Beloderm - instructions for use, dose, side effects, contraindications

Excipients: chlorocresol, polybasic sodium dihydrogen phosphate monohydrate, phosphoric acid, white petrolatum, mineral oil, macrogol cetostearyl ether 22, cetostearyl alcohol, sodium hydroxide, purified water.

Description:

White, homogeneous cream, without mechanical inclusions.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

H.02.A.B.01 Betamethasone

Pharmacodynamics:

BELODERM® is a glucocorticosteroid for external use. Has anti-inflammatory, antipruritic, anti-allergic, vasoconstrictive, antiexudative and antiproliferative action.

When applied to the surface of the skin, the drug has a quick and strong effect in the inflammatory focus, reducing the severity of objective symptoms (erythema, edema, lichenification) and subjective sensations (itching, irritation, pain).

Indications:

Conditions that respond to therapy with topical corticosteroids, including:

- atopic dermatitis / neurodermatitis;

- allergic contact dermatitis;

- eczema (various forms);

- contact dermatitis (including professional) and other non-allergic dermatitis (including sun and radiation dermatitis);

- reactions to insect bites;

- psoriasis;

- bullous dermatoses;

- discoid lupus erythematosus;

- red flat lichen;

- exudative erythema multiforme;

- itching of various etiologies.

Contraindications:

Hypersensitivity to betamethasone or to any of the auxiliary components of the drug.

Tuberculosis of the skin, cutaneous manifestations of syphilis, chickenpox, viral skin infections, skin post-vaccination reactions, open wounds, trophic ulcers, rosacea, vulgar acne, children under 6 months of age.

Pregnancy and lactation:

Local use of BELODERM® cream or ointment in pregnant women is allowed in cases where the intended benefit to the mother exceeds the risk to the fetus. In such cases, the use of the drug should be short and limited to small areas of skin.

During the period of breastfeeding, BELODERM® can be used according to strict indications, but the drug should not be applied to the skin of the breast before feeding.

Dosing and Administration:

For external use only.

BELODERM® (cream or ointment for external use) is applied to the affected area of the skin with a thin layer twice a day, lightly rubbing. On areas with more dense skin (for example, elbows, palms and feet), as well as places from which the drug is easily washed, BELODERM® can be applied more often. The duration of continuous treatment is usually not more than 4 weeks.To prevent relapse in the treatment of chronic diseases, therapy should continue for some time after the disappearance of all symptoms. During the year, repeated therapy is possible.

BELODERM® in the form of a cream for external use is used for acute therapy, incl. wetting skin lesions. BELODERM® in the form of ointment for external use is intended for the therapy of subacute and chronic dermatoses, incl. dry, lichenic and flaky lesions, or in cases where the occlusive effect of the ointment is necessary.

Side effects:

As a rule, they have a weak character.

Rarely, as with other glucocorticosteroids, a hypersensitivity reaction (itching, burning or redness), acne-like changes, hypopigmentation, striae, skin atrophy, hypertrichosis, telangiectasia, secondary skin infections may develop.

In case of a hypersensitivity reaction or side effects, therapy should be discontinued and consult a doctor.

Overdose:

With prolonged continuous use of the drug, especially in children, on extensive skin surfaces,when applied to the skin with broken integrity or when used under an occlusive dressing, it is possible to develop side effects associated with suppression and insufficiency of the function of the adrenal cortex.

Treatment: it is recommended to cancel the drug and, if necessary, symptomatic treatment.

Interaction:

The interactions of the preparation BELODERM® cream or ointments for external use with other drugs are unknown.

Special instructions:

It is not recommended long-term external application of the drug on the face skin, since it is possible to develop rosacea, perioral dermatitis and acne.

The drug should not be used in the eye area due to the likelihood of getting the drug on the mucous membrane, which can contribute to the development of cataracts, glaucoma, fungal infections of the eye and exacerbation of herpetic infection.

Some areas of the body, such as axillary cavities, inguinal folds, where there is a kind of natural occlusion, are more susceptible to the risk of streaking, so the use of the drug in these areas of the skin should be short-lived.

When developing fungal or bacterial infections on the skin, additional use of an antibacterial or antifungal agent is necessary.

Use in Pediatrics

BELODERM® can be given to children from 6 months with caution and for as short a time as possible. Do not apply the drug under the bandages and, especially, under plasticized diapers, as this increases the absorption of the drug and increases the risk of side effects.

Effect on the ability to drive transp. cf. and fur:

Data on the adverse effects of BELODERM® cream or ointment on the ability to drive vehicles and mechanisms are not available.

Form release / dosage:Cream for external use, 0.05%.

Packaging:For 5 g, 15 g, 20 g, 30 g and 40 g of cream in an aluminum tube. The tube opening is protected by a membrane. The tube is closed with a polyethylene lid with a thread and a punch.

Each tube together with the instruction for use is placed in a cardboard box.

Storage conditions:At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N014679 / 01

Date of registration:19.11.2007

Expiration Date:Unlimited

The owner of the registration certificate:Beluga, medicines and cosmetics.Beluga, medicines and cosmetics. Croatia

Manufacturer: & nbsp

BELUPO, Pharmaceuticals & Cosmetics, d.d. Croatia

Representation: & nbspBeluga, medicines and cosmetics. Beluga, medicines and cosmetics. Croatia

Information update date: & nbsp21.01.2017

Illustrated instructions

Instructions

Beloderm® (Beloderm®)