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Natural Product Number (NPN):

80044392

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Transdermal Nicotine Patch ;
Nicotine Patch ;
Stop Smoking System 14 mg

Licence holder:

Teva Canada Limited

Dosage Form:

Patch

Recommended route of administration:

Transdermal

Recommended use or purpose:

Transdermal nicotine patch is indicated as a temporary aid to help you stop smoking by reducing withdrawal symptoms such as nicotine cravings when used as part of a smoking cessation program.

Risk Information:

Cautions and Warnings 

Keep out of reach of children and pets. Avoid becoming pregnant while using nicotine patches. If you think you are pregnant remove the nicotine patch and see your doctor. Do not use more than 10 weeks without consulting a doctor. See your Doctor before using if you: Have ever had a heart attack, angina, heart arrhythmias or a stroke. Have or have ever had high blood pressure, heart disease, thyroid problems, blood circulation or stomach problems, stomach ulcers, kidney or liver disease, diabetes requiring insulin, stoke or treatment of circulation disorders of the brain, allergies to drugs, or have had any allergies to adhesive tape or bandages. Are taking any prescription medications. The following to be included on package insert: Remove the nicotine patch and consult your doctor if you experience irregular heartbeat, chest pain, palpitations or leg pain occurs or if severe or persistent stomach upset (indigestion, heartburn) develops. If the area under the patch becomes swollen or very red, or if you develop a rash, remove the patch and call your doctor. You could be allergic to one of the components of the patch. Remove the transdermal patch 2 hours before engaging in prolonged strenuous exercise.

Known Adverse Reactions 

Nicotine patches can cause skin irritation, headache, light-headedness, insomnia, stomach upset and vivid dreams.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
3-(1-Methyl-2-pyrrolidinyl)pyridine	14.0 mg 45.75 mg

List of non-medicinal ingredients:

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

Date of licensing:

2013-08-26

Revised date of licence:

2023-03-16