البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Nicotine
Johnson & Johnson (Ireland) Limited
N07BA; N07BA01
Nicotine
2 milligram(s)
Medicated chewing-gum
Product not subject to medical prescription
Drugs used in nicotine dependence; nicotine
Marketed
2007-10-14
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 X Do not use Nicorette Gum: ■ if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6). ■ if you are pregnant or breast feeding, unless advised by your doctor. ■ If you are a non-smoker or are under 18 years of age. ! Warnings and Precautions Talk to your doctor, nurse or pharmacist before using Nicorette Gum... ■ if you are in hospital because of heart disease (including heart attack, disorders of heart rate or rhythm, or stroke). ■ if you have high blood pressure, bad circulation. ■ if you have persistent indigestion or pai اقرأ الوثيقة كاملة
Health Products Regulatory Authority 31 July 2023 CRN00D680 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicorette 2mg Medicated Chewing-gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH PIECE OF MEDIATED CHEWING GUM CONTAINS 2 MG NICOTINE AS A RESIN COMPLEX. Excipients with known effect: Each piece contains: 0.56mg Butylated hydroxytoluene (E321) 190.25mg of Sorbitol (E420) Flavour for smoker (contains Cinnamal, Cinnamyl alcohol, Citral, Citronellol, Eugenol, Geraniol, Isoeugenol, Limonene, Linalool) 11 mg/chewing gum. 0.616mg ethanol For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Medicated Chewing-gum A square, 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 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 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 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 2mg Gum is indicated. If more than 20 cigarettes per day are smoked Nicorette 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 اقرأ الوثيقة كاملة