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Natural Product Number (NPN):

02091941

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Nicorette Gum

Licence holder:

Kenvue Canada Inc.

Dosage Form:

Gum

Recommended route of administration:

Buccal

Recommended use or purpose:

Fast nicotine craving relief to help you quit. NICORETTE(R) Gum is a medicine that can help you stop smoking by reducing withdrawal symptoms and nicotine cravings. NICORETTE(R) Gum is a form of Nicotine Replacement Therapy (NRT) that can help double your chances of quitting successfully. NICORETTE(R) Gum provides a lower level of nicotine to your blood than cigarettes and allows you to slowly decrease your body's need for nicotine. It works as a temporary aid to help you quit smoking by reducing nicotine withdrawal symptoms such as irritability, frustration, anxiety, difficulty in concentration and restlessness. Without these powerful urges for the cigarettes you "need", getting rid of the "habit" cigarettes becomes much easier. The good news is that NICORETTE(R) Gum contains no tar or carbon monoxide, and therefore doesn't present the same medical risks as cigarettes. It can be used to quit immediately (Stop to Quit) or to quit gradually (REDUCE TO QUIT(R)) by reducing the number of cigarettes you smoke each day. For people who have not been able to quit before, the NICORETTE(R) REDUCE TO QUIT(R) program may increase the chances of quitting by over 4 times. To increase your chances of quitting, use with a stop smoking support program as identified in the enclosed User Guide. NICORETTE(R) Gum can help double your chances of quitting successfully. Although quitting smoking is preferable, NICORETTE(R) Gum can also be used as part of a REDUCE TO QUIT(R) program in which it is used to reduce the number of cigarettes smoked prior to quitting in smokers who are not able or ready to quit abruptly. It can also be used in cases in which you temporarily refrain from smoking, for example, in smoke-free areas or in other situations when you wish to avoid smoking. Combination Nicotine Replacement Therapy - patch + as needed gum versus the nicotine patch or gum alone is: o Clinically proven to increase your chances of quitting. o A clinically proven approach to increase your chances of quitting. o If you have relapse or experience tough/intense cravings or failed with gum alone, you can use NICORETTE® gum with the patch at the same time to increase your chances of quit success. o Now you can have the combined support of NICODERM® patch and NICORETTE® as needed gum products together, for a successful quit. o Tackle cravings: NICODERM® (patch) for slow release constant support and NICORETTE as needed gum for an extra quick fix/dose when you really need to fight back the cravings / when something triggers intense cravings. o Combination therapy is 38%/1.38x more effective than using one Nicotine Replacement Therapy product alone. o Use NICODERM® patch + NICORETTE® gum together to increase your chance of quitting.

Risk Information:

Cautions and Warnings 

WARNING: Nicotine is highly addictive. Ask your doctor before use if you: have/have had heart, thyroid, circulation, stomach, throat or mouth problems, or high blood pressure; a history of epilepsy or seizures, take insulin or any prescription medicine. Before you use NICORETTE(R) Gum talk to your doctor or pharmacist if you have or have had: a tumour of the adrenal gland (phaeochromocytoma) or diabetes, because you may need to monitor yourblood sugar levels more closely than normal when you stop smoking and start using this product. Keep out ofreach of children and pets.

Contra-Indications 

Do not use if you: o are pregnant or breast feeding, unless you have consulted with a doctor or pharmacist before using this product o are under 18 years of age o have a jaw disorder, or are allergic to nicotine or to any of the non-medicinal ingredients in the product. WARNING: Do not use if you are an occasional or non-smoker.

Known Adverse Reactions 

Nicorette Gum can occasionally cause mouth or throat irritation, jaw ache, headaches, nausea, hiccups, upset stomach or dizziness. NICORETTE Gum can cause: headache, light-headedness, hiccups, upset stomach, and other stomach problems, especially if chewed too quickly or not chewed correctly, burping, increased salivation, jaw ache, unusual taste in your mouth, gingivitis, irritated or inflamed tongue, bleeding gums, tongue discoloration and sores. Other common side effects include mouth or throat soreness, but most people get used to this with ongoing use. Most of these side effects occur when you first start taking the product depending on how much you are using. Allergic reactions (including symptoms of anaphylaxis) occur rarely during use. Signs of an overdose include nausea/upset stomach, drooling, headache, abdominal pain, vomiting, diarrhea, cold sweat, dizziness, disturbed hearing and vision, mental confusion, marked weakness, fainting, rapid heartbeat or difficulty breathing. At high doses, these symptoms may be followed by low blood pressure, weak and irregular pulse, breathing difficulties, extreme exhaustion, circulatory collapse and general convulsions. If symptoms persist or get worse, or if new symptoms occur, stop use and consult a doctor.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
3-[(2S)-1-methylpyrrolidin-2-yl]pyridine	4.0 mg

List of non-medicinal ingredients:

• Acacia
• Acesulfame Potassium
• Black Iron Oxide
• Carnauba Wax
• Cinnamon flavour
• Corn starch
• D&C Yellow #10
• D&C Yellow No. 10 Lake
• Fruit flavour
• Glyceryl Monostearate
• Gum base
• Hypromellose
• Magnesium Oxide
• Menthol
• Mint flavour
• Peppermint oil
• Polysorbate 80
• Sodium carbonate
• Spearmint flavour
• Sucralose
• Titanium dioxide
• Xylitol

Date of licensing:

2007-11-21

Revised date of licence:

2025-03-12