LAEVOLAC Oral solution Ref.[49844] Active ingredients: Lactulose

In case of insufficient therapeutic effect after 3 days consultation of a physician is advised.

From the route of synthesis Laevolac Plum may contain small amounts of sugars (not more than 67 mg/ml lactose, 100 mg/ml galactose, 67 mg/ml epilactose, 27 mg/ml tagatose and 7 mg/ml fructose).

Lactulose should be administered with care to patients who are intolerant to lactose.

The dose normally used should not pose a problem for diabetics. 15 ml of lactulose contain 42.7 KJ (10.2 kcals) = 0.21 BU.

Patients with rare hereditary problems of galactose or fructose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.

For patients with gastro-cardiac syndrome (Roemheld syndrome) lactulose should only be taken after consultation of a physician. If symptoms like meteorism or bloating occur in such patients after lactulose intake, the dose should be reduced or the treatment should be discontinued.

Chronic use of unadjusted doses and misuse can lead to diarrhoea and disturbance of the electrolyte balance.

For elderly patients or patients that are in bad general condition and who take lactulose for a more than 6 months period, periodic control of electrolytes is indicated.

During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 l/day, equal to 6-8 glasses).

Paediatric Population

Use of laxatives in children and adolescents should be exceptional and under medical supervision.

Lactulose should be administrated with caution in infants and small children with autosomal recessive hereditary fructose intolerance.

The defecation reflex may be altered during the treatment with lactulose.

Lactulose may increase the loss of potassium induced by other drugs (e.g. thiazides, steroids and amphothericin B). Concomitant use of cardiac glycosides can increase the effect of the glycosides through potassium deficiency. With increasing dosage a decrease of pH-value in the colon is found. Therefore drugs which are released in the colon pH-dependently (e.g. 5-ASA) can be inactivated.

Pregnancy

There are no or limited amount of data from the use of lactulose in pregnant women. There are no relevant epidemiological data available. No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible.

Animal studies are insufficient with respect to reproductive toxicity, but do not indicate a teratogenic potential (see section 5.3).

Laevolac Plum can be used during pregnancy, if considered necessary.

Breast-feeding

No effects during pregnancy are anticipated, since systemic exposure to lactulose is negligible. Laevolac Plum can be used during breastfeeding, if considered necessary.

Fertility

For Laevolac Plum no clinical data on the effects on fertility are available

Laevolac Plum has no or negligible influence on the ability to drive and use machines.

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.

Because the following reactions were reported spontaneously from a population of uncertain size, the frequency is not known, i.e. the frequency cannot be estimated on the basis of the available data.

Gastrointestinal disorders

Flatulence, nausea and vomiting; if dosed too high, abdominal pain and diarrhoea

Investigations

Electrolyte imbalance due to diarrhoea

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.

Not applicable.