The safety and efficacy of Dovobet gel in children below 18 years have not been established. No data are available.

Method of administration

Dovobet 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

Dovobet ointment.

The word 'known' has been removed from the sentence 'Known hypersensitivity to the active substances or to any of the excipients.'

'Guttate psoriasis' is no longer listed as a contraindicated condition, the new wording is as follows:

'Dovobet ointment is contraindicated in erythrodermic, exfoliative and pustular psoriasis'.

The following contraindication has been removed:

'Dovobet is contraindicated in patients with severe renal insufficiency or sever hepatic disorders.'

The following wording has been removed:

'The patient must be instructed in correct use of the product to avoid application and accidental transfer to the scalp, face, mouth and eyes. Hands must be washed after each application.'

Under the subheading of 'Effects on endocrine system', 'adverse effects' are now known as 'adverse reactions'.

The reference to avoiding application under occlusive dressings due to increased absorption has been removed.

The following sentence regarding sensitive skin areas has been removed:

'These areas (i.e. Skin of the face and genitals) should only be treated with weaker corticosteroids'

A reference to the maximum weekly dose of 100g has been removed, and has been replaced with a reference to the maximum daily dose of 15 g.

The following wording is being removed: 'There is no experience with concurrent use of other anti-psoriatic products administered locally or systemically or with phototherapy', and has been replaced with:

'Dovobet ointment for body psoriasis lesions has been used in combination with Dovobet gel for scalp psoriasis lesions, but there is no experience of combination of Dovobet with other anti-psoriatic medicinal products administered systemically or with phototherapy.'

The following wording has been removed:

'There may be a risk of rebound when discontinuing a long term treatment with corticosteroids.'

'None known' has been replaced with 'No interaction studies have been performed.'

The heading 'Lactation' has been replaced with 'Breastfeeding'.

The following text has been added:

Studies in rats with oral doses of calcipotriol or bethamethasone diproprionate demonstrated no impairment of male and female fertility.

The classification frequencies have changed, they are now as follows:

Very common ≥1/10

Common ≥1/100 and <1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥1/10,000 and <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data)

The following undesirable effect has been added:

Not known: Rebound effect - included in section 4.4

Under the heading of 'Calcipotriol', 'undesirable effects' are now described as 'Adverse reactions'.

Under the heading of 'Bethamethasone (as diproprionate)', 'systemic effects' are now listed as 'systemic reactions'

The following sentence has been removed: 'This product contains a potent corticosteroid.'

The following wording has been removed:

'The undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported'

'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.'

In this section which describes a case of misuse, the quantities which were used by this patient are now listed as a corresponding daily dose used and this is contrasted with the maximum daily dose.

The following wording has been added: 'Pharmacotherapeutic group: Antipsoriatics. Other antipsoriatics for topical use, Calcipotriol combinations'

The ATC Code has been added: 'ATC Code: D05 AX52'.

A reference has been removed 'by a factor of 10', referencing penetrating through the stratum corneum from the following sentence:

'Through occlusion, the effect can be enhanced due to increased penetration of the stratum corneum'.

The following wording has been added:

'Adrenal response to ACTH was determined by measuring serum cortisol levels in patients with both extensive scalp and body psoriasis, using up to 106 g per week combined Dovobet gel and Dovobet ointment. A borderline decrease in cortisol response at 30 minutes post ACTH challenge was seen in 5 of 32 patients (15.6%) after 4 weeks of treatment and 2 of 11 patients (18.2%) who continued treatment until 8 weeks. In all cases, serum cortisol levels were normal at 60 minutes post ACTH challenge.

There was no evidence of change of calcium metabolism observed in these patients. With regard to HPA suppression, therefore, this study shows some evidence tht very high doses of Dovobet gel and ointment may have a weak effect on the HPA axis'.

The following sentence has been added:

'Following systemic exposure, both active ingredients - calcipotriol and bethamethasone diproprionate are rapidly and extensively metabolised.'

The following sentence with regard to excretion has been removed:

'Excretion takes palce by urine and faeces'

and has been replaced with:

'The main route of excretion of calcipotriol is via faeces (rats and minipigs) and for bethamethasone diproprionate it is via urine (rats and mice). In rats, tisue distribution studies with radiolabelled calcipotriol and bethamethasone diproprionate, respectively, showed that kidney and liver had the highest levels of radioactivity.'

The following sentence has been added:

'Calcipotriol and bethamethasone diproprionate were below the lower limit of quantification in all blood samples of 34 patients treated, for 4 or 8 weeks with both Dovobet gel and Dovobet ointment, for extensive posriasis invloving the body and scalp. One metabolite of calcipotriol and one metabolite of bethamethasone diproprionate were quantifiable in some of the patients.'

The wording regarding the study carried out on the UV exposure of albino hairless mice has been removed.

The following wording has been added:

'Photo(co)carcinogenicity studies in mice suggest that calcipotriol may enhnace the effect of UVR to induce skin tumours.