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Components:
Lactulose
Method of action:
Detoxifying, Hypoazotemic, Laxative, Ph-Lowering Of Intestinal Contents, Stimulating Peristalsis Of The Intestine
Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor. Last updated on 2019.12.11

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Laevolac is based on data of another medicine with exactly the same composition as the Laevolac of the medicine (Lactulose). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Laevolac directly from the package or from the pharmacist at the pharmacy.
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Laevolac has no or negligible influence on the ability to drive and use machines.

Undesirable effects

The information provided in Undesirable effects of Laevolac is based on data of another medicine with exactly the same composition as the Laevolac of the medicine (Lactulose). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Laevolac directly from the package or from the pharmacist at the pharmacy.
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Very common

> 1/10

Common

>1/100 to < 1/10

Uncommon

>1/1,000 to <1/100

Rare

>1/10,000 to < 1/1,000

Very rare

< 1/10,000

Not known

cannot be estimated from the available data

Flatulence may occur during the first few days of treatment. As a rule it disappears after a couple of days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased.

Gastrointestinal disorders

Very common (> 1/10):

Flatulence, abdominal pain,

Common (> 1/100 < 1/10):

Nausea and vomiting; if dosed too high, diarrhoea (sometimes including electrolyte imbalance).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Laevolac is based on data of another medicine with exactly the same composition as the Laevolac of the medicine (Lactulose). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Laevolac directly from the package or from the pharmacist at the pharmacy.
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Symptoms:

If the dose is too high, the following may occur: diarrhoea and abdominal pain.

Management: cessation of treatment or dose reduction. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Laevolac is based on data of another medicine with exactly the same composition as the Laevolac of the medicine (Lactulose). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Laevolac directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Drugs for constipation. Osmotically acting laxatives.

ATC code: A06A D11

Laevolac is a synthetic disaccharide formed from D-galactose and fructose. Laevolac as a prebiotic substance strengthens the growth of bifidobacteria and lactobacilli, whereas Clostridium and Escherichia coli may be suppressed.

In the colon Laevolac is metabolised by bacterial enzymes to short chain fatty acids mainly lactic and acetic acid as well as methane and hydrogen. This effect leads to a decrease of the pH-value and an increase of the osmotic pressure in the colon. This causes stimulation of peristalsis and an increase of the water content of the faeces.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Laevolac is based on data of another medicine with exactly the same composition as the Laevolac of the medicine (Lactulose). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Laevolac directly from the package or from the pharmacist at the pharmacy.
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Laevolac is practically not absorbed, because in man there is no corresponding disaccharidase available in the upper intestinal tract. Not being absorbed as such, it reaches the colon unchanged. There it is metabolised by the colonic bacterial flora. Metabolism is complete at doses up to 25-50 g or 40-75 ml; at higher dosages, a proportion may be excreted unchanged.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Laevolac is based on data of another medicine with exactly the same composition as the Laevolac of the medicine (Lactulose). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Laevolac directly from the package or from the pharmacist at the pharmacy.
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Drugs for constipation. Osmotically acting laxatives.

Preclinical safety data

The information provided in Preclinical safety data of Laevolac is based on data of another medicine with exactly the same composition as the Laevolac of the medicine (Lactulose). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Laevolac directly from the package or from the pharmacist at the pharmacy.
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Preclinical data based on studies of single and repeated dose toxicity reveal no special hazards for humans. A long-term animal study does not give reference to tumorigenic potential. Laevolac was not teratogenic in mice, rats and rabbits. After oral administration systemic toxicity is not to be expected due to the pharmacological and pharmacokinetic properties of Laevolac.

Incompatibilities

The information provided in Incompatibilities of Laevolac is based on data of another medicine with exactly the same composition as the Laevolac of the medicine (Lactulose). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Laevolac directly from the package or from the pharmacist at the pharmacy.
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Not applicable.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Laevolac is based on data of another medicine with exactly the same composition as the Laevolac of the medicine (Lactulose). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Laevolac directly from the package or from the pharmacist at the pharmacy.
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No special requirements.

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