LATTULOS EG SCIR 180ML 66,7%

LATTULOSO EG 66,7 G/100 ML SCIROPULATION

active ingredients

100 ml of syrup contain: Active ingredient: lattulose 66,7 g. Excipient with known effects: benzoate sodium (E211) 118 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Benzoate sodium (E211).

Therapeutic indications

Treatment of short duration of occasional constipation in adult and child.

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1, • acute or unknown abdominal pain, • nausea or vomiting, • obstruction or intestinal stenosis, • rectal bleeding of unknown origin, • severe dehydration.

Population

The correct dose is sufficient to produce an easy evacuation of soft feces. It is recommended to initially use the minimum doses provided. Do not exceed the recommended maximum daily dose. Adults The recommended dose is 15-30 ml (corresponding to 10-20 g of lattulose) to be taken in one or two administrations per day. When necessary the dose can be increased. The maximum daily dose is 45 ml (corresponding to 30 g of lattulose). Teenagers and children ≥ 10 years The recommended dose is 15 ml (corresponding to 10 g of lattulose) to be taken in one or two administrations per day. The maximum daily dose is 15 ml. Children 5- The recommended dose is 10 ml (corresponding to 6.67 g of lattulose) to be taken in one or two administrations per day. The maximum daily dose is 10 ml. Children- The recommended dose is 5 ml (corresponding to 3,33 g of lattulose) to be taken in one or two administrations per day. The maximum daily dose is 5 ml. Children 1 month - 1 year The recommended dose is 2.5 ml (corresponding to 1,66 g of lattulose) to be taken in one administration at night. The maximum daily dose is 2.5 ml. Duration of treatment Laxatives must be used as frequently as possible and for no more than seven days. The prescription for prolonged use should be established after proper clinical evaluation. Method of administration In case of single daily administration, preferably take in the evening. If the dose is divided into two administrations a day, preferably take in the morning and in the evening.

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. 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 (possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). If diarrhea appears, the therapy should be suspended. This medicine contains galactose and lactose. Patients suffering from rare hereditary problems of galactose intolerance, e.g. galactosemia, or from glucose-galactose mal absorption, should not take this medicine. This medicine contains fructose. 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. This medicine contains 1,18 mg of benzoate sodium per ml. This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially ‘without sodium’.

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 EG can lead to increased toxicity of potassium depletion digitals. It is possible a synergistic effect with neomycin. Wide spectrum antibacterial agents, administered orally at the same time as lattulose, can reduce their degradation by limiting the possibility of acidification of the intestinal content and consequently therapeutic effectiveness.

Effects

Below are the side effects organized according to the classification for MedDRA Systems and Organs. The frequency is so defined: very common (≥ 1/10), common (from ≥ 1/100 to Classification for Systems and Organs Frequency Undesirable effects Immune system disorders Notable Reactions from hypersensitivity Pathologies of skin and subcutaneous tissue Notable Skin rash, itching, hives Gastrointestinal diseases Very common Abdominal pain, flatulence Town Abdomen, urgency of evacuation, diarrhea, nausea Not common Vote General pathologies and conditions for administration Town Reduced appetite Diseases of the nervous system Town Cefa Disorders of metabolism and nutrition Notable Electrolytic depletion 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

Excessive doses can cause abdominal pain and diarrhea; in this case suspend the treatment and the consequent losses of liquids and electrolytes must be reintegrated.

There are no adequate and well-controlled studies on the use of the medicinal product during pregnancy or breastfeeding. The use of Lattulose EG must be taken into account only in case of actual need and if the expected benefit for the mother exceeds the risk for the child.

Source: Farmadati