Duphalac Lactulose Constipation Syrup 200ml

NAME
DUPHALAC

PHARMACOTHERAPEUTIC CATEGORY
Laxatives.

ACTIVE PRINCIPLES
Lactulose.

EXCIPIENTS
Purified water.

INDICATIONS
Short-term treatment of occasional constipation.

CONTRAINDICATIONS / SECONDARY EFFECT
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; generally contraindicated in pediatric age.

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 an easy evacuation of fecimolli. 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.

STORAGE
This medicine does not require any special storage conditions.

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 severe 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, possible need to progressively increase the dose), chronic constipation and loss of normal intestinal functions (intestinal atony). In children under the age of 12 the medicine can 'be used only after medical consultation. 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) which lasted for 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, the drug also contains traces of galactose, lactose and tagatose. This must be taken into account in the treatment of diabetic patients and in patients who follow low-calorie diets. Lactulose should be administered with caution to lactose intolerant patients.

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 5-ASA drugs).

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 dosages). Investigations: electrolyte imbalance due to diarrhea.

PREGNANCY AND BREASTFEEDING
There are no adequate and well-controlled studies on the use of the medicinal product in pregnancy or breastfeeding. Therefore the medicine should be used only in case of need, under direct medical supervision, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or infant.