LATTULOS TE OS 200ML670MG/ML

LATTULOS TEVA 670 MG/ML

active ingredients

100 ml contain: - active ingredient: 67 g of lattulose. For the full list of excipients, see paragraph 6.1.

Excellent

Purified water.

Therapeutic indications

Short-term treatment of occasional constipation, if a diet rich in fibres (crusca, vegetables and fruit) integrated by a considerable amount of liquids and an adequate exercise is not enough.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. - Contraindicated in subjects with galactosemia.- Laxatives are contraindicated in subjects with acute or unknown abdominal pain, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration.- Acute inflammatory bowel disease (ulcerative colitis, Crohn's disease), subocclusive syndromes, perforation or risk of perforation of the digestive tract, painful abdominal syndromes of undetermined cause.

Population

Population The correct dose is the minimum sufficient to produce an 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. Adults and teenagers over 14 years: usual daily dose: 10 - 20 ml a day in two administrations. This posology can be doubled or halved according to the individual response. Children and adolescents aged 6 to 14 years (see section 4.4): 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 (see section 4.4): average daily dose: 2.5 - 5 ml per day (corresponding to 1⁄2 teaspoon- 1 teaspoon respectively; a teaspoon corresponds to 5ml). Subsequently the dosage can be reduced by evaluating the individual cases according to the clinical response. Elderly and patients with renal and hepatic insufficiency: There are no specific dosage recommendations, since systemic exposure to lactulose is negligible. Method of administration For oral use.The lactulose solution must be swallowed with an adequate amount of water (a large glass).The doses given here are only indicative and must be adapted to the patient's needs.The package contains a 5 - 30 ml graduated measuring cup 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 must be taken in one go without keeping it in the mouth for a long time.Since lactulose only works after reaching the colon, 1 - 2 days may pass before its effects appear.

Conservation

Store at a temperature below 25°C.

Warnings

Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. Therefore, the condition of hydration of the patient must be carefully evaluated. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). Before starting the treatment, an eventual abdominal painful symptomatology of unknown cause must be evaluated in order to exclude undiagnosed perforations or obstructions or related undiagnosed predisposable pathologies/conditions. In case of insufficient therapeutic effect after several days, it is recommended to consult a doctor. Lattulose Teva 670 mg/ml oral solution may contain traces of sugar resulting from the synthesis process (no 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 suffering from rare hereditary problems of galactose intolerance, e.g. galactosemia, or fructose, from total lactase deficiency or glucose-galactose mal absorption, should not take this medicine. The additive effect of co-administration of medicinal products containing fructose (or sorbitol) and the intake of fructose (or sorbitol) with the diet must be considered. Lattulose should be given with caution to lactose intolerant patients. The dose normally used should not be a problem for diabetics. In diabetic patients undergoing treatment with high doses of lattulose, it may be necessary to adjust the dosage of antidiabetic medicines. 15 ml of Lattulose Teva 670 mg/ml oral solution contain 42,7 KJ (10,2 kcal) = 0.21 carbs. Patients with gastro-cardiac syndrome (Roemheld syndrome) must take lattulose only after consulting a doctor. If after taking lattulose, such patients complain about symptoms such as meteorism or swelling, you should reduce the dose or stop treatment. Chronic use of unsuitable doses and drug abuse can cause diarrhea and electrolytic balance disorders. During laxative therapy it is recommended to drink a sufficient amount of liquids (1.5 - 2 l/day, equal to 6 - 8 glasses). Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. Consult your doctor when the need for laxative comes from a sudden change of previous intestinal habits (frequency and evacuation characteristics) that lasts for more than two weeks or when the use of laxative fails to produce effects. You should also 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 may alter the electrolyte balance. . Pediatric population: In children under 12 years of age, the medicine may be used only after consulting a doctor.Lactulose should be administered with caution to infants and young children with hereditary autosomal recessive fructose intolerance.The defecation reflex may be affected during treatment with lactulose.

Interactions

Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid ingesting laxatives and other drugs at the same time: after taking a medicine let spend a range of at least 2 hours before taking laxative. Lattulose can increase the loss of potassium induced by other medicines (such as diuretics, corticosteroids and amphotericin B) and lead to dehydration and hypopotassiemia that can determine heart or neuromuscular dysfunctions (see paragraph 4.4). Concurrent use of certain cardiac glycosides can increase the action of glycosides due to potassium deficiency. The lowering of the pH in the intestine, characteristic of the mechanism of action of lattulose, can cause the inactivation of drugs that have a release profile dependent on the pH of the intestine (e.g. 5-ASA drugs). Wide spectrum antibiotics can reduce the bacterial flora responsible for the degradation of lattulose, with possible decrease in its therapeutic effectiveness.

Effects

Within each frequency group are reported undesirable effects in decreasing order of gravity.

Very common	≥ 1/10
Municipalities	≥ 1/100,
Not common	≥ 1/1.000,
Rare	≥ 1/10.000,
Very rare
Notable	Frequency cannot be defined on the basis of available data

Organo-system class	Frequency
Immune system disorders	Notable: hypersensitivity reactions
Gastrointestinal diseases	Very common: mild abdominal pain*, flatulence*.
	Municipalities: diarrhea* with electrolytic disorders, vomiting*, nausea*.
	Notable: insulated cramping pain or abdominal colic pain, more frequent in cases of severe constipation**.
Disorders of metabolism and nutrition	Rare: hypernatriemia.
	Notable: electrolytic imbalance due to diarrhea.
Pathologies of skin and subcutaneous tissue	Notable: rash, itching, hives

*mainly due to excessive dosages. ** occasionally appear during the first days of treatment and normally disappear after a few days. When taking a dose higher than prescribed, abdominal pain and diarrhea may appear. In this case the dosage must be reduced. If excessive doses are taken for long periods, the patient may manifest electrolytic breakdown due to diarrhea. Pediatric population The safety profile in children is expected to be similar to that of adults. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Excessive doses can cause abdominal pain, diarrhea, nausea, vomiting and electrolytic loss; the consequent losses of liquids and electrolytes must be replaced. In this case the dose must be reduced or the taking of lattulose must be suspended. See also the paragraph “Special Warnings and Precautions of Use” about the abuse of laxatives.

There are no adequate and well-controlled studies on the use of pregnant or nursing medicine. Therefore the medicinal product must be used only in case of need, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or for the infant. Animal studies showed no harmful, direct or indirect effects on pregnancy, embryo/fetal development, birth or postnatal development (see paragraph 5.3).

Fertility

There are no expected effects since systemic exposure to lattulose is negligible.

Source: Farmadati