Nicober Tablets 0.5 mg (Varenicline Salicylate)

Adult dose

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 unable to 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 during 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 unable or unwilling to stop smoking abruptly, gradual smoking cessation while taking this medicine may be considered. Patients should reduce the amount they smoke by 50% from baseline within the first 4 weeks after starting treatment, reduce it by a further 50% within the next 4 weeks, and continue reducing smoking so that they can achieve complete abstinence by week 12. Continue this medicine for an additional 12 weeks, for a total treatment period of 24 weeks. 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 used. No dose adjustment is required 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

Patients under 18 years of age: Use is not recommended because the safety and efficacy of this medicine have not been established in children.

This medication is intended to assist with quitting smoking, but caution is needed as it may cause various mental health issues during use. Significant neuropsychiatric symptoms such as depression, suicidal thoughts or behaviors, anxiety, hallucinations, and aggression have been reported. If such symptoms occur, dosing should be stopped immediately and a doctor consulted. Also, those who are allergic to this medication should not use it, and it should be used with caution in pregnant or breastfeeding women. This medication may cause various side effects such as nausea, headaches, insomnia, and abnormal dreams, so patients should notify healthcare providers if symptoms occur. Withdrawal symptoms that may appear while quitting smoking can overlap with the side effects of this medication, thus caution is warranted. This medication may increase the risk of seizures; therefore, patients with a history of seizures must consult a doctor prior to use. Drowsiness or reduced concentration may occur while driving or operating machinery, so care should be taken. Although interactions between this medication and other drugs are not significant, it is advisable to avoid alcohol consumption as it may exacerbate side effects. Patients with cardiovascular diseases should carefully weigh the risks and benefits of using this medication and report any new symptoms to their doctor immediately. Elderly patients or those with decreased kidney function may require dose adjustments and should consult healthcare providers. There is no specific antidote for overdose; patients should receive appropriate treatment based on symptoms, and the medication should be kept out of reach of children.

• 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 must be stored in a tightly closed container. Additionally, avoid very hot or very cold places, and store it at room temperature between 1°C and 30°C.

Appearance

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

Package unit

11 tablets (11 tablets/Alu-AluX1)