দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
ERYTHROMYCIN
GlaxoSmithKline (Ireland) Limited
ERYTHROMYCIN
2.0 %w/v
Cutaneous Solution
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
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 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 Stiemycin is and what it is used for 2. What you need to know before you use Stiemycin 3. How to use Stiemycin 4. Possible side effects 5. How to store Stiemycin 6. Contents of the pack and other information 1. WHAT STIEMYCIN IS AND WHAT IT IS USED FOR Stiemycin contains the active substance erythromycin. This is an antibiotic. Stiemycin is used to treat acne vulgaris (spots) in adults and adolescents. It is not for use by children under the age of 12 years. It works by fighting the bacteria that can cause the acne spots. You must talk to a doctor if you do not feel better or if you feel worse after 6-8 weeks. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE STIEMYCIN DO NOT USE STIEMYCIN: if you are allergic to erythromycin or any of the other ingredients of this medicine (listed in Section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Stiemycin if: • you are using any other acne treatments, creams or ointments, as possible irritation may occur. • you are using other antibiotics or clindamycin as possible irritation may occur and the bacteria causing the acne may become used to (resistant to) the antibiotic in this medicine and therefore may not work as well. • you have a history of inflammatory bowel disease or antibiotic-a সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Stiemycin 2% w/v Cutaneous Solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains erythromycin 20 mg/ml (2% w/v) Excipients with known effect: Contains propylene glycol 372.8 mg/ml (37.28% w/v) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution. A clear, colourless liquid with an odour of ethanol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Stiemycin is indicated in adults and adolescents for the topical treatment of acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply Stiemycin over the whole affected area twice daily, after washing with soap and water. Patients should be advised that a therapeutic effect may not be seen until after 6-8 weeks of treatment. Treatment duration should be kept to a minimum to avoid antimicrobial resistance If there has been no improvement after 6-8 weeks, or if the condition becomes worse, treatment should be discontinued. Due to the flammable nature of Stiemycin Cutaneous Solution, patients should avoid smoking or being near an open flame during application and immediately after use. Paediatric population The safety and efficacy of Stiemycin in children under the age of 12 years have not been established. Elderly patients There are no specific recommendations. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 09/01/2014_ _CRN 2138810_ _page number: 1_ 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with সম্পূর্ণ নথি পড়ুন