Notin Tablet 0.5 mg (Varenicline Salicylate)

Adult dose

1. Usual dose in adults Patients should set a quit date and start taking this medicine 1 week before that date. Alternatively, they may start quitting between day 8 and day 35 after starting this medicine. Take this medicine after meals with plenty of water. The recommended dose of this medicine is as follows: 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 to end of treatment 1 mg twice daily Patients who cannot tolerate the adverse reactions of this medicine may temporarily or permanently reduce the dose. The treatment period is 12 weeks. For patients who successfully quit smoking with the initial 12 weeks of treatment, an additional 12 weeks of treatment with this medicine is recommended to increase the likelihood of long-term abstinence. For patients who cannot or do not wish to stop smoking abruptly, consider gradual smoking cessation while taking this medicine. Reduce smoking by 50% from the amount smoked before starting treatment within the first 4 weeks after starting this medicine, and reduce it by a further 50% within the next 4 weeks. Continue to reduce smoking so that complete cessation is achieved by 12 weeks. Administer this medicine for an additional 12 weeks for a total treatment period of 24 weeks. Encourage patients to stop smoking sooner if they feel ready. Patients who fail to quit smoking during 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 smoking during the initial 12 weeks of treatment or resume smoking after treatment. 2. Patients with renal impairment 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. 3. Older patients and patients with hepatic impairment No dose adjustment is necessary in patients with hepatic impairment. In older patients, renal function is more likely to be reduced, so use caution when selecting the dose; monitoring renal function may be useful.

Child dose

Patients under 18 years of age: Use is not recommended.

This medication is used to assist in quitting smoking. During treatment, serious psychiatric symptoms such as depression, suicidal thoughts, aggression, and hallucinations may occur, so patients and caregivers should discontinue use immediately and consult a doctor if these symptoms arise. Patients with hypersensitivity or allergies to any components of this medication should not use it. Women who are pregnant or breastfeeding should use this medication cautiously and should consult a doctor if necessary. Symptoms such as insomnia, anxiety, headaches, and changes in appetite that may occur during smoking cessation can overlap with the side effects of this medication, so caution is advised. Nausea is the most common side effect, typically mild and improves over time, but may persist in some patients. Drowsiness, dizziness, and decreased concentration may occur during the use of this medication, so caution is advised when driving or operating machinery. When taken with alcohol, symptoms such as abnormal behavior or memory loss may occur, so it is advisable to avoid or minimize alcohol consumption. Patients with heart disease or a history of seizures should consult a doctor before taking this medication and discontinue use immediately if seizures occur. Since this medication is primarily excreted through the kidneys, dose adjustments may be necessary for patients with impaired kidney function. It is not recommended for children and adolescents under 18 years of age, as safety and efficacy have not been established.

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

This medication is easily affected by air or humidity, so it should be stored in a tightly sealed container. Additionally, it is advisable to store the medication at room temperature between 1°C and 30°C, rather than in extremely hot or cold conditions.

Appearance

Biconvex rectangular film-coated tablet, white or grayish-white

Package unit

11 tablets/box [11 tablets/BlisterX1]