Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Casen Recordati, S.L., AutovÃa de Logroño, Km 13,300, 50180 UTEBO, Zaragoza (Spain)
Symptomatic treatment of constipation in adults and children aged 8 years and above.
An organic disorder should have been ruled out before initiation of treatment PEGLAX 10 g should remain a temporary adjuvant treatment to appropriate lifestyle and dietary management of constipation, with a maximum 3-months treatment course in children. If symptoms persist despite associated dietary measures, an underlying cause should be suspected and treated.
Oral use
1 to 2 sachets per day, preferably taken as a single dose in the morning. It is recommended to drink 125 ml of liquids (e.g. water) after each dose.
The effect of Peglax becomes apparent within 24 to 48 hours after its administration.
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.
Treatment should be stopped gradually and resumed if constipation recurs.
1 to 2 sachets per day, preferably taken as a single dose in the morning. It is recommended to drink 125 ml of liquids (e.g. water) after each dose.
In children, treatment should not exceed 3 months due to a lack of clinical data for treatment lasting longer than 3 months. Treatment-induced restoration of bowel movements will be maintained by lifestyle and dietary measures.
Each sachet should be dissolved in a glass of water (125 ml approximately) just before use. The resultant solution will be clear and transparent like water.
Overdose could lead to diarrhoea, abdominal pain and vomiting which disappears when treatment is temporarily interrupted or the dosage is reduced.
Excessive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.
Cases of aspiration have been reported when extensive volumes of macrogol (polyethylene glycol) and electrolytes were administered with nasogastric tube. Neurologically impaired children who have oromotor dysfunction are particularly at risk of aspiration.
3 years.
This medicinal product does not require any special storage conditions.
Sachet made of heat-sealable polyethylene, aluminium and polyester film (polyester/aluminium/polyethylene complex).
Single dose sachets presented in pack sizes of 10, 20, 30, 50, 60 and 100 sachets.
Not all pack sizes may be marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
