NICOTROL® NS (nicotine) ADVERSE REACTIONS

(nicotine)

Prescribing Information

ADVERSE REACTIONS

Assessment of adverse events in the 730 patients who participated in controlled clinical trials is complicated by the occurrence of signs and symptoms of nicotine withdrawal in some patients and nicotine excess in others. The incidence of adverse events is confounded by the many minor complaints that smokers commonly have, by continued smoking by many patients and the local irritation from both active drug and the pepper placebo. No serious adverse events were reported during the trials.

Common Smoker's Complaints

Common complaints experienced by the smokers in the study (users of both active and placebo spray) include: chest tightness, dyspepsia, paresthesia (tingling) in limbs, constipation, and stomatitis.

Tobacco Withdrawal Symptoms

Symptoms of tobacco withdrawal were frequent in users of both active and placebo sprays. Common withdrawal symptoms seen in over 5% of patients included: anxiety, irritability, restlessness, cravings, dizziness, impaired concentration, weight increase, emotional lability, somnolence and fatigue, increased sweating, and insomnia. Less frequently seen probable withdrawal symptoms (under 5%) included: confusion, depression, apathy, tremor, increased appetite, incoordination, and increased dreaming.

Anxiety, irritability, restlessness, and tobacco cravings occurred about equally in both groups, while other symptoms tended to be slightly more common on placebo spray.

Effects of the Spray

NICOTROL NS and the pepper-containing placebo were both associated with irritant side effects on the nasopharyngeal and ocular tissues. During the first 2 days of treatment, nasal irritation was reported by nearly all (94%) of the patients, the majority of whom rated it as either moderate or severe. Both the frequency and severity of nasal irritation declined with continued use of NICOTROL NS but was still experienced by most (81%) of the patients after 3 weeks of treatment, with most patients rating it as moderate or mild.

Other common side effects for both active and placebo groups were: runny nose, throat irritation, watering eyes, sneezing, and coughing.

The following local events were reported somewhat more commonly for active than for placebo spray: nasal congestion, subjective comments related to the taste or use of the dosage form, sinus irritation, transient epistaxis, eye irritation, transient changes in sense of smell, pharyngitis, paresthesia of the nose, mouth or head, numbness of the nose, or mouth, burning of the nose or eyes, earache, facial flushing, transient changes in sense of taste, hoarseness, nasal ulcer or blister.

Effects of Nicotine

Feelings of dependence on the spray were reported by more patients on active spray than placebo. Drug-like effects such as calming were also more frequent on active spray (See DRUG ABUSE AND DEPENDENCE).

Other Adverse Effects

Adverse events which could not be classified and listed above and which were reported by >1% of patients on active spray are listed in the following table:

Adverse Events Not Attributable to Intercurrent Illness

Adverse Event	Active	Placebo
HEADACHE	18%	15%
BACK PAIN	6%	4%
DYSPNEA	5%	6%
NAUSEA	5%	5%
ARTHRALGIA	5%	1%
MENSTRUAL DISORDER	4%	4%
PALPITATION	4%	4%
FLATULENCE	4%	3%
TOOTH DISORDER	4%	1%
GUM PROBLEMS	4%	1%
MYALGIA	3%	4%
ABDOMINAL PAIN	3%	3%
CONFUSION	3%	3%
ACNE	3%	1%
DYSMENORRHEA	3%	0%
PRURITUS	2%	3%

Adverse events reported with a frequency of <1% among active spray users are listed below:

Body as a Whole: edema peripheral, pain, numbness, allergy
Gastrointestinal: dry mouth, hiccup, diarrhea
Hematologic: purpura
Neurological: aphasia, amnesia, migraine, numbness
Respiratory: bronchitis, bronchospasm, sputum increased
Skin and appendages: rash, purpura
Special Senses: vision abnormal

Adverse reactions not listed above that have been identified during post-marketing experience with the nicotine nasal spray formulation are listed below:

Gastrointestinal disorders: dysphagia

General disorders and administration site conditions: chest pain

Immune system disorders: anaphylactic reaction

Nervous system disorders: seizure

Medication Guide

NICOTROL®NS(NICOTINE NASAL SPRAY)

Nicotrol®NS (nicotine nasal spray)

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® NS Nasal Spray is designed to help you quit smoking by reducing your urge to smoke. What causes the urge to smoke? It is the nicotine in cigarettes. NICOTROL® NS contains nicotine. Your doctor may increase or decrease dosage during the first few weeks. As your body adjusts to not smoking, your doctor will either tell you to stop using NICOTROL® NS or gradually reduce your dose.

