MedPath
HSA Approval

NICORETTE QUICKMIST MOUTHSPRAY 1MG/SPRAY

SIN16567P

NICORETTE QUICKMIST MOUTHSPRAY 1MG/SPRAY

NICORETTE QUICKMIST MOUTHSPRAY 1MG/SPRAY

August 8, 2022

JOHNSON & JOHNSON PTE. LTD.

JOHNSON & JOHNSON PTE. LTD.

Regulatory Information

JOHNSON & JOHNSON PTE. LTD.

JOHNSON & JOHNSON PTE. LTD.

Therapeutic

Pharmacy Only

Formulation Information

SPRAY

**3 HOW TO TAKE NICORETTE® QUICKMIST** Always take Nicorette® QuickMist as stated in this package leaflet. You should check with your doctor or pharmacist if you are not sure. People under **18 years of age** should not use Nicorette® QuickMist, unless prescribed by a doctor. You should stop smoking completely during treatment with Nicorette® QuickMist. The following chart shows the recommended step by step process for Nicorette® QuickMist. **Step 1:** Weeks 1–6 Use 1 or 2 sprays when you would normally smoke a cigarette or have cravings to smoke. Use one spray first and if your cravings do not disappear within a few minutes use the second spray. If 2 sprays are required, future doses. may be delivered as 2 consecutive sprays. For most smokers this means about 1 or 2 sprays every 30 minutes to 1 hour. For example, if you smoke an average of 15 cigarettes per day, you should use 1 or 2 sprays at least 15 times during the day. The maximum dose is 2 sprays at a time, 3 sprays per hour and 48 sprays per day. **Step 2:** Weeks 7–9 Start reducing the number of sprays per day. By the end of week 9 you should be using HALF the average number of sprays per day that you used in Step 1. **Step 3:** Weeks 10–12 Continue reducing the number of sprays per day so that you are not using more than 3 sprays per day during week 12, Then stop using Nicorette® QuickMist. You may be tempted to smoke again after treatment has stopped. If you have a craving use one or two sprays if one spray does not help within a few minutes. Normally you should take Nicorette® QuickMist for 3 months, though no longer than 6 months. Consult your doctor or pharmacist if you need to use Nicorette® QuickMist for longer than 6 months. Save any remaining doses of the spray, as craving for smoking may suddenly occur. **Follow these instructions carefully and use the pictures to guide you** ![Nicorette QuickMist Dosage Image 1](https://cdn.medpath.com/drug/dosage/20240520/147b788e81d6e0abce35d31a2bec0a27.png) **How to open the dispenser** 1. Use your thumb to slide down the button (a) until it can be pushed **lightly** inwards (b). Do not push too hard. 2. While pushing in, slide upwards (c) to unlock the top of the dispenser. Then release the button. ![Nicorette QuickMist Dosage Image 2](https://cdn.medpath.com/drug/dosage/20240520/cf294744db87e5a0371cf3a984b95564.png) **How to load the dispenser** When you use the spray for the first time you must first load the spray pump. Point the spray nozzle safely away from you, any other adults, children or pets near you. Press the top of the QuickMist with your index finger 3 times until a fine spray appears. If you do not use the spray for 2 days, this loading procedure will need to be repeated. **How to use the dispenser** 1. Point the spray nozzle towards your open mouth and hold it as close to your mouth as possible. 2. Press the top of the QuickMist to release one spray into your mouth, avoiding the lips. To avoid getting spray down your throat do not inhale while spraying. For best results, do not swallow for a few seconds after spraying. ![Nicorette QuickMist Dosage Image 3](https://cdn.medpath.com/drug/dosage/20240520/18d076b5e44095cae1c1bcb6b5398b7f.png) **How to close the dispenser** 1. Slide the button down (d) until it can be pushed inwards (e). 2. While pushing in, slide the top of the dispenser downwards (f). Release the button. The QuickMist spray is now closed. To take another dose repeat the steps above. Close the dispenser every time after use to prevent use of the spray by children and accidental spraying. Care should be taken not to spray the eyes whilst administering the mouth spray. If the spray gets into your eyes, rinse thoroughly with water. **If you use more Nicorette® QuickMist than you should** Overdosing of nicotine may occur if you smoke at the same time as you take Nicorette® QuickMist. If a child takes Nicorette® QuickMist or if you have used more Nicorette® QuickMist than you should, contact your doctor or go to the nearest hospital **immediately.** Doses of nicotine that are tolerated by adult smokers during treatment may produce severe symptoms of poisoning in small **children** and may prove **fatal.** The symptoms of overdose are feeling sick (nausea), too much saliva, stomach pain, diarrhoea, sweating, headache, dizziness, changed hearing, and feeling very weak. At high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, difficulty breathing, extreme tiredness, circulatory collapse and general convulsions. Administration of nicotine should be stopped temporarily if any symptoms of nicotine excess occur. Nicotine intake should be decreased by either lowering dosing frequency or strength if nicotine excess symptoms persist. If you have any further questions on the use of this product, ask your doctor or pharmacist.

ORAL

Medical Information

**1 WHAT NICORETTE® QUICKMIST IS AND WHAT IT IS USED FOR** Nicorette® QuickMist is used to help you stop smoking when you want to quit. This is a type of treatment called Nicotine Replacement Therapy (NRT). Nicorette® QuickMist will give you fast relief of your cravings for nicotine and the withdrawal 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 Nicorette® QuickMist 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. Using Nicorette® QuickMist does not involve the health dangers of tobacco smoking. This is because it 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 BEFORE YOU TAKE NICORETTE® QUICKMIST** **Do not use Nicorette® QuickMist** If you are **allergic**(hypersensitive) to nicotine or any of the other ingredients in the mouth spray.

N07BA01

nicotine

Manufacturer Information

JOHNSON & JOHNSON PTE. LTD.

McNeil AB

Active Ingredients

Nicotine

1mg/spray

Nicotine

Documents

Patient Information Leaflets

1.4.4 Proposed PIL (Clean).pdf

Approved: May 31, 2023

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