4.1. Therapeutic indications

Topical treatment of scalp psoriasis in adults.

4.2. Posology and method of administration

Posology

Xamiol gel should be applied to affected areas once daily. The recommended treatment period is 4 weeks. 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. The body surface area treated with calcipotriol containing medicinal products should not exceed 30 % (see section 4.4). All the affected scalp areas may be treated with Xamiol 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 Xamiol gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Paediatric population

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

The bottle should be shaken before use and Xamiol gel applied to the affected area. Xamiol gel should not be applied directly to the face or eyes. The hands should be washed after use. In order to achieve optimal effect, it is not recommended to wash the hair immediately after application of Xamiol gel. Xamiol gel should remain on the scalp during the night or during the day.

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients. Xamiol gel is contraindicated in erythrodermic, exfoliative and pustular psoriasis. Due to the content of calcipotriol, Xamiol gel is contraindicated in patients with known disorders of calcium metabolism. Due to the content of corticosteroid, Xamiol gel is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds, perianal and genital pruritus.

4.4. Special warnings and precautions for use

Effects on endocrine system

Xamiol gel contains a potent group III steroid and concurrent treatment with other steroids on the scalp 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. Application on large areas of damaged skin or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids (see section 4.8). In a study in patients with both extensive scalp and extensive body psoriasis using a combination of high doses of Xamiol gel (scalp application) and high doses of Dovobet ointment (body application), 5 of 32 patients showed a borderline decrease in cortisol response to adrenocorticotropic hormone (ACTH) challenge after 4 weeks of treatment (see section 5.1). 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, however, quickly normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are followed. Treatment of more than 30 % of the body surface should be avoided (see section 4.2). Local adverse reactions

Skin of the face and genitals are very sensitive to corticosteroids. The medicinal product should not be used in these areas. Uncommon local adverse reactions (such as eye irritation or irritation of facial skin) were observed, when the medicinal product was accidentally administered in the area of face, or accidentally to the eyes or conjunctives (see sections 4.8 and 5.1). 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. However, if infection worsens, treatment with corticosteroids should be stopped. 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. The treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid (see section 4.8). Unevaluated uses

There is no experience for the use of Xamiol gel in guttate psoriasis. Concurrent treatment and UV exposure

Dovobet ointment for body psoriasis lesions has been used in combination with Xamiol gel for scalp psoriasis lesions, but there is no experience of combination of Xamiol with other topical anti-psoriatic products at the same treatment area, other anti-psoriatic medicinal products administered systemically or with phototherapy. During Xamiol gel treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UVR only if the physician and patient consider that the potential benefits outweigh the potential risks (see section 5.3). Adverse reactions to excipients

Xamiol gel contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of Xamiol gel in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity (see section 5.3), but a number of epidemiological studies have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, Xamiol gel should only be used when the potential benefit justifies the potential risk. Breastfeeding

Betamethasone passes into breast milk, but risk of an adverse effect on the infant seems unlikely with therapeutic doses. There are no data on the excretion of calcipotriol in breast milk. Caution should be exercised when prescribing Xamiol gel to women who breast-feed. Fertility

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

4.7. Effects on ability to drive and use machines

Xamiol gel has no influence on the ability to drive and use machines.

4.8. Undesirable effects

The clinical trial programme for Xamiol gel has so far included more than 4,400 patients of whom more than 1,900 were treated with Xamiol gel. Approximately 8 % of patients treated with Xamiol gel experienced a non-serious adverse reaction. These reactions are usually mild and cover mainly various skin reactions with pruritus being the most common.Based on data from clinical trials and postmarket use the following adverse reactions are listed for Xamiol gel. 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. The following terminologies have been used in order to classify the frequencies of adverse reactions: 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 the available data)

Eye disorders

Uncommon Eye irritation

Skin and subcutaneous tissue disorders

Common Pruritus

Uncommon Exacerbation of psoriasis Burning sensation of skin Skin pain or irritation Folliculitis Dermatitis Erythema Acne Dry skin Rash Pustular rash

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. Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria (see section 4.4). 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, 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. Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long-term treatment (see section 4.4).

4.9. Overdose

Use above the recommended dose may cause elevated serum calcium which should rapidly subside when treatment is discontinued.Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions, resulting in secondary adrenal insufficiency which is usually reversible. In such cases, symptomatic treatment is indicated. In case of chronic toxicity, the corticosteroid treatment must be discontinued gradually. It has been reported that due to misuse one patient with extensive erythrodermic psoriasis treated with 240 g of Dovobet ointment weekly (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g daily) developed Cushing's syndrome and pustular psoriasis after abruptly stopping treatment.