Nicobrex Buccal Dissolving Film 1 Milligram (Varenicline Salicylate)

Adult dose

Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may start quitting smoking between day 8 and day 35 after starting this medicine. After a meal, immediately remove 1 film from its individual package, place it on the tongue, and allow it to dissolve; take without water. The recommended dose of this medicine is as follows: after dose titration over 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 until end of treatment 1mg 2 times daily For patients who cannot tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. The duration of treatment with this medicine is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, it is recommended that this medicine 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 reducing smoking while taking this medicine. Within the first 4 weeks after starting treatment, patients should reduce the amount they smoke by 50% compared with before starting treatment, and reduce it by a further 50% within the next 4 weeks. They should continue to reduce smoking so that they can achieve complete abstinence by 12 weeks. Administer this medicine for an additional 12 weeks for a total treatment duration of 24 weeks. Encourage patients to stop smoking sooner if they feel ready. Patients who fail to quit smoking with the first 12 weeks of treatment or resume smoking after treatment should review the reasons for failure and try again. However, there are no data demonstrating the efficacy of an additional 12 weeks of treatment in patients who fail to quit during the first 12 weeks of treatment or resume smoking after treatment. 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. 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

The efficacy of varenicline in children has not been established; therefore, administration of this medicine is not recommended (see “8. Use in Children” under Precautions for Use).

This medication is used to assist with smoking cessation and may impact mental health during use, so caution is required. Especially serious mental symptoms such as depression, anxiety, or suicidal thoughts and behaviors may occur; if such symptoms appear, consult a doctor immediately. Prior to taking this medication, inform your physician of any psychiatric history, and closely monitor your mental state during treatment. Usage during pregnancy or breastfeeding should be decided with caution, and if breastfeeding, it is best to consult with a physician before proceeding. Common side effects during use may include nausea, headache, insomnia, and abnormal dreams, but most are mild and improve with time. Patients with cardiovascular diseases should discuss potential worsening of heart-related symptoms due to this medication with their healthcare provider. Take care when driving or operating hazardous machinery, as this medication may cause drowsiness or decreased concentration. Additionally, alcohol consumption may exacerbate the side effects of this medication, so it should be avoided or minimized. This medication has a low potential for interactions with specific drugs, and most can be used in combination without dosage adjustments. Those with hypersensitivity or allergy to any component of this medication should not take it. In case of overdose, contact a medical institution immediately for appropriate treatment. Finally, store this medication out of the reach of children and ensure it is stored in its original packaging for safety.

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

This medication must be stored in a tightly sealed container to prevent air and moisture from entering. It is important to maintain storage temperature between 1 degree and 30 degrees Celsius.

Appearance

White rectangular buccal dissolving film

Package unit

1 piece/pack, 14 pieces/box [(1 piece/pack X 14)], 28 pieces/box [(1 piece/pack X 28)]