Laevolac syrup 180ml minsan 029565013

LAEVOLAC*SCIR 180ML 66.7%

Therapeutic indications

Short-term treatment of occasional constipation in adults and children

Dosage and method of use

DosageThe correct dose is the minimum sufficient to produce an easy evacuation of loose stools. It is recommended to initially use the minimum doses envisaged. Do not exceed the maximum recommended daily dose.AdultsThe recommended dose is 15 - 30 ml (corresponding to 10 - 20 g of lactulose) to be taken in one or two administrations per day. When necessary the dose can be increased. The maximum daily dose is 45 ml (corresponding to 30 g of lactulose).Adolescents and children ≥ 10 yearsThe recommended dose is 15 ml (corresponding to 10 g of lactulose) to be taken in one or two doses per day. The maximum daily dose is 15 ml.Children 5 - The recommended dose is 10 ml (corresponding to 6.67 g of lactulose) to be taken in one or two administrations per day. The maximum daily dose is 10 ml.Children >1 - The recommended dose is 5 ml (corresponding to 3.33 g of lactulose) to be taken in one or two administrations per day. The maximum daily dose is 5 ml.Children 1 month - 1 yearThe recommended dose is 2.5 ml (corresponding to 1.66 g of lactulose) to be taken in a single administration in the evening. The maximum daily dose is 2.5 ml.Duration of treatmentLaxatives should be used as infrequently as possible and for no longer than seven days. The prescription for prolonged use must be established after adequate clinical evaluation.Method of administrationIn case of single daily administration, take preferably in the evening. If the dose is divided into two administrations per day, take preferably in the morning and in the evening.

Contraindications

• Hypersensitivity to lactulose or to any of the excipients listed in section 6.1. • Acute abdominal pain or pain of unknown origin, • nausea or vomiting, • intestinal obstruction or stenosis, • rectal bleeding of unknown origin, • severe dehydration.

Side effects

Below are the side effects organized according to the MedDRA System Organ classification. The frequency is defined as follows: very common (≥1/10), common (from ≥1/100 to

Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. 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

Special warnings

Warnings:Abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea resulting in 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 case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (possible need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). If diarrhea appears, therapy should be suspended. LAEVOLAC contains galactose and lactose. Patients with rare hereditary problems of galactose intolerance, e.g. galactosemia, or glucose-galactose malabsorption, should not take this medicine. LAEVOLAC contains fructose. The additive effect of co-administration of medicinal products containing fructose (or sorbitol) and dietary intake of fructose (or sorbitol) should be considered.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies on the use of the medicine during pregnancy or during breastfeeding. The use of LAEVOLAC should be considered only in case of real need and if the expected benefit for the mother outweighs the risk for the child.

Expiration and conservation

Syrup: Store below 25°C. Shelf life after first opening the bottle: 12 months if stored at temperatures below 25°C.

Interactions with other drugs

Laxatives can reduce the residence time in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. 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. Laevolac may 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, limiting the possibility of acidification of the intestinal contents and, consequently, the therapeutic efficacy.

Overdose

Excessive doses can cause abdominal pain and diarrhea, in which case treatment should be suspended and the resulting losses of fluids and electrolytes must be replenished.

Active principles

LAEVOLAC 66.7 g/100 ml syrup 100 ml of syrup contain: active ingredient: lactulose 66.7 g. For the full list of excipients, see section 6.1.

Excipients

Syrup: none.