DUPHALAC SCIR 200ML66,7G/100ML

DUPHALAC 66.7 G/100

active ingredients

100 ml of syrup contain: Active Ingredient: lattulose 66,7 g (such as lattulose, liquid 667g/L). For the full list of excipients, see paragraph 6.1.

Excellent

Purified water.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1, or sulphites. Contraindicated in subjects affected by galactosemia. Laxatives are contraindicated in subjects with acute or unknown abdominal pain, nausea or vomiting, obstruction or gastrointestinal stenosis, rectal bleeding of unknown origin, severe dehydration status, digestive tract drilling or digestive tract drilling risk.

Population

Population

Patients	Daily initial dose	Daily maintenance costs
Adults and teenagers	15-45 ml	15-30 ml
Children (7-14 years)	15 ml	10-15 ml
Children (1-6 years)	5-10 ml	5-10 ml
Children under 1 year	from 2.5 to 5 ml	from 2.5 to 5 ml

Elders and patients with kidney and liver failure: There are no particular indications for the dosage, since systemic exposure to lattulose is negligible. Posology must be adjusted according to the individual needs of the patient. After a few days of treatment the initial dose can be replaced with a maintenance dose based on the response to treatment. It may take several days (2-3 days) of treatment before reaching the desired effect Do not exceed the recommended doses. The correct dose is sufficient to produce an easy evacuation of soft feces. It is advisable to initially use the minimum doses provided. When necessary, the dose may be increased, but never exceed the maximum indicated. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods requires the doctor’s prescription after adequate evaluation of the individual case. Method of administration The solution of lattulose can be given diluted or so which together with an adequate amount of water (a abundant glass). A single dose of lattulose must be ingested all together and should not be held in the mouth for a prolonged period of time. Lattulose can be administered in a single daily dose or divided into two administrations per day. In the case of a single daily dose, this should always be taken at the same time, for example at breakfast. Use the dosing cup for administration, referring to the graduation signs shown on it. During treatment with laxatives it is important to drink a sufficient amount of liquids (1.5 - 2 liters per day, equivalent to 6-8 glasses).

Conservation

This medicine does not require any special condition of conservation.

Warnings

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 hypopotassemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of a 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). Precautions of employment 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. 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 (2-3 days) additional dose and/or measures must be reconsidered. DUPHALAC contains lactose, galactose and fructose. Patients suffering from rare hereditary problems of galactose intolerance or fructose, total lactase deficiency or glucose-galactose mal absorption should not take this medicine. The dose normally used in the treatment of constipation is not a problem for diabetic patients. In diabetic patients undergoing high dose treatment, it may be necessary to adjust the posology of antidiabete medicines. You should consider that the evacuation reflex can be altered during treatment. Chronic use of unsuitable doses and abuse of the drug may cause stipsis, diarrhea and electrolytic balance disorders. Lattulose should be given with caution in lactose intolerant patients. This medicine contains sulphites resulting from the production process (see paragraph 4.3). Pediatric population In children under 12 years the medicine can only be used under medical supervision.

Interactions

No interaction studies have been carried out. Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid the contemporary intake of laxatives to other medicines: after taking a medicine let spend a range of at least 2 hours before taking laxative. Wide spectrum antibiotics can reduce the bacterial flora responsible for the degradation of lattulose, with possible decrease in its therapeutic effectiveness. In the case of a contemporary treatment with cardiac glycosides, diuretics or corticosteroid, dehydration or hypopotassium may occur, which may cause heart or neuromuscular dysfunction (see paragraph 4.4). 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).

Effects

Summary of security profile Occasionally: insulated crampiform pains or abdominal colic pains, more frequent in cases of severe constipation and flatulence during the first days of treatment that normally disappears 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. Since the following reactions have been reported through spontaneous reports from an unknown population, it is not possible to estimate the frequency.

SOC MedDRA	Frequency
	Not Note (frequency cannot be defined on the basis of available data)
Gastrointestinal diseases	Flatulence, abdominal pain, nausea, vomiting, diarrhea (predominantly following excessive dosages).
Diagnostic examinations	Electrolytic imbalance due to diarrhea
Immune system disorders	Reactions from hypersensitivity
Pathologies of skin and subcutaneous tissue	Skin rash, itching, hives

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 the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Synonyms Excessive doses can cause abdominal pain, loss of electrolytes and diarrhea. See also in paragraph 4.4 about the abuse of laxatives. Treatment Interruption of treatment or reduction of dose. The resulting losses of liquids and electrolytes must be replaced.

Pregnancy

Effects are not expected during pregnancy since systemic exposure to lattulose is trascurabile.Duphalac can be used during pregnancy.

Food

There are no expected effects on infant/lactant fed with breast milk since systemic exposure to lactulose for nursing women is negligible. Duphalac can be used during lactation.

Fertility

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

Source: Farmadati