Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Nicotine
Clonmel Healthcare Ltd
N07BA; N07BA01
Nicotine
4 milligram(s)
Medicated chewing-gum
Product not subject to medical prescription
Drugs used in nicotine dependence; nicotine
Not marketed
2012-09-14
1/6 PACKAGE LEAFLET: INFORMATION FOR THE USER NICOCHEW FRUIT 2 MG MEDICATED CHEWING-GUM NICOCHEW FRUIT 4 MG 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 doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you cannot refrain from smoking after 6 months’ treatment with Nicochew Fruit. WHAT IS IN THIS LEAFLET: 1. What Nicochew Fruit is and what it is used for 2. What you need to know before you use Nicochew Fruit 3. How to use Nicochew Fruit 4. Possible side effects 5. How to store Nicochew Fruit 6. Contents of the pack and other information 1. WHAT NICOCHEW FRUIT IS AND WHAT IT IS USED FOR Nicochew Fruit is used to help people stop smoking. The nicotine in Nicochew Fruit relieves nicotine withdrawal symptoms and cravings when you stop smoking or temporarily reduce smoking in order to facilitate smoking cessation. It thereby counteracts a smoking relapse in smokers who are motivated to stop smoking. Nicochew Fruit is indicated for smokers aged 18 years and above. When you suddenly stop providing nicotine from tobacco to your body, you may feel different kinds of discomfort, called withdrawal symptoms. By means of Nicochew Fruit you can prevent or at least reduce this discomfort, by continuing to provide a small amount of nicotine to your body during a short period of time. Advice and support normally improve the success rate. You must talk to a doctor if you cannot refrain from smoking after 6 months treatment with Nicochew Fruit. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NICOCHEW FRUIT DO NOT USE NICOCHEW FRUIT - if you are allergic to nicotine or any of the other i Lugege kogu dokumenti
Health Products Regulatory Authority 10 November 2019 CRN008YJH Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicochew Fruit 4 mg medicated chewing-gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewing-gum contains 4 mg nicotine as nicotine resinate. Excipients with known effect: Each Nicochew Fruit 4 mg chewing-gum contains: Butylated hydroxytoluene up to 0.5 mg Maltitol 188 mg Sorbitol 211 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicated Chewing gum White to yellowish chewing gum, slightly convex, rectangular with an approximate size of 18x12x5 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicotine is indicated for the treatment of tobacco dependence by relieving nicotine withdrawal symptoms including cravings (see section 5.1), thereby facilitating smoking cessation or temporary smoking reduction in smokers motivated to quit smoking. Permanent cessation of tobacco use is the eventual objective. Nicochew Fruit is indicated in adults. Advice and support normally improve the success rate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The strength of the chewing-gum should be selected based on the user’s dependence on nicotine. For low nicotine dependence a 2 mg chewing-gum is indicated. For high nicotine dependence (FTND ≥ 6 or smoking of 20 cigarettes or more per day) or previous failure with 2 mg, a 4 mg chewing-gum is indicated. Initially one piece of gum can be taken every 1-2 hours. In most cases 8-12 chewing-gums a day will be sufficient. For smoking cessation the maximum daily dose is 24 chewing-gums. For smoking reduction when used in between periods of smoking the maximum daily dose is 24 chewing-gums of 2 mg or 12 chewing-gums of 4 mg. _Paediatric population_ Nicochew Fruit chewing-gum should not be used in children below 18 years of age unless prescribed by the physician. The safety and efficacy of Nicochew Fruit chewing-gum in children below 18 years of age has not been established. Health Products Regulatory A Lugege kogu dokumenti