Symptomatic treatment of constipation in children aged 6 months to 8 years.
An organic cause should be ruled out by the doctor before initiating treatment, especially in children under 2 years of age. MACROGOL 4000 BIOGARAN 4 g should remain a temporary treatment for constipation, lasting no more than 3 months, in combination with appropriate hygiene and dietetic measures. The persistence of the disorders at the end of the treatment, despite the maintenance of the hygienic and dietary measures, will have to seek and treat an underlying pathology
Dosage
From 6 months to 1 year: 1 sachet (4 g) per day.
Between 1 and 4 years: 1 to 2 sachets (4 to 8 g) per day.
From 4 years to 8 years: 2 to 4 sachets (8 to 16 g) per day.
The daily dose should be adjusted according to the clinical effects obtained.
The effect of macrogol is seen within 24 to 48 hours after administration.
Pediatric population
In children, given the absence of clinical data beyond 3 months, the duration of treatment should not exceed 3 months. The improvement in intestinal transit induced by the treatment will be maintained by the hygiene and dietetic measures.
Administration mode
The contents of each sachet should be dissolved in approximately 50 ml of water just before administration. The treatment will be taken in the morning in the case of a dosage of one sachet per day or divided between the morning and evening in the case of a higher dosage.
Caution
Efficacy data in children under 2 years of age have been obtained from a limited number of patients.
The drug treatment of constipation is only an adjunct to the hygieno-dietetic treatment such as:
- enrichment of the diet with vegetable fibers and drinks,
- adapted physical activity and rehabilitation of the exemption.
An organic cause should be ruled out before initiating treatment.
After three months of treatment, a clinical assessment of the constipation should be performed.
This medicine contains macrogol (polyethylene glycol). Hypersensitivity reactions (anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema) have been reported with medicinal products containing macrogol see section 4.8.
This medicine contains sulfur dioxide (E220) and in rare cases may cause severe allergic reactions and bronchospasm.
This medicinal product contains 0.72 mg of sorbitol (E420) per sachet.
This medicine contains less than 1 mmol (23 mg) sodium per sachet, that is to say essentially "sodium-free".
In the event of diarrhea, patients at risk of fluid and electrolyte imbalance (eg elderly, patient with hepatic or renal failure or under diuretic therapy) should be monitored and electrolyte monitoring should be considered.
Inhalation cases have been reported during administration by nasogastric tube of large volumes of polyethylene glycol and electrolytes. Children with neurological impairment with oromotor disorders are particularly exposed to this risk of inhalation.
Special precautions for use
MACROGOL 4000 BIOGARAN 4 g does not contain a significant amount of sugar or polyol, it can be prescribed to diabetic patients or to patients on a galactose-free diet.
Composition
Each sachet contains:
Macrogol 4000 ................................................ .................................................. .................. 4,000 g
For a bag of 4.07g.
Excipients with known effect :
Sorbitol (E420) .............................................. .................................................. .... 0.72 mg per sachet
Sulfur dioxide (E220) ............................................. ............................. 9.6 x 10-4 mg per sachet
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