Country: Malta
Lingwa: Ingliż
Sors: Medicines Authority
NICOTINE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
N07BA01
NICOTINE 14 mg/24 h
TRANSDERMAL PATCH
NICOTINE 14 mg/24 h
OTC
OTHER NERVOUS SYSTEM DRUGS
Withdrawn
2013-10-17
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EXMO7 MG/24 HOURS TRANSDERMAL PATCH EXMO 14 MG/24 HOURS TRANSDERMAL PATCH EXMO 21 MG/24 HOURS TRANSDERMAL PATCH Nicotine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use EXMO carefully to get the best results from it. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. - You must talk to a doctor if your symptoms worsen or do not improve after 6 months. WHAT IS IN THIS LEAFLET 1. What EXMO is and what it is used for 2. What you need to know before you use EXMO 3. How to use EXMO 4. Possible side effects 5. How to store EXMO 6. Contents of the pack and other information 1. WHAT EXMO IS AND WHAT IT IS USED FOR EXMO belongs to a group of medicines which are used to help you stop smoking. EXMO is a transdermal patch and is similar to a plaster which has the medicine contained on the side that sticks to your skin. This medicinal product is used to relieve the nicotine withdrawal symptoms in nicotine dependency in those wishing to quit smoking. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EXMO DO NOT USE EXMO - if you only smoke occasionally or if you are a non smoker. - if are are allergic (hypersensitive) to nicotine or any of the other ingredients of EXMO (see section 6 for a full list of ingredients). If you are not sure if Aqra d-dokument sħiħ
Page 1 of 8 1. NAME OF THE MEDICINAL PRODUCT EXMO 7 mg/24 hours transdermal patch EXMO 14 mg/24 hours transdermal patch EXMO 21 mg/24 hours transdermal patch 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch contains 15.76 mg of nicotine in a patch size of 9.67 cm 2 , releasing 7 mg of nicotine per 24 hours. Each transdermal patch contains 31.51 mg of nicotine in a patch size of 19.33 cm 2 , releasing 14 mg of nicotine per 24 hours. Each transdermal patch contains 47.27 mg of nicotine in a patch size of 29 cm 2 , releasing 21 mg of nicotine per 24 hours. Excipients: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Transdermal patch. Square patch with round corners, with “Nicotine 7 mg/day”, “Nicotine 14 mg/day” or “Nicotine 21 mg/day” printed randomly all over the patch. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation. Advice and support normally improve the success rate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Users should stop smoking completely during treatment with EXMO. Transdermal patches should also not be used simultaneously with another pharmaceutical form of nicotine replacement therapy such as gums or lozenges except under strict medical supervision. POSOLOGY EXMO transdermal patch is available in three strengths: 7 mg/24 hours, 14 mg/24 hours, 21 mg/24 hours. Adults The degree of nicotine dependence is to be assessed by the number of cigarettes smoked daily, or by the Fagerström's Test for Nicotine Dependence (test available in package leaflet). INITIAL PHASE 3 TO 4 WEEKS TREATMENT FOLLOW-UP Aqra d-dokument sħiħ