Macrogol 4000 Viatris powder for drinkable solution10 gr 20 sachets is intended for the symptomatic treatment of constipation in adults and children aged 8 and over.
Macrogol 4000 is an osmotic laxative, acting by increasing the water content of stools. This softens the stool, facilitating intestinal transit in cases of constipation.
An organic cause should be ruled out before initiating treatment. Macrogol 4000 Viatris should remain a temporary treatment for constipation, lasting no longer than 3 months in children, in conjunction with appropriate dietary and hygienic measures. Any persistence of constipation despite appropriate dietary and hygienic measures should be investigated and treated.
Directions for use Macrogol 4000 Viatris powder for drinkable solution10 gr 20 sachets
Dosage
Dosage is 1 to 2 sachets per day (10 to 20 g), preferably taken as a single dose in the morning.
The daily dose should be adapted according to the clinical effects obtained, and may range from 1 sachet every other day (particularly in children) to 2 sachets a day. The effect of Macrogol 4000 Viatris 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.
Method of administration
Oral administration.
The contents of each sachet should be dissolved in a glass of water just before administration.
Precautions for use Macrogol 4000 Viatris powder for drinkable solution10 gr 20 sachets
Contraindications:
- Hypersensitivity to the active substance or to any of the excipients listed under Excipients.
- Severe inflammatory bowel disease (ulcerative colitis, Crohn's disease) or toxic megacolon,
- Digestive perforation or risk of digestive perforation,
- Illeus or suspected intestinal obstruction, symptomatic stenosis,
- Abdominal pain syndromes of undetermined cause,
Special warnings
Medicinal treatment of constipation is only an adjuvant to hygienic dietary therapy, such as :
- enrichment of the diet with vegetable fibers and beverages,
- advice on appropriate physical activity and exoneration rehabilitation.
An organic cause should be ruled out before initiating treatment.
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.
This medicine contains sulfur dioxide (E220) and may, in rare cases, cause severe hypersensitivity reactions and bronchospasm.
This medicine contains sorbitol. Its use is not recommended in patients with fructose intolerance (a rare hereditary disease).
This medicine contains 2 mg sorbitol per sachet.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, i.e. it is essentially "sodium-free".
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 control should be considered. Use with caution in patients with impaired gag reflex, and in patients prone to regurgitation or false routes.
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.
Patients with glucose-galactose malabsorption syndrome (a rare hereditary disease) should not take this medicine.
In patients with swallowing problems, who require a thickening agent to be added to solutions to promote adequate intake, interactions should be considered, see Interactions with other medicinal products and other forms of interaction.Special precautions for use
As MACROGOL 4000 VIATRIS does not contain a significant amount of sugar or polyol, it may be prescribed to diabetic patients or patients on a galactose-free diet.
Pregnancy and lactation :
Pregnancy
Animal studies have shown no direct or indirect deleterious effects on reproduction (see Preclinical safety data). There are limited data (less than 300 pregnancies) on the use of MACROGOL 4000 VIATRIS in pregnant women.
No effects during pregnancy are expected, as systemic exposure to MACROGOL 4000 VIATRIS is negligible. MACROGOL 4000 VIATRIS may be used during pregnancy.
Lactation
There are no data on the excretion of macrogol 4000 in breast milk.
No effect on breast-fed newborns/infants is expected, as systemic exposure of breast-feeding women to macrogol 4000 is negligible. MACROGOL 4000 VIATRIS may be used during breast-feeding.
Fertility
No fertility studies have been conducted with MACROGOL 4000 VIATRIS. However, since macrogol 4000 is not significantly absorbed, no effect on fertility is expected.
Effects on ability to drive and use machines :
No studies on the effects of MACROGOL 4000 VIATRIS on the ability to drive vehicles and use machines have been carried out.
Composition Macrogol 4000 Viatris powder for drinkable solution10 gr 20 sachets
Powder for drinking solution (white to whitish, with orange and grapefruit odor and taste): Macrogol 4000 10 g.
Excipients : Saccharin sodium (E 954), Orange flavoring, Grapefruit flavoring, (Orange essential oil, Grapefruit essential oil, Citral, Acetic aldehyde, Linalool, Ethyl butyrate, Alpha terpineol, Octanal, Cis-3 Hexenol, Butylhydroxyanisole (E 320), Maltodextrin, Gum arabic (E 414), Sorbitol (E 420), Sulfur dioxide (E 220)), qsp 1 sachet.
Notable excipient(s): sulfur dioxide, sorbitol.
