CHIESI FARMACEUTICI SpA
Laevolac Constipation Syrup 180 ml
Laevolac Constipation Syrup 180 ml

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PRODUCT NET WEIGHT
PRODUCT NET WEIGHT
180ml
EAN
EAN
029565013
MINSAN
MINSAN
029565013
Laevolac is an osmotic laxative syrup based on lactulose to combat occasional constipation , promote increased intestinal motility and the consequent formation of hydrated, soft, voluminous and easy-to-expel stools. Laevolac Constipation Syrup is indicated for both adults and children.
ACTIVE INGREDIENTS
Active ingredients contained in Laevolac Constipation Syrup 180 ml - What is the active ingredient in Laevolac Constipation Syrup 180 ml?
LAEVOLAC 66.7 g/100 ml syrup 100 ml of syrup contain; active ingredient: lactulose 66.7 g. For the full list of excipients, see section 6.1.
EXCIPIENTS
Composition of Laevolac Constipation Syrup 180 ml - What does Laevolac Constipation Syrup 180 ml contain?
Syrup: none.
DIRECTIONS
Therapeutic indications Laevolac Constipation Syrup 180 ml - Why is Laevolac Constipation Syrup 180 ml used? What is it for?
Short-term treatment of occasional constipation in adults and children.
CONTRAINDICATIONS - SIDE EFFECTS
Contraindications Laevolac Constipation Syrup 180 ml - When should Laevolac Constipation Syrup 180 ml not be used?
Hypersensitivity to lactulose or to any of the excipients listed in section 6.1; acute or unknown abdominal pain, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration.
DOSAGE
Quantity and method of taking Laevolac Constipation Syrup 180 ml - How to take Laevolac Constipation Syrup 180 ml?
Dosage: the correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is recommended to initially use the minimum doses provided. Do not exceed the maximum recommended daily dose. Adults: the recommended dose is 15 - 30 ml (corresponding to 10 - 20 g of lactulose) 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 lactulose). Adolescents and children >= 10 years: the recommended dose is 15 ml (corresponding to 10 g of lactulose) to be taken in one or two administrations per day. The maximum daily dose is 15 ml. Children 5 - < 10 years: the recommended dose is 10 ml (corresponding to 6.67 g of lactulose) to be taken in one or two administrations per day. The maximum daily dose is 10 ml. Children >1 - < 5 years: the recommended dose is 5 ml (corresponding to 3.33 g of lactulose) 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 lactulose) to be taken in a single administration in the evening. The maximum daily dose is 2.5 ml. Duration of treatment: laxatives should be used as infrequently as possible and for no more than seven days. The prescription for prolonged use should be established after adequate clinical evaluation. Method of administration: in case of single daily administration, take preferably in the evening. If the dose is divided into two administrations per day, take preferably in the morning and in the evening.
CONSERVATION
Storage Laevolac Constipation Syrup 180 ml - How to store Laevolac Constipation Syrup 180 ml?
Syrup: store below 25 degrees C. Shelf life after first opening the bottle: 12 months if stored below 25 degrees C.
WARNINGS
Warnings Laevolac Constipation Syrup 180 ml - About Laevolac Constipation Syrup 180 ml it is important to know that:
Warnings: abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In the most serious cases, dehydration or hypokalaemia may occur, which may cause cardiac or neuromuscular dysfunction, especially in the case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids. Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). If diarrhea occurs, it is advisable to suspend therapy. LAEVOLAC contains galactose and lactose. Patients with rare hereditary problems of galactose intolerance, e.g. galactosemia, or glucose-galactose malabsorption, should not take this medicine. LAEVOLAC contains fructose. The additive effect of co-administration of medicinal products containing fructose (or sorbitol) and dietary fructose (or sorbitol) intake should be considered.
INTERACTIONS
Interactions Laevolac Constipation Syrup 180 ml - Which medicines or foods can modify the effect of Laevolac Constipation Syrup 180 ml?'
Laxatives may reduce the residence time in the intestine, and therefore the absorption, of other drugs administered orally at the same time. Avoid taking laxatives and other drugs at the same time: after taking a drug, leave an interval of at least 2 hours before taking the laxative. Laevolac may lead to increased toxicity of digitalis due to potassium depletion. A synergistic effect with neomycin is possible. Broad-spectrum antibacterial agents, administered orally at the same time as lactulose, may reduce degradation by limiting the possibility of acidification of the intestinal contents and, consequently, therapeutic efficacy.
SIDE EFFECTS
Like all medicines, Laevolac Constipation Syrup 180 ml can cause side effects - What are the side effects of Laevolac Constipation Syrup 180 ml?
The following adverse reactions are listed below, organised according to MedDRA System Organ Class. Frequency is defined as follows: very common (>=1/10), common (>=1/100 to <1/10), uncommon (>=1/1000 to <1/100), rare (>=1/10,000 to <1/1000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data). Gastrointestinal disorders. Very common: abdominal pain, flatulence; common: abdominal distension, urgency of evacuation, diarrhoea, nausea; uncommon: vomiting. General disorders and administration site conditions. Common: decreased appetite. Nervous system disorders. Common: headache. Metabolism and nutrition disorders. Not known: electrolyte depletion. Immune system disorders. Not known: hypersensitivity reactions. Skin and subcutaneous tissue disorders. Not known: rash, pruritus, urticaria. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
PREGNANCY AND BREASTFEEDING
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Laevolac Constipation Syrup 180 ml
There are no adequate and well-controlled studies on the use of the drug during pregnancy or breastfeeding. The use of LAEVOLAC should be considered only if clearly needed and if the expected benefit for the mother outweighs the risk for the child.
