Lactulose Pharmamentis 66.7% Laxative Syrup Bottle of 200 ml

Therapeutic indications

Short-term treatment of occasional constipation.

Dosage

Posology The correct dose is the minimum sufficient to produce an easy evacuation of soft faeces. It is advisable to initially use the minimum doses provided. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. Take preferably in the evening. Laxatives should be used as infrequently as possible and for no more than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case. Adults The average daily dosage is 10 - 15 g in two doses. This dosage can be doubled or halved depending on the individual response or clinical picture. Pediatric population From 2.5 to 10 g / day, even in a single administration, depending on the age and severity of the case. Infants On average 2.5 g per day. Method of administration LACTULOSE PHARMENTIS granules for oral solution can be administered dissolved in water or suitably diluted in milk or other drinks.

Overdose

Excessive doses can cause abdominal pain and diarrhea; consequent losses of fluids and electrolytes must be replaced. See also what is reported in section 4.4 about laxative abuse. Accidental intake of excessively high doses can cause diarrhea and abdominal cramps, which are reversible upon discontinuation of the drug.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Laxatives are contraindicated in subjects with acute abdominal pain or of unknown origin, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration. Contraindicated in subjects with galactosemia.

Side effects

Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation. In rare cases, lactulose can cause bloating and abdominal cramps, usually mild and which recede spontaneously after the first days of treatment. If not, a dose reduction is appropriate. Occasionally flatulence. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system of the Italian Medicines Agency.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies on the use of the drug in pregnancy or breastfeeding. Therefore, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant. There are, in general, no contraindications to the use of LACTULOSE PHARMENTIS during pregnancy and breastfeeding. However, medical advice should be sought.

Special warnings

Warnings The abuse of laxatives (frequent and 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 hypokalemia is possible, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glucosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Do not use the drug if abdominal pain, nausea and vomiting are present. If constipation is persistent, consult a doctor. In patients presenting with disorders caused by excessive intestinal meteorism it is advisable to start treatment with the minimum doses indicated; these doses can be gradually increased in relation to the patient's response. Lactulose is absorbed to a very small extent and has no caloric value. However, LACTULOSE PHARMENTIS contains, in addition to lactulose, also galactose, lactose and small quantities of other sugars. This must be taken into account in the treatment of diabetic patients and in patients on low calorie diets. Pediatric population In children under 12 years of age, the product should only be used after consulting your doctor and evaluating the risk / benefit ratio. Precautions The treatment of chronic or recurrent constipation always requires the intervention of the doctor for the diagnosis, the prescription of drugs and the surveillance during the course of therapy. Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks or when the use of the laxative fails to produce effects. It is also advisable that elderly people or those in poor health conditions consult their doctor before using the medicine.

Expiry and Retention

None.

Active principles

Bottle of 200 ml of syrup 100 ml of syrup contain: Active ingredient: Lactulose g 66.7 Sachet of 10 g One sachet of 10 g contains: Active ingredient: Lactulose g 10 For the full list of excipients, see section 6.1.

Excipients

Syrup: purified water. Granules : lemon flavor