Lactulose Teva Oral Solution 670mg/ml Bottle 200ml

NAME
LACTULOSE TEVA 670 MG / ML ORAL SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Laxatives with osmotic action.

ACTIVE PRINCIPLES
Lactulose.

EXCIPIENTS
Purified water.

INDICATIONS
Short-term treatment of occasional constipation, when a diet rich in fiber (bran, vegetables and fruit) supplemented by a large amount of fluids and adequate physical exercise is not sufficient.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the listed 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; acute inflammatory bowel disease (ulcerative colitis, Crohn's disease), sub-occlusive syndromes, perforation or risk of perforation of the digestive system, abdominal pain syndromes of undetermined cause.

DOSAGE
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. Adults and adolescents over 14 years: usual daily dose: 10 - 20 ml per day in two administrations. This dosage can be doubled or halved according to the individual response. >> Children and adolescents from 6 to 14 years. Usual daily dose: 5 - 15 ml per day even in a single administration depending on the age and severity of the case. >> Infants and children up to 6 years. Average daily dose: 2.5 - 5 ml per day (corresponding respectively to half a teaspoon - 1 teaspoon; one teaspoon corresponds to 5ml). Subsequently, the dosage can be reduced by evaluating individual cases on the basis of clinical response. Method of administration: for oral use. The lactulose solution must be swallowed together with an adequate quantity of water (a large glass). The doses given here are indicative only and should be adapted to the patient's needs. The package contains a graduated measuring cup of 5 - 30 ml to adjust the doses. 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. A diet rich in liquids favors the effect of the medicine. A single dose of lactulose should be taken at one time without keeping it in the mouth for a long time. Since lactulose works only after it reaches the colon, it can take 1 - 2 days for its effects to occur.

STORAGE
Store below 25 degrees C.

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 gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). The drug may contain traces of sugars deriving from the synthesis process (not more than 67 mg / ml of lactose, 100 mg / ml of galactose, 67 mg / ml of epilactose, 27 mg / ml of tagatose and 7 mg / ml of fructose). Patients with rare hereditary problems of galactose or fructose intolerance, lactase deficiency or glucose-galactose absorption should not take this medicine. Lactulose should be administered with caution to lactose intolerant patients. The dose normally used should not pose a problem for diabetics. 15 ml of the drug contains 42.7 KJ (10.2 kcal) = 0.21 units of carbohydrates. Patients with gastro-cardiac syndrome (Roemheld's syndrome) should only take lactulose after consulting a doctor. If, after taking lactulose, such patients complain of symptoms such as meteorism or swelling, the dose should be reduced or treatment discontinued. Chronic use of inadequate doses and drug abuse can cause diarrhea and electrolyte balance disturbances. During the therapy with laxatives it is recommended to drink a sufficient quantity of liquids (1,5 - 2l / day, equal to 6 - 8 glasses). 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) that last for more than two weeks or when the use of the laxative fails to produce effects. elderly or in poor health conditions consult your doctor before using the medicine. Inappropriate long-term use of lactulose in elderly patients or in patients who are in poor general condition can alter the electrolyte balance. Pediatric population: in children under 12 years the medicine can 'be used only after consulting your doctor. Lactulose should be administered with caution to infants and young children with hereditary autosomal recessive fructose intolerance. The defecation reflex may change during lactulose treatment.

INTERACTIONS
Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative. Lactulose may increase the potassium loss induced by other drugs (such as thiazides, steroids and amphotericin B). The concomitant use of some cardiac glycosides can increase the action of glycosides due to potassium deficiency. By increasing the dosage, the pH level in the colon decreases with possible inactivation of pH-dependent release drugs in the colon (eg 5-ASA).

SIDE EFFECTS
Within each frequency group undesirable effects are reported in decreasing order of severity. Gastrointestinal disorders. Very common: mild abdominal pain, flatulence; common: diarrhea with electrolyte disturbances, vomiting, nausea; not known: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation. Metabolism and nutrition disorders. Rare: hypernatremia. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

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 ', after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant. Animal studies have shown no direct or indirect harmful effects on pregnancy, embryonal / fetal development, parturition or postnatal development.