Medication info

Dopifree Tablet 0.5mg (Varenicline Salicylate)

Prescription medicationTabletOralExpired
Ingredient · strength
Varenicline Salicylate›0.825mg / 1 tablet
Manufacturer / importer
Light Pharmtech Co., Ltd.
Appearance
White or grayish-white, bilaterally convex, rectangular film-coated tablet
Packaging
11 tablets / blister
Approval status
Expired

MFDS item code 201904329 · Approved 2019.06.25

This product's status changed to Expired on 2024.06.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Adjunctive treatment for smoking cessation
Who takes it
Adults · Children
Adult dose
After setting a quit date, patients should start taking Smoex tablets 1 week before that date. Alternatively, they may begin smoking cessation between day 8 and day 35 after starting this medicine. This medicine should be taken after meals with plenty of water. The recommended dosage of Smoex tablets 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 until the end of treatment 1 mg twice daily For patients who cannot tolerate the adverse reactions of Smoex tablets, the dose may be reduced temporarily or permanently. Smoex tablets should be administered for 12 weeks. For patients who have successfully quit smoking after the initial 12 weeks of treatment, an additional 12 weeks of Smoex is recommended to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, gradual smoking cessation while taking this medicine should be considered. The amount smoked should be reduced by 50% from the pretreatment level within the first 4 weeks after starting treatment, and by a further 50% over the next 4 weeks. Smoking should then be reduced continuously, with complete cessation achieved by week 12. Continue this medicine for an additional 12 weeks, for a total treatment duration of 24 weeks. Encourage patients to stop smoking sooner if they feel ready. 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 Smoex tablets is 0.5 mg once daily. If needed, the maximum dose is 0.5 mg twice daily. In patients with end-stage renal disease undergoing 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. Since renal function is more likely to be reduced in elderly patients, care should be taken when selecting the dose, and monitoring renal function may be useful.
Child dose
Patients under 18 years of age: Use in patients under 18 years of age is not recommended because the safety and efficacy of Smoex have not been established in children.

Ingredients

Manufacturer
Light Pharmtech Co., Ltd.

Efficacy & effects

Adjunctive treatment for smoking cessation

View approved original text

This medication is used as an adjunct therapy to aid smoking cessation. It helps individuals looking to quit smoking, contributing to an increased success rate of quitting. It alleviates withdrawal symptoms that may occur during the cessation process and reduces cravings, aiding the transition to a healthier lifestyle.

How to take

Adult dose

After setting a quit date, patients should start taking Smoex tablets 1 week before that date. Alternatively, they may begin smoking cessation between day 8 and day 35 after starting this medicine. This medicine should be taken after meals with plenty of water. The recommended dosage of Smoex tablets 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 until the end of treatment 1 mg twice daily For patients who cannot tolerate the adverse reactions of Smoex tablets, the dose may be reduced temporarily or permanently. Smoex tablets should be administered for 12 weeks. For patients who have successfully quit smoking after the initial 12 weeks of treatment, an additional 12 weeks of Smoex is recommended to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, gradual smoking cessation while taking this medicine should be considered. The amount smoked should be reduced by 50% from the pretreatment level within the first 4 weeks after starting treatment, and by a further 50% over the next 4 weeks. Smoking should then be reduced continuously, with complete cessation achieved by week 12. Continue this medicine for an additional 12 weeks, for a total treatment duration of 24 weeks. Encourage patients to stop smoking sooner if they feel ready. 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 Smoex tablets is 0.5 mg once daily. If needed, the maximum dose is 0.5 mg twice daily. In patients with end-stage renal disease undergoing 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. Since renal function is more likely to be reduced in elderly patients, care should be taken when selecting the dose, and monitoring renal function may be useful.

Child dose

Patients under 18 years of age: Use in patients under 18 years of age is not recommended because the safety and efficacy of Smoex have not been established in children.