•: People who use NICOTROL® NS 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—During the first week or so most people experience the following side effects: hot, peppery feeling in back of throat or nose, sneezing, coughing, watery eyes, or runny nose. Wait 5 minutes before driving. Be sure to use regularly for the first week to help adjust to the side effects.

3.

Because nicotine is addictive, it is possible to become dependent on the Nasal Spray. It is important to use the Nasal Spray only for as long as needed to overcome your smoking habit (as directed by your doctor). Your chance of becoming dependent on the Nasal Spray increases if you use it longer than 6 months.

WARNINGS—Read before using NICOTROL® NS

1. Commit yourself—NO SMOKING! For NICOTROL® NS to help, you must be firmly committed to quitting! Stop smoking as soon as you start using NICOTROL® NS. Do not smoke or use any other tobacco product at any time while under treatment with NICOTROL® NS—nicotine overdose can occur. If symptoms of overdose occur, call a doctor or Poison Control Center. Nicotine 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
2. Keep out of reach of children and pets. NICOTROL® NS can cause serious illness in children and pets—even in very small amounts. If a child uses or handles NICOTROL® NS, call a doctor or Poison Control Center. When the bottle is empty, replace cap and throw away out of reach of children and pets. Even empty bottles contain enough nicotine to seriously harm children and pets. 3. Tell your doctor if you have:
• chronic nasal problems such as nasal allergies, inflammation, sinusitis or nasal polyps (growths) • heart problems (recent heart attack, irregular heartbeat, severe or worsening heart pain) • high blood pressure		• drug allergies • stomach ulcers or heartburn • wheezing or asthma • overactive thyroid • diabetes requiring insulin • kidney or liver disease
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® NS.
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.

FOLLOW DIRECTIONS

BEFORE YOU USE — Read information on both sides

BEFORE YOU USE—Read information on both sides

FOLLOW DOSAGE:	WHAT TO EXPECT (First Week):
• Use as directed by doctor. • But do not use more than 5 times an hour or 40 times in 24 hours. • Stop smoking completely during NICOTROL® NS treatment program.	• Hot, peppery feeling in back of throat or nose, sneezing, coughing, watery eyes, or runny nose. • To Help Adjust to Spray—use regularly for first week. • Side effects will lessen for most people in a few days—don't stop using the Nasal Spray. If side effects do not lessen after a week, call your doctor.

REMOVE CAP:	PRIME PUMP (before first use):
• Press in circles on sides of bottle. • Pull off cap as shown.	• Get a tissue or paper towel. • Hold bottle as shown. • Press up on bottom with thumb. • Pump into tissue until you see a fine spray (6 to 8 times). • Throw tissue away.
FOLLOW DIRECTIONS EXACTLY — Questions? (call 1-888-642-6876)

• Blow nose if it is not clear. • Tilt head back slightly. • Hold bottle as shown.	• Insert tip of bottle into nostril—as far as is comfortable. • Breathe through mouth. • Spray once in each nostril. Do not sniff or inhale while spraying. • If nose runs, gently sniff to keep the Nasal Spray in nose. Wait 2 or 3 minutes before blowing nose.
	AVOID contact with skin, eyes, and mouth. If bottle breaks, wear rubber gloves, wipe up with paper towel and wash surfaces thoroughly. Do not let nicotine come in contact with your skin, mouth, or eyes. If it does, rinse with plain water immediately. Nicotine overdose can occur when nicotine is absorbed through the skin. If symptoms of overdose occur (see other side for symptoms), call a doctor or Poison Control Center.
• Place cap back on bottle after use. • Store at room temperature, 59°F to 86°F (15°C to 30°C), out of reach of children. • If you don't use the Nasal Spray for 24 hours, prime pump in tissue 1 or 2 times. • Most vials of NICOTROL® NS contain 100 doses (200 sprays), but excessive priming will reduce the amount of medicine available for use. Avoid excessive priming.

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