Smokelin 0.5 mg (Varenicline Salicylate)

Adult dose

1. Usual dose in adults Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may start quitting between day 8 and day 35 after starting this medicine. Take this medicine 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 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 The dose may be reduced temporarily or permanently in patients who cannot tolerate adverse reactions to this medicine. 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 gradual cessation while taking this medicine. Reduce smoking by 50% compared with the amount smoked before treatment within the first 4 weeks after starting this medicine, 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 resume smoking after treatment should review the reasons for failure before trying again. However, there are no data demonstrating the efficacy of an additional 12 weeks of treatment in patients who fail to quit during the first 12 weeks of treatment or resume smoking after treatment. 2. Patients with renal impairment 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 necessary, the maximum dose is 0.5 mg twice daily. In patients with end-stage renal disease receiving hemodialysis, if well tolerated, the maximum dose of 0.5 mg once daily may be administered. 3. Elderly patients and patients with hepatic impairment 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.

Child dose

Younger than 18 years: Use is not recommended.

This medication is prescribed to assist in quitting smoking, and serious mental health issues such as mood changes, depression, or thoughts of suicide may occur during treatment. It is essential to inform your doctor of any history of psychiatric disorders before taking this medication, and if symptoms like anxiety, restlessness, depression, or unusual behavioral changes occur during treatment, consult your doctor immediately. This medication should not be used by patients with hypersensitivity and caution should be exercised for those who are pregnant or breastfeeding. Common side effects during treatment include nausea, headaches, insomnia, and abnormal dreams, which are usually mild or temporary. Caution is necessary when driving or operating machinery during treatment due to the potential for drowsiness or decreased concentration. Patients with cardiovascular diseases may experience heart-related abnormal symptoms while taking this medication; therefore, they should consult their healthcare provider. If seizures occur during treatment, discontinue the medication immediately and inform your doctor. Alcohol consumption may exacerbate the side effects of this medication, so it is advised to avoid or minimize alcohol intake during treatment. This medication is excreted through the kidney; therefore, elderly patients with compromised kidney function may require dosage adjustments. Use in children is not recommended as safety and efficacy have not been established.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is advisable to store it at room temperature between 1 and 30 degrees Celsius. Proper storage can help maintain the effectiveness of the medication for a longer time.

Appearance

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

Package unit

11 tablets (11 tablets/Alu-AluX1)