CALCIPOTRIOL/ BETAMETHASONE

Posology Calcipotriol/Betamethasone ointment should be applied to the affected area once daily. The recommended treatment period is 4 weeks. There is experience with repeated courses of Calcipotriol/Betamethasone ointment up to 52 weeks.

If it is necessary to continue or restart treatment after 4 weeks, 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). Special populations Renal and hepatic impairment The safety and efficacy of Calcipotriol/Betamethasone ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Paediatric population The safety and efficacy of Calcipotriol/Betamethasone ointment in children below 18 years have not been established.

1 but no recommendation on a posology can be made. Method of administration Calcipotriol/Betamethasone ointment should be applied to the affected area. In order to achieve optimal effect, it is not recommended to take a shower or bath immediately after application of Calcipotriol/Betamethasone ointment.

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 reactions during treatment are various skin reactions, like pruritus and skin exfoliation.

Pustular psoriasis and hypercalcaemia have been reported. 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.

4) Skin and subcutaneous tissue disorders Common (≥1/100 to <1/10) Skin exfoliation, Pruritus Uncommon (≥1/1,000 to <1/100) Skin atrophy, Exacerbation of psoriasis, Dermatitis, Erythema, Rash**, Purpura or Ecchymosis, Skin burning sensation, Skin irritation Rare (≥1/10,000 to <1/1,000) Pustular psoriasis, Skin striae, Photosensitivity reaction, Acne, dry skin General disorders and administration site conditions Uncommon (≥1/1,000 to <1/100) Application site pigmentation changes, 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. *** Application site burning is included in application site pain Paediatric population: In an uncontrolled open study, 33 adolescents aged 12-17 years with psoriasis vulgaris were treated with calcipotriol+betamethasone dipropionate ointment for 4 weeks to a maximum of 56 g per week.

No new adverse events were observed and no concerns regarding systemic corticosteroid effect were identified. The size of this study does however not allow firm conclusions regarding the safety profile of Calcipotriol/Betamethasone ointment in children and adolescents.

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.

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 with topical corticosteroids 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.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Effects on endocrine system Calcipotriol/Betamethasone ointment 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). 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 ointment 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.

Medical supervision should therefore continue in the post-treatment period. Long-term use With long-term use there is an increased risk of local and systemic corticosteroid adverse reactions. 8). Unevaluated use There is no experience with the use of Calcipotriol/Betamethasone ointment in guttate psoriasis.

Concurrent treatment and UV exposure There is limited experience for the use of this medicinal product on the scalp. Calcipotriol+betamethasone dipropionate ointment for body psoriasis lesions has been used in combination with calcipotriol+betamethasone dipropionate gel for scalp psoriasis lesions, but there is limited experience of combination of calcipotriol+betamethasone dipropionate ointment with other topical anti-psoriatic products at the same treatment area, other anti-psoriatic medicinal products administered systemically or with phototherapy.

During Calcipotriol/Betamethasone ointment treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. 3). 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 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.

g. contact dermatitis), or irritation to the eyes and mucous membranes. Topical steroid withdrawal syndrome Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome).

A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated.

Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advise is recommended in these cases or other treatment options should be considered.

The label will state strong steroid.

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