Equaline Nicotine Lozenge

Nicotine polacrilex, 2 mg (nicotine)

Stop smoking aid

• each lozenge contains: sodium 15 mg
• Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge
• sugar alcohol content: 1 g mannitol per lozenge
• store at 20-25°C (68-77°F)
• keep vial closed and protect from light

Compare to Commit® active ingredient

Nicotine Polacrilex Lozenge 2 mg (nicotine)

Stop Smoking Aid

For those who smoke their first cigarette more than 30 minutes after waking up.

If you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Lozenge, 4 mg

Includes User’s Guide

Actual Size

Mint Flavor

2 mg

QuitTube

2 mg each

(# QuitTube™ containers of #)

Nicotine Polacrilex Lozenge 2 mg (nicotine) Carton

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. The amount of nicotine in a used or unused lozenge or piece of gum can be fatal to a child who accidentally sucks or chews on it. Seek emergency medical attention if this happens.

Overdose symptoms may include severe dizziness, nausea, vomiting, diarrhea, weakness, and fast heart rate.

Applies to nicotine: compounding powder, inhalation device, nasal spray, oral transmucosal gum, oral transmucosal lozenge, transdermal film extended release

General

Oral Formulations: The most commonly reported side effects were cough and irritation of the throat and mouth.
Nasal Spray: The most commonly reported side effects included nasal irritation, watering eyes, and cough.
Transdermal Patch: The most commonly reported side effects included local skin reactions (e.g., burning, edema, erythema, irritation, urticaria).[Ref]

Respiratory

Very common (10% or more): Throat irritation (up to 40%), cough (up to 32%)
Common (1% to 10%): Hiccups, nasal congestion, pharyngitis, pharyngolaryngeal pain
Uncommon (0.1% to 1%): Bronchospasm, dysphonia, dyspnea, sneezing, throat tightness, oropharyngeal pain, rhinorrhea

INHALATOR/INHALER:
Very common (10% oR more): Cough (up to 32%), rhinitis (up to 23%)
Common (1% to 10%): Sinusitis, bronchitis, hiccup

MOUTH SPRAY:
Frequency not reported: Cough, nasopharyngitis, hiccups

NASAL SPRAY:
Common (1% to 10%): Cough, throat irritation, dyspnea, epistaxis
Frequency not reported: Hiccup, sneezing, transient epistaxis, pharyngitis, hoarseness, bronchitis, bronchospasm, increased sputum oropharyngeal discomfort and pain

NICOTINE BITARTRATE LOZENGE:
Common (1% to 10%): Hiccups

TRANSDERMAL PATCH:
Common (1% to 10%): Cough
Uncommon (0.1% to 1%): Dyspnea, upper respiratory tract infections[Ref]

Nervous system

Very common (10% or more): Headache (up to 26%)
Common (1% to 10%): Burning sensation, dizziness, dysgeusia, paresthesia
Frequency not reported: Poor concentration
Postmarketing reports: Tremor, seizures

INHALATOR/INHALER:
Very common (10% or more): Headache (up to 26%)
Common (1% to 10%): Paresthesia, dizziness

MOUTH SPRAY:
Frequency not reported: Dizziness

NASAL SPRAY:
Very common (10% or more): Headache (up to 18%)
Common (1% to 10%): Dizziness, paresthesia or mouth/head/limb paresthesia
Frequency not reported: Aphasia, numbness, amnesia, migraines, impaired/poor concentration, somnolence, tremor, incoordination, transient changes in taste

NICOTINE BITARTRATE LOZENGE:
Common (1% to 10%): Dizziness, headache

TRANSDERMAL PATCH:
Common (1% to 10%): Dizziness, headache, motor dysfunction
Uncommon (0.1% to 1%): Paresthesia, dysgeusia, somnolence
Rare (0.01% to 0.1%): Tremor[Ref]

Local

NASAL SPRAY:
Very common (10% or more): Rhinorrhea/nasal irritation or discomfort (up to 94%)
Frequency not reported: Nasal congestion, sinus irritation, transient changes in the sense of smell, runny nose, nasal paresthesia, numbness of nose, nasal ulcer/blister, burning of nose or eyes

