Medicinal Products

DAIVOBET 50 micrograms / 05 mg / g

Generic drug of the therapeutic class: Dermatology
active ingredients: Calcipotriol + Betamethasone
laboratory: Leo

Gel
carton of 1 cartridge of 60 g
All forms

Indication

Topical treatment of scalp psoriasis in adults.

Topical treatment of mild-to-moderate vulvar psoriasis plaques outside the scalp in adults.

Dosage DAIVOBET 50 micrograms / 05 mg / g gel carton of 1 cartridge of 60 g

Topical treatment of scalp psoriasis in adults.

Topical treatment of mild-to-moderate vulvar psoriasis plaques outside the scalp in adults.

Against indications

Known hypersensitivity to active ingredients or to any of the excipients.

Daivobet gel is contraindicated in case of erythrodermic, exfoliating and pustular psoriasis.

Due to the presence of calcipotriol, Daivobet gel is contraindicated in patients with a history of calcium metabolic disorders.

Due to the presence of corticosteroids, Daivobet gel is contraindicated in the following cases: skin lesions of viral origin (eg herpes or varicella), skin infections of fungal or bacterial origin, parasitic infections, cutaneous in connection with tuberculosis or syphilis, perioral dermatitis, skin atrophy, stretch marks, fragility of the cutaneous venous network, ichthyosis, acne vulgaris, rosacea, rosacea, ulcers, wounds, perianal and genital pruritus.

Daivobet side effects

The clinical trial program of Daivobet Gel has so far included more than 4, 700 patients, of whom more than 2, 100 have been treated with Daivobet Gel. Approximately 8% of patients treated with Daivobet gel experienced a non-serious adverse reaction.

These reactions are usually benign and cover mainly various skin reactions, pruritus being the most common.

Based on data from clinical trials and post-marketing use the following side effects are listed for Daivobet gel.

Adverse reactions are classified according to MedDRA System Organ Class, and individual adverse reactions are listed beginning with the most frequently reported. In each grouping of frequencies, adverse reactions are listed by decreasing severity.

The following terminologies have been used to classify adverse event frequencies:

Very common ≥1 / 10

Frequent ≥1 / 100 and <1/10

Uncommon ≥1 / 1, 000 and <1/100

Rare ≥1 / 10, 000 and <1/1000

Very rare <1/10 000

Not known (can not be evaluated with available data)

Eye disorders

Rare

Eye irritation

Skin and subcutaneous tissue disorders

Frequent

itching

Rare

Exacerbation of psoriasis

Burning sensation of the skin

Skin pain or irritation

folliculitis

Dermatitis

Erythema

Acne

Skin dryness

Eruption

Pustular eruption

The following adverse reactions are considered in relation to the pharmacological classes of calcipotriol and betamethasone, respectively:

calcipotriol

Side effects include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, worsening of psoriasis, photosensitivity, and hypersensitivity reactions including rare cases of angioedema and edema of the face.

Systemic effects after topical application may occur very rarely and cause hypercalcemia or hypercalciuria (see Warnings and Precautions section ).

Betamethasone (as dipropionate)

Local reactions may occur after topical use, especially during prolonged exposure, including skin atrophy, telangiectasia, stretch marks, folliculitis, hypertrichosis, perioral dermatitis, contact dermatitis, depigmentation, and colloid milium. When treating psoriasis, there may be a risk of generalized pustular psoriasis.

Systemic effects after topical application of corticosteroids are rare in adults, however, they can be severe. Braking of the hypothalamic-pituitary axis, cataract, infections, an impact on the control of metabolism of diabetes mellitus and an increase in intraocular pressure may occur, especially after prolonged treatment. Systemic effects occur more frequently when applied under occlusion (plastic, skin folds), when applied over large areas and during long-term treatment (see section Warnings and precautions for use). ).

Pediatric population

In 109 adolescents aged 12 to 17 years with psoriasis of the scalp treated with Daivobet gel for 8 weeks, no new adverse events and no new adverse reactions were observed. However, the size of the study does not make it possible to draw conclusions about the safety profile of Daivobet gel in adolescents compared to that of adults (see section 5.1 Pharmacodynamic properties ).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. Website: www.ansm.sante.fr.

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