NICOTROL- nicotine inhalant 
Pharmacia and Upjohn Company LLC

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Nicotrol® Inhaler
(nicotine inhalation system)
10 mg per cartridge
(4 mg delivered)

An Aid to Help You
Stop Smoking

Patient Information

Read and follow carefully.

If you have questions or want more information, ask your doctor or pharmacist.

IMPORTANT INFORMATION - Read carefully

1.
NICOTROL Inhaler helps you quit smoking by reducing your urge to smoke. Success in quitting with nicotine replacement therapy (such as NICOTROL Inhaler) usually involves behavior change.
Your doctor may adjust the number of Inhaler cartridges during the first few weeks. As your body adjusts to not smoking, your doctor will either tell you to stop using the Inhaler or slowly reduce the dose.
People who use Nicotrol Inhaler with a comprehensive behavioral smoking cessation program are more successful in quitting smoking. This program can include support groups, counseling or specific behavior change techniques.
2.
Side Effects: Many people experience mild irritation of the mouth or throat and cough when they first use the Nicotrol Inhaler. Most people get used to these effects in a short time. Stomach upset may also occur.
3.
Because you are already addicted to the nicotine in cigarettes, it is possible to stay dependent on the lower dose of nicotine found in the Nicotrol Inhaler. It is important to use the Inhaler for only as long as directed by your doctor to overcome your nicotine addiction and smoking habit.

NICOTROL Inhaler Contents

Inhaler Contents

WARNINGS: Read before using NICOTROL Inhaler

1.
Commit yourself - NO SMOKING! For the NICOTROL Inhaler to help, you must be firmly committed to quitting! Stop smoking as soon as you start using the Inhaler. Do not smoke or use any other tobacco products at any time while using the NICOTROL Inhaler.
Nicotine overdose can occur. If symptoms of overdose occur, call a doctor or Poison Control Center immediately. Overdose symptoms include: bad headaches, dizziness, upset stomach, drooling, vomiting, diarrhea, cold sweat, weak and irregular pulse, blurred vision, hearing difficulties, mental confusion, weakness and fainting.
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2.
Keep out of reach of children and pets. The NICOTROL Inhaler can cause serious illness in children and pets - even in very small amounts. If a child chews on or swallows NICOTROL Inhaler cartridges, call a doctor or Poison Control Center. After a cartridge is used, throw away out of reach of children and pets. Even used cartridges contain enough nicotine to seriously harm children and pets. The NICOTROL Inhaler is a child resistant product. Please read carefully the instructions regarding how to open, close and lock.
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3.
Tell your doctor if you have:
  • heart problems (recent heart attack, irregular heartbeat, severe or worsening heart pain)
  • stomach ulcers or heartburn
  • overactive thyroid
  • high blood pressure
  • allergies to drugs
  • diabetes requiring insulin
  • kidney or liver disease
  • wheezing or asthma
  • Tell your doctor about any medicines you are taking – the dosages may need to be changed. Check with your doctor before taking any new medicine while using NICOTROL Inhaler.
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4.
If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

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BEFORE YOU USE - Read information on both sides. FOLLOW ALL DIRECTIONS Exactly!

1.

Figure Step 1

  • Follow doctor's directions.
  • Stop smoking completely during the NICOTROL Inhaler treatment program.
2.

Figure Step 2

  • Remove mouthpiece from plastic wrap.
  • Push the top and bottom together and turn the two pieces to line up the markings.
  • Pull the top and bottom apart.
3.

Figure Step 3

  • Take out cartridge tray.
  • Peel back to release 1 cartridge.
  • Insert cartridge into Inhaler.
  • Push hard on the cartridge until it pops down into place.
4.

Figure Step 4

  • Line up the markings again and push the two pieces back together so they fit tight.
  • Turn the top and bottom pieces so the markings do not line up and it is locked again.
  • Store cartridges in plastic case when not in use.
5.

Figure Step 5

  • Inhale deeply into back of throat or puff in short breaths.
  • As you inhale or puff through the mouthpiece, nicotine turns into a vapor and is absorbed into your mouth and throat.
  • Use Inhaler longer and more often at first to help control cigarette cravings.
6.

Figure Step 6

  • Nicotine in cartridges is used up after about 20 minutes of active puffing.
  • Try different schedules to help control cravings. Puffing on the Inhaler for 5 min. at a time will give you enough nicotine for 4 uses. In a few days you'll find what works best and know when nicotine in cartridges is used up.
  • Use Inhaler at room temperature (above 60°F), cold temperatures reduce amount of nicotine you inhale.
7.

Figure Step 7

  • When cartridge is empty, take off top of mouthpiece.
  • Throw used cartridge away, out of reach of children and pets.
  • When not in use keep the mouthpiece in the locked position and always store mouthpiece and cartridges in plastic case, out of reach of children and pets.
 
READ & FOLLOW:
8.
  • Side Effects: You may experience mild irritation of the mouth or throat and cough when you first use the Nicotrol Inhaler. You should get used to these effects in a short time. Stomach upset may also occur.
  • Do not use more than 16 cartridges each day unless directed to do so by your doctor.
  • Do not use longer than 6 months.
  • Store cartridges at room temperature, not to exceed 77°F (25°C).
  • If you keep cartridges in car, be careful: interiors heat up quickly.
  • Protect from light.
  • Clean mouthpiece regularly with soap and water.

QUESTIONS? Call 1-888-642-6876

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LAB-0345-4.0
Revised August 2019

Revised: 9/2019
Document Id: 377b11d2-0b84-471e-8218-1a128040afd5
Set id: 62245d7d-b50d-48d9-9f03-071c61620ccf
Version: 8
Effective Time: 20190910
 
Pharmacia and Upjohn Company LLC