PAXABEL OS POLV 20BUST 4G

PAXABEL 4 G POWER FOR ORAL FUTURE IN BUSTINA

active ingredients

Each bag contains: Macrogol 4000: 4,00 g Aroma (orange-pompelmo)*: 0.06 g Sodium saccharin: 0.007 g For each 4.07 g *Sorbitol and sulfur dioxide sachet are components of orange-pompelmus aroma: Sorbitol (E420): 0,72 mg for each bag. Sulphur dioxide (E220): 9.6*10^-4 mg for each bag For the complete list of excipients: see paragraph 6.1.

Excellent

Sodium saccharin (E954), artificial aroma (orange-pompelmus)*******Composition of orange-pompelmo artificial aroma: orange and grapefruit oils, concentrated orange juice, citral, acetaldehyde, linalol, etilbutyrate, alphaterpineol, octal, beta-gammaesenol, maltodextrin, arabic rubber, sorbitol, BHA (E320) and sulfur dioxide (E220).

Therapeutic indications

Symptomatic treatment of stypsis in children from 6 months to 8 years. An organic disorder must be excluded from the doctor before starting treatment, especially in children under 2 years of age. PAXABEL 4 g should be considered a temporary adjuvant treatment to be associated with a suitable lifestyle and dietary regimen for stypsis, with a maximum therapy cycle of 3 months. If symptomatology persists despite the associated dietary measures, a pre-existing pathology must be suspected and treated.

Contraindications

- Severe organic inflammatory diseases of the colon (such as ulcerative colitis, Crohn disease) or toxic megacolons. - Gastrointestinal perforation or gastrointestinal drilling risk. - Ileo or suspect of intestinal obstruction or symptomatic stenosis. - Abdominal pain from undetermined causes. - Hypersensitivity to the active ingredient or any of the product excipients listed in the paragraph 6.1.

Population

Oral use. Population • From 6 months to 1 year: 1 sachet (4 g) per day. • From 1 to 4 years: 1 - 2 bags (4-8 g) per day. • From 4 to 8 years: 2 - 4 sachets (8 -16 g) per day. The daily dose must be adapted according to the clinical effect obtained. The effect of PAXABEL in the 24-48 hours after its administration. Pediatric population In children the treatment should not exceed 3 months as there is no clinical data on the use of the product for periods greater than 3 months. Regularization of intestinal motility induced by treatment should be maintained with lifestyle and dietary measures. Method of administration The contents of each bag must be dissolved in about 50 ml of water just before use. In case you have to take 1 sachet per day, the intake must take place in the morning. In case you have to hire more sachets, it will be necessary to divide them between morning and evening. The resulting solution will be clear and transparent as water.

Conservation

No special precaution for conservation.

Warnings

Special warnings Efficacy data in children under 2 years are poor. Treatment of stipsis with any medicinal product must be considered an adjuvant to an appropriate lifestyle and healthy diet, for example: - increase in plant fibers and liquids in the diet, - appropriate physical activity and re-education of intestinal motility. Before starting the treatment must be excluded any organic disorder. After three months of treatment a complete clinical evaluation of constipation must be carried out. This medicine contains macrogol (polyethylene-glycol). Cases of hypersensitivity reactions (shock-anaphylactic, angioedema, hives, rash, itching, erythema) have been reported to medicinal products containing macrogol (polyethylene- glycol) see paragraph 4.8. This drug contains sulphur dioxide, which can rarely cause serious reactions of hypersensitivity and bronchospasm. Patients with hereditary problems of fructose intolerance should not take this medicinal product. In the case of diarrhea, special precautions must be taken in patients prepared for hydroelectrolytic balance disorders (i.e. elderly or patients with altered liver or kidney function or patients undergoing diuretic treatment) and controls of the patient's electrolytic framework must be implemented. There have been cases of pulmonary aspiration in conjunction with administrations with nasogastric sondino of extensive volumes of polyethylene-glycol and electrolytes. Children with neurological damage that suffer from hormonal dysfunction are particularly at risk of pulmonary aspiration. In patients with swallowing problems, which need to add a thickener to solutions to ensure an adequate intake, interactions should be considered, see paragraph 4.5. Precautions for use PAXABEL 4 g, not containing significant amounts of sugar or polyols, can also be prescribed to diabetic children or subject to galactose-free food regime.

Interactions

There is a possibility that the absorption of other medicinal products may be temporarily reduced during use at the same time PAXABEL, in particular medicinal products with a strict therapeutic or short half-life index such as digoxin, antiepileptics, cumarines and immunosuppressive agents, leading to a decrease in effectiveness. Paxabel can result in a potential interaction effect when used with starch-based food thickeners. The polyethyleneglycol ingredient (PEG) contrasts the thickening effect of starch, effectively liquefying the preparations that must remain dense for people with swallowing problems.

Effects

During clinical studies of 147 children aged between 6 months and 15 years, and post-marketing experience were reported undesirable effects with the frequency indicated below. These effects have always been minor and transient effects and have been detected at the gastrointestinal level. The frequency of adverse reactions is classified as follows: very common (≥1/10); common (from ≥1/100 to Classification for Systems and Organs Adverse reactions Gastrointestinal diseases Town Abdominal pains Diarrhea* Not common Vomitus Abdominal Distension Nausea Immune system disorders Not known Hypersensitivity (anaphylactic shock, angioedema, urticaria, rash, itching,) *Diarrhea can cause perianal pain In adults, additional side effects have been observed in clinical or post-marketing studies as shown below: Gastrointestinal diseases Not common: urgency to defecate, fecal incontinence Disorders of metabolism and nutrition Notable: electrolyte disorders (hyponatremia, hypocalyemia) and/or dehydration, especially in elderly patients. Immune system disorders Notable: erythema 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 via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Diarrhea, abdominal pain and vomiting have been reported. The diarrhea caused by overdose disappears at the temporary suspension of the treatment or reduction of the dosage. Excessive liquid losses due to diarrhea or vomiting may require corrective measures of electrolytic disorders.

Pregnancy

Animal studies have not shown direct or indirect effects of reproductive toxicity (see paragraph 5.3). There is no sufficient data about the use of PAXABEL in pregnant women (less than 300 pregnancy outcomes are known). No side effects are expected in pregnancy, since systemic exposure to PAXABEL is negligible. PAXABEL can be used during pregnancy.

Food

There is no data on excretion of PAXABEL in breast milk. There are no expected effects on infants or breast-feededed children, since systemic exposure to macrogol 4000 in breastfeeding women is negligible. Paxabel can be administered during breastfeeding.

Fertility

Fertility studies have not been conducted with PAXABEL, but since macrogol 4000 is not significantly absorbed there are no expected effects on fertility

Source: Farmadati