Nicorette Invisipatch: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

^PRNICORETTE INVISIPATCH 25 mg/16 h is a prescription strength skin patch containing nicotine which can help motivated adults stop smoking when used as part of a comprehensive stop-smoking program. Although it may be an effective aid, it is only one part of your stop smoking program.

The entire process is a stepwise 12 week program to decrease the amount of nicotine you got from smoking, specifically:

• Step 1: 25mg/16hr
• Step 2: 15mg/16 hours
• Step 3: 10mg/16hours.

See the Proper Use of this Medication section for more information on how and when to apply the patch.

The 15 and 10mg strength are available without a prescription as natural health products.

The 25 mg patch is for people who smoke at least 15 cigarettes per day.

What it does:

When you put NICORETTE INVISIPATCH on your skin, nicotine passes from the patch through the skin and then into your blood. This replaces some of the nicotine you crave from cigarettes and therefore can help to relieve withdrawal symptoms associated with quitting smoking

When it should not be used:

Do not use NICORETTE INVISIPATCH if you:

• are hypersensitive or allergic to nicotine or any ingredient in the patch (see list below)

• are using CHAMPIX (varenicline), a prescription medication for quitting smoking. The combination of

  CHAMPIX and NICORETTE INVISIPATCH is not expected to improve your chances of quitting, and may result in more side effects than with nicotine replacement systems alone.

  • have heart problems, including heart attack (myocardial infarction) or stroke, irregular heart beat (arrhythmia), severe or worsening heart pain (angina), or heart disease.
  • are under 18 years old
  • have generalized skin disorders

  • are pregnant or nursing

  • are an occasional or non-smoker

Pregnant and Nursing women

Nicotine in any form may cause harm to your unborn baby if you use nicotine while you are pregnant. Do not use NICORETTE INVISIPATCH if you are pregnant or nursing. Be careful not to become pregnant while using NICORETTE INVISIPATCH. If you think you might be pregnant, do not use NICORETTE INVISIPATCH until you have talked to your doctor.

What the medicinal ingredient is:

Nicotine

What the nonmedicinal ingredients are:

• acrylic adhesive containing Durotak 387-2051,
• Butylated methacrylate copolymer and medium-chain triglycerides,
• polyethylene terephthalate
• croscarmellose sodium
• aluminum acetylacetonate

What dosage forms it comes in:

Transdermal system (patch applied to the skin)

The 25 mg/16 hr ^Pr NICORETTE INVISIPATCH is available by prescription only.

WARNINGS AND PRECAUTIONS

NICORETTE INVISIPATCH should be kept out of the reach of children and pets, as there is enough nicotine to cause severe poisoning and even death.

BEFORE you use NICORETTE INVISIPATCH talk to your doctor or pharmacist if you have:

• allergy to any type of glue or bandage
• an ulcer
• atopic or eczematous dermatitis
• high blood pressure
• history of any kind of heart or circulation problem
• hyperthyroidism
• insulin-dependent diabetes
• kidney disease
• liver disease
• pheochromocytoma( a type of tumor)
• or are over 60 years old

The NICORETTE INVISIPATCH should be removed 2 hours before engaging in prolonged strenuous exercise. This is because the increase in skin temperature and blood flow with prolonged sustained exercise may cause your body to absorb more nicotine than usual.

You should not wear the NICORETTE INVISPATCH into the hotub, sauna, hot whirlpool spa bath; if you are sunbathing; or if you are using heating pads, electric blankets, heated water beds, heat lamps or hot water bottles. High temperatures may cause your body to absorb more nicotine than usual. For the same reason, you should also be cautious and watch for any unusual side effects if you develop a fever.

Remove the NICORETTE INVISIPATCH prior to undergoing any Magnetic Resonance Imaging (MRI) procedures to prevent the risk of burns.

INTERACTIONS WITH THIS MEDICATION

DO NOT smoke, chew tobacco, use snuff or any other form of nicotine while using the NICORETTE INVISIPATCH because you may absorb more nicotine than your body is used to, and this excess could cause harm.

Unlike other strengths, the prescription strength ^PR NICORETTE INVISIPATCH 25 mg/16 hrs should NOT be used in combination with NICORETTE 2 mg gum as this may result in overdose of nicotine.

