FLUBASON 0.25% skin emulsion,FLUBASON 0,25% emulsione cutanea,Sanofi Spa

“Dose, regimen and time of administration:
Flubason should first be applied 2-3 times a day in a thin layer to the affected area of the skin, rubbing in lightly if possible. Later, after clinical improvement, only one daily application may be sufficient.
Contraindications:
Hypersensitivity to the active substance, to other cortico or to any of the excipients. Local tuberculosis or viral infections (for example, herpes, chicken pox, etc.), Syphilis, vaccinopathy. Flubason is not suitable for ophthalmic use.
Flubason contains paraffin, which can cause latex condoms to break down. Therefore, contact between Flubason and latex condoms should be avoided.
Pregnancy. Lactation. Occlusive therapy in patients with atopic dermatitis.
Precautions for use:
Flubason should not be used in infants or young children; this is because this age group has an increased risk of systemic effects due to glucocorticoid absorption (eg, growth retardation). In cases where treatment with Flubason is unavoidable, use should be limited to the minimum dose compatible with therapeutic success and it is advisable to limit use of the product to short periods of time.
In adults there may be exceptional circumstances in which the use of Flubason over large areas is unavoidable. In such cases, the possibility of suppression of the hypothalamic-pituitary-adrenal axis should be considered, especially with long-term use. If such suppression occurs, gradual discontinuation of Flubason may be necessary.
Topical use of cortico in the treatment of prolonged dermatoses and/or over long periods may cause undesirable effects from systemic absorption, such as arterial hypertension, asthenia, adynamia, cardiac arrhythmias, hypokalemia and metabolic alkalosis.
When topical preparations containing cortico, including Flubason, come into repeated contact with the conjunctival sac, an increase in intraocular pressure may develop over time. Therefore, repeated or long-term use of Flubason in close proximity to the eyes should be preceded by a careful risk-benefit assessment and should only be carried out under medical supervision.
Warnings:
The use, especially in case of long-term use, of topical products may cause sensitization phenomena. If this occurs, it is necessary to suspend treatment and prescribe appropriate therapy.
If skin infections are present, appropriate antibacterial and antifungal therapy should be instituted, and if worsening, corticosteroid treatment should be interrupted.
The drug contains cetostearyl alcohol, which may cause local skin reactions (for example, contact dermatitis).
Pregnancy and breastfeeding:
The use of Flubason during pregnancy and breastfeeding is contraindicated due to the risk of systemic absorption of deoxymethasone.
Overdose:
Systemic glucocorticoid effects may occur if large amounts of deoxymethasone are absorbed, particularly after Flubason is used on areas of extended skin or for prolonged periods.
In this case, the dose should be reduced or treatment discontinued. If suppression of the hypothalamic-pituitary-adrenal axis is suspected, treatment should be gradually discontinued.
Undesirable effects:
In the area of treated skin, folliculitis, hypertrichosis, acne, hyperpigmentation, telangiectasia, stretch marks, atrophy and maceration of the skin may be observed. These topical effects occur in particular in the case of long-term therapy and the use of occlusive dressings. In rare cases, Flubason may cause hypersensitivity skin reactions such as redness, swelling, peeling and itching.
When used over large areas or for long periods of time and when used under occlusive dressings, absorption of active systemic amounts is possible.
Packing: 15 monodoses”