patients. Therefore Movicol Children Without Aroma is not recommended for treating fecaloma in children with compromised cardiovascular function. Patients with kidney failure: There are no clinical data for this group of patients. Therefore Movicol Children Without Aroma is not recommended for treating fecaloma in children with compromised kidney function. Method of administration Each bag should be dissolved in 62.5 ml (a quarter glass) of water. The correct number of sachets can be reconstituted in advance and the solution kept up to 24 hours in the refrigerator, covered. For example, for the treatment of fecaloma, 12 sachets can be dissolved in 750 ml of water.

Conservation

Envelope: This medicine does not require any special conservation condition. Reconstituted solution: keep in the refrigerator (2°C - 8°C), covered.

Warnings

The content of Movicol Children Without Aroma liquids, after replenishment with water, does not replace the regular intake of liquids, therefore an adequate intake of liquids must be maintained. Diagnosis of the fecaloma/caric in the rectum must be confirmed by a physical or radiological examination of the abdomen and rectum. During the use of preparations containing macrogol in adults, symptoms of fluid/electrolyte exchanges were rarely reported, such as edema, short breath, fatigue, dehydration and heart failure. If this occurs, the administration of Movicol Children Without Aroma must be immediately interrupted, electrolytes and any alterations must be treated appropriately. When this medicine is used at high doses to treat the fecaloma, it should be administered carefully in patients with altered swallowing reflexes, esophagi by reflux or reduced levels of consciousness. The solution of Movicol Children Without Aroma reconstituted has no caloric power. The absorption of other medicines could be temporarily reduced due to the increase in gastrointestinal transit speed induced by Movicol Children Without Aroma (see paragraph 4.5). Movicol Children Without Aroma contains 93.4 mg (4.062 mmoli) of sodium (main component of kitchen salt) for sachet. This is 4.6% of the maximum daily intake recommended with the diet of an adult. In patients with swallowing problems, which require the addition of a thickener to solutions to favor proper intake, interactions must be taken into account, see paragraph 4.5.

Interactions

Medicines in solid form taken within an hour from the administration of large volumes of preparations containing macrogol (such as those used in the treatment of fecaloma) can be eliminated from the gastrointestinal tract and not absorbed. The macrogol increases the solubility of soluble drugs in alcohol and relatively insoluble in water. There is the possibility that the absorption of other medicinal products may be temporarily reduced during the use of Movicol Children Without Aroma (see paragraph 4.4). Insulated cases of reduction of the effectiveness of certain medicinal products administered in conjunction with anti-epileptics have been reported. Movicol Children Without Aroma can potentially interact with food thickeners based on starch. The active ingredient macrogol contrasts the thickening effect of starch, substantially liquefying the preparations that must remain dense for people with swallowing problems.

Effects

More commonly, gastrointestinal reactions occur. These reactions can appear as a result of the expansion of the content of the gastrointestinal tract and the increase of motility due to the pharmacological effects of Movicol Children Without Aroma. In the treatment of chronic stypsis, diarrhea or loss of feces normally improve by reducing the dose. Diarrhea, abdominal distension, abnormal discomfort and mild vomiting are observed more often during the treatment of the fecaloma. The vomiting can be solved if the dose is reduced or delayed. The frequency of adverse reactions listed below is defined by the following convention: very common (≥1/10); common (≥1/100, Classification for systems and organs Frequency Adverse event Immune system disorders Rare Allergic reactions including anaphylactic reactions. Notable Dispnea and skin reactions (see below). Pathologies of skin and subcutaneous tissue Notable Skin allergic reactions including angioedema, hives, itching, rash, erythema. Disorders of metabolism and nutrition Notable Electrolytic imbalances, especially hyperkaliemia and hypokaliemia. Diseases of the nervous system Notable Cephalea. Gastrointestinal diseases Very common Abdominal pain, borborigmas. Town Diarrhea, vomiting, nausea, anoretal discomfort. Not common Abdominal distension, flatulence. Notable Dispepsia and perianal inflammation. Systemic pathologies and conditions for administration Notable Peripheral edema. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction through the national reporting system https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Stern-grade abdominal pain or distension can be treated by nasogastric suction. Wide fluid leaks with diarrhea or vomiting may require correction of electrolytic alterations.

Pregnancy

The data relating to the use of Movicol in pregnant women are in limited number. Animal studies showed indirect reproductive toxicity (see paragraph 5.3). Clinically, it is not believed that macrogol 3350 can cause effects during pregnancy, since systemic exposure to macrogol 3350 is negligible. Movicol can be used during pregnancy.

Food

It is not believed that Macrogol 3350 can cause effects on infants/ infants, since systemic exposure to Macrogol 3350 of nursing women is negligible. Movicol can be used during feeding.

Fertility

There is no data on the effects of Movicol on fertility in man. Effects on fertility have not been observed in studies on male and female rats (see paragraph 5.3).

Source: Farmadati