البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nicotine
Omega Pharma Ltd
N07BA01
Nicotine
4mg
Medicated chewing-gum
Oromucosal
No Controlled Drug Status
Valid as a prescribable product
BNF: 04100200; GTIN: 5012616264610 5012616264634 5012616264658
2 MG OR 4 MG MEDICATED CHEWING GUM EXTRA FRESH MINT NICOTINE IN THIS LEAFLET: 1. What NiQuitin Extra Fresh Mint Gum does 2. Check before you use NIQUITIN EXTRA FRESH MINT GUM 3. How to use NIQUITIN EXTRA FRESH MINT GUM 4. Possible side-effects 5. How to store NIQUITIN EXTRA FRESH MINT GUM 6. Further information PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS MEDICINE. This medicine is available without prescription, but you still need to use NIQUITIN EXTRA FRESH MINT GUM carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask a healthcare professional (doctor, nurse, smoking cessation advisor or pharmacist). • Throughout this leaflet NIQUITIN EXTRA FRESH MINT 2 MG & 4 MG MEDICATED CHEWING GUMS are referred to as NIQUITIN EXTRA FRESH MINT GUM. 1. WHAT NIQUITIN EXTRA FRESH MINT GUM DOES 2. CHECK BEFORE YOU TAKE NIQUITIN EXTRA FRESH MINT GUM 3. HOW TO USE NIQUITIN EXTRA FRESH MINT GUM 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE NIQUITIN EXTRA FRESH MINT GUM • KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. • Do not use this medicine after the ‘EXP’ date shown on the blister pack and outer packaging. The expiry date refers to the last day of the month. • Store in the original package. • Do not store above 25˚C. • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION WHAT NIQUITIN EXTRA FRESH MINT GUM CONTAINS THE ACTIVE SUBSTANCE IS NICOTINE. Each piece of gum contains 2 mg or 4 mg (in the form of a resin complex called nicotine resinate). THE OTHER INGREDIENTS ARE chewing gum base, contains butylated hydroxytoluene (E321), Sorbitol (E420), Xylitol (E967), Calcium Carbonate (E170), Sodium Carbonate anhydrous (E500), Glycerol (E422), Acesulfame Potassium (E950), Sucralose (E995), Talc and Flavours. Coating contains Xylitol (E967), Mannitol (E421), اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NiQuitin Extra Fresh Mint 4 mg Medicated Chewing Gum. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each medicated chewing gum contains 4 mg nicotine (equivalent to 28.40 mg nicotine resinate). Excipients with known effect: Sorbitol (E420) 137.55 mg/piece gum Sodium 15.19 mg/piece gum Xylitol (E967) 353.89 mg/piece gum For full list of excipients see 6.1. 3 PHARMACEUTICAL FORM Medicated chewing gum. Off-white rectangular pillow shaped gum. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NiQuitin Extra Fresh Mint Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. This product is indicated in pregnant and lactating women making a quit attempt. NiQuitin Extra Fresh Mint Gum should preferably be used in conjunction with a behavioural support programme. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _DIRECTIONS FOR USE: _ NiQuitin Extra Fresh Mint Gum should be chewed slowly according to the instructions. NiQuitin Extra Fresh Mint 4 mg Gum is suitable for smokers who have their first cigarette of the day within 30 minutes of waking up. 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. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver. ADULTS (18 YEARS AND OVER) _ABRUPT CESSATION OF SMOKING: _ Users should make every effort to stop smoking completely during treatment with NiQuitin Extra Fresh Mint Gum. This product should be chewed as directed wheneve اقرأ الوثيقة كاملة