Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
NICOTINE RESIN
McNeil Healthcare (Ireland) Ltd
N07BA01
NICOTINE RESIN
4 Base Milligrams
Medicated Chewing Gum
Product not subject to medical prescription
Drugs used in nicotine dependence
Authorised
2005-01-14
Package leaflet: Information for the user 4mg medicated chewing gum freshmint 4mg medicated chewing gum freshfruit 4mg medicated chewing gum icy white 4mg 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 withdrawl symptoms when you cannot smoke, e.g. in smoke free areas such as on a plane or at the cinema. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE NICORETTE GUM X Do not use Nicorette Gum: n if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6). n if you are pregnant or breast feeding, unless advised by your doctor. n if you do not smoke n in children ! Warnings and Precautions Talk to your doctor, nurse or pharmacist before using Nicorette Gum .... n if you are in hospital because of heart disease (including heart attack, disorders of heart rate or rhythm, or stroke). n if you have high blood pressure, bad circulation. n if you have persistent indigestion or pains in the chest. n Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette Freshmint 4 mg Medicated Chewing Gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each medicated chewing gum containing 4 mg nicotine as a resin complex. For the full list of excipients see 6.1 3 PHARMACEUTICAL FORM Medicated chewing gum. A square, coated, cream coloured 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 smokers currently unable or not ready to stop smoking abruptly, Nicorette 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 Freshmint 4mg 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 Freshmint 2mg Gum is indicated. If more than 20 cigarettes per day are smoked Nicorette Freshmint 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 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. Not more that 15 pieces of the chewing gum may be used each day. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver. Administration of nicotine should be Διαβάστε το πλήρες έγγραφο