Macrogol 4000 EG Enfant Powder Oral Solution 4 g Box of 20 sachets

Macrogol 4000 EG Enfant Poudre solution buvable 4 g Boite de 20 sachets is indicated for the symptomatic treatment of constipation in children aged 6 months to 8 years.

An organic cause should be ruled out by the physician before initiating treatment, particularly in children under 2 years of age. MACROGOL 4000 EG 4 g should be used as a temporary treatment for constipation, for no more than 3 months, in conjunction with appropriate hygienic and dietary measures. Should problems persist at the end of treatment, despite the maintenance of hygienic and dietetic measures, an underlying pathology should be investigated and treated.

Recommendations for use Macrogol 4000 EG Enfant Powdered oral solution 4 g Box of 20 sachets

For oral use.

Dosage

- 6 months to 1 year: 1 sachet (4 g) per day.

- 1 to 4 years: 1 to 2 sachets (4 to 8 g) per day.

- 4 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 4000 EG is felt within 24 to 48 hours of administration.

Pediatric population

In children, in the absence of clinical data beyond 3 months, the duration of treatment should not exceed 3 months. The improvement in intestinal transit induced by treatment should be maintained by hygienic and dietary measures. Administration

The contents of each sachet should be dissolved in approximately 50 ml of water just before administration.

Treatment should be taken in the morning for a dosage of one sachet per day, or divided between morning and evening for a higher dosage.

Precautions for use Macrogol 4000 EG Enfant Poudre solution buvable 4 g Boite de 20 sachets

Contraindications:

- Severe inflammatory bowel disease (ulcerative colitis, Crohn's disease) or toxic megacolon,

- Digestive perforation or risk of digestive perforation,

- Ileus or suspected intestinal obstruction, symptomatic stenosis,

- Abdominal pain syndromes of undetermined cause,

- Hypersensitivity to the active substance or to any of the excipients listed in the Composition section.

Special warnings

Efficacy data in children under 2 years of age have been obtained from a limited number of patients.

Medicinal treatment of constipation is only an adjuvant to hygienic and dietetic treatment, such as :

- enrichment of the diet with vegetable fibers and beverages,

- physical activity and exoneration rehabilitation.

An organic cause must be ruled out before initiating treatment. After three months of treatment, a clinical assessment of constipation should be carried out.

This medicine contains macrogol (polyethylene glycol). Hypersensitivity reactions (anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema) have been reported with macrogol-containing products (see adverse reactions section).

In the event of diarrhoea, patients at risk of hydro-electrolyte imbalance (e.g. the elderly, patients with hepatic or renal insufficiency or those on diuretic therapy) should be monitored and electrolyte levels checked. Cases of inhalation have been reported during nasogastric tube administration of large volumes of polyethylene glycol and electrolytes.

Children with neurological impairment and oromotor disorders are particularly at risk of inhalation.

Pregnancy and lactation :

- Pregnancy

Animal studies have not demonstrated any direct or indirect deleterious effects on reproduction. There are limited data (less than 300 pregnancies) on the use of MACROGOL 4000 EG in pregnant women. No effect during pregnancy is expected, since systemic exposure to MACROGOL 4000 EG is negligible. MACROGOL 4000 EG may be used during pregnancy.

- Breast-feeding

There are no data on the excretion of MACROGOL 4000 EG in breast milk. No effect on breast-fed newborns/infants is expected, as systemic exposure to MACROGOL 4000 EG in nursing mothers is negligible. MACROGOL 4000 EG may be used during lactation.

- Fertility

No fertility studies have been conducted with MACROGOL 4000 EG. However, since macrogol 4000 is not significantly absorbed, no effect on fertility is expected.

Composition Macrogol 4000 EG Enfant Powder for oral solution 4 g Box of 20 sachets

powder for drinkable solution (white to whitish): Macrogol 4000 4 g, qsp 1 sachet.