WYNZORA

Posology Wynzora Cream should be applied to affected areas once daily. Rub in the cream thoroughly in a thin layer. The recommended treatment period is up to 8 weeks. Treatment should be discontinued when control is achieved. If it is necessary to continue or restart treatment after this period, treatment should be continued only 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 Wynzora Cream. Special populations Renal and hepatic impairment The safety and efficacy of Wynzora Cream in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.

Paediatric population The safety and efficacy of Wynzora Cream in children below 18 years have not been established. 2. Method of administration Wynzora Cream 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, immediately after application of Wynzora Cream.

It is recommended to allow 8 hours between the application and showering to avoid washing it off. Hands must be washed after use.

The estimation of the frequency of adverse reactions is based on a pooled analysis of data from clinical studies. All reported adverse reactions were seen at a frequency below 1%. The most frequently reported adverse reactions were “Application site reactions” including application site irritation, pain, pruritus, eczema, exfoliation, telangiectasia and folliculitis.

Adverse reactions are displayed by system organ class and frequency in Table 1 below. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. The frequency of the adverse reactions is expressed according to the following categories: uncommon (≥1/1,000 to <1/100); not known (cannot be estimated from available data).

4 Paediatric population In an uncontrolled clinical trial with 7 subjects aged 12 to 17 years no adverse reactions were reported. 1 for further details regarding the trial. In this limited sample, no clinically relevant differences have been observed between the safety profiles of Wynzora cream in adult and adolescent populations.

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 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). HPA (hypothalamic–pituitary–adrenal) axis suppression was evaluated in adult subjects (N=27) with extensive psoriasis (including scalp).

7%) after 4 weeks of treatment, and in one additional patient after 8 weeks of treatment. 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 in Wynzora Cream, hypercalcaemia may occur. Serum calcium is normalised when treatment is discontinued. 2). Local adverse reactions In a vasoconstrictor trial in healthy subjects, the skin blanching response of Wynzora Cream was consistent with a moderate (class II) corticosteroid when compared with other topical corticosteroids.

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 Long-term use of corticosteroids may increase the risk of local and systemic adverse reactions. 8). 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.

Unevaluated use There is no experience with the use of Wynzora Cream in guttate psoriasis. Concurrent treatment and UV exposure During Wynzora Cream treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight.

3). g. contact dermatitis) or irritation to the eyes and mucous membranes. Wynzora Cream contains macrogolglycerol hydroxystearate which may cause skin reactions. Instruct patients not to smoke or go near naked flames - risk of severe burns.

Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. The label will state moderate steroid.

1. Wynzora Cream is contraindicated in erythrodermic, exfoliative and pustular psoriasis. 4). g. 4).