LAEVOLAC*SCIR 180ML 66,7%
Short-term treatment of occasional constipation in adults and children
Dosage and method of use
Posology: The correct dose is the minimum sufficient to produce an easy evacuation of soft faeces. It is recommended to initially use the minimum doses provided. The dose can be increased when necessary. Do not exceed the maximum daily limited dose. Adults and adolescents over 14 years of age. The recommended doses are:
|Syrup||starting dose||maintenance dose|
|mild constipation||1 tablespoon / day||2 coffee spoons / day|
|severe constipation||1-2 tablespoons / day||2-3 teaspoons / day|
|stubborn constipation||2-3 tablespoons / day||2-4 coffee spoons / day|
Granulated: The recommended doses are 1-2 sachets per day. Children and adolescents up to 14 years. The recommended doses are:
|Syrup||starting dose||maintenance dose|
|1-6 years||1-2 teaspoons / day||1 teaspoon / day|
|6-14 years||1 tablespoon / day||2 coffee spoons / day|
Granulate: The recommended doses are ½-1 sachet per day. Infants
| ||starting dose||maintenance dose|
|Syrup||1 teaspoon / day||1 teaspoon / day|
1 tablespoon = 15 ml = 10 g of lactulose; 1 teaspoon = 5ml = 3.3g of lactulose. Duration of treatment: Laxatives should be used as infrequently as possible and for no more than seven days. Prescription for prolonged use should be established after adequate clinical evaluation. Method of administration: Take preferably in the evening.
• Hypersensitivity to lactulose or to any of the excipients listed in section 6.1., • acute abdominal pain or of unknown origin, • nausea or vomiting, • intestinal obstruction or stricture, • rectal bleeding of unknown origin, • severe dehydration.
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation and flatulence. These symptoms are generally mild and disappear spontaneously after the first days of treatment. In exceptional cases, after long treatment, the possibility of a loss of electrolytes may arise. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio 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.
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 severe cases, the onset of dehydration or hypokalaemia 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 addiction (possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). In case of diarrhea it is advisable to suspend the therapy. LAEVOLAC contains galactose and lactose. Patients with rare hereditary problems of galactose intolerance, eg. galactosemia, or from glucose-galactose malabsorption, should not take this medicine. LAEVOLAC contains fructose. The additive effect of co-administration of fructose (or sorbitol) containing medicinal products and dietary intake of fructose (or sorbitol) must be considered.
Pregnancy and breastfeeding
There are no adequate and well-controlled studies on the use of the medicinal product during pregnancy or during breastfeeding. The use of LAEVOLAC should only be considered when clearly needed and if the expected benefit to the mother outweighs any risk to the baby.
Expiry and retention
Syrup: Store below 25 ° C. Shelf life after first opening the bottle: 12 months if stored at a temperature below 25 ° C. Granulate: None.
Interactions with other drugs
Laxatives can reduce the time spent 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, leave an interval of at least 2 hours before taking the laxative. Laevolac can lead to increased toxicity of digitalis due to potassium depletion. A synergistic effect with neomycin is possible. Broad-spectrum antibacterial agents, 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.
Excessive doses can cause abdominal pain and diarrhea, in which case the treatment must be discontinued and the consequent loss of fluids and electrolytes must be replenished.
LAEVOLAC 66.7 g / 100 ml syrup. 100 ml of syrup contain: active ingredient: lactulose 66.7 g. LAEVOLAC 10 g granules. 1 sachet contains: active ingredient: lactulose 10 g. For the full list of excipients, see section 6.1.
Syrup: none. Granules: lemon flavor 0.05 g.