ZEN SCIR 200ML

LATTULOS ZENTIVA 66,7 G/100 ML SCIROPTION

active ingredients

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

Excellent

Syrup: benzoate sodium, purified water.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Contraindicated in subjects affected by galactosemia. Laxatives are contraindicated in subjects with acute or unknown abdominal pain, nausea, vomiting, obstruction or intestinal stenosis, rectal bleeding of unknown origin, severe state of dehydration. Generally contraindicated during pregnancy and nursing (see paragraph 4.6) and children under 3 years of age.

Population

Adults: daily posology is 10-15 g in two administrations. This may be doubled or halved depending on the individual response or the clinical picture. Children: 2.5 to 10 g/day, even in one administration, depending on the age and severity of the case. Milking: on average 2.5 g per day. The correct dose is sufficient to produce an easy evacuation of soft feces. It is advisable to initially use the minimum doses provided. When necessary, the dose may be increased, but never exceed the maximum indicated. Preferably in the evening. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods of time requires the doctor’s prescription after adequate evaluation of the individual case. Lattulose is very small and has no calorie value. However LATTULOSIO ZENTIVA contains, in addition to lattulose, also galactose, lactose and small amounts of other sugars. This should be taken into account in the treatment of diabetic patients and in patients following hypocaloric diets.

Conservation

None.

Warnings

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 result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. 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). Precautions of employment In children under 12 years, the medicine can only be used after consulting the doctor. Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. Consult your doctor when the need for laxative comes from a sudden change of previous intestinal habits (frequency and evacuation characteristics) that lasts for more than two weeks or when the use of laxative fails to produce effects. You should also consult your doctor before using the medicine. In patients who have disorders caused by excessive intestinal meteorism it is appropriate to begin treatment with the minimum doses indicated; these doses may be increased gradually in relation to the patient's response.

Interactions

Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid taking laxatives and other drugs at the same time: after taking a medicine let spend a range of at least 2 hours before taking laxative. In particular, the contemporary association of tetracicline must be avoided (see paragraph 4.4. "Special warnings and precautions of employment"). Wide-spectrum antibacterial agents, administered for os at the same time to lattulose, can reduce its degradation by limiting the possibility of acidification of the intestinal content and consequently therapeutic effectiveness.

Effects

Occasionally: isolated crampiform pain or abdominal colic pain, more frequent in cases of severe constipation. Flatulence. In rare cases, lattulose can cause abdominal meteorism and cramps, usually of a mild entity and which spontaneously leave after the first days of treatment. If not, a dose reduction is appropriate. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur 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 www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Excessive doses can cause abdominal pain and diarrhea; the consequent losses of liquids and electrolytes must be replaced. See also the paragraph “Special Warnings and Precautions of Use” about the abuse of laxatives.

There are no adequate and well-controlled studies on the use of pregnant or nursing medicine. Therefore the medicinal product must be used only in case of need, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or for the infant.

Source: Farmadati