Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Nicotine
Chefaro Ireland DAC
N07BA; N07BA01
Nicotine
2 milligram(s)
Medicated chewing-gum
oral use
4, 10, 30, 100 and 200
Product not subject to medical prescription
Drugs used in nicotine dependence
Drugs used in nicotine dependence; nicotine
NiQuitin Medicated Chewing Gum is used for the treatment of tobacco dependence by relief of nicotine withdrawal symptoms including cravings during a quit attempt (see section 5.1). Permanent cessation of tobacco use is the eventual objective.
Not marketed
2015-07-24
Package leaflet: Information for the user NiQuitin Tropical Fruit 2 mg and 4mg medicated chewing gum Nicotine Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your healthcare professional has told you. - Keep this leaflet. You may need to read it again. - Ask a healthcare professional e.g. doctor, nurse, smoking cessation advisor or pharmacist if you need more information or advice. - If you get any side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you have not been able to stop smoking after 9 months of treatment with NiQuitin Tropical Fruit 2 mg or 4mg Medicated Chewing Gums. - Throughout this leaflet NiQuitin Tropical Fruit 2 mg or 4 mg Medicated Chewing Gums are referred to as NiQuitin Tropical Fruit Gums. What is in this leaflet 1. What NiQuitin Tropical Fruit Gums are and what they are used for 2. What you need to know before you use NiQuitin Tropical Fruit Gums 3. How to use NiQuitin Tropical Fruit Gums 4. Possible side effects 5. How to store NiQuitin Tropical Fruit Gums 6. Contents of the pack and other information 1. What NiQuitin Tropical Fruit Gums are and what they are used for NiQuitin Tropical Fruit Gums are used to help people stop smoking. This type of treatment is called Nicotine Replacement Therapy or NRT. It is the nicotine in cigarettes that can make you physically addicted to them. • NiQuitin Tropical Fruit Gums help you to give up smoking by replacing some of the nicotine you get from cigarettes. • This nicotine relieves some of the unpleasant symptoms that smokers may have when they try to give up. These include feeling ill or irritable. • The nicotine can also relieve your cravings for a cigarette and help you to resist the urge to smoke. NiQuitin Tropical Fruit Gums do not have the health dangers of tobacco. This is because they Baca dokumen lengkapnya
Health Products Regulatory Authority 16 April 2021 CRN0096M8 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NiQuitin Tropical Fruit 2 mg medicated chewing gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewing gum contains 2 mg nicotine (equivalent to 14.20 mg nicotine resinate) Excipients with known effect: Butylated Hydroxytoluene (E321) 0.4266 mg/piece gum Sorbitol (E420) 112.60 mg/piece gum For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicated Chewing Gum Off-white rectangular pillow shaped gum and is approximately 20 x 12 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NiQuitin Tropical Fruit Medicated Chewing Gum is used for the treatment of tobacco dependence by relief of nicotine withdrawal symptoms including cravings during a quit attempt (see section 5.1). Permanent cessation of tobacco use is the eventual objective. NiQuitin Tropical Fruit Medicated Chewing Gum should preferably be used in conjunction with a behavioural support programme. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Users should make every effort to stop smoking completely during treatment with NiQuitin Tropical Fruit Medicated Chewing Gums. ADULTS (18 YEARS AND OVER) NiQuitin Tropical Fruit Medicated Chewing Gum 2mg is suitable for smokers who smoke fewer than 20 cigarettes a day. Behavioural therapy, advice and support will normally improve the success rate. The initial dosage should be individualised on the basis of the patients nicotine dependence. One piece of NiQuitin Tropical Fruit Medicated Chewing Gums should be chewed as directed whenever there is an urge to smoke, to maintain complete abstinence from smoking. Sufficient gums should be used each day usually 8-12, up to a maximum of 15. The treatment duration depends on the needs of each smoker. In general the use of the medicated chewing gum is 2- 3 months then the use of gums may be reduced gradually. When daily use is 1-2 gums, use should be stopped. Any spare gums should be retained, as cravings Baca dokumen lengkapnya