Dovobet® 50 microgram/g + 0.5 mg/g ointment.

Off-white to yellow ointment.

Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy.

Dovobet^® should be applied to the affected area once daily. The recommended treatment period is 4 weeks. After this period repeated treatment with Dovobet^® can be initiated under medical supervision.

The maximum daily dose should not exceed 15 g, the maximum weekly dose should not exceed 100 g, and the treated area should not be more than 30% of the body surface.

Dovobet^® is not recommended for the use in children and adolescents below the age of 18 years.

Known hypersensitivity to the active substances or to any of the excipients.

Due to the content of calcipotriol Dovobet^® is contra-indicated in patients with known disorders of calcium metabolism.

Due to the content of corticosteroid Dovobet® is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers, wounds, perianal and genital pruritus.

Dovobet^® is contraindicated in guttate, erythrodermic, exfoliative and pustular psoriasis.

Dovobet^® is contraindicated in patients with severe renal insufficiency or severe hepatic disorders.

The patient must be instructed in correct use of the product to avoid application and accidental transfer to the scalp, face, mouth and eyes. Hands must be washed after each application.

Treatment of more than 30% of the body surface should be avoided.

The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are fulfilled. Due to the content of calcipotriol hypercalcaemia may occur if the maximum weekly dose (100 g) is exceeded. Serum calcium is quickly normalised, however, when treatment is discontinued.

Dovobet^® contains a strong potent group III-steroid and concurrent treatment with other steroids must be avoided. Adverse effects found in connection with systemic corticosteroid treatment such as adrenocortical suppression or impact on the metabolic control of diabetes mellitus may occur also during topical corticosteroid treatment due to systemic absorption.

Application on large areas of damaged skin and under occlusive dressings or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids. Skin of the face and genitals are very sensitive to corticosteroids. Long-term treatment of these parts of the body should be avoided. These areas should only be treated with the weaker corticosteroids. When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, when infection worsens, treatment with corticosteroids should be stopped.

When treating psoriasis with topical corticosteroids there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.

With long-term use there is an increased risk of local and systemic corticosteroid undesirable effects. The treatment should be discontinued in case of undesirable effects related to long-term use of corticosteroid.

There may be a risk of rebound when discontinuing a long-term treatment with corticosteroids.

There is no experience for the use of this product on the scalp. There is no experience with concurrent use of other anti-psoriatic products administered locally or systemically or with phototherapy.

During Dovobet®treatment physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UV radiation only if the physician and patient consider that the potential benefits outweigh the potential risks.

None known.

Very common >1/10

Common >1/100 and <1/10

Uncommon >1/1,000 and <1/100

Rare >1/10,000 and <1/1000

Very rare <1/10,000

The trial programme for Dovobet® ointment has so far included more than 2,500 patients and has shown that approximately 10% of patients can be expected to experience a non-serious undesirable effect.

Based on data from clinical trials and postmarket use the common undesirable effects are pruritus, rash and burning sensation of skin. Uncommon undesirable effects are skin pain or irritation, dermatitis, erythema, exacerbation of psoriasis, folliculitis and application site pigmentation changes. Pustular psoriasis is a rare undesirable effect.

The undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

Skin and subcutaneous tissue disorders

Common: Pruritus

Common: Rash

Common: Burning sensation of skin

Uncommon: Skin pain or irritation

Uncommon: Dermatitis

Uncommon: Erythema

Uncommon: Exacerbation of psoriasis

Uncommon: Folliculitis

Uncommon: Application site pigmentation changes

Rare: Pustular psoriasis

Undesirable effects observed for calcipotriol and betamethasone, respectively:

Calcipotriol

Undesirable effects include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial oedema.

Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria.

Betamethasone (as dipropionate)

This product contains a potent corticosteroid.

Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia. When treating psoriasis there may be a risk of generalised pustular psoriasis.

Systemic effects due to topical use of corticosteroids are rare in adults, however they can be severe. Adrenocortical suppression, cataract, infections and increase of intra-ocular pressure can occur, especially after long term treatment. Systemic effects occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long term treatment.

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