Paxabel 10 g 20 sachets oral powder

Paxabel 10g 20 sachets oral powder is a laxative based on Macrogol 4000 , indicated for the symptomatic treatment of constipation (constipation) in adults and children over 8 years of age . Thanks to its oral powder formulation, Paxabel dissolves easily in water, creating an oral solution with a neutral flavor, which makes taking it simple and pleasant even for those who have difficulty swallowing tablets or capsules.

The 10g single-dose sachets guarantee precise and practical dosing, ideal for temporary use and for those looking for a quick and effective solution to regain intestinal regularity . The active ingredient, Macrogol 4000, works by softening the stool and promoting natural evacuation, without causing cramps or irritation, thus offering a delicate effect that is well tolerated by the body.

Paxabel 10g is sugar-free and gluten-free , also suitable for those who follow particular diets or have intolerances. The 20-sachet pack is designed to ensure optimal treatment coverage.

ACTIVE INGREDIENTS

Active ingredients contained in Paxabel 10 g 20 sachets oral powder - What is the active ingredient of Paxabel 10 g 20 sachets oral powder?

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

EXCIPIENTS

Composition of Paxabel 10 g 20 sachets oral powder - What does Paxabel 10 g 20 sachets oral powder contain?

Sodium saccharin (E954), flavouring (orange-grapefruit)**. ** Composition of orange-grapefruit flavouring : orange and grapefruit oils, concentrated orange juice, citral, acetaldehyde, linalool, ethyl butyrate, alpha-terpineol, octanal, beta-gammahexenol, maltodextrin, gum arabic, sorbitol, BHA (E320) and sulphur dioxide (E220).

DIRECTIONS

Therapeutic indications Paxabel 10 g 20 sachets oral powder - Why is Paxabel 10 g 20 sachets oral powder used? What is it used for?

Symptomatic treatment of constipation in adults and children over 8 years of age. An organic disorder must be ruled out by the physician before starting treatment. PAXABEL 10 g should be considered a temporary adjuvant treatment in association with an appropriate lifestyle and dietary regimen for constipation, with a maximum course of therapy of 3 months in children. If symptoms persist despite associated dietary measures, a pre-existing pathology should be suspected and treated.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Paxabel 10 g 20 sachets oral powder - When should Paxabel 10 g 20 sachets oral powder not be used?

- Severe 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 stenosis. - Abdominal pain of undetermined cause. - Hypersensitivity to the active substance or any of the excipients of the product listed in section 6.1.

DOSAGE

Quantity and method of taking Paxabel 10 g 20 sachets oral powder - How to take Paxabel 10 g 20 sachets oral powder?

Oral use. Dosage 1-2 sachets (10-20 g) per day, preferably taken as a single administration in the morning. The daily dose must be adapted based on the clinical effect obtained and can vary 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. Paediatric population 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. The regularisation of intestinal motility induced by treatment should be maintained with lifestyle and dietary measures. Method of administration Each sachet should be dissolved in a glass of water just before use.

CONSERVATION

Storage Paxabel 10 g 20 sachets oral powder - How to store Paxabel 10 g 20 sachets oral powder?

No special storage precautions.

WARNINGS

Warnings Paxabel 10 g 20 sachets oral powder - About Paxabel 10 g 20 sachets oral powder it is important to know that:

Special warnings The treatment of constipation with any medicinal product should be considered an adjunct to an appropriate lifestyle and a healthy diet, for example: - increased vegetable fibre and fluid intake, - appropriate physical activity and re-education of intestinal motility. An organic disorder must be ruled out by the doctor before starting treatment. This medicinal product contains macrogol (polyethylene glycol). Cases of hypersensitivity reactions (anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema) to medicinal products containing macrogol (polyethylene glycol) have been reported, see section 4.8. This medicinal product contains sulphur dioxide, which can rarely cause severe hypersensitivity reactions and bronchospasm. Patients with hereditary problems of fructose intolerance should not take this medicinal product. In case of diarrhoea, special precautions should be taken in patients predisposed to disturbances of fluid and electrolyte balance (i.e. elderly, or patients with impaired liver or kidney function or patients undergoing treatment with diuretics) and checks of the patient's electrolyte status should be carried out. Cases of pulmonary aspiration have been reported in association with nasogastric tube administration of large volumes of polyethylene glycol and electrolytes. Children with neurological impairment who suffer 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 use PAXABEL, as it does not contain significant quantities of sugars or polyols, can also be prescribed to diabetic patients or to subjects on a galactose-free diet.

INTERACTIONS

Interactions Paxabel 10 g 20 sachets oral powder - Which medicines or foods can modify the effect of Paxabel 10 g 20 sachets oral powder?

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 a decrease in efficacy. Paxabel may have a potential interaction effect when used with starch-based food thickeners. The ingredient polyethylene glycol (PEG) counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.

SIDE EFFECTS

Like all medicines, Paxabel 10 g 20 sachets oral powder can cause side effects - What are the side effects of Paxabel 10 g 20 sachets oral powder?

The frequency of adverse reactions is classified as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Adults 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 and were observed in the gastrointestinal system:

Classification by Systems and Organs	Adverse reactions
Gastrointestinal disorders
Common	Abdominal pain Abdominal distension Diarrhea Nausea
Uncommon	Vomiting Urgency to defecate Fecal incontinence
Metabolism and nutrition disorders
Not known	Electrolyte disturbances (hyponatremia, hypokalaemia) and/or dehydration, especially in elderly patients
Immune system disorders
Not known	Hypersensitivity (anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema)

Paediatric population During clinical studies in 147 children aged between 6 months and 15 years and in post-marketing experience, undesirable effects have been reported with the frequencies indicated in the table below. As in adults, these effects have always been minor and transient and have been detected mainly at the level of the gastrointestinal system.

Organic classification by systems and organs	Adverse Reactions
Gastrointestinal disorders
Common	Abdominal pain Diarrhea*
Uncommon	Vomiting Abdominal distension Nausea
Immune system disorders
Not known	Hypersensitivity (anaphylactic shock, angioedema, urticaria, rash, pruritus)

*diarrhea may cause perianal soreness Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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.

OVERDOSE

Overdose Paxabel 10 g 20 sachets oral powder - What are the risks of Paxabel 10 g 20 sachets oral powder in case of overdose?

Diarrhea, abdominal pain, and vomiting have been reported. Diarrhea caused by overdose disappears with temporary discontinuation of treatment or reduction of dosage. Excessive fluid loss due to diarrhea or vomiting may require corrective measures for electrolyte disturbances.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Paxabel 10 g 20 sachets oral powder.

Pregnancy Animal studies have not shown direct or indirect effects with respect to reproductive toxicity (see section 5.3). There are no adequate data from the use of PAXABEL in pregnant women (less than 300 pregnancy outcomes are known). No adverse effects are expected during pregnancy, since systemic exposure to PAXABEL is negligible. PAXABEL can be used during pregnancy. Breastfeeding There are no data on the excretion of PAXABEL in human milk. No effects on breast-fed newborns or infants are expected, since systemic exposure to macrogol 4000 in breast-feeding women is negligible. PAXABEL can be used during breast-feeding. Fertility Fertility studies have not been conducted with PAXABEL, but since macrogol 4000 is not significantly absorbed, no effects on fertility are expected.

DRIVING AND USE OF MACHINERY

Taking Paxabel 10 g 20 sachets oral powder before driving or using machines - Does Paxabel 10 g 20 sachets oral powder affect driving or using machines?

Not relevant.