Clinpix Tablet 0.5 mg (Varenicline Salicylate)

Adult dosage

1. Usual dosage in adults Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting between day 8 and day 35 after starting this medicine. Take this medicine after meals with plenty of water. The recommended dosage 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 For patients who cannot tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. 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 gradually stopping smoking while taking this medicine. Reduce smoking by 50% compared with baseline within the first 4 weeks after starting treatment, 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. Patients who fail to quit after 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 efficacy for an additional 12 weeks of treatment in patients who fail to quit during the initial 12 weeks or resume smoking after treatment. 2. Patients with renal impairment No dose adjustment is required 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. 3. Older adults and patients with hepatic impairment No dose adjustment is required in patients with hepatic impairment. Because renal function is more likely to be reduced in older adults, use caution when selecting the dose; monitoring renal function may be useful.

Children's dosage

Administration to patients under 18 years of age is not recommended.

This medication may cause significant neuropsychiatric symptoms, so patients must inform their doctor of any history of psychiatric illness before use. During treatment, if symptoms such as agitation, depression, unusual behavior or changes in thoughts, or suicidal thoughts appear, the patient should immediately stop taking the medication and consult a doctor. Use with caution during pregnancy or breastfeeding, and consult a doctor if necessary. This medication may have various side effects, including nausea, headache, insomnia, and abnormal dreams, with nausea particularly alleviated by adjusting the initial dose. Caution should be taken when engaging in hazardous activities such as driving or operating machinery, as drowsiness or dizziness may occur. Symptoms of depression or agitation associated with smoking cessation may overlap with the side effects of this medication, so symptoms should be closely monitored. If hypersensitivity reactions, angioedema, or serious skin reactions occur, the patient should immediately stop taking the medication and inform healthcare personnel. Patients with cardiovascular disease should carefully monitor for deterioration of heart-related symptoms while using this medication. While interactions with other drugs are low, alcohol consumption may exacerbate symptoms and should be avoided if possible. This medication is not recommended for children under 18 years of age, and dose adjustments may be necessary in elderly patients based on renal function. In the case of overdose, immediate medical attention should be sought for appropriate treatment. Keep out of reach of children and store in the original container to maintain quality.

• 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 and moisture, so it should be stored in a sealed container. It is best to maintain a storage temperature between 1°C and 30°C at room temperature. This will help preserve the medication's effectiveness.

Appearance

White or grayish, biconvex, rectangular film-coated tablet

Package unit

11 tablets (11 tablets/Blister×1)