Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
The Boots Company Plc
D07AA02
Hydrocortisone
10mg/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5000167082401
UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM WK360. TECHNICAL INFORMATION, PRINTER PLEASE NOTE: WK360 HAVE CREATED THIS ARTWORK TO A GENERIC PRINT PROCESS SPECIFICATION AND REPRO HAS NOT BEEN APPLIED. PLEASE CALL YOUR CLIENT CONTACT TO DISCUSS ANY AMENDS OR IF ANYTHING FALLS BENEATH YOUR PRINT TOLERANCES Applescan House, Latimer Road, Luton, Beds, LU1 3XE TEL: 01582 487580 / 01582 456082 WEB: wk360.com BRANDING 16/11/2021 Martyn Price PRINTING COLOURS PMS 280 C Cutter Guides TECHNICAL & NON-PRINTING SPECIAL FINISHES & FOILS 5481.004 THIS SCALE MEASURES 50MM WHEN ARTWORK IS AT 100% 0 10 20 30 40 50 CATEGORY: SYNERGIST JOB NO: BRAND: RANGE: PROJECT NO.: PRODUCT TITLE: FILE NAME: PROOF NUMBER: PROOF DATE: ARTWORKER: PACK TYPE: SUPPLIER CONTACT: FINISH: FINISH TYPE: SUBSTRATE: SUBSTRATE COLOUR: SUPPLIER DETAILS: PRINTER CONTACT: PRINTER DETAILS: NUMBER OF COLOURS: BRAILLE: Health Boots Own Brand Healthy Skin 45-89-327 N/A 00110010 (305) NENN9 3 Leaflet Paper White 1 WBA-2001-Boots Derma Care 1pc w_w Ointment Leaflet PACK MOCK UP ARTWORK TEXT SIZE MAIN HEADINGS: 11pt SUB HEADINGS: 9pt BODY HEADINGS: 8pt VERSION NO. DATE ISSUED REASON FOR CHANGE 1 08/10/2021 Introduction of leaflet 00014/0364 N/A Internally approved 15g Boots Derma Care 1% w/w Ointment PRODUCT NAME: PRODUCT LICENCE NO.: WORDING REF: STATUS: PACK DETAILS: PACK SIZE: Leaflet Artwork Only ITEM CODE: BARCODE TYPE: BARCODE NO.: COMPONENT CODE: PHARMA CODE NO.: ARTWORK Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • 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. • You must talk to a doctor if you do not feel better or if you feel worse after 7 days. WHAT IS IN THIS LEAFLET 1. What Boots Derma Care Ointment is and what it is us Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone Ointment Boots Derma Care Hydrocortisone 1% Ointment Almus Hydrocortisone 1% Ointment Boots Derma Care 1% w/w Ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient %w/w Hydrocortisone Ph Eur 1.0 3. PHARMACEUTICAL FORM Ointment 4.1 THERAPEUTIC INDICATIONS For the relief of irritant contact dermatitis, allergic contact dermatitis, insect bite reactions and mild to moderate eczema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For adults, the elderly and children over 10 years of age: Apply sparingly to a small area, once or twice a day, for a maximum of 7 days. Children under 10 years of age: Not recommended except under medical supervision. For topical application. 4.3 CONTRAINDICATIONS The product should not be used if allergic to any of the ingredients or on the eyes or face, the ano-genital area or on broken or infected skin including impetigo, cold sores, acne or athlete's foot. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Medical advice should be sought if the condition does not improve. Visual impairment: Visual impairment may be reported with systemic and topical use of corticosteroids. If patients develop symptoms such as blurred vision or other visual disturbances, consideration should be given to referring the patient to an ophthalmologist to establish the possible cause which may include cataract, glaucoma or rare conditions such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrenc Citiți documentul complet