国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NICOTINE
JOHNSON & JOHNSON SDN BHD
NICOTINE
7 Pieces
LTS LOHMANN THERAPIE-SYSTEM AG
NICORETTE ® INVISI TRANSDERMAL PATCH Nicotine (10mg/16hr, 15mg/16hr and 25mg/16hr) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Nicorette ® Invisi Transdermal Patch is used for 2. How Nicorette ® Invisi Transdermal Patch works 3. Before you use Nicorette ® Invisi Transdermal Patch 4. How to use Nicorette ® Invisi Transdermal Patch 5. While you are using it 6. Side effects 7. Storage and Disposal of Nicorette ® Invisi Transdermal Patch 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT NICORETTE ® INVISI TRANSDERMAL PATCH IS USED FOR Nicorette ® Invisi Transdermal Patch is used to relieve withdrawal symptoms and reduce the cravings for nicotine that you get when you try to stop smoking, or when you are cutting down the number of cigarettes you smoke while trying to stop smoking. HOW NICORETTE ® INVISI TRANSDERMAL PATCH WORKS When you stop smoking, or cut down the number of cigarettes you smoke, 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 apply a Nicorette ® Invisi Transdermal Patch to the skin, nicotine is released and passes into your body. The nicotine released from the patch is sufficient to relieve the unpleasant withdrawal symptoms. It will also help to stop the craving to smoke, but Nicorette ® Invisi Transdermal Patch will not give you the “buzz” you get from smoking a cigarette. BEFORE YOU USE NICORETTE ® INVISI TRANSDERMAL PATCH - _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 card 完全なドキュメントを読む
PRODUCT BRAND COMPONENT CODE VERSION DESIGN REPLACED COMP CODE MARKET DIELINE / TECH DRAWING REFERENCE COLOR ADDITIONAL INFORMATION 239x490 mm - 2 pages MY 6509134 6512464 InvisiPatch Leaflet NICORETTE SPRUCE LKL-f 9 pkt BLACK FONTSIZE PDD McNeil, HBG, SWE October 22, 2017 12:28:44 For Healthcare Professionals Use Only Nicorette ® Invisi Transdermal Patch NAME OF THE PRODUCT Nicorette ® Invisi Transdermal Patch 10mg/16 Hours. Nicorette ® Invisi Transdermal Patch 15mg/16 Hours. Nicorette ® Invisi Transdermal Patch 25mg/16 Hours. ACTIVE INGREDIENT Nicotine 1.75mg/cm 2 INACTIVE INGREDIENTS Medium chain triglycerides, basic butylated methacrylate copolymer, polyethy- lenterephthalate film (PET), acrylic adhesive solution, potassium hydroxide, croscarmellose sodium, aluminium acetylacetonate, siliconized PET release liner with aluminized single side. PHARMACEUTICAL FORM Transparent patch for topical application available in sizes of 22.5cm 2 / 13.5cm 2 / 9.0cm 2 . Nicorette ® Invisi Transdermal Patch is a beige, semi-transparent/clear patch consisting of pre-coated backing layer, nicotine source layer, and a skin contact adhesive layer on a pre-coated aluminized and siliconized release liner. PHARMACOLOGY Pharmacodynamics Pharmacotherapeutic group: Drug used in nicotine dependence. ATC code: N07B A01 Abrupt cessation of the established, regular use of tobacco-containing products results in the characteristic syndrome, with withdrawal symptoms including cravings (urges to smoke) as described below : Regardless of the means used, a variety of symptoms are known to be associa- ted with quitting habitual tobacco use. These include emotional or cognitive effects such as dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety;difficulty concentrating, and restlessness or impatience. There may also be physical effects such as decreased heart rate; increased appetite or weight gain, dizziness or presyncopal symptoms, cough, constipation, gingival bleeding or apthous ulceration,or nasopharyngiti 完全なドキュメントを読む