Symptoms of nicotine overdose include: nausea, abdominal pain, vomiting, diarrhea, cold sweat, dizziness, disturbed hearing and vision, mental confusion, marked weakness, rapid heartbeat or difficulty breathing (see also the OVERDOSE section)

Drugs that may interact with NICORETTE INVISIPATCH include:

• acetaminophen
• caffeine
• Champix (smoking cessation aid)
• imipramine (eg anti-depressant)
• insulin
• isoproterenol (for treating heart block or asthma)
• labetolol (for high blood pressure)
• oxazepam (sedative)
• pentazocine (pain medication)

• phenylephrine (decongestant)

  • prazosin (for high blood pressure)
  • propanolol (for high blood pressure)
  • theophylline (eg for asthma)

Smoking may alter the effects of some medicines. Once you have quit smoking, it may be necessary for your doctor to adjust the doses of medicines you may be using. Therefore, it is important to tell your doctor or pharmacist about ALL medicines you are taking and consult them before you use NICORETTE INVISIPATCH. (See also the WARNINGS AND PRECAUTIONS section above)

PROPER USE OF THIS MEDICATION

Do not use NICORETTE INVISIPATCH if the pouch is damaged or opened.

General Considerations:

NICORETTE INVISIPATCH is applied when you wake up each day and worn during your waking hours for 16 hours. The patch is removed at bedtime or 16 hours after you applied it, in order to allow a patch-free period while you sleep.

• Stop smoking completely before you start using NICORETTE INVISIPATCH.
• Do not smoke even when you are not wearing the patch, as the nicotine in your skin will still be entering your bloodstream for several hours after you take the patch off.
• Do not use more than one patch at a time, as this may cause nicotine overdose
• The 25 mg ^PrNICORETTE INVISIPATCH is not to be used in combination with NICORETTE Gum
• Do not use the 25 mg ^PrNICORETTE INVISIPATCH for more than 8 consecutive weeks or the complete NICORETTE stepwise smoking cessation system for more than 12 consecutive weeks without consulting a doctor (see Usual Dose below).
• Stop using NICORETTE INVISIPATCH and consult your doctor if you think you are pregnant when on the smoking cessation program.
• Exercising strenuously or exposure to extreme heart (e.g. saunas, hot tubs) can cause an increase in nicotine absorption into your blood. Remove the patch before any of these activities.
• Not all adhesive products stick to all people. If the patch does not stick well or loosens after applications, tape only the edges down with first aid tape.

Usual Dose:

For those who smoke at least 15 cigarettes per day:

Step 1: Establish your quit date and do not smoke before you put your first patch on. You will begin treatment with the 25 mg ^Pr NICORETTE INVISIPATCH. Use 1 patch

daily for 8 weeks.

Step 2: Begin your weaning phase by using the 15 mg NICORETTE product for 2 weeks.

Step 3: Complete your weaning phase by using the 10 mg NICORETTE product for 2 weeks.

Nicorette Gum (2 mg) can be used in combination with the two lower doses of patches (10 and 15 mg) to help deal with cravings; see the leaflets for those products for more information.

For those who smoke less than 15 cigarettes per day:

The 25 mg ^Pr NICORETTE INVISPATCH is not for you. Instead, start with 15 mg dose (see the leaflet instructions for that dose).

Where to apply NICORETTE INVISPATCH

Select a location for application of NICORETTE INVISIPATCH, on a healthy non-hairy, clean, dry area of the upper part of your arm, or your back, shoulder or hip. Do not shave the area, as this may be irritating to the skin, when the patch is applied. Do not put the NICORETTE INVISIPATCH, on skin that is very oily, inflamed, swollen, red, burned, broken out, cut, or irritated in any way, since these conditions may alter the amount of drug absorbed.

How to apply NICORETTE INVISPATCH

You should put on a new NICORETTE INVISIPATCH each day at about the same time after you wake up so that you don't forget. The patch should be removed at bedtime to provide a patch-free (nicotine-free) period. Do not wear it for more than 16 hours each day.

1. 1. Each patch is sealed in its own protective pouch. Do not remove the NICORETTE INVISIPATCH, from the pouch until you are ready to use it because it will lose strength if stored out of the pouch. Using scissors, cut along the dotted line to open the pouch. Save the pouch, because you will use it when throwing away the

NICORETTE INVISIPATCH, at bedtime (see 6).

1. 2.

