Xamiol Adverse Reactions

The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies including post-authorisation safety studies and spontaneous reporting. The most frequently reported adverse reaction during treatment is pruritus.
Adverse reactions are listed by MedDRA SOC and the individual adverse reactions are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from available data). (See Table 5.)

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The following adverse reactions are considered to be related to the pharmacological classes of calcipotriol and betamethasone, respectively: Calcipotriol: Adverse drug 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 Precautions.)
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 with topical corticosteroids, 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.
Paediatric population: No clinically relevant differences between the safety profiles in adult and adolescent populations have been observed. A total of 216 adolescent subjects were treated in three open label clinical trials. See Pharmacology: Pharmacodynamics under Actions for further details regarding the trials.