Precautions

This medication is designed to assist with smoking cessation, but during use, psychological changes such as depression, suicidal thoughts, and aggressive behavior may occur, so caution is necessary. Patients with a history of psychiatric disorders must consult their physician thoroughly and should discontinue use immediately and seek medical advice if symptoms arise. This drug should not be administered to patients who have allergic reactions or hypersensitivity to any of the components. Pregnant or nursing women should carefully consider the impact of this medication on the fetus or infant and consult a physician if necessary. Common side effects may include nausea, headache, insomnia, and abnormal dreams; if these symptoms are severe or persistent, notify a physician. Caution is required when engaging in hazardous activities such as driving or operating machinery, as this medication may cause drowsiness or decreased concentration. Patients with cardiovascular diseases may experience heart-related abnormal symptoms while using this medication; if symptoms occur, inform medical personnel immediately. While interactions with other drugs are minimal, side effects may worsen with alcohol consumption, so it is advisable to avoid or minimize alcohol intake while taking this medication. Safety and efficacy have not been established for children or adolescents under 18 years of age, and use is not recommended. Elderly patients may require dosage adjustments due to decreased kidney function, and should take the medication as directed by their physician. In case of overdose, seek appropriate medical treatment immediately, and keep this medication out of reach of children. Store the medication in its original container and avoid transferring it to other containers.

Side effects

Suicidal thoughts, suicidal behavior, suicide, changes in behavior or thoughts, depression, mania, mood changes, psychosis, aggressive behavior, hallucinations, paranoia, delusions, homicidal thoughts, 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 changes, decreased libido, discomfort, mental relaxation, headache, drowsiness, dizziness, taste abnormalities, tremors, hypersomnia, sensory loss, speech disorder, motor coordination disorder, taste hyposensitivity, circadian rhythm sleep disorder, conjunctivitis, eye pain, scotoma, glare, tinnitus, angina, tachycardia, palpitations, increased heart rate, atrial fibrillation, reduced electrocardiogram segment elevation, decreased electrocardiogram amplitude, increased blood pressure, facial flushing, upper respiratory tract disorder, dyspnea, cough, upper respiratory inflammation, airway congestion, phonation difficulty, 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, flatulence, dry mouth, passage of 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, heavy menstrual bleeding, sexual dysfunction, chest pain, fatigue, chest discomfort, influenza-like illness, fever, weakness, malaise, abnormal liver function tests, anemia, lymphadenopathy, leukocytosis, thrombocytopenia, splenomegaly, arrhythmia, bradycardia, ventricular extrasystole, myocardial infarction, cardiac arrhythmia, coronary artery disease, pulmonary heart disease, acute coronary syndrome, hearing loss, Ménière's disease, thyroid disease, dry eyes, eye irritation, blurriness, vision impairment, acquired night blindness, transient visual loss, cataract, ocular vascular disease, vitreous floaters, gingivitis, dysphagia, small intestinal colitis, gastrointestinal bleeding, oral ulcer, esophagitis, peptic ulcer, intestinal obstruction, acute pancreatitis, edema, thirst, chills, gallbladder disease, hypersensitivity, drug hypersensitivity, electrocardiogram abnormalities, muscle enzyme increase, urine test abnormalities, diabetes, hyperlipidemia, hypokalemia, hyperkalemia, hypoglycemia, muscle cramps, musculoskeletal pain, arthritis, osteoporosis, myositis, attention deficit disorder, sensory disorder, amnesia, migraine, abnormal olfaction, psychomotor hyperactivity, restless legs syndrome, syncope, balance disorder, cerebrovascular event, seizures, facial nerve paralysis, mental disorder, multiple sclerosis, eye twitches, psychomotor dysfunction, transient ischemic attack, visual field defect, anxiety, depression, emotional disorder, hypersensitivity, aggression, agitation, 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, pleurisy, pulmonary embolism, dermatitis, dry skin, eczema, psoriasis, urticaria, photosensitivity, hypotension, peripheral ischemia, thrombosis, excessive muscle tension, gastric ulcer, sleep disorders, nightmares, excessive dreaming, anxiety, abnormal thinking, angioedema, Stevens-Johnson syndrome, erythema multiforme, seizures, traffic accidents, proximate traffic accidents, accidental injuries, hypersensitivity, smoking urge, insomnia, increased phlegm, pneumonia exacerbation, arterial stenosis, nipple pain, worsening of malignant neoplasm, inadequate effect, feeling dazed, unpleasant feeling, mental distress, hair loss, memory abnormalities, coldness, deterioration of condition, irritation, burning sensation, blood pressure decrease, blood pressure increase

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This helps to preserve the medication's efficacy and safety for an extended period.

Appearance and packaging

Appearance

White or grayish-white, bilaterally convex, rectangular film-coated tablet

Package unit

11 tablets / blister

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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.

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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.