Medication info
Nicochems Tablet 0.5 mg (Varenicline Tartrate)

Nicochems Tablet 0.5 mg (Varenicline Tartrate)

Prescription medicationTabletOral
Ingredient · strength
Varenicline Salicylate›0.825mg / 1 tablet
Manufacturer / importer
Jeil Health Science Co., Ltd.
Appearance
White or grayish white, biconvex, rectangular film-coated tablet
Packaging
11 tablets (11 tablets/BlisterX1)
Approval status
Active

MFDS item code 202002939 · Approved 2020.04.23

Summary

Main use
Smoking cessation aid
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 smoking cessation between day 8 and day 35 after starting this medicine. This medicine should be taken after a meal with plenty of water. The recommended dose of this medicine is as follows: after dose titration over 1 week, administer 1 mg 2 times daily. Days 1 – 3 0.5 mg once daily Days 4 – 7 0.5 mg 2 times daily Day 8 – end of treatment 1 mg 2 times daily For patients who cannot tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. The treatment period for this medicine is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, it is recommended that this medicine be administered for an additional 12 weeks to increase the likelihood of long-term smoking cessation. For patients who cannot or do not wish to stop smoking abruptly, gradual smoking cessation while taking this medicine may be considered. Within the first 4 weeks after starting this medicine, patients should reduce their smoking by 50% compared with before starting treatment, and reduce it by a further 50% within the following 4 weeks. Smoking should continue to be reduced so that complete smoking cessation is achieved by week 12. 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 with the first 12 weeks of treatment, or who 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 failed to quit smoking during the first 12 weeks of treatment or resumed smoking after treatment. 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 2 times 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 required in patients with hepatic impairment. In elderly patients, renal function is more likely to be reduced, so care should be taken when selecting the dose; monitoring renal function may be useful.
Child dose
Administration is not recommended in patients under 18 years of age.

Ingredients

Manufacturer
Jeil Health Science Co., Ltd.

Efficacy & effects

Smoking cessation aid

View approved original text

This medication is used as an adjunct therapy in treatment methods for smoking cessation, aiding the will to quit smoking and alleviating withdrawal symptoms. It plays a role in helping patients increase their chances of quitting smoking successfully.

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 smoking cessation between day 8 and day 35 after starting this medicine. This medicine should be taken after a meal with plenty of water. The recommended dose of this medicine is as follows: after dose titration over 1 week, administer 1 mg 2 times daily. Days 1 – 3 0.5 mg once daily Days 4 – 7 0.5 mg 2 times daily Day 8 – end of treatment 1 mg 2 times daily For patients who cannot tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. The treatment period for this medicine is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, it is recommended that this medicine be administered for an additional 12 weeks to increase the likelihood of long-term smoking cessation. For patients who cannot or do not wish to stop smoking abruptly, gradual smoking cessation while taking this medicine may be considered. Within the first 4 weeks after starting this medicine, patients should reduce their smoking by 50% compared with before starting treatment, and reduce it by a further 50% within the following 4 weeks. Smoking should continue to be reduced so that complete smoking cessation is achieved by week 12. 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 with the first 12 weeks of treatment, or who 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 failed to quit smoking during the first 12 weeks of treatment or resumed smoking after treatment. 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 2 times 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 required in patients with hepatic impairment. In elderly patients, renal function is more likely to be reduced, so care should be taken when selecting the dose; monitoring renal function may be useful.

Child dose

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

Precautions

This medication is used to assist with smoking cessation. During the use of this medication, neuropsychiatric symptoms such as depression, anxiety, aggressive behavior, hallucinations, and suicidal thoughts may occur, hence caution is needed. If such symptoms appear, stop taking the medication immediately and consult a doctor. This medication should not be administered to patients with hypersensitivity, and should be used with caution in pregnant or breastfeeding women. During use, various side effects may occur, including nausea, headache, insomnia, and unusual dreams, and nausea may occur frequently. Patients with a history of seizures or those at risk for seizures should use this medication with greater caution, and should discontinue use immediately if a seizure occurs. While taking this medication, care should be taken when driving or operating machinery, as these activities may be hazardous. Additionally, while there are no major interactions with some medications, it is best to avoid alcohol consumption, as it may exacerbate side effects. Elderly patients may experience decreased kidney function, and dosage adjustments and monitoring of kidney function may be necessary. In cases of overdose, standard treatment should be provided, and the medication should be kept out of reach of children. Finally, it is essential to inform a doctor if there is a history of psychiatric disorders before taking this medication and to observe for neuropsychiatric symptoms when using this medication along with a smoking cessation attempt.

