Regulatory Information
GSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.
GSK CONSUMER HEALTHCARE SINGAPORE PTE. LTD.
Therapeutic
Pharmacy Only
Formulation Information
LOZENGE
**How to use Nicotinell Lozenge** Begin using this product on your quit day. In order to successfully quit smoking with this treatment, you should completely stop smoking. Use 1 lozenge when urge to smoke occurs; do not use more than 1 lozenge at a time. Do not use more than 1 lozenge per hour. Do not chew or swallow the lozenge. Do not eat or drink while you have a lozenge in your mouth. Avoid drinking acidic beverages such as coffee or soda for 15 minutes prior to sucking the lozenge because they may affect the absorption of nicotine. When starting treatment, 1 lozenge may be sucked every 1–2 hours. Most people suck 8–12 lozenges per day. Do not use more than **20 pieces** of 1mg lozenges per day. If you smoke 20 or more cigarettes per day you should use the 2mg lozenge; otherwise the 1mg dose lozenge is recommended. If an adverse event occurs with the use of the higher dose form of Nicotinell lozenge, it is recommended to use the lower dose form or consult your healthcare professional. **Duration of use** For best results, you are recommended to complete the 12-week treatment course. If you are still using the lozenge after 12 weeks, you should gradually reduce the nicotine dose and discontinue when the dose has been reduced to 1–2 pieces/day. If you are still using nicotine lozenge after 6 months, talk to your healthcare professional for advice. **Nicotinell sucking technique** 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 20 – 30 minutes for lozenges). **Sucking the lozenge slowly can help to overcome some of the side effects.** The lozenge must not be chewed or swallowed. Users should not eat or drink while a lozenge is in the mouth.
ORAL
Medical Information
**What you need to know about Nicotinell Lozenge** Nicotinell Lozenge contains nicotine. When you suck the lozenge, the nicotine is slowly released and absorbed through the lining of the mouth. The lozenge can alleviate some of the unpleasant withdrawal effects that frequently occur when giving up smoking, such as cravings and irritability. The lozenge can reduce your desire to smoke and help improve your willpower to resist smoking by providing some of the nicotine previously inhaled. Nicotinell Lozenge is best suited for those with low nicotine dependency. It is not recommended for those who have found other forms of nicotine replacement therapy unsatisfactory. The nicotine dependence makes it difficult to stop smoking. The craving for cigarettes can continue for some time after you have ceased smoking. You still need to use your willpower to resist the urge to smoke. Advice and support will improve your success.
**Before using Nicotinell Lozenge** Contains aspartame, a source of phenylalanine. This may be harmful to people with an inherited metabolic disease called phenylketonuria. Contains maltitol. If you cannot tolerate maltitol, do not use this product. **Contains 9.8mg sodium per lozenge.** Not to be taken by non-smokers. Do not use if you are allergic to nicotine or any of the other ingredients in the lozenge.
N07BA01
nicotine
Manufacturer Information
gsk consumer healthcare singapore pte. ltd.
Swissco Services AG
Active Ingredients
Documents
Patient Information Leaflets
1.4.4 Nicotinell mint 1mg Lozenges (proposed).pdf
Approved: April 14, 2020