DAIVOBET Gel

DAIVOBET Gel is used for: Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy in adults

Ointment Apply to the affected area once daily. The recommended treatment period is 4 weeks. NOTE: There is experience with repeated courses 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. The body surface area treated with calcipotriol containing medicinal products should not exceed 30 %

Safety and efficacy of Calcipotriol/Betamethasone ointment in children below 18 years have not been established

Renal impairment: Safety and efficacy of Calcipotriol/Betamethasone ointment in patients with severe renal insufficiency have not been evaluated. Hepatic impairment: Safety and efficacy of Calcipotriol/Betamethasone ointment in patients with severe hepatic disorders have not been evaluated

For External use. Apply to the affected area. In order to achieve optimal effect, it is not recommended to take a shower or bath immediately after application of the ointment. 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. Skin of the face and genitals are very sensitive to corticosteroids. Instruct patient to avoid application and accidental transfer to the face, genitals, mouth and eyes. Hands must be washed after each application to avoid accidental transfer to these areas Advise patients to limit or avoid excessive exposure to either natural or artificial sunlight during therapy

Hypersensitivity to the active substances or to any of the excipients. Avoid use in erythrodermic, exfoliative and pustular psoriasis. Due to the content of calcipotriol: Avoid use in patients with known disorders of calcium metabolism. Due to the content of corticosteroid, avoid use 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, - Perioral dermatitis, - Atrophic skin, - Striae atrophicae, - Fragility of skin veins, - Ichthyosis, - Acne vulgaris, acne rosacea, rosacea, ulcers and wounds

Effects on endocrine system: Betamethasone is 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. 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. 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 treated area does not exceed 30 % of the body surface. Local adverse reactions: Skin of the face and genitals are very sensitive to corticosteroids. Instruct patient to avoid application and accidental transfer to the face, genitals, 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 appropriate antimicrobial agent. 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. Unevaluated uses: There is no experience for the use of Calcipotriol/Betamethasone ointment in guttate psoriasis. Concurrent treatment and UV exposure: There is no experience for the use of this medicinal product on the scalp. Calcipotriol/Betamethasone ointment for body psoriasis lesions has been used in combination with the gel formulation for scalp psoriasis lesions, but there is no experience of combination therapy with other anti-psoriatic products or with phototherapy. Advise patients to limit or avoid excessive exposure to either natural or artificial sunlight during therapy. Topical calcipotriol should be used with UVR only if the potential benefits outweigh the potential risks

Pregnancy: There are no adequate data from the use of Calcipotriol/Betamethasone ointment in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity, 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, the ointment should only be used during pregnancy 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 prescribed to nursing mothers. The patient should be instructed not to use the ointment on the breast when breastfeeding

Side effects of Betamethasone + Calcipotriol : Common: - Pruritus - Rash - Burning sensation of skin Uncommon: - Exacerbation of psoriasis - Skin pain or irritation - Dermatitis - Erythema - Folliculitis - Application site pigmentation changes Rare: - Pustular psoriasis

DAIVOBET "50mcg, 0.5mg/g" Gel manufactured by LEO PHARMACEUTICAL PRODUCTS LTD. A/S (LEO PHARMA A/S). Its generic name is Betamethasone + Calcipotriol. DAIVOBET is availble in United Arab Emirates. Farmaco UAE drug index information on DAIVOBET Gel is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.