Lactulac 67 g/100 ml Lactulose Syrup 200 ml

Therapeutic indications

Short-term treatment of occasional constipation.

Dosage

1 tablespoon or 1 single-dose sachet = 15 ml = 10 g of lactulose 1 teaspoon = 5 ml = 3.3 g of lactulose The lactulose solution can be administered diluted or as it is together with an adequate quantity of water (a abundant glass). A diet rich in liquids favors the effect of the medicine. Take preferably in the evening. Adults : The average daily dosage is 10-15 g (10-20 ml) in two doses or 1 sachet / day. This dosage can be doubled or halved depending on the individual response or clinical picture. Children : From 2.5 to 10 g / day (5-15 ml), even in a single administration, depending on the age and severity of the case in the opinion of the doctor. For reduced doses to children (less than 10g / day in a single dose) the use of Lattulac syrup is recommended. Infants : On average 2.5 g / day (1 / 2-1 teaspoon), in the opinion of the doctor. For administration to infants, the use of Lattulac syrup is recommended. The correct dose is the minimum sufficient to produce easy evacuation of soft stools. 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. 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. Lactulose is absorbed to a very small extent and has no caloric value.

Overdose

Symptoms : Excessive doses can cause abdominal pain and reversible diarrhea upon discontinuation of the drug. The resulting loss of fluids and electrolytes must be replaced. See also the information in the section "Special warnings and precautions for use" regarding the abuse of laxatives. Treatment : Treatment interruption or dose reduction. The resulting loss of fluids and electrolytes must be replaced.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Contraindicated in subjects with galactosemia. Gastrointestinal obstruction. 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. Generally contraindicated in pregnancy and lactation (see section 4.6). Generally contraindicated in pediatric age (see section 4.4).

Side effects

Gastrointestinal disorders Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation and flatulence during the first days of treatment which normally disappear after a few days. Flatulence, abdominal pain, nausea and vomiting; diarrhea (with excessive dosages). Metabolism and nutrition disorders Electrolyte imbalance due to diarrhea.

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.

Special warnings

Warnings : 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. If constipation is stubborn, see your doctor. The abuse of laxatives (frequent or 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 the most severe cases, dehydration or hypokalaemia may develop, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, 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). Precautions for use : In children under 12 years of age, the medicine can only be used after consulting your doctor. It should be taken into account that the reflex to evacuate may be altered during treatment. 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. After a short period of treatment without appreciable results, consult your doctor. Patients on digitalis therapy should consult their physician before starting therapy. Lactulose is absorbed to a very small extent and has no caloric value. However, LATTULAC 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. For diabetic patients it is necessary to consult the doctor. It is also advisable that elderly people or those in poor health conditions consult their doctor before using the medicine. Patients with hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Expiry and Retention

Bottle of 200 ml: Store at a temperature not exceeding 25 ° C. Once the container has been opened, the product must be used within 12 months and stored at a temperature not exceeding 25 ° C. 15 ml single-dose sachet: Store at a temperature not exceeding 25 ° C.

Active principles

LATTULAC 67.0 g / 100 ml: 100 ml of syrup contain: Active ingredient : lactulose 67.0 g 15 ml of syrup contain: Active ingredient : lactulose 10.0 g For the full list of excipients, see section 6.1.

Excipients

Purified water.