Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clobetasol propionate
Mawdsley-Brooks & Company Ltd
D07AD01
Clobetasol propionate
500microgram/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
PATIENT INFORMATION LEAFLET CLOBETASOL PROPIONATE 0.05% W/W OINTMENT READ ALL OF THIS LEAFLET CAREFULLY 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What is Clobetasol Propionate Ointment and what is it used for? 2. Before you use Clobetasol Propionate Ointment 3. How to use Clobetasol Propionate Ointment 4. Possible side effects 5. Storing Clobetasol Propionate Ointment 6. Further information 1. WHAT IS CLOBETASOL PROPIONATE OINTMENT AND WHAT IS IT USED FOR? Clobetasol Propionate Ointment belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. Clobetasol Propionate Ointment is used to help reduce the redness and itchiness of certain skin problems. These skin problems include eczema, psoriasis and dermatitis that have not responded to milder steroid creams or ointments. 2. BEFORE YOU USE CLOBETASOL PROPIONATE OINTMENT DO NOT USE CLOBETASOL PROPIONATE OINTMENT: • if you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of Clobetasol Propionate Ointment (listed in Section 6) • on a child under 1 year old • to treat any of the following skin problems, it could make them worse: • acne • severe flushing of skin on and around your nose (rosacea) • spotty red rash around your mouth (perioral dermatitis) • itching around your back passage or private parts - unless your doctor has told you to do so • viral infections, such as cold sores, herpes or chicken pox • fungal infections, such as ringworm, athletes foot or thrush • skin blisters or sores that are caused by an infection. Do not use this medici Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clobetasol Propionate 0.05% w/w Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of ointment contains 0.5 mg of clobetasol 17-propionate (0.05% w/w). Also contains 50 mg of propylene glycol in each gram of ointment. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment Opaque ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clobetasol propionate is a very active topical corticosteroid which is of particular value when used in short courses for the treatment of more resistant dermatoses such as psoriasis (excluding widespread plaque psoriasis), recalcitrant eczemas, lichen planus, discoid lupus erythematosus, and other skin conditions which do not respond satisfactorily to less active steroids. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply sparingly to the affected area once or twice daily until improvement occurs. As with other highly active topical steroid preparations, therapy should be discontinued when control is achieved. In the more responsive conditions this may be within a few days. If no improvement is seen within two to four weeks, reassessment of the diagnosis, or referral, may be necessary. Repeated short courses of Clobetasol Propionate Ointment may be used to control exacerbations. If continuous steroid treatment is necessary, a less potent preparation should be used. In very resistant lesions, especially where there is hyperkeratosis, the anti- inflammatory effect of Clobetasol Propionate Ointment can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Thereafter improvement can usually be maintained by application without occlusion. For topical administration. 4.3 CONTRAINDICATIONS • Rosacea • Acne vulgaris • Perioral dermatitis • Perianal and genital pruritus • Primary cutaneous viral infections (e.g. herpes simplex, chickenpox) • Hypersensitivity to the preparat Pročitajte cijeli dokument