MACROGOL BIOGARAN 10 g Powder for oral solution in sachet 20Sachet

Macrogol 4000........................................................................................................................10,00 g per sachet.

Symptomatic treatment of constipation in adults and children from 8 years of age.

An organic cause should be ruled out before initiating treatment. MACROGOL BIOGARAN must remain a temporary treatment for constipation, for a duration not exceeding 3 months in children, in association with appropriate lifestyle and dietary measures. Persistence of symptoms despite the associated lifestyle and dietary measures should prompt investigation and treatment of an underlying pathology.

Oral use.

Dosage

The dose is 1 to 2 sachets per day (10 to 20 g), preferably to be taken in a single dose, in the morning.

The daily dose must be adjusted according to the clinical effects obtained and may range from 1 sachet every other day (particularly in children) to 2 sachets per day. The effect of MACROGOL BIOGARAN appears within 24 to 48 hours after 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 dietary and lifestyle measures.

Method of administration

The contents of each sachet must be dissolved in approximately 50 ml of water just before being administered in the morning. The resulting solution will be clear and transparent like water.

• Hypersensitivity to the active substance;

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

• Gastrointestinal perforation or risk of gastrointestinal perforation;

• Ileus or suspicion of intestinal obstruction, symptomatic stenosis;

• Abdominal pain syndromes of undetermined cause.

Special warnings

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

• Enrichment of the diet with plant fibres and fluids;

• Advice on appropriate physical activity and rehabilitation of defecation.

An organic cause must 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 medicines 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 BIOGARAN does not contain a significant quantity of sugar or polyol; it may be prescribed to diabetic patients or to patients on a galactose-free diet.

The absorption of other medicines may be transiently reduced when using MACROGOL BIOGARAN, in particular medicines with a narrow therapeutic index or a short half-life such as digoxin, antiepileptics, coumarins and immunosuppressants, resulting in a decrease in efficacy.

MACROGOL BIOGARAN 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 BIOGARAN in pregnant women.

No effect during pregnancy is expected since systemic exposure to MACROGOL BIOGARAN is negligible. MACROGOL BIOGARAN may be used during pregnancy.

Breast-feeding

There is no data on the excretion of MACROGOL BIOGARAN into human milk.

No effect on breastfed newborns/infants is expected since systemic exposure of the breastfeeding woman to MACROGOL BIOGARAN is negligible. MACROGOL BIOGARAN may be used during breastfeeding.

Fertility

No fertility study has been performed with MACROGOL BIOGARAN. However, since macrogol 4000 is not significantly absorbed, no effect on fertility is expected.

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

The frequency of undesirable effects may be classified as follows:

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

In adults :

The adverse effects listed in the table below were reported during clinical studies (including approximately 600 patients) and during marketing of the product. In general, these adverse effects were mild and transient, and mainly concerned the digestive system:

In children :

The adverse effects listed in the table below were reported during clinical studies including 147 children aged 6 months to 15 years and during marketing of the product. As in adults, these adverse effects were generally mild and transient and mainly concerned the digestive system:

*Diarrhoea may cause perianal pain.

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 reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - 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 dose reduction.

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 digestive 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 BIOGARAN with the gastrointestinal absorption of the substances studied.

No carcinogenicity study has been conducted.

3 years.

This medicine does not require any particular storage precautions.

No special requirements.