Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NICOTINE RESINATE
JNTL (MALAYSIA) SDN. BHD.
NICOTINE RESINATE
105pieces Pieces; 15 Pieces
McNeil AB
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ NICORETTE ® ICY MINT GUM Nicotine (as resinate) (2mg and 4mg) 1 WHAT IS IN THIS LEAFLET 1. What Nicorette ® Icy Mint Gum is used for 2. How Nicorette ® Icy Mint Gum works 3. Before you use Nicorette ® Icy Mint Gum 4. How to use Nicorette ® Icy Mint Gum 5. While you are using it 6. Side effects 7. Storage and disposal of Nicorette ® Icy Mint Gum 8. Product description 9. Manufacturer and Product Registration Holders 10. Date of revision WHAT NICORETTE ® ICY MINT GUM IS USED FOR Nicorette® Icy Mint Gum is used to relieve withdrawal symptoms and reduce the cravings for nicotine that you get when you try to stop smoking. HOW NICORETTE ® ICY MINT GUM WORKS When you stop smoking, your body misses the nicotine that you have been absorbing. You may experience unpleasant feelings and a strong desire to smoke (craving). This indicates you were dependent on nicotine. When you chew Nicorette® Icy Mint Gum, nicotine is released and passes into your body through the lining of your mouth. The nicotine released from the gum is sufficient to relieve the unpleasant withdrawal symptoms such as irritability, restlessness, anxiety, and frustration. It will also help to relieve the sudden intense urge to smoke but Nicorette® Icy Mint Gum will not give you the “buzz” you get from smoking a cigarette. BEFORE YOU USE NICORETTE ® ICY MINT GUM _When you must not use it _ Do not use • If you have an allergy to nicotine or any of the other ingredients. • If you are pregnant, trying to get pregnant or think you may be pregnant. • If you are breast-feeding. Ask your doctor or pharmacist for advice. _Before you start to use it _ Talk to your doctor or pharmacist • If you have experienced a serious cardiovascular event (heart disease), or hospitalization for a cardiovascular complaint, in the previous 4 weeks (e.g., stroke, myocardial infarction, unstable angina, cardiac arrhythmia, coronary artery bypass graft and angioplasty) or if you suffer from uncontrolled hypertens Baca dokumen lengkap
NICORETTE ® ICY MINT GUM NAME OF THE PRODUCT Nicorette ® icy mint 2mg gum Nicorette ® icy mint 4mg gum ACTIVE INGREDIENT Nicotine 2mg and 4mg INACTIVE INGREDIENTS - Nicorette ® icy mint 2mg gum • nicotine (as resinate): Chewing gum base, levomenthol, acesulfame potassium, talc, magnesium oxide (light), xylitol, peppermint oil, sodium carbonate anhydrous, and sodium hydrogen carbonate. - Nicorette ® icy mint 4mg gum • nicotine (as resinate): Chewing gum base, xylitol, levomenthol, quinolone yellow E104 Al-lake, acesulfame potassium, magnesium oxide (light), peppermint oil, sodium carbonate anhydrous, and talc. PHARMACEUTICAL FORM Nicorette ® icy mint 2mg gum • nicotine (as resinate): A white coloured coated square chewing gum with a size of about 15 x 15 x 6 mm Nicorette ® icy mint 4mg gum • nicotine (as resinate): A crème coloured coated square chewing gum with a size of about 15 x 15 x 6 mm PHARMACOLOGY Pharmacodynamics Pharmacotherapeutic group: Drug used in nicotine dependence. ATC code: N07B A01 A sudden stop of smoking for long term smokers will experience the following withdrawal symptoms: urge or craving to smoke, dysphoria or depressed mood, insomnia, irritability, frustration or aggression, anxiety, difficulty in concentrating, restlessness or impatience, reduced heart rate, increased appetite or increase in weight. Clinical studies have shown that nicotine replacement products can help smokers quit or reduce their smoking by helping these withdrawal symptoms. Pharmacokinetics Nicotine administered from a piece of nicotine chewing gum depends on the quantity of nicotine released into the oral cavity and readily absorbed through the oral mucosa. Maximum blood concentration is achieved after 30 minutes of chewing and is proportionate to the concentration 20- 30 minutes after smoking a cigarette. The major eliminating organ is the liver. Greatly impaired kidney function is assumed to affect total clearance of nicotine. INDICATION Nicorette ® is used for the treatment of tobacco dependence b Baca dokumen lengkap