Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
nicotine
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
N07BA01
nicotine
20mg
Medicated Chewing Gum
Oral use
packs of 4, 10, 30, 100 and 200
Product not subject to medical prescription
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
Drugs used in nicotine dependence
It is used for the treatment of tobacco dependence by relief of nicotine withdrawal symptoms including cravings during a quit attempt. Permanent cessation of tobacco use is the eventual objective
Authorised
2015-07-24
2 PACKAGE LEAFLET: INFORMATION FOR THE USER NIQUITIN 2 MG AND 4MG MEDICATED CHEWING GUM NICOTINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your healthcare professional has told you. - Keep this leaflet. You may need to read it again. - Ask a healthcare professional e.g. doctor, nurse, smoking cessation advisor or pharmacist if you need more information or advice. - If you get any side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you have not been able to stop smoking after 9 months of treatment with NiQuitin Menthol Mint 2 mg or 4mg Medicated Chewing Gums. - Throughout this leaflet NiQuitin2 mg or 4 mg Medicated Chewing Gums are referred to as NiQuitin Medicated Gums. WHAT IS IN THIS LEAFLET 1. What NiQuitin Medicated Gums are and what they are used for 2. What you need to know before you use NiQuitin Mint Gums 3. How to use NiQuitin Medicated Gums 4. Possible side effects 5. How to store NiQuitin Medicated Gums 6. Contents of the pack and other information 1. WHAT NIQUITIN MEDICATED GUMS ARE AND WHAT THEY ARE USED FOR NiQuitin Medicated Gums are used to help people stop smoking. This type of treatment is called Nicotine Replacement Therapy or NRT. It is the nicotine in cigarettes that can make you physically addicted to them. • NiQuitin Medicated Gums help you to give up smoking by replacing some of the nicotine you get from cigarettes. • This nicotine relieves some of the unpleasant symptoms that smokers may Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Niquitin 2 mg medicated chewing gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewing gum contains 2 mg nicotine (equivalent to 14.20 mg nicotine resinate) Excipients with known effect: Butylated Hydroxytoluene (E321) 0.4266 mg/piece gum Sorbitol (E420) 148.65 mg/piece gum Sodium 10.5 mg/piece gum For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicated Chewing Gum Off-white rectangular pillow shaped gum and is approximately 20 x 12 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NiQuitin Medicated Chewing Gum is used for the treatment of tobacco dependence by relief of nicotine withdrawal symptoms including cravings during a quit attempt (see section 5.1). Permanent cessation of tobacco use is the eventual objective. NiQuitin Medicated Chewing Gum should preferably be used in conjunction with a behavioural support programme. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Users should make every effort to stop smoking completely during treatment with NiQuitin Medicated Chewing Gums. _Adults (18 years and over)_ NiQuitin Medicated Chewing Gum 2mg is suitable for smokers who smoke fewer than 20 cigarettes a day. Behavioural therapy, advice and support will normally improve the success rate. The initial dosage should be individualised on the basis of the patients nicotine dependence. One piece of NiQuitin Medicated Chewing Gums should be chewed as directed whenever there is an urge to smoke, to maintain complete abstinence from smoking. Sufficient gums should be used each day usually 8-12, up to a maximum of 15. The treatment duration depends on the needs of each smoker . In general the use of the medicated chewing gum is 2- 3 months then the use of gums may be reduc Lees het volledige document