Nicobrex Tablets 0.5mg (Varenicline Salicylate)

Adult dose

Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may begin quitting between days 8 and 35 after starting this medicine. The recommended dose of this medicine is as follows: after dose titration over 1 week, administer 1 mg twice daily. Days 1–3 0.5mg once daily Days 4–7 0.5mg twice daily Day 8 until end of treatment 1mg twice daily For patients who cannot tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. The treatment period 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 cannot or do not wish to stop smoking abruptly, consider gradually stopping smoking while taking this medicine. Reduce the amount smoked by 50% from the pretreatment level within the first 4 weeks after starting this medicine, and by a further 50% within the next 4 weeks. Continue to reduce smoking so that complete abstinence can be achieved by week 12. Administer this medicine for an additional 12 weeks for a total treatment period of 24 weeks. Patients who fail to quit smoking with the first 12 weeks of treatment or who 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 failed to quit during the first 12 weeks of treatment or resumed 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 twice daily. In patients with end-stage renal disease undergoing 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 decreased in elderly patients, caution should be exercised 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 is used for the treatment of nicotine dependence and serves an aiding role in smoking cessation. Special attention must be given to mental health while taking this medication. Some patients may experience severe psychiatric symptoms such as depression, anxiety, aggression, hallucinations, or suicidal thoughts, and should consult a doctor immediately if these symptoms occur. Patients with a history of psychiatric illness must inform their doctor before taking this medication and continuously monitor their mental health during treatment. Pregnant or breastfeeding women should use this medication with caution, as the safety of its use during pregnancy has not been established. This medication can cause various side effects such as nausea, headaches, insomnia, and abnormal dreams, with nausea being particularly common. It is advisable to gradually increase the dose at the beginning of treatment to minimize the occurrence of side effects. Caution should be taken when engaging in activities that require alertness, such as driving or operating machinery, as drowsiness or dizziness may occur. This medication has relatively few drug interactions, but alcohol consumption may exacerbate side effects, so it is advisable to avoid or limit alcohol intake while on this medication. Elderly patients with impaired kidney function may require dose adjustments, and it is important to regularly monitor kidney function. In case of overdose, immediate medical attention should be sought, and appropriate treatment will be provided as needed. This medication is not recommended for children and should be stored out of reach of children. If unusual behavior or mood changes occur during treatment, immediate consultation with a healthcare professional is advised to avoid confusion with nicotine withdrawal symptoms that may appear when quitting smoking.

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

This medication should be stored in a tightly closed container to avoid contact with air or moisture. It is best kept at room temperature between 1 to 30 degrees Celsius.

Appearance

White or grayish-white, double convex, elongated film-coated tablet

Package unit

11 tablets (11 tablets/PTPX1)