Clofix 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 quit smoking between days 8 and 35 after starting this medicine. Take this medicine after meals with plenty of water. The recommended dose is 1 mg twice daily after titration over 1 week, as follows: Days 1–3 0.5 mg once daily Days 4–7 0.5 mg twice daily Day 8 until the end of treatment 1 mg twice daily For patients unable to tolerate the adverse reactions of this medicine, the dose may be reduced temporarily or permanently. The treatment period is 12 weeks. For patients who successfully quit smoking during the first 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 unable or unwilling to stop smoking abruptly, gradual smoking cessation while taking this medicine may be considered. Patients should reduce the amount they smoke by 50% from baseline within the first 4 weeks after starting treatment, reduce it by a further 50% within the next 4 weeks, and continue reducing smoking so that they can achieve complete abstinence by week 12. Continue this medicine for an additional 12 weeks, for a total treatment period of 24 weeks. 2. Patients with renal impairment No dose adjustment is required 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, if well tolerated, a maximum dose of 0.5 mg once daily may be used. 3. Elderly patients and patients with hepatic impairment No dose adjustment is required in patients with hepatic impairment. Because renal function is more likely to be reduced in elderly patients, care should be taken when selecting the dose, and monitoring renal function may be useful.

Child dose

Patients under 18 years of age: Use is not recommended because the safety and efficacy of this medicine have not been established in children.

This medication is an aid for smoking cessation and has been reported to be associated with neuropsychiatric symptoms and suicidal tendencies. Caution is required as mental changes such as depression, anxiety, hallucinations, and aggression may occur during treatment with this medication. If such symptoms appear, immediately discontinue use and consult a doctor. This medication should not be used in patients with hypersensitivity, and women who are pregnant or breastfeeding should use it carefully. Common side effects include nausea, headache, insomnia, unusual dreams, and in some patients, these symptoms may persist for a long time. This medication can provoke seizures, hence patients with a history of seizures should be especially cautious, and if seizures occur, discontinue use immediately. Caution is also required when driving or operating machinery, as drowsiness, dizziness, and decreased concentration may occur. Furthermore, this medication has been reported to cause certain cardiovascular adverse reactions more frequently in patients with cardiovascular diseases; therefore, such patients should use it only after consulting with their doctor. Alcohol consumption during treatment may lead to abnormal behavior or memory loss; thus, it is advisable to avoid or minimize alcohol intake while taking this medication. This medication has minimal interactions with other drugs, but it is safe to consult with a doctor or pharmacist if other medications are being taken. The safety and efficacy of this medication in children have not been established, hence it is advised not to use it in patients under 18 years of age. Caution is also needed for elderly patients as dosage adjustments may be required due to impaired renal function. In cases of overdose, standard treatment should be administered, and patients with severely impaired renal function may require dialysis. This medication should be stored out of the reach of children and kept in its original container to prevent misuse or degradation of quality.

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

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is best to maintain room temperature between 1 degree and 30 degrees.

Appearance

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

Package unit

11 tablets (11 tablets/PTP x 1)