Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Nicotine
Haleon Ireland Limited
N07BA; N07BA01
Nicotine
2 milligram(s)
Medicated chewing-gum
Product not subject to medical prescription
Drugs used in nicotine dependence; nicotine
Not marketed
2012-01-20
PACKAGE LEAFLET: INFORMATION FOR THE USER NICOTINELL TROPICAL FRUIT 2 MG MEDICATED CHEWING-GUM NICOTINELL TROPICAL FRUIT 4 MG MEDICATED CHEWING-GUM nicotine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your doctor or 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. WHAT IS IN THIS LEAFLET: 1. What Nicotinell Tropical Fruit is and what it is used for 2. What you need to know before you take Nicotinell Tropical Fruit 3. How to use Nicotinell Tropical Fruit 4. Possible side effects 5. How to store Nicotinell Tropical Fruit 6. Contents of the pack and other information 1. WHAT NICOTINELL TROPICAL FRUIT IS AND WHAT IT IS USED FOR Nicotinell Tropical Fruit belongs to a group of medicines which are used to help you stop smoking. Nicotinell Tropical Fruit chewing-gum contains the active substance nicotine. When chewed, nicotine is released slowly and absorbed through the lining of the mouth. This medicinal product is used to relieve nicotine craving and withdrawal symptoms in nicotine dependency. It thereby - counteracts the relapse in smoking in smokers who are motivated to stop or - facilitate smoking reduction in smokers who cannot or are reluctant to stop. Patient counselling and support normally improve the success rate. Nicotinell Tropical Fruit is indicated for smokers aged 18 years and above. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICOTINELL TROPICAL FRUIT DO NOT TAKE NICOTINELL TROPICAL FRUIT • if you are allergic to nicotine or any of the other ingredients of this medicine (listed in section 6). • if you are a non-smoker. WARNINGS AND PRECAUTIONS Talk to your doctor before using Nicotinell Tropical Fruit if you have: Διαβάστε το πλήρες έγγραφο
Health Products Regulatory Authority 18 April 2023 CRN00DGFF Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicotinell Tropical Fruit 2 mg medicated chewing-gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each piece of medicated chewing-gum contains: Active substance: 2 mg nicotine (as 10 mg nicotine polacrilin (1:4)). Excipients with known effect: sorbitol (0.1 g), sodium (11 mg) and butylhydroxytoluene (E321) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Medicated chewing-gum. The coated chewing-gum is off-white in colour and rectangular in shape. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of tobacco dependence by providing relief of nicotine craving and nicotine withdrawal symptoms, and by facilitating smoking cessation in smokers motivated to stop smoking or facilitating smoking reduction in smokers who cannot or are reluctant to stop. Patient counselling and support normally improve the success rate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS AND ELDERLY Users should stop smoking completely during treatment with Nicotinell Tropical Fruit medicated chewing-gum. The dosage should be chosen on the basis of the patient's nicotine dependence. The 4 mg medicated chewing-gum is intended to be used by smokers with a strong nicotine dependency and by those who have previously failed to stop smoking with the 2 mg gum. In other cases, the 2 mg gum shall be used. The optimal strength is selected according to the following table: Health Products Regulatory Authority 18 April 2023 CRN00DGFF Page 2 of 8 IF AN ADVERSE EVENT OCCURS WITH THE USE OF THE HIGH DOSE FORM, USE OF THE LOW DOSE FORM SHOULD BE CONSIDERED. THE INITIAL DOSAGE SHOULD BE INDIVIDUALIZED ON THE BASIS OF THE PATIENT'S NICOTINE DEPENDENCE. One piece of Nicotinell Tropical Fruit medicated chewing-gum to be chewed when the user feels the urge to smoke. Normal use is 8-12 pieces per day, up to a maximum of 24 pieces per day for the 2 mg gum. Do not use more than one gum per h Διαβάστε το πλήρες έγγραφο