País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
nicotine polacrilex, Quantity: 28.4 mg
Haleon Australia Pty Ltd
Nicotine polacrilex
Gum, chewing
Excipient Ingredients: glycerol; xylitol; menthol; Acacia; sorbitol; mannitol; titanium dioxide; acesulfame potassium; purified talc; sodium carbonate; Carnauba Wax; calcium carbonate; sucralose; Flavour; butylated hydroxytoluene; polyvinyl acetate; glycerol ester of partially hydrogenated gum rosin; microcrystalline wax; polyisobutylene; synthetic terpene resin; hydrogenated vegetable oil; mono- and di- glycerides
Buccal
100 + 30, 100, 200 + 100, 30, 24, 30 + 30, 250, 200, 300
Not scheduled. Not considered by committee
Relief of nicotine withdrawal symptoms including cravings associated with smoke cessation. Nicabate Coated Gum Extra Mint may also be used as part of a smoking reduction strategy by smokers who are unable or not ready to stop smoking abruptly as a step towards stopping completely.
Visual Identification: Rectangular, white/off-white coat; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-08-28
NICABATE GUM – CONSUMER MEDICINE INFORMATION PAGE 1 OF 6 NICABATE GUM _2 MG AND 4 MG NICOTINE _ CONSUMER MEDICINE INFORMATION _PLEASE READ THIS INFORMATION BEFORE YOU START USING THIS MEDICINE. _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NICABATE Gum. It does not contain all the available information. It does not take the place of talking to your pharmacist or doctor. All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you using NICABATE Gum against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR PHARMACIST OR DOCTOR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS NICABATE GUM USED FOR? NICABATE Gum is a mint flavoured stop smoking aid. It can help you stop smoking over a few months. You can also use it to help you stop smoking more gradually over a longer period of time. It helps you give up smoking by replacing some of the nicotine you are used to getting from cigarettes. It is the nicotine in cigarettes that can make you physically addicted to them. This type of treatment is called Nicotine Replacement therapy (NRT). It contains a nicotine resin. When it is chewed, nicotine is released slowly from the resin and is absorbed through the lining of the mouth. This medicine can reduce your urge to smoke by providing some of the nicotine previously inhaled from cigarettes and helps you resist cigarettes. This nicotine also relieves many of the withdrawal symptoms such as feeling ill or irritable and cravings that you may feel when you try to give up. NICABATE Gum does not have the health dangers of tobacco because it does not contain the tar, carbon monoxide or other toxins present in cigarette smoke. If possible, when giving up smoking, NICABATE Gum should be used with a stop smoking behavioural support programme. NICABATE 2 mg Gum is suitable for smokers who smoke less than 20 cigarettes a day. NICABATE 4 mg Gum is suitable for smokers who smoke more than 2 Leer el documento completo
1 AUSTRALIAN PRODUCT INFORMATION NICABATE GUM (NICOTINE) CHEWING GUM 1 NAME OF THE MEDICINE Nicotine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient: _ _Nicotine _ Nicotine is 3-[(2S)-1-methylpyrolidin-2-yl]pyridine and is the major pharmacologically active alkaloid of tobacco. The free alkaloid is absorbed rapidly through the skin and respiratory tract. Nicotine 2 mg coated chewing gum Nicotine 4 mg coated chewing gum _Excipients: _For the full list of excipients, see section 6.1 List of Excipients._ _ 3 PHARMACEUTICAL FORM Off-white rectangular pillow-shaped coated chewing gum and is approximately 20 x 12 mm. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS For the relief of nicotine withdrawal symptoms including nicotine cravings associated with smoking cessation. It may also be used as part of a smoking reduction strategy by smokers who are unable or not ready to stop smoking abruptly as a step towards stopping completely. If possible, when stopping smoking, it should be used in conjunction with a behavioural support programme as this normally improves the success rate. 4.2 D OSE AND METHOD OF ADMINISTRATION ADULTS (18 YEARS AND OVER INCLUDING THE ELDERLY) Nicabate gum 2 mg is suitable for smokers who smoke fewer than 20 cigarettes a day. Nicabate gum 4 mg is suitable for smokers who smoke more than 20 cigarettes a day. Users should make every effort to stop smoking completely during treatment with Nicabate gum. Behavioural therapy, advice and support will normally improve the success rate. 2 Nicabate gums should be chewed as directed whenever there is an urge to smoke, to maintain complete abstinence from smoking. Users should follow the schedule of treatment in Table 1 below: TABLE 1 STEP 1 STEP 2 STEP 3 Initial treatment period. 12 weeks Step down treatment period. 2 weeks Step off treatment period 2 weeks Chew 1 piece whenever there is an urge to smoke. Use 8 – 12 pieces/day of the 2 mg strength or 8-10 pieces/day of the 4 mg strength. Gradually reduce gum use to 4 - 6 pieces/day. Use 1 Leer el documento completo