Medication info

Champix Tablet 1 mg (Varenicline Salicylate)

Prescription medicationTabletOralExpired
Ingredient · strength
Varenicline Salicylate›1.65mg / 1 tablet
Manufacturer / importer
The U Pharmaceutical Co., Ltd.
Appearance
Light blue, bidirectional convex film-coated tablet
Packaging
28 tablets/box [14 tablets/Blister x 2]
Approval status
Expired

MFDS item code 202004814 · Approved 2020.07.02

This product's status changed to Expired on 2025.07.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Smoking cessation aid
Who takes it
Adults · Children
Adult dose
After choosing a quit date, the patient should start taking this medicine 1 week before that date. Alternatively, smoking cessation may be started between day 8 and day 35 after starting this medicine. Take this medicine after a meal with plenty of water. The recommended dose of this medicine is as follows: after dose titration over 1 week, take 1 mg twice daily. Days 1–3 0.5 mg once daily Days 4–7 0.5 mg twice daily Day 8–end of treatment 1 mg twice daily For patients who cannot tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. The treatment period is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, it is recommended to continue taking this medicine for an additional 12 weeks to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, consider gradually reducing smoking while taking this medicine. Within the first 4 weeks after starting this medicine, smoking should be reduced by 50% compared with before treatment; within the next 4 weeks, it should be reduced by a further 50%. Continue reducing smoking so that complete cessation is achieved by week 12. Continue taking this medicine for an additional 12 weeks for a total treatment period of 24 weeks. No dose adjustment is required in patients with mild (estimated creatinine clearance > 50 ml/min and ≤ 80 ml/min) to moderate (estimated creatinine clearance ≥ 30 ml/min and ≤ 50 ml/min) renal impairment. In patients with severe renal impairment (estimated creatinine clearance < 30 ml/min), the recommended starting dose of varenicline is 0.5 mg once daily. If needed, the maximum dose is 0.5 mg twice daily. In patients with end-stage renal disease receiving hemodialysis, if well tolerated, a maximum dose of 0.5 mg once daily may be administered. No dose adjustment is required in patients with hepatic impairment. In older patients, caution should be exercised when selecting the dose, as renal function is more likely to be reduced; monitoring renal function may be useful.
Child dose
Patients under 18 years of age: Use is not recommended.

Ingredients

Manufacturer
The U Pharmaceutical Co., Ltd.

Efficacy & effects

Smoking cessation aid

View approved original text

Adjunctive therapy for smoking cessation is a method used to improve smoking habits and increase the success rate of quitting smoking. This therapy includes nicotine replacement therapy, pharmacotherapy, and behavioral therapy. These therapies help alleviate withdrawal symptoms and control cravings. Combining medications with counseling can enhance the effectiveness of quitting smoking. This adjunctive therapy for smoking cessation is effective for quitting smoking.

How to take

Adult dose

After choosing a quit date, the patient should start taking this medicine 1 week before that date. Alternatively, smoking cessation may be started between day 8 and day 35 after starting this medicine. Take this medicine after a meal with plenty of water. The recommended dose of this medicine is as follows: after dose titration over 1 week, take 1 mg twice daily. Days 1–3 0.5 mg once daily Days 4–7 0.5 mg twice daily Day 8–end of treatment 1 mg twice daily For patients who cannot tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. The treatment period is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, it is recommended to continue taking this medicine for an additional 12 weeks to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, consider gradually reducing smoking while taking this medicine. Within the first 4 weeks after starting this medicine, smoking should be reduced by 50% compared with before treatment; within the next 4 weeks, it should be reduced by a further 50%. Continue reducing smoking so that complete cessation is achieved by week 12. Continue taking this medicine for an additional 12 weeks for a total treatment period of 24 weeks. No dose adjustment is required in patients with mild (estimated creatinine clearance > 50 ml/min and ≤ 80 ml/min) to moderate (estimated creatinine clearance ≥ 30 ml/min and ≤ 50 ml/min) renal impairment. In patients with severe renal impairment (estimated creatinine clearance < 30 ml/min), the recommended starting dose of varenicline is 0.5 mg once daily. If needed, the maximum dose is 0.5 mg twice daily. In patients with end-stage renal disease receiving hemodialysis, if well tolerated, a maximum dose of 0.5 mg once daily may be administered. No dose adjustment is required in patients with hepatic impairment. In older patients, caution should be exercised when selecting the dose, as renal function is more likely to be reduced; monitoring renal function may be useful.

Child dose

Patients under 18 years of age: Use is not recommended.

Precautions

This drug is used to treat nicotine addiction. When taking this drug, there may be psychiatric symptoms, such as depression, anxiety, and suicidal thoughts, so caution is needed. In particular, patients with a history of psychiatric disorders should be monitored more carefully, and if symptoms occur, they should consult a doctor immediately. Patients with allergies or hypersensitivity to this drug should not take it. Pregnant or breastfeeding women must consult a doctor before using this drug. Common side effects during treatment include nausea, headache, insomnia, and abnormal dreams, most of which are mild or temporary. This drug can also be used in patients with cardiovascular diseases, but if heart-related symptoms worsen, they should inform their doctor immediately. Caution should be taken while driving or operating machinery, as drowsiness or dizziness may occur. Additionally, alcohol consumption should be avoided or minimized while taking this drug. This drug is excreted through the kidneys, so patients with impaired kidney function may require dosage adjustments. In the case of overdose, there is no specific antidote, so appropriate treatment must be administered according to the symptoms. This drug should be kept out of reach of children, and it is safe to store it in its original container.

