Smopix Tablets 1mg (Varenicline Salicylate)

Adult dosage

Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting between days 8 and 35 after starting this medicine. Take this medicine after meals 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 until 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 with this medicine is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, it is recommended that this medicine be administered for an additional 12 weeks 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 the amount smoked by 50% from the pretreatment level within the first 4 weeks after starting this medicine, and by a further 50% within the next 4 weeks. Continue to reduce smoking so that complete abstinence can be achieved by week 12. Administer this medicine for an additional 12 weeks for a total treatment period of 24 weeks. Patients who fail to quit smoking with 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 the efficacy of an additional 12 weeks of treatment in patients who failed to quit during the first 12 weeks of treatment or resumed smoking after treatment. 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 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. Because renal function is more likely to be decreased in elderly patients, caution should be exercised when selecting the dose, and monitoring renal function may be useful.

Children's dosage

Use is not recommended in patients under 18 years of age.

This medication is intended to assist with smoking cessation; however, it may cause neuropsychiatric symptoms or suicidal tendencies during treatment, so caution is required. If you experience changes in mental health such as depression, anxiety, hallucinations, aggression, or suicidal thoughts while taking this medication, you should consult a physician immediately. Patients with a history of psychiatric disorders must inform their doctor before taking this medication and should be closely monitored for any changes in mental state during treatment. This medication should not be given to patients with hypersensitivity, and its use in pregnant or breastfeeding women should be cautious. Initial doses may commonly cause symptoms such as nausea, headache, insomnia, and abnormal dreams; most of these symptoms are mild, but they may persist in some patients. Patients with cardiovascular diseases should observe closely for any cardiac-related abnormal symptoms and should inform their physician immediately of any new symptoms. This medication is excreted through the kidneys, so patients with reduced kidney function or the elderly may require dosage adjustments. Care should be taken when performing activities requiring attention, such as driving or operating machinery, as sleepiness and dizziness may occur after taking this medication. Alcohol consumption may exacerbate the side effects of this medication, so it is advisable to avoid or limit alcohol while taking it. This medication tends to have fewer interactions with other drugs; however, if you are taking other medications, consult a physician or pharmacist. It is not recommended for children or adolescents under the age of 18, as safety and efficacy have not been established. In case of overdose, you should visit a medical facility immediately for appropriate treatment, as there is no specific antidote, and symptom-based treatment will be necessary. This medication should be kept out of the reach of children and stored in its original container to maintain the quality of the drug.

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

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This will help ensure the medication's efficacy is safely maintained.

Appearance

Light blue, bilaterally convex, rectangular film-coated tablet

Package unit

28 tablets (14 tablets/PTP X 2)