MedPath
HSA Approval

Nicorette Icy Mint Medicated Chewing Gum 4mg

SIN14327P

Nicorette Icy Mint Medicated Chewing Gum 4mg

Nicorette Icy Mint Medicated Chewing Gum 4mg

March 12, 2013

JOHNSON & JOHNSON PTE. LTD.

JOHNSON & JOHNSON PTE. LTD.

Regulatory Information

JOHNSON & JOHNSON PTE. LTD.

JOHNSON & JOHNSON PTE. LTD.

Therapeutic

Pharmacy Only

Formulation Information

GUM, CHEWING

**HOW TO USE NICORETTE® ICY MINT GUM AND HOW MUCH** 1. **Monotherapy** _How much to use_ The initial dosage should be individualized on the basis of the smoker’s nicotine dependence. The 4 mg Nicorette® Icy Mint Gum is recommended for smokers who are highly dependent (for example smoking 20 cigarettes or more per day or smoking the first cigarette in the morning 30 minutes or less after waking up). Other smokers should begin treatment with the 2 mg dosage strength. ![Nicorette Gum Dosage Table 1](https://cdn.medpath.com/drug/dosage/20240520/b8e88d3a3c8be7599669d78993dd4f01.png) Most people use between 8 to 12 gums per day. Do not exceed the following quantity in any 24-hour period: - 2mg: 30 gums - 4mg: 24 gums Chew a piece of chewing gum when feeling the need to smoke. Each piece of Nicorette® Icy Mint Chewing Gum should be chewed slowly for approximately 30 minutes, with pauses. The gum should be chewed until a strong taste or mild burning sensation is experienced, then rested between the cheek and gums until the taste and/or sensation have disappeared, then chew again slowly and repeat. The chewing gum is chewed to release nicotine, then rested so that nicotine can be taken in through the lining of the mouth. Nicotine swallowed in the saliva is not beneficial and in excess may irritate your throat or upset your stomact causing e.g. hiccups. To avoid this, refer to the Nicorette® Chewing Gum Technique below. ![Nicorette Gum Dosage Image 1](https://cdn.medpath.com/drug/dosage/20240520/3357efb06959872a556c9176515bb14b.png) When the chewing gum has lost its strength dispose of it carefully, such as back in the hole of the blister. 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. _How long to use it_ The full course for using Nicorette® Icy Mint Gum lasts around 16 weeks, from quitting cigarettes to no longer requiring Nicorette® Icy Mint Gum. During that time you should gradually reduce your intake of nicotine, until you can do without it. We suggest that you use Nicorette® Icy Mint Gum for 12 weeks, reducing the number of pieces used in the next 4 weeks. ![Nicorette Gum Dosage Table 2](https://cdn.medpath.com/drug/dosage/20240520/0cf891acf6928e51f8df6bc90881aa05.png) Stop smoking completely at the same time in order to increase your chances of success. To help stay smoke free after treatment, some smokers may need to use the Nicorette® Icy Mint Gum in situations when they are strongly tempted to smoke. Regular use beyond 12 months is generally not recommended. 2. **Combination Therapy** Highly dependent smokers, smokers who experience ‘breakthrough’ cravings or those who have failed with single Nicotine Replacement Therapy (NRT) treatment, can use a flexible smoking cessation format, in combination with the patch for fast relief of cravings. **How to combine the use of Nicorette® Invisi Transdermal Patch with Nicorette® Icy Mint Gum 2mg:** - The treatment involves the addition of Nicorette® Icy Mint Gum 2mg to the patch. - The Nicorette® Invisi Transdermal Patch should be applied daily to an intact area of the skin upon waking and removed at bedtime, and the 2mg Gum should be used as required when cravings occur. **For heavy smokers (more than 15 cigarettes in a 24-hour period):** Use one Nicorette® Invisi Transdermal Patch 25mg/16 hours per day for 12 weeks plus the Nicorette® Icy Mint Gum 2mg. For best results, try to use at least 4 2mg Gums every day. Most people will use 5 – 6 Gums. The maximum number of 2mg Gums that can be taken in conjunction with Nicorette® Invisi Transdermal Patch is 12. The combination of Nicorette® Icy Mint Gum 2mg and Nicorette® Invisi Transdermal Patch should be used in this way for 12 weeks. After this, you should wean yourself off NRT by either: 1. Using the Nicorette® Invisi Transdermal Patch 15mg/16 hours for 2 weeks, followed by the Nicorette® Invisi Transdermal Patch 10mg/16 hours for 2 weeks, while using the same number of 2mg Gums a day that you have routinely used. Then, when a Patch is no longer needed, gradually reduce the number of 2mg Gums until you no longer need them. OR 2. Stop using the Nicorette® Invisi Transdermal Patch 25mg/16 hours, then gradually reduce the number of 2mg Gums that you use until you no longer need them. **For light smokers (less than 15 cigarettes in a 24-hour period):** Use one Nicorette® Invisi Transdermal Patch 15mg/16 hours per day for 12 weeks plus the Nicorette® Icy Mint Gum 2mg. For best results, try to use at least 4 2mg Gums every day. Most people will use 5 – 6 Gums. The maximum number of 2mg Gums that can be taken in conjunction with Nicorette® Invisi Transdermal Patch is 12. The combination of Nicorette® Icy Mint Gum 2mg and Nicorette® Invisi Transdermal Patch should be used in this way for 12 weeks. After this, you should wean yourself off NRT by either: 1. Using the Nicorette® Invisi Transdermal Patch 10mg/16 hours for 4 weeks, while using the same number of 2mg Gums a day that you have routinely used. Then, when a Patch is no longer needed, gradually reduce the number of 2mg Gums until you no longer need them. OR 2. Stop using the Nicorette® Invisi Transdermal Patch 15mg/16 hours, then gradually reduce the number of 2mg Gums that you use until you no longer need them. The Nicorette® Invisi Transdermal Patch should **NOT** be used with Nicorette® Icy Mint Gum 4mg. Smokers should stop smoking completely during the course of treatment with Nicorette® Icy Mint Gum and Nicorette® Invisi Transdermal Patch.

ORAL

Medical Information

**WHAT IS NICORETTE® ICY MINT GUM FOR?** Nicorette® Icy Mint Gum is used to relieve withdrawal symptoms and reduce the cravings for nicotine that you get when you try to stop smoking. Advice and support normally improve the success rate.

**WHEN NOT TO USE NICORETTE® ICY MINT GUM** Do not use if you have an allergy to nicotine or any of the other ingredients.

N07BA01

nicotine

Manufacturer Information

JOHNSON & JOHNSON PTE. LTD.

McNeil AB

Active Ingredients

Nicotine resinate 20mg equiv Nicotine

4mg

Nicotine

Documents

Patient Information Leaflets

Nicorette Icy Mint Medicated Chewing Gum_PIL.pdf

Approved: March 13, 2023

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