Paxabel 4g Macrogol 4000 Polvere Soluzione Orale 20 Bustine

Macrogol 4000 based powder for oral solution in sachets.

Therapeutic indications

Paxabel 4g is administered in the symptomatic treatment of constipation in children aged 6 months to 8 years. An organic disorder must be ruled out by the physician before starting treatment, particularly in children under 2 years of age.

Paxabel 4 g should be considered as a temporary adjuvant treatment to be combined with a lifestyle and dietary regimen appropriate for constipation, with a maximum therapy course of 3 months. If symptoms persist despite associated dietary measures, pre-existing disease should be suspected and treated.

Dosage and posology

For oral use. Take following these indications:

• From 6 months to 1 year: 1 sachet per day.
• From 1 to 4 years: 1 - 2 sachets per day.
• From 4 to 8 years: 2 - 4 sachets per day.

The contents of each sachet should be dissolved in approximately 50ml of water just before use. If you have to take 1 sachet per day, take it in the morning. If you have to take more sachets, you will need to divide them between morning and evening. The effect of Paxabel occurs within 24-48 hours following its administration.

In children, treatment should not exceed 3 months as there is no clinical data on the use of the product for periods longer than 3 months. Treatment-induced intestinal motility regularization should be maintained with lifestyle and dietary measures. The daily dose should be adjusted according to the clinical effect obtained.

Overdose

Overdose induces diarrhea which disappears upon temporary suspension of treatment or reduction of dosage. Excessive fluid loss due to diarrhea or vomiting may require corrective measures of electrolyte disorders. Cases of pulmonary aspiration have been reported in conjunction with nasogastric tube administration of large volumes of polyethylene glycol and electrolytes. Neurologically impaired children suffering from oromotor dysfunction are particularly at risk of pulmonary aspiration.

Cases of inflammation and pain at the perianal level have been reported in conjunction with the administration of large volumes of macrogol solutions (from 4 to 11 liters) for intestinal washing, both for preparation before colonoscopy and for the removal of fecal stagnation in case of encopresis. .

Contraindications

• Serious organic inflammatory diseases of the colon (such as ulcerative colitis, Crohn's disease), toxic megacolon associated with symptomatic stenosis.
Gastrointestinal perforation or risk of gastrointestinal perforation.
• Ileus or suspicion of intestinal obstruction.
• Abdominal pain of undetermined causes.
• Known individual hypersensitivity to macrogol (polyethylene glycol) or to any of the excipients of the product.

Side effects

During clinical trials in 147 children aged 6 months to 15 years, undesirable effects were reported with the frequency indicated below. These effects were always minor and transient effects and were found in the gastrointestinal system.

Gastrointestinal disorders: Common (≥1 / 100, <1/10): diarrhea and abdominal pain Uncommon (≥1 / 1000, <1/100): bloating, vomiting and nausea.

There is no additional information from post-marketing surveillance: hypersensitivity reactions have not yet been reported in the child. However, such reactions can occur, as reported for the adult. Excessive doses can cause diarrhea, which generally disappears when the dosage is reduced or treatment is temporarily stopped. Diarrhea can cause pain in the perianal area.

Special warnings

Efficacy data in children less than 2 years of age are scarce. Treatment of constipation with any medicinal product should be considered an adjuvant to an appropriate lifestyle and healthy diet:

• increase of vegetable fibers and liquids in the diet,
• appropriate physical activity and re-education of intestinal motility.

Any organic disorder must be ruled out before starting treatment. A full clinical evaluation of constipation should be performed after three months of treatment. Patients with hereditary problems of fructose intolerance should not take Paxabel.

In case of diarrhea, special precautions should be taken in patients predisposed to disturbances in the water and electrolyte balance (i.e. patients with impaired liver and kidney function or patients on treatment with diuretics) and checks of the patient's electrolyte status should be implemented.

Very rare cases of hypersensitivity reactions (rash, urticaria, edema) have been reported with drugs containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported. Paxabel 4 g, as it does not contain significant amounts of sugars or polyols, can also be prescribed to children with diabetes or on a galactose-free diet.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

1 sachet of Paxabel 10g contains:

Active principle

10 g of macrogol 4000.

Excipients

Saccharin sodium (E954), artificial flavor (orange-grapefruit) **. ** Composition of the orange-grapefruit artificial aroma : orange and grapefruit oils, concentrated orange juice, citral, acetaldehyde, linalool, ethylbutyrate, alpha-terpineol, octanal, beta-gammahexenol, maltodextrin, gum arabic, sorbitol.