Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nicotine
McNeil Products Ltd
N07BA01
Nicotine
2mg
Lozenge
Oromucosal
No Controlled Drug Status
Valid as a prescribable product
BNF: 04100200; GTIN: 3574660698169 3574660710656
COOLS 2 MG AND 4 MG LOZENGE NICOTINE COMPRESSED LOZENGE WHAT YOU SHOULD KNOW ABOUT NICORETTE ® COOLS LOZENGE NICORETTE ® COOLS 2 MG LOZENGE (2 MG NICOTINE COMPRESSED LOZENGE) NICORETTE ® COOLS 4 MG LOZENGE (4 MG NICOTINE COMPRESSED LOZENGE) 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 ® cools lozenge 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. NICORETTE ® cools lozenge 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 ® cools lozenge to achieve this by using it to completely replace all your cigarettes. However NICORETTE ® cools lozenge 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 motivation to quit. When making a quit attempt a behavioural support programme will increase your chances of success. WHAT DOES NICORETTE ® COOLS LOZENGE 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 unp Aqra d-dokument sħiħ
OBJECT 1 NICORETTE COOLS 2MG LOZENGE Summary of Product Characteristics Updated 02-Jun-2016 | McNeil Products Ltd 1. Name of the medicinal product Nicorette Cools 2 mg Lozenge 2. Qualitative and quantitative composition Each lozenge contains 2 mg nicotine (as nicotine resinate). For a full list of excipients, see section 6.1. 3. Pharmaceutical form Compressed lozenge. An oval, white to off-white lozenge imprinted with a n on one side and 2 on the other side. 4. Clinical particulars 4.1 Therapeutic indications Nicorette Cools 2 mg Lozenge 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 Cools 2 mg Lozenge is indicated in pregnant and lactating women making a quit attempt. 4.2 Posology and method of administration This product is suitable for smokers who smoke 20 or less cigarettes per day. _Adults and Children over 12 years of age_ This product 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 lozenge and as soon as they are able, reduce the number of lozenges used until they have stopped completely. Smokers aiming to reduce cigarettes should take the lozenge, 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. Most smokers require 8 to 12 lozenges per day, not to exceed 15 lozenges. 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 with the lozenge are recommended to contact their pharmacist or do Aqra d-dokument sħiħ