Abbott

Duphalac 66,7g / 100ml Syrup

Occasional Constipation Treatment; 200ml bottle

Active principles

100 ml of syrup contain: Active ingredient: 66.7 g lactulose. For the full list of excipients, see section 6.1.

Excipients

Purified water.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

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

Dosage

Use the measuring cup for administration, referring to the tick marks on it. The lactulose solution can be administered diluted or as it is together with an adequate quantity of water (a large glass). A diet rich in liquids favors the effect of the medicine. Take preferably in the evening. Adults The recommended dose is 15 ml per day. Children The recommended dose is on average 10 ml per day and 5 ml per day for infants. Do not exceed the recommended dose. 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.

Warnings and Precautions

Warnings 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 serious cases, the onset of dehydration or hypokalaemia is possible, which can cause 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. It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine. Lactulose is absorbed to a very small extent and has no caloric value. In addition to lactulose, DUPHALAC also contains traces of galactose, lactose and tagatose. This must be taken into account in the treatment of diabetic patients and in patients on low calorie diets. Lactulose should be administered with caution in lactose intolerant patients. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Interactions

No interaction studies have been performed. Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives at the same time as other drugs: after taking a medicine, leave an interval of at least 2 hours before taking the laxative. Broad-spectrum antibiotics can reduce the bacterial flora responsible for the degradation of lactulose, with a possible decrease in its therapeutic efficacy. The lowering of pH in the intestine, characteristic of the mechanism of action of lactulose, can cause the inactivation of drugs that have a release profile dependent on the pH of the intestine (for example drugs 5 – ASA).

Side effects

Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation and flatulence during the first days of treatment which normally disappears after a few days. Gastrointestinal disorders Flatulence, abdominal pain, nausea and vomiting; diarrhea (with excessive doses) Investigations 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.