Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NICOTINE RESINATE
JOHNSON & JOHNSON SDN BHD
NICOTINE RESINATE
15pieces Pieces; 15pieces Pieces; 105pieces Pieces; 105pieces Pieces
McNeil AB
_Consumer Medication Information Leaflet (RiMUP) _ 1 NICORETTE ® ICY MINT GUM Nicotine (as resinate) (2mg and 4mg) 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 of nicorette ® icy mint gum 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. It will also help to stop the craving 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 hypertension (high blood pressure). • If you have sto Soma hati kamili
PRODUCT BRAND COMPONENT CODE VERSION DESIGN REPLACED COMP CODE MARKET DIELINE / TECH DRAWING REFERENCE COLOR ADDITIONAL INFORMATION CH020004 MY 651363 651674 Gum 2/4mg CEM Leaflet NICORETTE SPRUCE LKL-d BLACK PDD McNeil, HBG, SWE July 27, 2017 13:26:17 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 Abruptly interrupted use of tobacco products after a long period of daily use may give characteristic withdrawal symptoms comprising four or more of the following: 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. Urge to smoke is recognized as a clinically relevant symptom, and is an important part of the withdrawal symptoms when giving up smoking. Clinical studies have shown that nicotine replacement products can help smokers abstain from or reduce their smoking by relieving these withdrawals symptoms. Pharmacokinetics The amount of nicotine absorbed from a piece of nicotine chewing gum depends on the quantity of Soma hati kamili