RECTOPANBILINE Adult suppositories 1blister/10

Bile fluid extract titrated to 12,86 % as cholic acid..........................................................................0,700 g

Bile fluid extract:

Ox bile extract titrated to 45 % (w/w) as cholic acid..............................................................0,200 g

Purified water..................................................................................................................................................0,500 g

For 1 suppository.

Excipient with known effect: glycerol.

• Symptomatic treatment of lower constipation, in particular due to rectal dyschezia.

• Preparation for endoscopic examinations of the rectum.

Adults:

1 adult suppository 5 to 30 minutes before the time chosen for bowel evacuation.

Maximum dosage of 2 suppositories per day.

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition.

• Child under 12 years, unless prescribed by a doctor.

Special warnings

Prolonged use is not recommended.

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

• enrichment of the diet with vegetable fibers and fluids,

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

Precautions for use

It is preferable not to use this medicine in case of colonic or rectal pathology.

This medicine contains glycerol and may have a mild laxative effect.

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

Given the available data, use in pregnant or breast-feeding women is possible occasionally.

A prolonged effect may give rise to anal burning sensations and, exceptionally, congestive proctitis.

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

No cases of overdose have been reported.

Pharmacotherapeutic class: Laxative for rectal use. ATC code: A06AB

It causes rapid evacuation of the rectosigmoid by triggering the defecation reflex. This occurs within 5 to 30 minutes after administration.

Data published in the literature reveal no unexpected risk for humans, based on studies of each active ingredient for repeated-dose toxicity, genotoxicity, and carcinogenic potential.

No conventional reproductive and developmental toxicity study has been conducted.

Local tolerance studies of RECTOPANBILINE ADULTES suppositories in rabbits at doses of 7 to 10 times the therapeutic dose indicate that the product is well tolerated, without signs of inflammation of the rectal mucosa.

No long-term carcinogenicity study of RECTOPANBILINE ADULTES, suppository for rectal use, has been performed. Certain secondary bile acids administered orally may increase the incidence of tumours directly caused by carcinogens in rodents. The relevance of these results is not clear, given that bile acids are produced endogenously and play an essential role in human metabolism. The limited exposure resulting from use of the product in accordance with the directions for use shows a negligible risk for humans.

3 years.

Store below 25°C.

No special requirements.