Short-term treatment of occasional constipation. Adults : occasional constipation; adjuvant in intestinal bacterial affections caused by coliform germs (Salmonella, Shigella, etc.). Children and infants : constipation; treatment of putrefactive syndromes, due to eating disorders; as a corrective to the infant's diet, especially in the transition from breastfeeding to bottle feeding.
Dosage and method of use
Adults: the average daily dosage is 10-15 g in two administrations. This dosage can be doubled or halved depending on the individual response or the clinical picture. Children : from 2.5 to 10 g/day, even in a single administration, according to the age and severity of the case. Infants : on average 2.5 g per day. The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is advisable to initially use the minimum doses foreseen. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. Take preferably in the evening. Laxatives should be used as infrequently as possible and for no longer than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case. Ingest together with an adequate amount of water (a large glass). A diet rich in liquids favors the effect of the medicinal product.
Hypersensitivity to the active substance or to any of the excipients. Laxatives are contraindicated in subjects with acute abdominal pain or pain of unknown origin, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration. Contraindicated in subjects with galactosemia. Generally contraindicated during pregnancy and lactation (see p. 4.6). Generally contraindicated in children (see p. 4.4).
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation. Occasionally: flatulence.
Warnings Lactulose is absorbed to a very small extent and has no caloric value. However Lactulosio Sandoz contains in addition to lactulose also galactose, lactose and small amounts of other sugars. This must be taken into account in the treatment of diabetic patients and in patients on low-calorie diets. 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. In the most serious cases, the onset of dehydration or hypokalaemia is possible, which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glucosides, diuretics or corticosteroids. 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). Precautions for use Do not use the drug if abdominal pain, nausea and vomiting are present. If the constipation is persistent consult a doctor. In patients with disorders caused by excessive intestinal meteorism, it is advisable to start the treatment with the minimum doses indicated; these doses can be increased gradually in relation to the patient's response. In children under the age of 12, the medicine can only be used after consulting the doctor. The treatment of chronic or recurrent constipation always requires the intervention of the doctor for the diagnosis, the prescription of medicines and the surveillance during the therapy. Consult your doctor when the need for a laxative derives from a sudden change in previous bowel habits (frequency and characteristics of evacuations) that has lasted for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable that the elderly or in poor health conditions consult their doctor before using the medicine.
Pregnancy and breastfeeding
There are no adequate and well-controlled studies on the use of the medicinal product during pregnancy or lactation. Therefore, the medicinal product should only be used if necessary, under direct medical supervision, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or infant.
Expiration and conservation
Keep the sachets at a temperature not exceeding 25°C.
Interactions with other drugs
Broad-spectrum antibacterial agents, administered orally at the same time as lactulose, can reduce the degradation, limiting the possibility of acidification of the intestinal contents and consequently the therapeutic efficacy. Laxatives can reduce the residence time in the intestine, and therefore the absorption, of other drugs administered orally at the same time. 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.
Excessive doses can cause abdominal pain and diarrhea; resulting fluid and electrolyte losses must be replaced. See also what is reported in the paragraph "Special warnings and precautions for use" about the abuse of laxatives.
66.7% syrup, 180 ml bottle 100 ml of syrup contain: Active ingredient: Lactulose g 66.7
Syrup: sodium benzoate; purified water. 5 g sachet: citric acid; lemon flavour. 10 g sachet: citric acid; lemon flavour.
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