Barekul Tablet 0.5 mg (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. 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 until end of treatment 1 mg 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. Encourage patients to stop smoking sooner if they feel ready. 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 to assist in quitting smoking. While taking this medication, changes in mental health may occur; therefore, if symptoms such as depression, anxiety, or suicidal thoughts appear, immediate consultation with a physician is necessary. Patients with a history of psychiatric disorders or a past experience of depression must inform their doctor and closely monitor their mental state before starting and during treatment. This medication should not be administered to individuals with allergic reactions, and pregnant or breastfeeding individuals should consult their doctor before use. The most common side effect is nausea, which usually occurs frequently at first and decreases over time. Other side effects may include insomnia, headache, abnormal dreams, and indigestion; if symptoms are severe, notify a doctor. Caution is required when driving or operating machinery while taking this medication. Additionally, consuming alcohol with this medication may result in abnormal behavior or memory impairment, so it is advisable to avoid alcohol consumption. Patients with cardiovascular diseases should fully consult their doctor before taking this medication and seek immediate medical attention if heart-related symptoms occur. There are no specific antidotes for overdose; therefore, adhere strictly to the prescribed dosage, and seek hospital treatment in the case of suspected overdose. This medication is not recommended for children, and elderly patients may require dosage adjustments based on renal function. Finally, keep the medication in its original container and store it out of reach of children.

• 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 protect it from air or moisture, preferably at room temperature between 1 and 30 degrees Celsius. This storage method helps maintain the medication's effectiveness and ensures safe use.

Appearance

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

Package unit

11 tablets (11 tablets/blister x 1)