IN THE CASE OF PRODUCTS OF HEADINGS 170 TO 170

LATTULOSO ALTER 66.7% ORAL DEAL

active ingredients

100 ml of solution contain: Active ingredient: Lattulose g 66,7 For the list of excipients see par. 6.1

Excellent

Excipients; Sodium benzoate, purified water

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Galattosemia. Individual hypersensitivity ascertained towards components and substances closely related to chemical. Gastrointestinal obstruction. Laxatives are contraindicated in subjects with acute or unknown abdominal pain, nausea or vomiting, obstruction or intestinal stenosis, rectal bleeding of unknown origin, severe state of dehydration.

Population

1 tablespoon = 15 ml = 10 g lattulose. 1 teaspoon coffee = 5 ml = 3,3 g lattulose. Adults: the average daily dosage is 1 tablespoon. This may be doubled or halved depending on the individual response or the clinical picture. Pediatric population: the average daily dosage is 2 teaspoons of coffee, even in one administration, depending on the age and severity of the case, according to the doctor. Milking: the average daily posology is 1 teaspoon coffee at the doctor's judgment. The correct dose is sufficient to produce an easy evacuation of soft feces. It is advisable to initially use the minimum doses provided. When necessary, the dose may be increased, but never exceed the maximum indicated. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods requires the doctor’s prescription after adequate evaluation of the individual case. Method of administration The medicine should be taken preferably in the morning to fast or in the evening before the meal. Lattulose is very small and has no calorie value. However, LATTULOSIO ALTER contains, in addition to lattulose, also galactose, lactose and small amounts of other sugars. This should be taken into account in the treatment of diabetic patients and in patients following hypocaloric diets (see paragraph 4.4).

Conservation

This medicine does not require any special condition for storage.

Warnings

Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose mal absorption should not take this medicine. Laxative abuse can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with heart glucosides, diuretics or corticosteroids. The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). Although the active ingredient of LATTULOSIO ALTER is a poorly absorbable and not metabolized sugar, for the presence of other sugars such as lactose, galactose and tagatose, for diabetic patients it is necessary to consult the doctor. Continuous use of laxatives can result in a different kind of addiction or damage. If constipation is stubborn, consult your doctor. Do not use the drug if there are abdominal pain, nausea and vomiting. In patients who have disorders caused by excessive intestinal meteorism it is appropriate to begin treatment with the minimum doses indicated; these doses may be increased gradually in relation to the patient's response. Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. Consult your doctor when the need for laxative comes from a sudden change of previous intestinal habits (frequency and evacuation characteristics) that lasts for more than two weeks or when the use of laxative fails to produce effects. You should also consult your doctor before using the medicine. Pediatric population In children under 12 years the product can only be used after consulting the doctor.

Interactions

Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid ingesting laxatives and other drugs at the same time: after taking a medicine let spend a range of at least 2 hours before taking laxative. Wide-spectrum antibacterial and antacid agents, administered orally at the same time as lattulose, can reduce their degradation by limiting the possibility of acidification of the intestinal content and, consequently, therapeutic effectiveness. It is also possible to increase the activity of lattulose, if this is administered simultaneously to neomycin. The drug may result in an increase in the toxicity of digital drugs for potassium loss.

Effects

Gastrointestinal diseases Flatulence, abdominal pain, nausea,vomite, diarrhea (with excessive dosages). Immune system disorders Frequency not known: Reactions from hypersensitivity. Pathologies of skin and subcutaneous tissue Frequency not known: Skin rash, itching, hives.Diagnostic examinations Electrolytic imbalance due to diarrhea. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Excessive doses can cause abdominal pain and reversible diarrhea with the suspension of the drug. The resulting losses of liquids and electrolytes must be replaced. See also in paragraph 4.4 about the abuse of laxatives.

There are no adequate and well-controlled studies on the use of pregnant or nursing medicine. Therefore the medicinal product must be used only in case of need, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or for the infant.

Source: Farmadati