Paxabel os powder 20 sachets 10 g

PAXABEL * OS POLV 20BUST 10G

Therapeutic indications

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 10 g should be considered a temporary adjuvant treatment to be associated 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 method of use

Oral use.Dosage1-2 sachets (10-20 g) per day, preferably taken as a single administration in the morning. 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. The effect of PAXABEL occurs within 24-48 hours following its administration.Pediatric populationIn 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.Method of administrationEach sachet should be dissolved in a glass of water just before use.

Contraindications

- Serious organic inflammatory diseases of the colon (such as ulcerative colitis, Crohn's disease) or toxic megacolon. - Gastrointestinal perforation or risk of gastrointestinal perforation. - Ileus or suspicion of intestinal obstruction or symptomatic stricture. - Abdominal pain of undetermined causes. - Hypersensitivity to the active substance or to any of the excipients of the product listed in section 6.1.

Side effects

The frequency of adverse reactions is classified as follows: very common (≥1 / 10); common (≥1 / 100 to Adult The undesirable effects listed in the table below have been reported during clinical trials (in 600 adult patients) and from post-marketing experience. These effects were always minor and transient effects and were reported at the level of the gastrointestinal system:

Pediatric population

Undesirable effects have been reported in clinical trials in 147 children aged 6 months to 15 years and in post-marketing experience with the frequency shown in the table below. As in adults, these effects were always minor and transient effects and were mainly found in the gastrointestinal system.

* diarrhea can cause perianal sorenessReporting 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Special warningsThe treatment of constipation with any medicinal product should be considered an adjuvant to an appropriate lifestyle and a healthy diet, for example: - increase in plant fibers and fluids in the diet, - appropriate physical activity and re-education of intestinal motility . An organic disorder must be ruled out by the doctor before starting treatment. This medicine contains macrogol (polyethylene glycol). Cases of hypersensitivity reactions (anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema) have been reported to macrogol (polyethylene glycol) containing medicinal products, see section 4.8. This medicine contains sulfur dioxide, which can rarely cause severe hypersensitivity reactions and bronchospasm. Patients with hereditary problems of fructose intolerance should not take this medicine. In case of diarrhea, special precautions should be taken in patients predisposed to disturbances in the water and electrolyte balance (i.e. elderly, or patients with impaired liver or kidney function or patients on treatment with diuretics) and controls of the picture should be put in place. electrolyte of the patient. 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. In patients with swallowing problems who require the addition of a thickener to solutions to ensure adequate intake, interactions should be considered, see section 4.5.Precautions for usePAXABEL, as it does not contain significant quantities of sugars or polyols, can also be prescribed to diabetic patients or to subjects with a galactose-free diet.

Pregnancy and breastfeeding

PregnancyStudies in animals have not shown direct or indirect effects of reproductive toxicity (see section 5.3). There are insufficient data from the use of PAXABEL in pregnant women (less than 300 pregnancy outcomes are known). No undesirable effects are expected in pregnancy as systemic exposure to PAXABEL is negligible. PAXABEL can be used during pregnancy.Feeding timeThere are no data on the excretion of PAXABEL in human milk. No effects on breastfed newborns or infants are expected as systemic exposure to macrogol 4000 in breastfeeding women is negligible. PAXABEL can be used during breastfeeding.FertilityFertility studies have not been conducted with PAXABEL, but since macrogol 4000 is not significantly absorbed, no effects on fertility are expected.

Expiration and retention

No special storage precautions.

Interactions with other drugs

There is a possibility that the absorption of other medicinal products may be temporarily reduced during use with PAXABEL, particularly medicinal products with a narrow therapeutic index or short half-life such as digoxin, antiepileptics, coumarins and immunosuppressive agents, leading to decreased efficacy. Paxabel may have a potential interaction effect when used with starch-based food thickeners. The polyethylene glycol (PEG) ingredient counteracts the thickening effect of starch, effectively liquefying preparations that must remain thick for people with swallowing problems.

Overdose

Diarrhea, abdominal pain and vomiting have been reported. Diarrhea caused by overdose 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.

Active principles

Each sachet contains 10 g of macrogol 4000. Macrogol 4000 10.00 g Flavor (orange-grapefruit) * 0.15 g Saccharin sodium 0.017 g For each 10.17 g sachet * Sorbitol and sulfur dioxide are the components of the aroma of orange-grapefruit: Sorbitol (E420) 1.8 mg for each sachet. Sulfur dioxide (E220) 0.24 * 10^-2mg for each sachet For the full list of excipients: see section 6.1.

Excipients

Saccharin sodium (E954), flavor (orange-grapefruit) **. **Composition of the orange-grapefruit aroma: Orange and grapefruit oils, concentrated orange juice, citral, acetaldehyde, linalool, ethylbutyrate, alpha-terpineol, octanal, beta-gammahexenol, maltodextrin, gum arabic, sorbitol, BHA (E320) and sulfur dioxide (E220).