Lactulose Almus

Syrup

Composition:

100 ml of syrup contains 66.7 g of lactulose. For excipients, see section 6.1.

Excipients

Potassium sorbate, orange essence, purified water.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. 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. Contraindicated in subjects with galactosemia. Generally contraindicated during pregnancy and lactation (see p. 4.6). Generally contraindicated in pediatric age (see p. 4.4).

Dosage

Adults 10 g per day (equivalent to 1 tablespoon) as a starting dose, followed by 5 g per day as maintenance therapy. In some subjects, a higher starting dose (10 - 20 g) may be required, which must then be progressively reduced to the ordinary maintenance dose. In sensitive subjects it is advisable instead to adopt lower posologies. Children • from 6 to 14 years: 10 g per day (3 teaspoons) as an initial dose, followed by 6 g per day as maintenance therapy (2 teaspoons). • from 1 to 5 years: 3 - 6 g per day (1 - 2 teaspoons). • infants: 3 g per day (1 teaspoon). 1 tablespoon = 15ml = 10g of lactulose. 1 teaspoon = 5ml = 3.3g of lactulose. 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. Take preferably in the evening. The daily dose can also be taken in a single dose, preferably in the morning on an empty stomach or in the evening before a meal. Swallow with an adequate amount of water (a large glass). A diet rich in liquids favors the effect of the medicine. 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.

Warnings and Precautions

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. In the most severe cases, dehydration or hypokalaemia may develop, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, 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). Do not use the drug if abdominal pain, nausea and vomiting are present. After a short period of treatment with no appreciable results, consult your doctor. Keep this medicine out of the reach and sight of children. Precautions for use In children under 12 years of age, the medicine can only be used after consulting your doctor. 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. Patients on digitalis therapy should consult their physician before starting therapy. It is also advisable that elderly people or those in poor health conditions consult their doctor before using the medicine. Lactulose is a poorly absorbable and non-metabolized sugar; however, due to the presence of other sugars such as lactose, galactose and tagatose, for diabetic patients it is necessary to inform the doctor.

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 simultaneously with lactulose, can reduce its degradation by limiting the possibility of acidification of the intestinal contents and consequently the therapeutic efficacy. In case of potassium depletion LACTULOSE ALMUS increases the toxicity of digitalis. A synergistic effect with neomycin is possible.

Side effects

Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation, flatulence. These symptoms are usually mild and usually subside after the first days of treatment; otherwise, a reduction of the dose is appropriate. Exceptionally, loss of electrolytes may occur after long treatment.

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.