Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Acino Pharma (Pty) Ltd, 106 16th Road, Midrand, 1686
Symptomatic treatment of chronic functional constipation in adults and children aged 8 years and above.
An organic disorder should have been ruled out before initiation of treatment.
FORLAX should remain a temporary adjuvant treatment to appropriate lifestyle and dietary management of constipation, with a maximum 3-month treatment course in children. If symptoms persist despite associated dietary measures, an underlying cause should be suspected and treated.
1 to 2 sachets per day, preferably taken as a single dose in the morning. The effects of FORLAX becomes apparent within 24 to 48 hours after its administration.
In children, treatment should not exceed 3 months due to the lack of clinical data for more than 3 months. Treatment-induced restoration of bowel movements will be maintained by lifestyle and dietary measures.
In adults the need for continuing treatment should be reassessed at 3 months.
The daily dose should be adapted according to the clinical effects and may range from one sachet every other day (especially in children) up to 2 sachets a day.
Oral use.
The content of each sachet should be dissolved in a glass about 50 ml of water just before use. The resultant solution will be clear and transparent like water.
Excessive doses may cause diarrhoea, generally stops when the dosage is reduced, or treatment temporarily interrupted.
Diarrhoea, abdominal pain and vomiting have been reported. In cases of severe diarrhoea, weight loss and electrolytes imbalance may occur. Excessive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
36 months.
Store at or below 30°C.
For single use only. Discard unused solution.
Single dose white sachets packed in cardboard cartons of 10 or 20.
The sachet consists of paper/aluminium/polyethylene layers.
No special requirements.
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