Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
NICOTINE
McNeil Products Limited
N07BA01
NICOTINE
INHALATION POWDER
NICOTINE 15 milligram(s)
OTC
OTHER NERVOUS SYSTEM DRUGS
Authorised
2013-09-27
PRODUCT BRAND COMPONENT CODE VERSION DESIGN REPLACED COMP CODE MARKET DIELINE / TECH DRAWING REFERENCE COLOR ADDITIONAL INFORMATION CH020025 560x180mm GB 651379 651536 Inhaler 15mg Leaflet NICORETTE SPRUCE LKL-g 9 pt BLACK PMS 355 PDD McNeil, HBG, SWE June 30, 2017 08:41:46 Brand: Nicorette Product: Inhaler 15mg Leaflet Component code: 651536 Version number: LKL-g 15MG INHALATOR NICOTINE INHALATION CARTRIDGES WHAT SHOULD YOU KNOW ABOUT NICORETTE ® 15MG INHALATOR (nicotine 15 mg per cartridge) 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 ® inhalator 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 ® inhalator to achieve this by using it to completely replace all your cigarettes. However NICORETTE ® inhalator can also be used in other ways, n 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, n 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 motivation to quit. When making a quit attempt a behavioural support programme will increase your chances of success. WHAT DOES NICORETTE ® INHALATOR DO? When you stop smoking or cut down the number of cigarettes you smoke, your body misses the nicotine that you have been absorbing. You may experience unpleasant feelings and a strong d Baca dokumen lengkapnya
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette 15mg Inhalator / Boots NicAssist 15 mg Inhalator. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nicotine 15mg per cartridge. For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Inhalation cartridge for oromucosal use. A white to slightly coloured porous plug in a sealed, transparent plastic tube. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicorette Inhalator 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 Inhalator is indicated in pregnant and lactating women making a quit attempt. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults and Children over 12 years of age _ Nicorette Inhalator should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur. Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Inhalator and as soon as they are able, reduce the number of cartridges used until they have stopped completely. Smokers aiming to reduce cigarettes should use the Inhalator, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible. As soon as they are ready smokers should aim to quit smoking completely. Maximum daily dose: 6 cartridges. Page 2 of 9 When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing their Inhalator are recommended to contact their pharmacist or doctor for advice. Each cartridge can be used for approximately eight 5-minute sessions, with each cartridge lasting approximately 40 minutes of intense use. The more the subject Baca dokumen lengkapnya