Movicol Children's Chocolate 20 Bags 6.9g

NAME
MOVICOL CHILDREN 6.9 G, POWDER FOR ORAL SOLUTION, CHOCOLATE FLAVOR

PHARMACOTHERAPEUTIC CATEGORY
Constipation medications.

ACTIVE PRINCIPLES
Macrogol 3350 6.563 g; sodium chloride 0.1754 g; sodium hydrogen carbonate 0.0893 g; potassium chloride 0.0159 g.

EXCIPIENTS
Acesulfame potassium (E950); chocolate flavor (The chocolate flavor consists of maltodextrin (potato), gum arabic / acacia gum E414, vegetable oils and fats (coconut), propylene glycol E1520 and benzyl alcohol E1519).

INDICATIONS
For the treatment of chronic constipation in children from 2 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.

CONTRAINDICATIONS / SECONDARY EFFECT
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 substances or to any of the listed excipients.

DOSAGE
Chronic constipation: the usual starting dose in children from 2 to 6 years is one sachet per day, and two sachets per day in children from 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. The maximum 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 the medicine have only been demonstrated for a period of up to 3 months. Treatment should be gradually discontinued and resumed if constipation reappears. Fecaloma: a course of fecaloma treatment with medication for up to 7 days is as follows. >> Daily dosage regimen. Age 5-11. Day 1: 4, day 2: 6, day 3: 8, day 4: 10, day 5:12, day 6: 12, day 7: 12. 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 the faecal disimpact is the passage of a large amount of feces. After resolution, it is recommended that the child follow an appropriate bowel treatment program to prevent the onset of new fecal impaction (the dosage to prevent fecal impaction recurrence is that for patients with chronic constipation). The use of the drug is not recommended in children under five years for the treatment of fecal impaction, or in children under two years for the treatment of chronic constipation. For patients aged 12 years and over, the use of the drug is recommended. Patients with impaired cardiovascular function: There are no clinical data for this patient group. Therefore the medicine 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 the product is not recommended for the treatment of fecal matter 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.

STORAGE
Sachet: Do not store above 25 degrees C. Reconstituted solution: store in a refrigerator (2 degrees C - 8 degrees C), covered.

WARNINGS
The liquid content of the medicinal product, after reconstitution with water, does not replace regular fluid intake, therefore an adequate fluid intake 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, administration of the drug should be stopped immediately, electrolytes measured and any alterations should be 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 medicinal solution has no calorific value. Absorption of other medicinal products may be temporarily reduced due to the drug-induced increase in gastrointestinal transit rate. The product contains 7.0 mg of benzyl alcohol per sachet. Benzyl alcohol can cause anaphylactoid reactions.

INTERACTIONS
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 drugs 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 while using the medicinal product. There have been isolated reports of decreased efficacy of some concomitantly administered medicinal products, e.g. antiepileptics.

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 the drug. In the treatment of chronic constipation, diarrhea or loose stools are usually improved 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, <1/10); uncommon (> = 1 / 1,000, <1/100); rare (> = 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); not known. Disorders of the immune system. Rare: allergic reactions including anaphylactic reactions; not known: dyspnoea and skin reactions. Skin and subcutaneous tissue disorders. Not known: allergic skin reactions including angioedema, urticaria, pruritus, rash, erythema. Metabolism and nutrition disorders. Not known: electrolyte imbalances, particularly hyperkalaemia and hypokalaemia. Nervous system disorders. Not known: headache. Gastrointestinal disorders. Very common: abdominal pain, borborygmas; common: diarrhea, vomiting, nausea and anorectal discomfort; uncommon: abdominal distension, flatulence; not known: dyspepsia and perianal inflammation. General disorders and administration site conditions. Not known: peripheral edema. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
There are limited data on the use of the drug in pregnant women. Animal studies 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 of lactating women to Macrogol 3350 is negligible. The medicine can 'be used during breastfeeding. There are no data on the effects of the product on fertility in humans. In studies on male and female rats, no effects on fertility were observed.