Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
NICOTINE
Novartis Consumer Health UK Limited
N07BA01
NICOTINE
2 Milligram
Medicated Chewing Gum
Product not subject to medical prescription
Drugs used in nicotine dependence
Authorised
2003-11-28
PACKAGE LEAFLET: INFORMATION FOR THE USER NICOTINELL CLASSIC 2 MG MEDICATED CHEWING-GUM nicotine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Nicotinell Classic 2 mg medicated chewing-gum carefully to get the best results from it. Always take this medicine exactly as described in this leaflet or as your pharmacist has told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if you still need to use Nicotinell after 9 months. 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. In this leaflet: 1. What Nicotinell is and what it is used for 2. What you need to know before you take Nicotinell 3. How to take Nicotinell 4. Possible side effects 5. How to store Nicotinell 6. Contents of the pack and other information 1. WHAT NICOTINELL IS AND WHAT IT IS USED FOR Nicotinell belongs to a group of medicines which are used to help you to stop smoking. Nicotinell contains nicotine, which is one of the substances contained in tobacco. When chewed, nicotine is released slowly and absorbed through the lining of the mouth. This medicinal product is used to relieve the nicotine withdrawal symptoms in nicotine dependency, as an aid to smoking cessation. Patient counselling and support normally improve the success rate. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICOTINELL DO NOT TAKE NICOTINELL If you are allergic (hypersensitive) to nicotine or any of the other ingr Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicotinell Classic 2 mg, medicated chewing-gum. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each piece of medicated chewing-gum contains: Active substance: 2 mg nicotine (as 10 mg nicotine –polacrilin (1:4)). Excipient(s) with known effect: maltitol liquid (0.03 g), sorbitol (0.2 g), sodium (11.50 mg) and butylhydroxytoluene (E321) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Medicated chewing-gum. Each piece of coated chewing-gum is off-white in colour and rectangular in shape. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation. Patient counselling and support normally improve the success rate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS AND OLDER PEOPLE Nicotinell Classic medicated chewing-gum is a gum with reduced amount of flavouring. It is more appropriate for smokers who prefer the classic nicotine taste. Users should stop smoking completely during treatment with Nicotinell medicated chewing-gum. The 2 mg medicated chewing-gum is not recommended for smokers with a strong or very strong nicotine dependency. The optimal dosage form is selected according to the following table: HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 03/06/2015_ _CRN 2160912_ _page number: 1_ If an adverse event occurs with the use of the high dose form (4 mg medicated chewing-gum), use of the low dose form (2 mg medicated chewing-gum) should be considered. The initial dosage should be individualised on the basis of the patients nicotine dependence. One piece of Nicotinell medicated chewing-gum to be chewed wh Pročitajte cijeli dokument