Paxabel 10g Macrogol 4000 Polvere Soluzione Orale 20 Bustine

Macrogol 4000 based powder for oral solution in sachets.

Therapeutic indications

Paxabel 10g is administered in the symptomatic treatment of constipation in adults and children over 8 years of age. An organic disorder must be ruled out by the doctor before starting treatment.

Paxabel 10g should be considered a temporary adjuvant treatment to be combined with a lifestyle and dietary regimen appropriate for constipation, with a maximum therapy course of 3 months in children. If symptoms persist despite associated dietary measures, pre-existing disease should be suspected and treated.

Dosage and posology

For oral use. To hire:

1-2 sachets per day, preferably taken as a single administration in the morning. Each sachet should be dissolved in a glass of water just before use.

The effect of Paxabel occurs within 24-48 hours following its administration. In children, treatment should not exceed 3 months, in the absence of 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 and can range from 1 sachet every other day (especially in children) up to 2 sachets per day.

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.

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

• Adults

During clinical trials, in which nearly 600 patients were included, undesirable effects were reported at the frequency indicated below. These effects were always minor and transient effects and were found in the gastrointestinal system.

Common (≥1 / 100, <1/10): abdominal distension and / or abdominal pain, nausea, diarrhea. Uncommon (≥1 / 1000, <1/100): vomiting and the most common consequence of diarrhea: urge to defecate and fecal incontinence. Additional information from post-marketing surveillance includes very rare cases (<1/10000) of hypersensitivity reactions: pruritus, urticaria, rash, face edema, Quinke's edema and isolated cases of anaphylactic shock. Excessive doses can cause diarrhea, which generally disappears when the dosage is reduced or treatment is temporarily stopped.

• Children

During clinical trials in 147 children aged 6 months to 15 years, undesirable effects were reported at 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): meteorism, 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.

Pregnancy and breastfeeding

There are insufficient data from the use of Paxabel 10g in pregnant women, therefore administration under such circumstances should be practiced with caution. There are no data on the excretion of macrogol 4000 in breast milk, but since macrogol 4000 is not significantly absorbed, Paxabel can be administered during breastfeeding.

Special warnings

The treatment of constipation with any medicinal product should be considered an adjuvant to an appropriate lifestyle and a healthy diet, for example:

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

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.

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.