Medication info

Varecle 1mg (Varenicline Tartrate)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Varenicline Salicylate›1.65mg
Manufacturer / importer
Kyungbo Pharmaceutical Co., Ltd.
Appearance
Light blue, bi-convex, rectangular film-coated tablets
Packaging
28 tablets (14 tablets/blister x 2)
Approval status
Approval withdrawn

MFDS item code 201803334 · Approved 2018.08.14

This product's status changed to Approval withdrawn on 2024.07.12. 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
Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting smoking between days 8 and 35 after starting this medicine. Take this medicine after a meal with plenty of water. Days 1–3: 0.5 mg once daily Days 4–7: 0.5 mg twice daily Day 8 through the end of treatment: 1 mg twice daily For patients who cannot tolerate the adverse reactions to this medicine, the dose may be reduced temporarily or on an ongoing basis. Treatment with this medicine lasts 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 are unable or unwilling to stop smoking abruptly, gradual smoking cessation while taking this medicine may be considered. Within the first 4 weeks after starting treatment, smoking should be reduced by 50% compared with the amount smoked before treatment began, and by an additional 50% within the next 4 weeks. Smoking should continue to be reduced so that complete abstinence is achieved by 12 weeks. Take this medicine for an additional 12 weeks for a total treatment period of 24 weeks. 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, if well tolerated, a maximum dose of 0.5 mg once daily may be administered. No dose adjustment is necessary in patients with hepatic impairment. In elderly patients, renal function is more likely to be reduced, so caution should be exercised when selecting the dose, and monitoring renal function may be useful.
Child dose
Under 18 years of age: administration is not recommended.

Ingredients

Manufacturer
Kyungbo Pharmaceutical Co., Ltd.

Efficacy & effects

Smoking cessation aid

View approved original text

This medication is used as an adjunct therapy to assist in smoking cessation treatment. It helps alleviate withdrawal symptoms that occur during attempts to quit smoking and reduces cravings, thereby enhancing the rate of successful smoking cessation. Therefore, it provides effective support for those planning to quit smoking.

How to take

Adult dose

Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting smoking between days 8 and 35 after starting this medicine. Take this medicine after a meal with plenty of water. Days 1–3: 0.5 mg once daily Days 4–7: 0.5 mg twice daily Day 8 through the end of treatment: 1 mg twice daily For patients who cannot tolerate the adverse reactions to this medicine, the dose may be reduced temporarily or on an ongoing basis. Treatment with this medicine lasts 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 are unable or unwilling to stop smoking abruptly, gradual smoking cessation while taking this medicine may be considered. Within the first 4 weeks after starting treatment, smoking should be reduced by 50% compared with the amount smoked before treatment began, and by an additional 50% within the next 4 weeks. Smoking should continue to be reduced so that complete abstinence is achieved by 12 weeks. Take this medicine for an additional 12 weeks for a total treatment period of 24 weeks. 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, if well tolerated, a maximum dose of 0.5 mg once daily may be administered. No dose adjustment is necessary in patients with hepatic impairment. In elderly patients, renal function is more likely to be reduced, so caution should be exercised when selecting the dose, and monitoring renal function may be useful.

Child dose

Under 18 years of age: administration is not recommended.

Precautions

This medication is used to aid in smoking cessation. Serious mental health issues such as depression, suicidal thoughts, aggressive behavior, and hallucinations may occur during treatment, so careful observation is necessary. Individuals with a history of psychiatric disorders should cautiously use this medication after consulting their physician. Women who are pregnant or breastfeeding should consult a doctor before using this medication. Side effects such as nausea, headaches, insomnia, abnormal dreams, and anxiety can commonly occur during treatment. Any unusual symptoms should be reported to a physician immediately, and the medication should be discontinued. Dangerous activities such as driving or operating machinery should be performed cautiously after taking this medication. Because this medication is excreted through the kidneys, elderly patients or those with impaired kidney function may require dose adjustment. In case of an overdose, immediate medical attention should be sought. Interactions with other medications are not significant, but alcohol consumption should be minimized or avoided. Use in children is not recommended as safety and efficacy have not been established. This medication can cause physical and mental changes related to smoking cessation, so it is important to closely follow a physician's instructions before and during treatment.

