NORMASE SCIR 200ML 66,7G/100ML

NORMASE 66,7 G/100 ML SCIROPTION

active ingredients

100 ml of syrup contain: active ingredient: lattulose 66,7 g For the full list of excipients see paragraph 6.1.

Excellent

Citric acid, aroma Curt Georgi n. 7 bis, purified water

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to lattulose or any of the excipients listed in paragraph 6.1. Acute or unknown abdominal pain Nausea or vomiting Ostruction or intestinal stenosis Rectal bleeding of unknown origin Grave dehydration status.

Population

Population The correct dose is sufficient to produce an easy evacuation of soft feces. It is recommended to initially use the minimum doses provided. Do not exceed the recommended maximum daily dose. Adults: The initial dose is 20 ml per day followed by 10 ml per day, as a maintenance dose. In some cases, a higher initial dose (30-40 ml) may be required, which must be gradually reduced to the maintenance dose. Children: 5 - 15 ml per day, depending on body weight. Milking: 0.5 - 1 ml per day for each kg of body weight. Method of administration In case of single daily administration, preferably take in the evening. If the dose is divided into two administrations a day, preferably take in the morning and in the evening. Eating together with an adequate amount of water (a plentiful glass). 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.

Conservation

None.

Warnings

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 glycosides, diuretics or corticosteroids (see paragraph 4.5). The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). If diarrhea appears, the therapy should be suspended. NORMASE contains galactose and lactose. Patients with rare hereditary problems of galactose intolerance, e.g. galactosemia, or galactose glucose mal absorption, should not take this medicine. NORMASE contains fructose. The additive effect of co-administration of medicinal products containing fructose (or sorbitol) and the intake of fructose (or sorbitol) with the diet must be considered.

Interactions

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. NORMASE can lead to increased toxicity of digital, diuretic and corticosteroid for potassic depletion (see paragraph 4.4). Wide-spectrum bactericidal agents and antacids, administered orally at the same time as lattulose, can reduce their degradation by limiting the acidifying effect of the intestinal content and, consequently, therapeutic effectiveness. It is possible a synergistic effect with neomycin.

Effects

Occasionally: isolated crampiform pain or abdominal colic pain, more frequent in cases of severe constipation and flatulence. Such symptoms are mild and spontaneously release after the first days of treatment. 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 the address 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 NORMASE should be considered only in case of actual need and if the expected benefit for the mother exceeds risk for the child.

Source: Farmadati