Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fludroxycortide
Colorama Pharmaceuticals Ltd
D07AC07
Fludroxycortide
125microgram/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
_Colours_ _(Printed)_ _Title:_ _Ref:_ _Date:_ _Size (mm):_ _Modified:_ Fludroxycortide 0.0125% w/w Ointment FO/TY/PIL 08/11/15 148(W) x 300(H) 27/03/19 _Colours_ _(Non printed)_ PROCESS BLACK REFERENCE TRIM PACKAGE LEAFLET: INFORMATION FOR THE USER FLUDROXYCORTIDE 0.0125% W/W OINTMENT READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. - IF YOU HAVE ANY FURTHER QUESTIONS, ASK YOUR DOCTOR OR PHARMACIST. - THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU ONLY. DO NOT PASS IT ON TO OTHERS. IT MAY HARM THEM, EVEN IF THEIR SIGNS OF ILLNESS ARE THE SAME AS YOURS. - IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR OR PHARMACIST. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4. WHAT IS IN THIS LEAFLET: 1. What Fludroxycortide 0.0125% w/w Ointment is and what it is used for 2. What you need to know before you use Fludroxycortide 0.0125% w/w Ointment 3. How to use Fludroxycortide 0.0125% w/w Ointment 4. Possible side effects 5. How to store Fludroxycortide 0.0125% w/w Ointment 6. Contents of the pack and other information 1. WHAT FLUDROXYCORTIDE 0.0125% W/W OINTMENT IS AND WHAT IT IS USED FOR Fludroxycortide 0.0125% w/w Ointment is a white ointment for application to the skin. Fludroxycortide 0.0125% w/w Ointment belongs to a group of medicines called topical steroids and is used to treat skin conditions such as eczema and dermatitis of all types, especially when the skin is dry and scaly. Fludroxycortide 0.0125% w/w Ointment can be used in adults and children. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUDROXYCORTIDE 0.0125% W/W OINTMENT DO NOT USE FLUDROXYCORTIDE 0.0125% W/W OINTMENT • for skin tuberculosis. • for rosacea of the face. • for acne. • for dermatitis around the mouth. • for itchiness of the genitals or anus. • for skin conditions in babies including eczema or napkin rash. • for bacterial skin infections such as impetigo. • for viral skin infection Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Haelan Ointment Fludroxycortide 0.0125% w/w Ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fludroxycortide 0.0125% w/w. Excipient with known effect Cetyl alcohol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ointment for topical administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults and children: Eczema and dermatitis of all types including childhood and adult atopic eczema, photodermatitis, primary irritant and allergic dermatitis, lichen planus, lichen simplex, prurigo nodularis, discoid lupus erythematosus, necrobiosis lipoidica, pretibial myxoedema and erthroderma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For dry, scaly lesions, the ointment should be applied as a thin film to the affected area two or three times daily. Method of administration The elderly: As the skin is likely to be thin, apply sparingly to avoid development of atrophy. Dilution is not recommended, but if considered necessary, white soft paraffin BP may be used. 4.3 CONTRAINDICATIONS Tuberculosis of the skin, facial rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, dermatoses in infancy including eczema, dermatitic napkin eruption, bacterial (impetigo), viral (herpes simplex) and fungal (candida or dermatophyte) infections. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Preparations of Haelan are not intended for ophthalmic use. Local and systemic toxicity is common especially following long-term continuous use, continued use on large areas of damaged skin, flexures and with polythene occlusion. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression (see section 4.8). Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodical Izlasiet visu dokumentu