Xamiol Gel

Contents: Calcipotriol

Indications/UsesTopical treatment of scalp and non-scalp plaque psoriasis vulgaris in adults.

Dosage/Direction for Use

• Xamiol Gel should be applied to affected areas once daily.
• The recommended treatment period is 4 weeks for scalp areas and 8 weeks for “non-scalp” areas.
• If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular medical supervision.
• When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30%.
• If used on the scalp: All the affected scalp areas may be treated with Xamiol Gel. Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4 g corresponds to one teaspoon).
• Special Populations: Renal and hepatic impairment: The safety and efficacy of Xamiol Gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
• Paediatric population: The safety and efficacy of Xamiol Gel in children below 18 years have not been established.
• Currently available data in children aged 12 to 17 years are described in Adverse Reactions and Pharmacodynamics, but no recommendation on a posology can be made.

Method of administration:

• Xamiol Gel should not be applied directly to the face or eyes. In order to achieve optimal effect, it is not recommended to take a shower or bath, or to wash the hair in case of scalp application, immediately after application of Xamiol Gel.
• Xamiol Gel should remain on the skin during the night or during the day.
• When using the bottle: The bottle should be shaken before use and Xamiol Gel applied to the affected area. The hands should be washed after use.