TRANSDERMAL PATCH:
Very common (10% or more): Local skin/application site reactions (up to 20%)
Uncommon (0.1% to 1%): Localized myalgia, irritation, burning, edema, pain and discomfort[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, abdominal pain/upper abdominal pain, diarrhea, dry mouth, dyspepsia, flatulence, salivary hypersecretion, constipation, vomiting, oral discomfort, stomatitis, toothache
Uncommon (0.1% to 1%): Eructation, glossitis, oral paresthesia, gingivitis, oral mucosal blistering and exfoliation
Rare (0.01% to 0.1%): Dysphagia, oral hypoesthesia, retching
Frequency not reported: Dry throat, gastrointestinal discomfort, lip pain
Postmarketing reports: Ulcerative/aphthous stomatitis

GUM:
Frequency not reported: Indigestion and heartburn

INHALATOR/INHALER:
Very common (10% or more): Dyspepsia (up to 18%)
Common (1% to 10%): Tooth disorders, taste disturbances, nausea, diarrhea, flatulence, mouth and throat irritation
Frequency not reported: Aphthous stomatitis

MOUTH SPRAY:
Frequency not reported: Constipation, mouth ulceration, gingival bleeding, mouth or throat irritation

NASAL SPRAY:
Common (1% to 10%): Nausea, vomiting, dyspepsia, constipation, stomatitis, flatulence, tooth disorder, gum problems
Frequency not reported: Gastrointestinal discomfort, abdominal pain, nausea, dry mouth, diarrhea, aphthous ulcer

NICOTINE BITARTRATE LOZENGE:
Common (1% to 10%): Nausea, flatulence, gastritis, dry mouth, stomatitis, esophagitis


TRANSDERMAL PATCH:
Common (1% to 10%): Nausea, vomiting, abdominal pain, dyspepsia
Rare (0.01% to 0.1%): Gastrointestinal discomfort, constipation, diarrhea, flatulence, dry mouth
Frequency not reported: Aphthous stomatitis[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Abnormal dreams
Frequency not reported: Dysphoria, depression/depressed mood, irritability, aggression, frustration/anger, restlessness/impatience, anxiety, cravings/urges to smoke, nighttime awakenings/sleep disturbances
Postmarketing reports: Nervousness

INHALATOR/INHALER:
Common (1% to 10%): Withdrawal symptoms/syndrome, anxiety, sleep disorder, depression, drug dependence

MOUTH SPRAY:
Frequency not reported: Dysphoria, depression/depressed mood, irritability, frustration/anger, difficulty concentrating, restlessness/impatience, insomnia, anxiety

NASAL SPRAY:
Common (1% to 10%): Anxiety, irritability, restlessness, emotional lability, insomnia, withdrawal symptoms, cravings/urges to smoke
Frequency not reported: Confusion, aggression, dysphoria, depression, apathy, nighttime awakenings/sleep disturbances, increased dreaming, feelings of dependence

NICOTINE BITARTRATE LOZENGE:
Frequency not reported: Insomnia, nicotine dependence, withdrawal symptoms

TRANSDERMAL PATCH:
Common (1% to 10%): Agitation, anxiety, nervousness, insomnia, abnormal dreams
Uncommon (0.1% to 1%): Attention disturbance, affect lability, irritability, depressed mood, confusion
Frequency not reported: Sleep disturbances[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions
Rare (0.01% to 0.1%): Allergic reactions and angioedema
Frequency not reported: Anaphylactic reactions

NASAL SPRAY:
Uncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Angioedema, anaphylactic reactions

NICOTINE BITARTRATE LOZENGE:
Rare (0.01% to 0.1%): Hypersensitivity, anaphylactic reactions

TRANSDERMAL PATCH:
Uncommon (0.1% to 1%): Hypersensitivity reaction
Rare (0.01% to 0.1%): Anaphylactic reaction, angioedema[Ref]

