CRISTAL Children's suppositories 10Sachet

Glycerol ......................................................................................................................................................................1,290 g

For a suppository of 2,15 g.

• Symptomatic treatment of low constipation, particularly due to rectal dyschezia.
• Preparation for endoscopic examinations of the rectum.

Children aged 2 to 6 years: 1 suppository 5 at 30 minutes before the time chosen for evacuation.

Children over 6 years: 1 suppository 5 at 30 minutes before the time chosen for evacuation, to be repeated if necessary within the half-hour or hour that follows in case of stubborn constipation.

The treatment of constipation should not, on average, exceed 10 days.

History of hypersensitivity to glycerol or to any of the other constituents mentioned in the section Composition.

Warnings

Prolonged use is not recommended.

In children, the prescription of laxatives by the rectal route should be exceptional: it must take into account the risk of impairing the normal functioning of the evacuation reflex.

Precautions for use

It is preferable not to use this medicine in cases of colonic or rectal diseases.

The data available to date do not suggest the existence of clinically significant interactions.

Prolonged use may give rise to sensations of anal burning and, exceptionally, congestive proctitis.

Reporting of suspected adverse reactions

Reporting suspected adverse effects after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Health professionals should report any suspected adverse effect via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: www.ansm.sante.fr.

No cases of overdose have been reported. However, in case of prolonged use, increased risk of proctitis and diarrhoea.

Pharmacotherapeutic class: OTHER LAXATIVES, ATC code A06AX01

(A: Alimentary tract and metabolism)

Rectal route.

Glycerin suppositories cause rapid evacuation of the rectosigmoid by triggering the defecation reflex. Defecation occurs within 5 to 30 minutes after administration.

Glycerol stimulates peristaltic movements and decreases water reabsorption through its osmotic and hygroscopic properties. It also has a local irritant effect that contributes to the reflex defecation.

3 years.

To be stored at a temperature not exceeding 25°C.

No special requirements.