PRAMOCAINE CHLORHYDRATE BIOGARAN CONSEIL 1 % Gel appl locale T/30g

Pramocaine hydrochloride................................................................................................................................1 g

For 100 g of gel.

Excipient with known effect: propylene glycol (E1520); this medicine contains 6 g of propylene glycol per tube of 30 g.

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

Dosage

1 application morning and evening to the painful area.

Method of administration

Rectal route.

By direct application or using a compress.

• Hypersensitivity to the active substance, to local anaesthetics or to any of the excipients listed in section Composition.
• In case of bronchoscopy, gastroscopy.

Do not bring into contact with the nose or eyes.

Administration of this product does not replace specific treatment of other anal diseases.

Treatment should be of short duration. If symptoms do not quickly subside, a proctological examination should be performed and the treatment should be reviewed.

This medicine contains 6 g of propylene glycol per tube of 30 g. Propylene glycol may cause skin irritation.

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

Pregnancy

None of the local anaesthetics is known to be teratogenic.

However, local anaesthetics administered epidurally may cause adverse effects in the mother (cardiovascular, neurological) and in the foetus (acidosis).

Consequently, given the risk of substantial absorption via the rectal route and the analogy with local anaesthetics, administration of this medicinal product should be avoided during pregnancy.

Breast-feeding

In the absence of studies, avoid during breastfeeding.

Possibility of allergy, irritation.

Reporting of suspected adverse effects.

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 reactions 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/.

Minor clinical effects reported in patients who ingested 50 mg to 250 mg of pramocaine gel orally. For side effects such as nausea, vomiting, diarrhoea, drowsiness, treatment is symptomatic.

Pharmacotherapeutic class: LOCAL ANAESTHETIC, ATC code: D04AB07

3 years.

This medicine does not require any particular storage precautions.

No special requirements.