Alaxa 5mg 20 gastro-resistant tablets

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Short-term treatment of occasional constipation.

CONTRAINDICATIONS

- Hypersensitivity to the active substance or to other chemically related substances or to any of the excipients listed in paragraph 6.1. - Children under 3 years of age. - Generally contraindicated during pregnancy and breastfeeding (see section 4.6). - Subjects with acute abdominal pain or pain of unknown origin, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration, acute surgical abdomen, appendicitis, gastroenteritis.

WARNINGS AND PRECAUTIONS FOR USE

Abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In more severe cases, the onset of dehydration or hypokalemia is possible, which can cause cardiac or neuromuscular dysfunction, especially in case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. Furthermore, the abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and therefore the possible need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Frequent or prolonged use of the medicine must be avoided as it can cause addiction and atonic colitis. The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of drugs and monitoring during the course of therapy. Caution is recommended if the need for the laxative derives from a sudden change in previous intestinal habits (frequency and characteristics of evacuations) that lasts for more than two weeks; when rectal bleeding is present; when the use of the laxative fails to produce effects or when the patient suffers from diabetes mellitus, hypertension or heart disease. It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine. Pediatric population: In children under 12 years of age the medicine can only be used after consulting a doctor. Important information about some excipients: ALAXA contains: - lactose monohydrate: patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine; - sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. - sodium: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially 'sodium-free'.

INTERACTIONS

Milk or antacids can change the effect of the medicine; leave an interval of at least one hour before taking the laxative. Concomitant use of diuretics, cardiac glycosides or adrenocorticosteroids may promote electrolyte imbalance. Laxatives can reduce the residence time in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other medicines at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative.

SIDE EFFECTS

Occasionally: isolated cramping pain or abdominal colic. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. 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.