Side effects

  • suicidal ideation
  • suicidal behavior
  • suicide
  • changes in behavior or thought
  • depression
  • mania
  • mood changes
  • psychosis
  • aggressive behavior
  • hallucinations
Show 201 more
  • paranoia
  • delusions
  • homicidal thoughts
  • hostility
  • restlessness
  • anxiety
  • panic state
  • discomfort
  • depressive mood
  • insomnia
  • irritability
  • frustration
  • anger
  • difficulty concentrating
  • restlessness
  • decreased heart rate
  • increased appetite
  • weight gain
  • decreased platelet count
  • weight gain
  • decreased appetite
  • increased appetite
  • abnormal dreams
  • insomnia
  • abnormal thoughts
  • restlessness
  • mood changes
  • decreased libido
  • discomfort
  • mental relaxation
  • headache
  • drowsiness
  • dizziness
  • taste disorder
  • tremors
  • excessive sleepiness
  • sensory decrease
  • dysarthria
  • movement coordination disorder
  • taste impairment
  • circadian rhythm sleep disorder
  • conjunctivitis
  • eye pain
  • scotoma
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • ST segment depression in ECG
  • decreased amplitude in ECG
  • increased blood pressure
  • facial flushing
  • upper respiratory tract disorders
  • dyspnea
  • cough
  • upper respiratory tract infection
  • airway congestion
  • voice disorders
  • allergic rhinitis
  • throat irritation
  • sinus congestion
  • upper respiratory cough syndrome
  • runny nose
  • snoring
  • nausea
  • gastroesophageal reflux disease
  • vomiting
  • constipation
  • diarrhea
  • abdominal distension
  • abdominal pain
  • toothache
  • dyspepsia
  • bloating
  • dry mouth
  • blood in stool
  • gastritis
  • burping
  • aphthous stomatitis
  • gum pain
  • hematemesis
  • rash
  • itching
  • erythema
  • acne
  • hyperhidrosis
  • arthralgia
  • myalgia
  • back pain
  • muscle spasms
  • joint stiffness
  • frequent urination
  • nocturia
  • diabetes
  • polyuria
  • heavy menstrual bleeding
  • sexual dysfunction
  • chest pain
  • fatigue
  • chest discomfort
  • influenza-like illness
  • fever
  • asthenia
  • lethargy
  • abnormal liver function tests
  • anemia
  • lymphadenopathy
  • leukocytosis
  • thrombocytopenia
  • splenomegaly
  • arrhythmia
  • bradycardia
  • ventricular extrasystole
  • myocardial infarction
  • cardiac flutter
  • coronary artery disease
  • cor pulmonale
  • acute coronary syndrome
  • dizziness
  • hearing loss
  • Meniere's disease
  • thyroid disease
  • dry eyes
  • eye irritation
  • blurriness
  • vision impairment
  • acquired night blindness
  • transient vision loss
  • cataracts
  • ocular vascular disease
  • floaters
  • gingivitis
  • dysphagia
  • enterocolitis
  • gastrointestinal bleeding
  • oral ulcers
  • esophagitis
  • peptic ulcers
  • bowel obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity
  • drug hypersensitivity
  • ECG abnormalities
  • increased muscle enzymes
  • abnormal urine tests
  • diabetes mellitus
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention deficit disorder
  • sensory disorders
  • amnesia
  • migraine
  • olfactory disturbances
  • psychomotor agitation
  • restless legs syndrome
  • syncope
  • balance disorders
  • cerebrovascular events
  • seizures
  • traffic accidents
  • near traffic accidents
  • drowsiness
  • dizziness
  • loss of consciousness
  • decreased concentration
  • relief
  • sleep disturbances
  • smoking urges
  • increased irritability
  • excessive dreaming
  • neuritis
  • increased sputum
  • pneumonia exacerbation
  • arterial stenosis
  • nipple pain
  • malignant neoplasm exacerbation
  • ineffective treatment
  • unpleasant feeling
  • mental anguish
  • hair loss
  • memory disturbances
  • coldness
  • worsening condition
  • irritation
  • burning sensation
  • decreased blood pressure
  • increased blood pressure

Not everyone experiences these, and they can vary from person to person.

Storage

This drug may be sensitive to air or humidity, so it should be stored in a tightly sealed container. Additionally, it is safe to store it at room temperature, specifically between 1 to 30 degrees Celsius, away from extreme heat or cold.

Appearance and packaging

Appearance

Light blue, bidirectional convex film-coated tablet

Package unit

28 tablets/box [14 tablets/Blister x 2]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.