Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: Fresenius Kabi Austria GmbH, Hafnerstraße 36, 8055 Graz, Austria
Symptomatic Treatment of Constipation.
Laevolac Plum 10 g/15 ml oral solution is indicated in adults and in children and adolescents aged 7 to 18 years.
Laevolac Plum may be administered diluted or undiluted. The dose should be titrated according to the clinical response. Lactulose may be given as a single daily dose or in two to three divided doses.
A single dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time.
The posology should be adjusted according to the individual needs of the patient. The starting dose can be adjusted after adequate treatment effect individually (maintenance dose). Several days (2-3 days) of treatment may be needed in some patients before adequate treatment effect occurs. In case of single daily dose, this should be taken at the same time of the day, e.g. during breakfast. During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 l/day, equal to 6-8 glasses).
If diarrhoea occurs, the dosing regimen should be reduced.
| Starting dose | Maintenance dose | |||
|---|---|---|---|---|
| Adults | 15-45 ml daily | 1-3 sachets, corresponding to 10-30 g lactulose | 15-30 ml daily | 1-2 sachets, corresponding to 10-20 g lactulose |
In elderly patients (≥65 years) and patients with renal or hepatic insufficiency no special dosage recommendations exist.
| Starting dose | Maintenance dose | |||
|---|---|---|---|---|
| Adolescents over 14 years | 15-45 ml daily | 1-3 sachets, corresponding to 10-30 g lactulose | 15-30 ml daily | 1-2 sachets, corresponding to 10-20 g lactulose |
| Children and Adolescents (7-14 years) | 15 ml daily | 1 sachet, corresponding to 10 g lactulose | 15 ml daily | 1 sachet, corresponding to 10 g lactulose |
For a precise dosing for babies, toddlers and children up to 6 years, lactulose is available in bottles.
Oral use.
The duration of treatment has to be adopted according to the symptoms.
If the dose is too high, the following may occur:
Symptom: Diarrhoea and abdominal pain.
Treatment: Cessation of treatment or dose reduction. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
3 years.
Partially used sachets have to be discarded.
Do not store above 25°C.
Sachets containing 15 ml made of polyester/aluminium/polyethylene layer membrane: 10 and 20 sachets.
Not all pack sizes may be marketed.
No special requirements.
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