Other

Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Asthenia, malaise
Postmarketing reports: Influenza-type illness

GUM:
Frequency not reported: Denture damage

INHALATOR/INHALER:
Common (1% to 10%): Influenza-like symptoms, fatigue, pain, fever

NASAL SPRAY:
Uncommon (0.1% to 1%): Fatigue, malaise
Frequency not reported: Asthenia, pain, earache, calming sensation, abnormal taste or use of dosage form

TRANSDERMAL PATCH:
Uncommon (0.1% to 1%): Asthenia/asthenic conditions, malaise, fatigue[Ref]

Ocular

Frequency not reported: Blurred vision, increased lacrimation

NASAL SPRAY:
Common (1% to 10%): Increased lacrimation/watering eyes
Frequency not reported: Eye irritation, abnormal vision

TRANSDERMAL PATCH:
Uncommon (0.1% to 1%): Blurred vision[Ref]

Genitourinary

NASAL SPRAY:
Common (1% to 10%): Dysmenorrhea
Frequency not reported: Menstrual disorder[Ref]

Immunologic

INHALATOR/INHALER:
Common (1% to 10%): Allergy

NASAL SPRAY:
Frequency not reported: Allergy[Ref]

Dermatologic

Uncommon (0.1% to 1%): Flushing, hyperhidrosis, pruritus, rash, urticaria, dry skin
Frequency not reported: Erythema

NASAL SPRAY:
Common (1% to 10%): Hyperhidrosis/increased sweating, pruritus, rash, acne
Uncommon (0.1% to 1%): Flushing/facial flushing
Frequency not reported: Erythema, urticaria

NICOTINE BITARTRATE LOZENGE:
Rare (0.01% to 0.1%): Angioneurotic edema

TRANSDERMAL PATCH:
Common (1% to 10%): Pruritus, rash, urticaria with/without vesicles
Uncommon (0.1% to 1%): Flushing/hot flush, hyperhidrosis
Rare (0.01% to 0.1%): Erythema, skin discoloration, cutaneous vasculitis
Frequency not reported: Angioneurotic edema[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Palpitations, tachycardia, hypertension, chest discomfort and pain
Very rare (less than 0.01%): Reversible atrial fibrillation
Frequency not reported: Bradycardia/decreased heart rate, atrial fibrillation

INHALATOR/INHALER:
Common (1% to 10%): Chest discomfort, hypertension

NICOTINE BITARTRATE LOZENGE:
Uncommon (0.1% to 1%): Palpitations
Rare (0.01% to 0.1%): Atrial arrhythmia

MOUTH SPRAY:
Frequency not reported: Presyncopal symptoms

NASAL SPRAY:
Common (1% to 10%): Palpitations, chest discomfort/tightness and pain
Uncommon (0.1% to 1%): Hypertension
Very rare (less than 0.01%): Reversible atrial fibrillation
Frequency not reported: Tachycardia, peripheral edema, decreased heart rate/bradycardia

TRANSDERMAL PATCH:
Uncommon (0.1% to 1%): Palpitations, tachycardia, hypertension, chest discomfort and pain
Very rare (less than 0.01%): Reversible atrial fibrillation[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Jaw pain, musculoskeletal pain
Frequency not reported: Muscle tightness

INHALATOR/INHALER:
Common (1% to 10%): Myalgia, back pain, jaw and neck pain

NASAL SPRAY:
Common (1% to 10%): Back pain, arthralgia
Frequency not reported: Myalgia

TRANSDERMAL PATCH:
Common (1% to 10%): Myalgia, arthritis
Uncommon (0.1% to 1%): Arthralgia, muscle cramp, back pain
Rare (0.01% to 0.1%): Pain in extremity[Ref]

Metabolic

Frequency not reported: Increased appetite, weight gain

MOUTH SPRAY:
Frequency not reported: Increased appetite, weight gain

NASAL SPRAY:
Frequency not reported: Weight gain, increased appetite[Ref]

Hematologic

NASAL SPRAY:
Frequency not reported: Purpura[Ref]

Some side effects of nicotine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.