Nicofix Tablet 0.5mg (Varenicline Salicylate)

Adult dose

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 to this drug, the dose may be reduced temporarily or permanently. The treatment period for this drug is 12 weeks. For patients who have successfully stopped smoking after the initial 12 weeks of treatment, an additional 12 weeks of treatment with this drug is recommended to increase the likelihood of long-term abstinence from smoking. Administer this drug for an additional 12 weeks for a total treatment period 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 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: Administration is not recommended.

This medication may cause neuropsychiatric symptoms and suicidal tendencies, so if depression, anxiety, aggressive behavior, or suicidal thoughts occur during treatment, it is essential to consult a doctor immediately. This drug should not be used by patients with hypersensitivity or allergies to any of its ingredients. Pregnant or breastfeeding women should use this drug cautiously and consult a doctor before use. Discomfort, depression, insomnia, anxiety, and other symptoms that can occur during smoking cessation may appear alongside taking this medication, and caution is advised. The most common side effect is nausea, which is usually mild to moderate and temporary, although it may persist for months in some patients. Drowsiness, dizziness, and decreased concentration may occur during treatment, so caution is advised when driving or operating machinery. Patients with a history of psychiatric disorders or seizures should be especially careful with this medication, and if a seizure occurs, they should stop taking it immediately and consult a doctor. If angioedema or severe skin reactions occur, treatment should be stopped immediately and healthcare personnel should be informed. Patients with cardiovascular diseases should discuss the possibility of cardiovascular adverse reactions associated with this medication with their doctor. This drug has low potential for interactions with other medications; however, the side effects may increase with alcohol consumption, so it is advisable to avoid or minimize alcohol intake during treatment. Pregnant and breastfeeding women should consider the effects on the fetus or newborn when deciding to take this drug. The safety and efficacy for children and adolescents under 18 years have not been established, so its use is not recommended. Elderly patients may require dosage adjustments considering the risk of renal function decline, and renal function should be monitored regularly. In the case of overdose, standard supportive treatment should be implemented, and patients with severely impaired renal function may require dialysis. This medication should be kept out of reach of children and stored in its original container to prevent deterioration or misuse.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, the drug should be stored at room temperature between 1°C and 30°C, avoiding excessively hot or cold places.

Appearance

White or grayish-white, biconvex, rectangular film-coated tablet

Package unit

11 tablets (11 tablets/BlisterX1)