Normase 66.7%

Syrup

Composition :

100 ml of syrup contain: Lactulose 66.7 g 15 ml of syrup contain 10 g of lactulose. For excipients see § 6.1.

Excipients

Citric acid, Curt Georgi aroma n. 7 bis, purified water

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Galactosemia. 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 during pregnancy and lactation (see § 4.6). Generally contraindicated in pediatric age (see § 4.4).

Dosage

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. Adults: The starting dose is usually 20ml per day followed by 10ml per day as a maintenance dose. A higher starting dose (30–40 ml) may be required in some individuals and should then be progressively reduced to the normal maintenance dose. In sensitive subjects it is advisable to start with lower doses instead. Children: 5 to 15 ml per day, depending on body weight. Infants: half - 1 ml per day for each kg of body weight. The quantities indicated above can also be taken in a single daily dose, preferably in the morning on an empty stomach or in the evening before a meal. 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. Swallow with an adequate amount of water (a large glass). A diet rich in liquids favors the effect of the medicine.

Warnings and Precautions

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). The active ingredient of NORMASE is a poorly absorbable and non-metabolized sugar. Due to the presence of other sugars, such as lactose, galactose and tagatose, diabetic patients must inform their doctor. Patients on digitalis therapy should consult their physician before starting therapy. In children under the age of 12, 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. It is also advisable that elderly people or those in poor health conditions consult their doctor before using the medicine.

Interactions

Broad spectrum bactericidal agents and antacids, administered orally at the same time as lactulose, can reduce its degradation by limiting the acidifying effect of the intestinal contents and, consequently, the therapeutic efficacy. On the other hand, a synergistic effect with neomycin is possible. 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 two hours before taking the laxative.

Side effects

Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation, flatulence. These symptoms are usually mild and subside spontaneously after the first few days of treatment. Only in the event of diarrhea is it advisable to reduce the dosage or to suspend the treatment if necessary. After prolonged treatment, loss of electrolytes may occur.

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.