LAEVOLAC SCIR 180ML 66,7%

LAEVOLAC 66,7 G/100 ML SCIROPTION

active ingredients

LAEVOLAC 66,7 g/100 ml syrup 100 ml syrup contain: active ingredient: lattulose 66,7 g. For the full list of excipients, see paragraph 6.1.

Excellent

No one.

Therapeutic indications

Short-term treatment of occasional constipation in adult and child

Contraindications

• Hypersensitivity to lattulose 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 state.

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 1O - 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. 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

Syrup: Store at a temperature below 25°C. Valid after opening the bottle: 12 months if stored at a temperature below 25°C.

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 lead to 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 the norms and intestinal functions (intestinal atony). If diarrhea appears, the therapy should be suspended. LAEVOLAC contains galactose and lactose. Patients with rare hereditary problems of galactose intolerance, e.g. galactosemia, or glucosegalactose mal absorption, should not take this medicine. LAEVOLAC 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.

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. Laevolac can lead to increased toxicity of potassic 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 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 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 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 LAEVOLAC should be considered only in case of actual need and if the expected benefit for the mother exceeds risk for the child.

Source: Farmadati