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Natural Product Number (NPN):

02247347

Market status:

Not Marketed

Licence Status:

Active

Brand name(s):

Nicorette Lozenge ;
Nicorette® Mini Lozenge

Licence holder:

Kenvue Canada Inc.

Dosage Form:

Lozenge

Recommended route of administration:

Buccal

Recommended use or purpose:

NICORETTE(R) Lozenge is a medicine that can help you stop smoking by reducing withdrawal symptoms and nicotine cravings. NICORETTE(R) Lozenge is a form of Nicotine Replacement Therapy (NRT) that can help double your chances of quitting successfully. NICORETTE(R) Lozenge 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) Lozenge contains no tar or carbon monoxide, and therefore doesn't present the same medical risks as cigarettes. NICORETTE(R) Lozenge can be used to quit immediately or to quit gradually by reducing the number of cigarettes you smoke each day before making a quit attempt. Although smoking cessation is preferable, 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 lozenge versus the nicotine patch or lozenge alone is: o Clinically proven to increase your chances of quitting. o A clinically proven approach to increase your chances of quitting. oIf you have relapse or experience tough/intense cravings or failed with lozenge alone, you can use NICORETTE® lozenge 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 lozenge products together, for a successful quit. o Tackle cravings: NICODERM® (patch) for slow release constant support and NICORETTE as needed lozenge for an extra quick fix/dose when you really need to fight back the cravings / when something triggers intense cravings. o Combination therapy is 18%/1.18x more effective than using one Nicotine Replacement Therapy product alone. o Use NICODERM® patch + NICORETTE® lozenge together to increase your chance of quitting.

Risk Information:

Cautions and Warnings 

Stop using NICORETTE® Lozenge and consult your doctor if: -mouth problems occur -chest pain or leg pain occurs, irregular heartbeat or palpitations occur, or if severe persistent stomach upset (indigestion, heartburn) develops -symptoms persist or get worse, or if new symptoms occur

Consult your doctor before using this product if you have/have had heart, thyroid, circulation, stomach problems, high blood pressure, or if you are taking insulin or any prescription medicine. If you have diabetes, you may need to monitor your blood sugar levels more closely than normal when you stop smoking and start using this product. Keep out of reach of children and pets.

Before you use NICORETTE® Lozenge talk to your doctor or pharmacist if you have/have had: -stomach ulcer or esophagitis, throat, mouth or dental problems -angina, coronary artery disease, high blood pressure, irregular heartbeat, peripheral vascular disease -kidney or liver problems, a tumour of the adrenal gland (phaeochromocytoma), treatment for circulation disorders of the brain

Contra-Indications 

Do not use if you are under 18 years of age, are pregnant or breastfeeding, are an occasional or non-smoker or are allergic to nicotine or to any of the non-medicinal ingredients in the product.

Known Adverse Reactions 

For some people, the nicotine in NICORETTE® Mini Lozenge can occasionally cause mouth or throat irritation but most people get used to this with ongoing use. It can also cause headaches, nausea, hiccups, upset stomach or dizziness. Most of these side effects occur when you first start taking the product and depend on how much you are using. If you have used too many lozenges, you may develop symptoms of overdose such as 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.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
3-[(2S)-1-methylpyrrolidin-2-yl]pyridine	2.0 mg

List of non-medicinal ingredients:

• Acesulfame Potassium
• Magnesium Stearate
• Mannitol
• Masking flavour
• Menthol flavour
• Peppermint
• Potassium Bicarbonate
• Sodium alginate
• Sodium carbonate (anhydrous)
• Water
• Xanthan Gum
• calcium polycarbophil

Date of licensing:

2007-12-13

Revised date of licence:

2024-07-26