Medication info

Notin 1mg (Varenicline Salicylate)

Prescription medicationTabletOralExpired
Ingredient · strength
Varenicline Salicylate›1.65mg / 1 tablet
Manufacturer / importer
Os Korea Pharmaceutical Co., Ltd.
Appearance
Light blue, double-sided convex film-coated tablet in rectangular shape
Packaging
28 tablets/box [14 tablets/BlisterX2]
Approval status
Expired

MFDS item code 202003290 · Approved 2020.05.06

This product's status changed to Expired on 2025.05.06. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Aids to smoking cessation
Who takes it
Adults · Children
Adult dose
Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may start quitting between day 8 and day 35 after starting this medicine. Take this medicine after meals with plenty of water. The recommended dose of this medicine is as follows: after dose titration over 1 week, administer 1 mg twice daily. Days 1–3 0.5 mg once daily Days 4–7 0.5 mg twice daily Day 8 to end of treatment 1 mg twice daily Patients who cannot tolerate the adverse reactions of this medicine may temporarily or permanently reduce the dose. The treatment period is 12 weeks. For patients who successfully quit smoking with the initial 12 weeks of treatment, an additional 12 weeks of treatment with this medicine is recommended to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, consider gradual smoking cessation while taking this medicine. Reduce smoking by 50% from the amount smoked before starting treatment within the first 4 weeks after starting this medicine, and reduce it by a further 50% within the next 4 weeks. Continue to reduce smoking so that complete cessation is achieved by 12 weeks. Administer this medicine for an additional 12 weeks for a total treatment period of 24 weeks. Encourage patients to stop smoking sooner if they feel ready. Patients who fail to quit smoking during the first 12 weeks of treatment or resume smoking after treatment should review the reasons for failure and try again. However, there are no data demonstrating the efficacy of an additional 12 weeks of treatment in patients who fail to quit smoking during the initial 12 weeks of treatment or resume smoking after treatment. No dose adjustment is necessary 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, a maximum dose of 0.5 mg once daily may be administered if well tolerated. No dose adjustment is necessary in patients with hepatic impairment. In older patients, renal function is more likely to be reduced, so use caution when selecting the dose; monitoring renal function may be useful.
Child dose
Use is not recommended in patients under 18 years of age.

Ingredients

Manufacturer
Os Korea Pharmaceutical Co., Ltd.

Efficacy & effects

Aids to smoking cessation

View approved original text

The adjunctive treatment for smoking cessation helps individuals stop smoking and increases the chances of successful cessation. This adjunctive therapy may include nicotine replacement therapy, pharmacotherapy, and behavioral therapy. It alleviates withdrawal symptoms and reduces the desire to smoke. It plays a role in supporting patients throughout the overall smoking cessation process. This adjunctive therapy is used to support sustained smoking cessation.

How to take

Adult dose

Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may start quitting between day 8 and day 35 after starting this medicine. Take this medicine after meals with plenty of water. The recommended dose of this medicine is as follows: after dose titration over 1 week, administer 1 mg twice daily. Days 1–3 0.5 mg once daily Days 4–7 0.5 mg twice daily Day 8 to end of treatment 1 mg twice daily Patients who cannot tolerate the adverse reactions of this medicine may temporarily or permanently reduce the dose. The treatment period is 12 weeks. For patients who successfully quit smoking with the initial 12 weeks of treatment, an additional 12 weeks of treatment with this medicine is recommended to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, consider gradual smoking cessation while taking this medicine. Reduce smoking by 50% from the amount smoked before starting treatment within the first 4 weeks after starting this medicine, and reduce it by a further 50% within the next 4 weeks. Continue to reduce smoking so that complete cessation is achieved by 12 weeks. Administer this medicine for an additional 12 weeks for a total treatment period of 24 weeks. Encourage patients to stop smoking sooner if they feel ready. Patients who fail to quit smoking during the first 12 weeks of treatment or resume smoking after treatment should review the reasons for failure and try again. However, there are no data demonstrating the efficacy of an additional 12 weeks of treatment in patients who fail to quit smoking during the initial 12 weeks of treatment or resume smoking after treatment. No dose adjustment is necessary 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, a maximum dose of 0.5 mg once daily may be administered if well tolerated. No dose adjustment is necessary in patients with hepatic impairment. In older patients, renal function is more likely to be reduced, so use caution when selecting the dose; monitoring renal function may be useful.

Child dose

Use is not recommended in patients under 18 years of age.

