|The clinical trial programme for Xamiol gel has so far included more than 4,400 patients of whom more than 1,900 were treated with Xamiol gel. Approximately 8 % of patients treated with Xamiol gel experienced a non-serious adverse reaction. These reactions are usually mild and cover mainly various skin reactions with pruritus being the most common.Based on data from clinical trials and postmarket use the following adverse reactions are listed for Xamiol gel. The adverse reactions are listed by MedDRA System Organ Class, and the individual adverse reactions are listed starting with the most frequently reported. Within each frequency grouping, the adverse reactions are listed in order of decreasing seriousness. The following terminologies have been used in order to classify the frequencies of adverse reactions:|
||≥1/100 to <1/10
||≥1/1,000 to <1/100
||≥1/10,000 to <1/1,000
|Not known (cannot be estimated from the available data)
The following adverse reactions are considered to be related to the pharmacological classes of calcipotriol and betamethasone, respectively:
|Skin and subcutaneous tissue disorders|
||Exacerbation of psoriasis
Burning sensation of skin
Skin pain or irritation
Calcipotriol Adverse reactions 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 (see section 4.4).
Betamethasone (as dipropionate) 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 reactions due to topical use of corticosteroids are rare in adults, however they can be severe. Adrenocortical suppression, cataract, infections, impact on the metabolic control of diabetes mellitus and increase of intra-ocular pressure can occur, especially after long-term treatment. Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long-term treatment (see section 4.4).