PAXABEL OS POLV 20BUST 10G

PAXABEL 10 G POLVER FOR ORAL FUTURE IN BUSTINA

active ingredients

Each bag contains 10 g macrogol 4000. Macrogol 4000 10,00 g Aroma (orange-pompelmo)* 0.15 g Sodium saccharin 0.017 g For each bag of 10,17 g *Sorbitol and sulfur dioxide are the components of orange-pompelmus aroma: Sorbitol (E420) 1.8 mg per bag. Sulphur dioxide (E220) 0.24*10^-2 mg for each bag For the complete list of excipients: see paragraph 6.1.

Excellent

Sodium saccharin (E954), aroma (orange-pompelmo)**. *Composition of orange-pompelmo 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 adults and children aged over 8 years. An organic disorder must be excluded from the doctor before starting treatment. PAXABEL 10 g should be considered a temporary adjuvant treatment to be associated with an appropriate lifestyle and dietary regime for stypsis, with a maximum 3-month therapy cycle in children. 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 1-2 sachets (10-20 g) per day, preferably taken in single administration in the morning. The daily dose must be adapted according to the clinical effect obtained and may vary from 1 sachet to alternate days (especially in children) up to 2 sachets per day. The effect of PAXABEL in the 24-48 hours after its administration. Pediatric population In children the treatment should not exceed 3 months, in the absence of 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 Each envelope must be dissolved in a glass of water just before use.

Conservation

No special precaution for conservation.

Warnings

Special warnings Treatment of stipsis with any medicinal product should 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. An organic disorder must be excluded from the doctor before starting treatment. This medicine contains macrogol (polyethyl glycol). Cases of hypersensitivity reactions (shock-anaphylactic, angioedema, hives, rash, itching, erythema) have been reported to medicinal products containing macrogol (poliethylene-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 medicine. In case of diarrhea, special precautions must be taken in patients prepared for hydro-electrolytic balance disorders (i.e. elderly, or patients with altered liver or kidney function or patients in treatment with diuretics) 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, not containing significant amounts of sugar or polyols, it may also be prescribed to diabetic patients or subjects with 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

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

Classification for Systems and Organs	Adverse reactions
Gastrointestinal diseases
Town	Abdominal Pain Abdominal Distension Diarrhea nausea
Not common	Vomito Urgence to defecate Fetal Incontinence
Disorders of metabolism and nutrition
Notable	Electrolyte disorders (hyponatremia, hypocalyemia) and/or dehydration, especially in elderly patients
Immune system disorders
Notable	Hypersensitivity (anaphylactic shock, angioedema, urticaria, rash, itching, erythema)

Pediatric population During clinical studies of 147 children aged between 6 months and 15 years and in post-marketing experience, undesirable effects were reported with the frequency indicated in the table below. As in adults, these effects have always been minor and transient effects and have been detected especially at the gastro-intestinal system.

Organic classification for systems and organs	References
Gastrointestinal diseases
Town	Abdominal pain Diarrhea*
Not common	Vomitus Abdominal Distension Nausea
Immune system disorders
Notable	Hypersensitivity (anaphylactic shock, angioedema, urticaria, rash, itching)

*diarrhea can cause perianal pain 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 used 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