   A clear protective release liner covers the sticky side of the NICORETTE INVISIPATCH - the side that will be put on your skin. The liner has a partial cut in it to help you

   remove it from the patch. With the sticky side facing you, pull the liner away from the NICORETTE INVISIPATCH. Try not to touch the adhesive surface with your hands.

   1. 3. Immediately apply the sticky side of the NICORETTE INVISIPATCH, to your skin on a clean, dry, non-hairy portion of your upper arm, shoulder, back or hip. Firmly press down on the patch and rub it with your palm for 10-20 seconds to ensure that the patch sticks well especially around the edges.

If the NICORETTE INVISPATCH falls off, put a new one on a different skin area that is clean and dry. Remove the new patch, as usual, at bedtime.

1. 4. Rinse your hands with water (DO NOT USE SOAP, soap increases the absorption of nicotine) when you have finished applying the NICORETTE INVISIPATCH, Nicotine on your hands could get into your eyes and nose and could cause stinging, redness, or more serious problems.
2. 5. After wearing the patch, remove it before you go to bed or no longer than 16 hours from when you first applied it, thus allowing for a patch-free period during sleep. Fold the used patch in half with the sticky side together. Place it in its pouch (kept from the morning application) or place it in a piece of aluminum foil. Dispose of the used patch out of the reach of children and pets.
3. 6. The next day, choose a different place on your skin to apply a new NICORETTE INVISIPATCH, and repeat 1-6 above. The same area should not be used again for at least one week.
4. 7. Not all adhesive products stick to all people. If the patch does not stick well, or loosens after application, tape only the edges down with first aid tape.

Water and NICORETTE PATCH

The NICORETTE INVISIPATCH generally adheres firmly to the skin, so you may keep it on while bathing, swimming or showering.

Overdose:

Remove the nicotine patch and consult your doctor if you experience symptoms of overdose, including severe headaches, dizziness, severe stomach upset (indigestion, heartburn), cold sweats, blurred vision, weakness, fainting, mental confusion, irregular heart beat, chest pain, palpitations

Missed Dose:

If you forget to put your patch on in the morning, put it on as soon as you remember. Remove it at bedtime. Put on a

In case of drug overdose, contact your regional poison control centre immediately even if there are no symptoms.

new patch the next morning.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, NICORETTE INVISIPATCH, can cause some side effects. For most patients these side effects are likely to be minor and temporary. However, some may be serious.

The most common side effects experienced with NICORETTE INVISIPATCH are:

• constipation
• dry mouth
• feeling nervous
• headache
• indigestion
• mild redness, itchiness, burning at the application site
• sleeping problems

When you first put on NICORETTE INVISIPATCH, mild itching, burning or tingling is normal and should go away within an hour.

After you remove NICORETTE INVISIPATCH, the skin under the patch might be somewhat red. Your skin should not stay red for more than one day. SIDE EFFECTS, HOW

EN TH

PEN AND WHAT TO DO ABOUT

THEM

Stop using NICORETTE INVISIPATCH and contact your doctor immediately if you have an allergic reaction (including skin rash, hives, swelling, very red skin, trouble breathing) or any severe or unusual side effects. Remove the patch and, wash the area with water (do not use soap) . Do not put on a new patch. You may be allergic to one of the components of the NICORETTE INVISIPATCH. If you do become allergic to the NICORETTE INVISIPATCH you could get sick from using cigarettes or other nicotine-containing products.

This is not a complete list of side effects. For any unexpected effects while using NICORETTE

INVISIPATCH, contact your doctor or pharmacist.

HOW TO STORE IT

NICORETTE INVISIPATCH can be poisonous and extremely dangerous to children or pets if applied to the skin or swallowed. Keep used and new NICORETTE INVISIPATCH systems out of the reach of children and pets.

Keep each NICORETTE INVISPATCH in its protective pouch until you are ready to use it because the patch will lose nicotine into the air if it is stored outside the pouch.

Do not store above 25°C. Protect from light.

Remember, the inside of your car can reach temperatures much higher than this in the summer.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701D Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, McNeil Consumer Healthcare, division of Johnson & Johnson Inc. at 1-800-611-5889.

Questions about NICORETTE INVISIPATCH

1-866-311-5655

Product Monograph available to doctors and pharmacists upon request.

McNeil Consumer Healthcare, division of Johnson & Johnson INC., Markham, Canada L3R 5L2. © J&J Inc. 2011.

Last revised: February 1, 2011