Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nicotine
Novartis Consumer Health UK Ltd
N07BA01
Nicotine
2mg
Medicated chewing-gum
Oromucosal
No Controlled Drug Status
Valid as a prescribable product
BNF: 04100200; GTIN: 5051562020000
Recto Pharma code XXXX PACKAGE LEAFLET: INFORMATION FOR THE USER Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Nicotinell chewing- gum carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your doctor, nurse or pharmacist if you need more information or advice. • If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. What Nicotinell chewing-gum is and what it is used for 2. Before you take Nicotinell chewing-gum 3. How to take Nicotinell chewing-gum 4. Possible side effects 5. How to store Nicotinell chewing-gum 6. Further information 1. What Nicotinell chewing-gum is and what it is used for Nicotinell medicated chewing-gum is a nicotine replacement therapy (NRT) which is used to help you to stop smoking. It is available in two strengths (2 mg and 4 mg). This leaflet is for Nicotinell Support Icemint 2mg and 4mg medicated chewing-gum. The chewing-gum contains nicotine, which is one of the substances in tobacco. When chewed, nicotine is released slowly and absorbed through the lining of the mouth. Nicotinell chewing-gum does not contain the other harmful substances found in the tobacco smoke such as tar and carbon monoxide. Follow the chewing technique instructions in section 3 to get the best effect. The gum contains a number of ingredients which help remove dental staining, chewing Nicotinell Gums will help improve the whiteness of your teeth. Nicotinell 2mg and 4mg gums can be used to help you: • Stop smoking completely • Cut down the amount you smoke – perhaps before you go on to stop completely In addition, they may be used when you: • Do not wish to smoke. For example in confined spaces (in the car; in the house) or where others (such as children) could be harmed by tobacco smoke • Are unable to smoke • Develop cravings onc Прочетете целия документ
OBJECT 1 NICOTINELL ICEMINT 2MG MEDICATED CHEWING GUMS Summary of Product Characteristics Updated 04-Apr-2016 | GlaxoSmithKline Consumer Healthcare 1. Name of the medicinal product Nicotinell Icemint 2mg Medicated Chewing Gum 2. Qualitative and quantitative composition One piece of medicated chewing gum contains 2 mg nicotine (as 10 mg nicotine polacrilin (1:4)). For excipients, see section 6.1 3. Pharmaceutical form Medicated chewing gum. Each piece of coated chewing gum is off-white in colour and rectangular in shape. 4. Clinical particulars 4.1 Therapeutic indications Nicotinell 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. Nicotinell gum is indicated in pregnant and lactating women making a quit attempt. Nicotinell gum should preferably be used in conjunction with a behavioural support programme. 4.2 Posology and method of administration ADULTS AND ELDERLY One piece of Nicotinell gum to be chewed when the user feels the urge to smoke. Normally, 8-12 pieces per day can be used, up to a maximum of 25 pieces per day. The 2 mg chewing gum is recommended in smokers with a low to moderate nicotine dependency. The 2 mg chewing gum may not be well suited to smokers with a strong or very strong nicotine dependency. The optimal dosage form is selected according to the following table: If an adverse event is noted when high dose forms are initiated, this should be replaced by the lower dosage form. The characteristics of chewing-gum as a pharmaceutical form are such that individually different nicotine levels can result in the blood. Therefore, dosage frequency should be adjusted according to individual requirements within the stated maximum limit. Directions for use: 1. One piece of gum should be chewed until the taste becomes strong. 2. The chewing gum sh Прочетете целия документ