Laevolac contains lactulose, a laxative also classified for its role in lowering the pH of intestinal contents and supporting the clearance of nitrogenous compounds from the gut. The brand is registered in 12 countries, with a footprint that stretches across parts of Europe, the Mediterranean, East and Southeast Asia, and Oceania — including Italy, the Netherlands, Thailand, Israel, and New Zealand.
Lactulose-containing products are used for two quite different therapeutic purposes that share a single underlying mechanism. The first is the management of constipation and certain inflammatory conditions of the intestine such as enteritis, where the medication acts as an osmotic laxative and stimulates intestinal peristalsis. The second is the management of hepatic encephalopathy, where the same pH-lowering and hypoazotemic effects in the gut are used to reduce the absorption of ammonia in patients with significant liver dysfunction. The structured indication block further down this page lists each registered use in the markets where Laevolac is sold.
Because the indications span both routine gastrointestinal use and a serious neurological complication of liver disease, the appropriate product, route, and prescribing context can differ significantly from one country to another. Travellers and expatriates may find Laevolac on shelves in some of the listed markets, while in others lactulose is sold only under a different brand name or as a generic syrup or oral solution. A local pharmacist can confirm what is available in any given country.
Other osmotic laxatives and lactulose-equivalent preparations are marketed worldwide under various brand names, particularly in countries where Laevolac itself is not registered. Patients using lactulose for hepatic encephalopathy in particular should treat any change of brand or formulation as a clinical matter, and any decision to start, continue, or substitute the medication should involve the prescribing healthcare provider.
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.
Not applicable.
| 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.
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.
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.
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.
Laevolac has no or negligible influence on the ability to drive and use machines.
No special requirements.
Laevolac is used in the management of constipation and certain inflammatory intestinal conditions such as enteritis, and also in the management of hepatic encephalopathy in patients with liver dysfunction. The same active ingredient supports both indications through its laxative and pH-lowering effects in the gut. The structured indication section below this introduction details each registered use in the markets where Laevolac is sold.
Laevolac contains lactulose, classified as a laxative with additional pH-lowering and hypoazotemic effects in the intestine, and an action that stimulates intestinal peristalsis. Lactulose is widely available internationally — the same molecule circulates under several brand names and as generic oral solutions and syrups, depending on the country and its regulatory framework for gastrointestinal medications.
Laevolac is registered in 12 countries, including Italy, the Netherlands, Thailand, Israel, New Zealand, Portugal, Turkey, and China. The footprint is geographically scattered rather than concentrated in one region. If your country is not on this list, a local pharmacist can usually confirm whether a lactulose-containing product is available locally under a different brand name or as a generic preparation.
Lactulose is sold under multiple brand names worldwide, and is also widely available as generic oral solutions and syrups. Other osmotic laxatives exist in the broader class as well, although they are not freely interchangeable — particularly in the context of hepatic encephalopathy, where lactulose has a specific role. To identify a regional equivalent, search the active ingredient on Pill2Trip or ask a pharmacist in your country.
Yes. While lactulose is available without prescription in some countries for short-term use in constipation, its role in hepatic encephalopathy is a clinical matter that requires medical supervision. Regulatory status, available formulations, and prescribing pathways differ between countries, which is particularly relevant for travellers and expatriates. A healthcare provider familiar with the patient's situation is the right person to guide use, substitution, or any change of product.
