SEDORRHOIDE CRISE HEMORROIDAIRE Suppos Plq/8

Dodeclonium bromide............................................................................................................................1.3 mg

Esculoside sesquihydrate...........................................................................................................................6.0 mg

Enoxolone....................................................................................................................................................23.0 mg

Benzocaine.................................................................................................................................................50.0 mg

For one suppository.

Symptomatic treatment of painful and pruritic anal manifestations, particularly in haemorrhoidal crisis.

Dosage

2 to 3 suppositories per day.

Treatment must be of short duration (maximum 7 days).

Method of administration

Rectal route.

Allergy to benzocaine.

Warning

It is necessary to seek medical advice before use in children.

The presence of benzocaine may cause methaemoglobinaemia.

Athletes should be made aware that this specialty contains an active substance that may induce a positive result in tests carried out during anti-doping controls.

Precautions for use

Administration of this product does not replace specific treatment of the anal disease.

If the symptoms do not subside rapidly, treatment must be discontinued and a proctological examination is essential.

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

To be avoided during pregnancy and breastfeeding due to a lack of usable clinical and experimental data.

Possible hypersensitivity reactions to one of the components.

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: www.ansm.sante.fr.

No cases of overdose have been reported to date; however, excessive use could lead to an increase in adverse effects.

ATC code: C05AAX03

Benzocaine: local anaesthetic.

Enoxolone: anti-inflammatory.

Dodeclonium bromide: antiseptic.

Escinoside: vasoprotective agent.

Benzocaine can be absorbed through the skin and mucous membranes and is hydrolysed by esterases in the plasma and in the liver. The metabolites and unchanged benzocaine are excreted in the urine.

In the absence of data on the use of enoxolone, systemic passage cannot be ruled out.

No animal studies have been conducted on the product "SEDORRHOÏDE CRISE HEMORROÏDAIRE, suppository"

2 years.

Store at a temperature not exceeding 25°C.

No special requirements for disposal.