Paxabel 4 g powder for oral solution - against constipation 20 sachets

Product Description

Powder For Oral Solution

Composition:

Active ingredient: Each sachet contains 4 g of macrogol 4000. For the full list of excipients, see section 6.1.

Excipients

Sodium saccharin (E954), artificial flavour (orange-grapefruit)**.**Composition of the artificial orange-grapefruit flavour: orange and grapefruit oils, concentrated orange juice, citral, acetaldehyde, linalool, ethylbutyrate, alpha-terpineol, octanal, beta-gammahexenol, maltodextrin, gum arabic, sorbitol.

Therapeutic indications

Symptomatic treatment of constipation in children aged 12 years and over. 6 months to 8 years. An organic disorder must be ruled out by the physician before starting treatment, particularly in children under 2 years of age. PAXABEL 4 g should be considered a temporary adjuvant treatment in combination with an appropriate lifestyle and dietary regimen for constipation, with a maximum course of therapy of 3 months. If symptoms persist despite associated dietary measures, a pre-existing pathology should be suspected and treated.

Contraindications

Severe organic inflammatory diseases of the colon (such as ulcerative colitis, Crohn's disease), toxic megacolon. Gastrointestinal perforation or risk of gastrointestinal perforation. - Ileus or suspected intestinal obstruction or symptomatic stenosis. Abdominal pain of undetermined cause. - Known individual hypersensitivity to macrogol (polyethylene glycol) or any of the product's excipients.

Dosage

For oral use: From 6 months to 1 year: 1 sachet per day. From 1 to 4 years: 1–2 sachets per day. From 4 to 8 years: 2–4 sachets per day. The contents of each sachet must be dissolved in approximately 50 ml of water shortly before use. If 1 sachet per day is to be taken, it should be taken in the morning. If multiple sachets are to be taken, they should be divided between morning and evening. The effect of PAXABEL appears within 24–48 hours of administration. In children, treatment should not exceed 3 months as there is no clinical data on the use of the product for periods longer than 3 months. Treatment-induced intestinal motility regulation should be maintained with lifestyle and dietary measures. The daily dose should be adjusted based on the clinical effect achieved.

Warnings and Precautions

Special Warnings Efficacy data in children under 2 years of age are limited. Treatment of constipation with any medicinal product should be considered an adjunct to an appropriate lifestyle and a healthy diet: increased plant fiber and fluid intake, appropriate physical activity, and intestinal motility retraining. Any organic disorder must be ruled out before starting treatment. A complete clinical evaluation for constipation must be performed after three months of treatment. Patients with hereditary fructose intolerance problems should not take Paxabel. In case of diarrhea, special precautions must be taken in patients predisposed to fluid and electrolyte balance disorders (i.e., patients with impaired liver and kidney function or patients undergoing treatment with diuretics), and the patient's electrolyte status must be monitored. Precautions for use: Very rare cases of hypersensitivity reactions (rash, urticaria, edema) have been reported with drugs containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported. PAXABEL 4 g, as it does not contain significant quantities of sugars or polyols, can also be prescribed to diabetic children or children on a galactose-free diet.

Interactions

Not applicable.

Undesirable effects

During clinical studies on 147 children aged between 6 months and 15 years, undesirable effects were reported with the frequencies indicated below. These effects were always minor and transient and were observed at the gastrointestinal level. Gastrointestinal disorders: Common (