Medication info

Clinfix Tablets 1 mg (Varenicline Salicylate)

Prescription medicationExpired
Ingredient · strength
Varenicline Salicylate›Strength being verified
Manufacturer / importer
HanKook Pavis Pharmaceutical Co., Ltd.
Appearance
Light blue, double-sided convex, rectangular film-coated tablets
Packaging
28 tablets (14 tablets/Blister × 2)
Approval status
Expired

MFDS item code 201802486 · Approved 2018.06.15

This product's status changed to Expired on 2023.06.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Adjunctive treatment for smoking cessation
Who uses it
Adults · Children
Adult dosage
Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting between day 8 and day 35 after starting this medicine. Take this medicine after meals with plenty of water. The recommended dosage 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 – 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 after the first 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 gradually stopping smoking while taking this medicine. Reduce smoking by 50% compared with baseline within the first 4 weeks after starting treatment, and by an additional 50% over the next 4 weeks. Continue to reduce smoking so that complete cessation is achieved by week 12. Continue 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 after 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 efficacy for an additional 12 weeks of treatment in patients who fail to quit during the initial 12 weeks or resume 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 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. Because renal function is more likely to be reduced in older adults, use caution when selecting the dose; monitoring renal function may be useful.
Children's dosage
Patients under 18 years of age: Use is not recommended.

Ingredients

Manufacturer
HanKook Pavis Pharmaceutical Co., Ltd.

Efficacy & effects

Adjunctive treatment for smoking cessation

View approved original text

The adjunct therapy for smoking cessation is used to assist patients in quitting smoking. This treatment helps reduce withdrawal symptoms and cravings that may occur during the quitting process and aids in increasing the success rate of quitting. Common adjunct therapies include nicotine replacement therapy and the administration of smoking cessation aids, and are often conducted alongside professional counseling. This treatment helps the patient maintain healthy lifestyle habits while quitting smoking.

Dosage and Administration

Adult dosage

Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting between day 8 and day 35 after starting this medicine. Take this medicine after meals with plenty of water. The recommended dosage 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 – 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 after the first 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 gradually stopping smoking while taking this medicine. Reduce smoking by 50% compared with baseline within the first 4 weeks after starting treatment, and by an additional 50% over the next 4 weeks. Continue to reduce smoking so that complete cessation is achieved by week 12. Continue 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 after 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 efficacy for an additional 12 weeks of treatment in patients who fail to quit during the initial 12 weeks or resume 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 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. Because renal function is more likely to be reduced in older adults, use caution when selecting the dose; monitoring renal function may be useful.

Children's dosage

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

Precautions

This medication is used to help quit smoking. During the course of treatment, neuropsychiatric symptoms such as depression, anxiety, hallucinations, and aggression may occur, so caution is necessary. If thoughts or behaviors of suicide occur, discontinue use immediately and consult a doctor. This medication should be closely monitored for neuropsychiatric symptoms in patients with a history of psychiatric disorders. For pregnant individuals, it is important to carefully consider the risks to the fetus and the benefits of this medication, and breastfeeding women should discuss with their doctor whether to discontinue breastfeeding. This medication is not recommended for children or individuals under 18 years old. Elderly patients may require dosage adjustments based on renal function, so care is needed. Common side effects during medication include nausea, headache, insomnia, and abnormal dreams, and in some patients, these symptoms may persist. Serious side effects such as angioedema, cardiovascular issues, or severe skin reactions have rarely been reported, so any abnormal symptoms should be immediately reported to healthcare professionals. Caution should be exercised when driving or operating machinery, as drowsiness or dizziness may occur. Alcohol consumption may increase the risk of side effects, so it should be avoided or minimized during treatment. The risk of drug interactions with this medication is low; however, if other medications are being taken, inform a physician or pharmacist. In cases of overdose, seek medical assistance immediately, and keep this medication out of the reach of children. Medicines should be stored in their original containers to maintain quality.

