Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Intrapharm Laboratories Ltd, The Courtyard Barns, Choke Lane, Maidenhead, Berkshire SL6 6PT, United Kingdom
Lactugal is contra-indicated in patients with:
Consultation of a physician is advised in case of:
Lactulose should be administered with care to patients who are intolerant to lactose (see section ‘List of excipients’). The dose normally used in constipation should not pose a problem for diabetics.
The dose used in the treatment of hepatic encephalopathy is usually much higher and may need to be taken into consideration for diabetics.
Chronic use of unadjusted doses and misuse can lead to diarrhoea and disturbance of the electrolyte balance.
This product contains lactose, galactose and small amounts of fructose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use of laxatives in children should be exceptional and under medical supervision.
It should be taken into account that the defaecation reflex could be disturbed during the treatment.
No interaction studies have been performed.
No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible.
Lactulose can be used during pregnancy.
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to lactulose is negligible.
Lactugal can be used during breast feeding.
No effects are to be expected, since systemic exposure to lactulose is negligible.
Lactulose has no or negligible influence on the ability to drive and use machines.
A normal dosage of lactulose may cause mild abdominal pain and flatulence which will disappear spontaneously after a few days. High doses may provoke nausea in some patients and this can be minimised by administration with water, fruit juice or meals. Administration of higher doses than those instructed can result in abdominal pain and diarrhoea, in this instance the dose should be decreased (see also section 4.9).
If high doses (such as those associated with the treatment of portosystemic encephalopathy) are used for extended periods of time, the patient may experience an electrolyte imbalance due to diarrhoea. The dose should be adjusted to obtain two to three formed stools per day.
The following undesirable effects have been experienced with the below indicated frequencies in lactulose-treated patients: 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).
| MedDRA SOC | Frequency category | |||
|---|---|---|---|---|
| Very common | Common | Uncommon | Rare | |
| Gastrointestinal disorders | Diarrhoea | Flatulence, abdominal pain, nausea, vomiting | ||
| Investigations | Electrolyte imbalance due to diarrhoea | |||
The safety profile in children is expected to be similar as in adults.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
There are no known incompatibilities.
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