Smophix Tablet 0.5 mg (Varenicline Salicylate)

Adult dosage

Patients should set a quit date and start taking this medication 1 week before that date. Alternatively, they may start quitting between days 8 and 35 after starting this medication. This medication should be taken after meals with plenty of water. The recommended dosage 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 to this medication, the dose may be reduced temporarily or on an ongoing basis. The treatment period is 12 weeks. For patients who successfully quit smoking after the initial 12 weeks of treatment, an additional 12 weeks of treatment with this medication 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 medication should be considered. Smoking should be reduced by 50% from the level before treatment within the first 4 weeks after starting this medication, and by an additional 50% within the following 4 weeks. Smoking should continue to be reduced so that complete cessation is achieved by week 12. Continue this medication 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. Because 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.

Children's dosage

Because the safety and efficacy of this medication have not been established in children, use is not recommended in patients under 18 years of age.

This medication is used to assist in quitting smoking. During the course of treatment, serious neuropsychiatric symptoms may arise, such as depression, anxiety, or suicidal thoughts and behaviors, warranting caution. Particularly for patients with a history of psychiatric disorders, careful use should be exercised after consulting with a physician, and if any unusual symptoms occur, treatment should be discontinued immediately and a doctor informed. This drug should not be administered to patients with hypersensitivity. Pregnant or nursing women should consult a doctor before taking this medication. Common side effects during treatment may include nausea, headache, insomnia, and abnormal dreams. If these symptoms are severe or persistent, consult a physician. Additionally, seizures may occur during treatment with this drug; therefore, patients with a history of seizures should take special care. Be cautious when engaging in activities requiring attention, such as driving or operating machinery, as drowsiness or dizziness may occur. Elderly patients with decreased kidney function may require dosage adjustment. In case of overdose, contact medical personnel immediately and receive necessary treatment. This medication has a low potential for drug interactions; however, alcohol consumption may exacerbate symptoms, so it is advised to avoid alcohol during treatment. If any unusual symptoms or discomfort arise while taking this medication, be sure to consult a physician or pharmacist.

• suicidal ideation
• suicidal behavior
• suicide
• changes in behavior or thoughts
• depression
• mania
• mood changes
• psychosis
• aggressive behavior
• hallucinations

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is best to maintain a storage temperature between 1°C and 30°C at room temperature. This way, the efficacy of the medication can be safely maintained for an extended period.

Appearance

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

Package unit

11 tablets (11 tablets/PTP X 1)