Topix Tablet 1mg (Varenicline Salicylate)

Adult dose

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. 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. 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. No dose adjustment is required in patients with hepatic impairment.

Child dose

Use in patients under 18 years of age is not recommended.

This medication is used to aid smoking cessation and may cause changes in mental health during use. Serious mental symptoms such as depression, anxiety, agitation, and suicidal thoughts may occur while taking this medication, so immediate consultation with a doctor is necessary if such symptoms arise. Individuals who have a history of allergy or hypersensitivity to this medication should not use it. Pregnant or breastfeeding women should use this medication with caution and consult a doctor if necessary. During the initial stages of treatment, side effects such as nausea, headache, insomnia, and abnormal dreams may frequently occur. Nausea, in particular, is reported in about 30% of patients taking this medication, mostly being mild or temporary, but some may persist. Seizures may occur while taking this medication, so patients with a history of seizures or at risk of seizures should consult their doctor before taking it. Caution should be exercised when engaging in hazardous activities such as driving or operating machinery, as this medication may cause drowsiness or decreased concentration. Dosage adjustment may be necessary based on kidney function, especially for elderly patients or those with kidney disease, who should follow medical advice. Alcohol consumption during treatment may worsen side effects, so it is advisable to avoid or minimize intake. The safety and efficacy of this medication have not been adequately verified with the concurrent use of other smoking cessation aids, so consultation with a doctor is essential before combining treatments. If an allergic reaction occurs during treatment, such as skin rash, difficulty breathing, or swelling of the face or lips, discontinue use immediately and seek medical attention. Patients with cardiovascular diseases may experience worsening heart-related symptoms while taking this medication, so they should inform their doctor immediately if new symptoms arise or existing symptoms worsen. This medication is not recommended for children and adolescents under 18 years of age as safety and efficacy have not been established.

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

This medication should be stored in a sealed container to prevent air or moisture from entering and ideally kept at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness for a longer period.

Appearance

Light blue, biconvex rectangular film-coated tablet

Package unit

28 tablets (14 tablets/Alu-AluX2)