Lactulose Sand Syrup 180 ml

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Short-term treatment of occasional constipation. Adults: occasional constipation; adjuvant in intestinal bacterial diseases 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 maternal to artificial breastfeeding.

ACTIVE INGREDIENTS

66.7% syrup, 180 ml bottle 100 ml of syrup contains 66.7 g of lactulose Excipients with known effect: 100 ml of syrup contains 0.118 g of sodium benzoate. For the complete list of excipients see section 6.1

EXCIPIENTS

sodium benzoate; purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. 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 suffering from galactosemia. Generally contraindicated in pediatric age (see section 4.4).

DOSAGE

Dosage 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 clinical picture. Pediatric population Children: from 2.5 to 10 g/day, even in a single administration, depending on the age and severity of the case. Infants: on average 2.5 g per day. The correct dose is the minimum sufficient to produce an easy evacuation of loose 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. 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. Swallow together with an adequate quantity of water (a large glass). A diet rich in liquids favors the effect of the medicine.

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

Special warnings Lactulose is absorbed to a very small extent and has no caloric value. However, in addition to lactulose, Lactulose Sandoz also contains galactose, lactose and small quantities of other sugars. This must be taken into account in the treatment of diabetic patients and in patients following low-calorie diets. 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 more severe cases, the onset of dehydration or hypokalemia is possible which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, possible need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Precautions for use Do not use the medicine if abdominal pain, nausea and vomiting are present. If constipation is stubborn, consult a doctor. In patients who present 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. In children under 12 years of age the medicine can only be used after consulting a doctor. The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of medicines and monitoring during the course of therapy. Consult your doctor when the need for the laxative derives from a sudden change in previous intestinal habits (frequency and characteristics of evacuations) that lasts for 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. Important information about some excipients Lactulose Sandoz contains 26.4 mg of sodium benzoate per average daily dose equivalent to 0.14 mg/ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age. The increase in bilirubin following its detachment from albumin can increase neonatal jaundice which can progress to kernicterus (deposits of unconjugated bilirubin in the brain tissue). Lactulose Sandoz contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially 'sodium-free'.

INTERACTIONS

Broad-spectrum antibacterial agents, administered orally at the same time as lactulose, can reduce 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 medicines administered simultaneously orally. 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.

SIDE EFFECTS

Gastrointestinal disorders: Occasionally: isolated cramping pain or abdominal colic, more frequent in cases of severe constipation. Frequency not known: flatulence. Immune system disorders: Frequency not known: hypersensitivity reactions. Skin and subcutaneous tissue disorders: Frequency not known: rash, itching, urticaria. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

OVERDOSE

Excessive doses can cause abdominal pain and diarrhea; the resulting losses of fluids and electrolytes must be replaced. Also see what is reported in the paragraph “Special warnings and precautions for use” regarding the abuse of laxatives.

PREGNANCY AND BREASTFEEDING

There are no adequate and well-controlled studies on the use of the medicine during pregnancy or breastfeeding. Therefore the medicine must be used only if necessary, under the direct supervision of the doctor, after having evaluated the expected benefit for the mother in relation to the possible risk for the fetus or infant.

EFFECTS ON DRIVING ABILITY

Lactulose sandoz does not alter the ability to drive and use machines.