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nicotine
McNeil Products Ltd
N07BA01
nicotine
6mg
Medicated Chewing Gum
Oral use
packs of 105 and 210 pieces.
GSL - General Sales List
McNeil AB
Drugs used in nicotine dependence
relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence in highly dependent smokers (> 20 cigarettes per day). It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them
Authorised
2015-09-15
BRAND: Nicorette Gum Flat leaflet DATE: 2013-08-13/MPS-j ARTICLE NO: 651253 DESCRIPTION: Nico gum 6mg FF LP MP REPLACES NO: New COUNTRY: England/GB SIZE: 280x180 mm -- 2 pages PMS COLORS: BLACK 355 PDD McNeil, HBG, SWE August 13, 2013 10:39:37 651253 651253 FRUITFUSION 6 MG GUM NICOTINE CHEWING GUM WHAT YOU SHOULD KNOW ABOUT NICORETTE ® FRUITFUSION 6 MG GUM (6 mg nicotine chewing gum) PLEASE READ THIS LEAFLET CAREFULLY before you start using this medicine. It provides useful information on how to use it safely. Keep the leaflet, you might need it again. If you think you are having side-effects, have any questions or are not sure about anything please ASK YOUR DOCTOR, NURSE OR PHARMACIST. 1 WHAT THE MEDICINE IS FOR NICORETTE ® fruitfusion 6 mg gum is a nicotine replacement therapy (NRT) for heavy smokers. It is used to relieve and/or prevent withdrawal symptoms and reduce the cravings for nicotine that you get when you try to stop smoking, or when cutting down the number of cigarettes you smoke. NICORETTE ® fruitfusion 6 mg gum can also be used when you are pregnant or breast-feeding to help you stop smoking, as the risks to your baby are far less than if you continue to smoke. For more information, see _’’If you are pregnant or _ _breast-feeding’’_ section. Ideally you should always aim to stop smoking. You can use NICORETTE ® fruitfusion 6 mg gum to achieve this by using it to completely replace all your cigarettes. However NICORETTE ® fruitfusion 6 mg gum can also be used in other ways, if you feel unable to stop smoking completely, or wish to replace certain cigarettes and therefore it can help you to cut down the number of cigarettes you smoke, at those times when you can’t or do not want to smoke. For example, - Where you don’t want to smoke and avoid harm to others e.g children or family. - Smoke free areas e.g Pub, work, public transport e.g aeroplanes. It may also help increase your Կարդացեք ամբողջական փաստաթուղթը
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette Fruitfusion 6 mg Gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chewing Gum containing 6 mg nicotine, as nicotine resinate. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Medicated Chewing Gum A square, coated and whitish coloured piece of gum. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicorette Fruitfusion 6mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence in highly dependent smokers (> 20 cigarettes per day). It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. _ _ Nicorette Fruitfusion 6mg Gum is indicated in pregnant and lactating women making a quit attempt. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Highly dependent smokers (> 20 cigarettes per day), adults and children over 12 years of age. Nicorette Fruitfusion 6mg Gum should be chewed slowly according to the instructions. In general, if the patient smokes 20 or fewer cigarettes a day, 2mg nicotine gum is indicated. If more than 20 cigarettes per day are smoked, 4mg or 6mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking. The 6 mg gum can be recommended particularly to those requiring enhanced craving relief compared to 4mg gum (See section 5.1). The duration and frequency of nicotine dosing may be adapted to individual needs: Treatment with Nicorette Fruitfusion 6 mg Gum for highly dependent children and adolescent smokers should be discussed with a healthcare professional (e.g. a doctor, pharmacist or nurse). _ _ Nicorette Fruitfusion 6 mg Gum should be used when Կարդացեք ամբողջական փաստաթուղթը