Side effects

  • Suicidal thoughts
  • suicidal behavior
  • suicide
  • changes in behavior or thoughts
  • depression
  • mania
  • mood changes
  • psychosis
  • aggressive behavior
  • hallucinations
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  • paranoia
  • delusions
  • homicidal thoughts
  • hostility
  • restlessness
  • anxiety
  • panic
  • discomfort
  • depressed mood
  • insomnia
  • irritability
  • frustration
  • anger
  • difficulty concentrating
  • restlessness
  • decreased heart rate
  • increased appetite
  • weight gain
  • nausea
  • headache
  • abnormal dreams
  • abnormal thoughts
  • decreased libido
  • mental haze
  • drowsiness
  • dizziness
  • altered taste
  • tremors
  • excessive sleepiness
  • sensory impairment
  • speech disorders
  • coordination disorders
  • taste loss
  • circadian rhythm sleep disorders
  • conjunctivitis
  • eye pain
  • floaters
  • photophobia
  • tinnitus
  • angina
  • tachycardia
  • palpitations
  • increased heart rate
  • atrial fibrillation
  • decreased ECG segment
  • reduced ECG wave amplitude
  • increased blood pressure
  • facial flushing
  • upper respiratory disorders
  • shortness of breath
  • cough
  • upper respiratory inflammation
  • nasal congestion
  • vocal cord disorders
  • allergic rhinitis
  • throat irritation
  • sinus congestion
  • upper respiratory cough syndrome
  • rhinorrhea
  • snoring
  • gastroesophageal reflux disease
  • vomiting
  • constipation
  • diarrhea
  • abdominal distension
  • abdominal pain
  • toothache
  • indigestion
  • 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
  • discomfort in the chest
  • influenza-like illness
  • fever
  • asthenia
  • lethargy
  • abnormal liver function tests
  • anemia
  • lymphadenopathy
  • leukocytosis
  • thrombocytopenia
  • splenomegaly
  • arrhythmia
  • bradycardia
  • ventricular extrasystoles
  • myocardial infarction
  • cardiac arrhythmias
  • coronary artery disease
  • pulmonary heart disease
  • acute coronary syndrome
  • hearing loss
  • Ménière's disease
  • thyroid disorders
  • dry eyes
  • eye irritation
  • blurred vision
  • visual disturbances
  • acquired night blindness
  • transient visual loss
  • subcapsular cataract
  • ocular vascular diseases
  • vitreous floaters
  • gingivitis
  • dysphagia
  • small bowel colitis
  • gastrointestinal bleeding
  • oral ulcers
  • esophagitis
  • peptic ulcers
  • bowel obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disorders
  • hypersensitivity reactions
  • drug hypersensitivity reactions
  • abnormal ECG findings
  • increased muscle enzymes
  • abnormal urinalysis
  • diabetes mellitus
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention disorders
  • sensory disturbances
  • amnesia
  • migraines
  • olfactory disturbances
  • psychomotor agitation
  • restless legs syndrome
  • syncope
  • balance disorders
  • cerebrovascular events
  • seizures
  • facial nerve palsy
  • mental disorders
  • multiple sclerosis
  • eye twitching
  • psychomotor dysfunction
  • transient ischemic attacks
  • visual field deficits
  • anxiety
  • emotional disturbances
  • hypersensitivity
  • aggression
  • disorientation
  • dissociation
  • euphoria
  • suicidal thoughts
  • nephrolithiasis
  • abnormal urine
  • urethral syndrome
  • acute renal failure
  • urinary retention
  • menstrual disorders
  • erectile dysfunction
  • epistaxis
  • respiratory diseases
  • asthma
  • pleurisy
  • pulmonary embolism
  • dermatitis
  • skin dryness
  • eczema
  • psoriasis
  • urticaria
  • photosensitivity reactions
  • hypotension
  • peripheral ischemia
  • thrombosis
  • insomnia
  • sleep disturbances
  • nightmares
  • excessive dreaming
  • sleep disturbances
  • nightmares
  • excessive dreaming
  • discomfort
  • mental anguish
  • hair loss
  • memory disturbances
  • coldness
  • worsening condition
  • irritation
  • burning sensation
  • decreased blood pressure
  • increased blood pressure
  • excessive muscle tension syndrome
  • gastric ulcers
  • seizures
  • traffic accidents
  • near traffic accidents
  • drowsiness
  • dizziness
  • loss of consciousness
  • decreased concentration
  • relief
  • sleep disturbances
  • increased irritability
  • death due to overdose of illicit drugs
  • angioedema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • cerebrovascular events
  • myocardial infarction
  • angioedema
  • edema of the face
  • mouth
  • neck
  • and limbs due to angioedema
  • respiratory distress due to angioedema
  • unstable angina
  • insomnia
  • anxiety
  • abnormal thoughts
  • neuritis
  • syncope
  • pneumonia exacerbation
  • arterial stenosis
  • head fog
  • increased sputum
  • pneumonia exacerbation
  • malignant neoplasm exacerbation
  • nipple pain

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

Storage

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture. It is best kept at room temperature, specifically between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Light blue, double-sided convex, rectangular film-coated tablets

Package unit

28 tablets (14 tablets/Blister × 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.