Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
Topical treatment of scalp psoriasis in adults. Topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris in adults.
Dovobet 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% (see section 4.4).
All the affected scalp areas may be treated with Dovobet 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).
The safety and efficacy of Dovobet gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.
The safety and efficacy of Dovobet gel in children below 18 years have not been established. Currently available data in children aged 12 to 17 years are described in section 4.8 and 5.1, but no recommendation on a posology can be made.
Dovobet 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 Dovobet gel. Dovobet gel should remain on the skin during the night or during the day.
Prior to the first use of the Applicator the cartridge and the applicator head must be assembled.
After priming, each full actuation delivers 0.05 g of Dovobet gel.
Dovobet gel is applied to the affected area by using the Applicator.
The hands should be washed after use if Dovobet gel gets on the fingers.
Dovobet gel Applicator is accompanied by the package leaflet with detailed instructions for use.
The bottle should be shaken before use and Dovobet gel applied to the affected area.
The hands should be washed after use.
Use above the recommended dose may cause elevated serum calcium which subsides when treatment is discontinued. The symptoms of hypercalcemia include polyuria, constipation, muscle weakness, confusion and coma.
Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions, resulting in secondary adrenal insufficiency which is usually reversible. In such cases, symptomatic treatment is indicated.
In case of chronic toxicity, the corticosteroid treatment must be discontinued gradually.
It has been reported that due to misuse one patient with extensive erythrodermic psoriasis treated with 240 g of Dovobet ointment weekly (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g daily) developed Cushing’s syndrome during treatment and then pustular psoriasis after abruptly stopping treatment.
3 years.
Bottle: After first opening: 6 months.
Applicator: After first opening: 6 months.
Do not refrigerate.
Bottle: Keep in the outer carton in order to protect from light.
Bottles: High-density polyethylene bottles with low-density polyethylene nozzle and a high-density polyethylene screw cap. The bottles are placed in cartons.
Pack sizes: 15 g, 30 g, 60 g, 80 g, 2 × 60 g, 2 × 80 g and 3 × 60 g.
Applicator: The Applicator consists of a polypropylene cartridge (with a high-density polyethylene plunger and screw cap), an applicator head (polypropylene outer casing, polyoxymethylene lever and thermoplastic elastomer nozzle) and polypropylene cover. The cartridge, applicator head and cover are assembled prior to use. The cartridge(s), applicator head(s) and cover(s) are placed in a carton.
Pack sizes: 60 g (equivalent to 68 ml) and 2 × 60 g (equivalent to 2 × 68 ml)
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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