Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Nicotine
Haleon Ireland Limited
N07BA; N07BA01
Nicotine
4 milligram(s)
Medicated chewing-gum
Product not subject to medical prescription
Drugs used in nicotine dependence; nicotine
Marketed
2001-04-06
GSK Consumer Healthcare PACKAGE LEAFLET: INFORMATION FOR THE USER NICOTINELL COOL MINT 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. This medicine is available without prescription. However, you still need to use Nicotinell Cool Mint 4 mg medicated chewing-gum carefully to get the best results from it. 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 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 contact a doctor if you still need to use Nicotinell after 9 months WHAT IS IN THIS LEAFLET: 1. What Nicotinell medicated chewing-gum is and what it is used for 2. What you need to know before you take Nicotinell medicated chewing-gum 3. How to take Nicotinell medicated chewing-gum 4. Possible side effects 5. How to store Nicotinell medicated chewing-gum 6. Contents of the pack and other information 1. WHAT NICOTINELL IS AND WHAT IT IS USED FOR Nicotinell belongs to a group of medicines which are used to help you to stop smoking. Nicotinell 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 the nicotine withdrawal symptoms in nicotine dependency, as an aid to smoking cessation. Patient counselling and support normally improve the success rate. GSK Consumer Healthcare 1.3.1- PIL Confidential Page 2 Nicotinell Mint 2 mg, 4 mg medicated chewing-gum 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICOTINELL DO NOT TAKE NICOTINELL • If you are allergic (hypersensitive) 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 Baca dokumen lengkap
Health Products Regulatory Authority 18 April 2023 CRN00DGFF Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicotinell Cool Mint 4 mg, medicated chewing-gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each piece of medicated chewing-gum contains: Active substance: 4 mg nicotine (as 20 mg nicotine – polacrilin (1:4)). Excipient(s) with known effect: sorbitol (0.1 g)and butylhydroxytoluene (E321). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicated chewing-gum. Each piece of coated medicated chewing-gum is off-white in colour and rectangular in shape. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation. The 4 mg strength is used when severe withdrawal symptoms are experienced. Patient counselling and support normally improve the success rate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS OVER 18-YEARS OLD AND ELDERLY Users should stop smoking completely during treatment with Nicotinell medicated chewing-gum. The 4 mg medicated chewing-gum is intended to be used by smokers with a strong or very strong nicotine dependency and those who have previously failed to stop smoking with the aid of nicotine replacement therapy. The optimal dosage form is selected according to the following table: If an adverse event occurs with the use of the high dose form (4 mg medicated chewing-gum), use of the low dose form (2 mg medicated chewing-gum) should be considered. The initial dosage should be individualised on the basis of the patients nicotine dependence. One piece of Nicotinell medicated chewing-gum to be chewed when the user feels the urge to smoke. If Nicotinell 4 mg medicated chewing-gum is selected, normally use 8-12 pieces per day, up to a maximum of 15 pieces per day. Do not use more than 1 gum per hour. Health Products Regulatory Authority 18 April 2023 CRN00DGFF Page 2 of 7 The characteristics of medicated chewing-gum as a pharmaceutical form are such that Baca dokumen lengkap