Medicines
Update of the 03/06/2024
MACROGOL 3350 NORGINE® Children 6,563 g
Forms and presentations
Powder for oral solution (white, fine and light): Sachets-dose, box of 20.Composition
| per sachet | |
| Macrogol 3350
|
6,563 g |
| Sodium bicarbonate
|
89,3 mg |
| Potassium chloride
|
23,3 mg |
| Sodium chloride
|
175,4 mg |
Excipients with known effect: each sachet contains 93,4 mg of sodium and 13,19 mg of potassium.
Indications
Treatment of faecal impaction in children from 2 years of age. Faecal impaction is defined as an accumulation of faeces in the rectum with no evacuation for several days.Dosage and administration
DosageThe dosage is to be adjusted according to the child's age.
The recommended dose is divided into 2 daily intakes as follows:- from 2 to 3 years: 4 to 5 sachets-dose per day (2 sachets-dose in the morning, 2 or 3 sachets-dose in the evening);
- from 4 to 8 years: 6 to 8 sachets-dose per day (3 or 4 sachets-dose morning and evening, in 2 intakes);
- from 9 to 15 years: 8 to 10 sachets-dose per day (4 or 5 sachets-dose morning and evening, in 2 intakes).
Treatment will be continued until satisfactory evacuation of the accumulated faeces is achieved (on average 6 days of treatment), with a maximum duration of 7 days.
Special measures will be put in place to minimise the risk of recurrence.
Method of administration:
Each sachet-dose must be dissolved in half a glass of water. The reconstituted solution may be stored for 24 hours in a closed container in the refrigerator.
Contraindications
- Severe inflammatory bowel diseases (haemorrhagic rectocolitis, Crohn's disease...).
- Toxic megacolon.
- Digestive perforation or risk of digestive perforation.
- Ileus or obstructive syndrome.
- Abdominal painful syndromes of undetermined cause.
- Hypersensitivity to the active substances or to any of the excipients listed in section Composition.
Warnings and precautions
Warnings:
The liquid contained in MACROGOL 3350 NORGINE Children 6,563 g after reconstitution with water does not replace regular fluid intake. Adequate fluid intake must be maintained.
If the patient presents with symptoms suggestive of fluid and electrolyte disturbances (in particular, in cases of dehydration or episodes of heart failure), treatment with MACROGOL 3350 NORGINE Children 6,563 g must be stopped immediately, an electrolyte assessment must be carried out, and any abnormality detected must be treated appropriately.
The absorption of other medicinal products may be temporarily reduced by the shortening of intestinal transit time induced by MACROGOL 3350 NORGINE Children 6,563 g (see Interactions).
In order to minimise the risk of recurrence of faecal impaction, the treatment will include, among other things:
- enrichment of the diet with vegetable fibres and fluids,
- Advice on physical activity and rehabilitation of evacuation.
In patients with swallowing disorders who need to add a thickener to solutions to allow adequate intake, interactions must be taken into account, see Interactions.
Precautions for useThis medicine contains polyethylene glycol.
Very rare allergic-type reactions (rash, urticaria, oedema) have been described with products based on polyethylene glycol. Exceptional cases of anaphylactic shock have been reported. It is therefore not recommended to prescribe this medicine to a patient with a known sensitivity to polyethylene glycol.
MACROGOL 3350 NORGINE Children 6,563 g contains no sugar or polyol; it may be prescribed to diabetic patients or to subjects on a galactose-free diet.
This medicine contains 93,4 mg of sodium per sachet. To be taken into account in patients monitoring their dietary sodium intake.
This medicine contains 13,19 mg of potassium per sachet. To be taken into account in patients with renal impairment or in patients monitoring their dietary potassium intake.
The efficacy and safety of MACROGOL 3350 NORGINE Children 6,563 g in the treatment of faecaloma have not been studied.
Interactions
The absorption of other medicinal products may be temporarily reduced during treatment with MACROGOL 3350 NORGINE Children 6,563 g (see Warnings and Precautions for Use). Isolated cases of reduced efficacy have been reported for treatments taken at the same time as MACROGOL 3350 NORGINE Children 6,563 g (for example: antiepileptics). Therefore, other medicinal products should not be taken orally from one hour before, during, and up to one hour after taking MACROGOL 3350 NORGINE Children 6,563 g.
MACROGOL 3350 NORGINE Children 6,563 g 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.
Fertility, pregnancy and breastfeeding
Although the treatment is intended for children aged 2 to 15 years, the following data are provided for information.
