Macklin Tablet 0.5 mg (Varenicline Salicylate)

Adult dose

This medicine should be taken after meals with plenty of water. The recommended dosage of this medicine is as follows: after 1 week of dose titration, take 1 mg twice daily. 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 who cannot tolerate adverse reactions to this medicine, the dose may be reduced temporarily or permanently. The treatment period is 12 weeks. For patients who successfully quit smoking with the first 12 weeks of treatment, an additional 12 weeks of this medicine is recommended to increase the likelihood of long-term abstinence. Take this medicine for an additional 12 weeks for a total treatment period of 24 weeks. 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, 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. In elderly 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: The safety and efficacy of this medicine have not been established in children; use is not recommended.

This drug may cause psychiatric symptoms and suicidal tendencies, so if any mood changes or abnormal behaviors occur during treatment, you should consult your doctor immediately. This drug should not be administered to patients with hypersensitivity, and caution is advised for women who are pregnant or breastfeeding. Common symptoms such as nausea, headache, insomnia, and abnormal dreams may occur, and if these persist, medical personnel should be informed. This drug may increase the risk of seizures, so caution is required for those with a history of seizures or risk factors. When engaging in activities that require concentration, such as driving or operating machinery, caution should be taken as drowsiness or dizziness may occur. There is a low likelihood of significant drug interactions, but it is advisable to avoid alcohol consumption. Pregnant women should consider the potential benefits and risks of using this drug, while breastfeeding mothers should discuss with their physician whether to discontinue breastfeeding or the use of the medication. It is not recommended for children under 18 years of age, as safety and efficacy have not been established. Elderly patients may require dosage adjustments due to decreased renal function, so follow the guidance of medical personnel. In the case of overdose, notify healthcare personnel immediately and obtain necessary treatment, and store the medication out of reach of children.

• 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 tightly closed container to protect it from exposure to air and moisture. The storage temperature should be maintained between 1 to 30 degrees Celsius in a cool place.

Appearance

White or grayish-white, convex, rectangular film-coated tablet on both sides

Package unit

11 tablets (11 tablets/PTPX1)