البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
NICOTINE
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
4 Milligram
Medicated Chewing Gum
2005-03-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NiQuitin CQ 4 mg Mint Gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewing gum contains 4 mg nicotine (equivalent to 21.80 mg of nicotine resinate). Excipients (per gum): Sorbitol (E420) 144.41 mg Maltitol liquid (E965) 25 mg Sodium 11.4 mg For a full list of excipients , see section 6.1 3 PHARMACEUTICAL FORM Medicated chewing gum. Yellow rectangular pillow-shaped gum. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NiQuitin CQ 4 mg Mint Gum is for the relief of nicotine withdrawal symptoms as an aid to smoking cessation. It should preferably be used in conjunction with a behavioural support programme, as this normally improves the success rate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _DIRECTIONS FOR USE:_ NiQuitin CQ Mint Gum should be chewed slowly according to the instructions. NiQuitin CQ 4 mg Mint Gum is suitable for smokers who smoke more than 20 cigarettes a day. Behavioural therapy, advice and support will normally improve the success rate. The chewing gums 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 than 15 pieces of the chewing gum may be used each day. Users should not eat or drink while gum is in the mouth. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/06/2011_ _CRN 2096250_ _page number: 1_ ADULTS (18 YEARS AND OVER) _ABRUPT CESSATION OF SMOKING:_ Users should make every effort to stop smoking completely during treatment with NiQuitin CQ Mint Gum. NiQuitin CQ Mint Gum should be chewed as directed whenever there is an urge to smoke to اقرأ الوثيقة كاملة