ETRIVEX Shampoo Ref.[49925] Active ingredients: Clobetasol propionate

Clobetasol propionate belongs to the most potent class of topical corticosteroids (Group IV) and prolonged use may result in serious undesirable effects (see section 4.4). If treatment with a local corticosteroid is clinically justified beyond 4 weeks, a less potent corticosteroid preparation should be considered. Repeated but short courses of clobetasol propionate may be used to control exacerbations (see details below).

Posology

Etrivex 500 micrograms/g shampoo should be applied directly on dry scalp once daily taking care to well cover and massage the lesions. An amount equivalent to around a half tablespoon (around 7.5 ml) per application is sufficient to cover all the scalp.

The total dosage should not exceed 50 g per week.

Method of administration

For cutaneous use on the scalp only.

After application, Etrivex 500 micrograms/g shampoo should be kept in place without covering for 15 minutes. Hands should be washed carefully after application. After 15 minutes, the product must be thoroughly rinsed with water and/or hair can be washed by using an additional amount of regular shampoo if needed to facilitate washing. Then, hair can be dried as usual.

The treatment duration should be limited to a maximum of 4 weeks. As soon as clinical results are observed, applications should be spaced out or replaced, if needed, by an alternative treatment. If no improvement is seen within four weeks, reassessment of the diagnosis may be necessary.

Repeated courses of Etrivex 500 micrograms/g shampoo may be used to control exacerbations provided the patient is under regular medical supervision.

Special population

Elderly

The safety and efficacy of Etrivex 500 micrograms/g shampoo in geriatric patients aged 65 years and above have not been established.

Renal impairment

Etrivex 500 micrograms/g shampoo has not been studied in patients with renal impairment.

Hepatic impairment

Patients with severe liver dysfunction should be treated with special caution and closely monitored for side-effects.

Paediatric population

The experience in the paediatric population is limited. Etrivex 500 micrograms/g shampoo is not recommended for use in children and adolescents below 18 years of age. It is contraindicated in children under 2 years of age (see sections 4.3 and 4.4).

Acute overdose is very unlikely to occur, however, in the case of chronic overdose or misuse, the features of hypercortisolism may appear and in this situation, treatment should be discontinued gradually. However, because of the risk of acute adrenal suppression, this should be done under medical supervision.

3 years.

Shelf life after first opening: 6 months.

Store in the original container in order to protect from light.

The product is packaged in high density polyethylene (HDPE) bottles of 60 ml or 125 ml fitted with polypropylene snap closures. The HDPE bottle of 30 ml is fitted with polypropylene screw closure.

Bottles contain 30 ml, 60 ml or 125 ml of shampoo.

1 g of shampoo corresponds to 1 millilitre of shampoo.

Not all pack sizes may be marketed.

No special requirements.