Nicotin ES Tablets 0.5 mg (Varenicline Salicylate)

Adult dose

After titrating the dose for 1 week, administer 1 mg 2 times daily. Days 1 – 3: 0.5mg once daily Days 4 – 7: 0.5mg 2 times daily Day 8 – end of treatment: 1mg 2 times daily In patients unable to tolerate adverse reactions to this drug, the dose may be reduced temporarily or continuously. The treatment period with this drug is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, it is recommended that this drug be administered for an additional 12 weeks to increase the likelihood of long-term abstinence. For patients who are unable or unwilling to stop smoking abruptly, consider gradually stopping smoking while taking this drug. Within the first 4 weeks after starting this drug, smoking should be reduced by 50% compared with before treatment; within the next 4 weeks, it should be reduced by an additional 50%. Continue to reduce smoking so that complete abstinence is achieved by 12 weeks. Administer this drug for an additional 12 weeks for a total treatment duration of 24 weeks. 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 2 times 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. No dose adjustment is necessary in patients with hepatic impairment. In elderly patients, renal function is more likely to be reduced, so 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.

This medication may cause neuropsychiatric symptoms and suicidal tendencies, so if abnormal symptoms such as mood changes, depression, anxiety, aggression, or hallucinations occur during treatment, consult a healthcare provider immediately. Patients with hypersensitivity to this medication should not use it, and it should be administered cautiously during pregnancy or breastfeeding. Commonly experienced side effects include nausea, headache, insomnia, and unusual dreams, which are generally mild but may persist in some patients. Physical and mental changes may occur due to quitting smoking, so symptoms related to cessation attempts and medication use should be carefully monitored. Patients with a history of seizures or at risk for seizures should be evaluated for risk before taking this medication and discontinue use immediately if seizures occur. When engaging in activities such as driving or operating machinery, be cautious as this medication may cause drowsiness or dizziness. There have been reports of heart-related adverse reactions in some patients with cardiovascular diseases, so those with cardiovascular conditions should consult their healthcare provider if symptoms worsen. Alcohol consumption may worsen side effects of this medication, so it is advisable to avoid or limit alcohol intake during treatment. This medication has a low potential for drug interactions; however, inform your healthcare provider about any other medications you are taking. Elderly patients may experience reduced kidney function, so dosage adjustment may be necessary, and regular monitoring of kidney function is important. In case of overdose, standard treatment should be carried out; as there is no specific antidote, follow the instructions of healthcare providers. Keep this medication out of the reach of children and store it 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 should be stored in a tightly closed container to prevent exposure to air and moisture, preferably at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain its efficacy and ensure safe use.

Appearance

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

Package unit

11 tablets (11 tablets/PTPX1)