Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
NICOTINE RESIN
McNeil Healthcare (Ireland) Ltd
N07BA01
NICOTINE RESIN
2 Milligram
Medicated Chewing Gum
Product not subject to medical prescription
Drugs used in nicotine dependence
Authorised
2005-09-09
PIL – draft SNAS BV 1471 Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER NICORETTE MINT 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. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. WHAT IS IN THIS LEAFLET 1. What Nicorette Gum is and what it is used for 2. What you need to know before you use Nicorette Gum 3. How to use Nicorette Gum 4. Possible side effects 5. How to store Nicorette Gum 6. Contents of the pack and other information 1. WHAT NICORETTE GUM IS AND WHAT IT IS USED FOR Nicorette Gum is a nicotine replacement therapy (NRT). It is used to relieve withdrawal symptoms and reduce the cravings for nicotine that you get when you try to stop smoking, or when you are cutting down the number of cigarettes you smoke while trying to stop smoking. Nicorette Gum can also be used to relieve cravings and withdrawal symptoms when you cannot smoke, e.g. in smoke free areas such as on a plane or at the cinema. Nicorette 2mg Gum can sometimes be used in combination with Nicorette Invisi 10mg and 15mg Patch for the treatment of tobacco dependence as part of a stop smoking programme. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NICORETTE GUM DO NOT USE NICORETTE GUM: IF YOU ARE ALLERGIC TO NICOTINE or any of the other ingredients of this medicine (listed in section 6). Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette Mint 2mg Medicated Chewing-gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each piece of medicated chewing gum contains 2mg nicotine as a resin complex. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Medicated Chewing-gum A square, light beige medicated chewing-gum 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms: - thereby facilitating smoking cessation in smokers motivated to quit. - Helping smokers temporarily abstain from smoking. In certain circumstances, Nicorette Mint 2mg Gum may be used in combination with Nicorette Invisi 10mg and 15mg Transdermal Patch for the treatment of tobacco dependence as part of a stop smoking programme. In smokers currently unable or not ready to stop smoking abruptly, Nicorette Mint 2mg gum may also be used as part of a programme to reduce smoking prior to stopping completely. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nicorette Mint 2mg Gum should be chewed slowly. _SMOKING CESSATION_ _ADULTS_ The strength of gum to be used will depend on the smoking habit of the individual. In general, if the patient smokes fewer than 20 cigarettes a day, Nicorette Mint 2mg Gum is indicated. If more than 20 cigarettes per day are smoked Nicorette Mint 4mg Gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking. The patient should be urged to stop smoking completely when starting therapy with Nicorette Mint 2mg Gum. The chewing gum should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Preberite celoten dokument