Lactulose Alter 66.7%

Syrup

Composition :

100 ml of solution contain: Active ingredient: Lactulose g 66.7 For the list of excipients see par. 6.1

Excipients

Excipients; Sodium benzoate, purified water

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Galactosemia. Individual hypersensitivity to strictly correlated components and substances from a chemical point of view. Gastrointestinal obstruction. Laxatives are contraindicated in subjects with acute abdominal pain or of unknown origin, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration. Generally contraindicated in pregnancy and lactation (see section 4.6).

Dosage

1 tablespoon = 15 ml = 10 g of lactulose 1 teaspoon = 5 ml = 3.3 g of lactulose Adults: the average daily dosage is 1 tablespoon. This dosage can be doubled or halved depending on the individual response or clinical picture. Children: the average daily dosage is 2 coffee spoons, even in a single dose, depending on the age and severity of the case, in the opinion of the doctor. Infants: the average daily dosage is 1 teaspoon in the opinion of the doctor. The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is advisable to initially use the minimum doses provided. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. Laxatives should be used as infrequently as possible and for no more than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case. The medicine should preferably be taken in the morning on an empty stomach or in the evening before a meal. Lactulose is absorbed to a very small extent and has no caloric value. However, LACTULOSE ALTER contains, in addition to lactulose, also galactose, lactose and small quantities of other sugars. This must be taken into account in the treatment of diabetic patients and in patients on low calorie diets.

Warnings and Precautions

Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine. The abuse of laxatives can cause persistent diarrhea with consequent loss of water, minerals (especially potassium) and other essential nutritional factors. 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 (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Although the active ingredient of LACTULOSE ALTER is a poorly absorbable and non-metabolized sugar, due to the presence of other sugars such as lactose, galactose and tagatose, it is necessary to consult a doctor for diabetic patients. The continued use of laxatives can cause addiction or damage of various kinds. If constipation is stubborn, see your doctor. Do not use the drug if abdominal pain, nausea and vomiting are present. In children under 12 years of age, the product can only be used after consulting your doctor. In patients presenting with disorders caused by excessive intestinal meteorism it is advisable to start treatment with the minimum doses indicated; these doses can be gradually increased in relation to the patient's response. The treatment of chronic or recurrent constipation always requires the intervention of the doctor for the diagnosis, the prescription of drugs and the surveillance during the course of therapy. Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks or when the use of the laxative fails to produce effects. It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine.

Interactions

Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative. Broad spectrum antibacterial agents and antacids, administered orally at the same time as lactulose, can reduce its degradation by limiting the possibility of acidification of the intestinal contents and, consequently, the therapeutic efficacy. An increase in the activity of lactulose is also possible if it is administered simultaneously with neomycin. The drug can cause increased toxicity of digitalis due to potassium loss.

Side effects

Gastrointestinal disorders Flatulence, abdominal pain, nausea, vomiting, diarrhea (with excessive doses). Investigations Electrolyte imbalance due to diarrhea.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies on the use of the drug in pregnancy or breastfeeding. Therefore, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.