MACROGOL 4000 EG 4 g Powder for oral solution in sachet 20Sachet/4g

Macrogol ..............................................................................................................................................................4 g

Per sachet.

Symptomatic treatment of constipation in children from 6 months to 8 years.

An organic cause must be ruled out by the physician before initiating treatment, particularly in children under 2 years. MACROGOL 4000 EG 4 g must remain a temporary treatment for constipation, for a duration not exceeding 3 months, in association with appropriate hygienic and dietary measures. Persistence of disorders at the end of treatment, despite maintenance of hygienic and dietary measures, must lead to investigation and treatment of an underlying condition.

Oral use.

Dosage

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

Between 1 year 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 must be adjusted according to the clinical effects obtained.

The effect of MACROGOL 4000 EG manifests within 24 to 48 hours following its administration.

Paediatric 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 treatment will be maintained by hygienic and dietary measures.

Method of administration

The contents of each sachet must be dissolved in approximately 50 ml of water just before administration. Treatment will be taken in the morning for a dosage of one sachet per day, or divided between morning and evening for a higher dosage. The resulting solution will be clear and transparent like water.

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

• Gastrointestinal perforation or risk of gastrointestinal 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 section Composition.

Special warnings

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

Drug treatment of constipation is only an adjunct to hygienic and dietary treatment such as:

• enrichment of the diet with plant fibres and fluids;

• advice on appropriate physical activity and re-education of defecation.

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 medicinal products containing macrogol see section Adverse effects.

In case of diarrhoea, patients at risk of fluid and electrolyte imbalance (for example elderly patients, patients with hepatic or renal impairment or patients receiving diuretic treatment) should be monitored and electrolyte checks should be considered.

To be used with caution in patients with impaired gag reflex and in patients prone to regurgitation or aspiration.

Cases of inhalation have been reported when large volumes of polyethylene glycol and electrolytes were administered via nasogastric tube. Children with neurological impairment and oromotor disorders are particularly exposed to this risk of inhalation.

In patients with swallowing problems who need to add a thickener to solutions to ensure appropriate intake, interactions should be considered, see section Interactions.

Special precautions for use

MACROGOL 4000 EG does not contain sugar or polyol and may be prescribed to diabetic patients or to patients on a galactose-free diet.

Absorption of other medicinal products may be transiently reduced when used with MACROGOL 4000 EG, in particular medicinal products with a narrow therapeutic index or a short half-life such as digoxin, antiepileptics, coumarins and immunosuppressants, resulting in decreased efficacy.

MACROGOL 4000 EG may potentially interact with starch-based food thickeners. The active substance macrogol neutralises the thickening effect of starch, leading to liquefaction of preparations that must remain thickened for people with swallowing disorders.

Pregnancy

Animal studies have not shown direct or indirect harmful effects on reproduction (see section Preclinical safety). There are limited data (fewer than 300 pregnancies) on the use of MACROGOL 4000 EG in pregnant women.

No adverse effects during pregnancy are 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 into human milk.

No effects on breastfed newborns/infants are expected since systemic exposure to MACROGOL 4000 EG in the breastfeeding woman is negligible. MACROGOL 4000 EG may be used during breastfeeding.

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.

No studies on the effects of MACROGOL 4000 EG on the ability to drive and use machines have been performed.

The adverse reactions listed in the table below were reported during clinical studies involving 147 children aged 6 months to 15 years and during marketing of the product. Generally, these adverse reactions were mild and transient and mainly concerned the gastrointestinal tract.

The frequency of these adverse reactions can be classified as follows:

Very common (> 1/10), frequent (≥ 1/100 to < 1/10), uncommon (≥ 1/ 1000 to < 1/100), rare (≥ 1/10 000 to <1/1000), very rare (< 1/10 000), frequency not known (cannot be estimated from the available data).

* Diarrhoea may cause perianal pain.

In adults, the following adverse effects have been observed during clinical studies and during marketing of the product:

Gastrointestinal disorders:

Uncommon: Urgent defecation, faecal incontinence.

Metabolism and nutrition disorders:

Frequency not known: electrolyte disturbances (hyponatraemia, hypokalaemia) and/or dehydration, particularly in elderly subjects.

Immune system disorders:

Frequency not known: Erythema.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/.

Diarrhoea, abdominal pain and vomiting have been reported. In cases of severe diarrhoea, weight loss and a hydro-electrolytic imbalance may occur. Diarrhoea due to an excessive dose disappears when treatment is temporarily stopped, or after reduction of the dosage.

In cases of significant fluid loss secondary to diarrhoea or vomiting, it may be necessary to correct the hydro-electrolytic disorders.

Pharmacotherapeutic class: OSMOTIC LAXATIVE, ATC code: A06AD15 (A: alimentary tract and metabolism).

High molecular weight macrogols (4000) are long linear polymers to which water molecules are retained by hydrogen bonds. Administered orally, they cause an increase in the volume of intestinal fluids.

The volume of unabsorbed intestinal fluid is responsible for the laxative properties of the solution.

Pharmacokinetic data confirm the absence of intestinal absorption and biotransformation of macrogol 4000 after oral ingestion.

Toxicological studies carried out in different animal species revealed no sign of systemic toxicity or local gastrointestinal toxicity. Macrogol 4000 did not reveal any teratogenic or mutagenic effect.

Studies of potential interactions, carried out in rats with certain NSAIDs, anticoagulants, gastric antisecretory agents and a hypoglycaemic sulfonamide, did not show any interference of MACROGOL 4000 EG with the gastrointestinal absorption of the substances studied.

No study on carcinogenic effects has been conducted.

3 years.

This medicine does not require any particular storage precautions.

No special requirements for disposal.

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree