Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Nicotine
Clonmel Healthcare Ltd
N07BA01
Nicotine
1 mg/spray
Oromucosal spray, solution
nicotine
Not marketed
2019-11-08
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER NICOSPRAY 1MG/SPRAY OROMUCOSAL SPRAY, SOLUTION 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 have not been able to stop smoking after 6 months of treatment with Nicospray. WHAT IS IN THIS LEAFLET 1. What Nicospray is and what it is used for 2. What you need to know before you use Nicospray 3. How to use Nicospray 4. Possible side effects 5. How to store Nicospray 6. Contents of the pack and other information 1. WHAT NICOSPRAY IS AND WHAT IT IS USED FOR Nicospray is used to help you stop smoking when you want to quit. This is a type of treatment called Nicotine Replacement Therapy (NRT). Nicospray relieves nicotine withdrawal symptoms including cravings, symptoms you get when stopping smoking. When you suddenly stop providing nicotine from tobacco to your body, you get hit by different kinds of unpleasant feelings called withdrawal symptoms. By using Nicospray you can prevent or reduce these unpleasant feelings and cravings for smoking. This is because you continue to provide a small amount of nicotine to your body for a short period of time. Nicospray does not contain the tar, carbon monoxide or other toxins in cigarette smoke. To improve the chances of helping you to stop smoking, you should also seek counselling advice and support, if you can. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE NICOSPRAY DO NOT USE NICOSPRAY • If you are ALLERGIC to nicotine or any of the other ingredients of this medicine (listed in section 6). • If you are UNDER THE AGE OF 18 YEARS . Soma hati kamili
Health Products Regulatory Authority 01 September 2022 CRN00CZZ1 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nicospray 1 mg/spray oromucosal spray, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One spray delivers 1 mg nicotine in 0.07 ml solution. 1 ml solution contains 13.6 mg nicotine. Excipientwithknown effect Ethanol 7 mg/spray Propylene glycol 10.5 mg/spray Benzyl alcohol 0.018 mg/spray For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal spray, solution A clear colourless to brownish solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nicospray is to be used for the treatment of tobacco dependence in adults by relief of nicotine withdrawal symptoms, including cravings, during a quit attempt. Permanent cessation of tobacco use is the eventual objective. Nicospray should preferably be used in conjunction with a behavioural support program. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Subjects should stop smoking completely during the course of treatment with Nicospray. _Adults and Elderly_ The following chart lists the recommended usage schedule for the oromucosal spray during full treatment (Step I) and during tapering (Step II and Step III). Up to 4 sprays per hour may be used. Do not exceed 2 sprays per dosing episode and do not exceed 64 sprays (4 sprays per hour, over 16 hours) in any 24-hour period. STEP I: WEEKS 1-6 Use 1 or 2 sprays when cigarettes normally would have been smoked or if cravings emerge. If after a single spray cravings are not controlled within a few minutes, a second spray should be used. If 2 sprays are required, future doses may be delivered as 2 consecutive sprays. Most smokers will require 1-2 sprays every 30 minutes to 1 hour. STEP II: WEEKS 7-9 Start reducing the number of sprays per day. By the end of week 9 subjects should be using HALF the average number of sprays per day that was used in Step I. STEP III: WEEKS 10-12 Continue reducing the number of sprays per day so that subjects are not us Soma hati kamili