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
  • murderous thoughts
  • hostility
  • restlessness
  • anxiety
  • panic state
  • discomfort
  • depressed 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 slowing
  • headache
  • drowsiness
  • dizziness
  • taste abnormalities
  • tremors
  • hypersomnia
  • sensory impairment
  • dysarthria
  • motor coordination disorder
  • 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 T-wave amplitude on ECG
  • increased blood pressure
  • facial flushing
  • upper respiratory tract disorders
  • dyspnea
  • cough
  • upper respiratory tract inflammation
  • airway congestion
  • voice disorders
  • allergic rhinitis
  • throat irritation
  • sinus congestion
  • upper airway cough syndrome
  • runny nose
  • snoring
  • nausea
  • gastroesophageal reflux disease
  • vomiting
  • constipation
  • diarrhea
  • abdominal distension
  • abdominal pain
  • toothache
  • dyspepsia
  • flatulence
  • 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
  • splenomegaly
  • arrhythmia
  • bradycardia
  • ventricular extrasystole
  • myocardial infarction
  • cardiac palpitations
  • coronary artery disease
  • pulmonary heart disease
  • acute coronary syndrome
  • dizziness
  • hearing loss
  • Meniere's disease
  • thyroid disorders
  • dry eyes
  • eye irritation
  • blurry vision
  • visual disturbances
  • acquired night blindness
  • transient visual loss
  • cataract
  • vascular diseases
  • vitreous floaters
  • gingivitis
  • dysphagia
  • enterocolitis
  • gastrointestinal bleeding
  • oral ulcers
  • esophagitis
  • peptic ulcers
  • intestinal obstruction
  • acute pancreatitis
  • edema
  • thirst
  • chills
  • gallbladder disorders
  • hypersensitivity reactions
  • drug hypersensitivity reactions
  • abnormal ECG findings
  • increased muscle enzymes
  • abnormal urine tests
  • diabetes
  • hyperlipidemia
  • hypokalemia
  • hyperkalemia
  • hypoglycemia
  • muscle cramps
  • musculoskeletal pain
  • arthritis
  • osteoporosis
  • myositis
  • attention disorders
  • sensory disorders
  • amnesia
  • migraine
  • abnormal olfaction
  • psychomotor agitation
  • 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 defects
  • anxiety
  • depression
  • emotional disorders
  • hypersensitivity
  • aggression
  • restlessness
  • disorientation
  • dissociation
  • euphoria
  • hallucinations
  • suicidal thoughts
  • nephrolithiasis
  • abnormal urine
  • urethral syndrome
  • acute renal failure
  • urinary retention
  • erectile dysfunction
  • nasal bleeding
  • respiratory diseases
  • asthma
  • pleurisy
  • pulmonary embolism
  • dermatitis
  • dry skin
  • eczema
  • psoriasis
  • hives
  • photosensitivity
  • hypotension
  • peripheral ischemia
  • thrombosis
  • insomnia
  • abnormal dreams
  • sleep disorders
  • nightmares
  • excessive dreaming
  • anxiety
  • abnormal thoughts
  • suicidal thoughts
  • hallucinations
  • headache
  • drowsiness
  • dizziness
  • feeling dazed
  • taste abnormalities
  • syncope
  • fatigue
  • lethargy
  • asthenia
  • chest discomfort
  • chest pain
  • decreased appetite
  • anorexia
  • increased appetite
  • itching
  • dyspnea
  • increased sputum
  • myalgia
  • gingival swelling
  • nipple pain
  • seizures
  • traffic accidents
  • close traffic accidents
  • accidental injury
  • relief
  • sleep disorders
  • smoking urges
  • increased irritability
  • relief
  • death from overdose of illegal drugs
  • angioedema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • cerebrovascular events
  • myocardial infarction
  • unstable angina
  • hyperthermia
  • exacerbation of malignant neoplasm
  • inadequate effect
  • unpleasant feeling
  • psychological distress
  • hair loss
  • memory abnormalities
  • coldness
  • worsening condition
  • stimulation
  • burning sensation
  • decreased blood pressure
  • increased blood pressure

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

Storage

This medication is susceptible to air and moisture; therefore, it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 to 30 degrees Celsius. This will help safely preserve the medication's effectiveness.

Appearance and packaging

Appearance

Light blue, bi-convex, rectangular film-coated tablets

Package unit

28 tablets (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.