NicoFix Tablet 1 mg (Varenicline Salicylate)

Adult dose

Patients should set a quit date and start taking this drug 1 week before that date. Alternatively, they may begin quitting between days 8 and 35 after starting this drug. This drug should be taken after meals with plenty of water. The recommended dose of this drug 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 the adverse reactions of this drug. The treatment duration is 12 weeks. For patients who quit smoking after the first 12 weeks of treatment, an additional 12 weeks of treatment with this drug is recommended to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, consider gradually reducing smoking while taking this drug. Smoking should be reduced by 50% from pretreatment levels within the first 4 weeks after starting treatment, and by a further 50% within the next 4 weeks. Continue reducing smoking to achieve complete abstinence by 12 weeks. Continue this drug 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 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, a maximum dose of 0.5 mg once daily may be administered if well tolerated. No dose adjustment is necessary in patients with hepatic impairment. Because renal function is more likely to be reduced in elderly patients, use caution when selecting the dose; monitoring renal function may be useful.

Child dose

Under 18 years of age: The safety and efficacy of this drug have not been established in children; therefore, its use is not recommended in patients under 18 years of age.

This medication may cause neuropsychiatric symptoms and tendencies toward suicide, so if mood changes or abnormal behavior occur during use, consult a doctor immediately. Patients with hypersensitivity to this medication or with a history of allergic reactions to similar drugs should not use it. Women who are pregnant or breastfeeding should use this medication with caution and consult their doctor if necessary. Various side effects such as nausea, headache, insomnia, and abnormal dreams may occur with this medication, and some symptoms may be due to the process of quitting smoking itself. If seizures occur during treatment, stop taking the medication immediately and inform a doctor, as patients with a history of seizures should exercise particular caution. Caution is advised while engaging in hazardous activities like driving or operating machinery, as this medication may cause drowsiness or decreased concentration. There is a low risk of interaction with other medications, but alcohol consumption during use may lead to side effects such as aggressive behavior or memory loss, so it is recommended to avoid or minimize alcohol intake. Elderly patients with decreased renal function may require dose adjustments, thus should take this medication under doctor's instruction. There is no specific antidote for overdose; therefore, appropriate treatment should be administered according to symptoms, and keep out of reach of children.

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

Store this medication in a tightly closed container to protect it from air and moisture, and it is advisable to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and prevents degradation.

Appearance

Light blue, double-sided convex film-coated tablet

Package unit

28 tablets (14 tablets/Blister X 2)