PENSA OS 180ML66,7%

PENSA LATTULOS 66,7 G/100 ML SCIROPULATION

active ingredients

100 ml of syrup contain: Active ingredient: Lattulose: 66,7 g. Excipients with known effects: benzoate sodium 0.118 g. For the full list of excipients, see paragraph 6.1.

Excellent

Sodium Benzoate and purified water.

Therapeutic indications

Short-term treatment of occasional constipation in adult, child and infant.

Contraindications

Hypersensitivity to lattulose or any of the excipients listed in paragraph 6.1; Acute or unknown abdominal pain; Nausea and vomiting; Obstruction or intestinal stenosis; Rectal bleeding of unknown origin; Severe dehydration.

Population

Population The correct dose is sufficient to produce an easy evacuation of feces soft. It is recommended to initially use the minimum doses provided. Do not exceed the recommended maximum daily dose. Adults: the recommended dose is 10-15 g to be taken in one or two administrations per day. When necessary the dose can be increased. The maximum daily dose is 30 g lattulose. Pediatric population Children: the recommended dose is 2.5 -10 g per day, to be taken in one or two administrations per day, depending on the age and severity of the case. The maximum daily dose is 10 g lattulose. Milking: the recommended dose is 2.5 g per day. 1 tablespoon = 15 ml = 10 g lattulose; 1 teaspoon coffee = 5 ml = 3,3 g lattulose. Do not exceed the recommended maximum daily dose. Duration of treatment Laxatives must be used as frequently as possible and for no more than seven days. The prescription for prolonged use should be established after proper clinical evaluation. Method of administration Take it by mouth, preferably in the evening.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Warnings. In case of excessive intestinal meteorism it is appropriate to start treatment with the minimum effective dose; it is recommended to increase the dosage gradually after careful reassessment of the observed response. Laxative abuse (frequent or prolonged use or excessive doses) 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 lead to cardiac or neuromuscular dysfunctions, especially in the elderly, debilitated subjects and in the case of a contemporary treatment with cardiac, diuretic or corticosteroid glucosides (see paragraph 4.5). 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). LATTULOSIO PENSA contains galactose and lactose. Patients suffering from rare hereditary problems of galactose intolerance, e.g. galactosemia, or from glucose-galactose mal absorption, should not take this medicine. Important information about some excipients This medicine contains 1,18 mg of benzoate sodium for 1 ml. The increase in bilirubinemia following its detachment from albumin can increase the neonatal hetero that can evolve in kernittero (deposits of bilirubin not conjugated in the brain tissue). This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially ‘without sodium’.

Interactions

The simultaneous administration of antibiotics can reduce the degradation of lattulose and consequently limit the possibility of acidification of the intestinal content with decrease in its therapeutic effectiveness. Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid the contemporary administration of laxatives and other drugs: the administration of other medicinal products must precede that of laxative at least 2 hours before taking laxative. In the case of a contemporary treatment with cardiac glycosides, diuretics or corticosteroid, dehydration or hypopotassium may occur, which may cause heart or neuromuscular dysfunction (see paragraph 4.4).

Effects

Occasionally: isolated crampiform pain, abdominal colic, more frequent in cases of severe constipation, flatulence and diarrhea. Reactions from hypersensitivity, rash, itching and unknown frequency hives (frequency cannot be defined on the basis of available data). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Excessive doses can cause abdominal pain and diarrhea, in which case suspend treatment and the consequent losses of liquids and electrolytes must be reintegrated.

There are no adequate and well-controlled studies on the use of the medicinal product during pregnancy or breastfeeding. The use of LATTULOSIO PENSA must be taken into account only in case of actual need and if the expected benefit for the mother exceeds risk for the child.

Source: Farmadati