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.
