Nicobrex Oral Dissolving Film 0.5 mg (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

This medication is used to assist with smoking cessation. During the use of this medication, attention must be paid to mental health, as serious psychiatric symptoms such as depression or suicidal thoughts may occur. If experiencing anxiety or depressed mood, unusual behavior, or changes in thoughts, including thoughts of suicide, discontinuation should be immediate and consultation with a physician is necessary. This medication should not be administered to individuals with allergic reactions, and those who are pregnant or breastfeeding should use it cautiously after consulting a physician. Various side effects such as nausea, headaches, insomnia, and abnormal dreams may occur, and if symptoms are severe, consultation with a physician is recommended. Caution is advised when engaging in hazardous activities like driving or operating machinery due to potential drowsiness or dizziness. It is advisable to avoid alcohol consumption during the course of this medication. Patients with cardiovascular diseases should carefully monitor their heart condition before and after use of this medication, and any worsening symptoms should be reported to a physician immediately. This medication is not recommended for children, and elderly patients may require dosage adjustments based on kidney function. In case of overdose, immediate medical assistance is required.

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

This medication should be stored in a sealed container to protect it from air and moisture. It is best to maintain storage temperatures between 1 degree Celsius and 30 degrees Celsius.

Appearance

White rectangular oral dissolving film

Package unit

1 film/packet, 11 films/box [(1 film/packet X 11)]