Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
nicotine, Quantity: 4 mg
Haleon Australia Pty Ltd
Nicotine
Lozenge
Excipient Ingredients: sodium alginate; purified water; magnesium stearate; calcium polycarbophil; sodium carbonate; polacrilin; mannitol; acesulfame potassium; xanthan gum; potassium bicarbonate; Flavour
Buccal
60, 20 + 20, 120, 60 + 60, 20
Not Scheduled after consideration by Committee, Not scheduled. Not considered by committee
For the relief of nicotine withdrawal symptoms including 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 smoking. It should be used as part of a behavioural support programme.
Visual Identification: White to off white oval tablet with convex surfaces. One surface bearing a debossed "F" logo.; Container Type: Tube; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2008-11-10
NICABATE MINIS MINT – CONSUMER MEDICINE INFORMATION PAGE 1 OF 5 _ _ NICABATE MINIS MINT _1.5 MG AND 4 MG NICOTINE _ _MINI LOZENGES_ CONSUMER MEDICINE INFORMATION _PLEASE READ THIS INFORMATION _ _BEFORE YOU START TAKING THIS _ _MEDICINE. _ WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about NICABATE Minis. 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 doctor or pharmacist has weighed the risks of you using NICABATE Minis against the benefits this medicine is expected to have for you. If you have any concerns about using this medicine, ask your pharmacist or doctor. KEEP THIS INFORMATION WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT ARE NICABATE MINIS USED FOR? NICABATE Minis are a stop smoking aid. They can help you stop smoking over a few months. You can also use them to help you stop smoking more gradually over a longer period of time. They help you to 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). NICABATE Minis contain a nicotine resin and, when used, nicotine is released slowly from the resin and 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. You may feel the following withdrawal symptoms when you stop smoking; anger, irritability, frustration; anxiety; difficulty concentrating; restlessness; increased appetite and or weight gain; insomnia; depression. The nicotine in NICABATE Minis may help relieve some or many of these symptoms. There are no health benefits to smoking. It is always better to give up smoking and using NRT can help. In general any possible side effects associated with NRT are far outweighed by the well-established dan Izlasiet visu dokumentu
1 AUSTRALIAN PRODUCT INFORMATION NICABATE MINIS MINT (NICOTINE) LOZENGES 1 NAME OF THE MEDICINE Nicotine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient: _ _Nicotine _ Nicotine 1.5 mg lozenge Nicotine 4 mg lozenge _Excipients: _For the full list of excipients, see section 6.1 List of Excipients._ _ 3 PHARMACEUTICAL FORM NICABATE MINIS MINT NICOTINE 1.5 MG LOZENGES White to off white oval tablet with convex surfaces; one surface bearing a debossed “L” logo. NICABATE MINIS MINT NICOTINE 4 MG LOZENGES White to off white oval tablet with convex surfaces; one surface bearing a debossed “F” logo. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS For the relief of nicotine withdrawal symptoms including 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 smoking. It should be used as part of a behavioural support programme. 4.2 D OSE AND METHOD OF ADMINISTRATION DIRECTIONS FOR USE One lozenge should be placed in the mouth and allowed to dissolve. Periodically, the lozenge should be moved from one side of the mouth to the other and repeated, until the lozenge is completely dissolved (approximately 10 – 13 minutes). The lozenge should not be chewed or swallowed whole. 2 Users should not eat or drink while a lozenge is in the mouth. ADULTS (18 YEARS AND OVER INCLUDING THE ELDERLY) ABRUPT CESSATION OF SMOKING Nicabate Minis 1.5 mg are suitable for smokers who smoke 20 cigarettes or less a day. Nicabate Minis 4 mg are suitable for smokers who smoke more than 20 cigarettes a day. Users should make every effort to stop smoking completely during treatment with Nicabate Minis. Behavioural therapy, advice and support will normally improve the success rate. Users should follow the schedule of treatment below: TABLE 1 STEP 1 WEEKS 1 TO 6 STEP 2 WEEKS 7 TO 9 STEP 3 WEEKS 10 TO 12 To help stay smoke free over the next 12 weeks: take a lozenge in situations when strongl Izlasiet visu dokumentu