Страна: Мальта
Язык: английский
Источник: Medicines Authority
NICOTINE
McNeil Products Limited
N07BA01
NICOTINE
OROMUCOSAL SPRAY
NICOTINE 1 milligram(s)/dose
OTC
OTHER NERVOUS SYSTEM DRUGS
Authorised
2012-12-03
PRODUCT BRAND COMPONENT CODE VERSION DESIGN REPLACED COMP CODE MARKET DIELINE / TECH DRAWING REFERENCE COLOR ADDITIONAL INFORMATION CH020038 558x179mm GB 651540 651766 Ons 1mg Mint Leaflet NICORETTE SPRUCE MPS-c 10 pt BLACK PMS 355 J&J AD, HBG, SWE August 9, 2018 12:49:54 651540 b b c e e f a d TO LOCK NOZZLE QUICKMIST 1MG/SPRAY MOUTHSPRAY NICOTINE WHAT SHOULD YOU KNOW ABOUT NICORETTE ® QUICKMIST MOUTHSPRAY (nicotine 1 mg per spray) 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 THIS MEDICINE IS FOR NICORETTE ® QuickMist is a nicotine replacement therapy (NRT). It is used to relieve and /or prevent withdrawal symptoms and reduce the cravings you get when you try to stop smoking or when cutting down the number of cigarettes you smoke. Ideally you should always aim to stop smoking. You can use NICORETTE ® mouthspray to achieve this by using it to completely replace all your cigarettes. However NICORETTE ® mouthspray 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 and 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 motivation to quit. When making a quit attempt a behavioural support programme will increase your chances of success. WHAT DOES NICORETTE ® QUICKMIST DO? When you stop smoking your body misses the nicotine that you have been absorbing. You may experience unpleasant feelings and a strong desire to smoke (craving). This indicates that you were dependent on nicotine. When you use NICORETTE Прочитать полный документ
Version No: 9, Draft SNAS BV 3035 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette QuickMist 1mg/spray mouthspray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 0.07 ml contains 1 mg nicotine, corresponding to 1 mg nicotine/spray dose. Excipients with known effect: Ethanol ( contains less than 100 mg of ethanol/spray dose). Propylene glycol Butylated hydroxytoluene For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal spray. A clear to weakly opalescent, colourless to light yellow solution with a scent of peppermint. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicorette QuickMist relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. 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 QuickMist is indicated in pregnant and lactating women making a quit attempt. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The patient should make every effort to stop smoking completely during treatment with Nicorette QuickMist. Behavioural therapy, advice and support will normally improve the success rate. _ _ _Directions for use _ If you are using Nicorette QuickMist for the first time or if you have not used the spray for 2 days, you must first prime the spray pump. Priming 1. Point the spray safely away from you and any other adults, children or pets that are near you. 2. Press the top of the QuickMist with your index finger 3 times until a fine spray appears. Note: priming reduces the number of sprays you may get from Nicorette QuickMist. Version No: 9, Draft SNAS BV 3035 _ _ After priming, point the spray nozzle as close to the open mouth as possible. Press the top of the dispenser and release one spray into your mouth, avoiding the lips. Do not inhale while spraying to avoid getting spray down your throat. For best results, do not swallow for a few seconds after Прочитать полный документ