LATTULOSIO MY OS 200ML 66.7%

LATTULOS MYLAN GENERICS 66,7 G/100 ML SCIROP

active ingredients

100 mL of syrup contain: - active ingredient: lattulose 66,7 g. Excipients with known effects: - 1,18 mg of benzoate sodium per ml. - For the full list of excipients, see paragraph 6.1.

Excellent

• Sodium benzoate 0.118 g • Aroma citrus 0.7 g • Purified water q.b. 100 ml

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

• Hypersensitivity to lattulose, to any of the excipients listed in paragraph 6.1, or to residues of the production process (see paragraph 4.4). • Acute or unknown abdominal pain, • Nausea or vomiting, • Obstruction or intestinal stenosis, • Rectal bleeding of unknown origin, • Severe dehydration status • Perforation of the digestive tract or risk of perforation of the digestive tract.

Population

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 >1 - 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. Special popularity Elders and patients with kidney and liver failure: There are no particular indications for the dosage, since systemic exposure to lattulose is negligible. 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 Oral use. 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. 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.

Conservation

This medicine does not require any special condition of conservation.

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 lead to heart or neuromuscular dysfunctions, especially in the elderly, debilitated subjects and in the case of a contemporary treatment with cardiac, diuretic or corticosteroid glucosides. 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). If diarrhea appears, the therapy should be suspended. You should consider that the evacuation reflex can be altered during treatment. In case of insufficient therapeutic effect after 2-3 days the additional dose and/or measures must be reconsidered. Lattulose Mylan Generics contains benzoate sodium This medicine contains 1,18 mg of benzoate sodium for 1 ml. The increase in bilirubinemia following its detachment from albumin can increase the neonatal hetero that can evolve in kernittero (deposits of bilirubin not conjugated in the brain tissue). Lactulose Mylan Generics contains sodium This medicine contains less than 1 mmol (23 mg) of sodium per dose of 15 ml, i.e. essentially ‘without sodium’. Lattulose Mylan Generics contains traces of galactose and lactose. Patients with rare hereditary problems of galactose intolerance, e.g. galactosemia, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine. Lattulose Mylan Generics contains traces of 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. Lattulose Mylan Generics contains traces of sulphites Rarely it can cause serious reactions of hypersensitivity and bronchospasm. Lattulose Mylan Generics contains propylene glycol (in citrus aroma) This medicine contains 2,45 mg of propylene glycol for 1 mL. Co-administration with any dihydrogenase alcohol substrate as ethanol can induce severe adverse effects in infants. Lattulose Mylan Generics contains ethanol (in citrus aroma) This medicine contains 2,39 mg of ethanol (alcohol) for each ml syrup equivalent to 35,9 mg of ethanol in a dose of 15 ml. The quantity in 1 ml of this medicine is equivalent to 0.06 ml of beer or 0.024 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

Interactions

Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid the contemporary administration of laxatives and other drugs: the administration of other medicinal products must precede that of laxative at least 2 hours. Lattulose Mylan Generics can lead to increased toxicity of potassium depletion digital. It is also possible to have 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

Summary of the safety profile The crampiform pains and abdominal colics are more frequent in cases of severe constipation; flatulence that appears mainly in the first days of treatment tends to disappear after a few days. Below are the side effects organized according to the classification for MedDRA Systems and Organs. The frequency is thus defined: very common (≥1/10), common (from ≥1/100 to Classification for Systems and Organs Frequency Undesirable effect 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 Immune system disorders Notable Reactions from hypersensitivity Pathologies of skin and subcutaneous tissue Notable 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: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Excessive doses can cause abdominal pain and diarrhea, in which case suspend 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 Lattulosio Mylan Generics should be taken into account only in case of actual need and if the expected benefit for the mother exceeds risk for the child, see also paragraph 4.4.

Source: Farmadati