Pregnancy:No effect during pregnancy is expected since systemic exposure to macrogol is negligible. MACROGOL 3350 NORGINE Children 6,563 g may therefore be used during pregnancy.
Breastfeeding:
No effect is expected in the breastfed infant/child since maternal systemic exposure to macrogol is negligible. MACROGOL 3350 NORGINE Children 6,563 g may therefore be used during breastfeeding.
Fertility:There are no data on the effects of MACROGOL 3350 NORGINE Children 6,563 g on fertility in humans. There was no effect on fertility in studies in male and female rats (see Preclinical safety).
Driving and using machines
MACROGOL 3350 NORGINE Children 6,563 g has no influence on the ability to drive or use machines.Adverse effects
Summary of the safety profile:
The undesirable effects below are presented in order of frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10 000, < 1/1000); very rare (< 1/10 000); frequency not known (cannot be estimated from the available data).
Tabulated summary of side effects:
| System organ class | Frequency | Adverse effects |
| Immune system disorders | Very rare | Hypersensitivity reactions such as anaphylactic reactions, dyspnoea and skin reactions (see below) |
| Skin and subcutaneous tissue disorders | Frequency not known | Allergic-type manifestations including angioedema, urticaria, pruritus, rash and erythema |
| Metabolism and nutrition disorders | Frequency not known | Electrolyte disturbances, in particular hyperkalaemia and hypokalaemia |
| Nervous system disorders | Frequency not known | Headache |
| Gastrointestinal disorders | Frequency not known | Abdominal pain*, nausea, vomiting, bloating, diarrhoea** |
| General disorders and administration site conditions | Frequency not known | Peripheral oedema |
Description of certain adverse effects:
* In particular in subjects suffering from functional intestinal disorders.** In case of an excessive dose, diarrhoea occurs, ceasing within 24 to 48 hours after stopping treatment. Treatment may then be resumed at a lower dose.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should 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 Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.
Overdose
This medicine may cause diarrhoea, which resolves on temporary discontinuation of treatment or on dose reduction. Significant digestive losses related to diarrhoea or vomiting may require correction of fluid and electrolyte disturbances.
Pharmacodynamics
Pharmacotherapeutic class: osmotic laxative (ATC code: A06AD65).
MACROGOL 3350 NORGINE Children 6,563 g is an iso-osmotic laxative, a mixture of macrogol 3350 and electrolytes.
High molecular weight macrogols (3350) are long linear polymers to which water molecules are retained by hydrogen bonds. When administered orally, they cause an increase in the volume of intestinal fluids which stimulate colonic motility via neuromuscular receptors located in its wall. The result is improved transport of softened stools.
MACROGOL 3350 NORGINE Children 6,563 g, a mixture of macrogol 3350 and electrolytes, maintains an iso-osmotic fluid flow along the entire length of the intestinal tract. The electrolytes associated with macrogol 3350 are exchanged throughout the intestinal mucosa with plasma electrolytes and excreted in the faecal fluid without net gain or loss of sodium and potassium.
Pharmacokinetics
The electrolyte content of the reconstituted solution is such that intestinal-plasma electrolyte exchanges may be considered negligible.
On the other hand, the pharmacokinetic data confirm the absence of digestive absorption and biotransformation of macrogol 3350 after oral ingestion.
Preclinical safety
Preclinical studies have shown that macrogol 3350 does not have significant systemic toxicity potential based on safety pharmacology, repeated-dose toxicity, genotoxicity and reproductive toxicity studies.
There are no carcinogenesis studies with macrogol 3350.
Storage conditions
- Shelf life
- 3 years.
Store in the outer packaging, protected from moisture.
- After reconstitution:
- The reconstituted solution may be stored for a maximum of 24 hours at a temperature between + 2 °C and + 8 °C (in a refrigerator), in a closed container.
- Any solution not used within 24 hours after reconstitution must be discarded.
Prescription, supply and reimbursement
| Marketing authorisation (AMM) | 3400936409705 (2004, SmPC rev 31.10.2023). |
| Price: | 4,55 euros (20 sachets). |
| Social Security reimbursement at 30%. Collect. | |
Marketing authorisation holder: Norgine Healthcare B.V., Antonio Vivaldistraat 150, 1083HP Amsterdam, The Netherlands.
NORGINE SAS
23, rue François-Jacob. 92500 Rueil-Malmaison
Tel: 01 41 39 94 00
Source: VIDAL · Updated on 11/11/2026. This information does not replace advice from a healthcare professional.