Casenlax * 10g

Oral Suspension Powder

Composition:

Each sachet contains 10 g of macrogol 4000. Excipient with known effect: This medicinal product contains 0.0000018 mg of sulfur dioxide (E220) per sachet. For the full list of excipients, see section 6.1.

Excipients

Sodium saccharin (E954); apple flavor *. * Composition of the apple aroma: Natural aroma; maltodextrin; gum arabic E414; sulfur dioxide E220; alpha tocopherol E307.

Therapeutic indications

Symptomatic treatment of constipation in adults and children over 8 years of age. 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.

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.

Dosage

Oral use. Dosage: 1 to 2 sachets per day, preferably taken as a single dose in the morning. The effect of Casenlax occurs within 24–48 hours after administration. The daily dose should be adapted according to the clinical effects and can vary from one sachet every other day (especially in children) up to 2 sachets per day. Pediatric population: 1 to 2 sachets per day, preferably taken as a single dose in the morning. 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 administration: Each sachet should be dissolved in a glass of water (approximately 125 ml) just before use. The resulting solution will be clear and transparent like water.

Warnings and Precautions

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 the event 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 sugar or polyols and can be prescribed to diabetic patients or to patients on a galactose-free diet.

Interactions

No interaction studies have been performed.

Side effects

Undesirable effects are listed by frequency using the following categories: Very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1,000 to <1/100); rare (≥1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); not known (frequency cannot be estimated from the available data). 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:

Pediatric population: 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:

Systems and organs Adverse reactions
Disorders of the immune system
Not known Hypersensitivity reactions
Gastrointestinal disorders
Common Abdominal pain
Diarrhea*
Uncommon Vomiting
Swelling
Nausea

* Diarrhea can cause perianal pain. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Pregnancy: Animal 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. Lactation: There 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. Fertility: Fertility studies have not been conducted with Casenlax; however, since macrogol 4000 is not significantly absorbed, no effects are expected.