Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clotrimazole; Betamethasone dipropionate
Necessity Supplies Ltd
D07CC01
Clotrimazole; Betamethasone dipropionate
10mg/1gram ; 640microgram/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
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. Your medicine is called Lotriderm Cream and will be referred to as Lotriderm Cream throughout the leaflet. WHAT IS IN THIS LEAFLET: What Lotriderm Cream is and what it is used for What you need to know before you use Lotriderm Cream How to use Lotriderm Cream Possible side effects How to store Lotriderm Cream Contents of the pack and other information WHAT LOTRIDERM CREAM IS AND WHAT IT IS USED FOR Lotriderm Cream contains the active ingredients 0.064% w/w betamethasone dipropionate (equivalent to 0.05 % w/w betamethasone) and 1.0% w/w clotrimazole. Betamethasone belongs to a group of medicines called topical corticosteroids which are used on the surface of the skin to reduce the redness and itchiness caused by certain skin problems. Clotrimazole is a topical anti-fungal medicine used to treat some fungal infections of the skin. Lotriderm Cream is used for the short-term treatment of certain fungal infections of the skin, when redness and itchiness may also be a problem. WHAT YOU NEED TO KNOW BEFORE YOU USE LOTRIDERM CREAM DO NOT USE LOTRIDERM CREAM • if you are allergic to betamethasone dipropionate, clotrimazole or any of the other ingredients of this medicine (listed in section 6). • if your skin becomes irritated, or you develop an allergic reaction. • on any other skin infections as it could make them worse, especially rosacea (a skin condition affecting the face), acne, dermatitis (skin inflammation) around the mouth, nappy rash or other skin infections. WARNINGS AND P Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT LOTRIDERM 0.05% w/w/1.0% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Betamethasone dipropionate 0.064% w/w* (* equivalent to 0.05% betamethasone) Clotrimazole 1.0% w/w Excipients with known effect Cetostearyl alcohol, Propylene glycol, 100mg/g of cream Benzyl alcohol, 10mg/g of cream For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream Smooth, uniform, white to off-white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short-term topical treatment of tinea infections due to Trichophyton rubrum; T. mentagrophytes; Epidermophyton floccusum and Microsporum canis; candidiasis due to Candida albicans. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and children over the age of 12 years. Topical administration twice daily for two weeks (tinea cruris, tinea corporis and candidiasis) or for four weeks (tinea pedis). Paediatric population Lotriderm cream is not recommended for children under the age of twelve years. Method of administration Topical administration only. 4.3 CONTRAINDICATIONS Lotriderm is contraindicated in those patients with a history of sensitivity to any of its components or to other corticosteroids or imidazoles. If irritation or sensitisation develops with the use of Lotriderm cream, treatment should be discontinued and appropriate therapy instituted. Lotriderm is contraindicated in facial rosacea, acne vulgaris, perioral dermatitis, napkin eruptions and bacterial or viral infections. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Local and systemic toxicity is common especially following long continued use on large areas of damaged skin and in flexures. If used on the face, courses should be limited to 5 days. LOTRIDERM CREAM SHOULD NOT BE USED WITH OCCLUSIVE DRESSING. Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following the development of tolerance, risk of generalised pustular psoriasis and local and systemic toxicity due Lugege kogu dokumenti