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Natural Product Number (NPN):

80013549

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Nicotine Transdermal System ;
Clear Transdermal Nicotine Patch ;
Nicotine Transdermal Patch ;
Nicotine Transdermal System USP ;
QUIT! ;
Quit! Transdermal Nicotine Patch

Licence holder:

Aveva Drug Delivery Systems Inc.

Dosage Form:

Patch

Recommended route of administration:

Transdermal

Recommended use or purpose:

Stop smoking aid. Reduces withdrawal symptoms, including nicotine cravings, associated with quitting smoking.

Risk Information:

Cautions and Warnings 

Do not use nicotine patches if you are an occasional smoker, are pregnant or nursing a child, are not an adult 18 years and older or have generalized skin conditions or allergies to adhesive tape or bandages. Ask a doctor before use 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, stroke or treatment of circulation disorders of the brain, allergies to drugs, or have had any allergies to adhesive tape or bandages; or, are taking any prescription medications. Do not smoke, chew nicotine gum nor use any other form of nicotine while using nicotine patches. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Do not use nicotine patches if you are pregnant or nursing a child. Avoid becoming pregnant while using nicotine patches. If you think you are pregnant, remove the nicotine patch and see your doctor. Remove the transdermal patch 2 hours before engaging in prolonged strenuous exercise.

Contra-Indications 

Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug, taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. When using this product do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch. If you have vivid dreams or other sleep disturbances, remove this patch at bedtime.

Known Adverse Reactions 

Remove the nicotine patch and consult your doctor if you experience irregular heart beat, chest pain, palpitations or leg pain occurs or if severe 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. While wearing a nicotine replacement patch, you may experience one or more of the following side effects; nausea, dizziness, dry mouth, diarrhea, nervousness or restlessness, headache, vivid dreams or other sleep disturbances, and irritability.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
Nicotine	31.5 mg		14.0   mg Nicotine

List of non-medicinal ingredients:

• Acrylate adhesive
• Aluminized polyester
• Polyester
• Silicone adhesive

Date of licensing:

2009-10-05

Revised date of licence:

2021-03-09