Side effects

  • Suicidal thoughts
  • suicidal behavior
  • suicide
  • changes in behavior or thoughts
  • depression
  • mania
  • psychosis
  • aggressive behavior
  • hallucinations
  • paranoia
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  • delusions
  • homicidal thoughts
  • hostility
  • restlessness
  • anxiety
  • panic state
  • discomfort
  • depressive mood
  • insomnia
  • irritability
  • frustration
  • anger
  • difficulty concentrating
  • fidgeting
  • decreased heart rate
  • increased appetite
  • weight gain
  • decreased platelet count
  • weight gain
  • decreased appetite
  • increased appetite
  • abnormal dreams
  • insomnia
  • abnormal thoughts
  • fidgeting
  • mood changes
  • decreased libido
  • discomfort
  • mental withdrawal
  • headache
  • drowsiness
  • dizziness
  • taste disturbances
  • tremors
  • somnolence
  • sensory reduction
  • dysarthria
  • motor coordination disorders
  • hypogeusia
  • circadian rhythm sleep disorder
  • conjunctivitis
  • eye pain
  • scotoma
  • glare
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • ST segment depression on ECG
  • decreased amplitude of ECG
  • increased blood pressure
  • flushing
  • upper respiratory disorder
  • dyspnea
  • cough
  • upper respiratory inflammation
  • airway congestion
  • vocal cord dysfunction
  • 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
  • indigestion
  • bloating
  • dry mouth
  • passage of bloody stools
  • gastritis
  • belching
  • aphthous stomatitis
  • gum pain
  • hematemesis
  • rash
  • itching
  • erythema
  • acne
  • hyperhidrosis
  • arthralgia
  • myalgia
  • back pain
  • muscle cramps
  • joint stiffness
  • frequent urination
  • nocturia
  • diabetes
  • polyuria
  • menorrhagia
  • 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 ectopy
  • myocardial infarction
  • heart flutter
  • coronary artery disease
  • cor pulmonale
  • acute coronary syndrome
  • dizziness
  • hearing loss
  • Meniere's disease
  • thyroid disease
  • dry eyes
  • eye irritation
  • blurred vision
  • visual disturbances
  • acquired night blindness
  • transient visual loss
  • subcapsular cataract
  • ocular vascular disease
  • vitreous floaters
  • gingivitis
  • dysphagia
  • enterocolitis
  • gastrointestinal bleeding
  • oral ulcers
  • esophagitis
  • peptic ulcer
  • bowel obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disease
  • hypersensitivity
  • drug hypersensitivity
  • abnormal ECG
  • increased muscle enzymes
  • abnormal urinalysis
  • diabetes mellitus
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention deficit disorder
  • sensory disorders
  • amnesia
  • migraine
  • parosmia
  • psychomotor agitation
  • restless legs syndrome
  • syncope
  • balance disorders
  • cerebrovascular events
  • convulsions
  • facial nerve paralysis
  • mental disorders
  • multiple sclerosis
  • eye twitching
  • psychomotor dysfunction
  • transient ischemic attack
  • visual field loss
  • anxiety
  • depression
  • emotional disorders
  • irritability
  • aggression
  • restlessness
  • disorientation
  • dissociation
  • euphoria
  • hallucinations
  • suicidal thoughts
  • nephrolithiasis
  • abnormal urine
  • urethral syndrome
  • acute renal failure
  • urinary retention
  • menstrual disorders
  • erectile dysfunction
  • nasal bleeding
  • respiratory diseases
  • asthma
  • pleuritis
  • pulmonary embolism
  • dermatitis
  • dry skin
  • eczema
  • psoriasis
  • urticaria
  • photodermatosis
  • hypotension
  • peripheral ischemia
  • thrombosis
  • insomnia
  • sleep disturbances
  • nightmares
  • excessive dreaming
  • sleep disturbances
  • nightmares
  • excessive dreaming
  • anxiety
  • abnormal thoughts
  • hallucinations
  • insomnia
  • anxiety
  • abnormal thoughts
  • syncope
  • mental fog
  • excessive dreaming
  • neuritis
  • increased sputum
  • pneumonia exacerbation
  • arterial stenosis
  • nipple pain
  • malignant neoplasm exacerbation
  • inadequate response
  • unpleasant feeling
  • mental distress
  • hair loss
  • memory disorders
  • coldness
  • worsening condition
  • irritation
  • burning sensation
  • decrease in blood pressure
  • increase in blood pressure
  • excessive muscle tension
  • gastric ulcer
  • seizures
  • traffic accidents
  • near traffic accidents
  • accidental injuries
  • drowsiness
  • dizziness
  • loss of consciousness
  • decreased concentration
  • relief
  • vomiting
  • increased irritability
  • smoking impulse
  • depression
  • insomnia

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature. This will help to safely preserve the efficacy of the medication.

Appearance and packaging

Appearance

White or grayish white, biconvex, rectangular film-coated tablet

Package unit

11 tablets (11 tablets/BlisterX1)

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.