MADECASSOL 1 % Cream Tube/10g

Hydrocotyle* (reconstituted dry extract titrated at 40 % asiaticoside and 60 % madecassic and asiatic acids) ………………………………………………………………………………………..1,000 g

For 100 g of cream.

*Centella asiatica

Excipients with known effect: terpene derivatives, propylene glycol.

Adjunctive local treatment of skin ulcerations.

Dosage

Apply on average 1 to 2 times a day.

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition
• Superinfected lesions,
• Children with a history of febrile or non-febrile convulsions (due to the presence of terpene derivatives as excipients).

• Form not suitable for ophthalmic use.
• Avoid use of this medicinal product on lesions that tend to macerate.

Special warnings

This specialty contains terpene derivatives, as excipients, which may lower the epileptogenic threshold. At excessive doses, risk of neurological adverse events of the convulsion type in infants and children.

Observe the dosages and instructions for use, in particular:

• Do not apply to an extensive body surface,
• Do not apply to the breasts during breastfeeding.

Precautions for use

In case of a history of epilepsy, take into account the presence of terpene derivatives as excipients.

During breastfeeding, it is preferable not to use this medicine due to:

• Due to the absence of kinetic data on the passage of terpene derivatives into milk,
• Due to their potential neurological toxicity in infants.

Possibility of skin sensitisation reactions.

Due to the presence of terpene derivatives, as excipients, and in case of non-compliance with the recommended doses  :

• Risk of convulsions in infants and children,
• Possibility of agitation and confusion in elderly subjects.

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 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:www.signalement-sante.gouv.fr.

Pharmacotherapeutic class: SKIN PROTECTANT

(D. Dermatology)

Not specified.

Not specified.

3 years.

To be stored at a temperature not exceeding 30°C.