Precautions

This medication is a drug that aids in smoking cessation and caution is needed as neuropsychiatric symptoms and suicidal tendencies may occur. During the intake of this medication, psychiatric symptoms such as depression, anxiety, aggression, hallucinations, and suicidal thoughts may appear; if any of these symptoms occur, the medication should be stopped immediately and a doctor should be consulted. Patients with a history of psychiatric disorders, or those who have experienced depression or suicide attempts in the past, should be observed particularly carefully. This medication is not administered to patients with hypersensitivity and pregnant or breastfeeding women should consult a doctor before use. Common side effects such as nausea, headache, insomnia, and unusual dreams may occur, but most are mild to moderate and often temporary. Patients with cardiovascular diseases may experience chest pain, myocardial infarction, and other heart-related abnormal symptoms after taking this medication; any symptoms should be reported to a doctor immediately. This medication is excreted through the kidneys, therefore dosage adjustment may be necessary for elderly patients or patients with impaired renal function. Drowsiness or dizziness may occur while driving or operating machinery, so caution is advised, and it is best to minimize or avoid alcohol consumption. Weird dreams or mood changes may occur while taking this medication; patients and caregivers should observe these changes closely. In case of overdose, standard treatment should be administered, and it should be kept out of reach of children.

Side effects

  • Suicidal ideation
  • suicidal behavior
  • suicide
  • changes in behavior or thoughts
  • depression
  • mania
  • mood swings
  • psychosis
  • aggressive behavior
  • hallucinations
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  • paranoia
  • delusions
  • homicidal ideation
  • hostility
  • agitation
  • 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 swings
  • decreased libido
  • discomfort
  • mental relaxation
  • headache
  • drowsiness
  • dizziness
  • altered taste
  • trembling
  • somnolence
  • sensory impairment
  • dysarthria
  • motor coordination disorder
  • hypogeusia
  • circadian rhythm sleep disorder
  • conjunctivitis
  • eye pain
  • scotoma
  • photophobia
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • decreased ECG voltage
  • reduced ECG amplitude
  • increased blood pressure
  • facial flushing
  • upper respiratory disorder
  • shortness of breath
  • cough
  • upper respiratory tract infection
  • airway congestion
  • voicing disability
  • 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
  • belching
  • aphthous stomatitis
  • gum pain
  • hematemesis
  • rash
  • itching
  • erythema
  • acne
  • hyperhidrosis
  • arthralgia
  • myalgia
  • back pain
  • muscle spasms
  • joint stiffness
  • frequent urination
  • nocturia
  • diabetes
  • polyuria
  • menorrhagia
  • sexual dysfunction
  • chest pain
  • fatigue
  • chest discomfort
  • influenza-like illness
  • fever
  • weakness
  • lethargy
  • liver function test abnormalities
  • anemia
  • lymphadenopathy
  • leukocytosis
  • splenomegaly
  • arrhythmia
  • bradycardia
  • ventricular extrasystole
  • myocardial infarction
  • heart flutter
  • coronary artery disease
  • pulmonary heart disease
  • acute coronary syndrome
  • dizziness
  • hearing loss
  • Meniere's disease
  • thyroid disease
  • dry eyes
  • eye irritation
  • blurred vision
  • visual impairment
  • acquired night blindness
  • transient visual loss
  • subcapsular cataract
  • ocular vascular disease
  • vitreous floaters
  • gingivitis
  • dysphagia
  • enterocolitis
  • gastrointestinal bleeding
  • oral ulcer
  • esophagitis
  • peptic ulcer
  • intestinal obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity reaction
  • drug hypersensitivity reaction
  • abnormal ECG
  • increased muscle enzymes
  • abnormal urinalysis
  • diabetes
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention deficit disorder
  • sensory dysfunction
  • amnesia
  • migraine
  • olfactory disturbance
  • psychomotor hyperactivity
  • restless legs syndrome
  • syncope
  • balance disorders
  • cerebrovascular events
  • seizures
  • facial nerve paralysis
  • mental disorders
  • multiple sclerosis
  • eye twitching
  • psychomotor dysfunction
  • transient ischemic attack
  • visual field loss
  • anxiety
  • depression
  • emotional disorders
  • irritability
  • aggression
  • agitation
  • disorientation
  • dissociation
  • euphoria
  • hallucinations
  • suicidal ideation
  • nephrolithiasis
  • abnormal urine
  • urethral syndrome
  • acute renal failure
  • urinary retention
  • erectile dysfunction
  • nasal bleeding
  • respiratory diseases
  • asthma
  • pleuritis
  • pulmonary embolism
  • dermatitis
  • dry skin
  • eczema
  • psoriasis
  • urticaria
  • photosensitivity reaction
  • hypotension
  • peripheral ischemia
  • thrombosis
  • angioedema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • seizures
  • traffic accidents
  • near traffic accidents
  • drowsiness
  • dizziness
  • loss of consciousness
  • decreased concentration
  • happiness
  • sleep disorders
  • increased irritability
  • excessive dreaming
  • neuritis
  • increased phlegm
  • pneumonia exacerbation
  • arterial stenosis
  • nipple pain
  • malignant neoplasm exacerbation
  • inadequate effect
  • unpleasant feelings
  • mental distress
  • hair loss
  • memory abnormalities
  • 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 medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and the storage temperature should maintain room temperature between 1°C and 30°C. Storing it this way will help maintain the medication's effectiveness for a long time.

Appearance and packaging

Appearance

Light blue, double-sided convex film-coated tablet in rectangular shape

Package unit

28 tablets/box [14 tablets/BlisterX2]

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.