LACTULOSE ABC * SCIR 180ML66.7%

LACTULOSE ABC * SCIR 180ML66.7%

Therapeutic indications

Short-term treatment of occasional constipation in adults and children.

Dosage and method of use

Dosage

1 tablespoon: 15 ml - 10 g of lactulose; 1 teaspoon: 5 ml - 3.3 g of lactulose.Elderly and patients with renal and hepatic insufficiency: There are no special recommendations for dosing, since systemic exposure to lactulose is negligible. The posology should be adjusted according to the individual needs of the patient. After a few days of treatment, the initial dose can be replaced with a maintenance dose based on the response to treatment. It may take several days (2-3 days) of treatment before the desired effect is achieved. Do not exceed the recommended doses. The correct dose is the minimum sufficient to produce an easy evacuation of soft stools. It is recommended to use the minimum doses provided initially. When necessary, the dose can be increased. Do not exceed the maximum recommended daily dose.Duration of treatment: Laxatives should be used as infrequently as possible and for no more than seven days. Prescription for prolonged use should be established after adequate clinical evaluation.Method of administration: The lactulose solution can be administered diluted or as it is together with an adequate quantity of water (a large glass). A single dose of lactulose should be swallowed whole and should not be kept in the mouth for an extended period of time. Lactulose can be administered as a single daily dose or divided into two administrations per day. In the case of a single daily dose, this must always be taken at the same time, for example at breakfast.

Contraindications

Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1. Acute abdominal pain or of unknown origin, Nausea or vomiting, Intestinal obstruction or stricture, Rectal bleeding of unknown origin, Severe dehydration, Perforation of the digestive tract or risk of perforation of the digestive tract.

Side effects

Summary of the safety profile: Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation and flatulence during the first days of treatment which normally disappears after a few days. As the following reactions have been reported through spontaneous reports from a population of unknown size, it is not possible to estimate their frequency.

Pediatric population

: The safety profile in children is expected to be similar to that in adults.Reporting of suspected adverse reactions. Reporting 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 system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Warnings:The 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. Therefore the patient's hydration status must be carefully evaluated. In severe cases, the onset of dehydration or hypokalemia is possible, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glucosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).Precautions for use: Before starting treatment, any abdominal pain symptoms of unknown cause should be evaluated in order to exclude undiagnosed perforations or obstructions or related undiagnosed predisposing pathologies / conditions. In case of insufficient therapeutic effect after 2-3 days the dose and / or additional measures must be reconsidered. It should be taken into account that the reflex to evacuate may be altered during treatment.Lactulose ABC contains galactose and lactose: Patients with rare hereditary problems of galactose intolerance, eg. galactosemia, or from glucose-galactose malabsorption, should not take this medicine.Lactulose ABC contains fructose.Lactulose ABC contains sodium benzoate: This medicinal product contains 53 mg of sodium benzoate per 45 ml dose. Sodium benzoate can increase jaundice (yellowing of the skin and eyes) in infants up to 4 weeks of age.Lactulose ABC contains sodium: This medicinal product contains less than 1 mmol (23 mg) sodium per 45 ml dose, i.e. essentially 'sodium-free'.

Pregnancy and breastfeeding

PregnancyEffects during pregnancy are not expected as systemic exposure to lactulose is negligible. Lactulose ABC can be used during pregnancy.Feeding time:No effects on the breast-fed newborn / infant are expected as systemic exposure to lactulose of breastfeeding women is negligible. Lactulose ABC can be used during breastfeeding.Fertility: No effects are expected as systemic exposure to lactulose is negligible.

Expiration and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

No interaction studies have been performed. Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid concomitant use of laxatives with other medicines: after taking a medicine leave an interval of at least 2 hours before taking the laxative. Broad-spectrum antibiotics can reduce the bacterial flora responsible for the degradation of lactulose, with a possible decrease in its therapeutic efficacy. An increase in the activity of lactulose is also possible if it is administered simultaneously with neomycin. In case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids, the onset of dehydration or hypokalaemia which can lead to cardiac or neuromuscular dysfunction is possible (see section 4.4). The lowering of pH in the intestine, characteristic of the mechanism of action of lactulose, can cause the inactivation of drugs that have a pH-dependent release profile of the intestine (for example, 5-ASA drugs).

Overdose

SymptomsExcessive doses can cause abdominal pain, loss of electrolytes and diarrhea.TreatmentDiscontinue treatment or reduce the dose. The resulting loss of fluids and electrolytes must be replenished.

Active principles

100 ml of syrup contain: Active ingredient: 66.7 g lactulose. Excipients with known effects: sodium, sodium benzoate. For the full list of excipients see section 6.1.

Excipients

Syrup: sodium benzoate, purified water.