Casenlax 10 g - against occasional constipation - powder for oral suspension 20 sachets

Product Description

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 sulphur dioxide (E220) per sachet. For the full list of excipients, see section 6.1.

Excipients

Sodium saccharin (E954), apple flavour*. *Apple flavor composition: Natural flavor, 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 excluded before starting treatment. Casenlax should remain a temporary adjuvant treatment to a lifestyle and dietary regimen appropriate for constipation, with a maximum treatment cycle 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 tract or risk of perforation of the digestive tract. – Paralytic ileus or suspected intestinal obstruction. – Painful abdominal syndromes of undetermined 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 adjusted according to clinical effects and can vary from one sachet every other day (especially in children) up to 2 sachets per day. Paediatric 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 the lack of clinical data on treatments lasting longer than 3 months. The regularization of intestinal motility induced by treatment 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 adjunct to a healthy lifestyle and diet, for example: – Increased intake of fluids and dietary fiber, – Adequate physical activity and re-education of intestinal motility. Due to the presence of sulfur dioxide, Casenlax can rarely cause serious hypersensitivity reactions and bronchospasm. In case of diarrhea, caution should be exercised in patients predisposed to disturbances in fluid and/or electrolyte balance (e.g., the elderly, patients with hepatic or renal impairment, or patients treated with diuretics) and electrolyte monitoring 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 patients on a galactose-free diet.

Interactions

No interaction studies have been performed.

Undesirable effects

Undesirable effects are listed by frequency using the following categories: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <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 involved the gastrointestinal system:

Paediatric population: The undesirable effects listed in the following table have been reported during 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 involved the gastrointestinal system:

* Diarrhea may cause perianal pain Reporting of suspected adverse reactions: Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as 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: www.agenziafarmaco.gov.it/it/responsabili.

Overdose

Overdose may lead to diarrhea that disappears 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 nasogastric tube. Neurologically compromised children with oromotor dysfunction are particularly at risk of aspiration.

Format

Pack of 20 sachets.