RECREOL Cream Ref.[8321] Active ingredients: Dexpanthenol

Source: European Medicines Agency (EU)  Revision Year: 2017  Publisher: AS GRINDEKS., Krustpils iela 53, RÄ«ga, LV-1057, Latvia, Tel.: +371 67083205, Fax: +371 67083505, E-mail: grindeks@grindeks.lv

Therapeutic indications

Supportive treatment of superficial skin lesion (such as small burns and lacerations, skin abrasions and cracking), skin inflammation (resulting from exposure of radiation therapy, phototherapy or ultraviolet radiation).

Posology and method of administration

Posology

Dexpanthenol should be applied topically one to several times a day.

Paediatric population

Dexpanthenol can be used in pediatric population.

Patients with renal and hepatic impairment

No studies performed in patients with renal and hepatic impairment.

Elderly patients

No studies have been performed in elderly patients (65 years old and over).

Method of administration

For external use.

The usual dose is once or several times a day in a thin layer to the affected skin. The duration of treatment depends on the nature and course of the disease.

Most studies of topical effects of dexpanthenol have been short-term, typically 3-4 weeks or so.

Overdose

No data concerning overdose in humans are available. Even in case of unconventional use of excessive dexpanthenol amounts it has low systemic toxicity and causes no undesirable effects that would be dangerous to patient’s health.

Shelf life

Shelf life: 2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Do not freeze.

Nature and contents of container

30 g or 50 g of cream in aluminium tube, interior lacquered with epoxy phenolic coating, and with sealing compound in the fold. Tube is closed with an aluminium membrane and fitted with a white HDPE screw cap. Aluminium tube in carton box.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

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