País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clioquinol; Fluocinolone acetonide
Reig Jofre UK Ltd
D07BC02
Clioquinol; Fluocinolone acetonide
30mg/1gram ; 250microgram/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5012564001879
000000 000000 Patient Information Leaflet cream 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Synalar N cream is and what it is used for 4. Possible side effects 2. What you need to know before you use 5. How to store Synalar N cream Synalar N cream 6. Contents of the pack and other information 3. How to use Synalar N cream 1. WHAT SYNALAR N CREAM IS AND WHAT IT IS USED FOR Synalar N cream contains two active ingredients. One is called fluocinolone acetonide which is a steroid and reduces inflammation. The other is called neomycin sulfate which is an antibiotic effective against bacterial skin infections. Synalar N cream is used to treat certain inflammatory, itchy or allergic skin conditions such as eczema and dermatitis when infection may be present. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SYNALAR N CREAM Do not use Synalar N cream: • If you are allergic to fluocinolone acetonide, neomycin sulfate or any of the other ingredients of this medicine (listed in section 6). • Where infection is the main cause of the skin problem. • For acne. • For nappy rash. • If you have a skin condition called rosacea which is red rash, sometimes with spots and pustules, on the cheeks of the face. • If you have a skin condition called perioral dermatitis which is a dry sore red rash around the mouth. • If you have a damaged ear drum do not put any cream into the ears. • If it is for a child under the age of one. • If breast-feeding, do not apply to the breasts prior to nu Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ‘Synalar’ N Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fluocinolone Acetonide Ph. Eur 0.025% w/w Neomycin Sulfate Ph. Eur 3250 IU/g 3 PHARMACEUTICAL FORM Cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Synalar-N combines the effective topical corticosteroid fluocinolone acetonide with an effective antibacterial agent neomycin sulfate. It is indicated for inflammatory dermatoses including eczema, dermatitis, seborrhoea and intertrigo, where secondary bacterial infection is present or is likely to occur. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the elderly) and Children A small quantity of the Synalar N preparation is applied lightly to the affected area two or three times a day and massaged gently and thoroughly into the skin. These recommendations apply to both children and adults, including the elderly. Treatment should not normally be for longer than seven days, and it is preferable to identify’ the causative organism. It is recommended that treatment on the face and for children should not normally be extended beyond five days and occlusion should not be used. If an occlusive dressing is indicated, the affected area should first be thoroughly cleansed. The Synalar N preparation is then applied and covered with a suitable dressing. Synalar N cream is particularly suitable for very inflamed or weeping surfaces and for flexures of the body. 4.3 CONTRAINDICATIONS Synalar N is contra-indicated in primary infections of the skin caused by bacteria, fungi or viruses and in rosacea, acne, perioral dermatitis and napkin eruption. Synalar preparations are not advised in the treatment of children under one year of age. Synalar N is contra-indicated in those patients with a history of hypersensitivity to neomycin. Topical neomycin preparation should not be applied to the external auditory canal of patients with perforated eardrums. The eyes should be avoided. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Long-term cont Leer el documento completo