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Natural Product Number (NPN):

80044503

Market status:

Marketed

Licence Status:

Active

Brand name(s):

NICODERM(R) 14 mg Step 2

Licence holder:

Kenvue Canada Inc.

Dosage Form:

Patch

Recommended route of administration:

Transdermal

Recommended use or purpose:

NICODERM® 14mg Step 2 is a medicine that can help you stop smoking by reducing withdraw symptoms and nicotine cravings. NICODERM® provides a lower level of nicotine to your blood than cigarettes, and allows you to gradually do away with 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 concentrating and restlessness. Without these powerful urges for the cigarettes you "need", getting rid of the "habit" cigarettes becomes much easier. NICODERM® provides 24 hour rate-controlled delivery of nicotine following its application to intact skin. NICODERM®) reduces the withdrawal symptoms associated with smoking cessation and thus increased the success rate of smoking cessation programs. NICODERM® is the only patch that has a rate controlling membrane, to give your body a steady supply of nicotine to help protect you against cravings. Following the first NICODERM® application, the plasma nicotine concentration rises rapidly, plateaus within 2 to 4 hours and then slowly declines until the system is removed; after which it declines more rapidly. Nicotine in the adhesive layer is absorbed into and through the skin, causing the initial rapid rise in plasma concentration. The nicotine from the reservoir is released slowly through the membrane with a constant release rate. The rate of release of nicotine for NICODERM® 14mg/24hr patch is 1.0mg/hr. Following the second daily NICODERM® system application, steady state plasma nicotine concentration is achieved and is on average 30% higher compared with single dose applications. The quit rate for NICODERM® 14mg/day was 54%. The unique feature offers 24-hour protection, even against the early morning cravings many people find the most difficult.

Combination Nicotine Replacement Therapy - Nicoderm(R) patch + as needed Nicorette(R) gum/lozenge/oral inhaler/oral mist versus mono Nicotine Replacement Therapy is: - Clinically proven to maximize your chances of quitting - A clinically proven approach to increase your chances of quitting for good -If you have a relapse or experience tough/intense cravings or failed with the patch alone, you can use the patch with as needed Nicorette(R) gum/lozenge/oral inhaler/oral mist at the same time to increase your chances of quit success. - Now you can have the combined support of NICODERM(R) patch and NICORETTE(R) as needed (gum/lozenge, oral inhaler/ oral mist) products together, for a successful quit - Tackle cravings: NICODERM(R) (patch) for slow release constant support and NICORETTE(R) ad lib (as needed gum/lozenge, oral inhaler/ oral mist) for an extra quick fix/dose when you really need to fight back the cravings / when something triggers intense cravings. - Combination therapy is 30%/1.3x more effective than using one Nicotine Replacement Therapy product alone - Use NICODERM® patch + NICORETTE® (gum/lozenge/inhaler/oral mist) together to increase your chance of quitting

Risk Information:

Cautions and Warnings 

Keep out of reach of children. DO NOT USE IF YOU: are under 18 years of age; are an occasional or non-smoker; are pregnant or nursing; have generalized skin disorders (e.g., eczema, rash); are allergic to nicotineor any of the non-medicinal ingredients. Check with your doctor or pharmacist before using NICODERM®patches if you have had any of the following: a heart attack (myocardial infarction), irregular heart beat (arrhythmia), high blood pressure, a history of epilepsy or seizures, thyroid problems, stomach problems, kidney or liver disease, treatment of circulation disorders of the brain, are taking any prescription drugs, rashes from adhesive tape or bandages, inflammation of the esophagus, heart pain (angina), stroke, heart disease, blood circulation problems, stomach ulcers, diabetes requiring insulin, allergies to drugs, skin diseases, a tumor of the adrenal gland (phaeochromocytoma). If you have diabetes, you may need to monitoryour blood sugar levels more closely than normal when you stop smoking and start using this product. Signs of an overdose include bad headaches, dizziness, nausea, abdominal pain, drooling, vomiting, diarrhea, coldsweat, blurred vision, difficulty with hearing, mental confusion, weakness and fainting, rapid heartbeat and 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.

Known Adverse Reactions 

Minor skin irritation, headache, light-headedness, insomnia, upset stomach and vivid dreams. Allergic reactions (including symptoms or anaphylaxis) occur rarely during use.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
3-(1-Methyl-2-pyrrolidinyl)pyridine	78.0 mg

List of non-medicinal ingredients:

• Ethylene Vinyl Acetate
• Polyester-1
• Polyethylene
• Polyethylene terephthalate
• Polyisobutylene

Date of licensing:

2013-08-30

Revised date of licence:

2024-07-29