CALCIPOTRIOL/BETAMETHASONE

Posology Calcipotriol/Betamethasone 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. 4). If used on the scalp All the affected scalp areas may be treated with Calcipotriol/Betamethasone 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).

Special populations Renal and hepatic impairment The safety and efficacy of Calcipotriol/Betamethasone gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Paediatric population The safety and efficacy of Calcipotriol/Betamethasone gel in children below 18 years have not been established.

1, but no recommendation on a posology can be made. Method of administration Calcipotriol/Betamethasone 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 Calcipotriol/Betamethasone gel.

Calcipotriol/Betamethasone gel should remain on the skin during the night or during the day. The bottle should be shaken before use and Calcipotriol/Betamethasone gel applied to the affected area. The hands should be washed after use.

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) Infections and infestations Uncommon ≥1/1,000 to <1/100 Skin infection* Folliculitis Immune system disorders Rare ≥1/10,000 to <1/1,000 Hypersensitivity Eye disorders Uncommon ≥1/1,000 to <1/100 Eye irritation Not known Vision, blurred***** Skin and subcutaneous tissue disorders Common ≥1/100 to < 1/10 Pruritus Uncommon ≥1/1,000 to <1/100 Exacerbation of psoriasis Dermatitis Erythema Rash** Acne Skin burning sensation Skin irritation Dry skin Rare ≥1/10,000 to <1/1,000 Skin striae Skin exfoliation Not known (cannot be estimated from available data) Hair colour changes*** Withdrawal reactions† General disorders and administration site conditions Uncommon ≥1/1,000 to <1/100 Application site pain**** Rare ≥1/10,000 to <1/1,000 Rebound effect Skin infections including bacterial, fungal and viral skin infections have been reported.

** Various types of rash reactions such as exfoliative rash, rash papular and rash pustular have been reported. *** Transient discolouration of the hair at scalp application site, to a yellowish colour in white or grey hair, has been reported.

4. † redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. 4). The following adverse reactions are considered to be related to the pharmacological classes of calcipotriol and betamethasone, respectively: 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.

Effects on endocrine system Calcipotriol/Betamethasone gel contains a potent group III steroid and concurrent treatment with other steroids must be avoided. Adverse reactions 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 under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. 8). 1). Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for a referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Effects on calcium metabolism Due to the content of calcipotriol, hypercalcaemia may occur if the maximum daily dose (15 g) is exceeded. Serum calcium is normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are followed.

2). Local adverse reactions Calcipotriol/Betamethasone gel contains a potent group III-steroid and concurrent treatment with other steroids on the same treatment area must be avoided. Skin of the face and genitals are very sensitive to corticosteroids.

The medicinal product should not be used in these areas. The patient must be instructed in correct use of the medicinal product to avoid application and accidental transfer to the face, mouth and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.

Concomitant skin infections When lesions become secondarily infected, they should be treated with antimicrobiological therapy. 3). Discontinuation of treatment When treating psoriasis with topical corticosteroids there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment.

1. Calcipotriol/Betamethasone gel is contraindicated in erythrodermic, exfoliative and pustular psoriasis. 4). g. 4).