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Natural Product Number (NPN):

80069491

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Nicorette Inhaler 10 mg

Licence holder:

Kenvue Canada Inc.

Dosage Form:

Vapour

Recommended route of administration:

Buccal

Recommended use or purpose:

NICORETTE(R) Inhaler is a medicine that can help you stop smoking by reducing withdrawal symptoms and nicotine cravings. NICORETTE(R) Inhaler is a form of Nicotine Replacement Therapy (NRT) that can help double your chances of quitting successfully. While still satisfying the hand to mouth ritual of a smoker, NICORETTE(R) Inhaler 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) Inhaler contains no tar or carbon monoxide, and therefore doesn't present the same medical risks as cigarettes. And NICORETTE(R) Inhaler can be used anywhere, e.g., on a plane, in a movie theatre or in a restaurant.

Risk Information:

Cautions and Warnings 

Ask a doctor before use if you have/have had heart disease, a heart attack, heart pain, irregular heart beat or a stroke; or have ever had high blood pressure, a history of epilepsy or seizures, blood circulation problems or treatment for circulation disorders of the brain, asthma, chronic lung problems, throat diseases, thyroid problems, stomach problems, ulcers or inflammation of the esophagus, kidney or liver disease, diabetes requiring insulin, a tumour of the adrenal gland (phaeochromocytoma) or are taking any prescription medication. Before you use NICORETTE® Inhaler talk to your doctor or pharmacist if you have diabetes, because you may need to monitor your blood sugar levels more closely than normal when you stop smoking and start using this product.

Contra-Indications 

Do not use if you are under 18 years of age, are pregnant or breastfeeding, are an occasional or no-smoker or are allergic to nicotine or any of the non-medicinal ingredients in the product.

Known Adverse Reactions 

Like all drugs, the NICORETTE(R) Inhaler can cause side effects. Many people experience mild irritation of the mouth or throat, and cough when they first use it. Stomach upset may occur. In clinical studies, the frequency of cough and mouth or throat irritation declined with the continued use of the NICORETTE(R) Inhaler. Allergic reactions (including symptoms of anaphylaxis) occur rarely during use. Signs of a nicotine overdose include bad headaches, dizziness, nausea/upset stomach, drooling, abdominal pain, vomiting, diarrhea, cold sweat, blurred vision, difficulty hearing, mental confusion, 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 you experience any of these symptoms, stop using this product and consult your doctor or local Poison Control Centre immediately. Stop using if chest pain, leg pain or irregular heartbeat occurs. 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-Methyl-2-pyrrolidinyl]pyridine	10.0 mg

List of non-medicinal ingredients:

• Ethanol
• Menthol
• Nitrogen

Date of licensing:

2016-05-17

Revised date of licence:

2024-07-29