Dovonex Ointment Ref.[2602] Active ingredients: Calcipotriol

Dovonex Ointment should not be used on the face. Patients should be advised to wash their hands after applying the ointment and to avoid inadvertent transfer to other body areas, especially the face.

The risk of hypercalcaemia is minimal when the dosage recommendations are followed. Hypercalcaemia may occur if the maximum weekly dose is exceeded. Care should be exercised in patients with other types of psoriasis, since hypercalcaemia has been reported in patients with generalised pustular or erythrodermic exfoliative psoriasis. However, serum calcium is quickly normalised when treatment is discontinued.

During treatment with Dovonex Ointment 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 (see section 5.3).

There is no experience of concomitant therapy with other antipsoriatic products applied to the same skin area at the same time.

Pregnancy

The safety of the use of calcipotriol during human pregnancy has not been established, and studies in animals have shown reproductive toxicity when calcipotriol was administered orally. Calcipotriol should not be used during pregnancy unless clearly necessary.

Lactation

It is not known whether calcipotriol is excreted in breast milk. A decision on whether to abstain from breast-feeding or to abstain from therapy with Dovonex should be made taking into account the benefit of breast-feeding to the newborn/infant and the benefit of Dovonex therapy to the woman.

Calcipotriol has no or negligible influence on the ability to drive and to use machines.

Very common >1/10
Common >1/100 and <1/10
Uncommon >1/1,000 and <1/100
Rare >1/10,000 and <1/1,000
Very rare <1/10,000

Approximately 25% of the patients treated with Dovonex Ointment could experience an adverse reaction. These reactions are usually mild.

Immune system disorders

Very rare: allergic reactions (including angioedema).

Metabolism and nutrition disorders

Very rare: hypercalcaemia, hypercalciuria, especially if the total recommended dose is exceeded (see section 4.2).

Skin and subcutaneous tissue disorders

Very common: skin irritation

Common: rash, burning sensation, stinging sensation, dry skin, pruritus, erythema, contact dermatitis including facial and perioral.

Uncommon: psoriasis aggravated, eczema.

Unknown frequency: transient changes in skin pigmentation, transient photosensitivity, urticaria, angioedema, periorbital or face oedema.

Various types of rash reactions such as scaly, erythematous, maculo-papular, pustular, bullous have been reported.

Should not be mixed with other medicinal products.