A brief overview of smoking and nicotine addiction

Nicotine is a drug that is inhaled from the tobacco in cigarettes. It gets into the bloodstream, and stimulates the brain. Most regular smokers are addicted to nicotine.

If you are a smoker, when the blood level of nicotine falls, you usually develop withdrawal symptoms such as restlessness, increased appetite, inability to concentrate, irritability, dizziness, constipation, nicotine craving, or just feeling awful. These symptoms begin within a few hours after having the last cigarette. If they are not relieved by the next cigarette, withdrawal symptoms get worse. If you do not smoke any more cigarettes, the withdrawal symptoms peak after about 24 hours, and then gradually ease over about 2-4 weeks. So, most smokers smoke regularly to prevent withdrawal symptoms.

About 2 in 3 smokers want to stop smoking but, without help, many fail to succeed. The main reason why so few smokers succeed, even though they want to stop smoking, is because nicotine addiction is strong and difficult to break. This is where varenicline can help.

For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHAMPIX at 1 mg twice daily may be considered (see section 5.1).

No data are available on the efficacy of an additional 12 weeks course of treatment for patients who do not succeed in stopping smoking during initial therapy or who relapse after treatment.

Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support.

In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment. In patients with a high risk of relapse, dose tapering may be considered (see section 4.4).

Patients with renal impairment

No dosage adjustment is necessary for 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.

For patients with moderate renal impairment who experience adverse reactions that are not tolerable, dosing may be reduced to 1 mg once daily.

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For patients with severe renal impairment (estimated creatinine clearance < 30 ml/min), the recommended dose of CHAMPIX is 1 mg once daily. Dosing should begin at 0.5 mg once daily for the first 3 days then increased to 1 mg once daily. Based on insufficient clinical experience with CHAMPIX in patients with end stage renal disease, treatment is not recommended in this patient population (see section 5.2).

What is varenicline and how does it work?

Varenicline (trade name Champix®) is a medicine that was first licensed in the UK in December 2006. It was developed to help smokers to stop smoking. Varenicline mimics the effect of nicotine on the body. Therefore, it both reduces the urge to smoke and relieves withdrawal symptoms.

The precise action of varenicline is that it interferes with the receptors in the brain that nicotine stimulates. (The nicotine in cigarettes attaches to receptors in brain cells to stimulate part of the brain - this is how nicotine has its effect.) What varenicline does is to partly stimulate the nicotine receptors. This mimics the effects of nicotine, to reduce cravings and withdrawal effects when you stop smoking. However, at the same time, it partially blocks the receptors and prevents nicotine from attaching to the receptors. This blocks or blunts the effect of nicotine in people who give in to temptation and have a cigarette.