Casenlax 20 sachets 10g 042583029

CASENLAX * OS POLV 20BUST 10G

Therapeutic indications

Symptomatic treatment of constipation in adults and children aged 8 years and over. An organic disorder must be ruled out before starting treatment. Casenlax should remain a temporary adjuvant treatment to an appropriate lifestyle and diet for constipation, with a maximum treatment course of 3 months in children. If symptoms persist despite associated dietary measures, a different underlying cause should be suspected and treated.

Dosage and method of use

Oral useDosage1 to 2 sachets per day, preferably taken as a single dose in the morning. It is recommended to drink 125ml of liquids (e.g. water) after each dose. The effect of Casenlax occurs within 24-48 hours after administration. The daily dose should be adapted according to the clinical effects and can range from one sachet every other day (especially in children) up to 2 sachets per day. Treatment should be discontinued gradually and resumed if constipation recurs.Pediatric population1 to 2 sachets per day, preferably taken as a single dose in the morning. It is recommended to drink 125ml of liquids (e.g. water) after each dose. In children, treatment should not exceed 3 months due to lack of clinical data in treatments lasting more than 3 months. Treatment-induced intestinal motility regularization will be maintained by lifestyle and dietary measures.Method of administrationEach sachet should be dissolved in a glass of water (approximately 125ml) just before use. The resulting solution will be clear and transparent like water.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon, associated with symptomatic stenosis. - Perforation of the digestive system or risk of perforation of the digestive system. - Paralytic ileus or suspected intestinal obstruction. - Painful abdominal syndromes of indeterminate nature.

Side effects

Undesirable effects are listed by frequency using the following categories: Very common (≥1 / 10); common (≥1 / 100,Adult population: The undesirable effects listed in the following table have been reported in clinical trials including 600 adult patients and in post-marketing experience. In general, adverse reactions were mild and transient and mainly concerned the gastrointestinal system:

The undesirable effects listed in the following table have been reported in clinical trials involving 147 children aged 6 months to 15 years and in post-marketing use. As in the adult population, adverse reactions were generally mild and transient and mainly concerned the gastrointestinal system:

* Diarrhea can cause perianal painReporting of suspected adverse reactionsReporting 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 systemhttp://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

The treatment of constipation with any medicine is only an adjuvant to a healthy lifestyle and diet, for example: - Greater intake of liquids and dietary fiber, - Adequate physical activity and re-education of intestinal motility. Due to the presence of sulfur dioxide Casenlax can rarely cause severe hypersensitivity reactions and bronchospasm. In case of diarrhea, caution should be exercised in patients predisposed to fluid and / or electrolyte balance disturbances (e.g. the elderly, patients with hepatic or renal impairment or patients receiving diuretics) and electrolyte control should be considered. Hypersensitivity reactions (rash, urticaria and edema) have been reported with drugs containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported. Casenlax contains an insignificant amount of sugars or polyols and can be prescribed to diabetic patients or to patients on a galactose-free diet. This medicinal product contains less than 1 mmol (23 mg) sodium per sachet, ie essentially “sodium-free”. Based on the mechanism of action of macrogol, fluid intake is recommended during treatment with this medicinal product (see section 5.1). Absorption of other medicinal products may be temporarily reduced due to macrogol-induced increase in gastrointestinal transit rate (see section 4.5).

Pregnancy and breastfeeding

PregnancyAnimal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). There are limited data from the use of Casenlax in pregnant women (less than 300 exposed pregnancies). Casenlax is not expected to cause effects during pregnancy, since systemic exposure to Casenlax is negligible. Casenlax can be used during pregnancy.Feeding timeThere are no data on the excretion of Casenlax in human milk. Macrogol 4000 is not expected to cause effects on newborns / infants, since systemic exposure to macrogol 4000 of breastfeeding women is negligible. Casenlax can be used during breastfeeding.FertilityFertility studies have not been conducted with Casenlax; however, as macrogol 4000 is not significantly absorbed, no effects are expected.

Expiry and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

There is a possibility that the absorption of other medicines may be temporarily reduced while using Casenlax. The therapeutic effect of medicinal products with a narrow therapeutic index (e.g. antiepileptics, digoxin and immunosuppressive agents) may be particularly affected.

Overdose

Overdose can lead to diarrhea, abdominal pain and vomiting which disappear when treatment is temporarily stopped or the dosage is reduced. Excessive fluid loss due to diarrhea or vomiting may require correction of electrolyte imbalances. Cases of aspiration have been reported when large volumes of macrogol (polyethylene glycol) and electrolytes were administered via a nasogastric tube. Neurologically impaired children suffering from oromotor dysfunction are particularly at risk of aspiration.

Active principles

Each sachet contains 10 g of macrogol 4000. Excipients with known effects: 0.0000018 mg of sulfur dioxide (E220) per sachet and less than 1 mmol (23 mg) of sodium per sachet. For the full list of excipients, see section 6.1.

Excipients

Saccharin sodium (E954), apple flavor * * Composition of the apple flavor: Natural flavor, maltodextrin, gum arabic E414, sulfur dioxide E220, alpha tocopherol E307.