Macrogol 4000 Viatris powder for drinkable solution10 gr 20 sachets is intended for the symptomatic treatment of constipation in adults and children aged 8 and over.
Macrogol 4000 is an osmotic laxative, acting by increasing the water content of stools. This softens the stool, facilitating intestinal transit in cases of constipation.
An organic cause should be ruled out before initiating treatment. Macrogol 4000 Viatris should remain a temporary treatment for constipation, lasting no longer than 3 months in children, in conjunction with appropriate dietary and hygienic measures. Any persistence of constipation despite appropriate dietary and hygienic measures should be investigated and treated.
Directions for use Macrogol 4000 Viatris powder for drinkable solution10 gr 20 sachets
Dosage
Dosage is 1 to 2 sachets per day (10 to 20 g), preferably taken as a single dose in the morning.
The daily dose should be adapted according to the clinical effects obtained, and can range from 1 sachet every other day (particularly in children) to 2 sachets a day. The effect of Macrogol 4000 Viatris 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.
Method of administration
Oral administration.
The contents of each sachet should be dissolved in a glass of water just before administration.
Precautions for use Macrogol 4000 Viatris powder for drinkable solution10 gr 20 sachets
Contraindications:
- Hypersensitivity to the active substance or to any of the excipients listed under Excipients.
- Severe inflammatory bowel disease (ulcerative colitis, Crohn's disease) or toxic megacolon,
- Digestive perforation or risk of digestive perforation,
- Illeus or suspected intestinal obstruction, symptomatic stenosis,
- Abdominal pain syndromes of undetermined cause,
Special warnings
Medicinal treatment of constipation is only an adjuvant to hygienic dietary therapy, such as :
- enrichment of the diet with vegetable fibers and beverages,
- advice on appropriate physical activity and exoneration rehabilitation.
An organic cause should be ruled out before initiating treatment.
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.
This medicine contains sulfur dioxide (E220) and may, in rare cases, cause severe hypersensitivity reactions and bronchospasm.
This medicine contains sorbitol. Its use is not recommended in patients with fructose intolerance (a rare hereditary disease).
This medicine contains 2 mg sorbitol per sachet.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, i.e. it is essentially "sodium-free".
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 control should be considered. Use with caution in patients with impaired gag reflex, and in patients prone to regurgitation or false routes.
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.
Patients with glucose-galactose malabsorption syndrome (a rare hereditary disease) should not take this medicine.
In patients with swallowing problems, who require a thickening agent to be added to solutions to promote adequate intake, interactions should be considered, see Interactions with other medicinal products and other forms of interaction.Special precautions for use
As MACROGOL 4000 VIATRIS does not contain a significant amount of sugar or polyol, it may be prescribed to diabetic patients or patients on a galactose-free diet.
Pregnancy and lactation :
Pregnancy
Animal studies have shown no direct or indirect deleterious effects on reproduction (see Preclinical safety data). There are limited data (less than 300 pregnancies) on the use of MACROGOL 4000 VIATRIS in pregnant women.
No effect during pregnancy is expected, as systemic exposure to MACROGOL 4000 VIATRIS is negligible. MACROGOL 4000 VIATRIS may be used during pregnancy.
Lactation
There are no data on the excretion of macrogol 4000 in breast milk.
No effect on breast-fed newborns/infants is expected, since systemic exposure of breast-feeding women to macrogol 4000 is negligible. MACROGOL 4000 VIATRIS may be used during breast-feeding.
Fertility
No fertility studies have been conducted with MACROGOL 4000 VIATRIS. However, since macrogol 4000 is not significantly absorbed, no effect on fertility is expected.
Effects on ability to drive and use machines :
No studies on the effects of MACROGOL 4000 VIATRIS on the ability to drive vehicles and use machines have been carried out.
Composition Macrogol 4000 Viatris powder for drinkable solution10 gr 20 sachets
Powder for drinking solution (white to whitish, with orange and grapefruit odor and taste): Macrogol 4000 10 g.
Excipients : Saccharin sodium (E 954), Orange flavoring, Grapefruit flavoring, (Orange essential oil, Grapefruit essential oil, Citral, Acetic aldehyde, Linalool, Ethyl butyrate, Alpha terpineol, Octanal, Cis-3 Hexenol, Butylhydroxyanisole (E 320), Maltodextrin, Gum arabic (E 414), Sorbitol (E 420), Sulfur dioxide (E 220)), qsp 1 sachet.
Notable excipient(s): sulfur dioxide, sorbitol.
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