País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Erythromycin; Tretinoin
Lexon (UK) Ltd
D10AF52
Erythromycin; Tretinoin
40mg/1gram ; 250microgram/1gram
Cutaneous solution
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13060100
Date and Signature PROOF: DESCRIPTION: REGULATORY TEXT: ITEM NUMBER: MATERIAL SIZE: DESIGNER: FONTS: DATE: MINIMUM FONT SIZE: PREFIXES (EG.LOT/EXP) FONT SIZE: ARTWORK INFORMATION PANEL LEADING: PRINTING COLOURS NON PRINTING COLOURS INLINE CONTROL CODE COLOUR REFERENCE IN PMS BRIDGE EQUATE WITH CMYK MANUFACTURER’S TECHNICAL CHECK Manufacturer confirms the printability and technical compliance of this packaging material for correct use during packaging process. _“8pt in Graphic Font equal to 9pt on Times New Roman”_ PHES CODE PIL Aknemycin Plus Solution GB Mock up PIL Aknemycin Plus Solution GB 80015571annotated / uk-pl-aknemycinplus-QRD-Sep2018_annotated (1-2) Graphik Regular / _Regular Italic _/ SEMIBOLD 00000000 148 x 297 mm 30.03.2020 8 pt 3 mm 1 P Black Die Cut PACKAGE LEAFLET: INFORMATION FOR THE USER AKNEMYCIN PLUS 4.0% W/W AND 0.025% W/W CUTANEOUS SOLUTION Erythromycin and Tretinoin 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 Aknemycin Plus is and what it is used for 2. What you need to know before you use Aknemycin Plus 3. How to use Aknemycin Plus 4. Possible side effects 5. How to store Aknemycin Plus 6. Contents of the pack and other information 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AKNEMYCIN PLUS DO NOT USE AKNEMYCIN PLUS • if you are allergic to Erythromycin, Tretinoin or any of the other ingredients of this medicine (listed in section 6). characterised by redness, pimples and peeling) or acute inflammatory conditions of the skin, especially around the mouth. • Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aknemycin Plus 4.0% w/w and 0.025% w/w cutaneous solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cutaneous solution contains 40 mg of erythromycin and 0.25 mg of tretinoin. Excipients with known effect: 1 ml of solution contains 752 mg of alcohol (ethanol). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous solution. Aknemycin Plus is a clear solution for topical administration. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aknemycin Plus is indicated for the treatment of all forms of acne, both non-inflammatory forms with comedones and inflammatory forms with papules and pustules particularly those associated with a very oily skin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology To be applied to the affected areas once or twice daily. Treatment should continue for 9-12 weeks according to the condition of the skin. It should be noted that therapeutic improvement may not be observed for several weeks after starting treatment. Consistent application makes a significant contribution to the success of the therapy. Excess application of Aknemycin Plus should be avoided since it may result in marked erythema, drying and discomfort of the treated areas. The dosage is the same for all ages. Method of administration For application to the skin. The applicator allows direct administration to the skin. The patient should press the top of the screw cap on the foam pad before each use and should feel a 'click' which indicates that the applicator will close again automatically. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • A family history of cutaneous epithelioma. • In acute eczemas, rosacea and acute inflammatory conditions of the skin, especially around the mouth. • When underlying sunburn is present • Concomitant use with other skin medications particularly those containing keratolytic agents (see section 4.5). • P Leia o documento completo