ANTI SMOKING PRODUCT

How does this medication work? What will it do for me?

Varenicline belongs to the class of medications called smoking cessation therapies. It is used to help people quit smoking when nicotine replacement therapy has not been effective or is not appropriate. Varenicline is intended to be used by adults in combination with quit-smoking education and counselling.

Varenicline works in the brain to reduce cravings and withdrawal symptoms. It also decreases the pleasure that people get from smoking. It is thought to have these effects by working at the same receptors that nicotine from cigarettes affects, although how varenicline exactly works is not clear.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it. Do not stop taking this medication without consulting your doctor.

What form(s) does this medication come in?

0.5 mg
Each capsular, biconvex, white-to-off-white, film-coated tablet debossed with "Pfizer" on one side and "CHX 0.5" on the other side contains 0.5 mg of varenicline (as tartrate). Nonmedicinal ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose; film-coating: hypromellose, polyethylene glycol, titanium dioxide, and triacetin.

1 mg
Each capsular, biconvex, light blue film-coated tablet debossed with "Pfizer" on one side and "CHX 1.0" on the other side contains 1 mg of varenicline (as tartrate). Nonmedicinal ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose; film-coating: hypromellose, polyethylene glycol, titanium dioxide, triacetin, and FD&C Blue No. 2 Indigo Carmine Aluminum Lake.

How should I use this medication?

The usual starting dose of varenicline is 0.5 mg once daily for the first 3 days, then 0.5 mg twice daily for the next 4 days, then continue on 0.5 mg twice daily or increase to 1 mg twice daily thereafter. The maximum dose of varenicline is 1 mg twice daily. Varenicline should be taken with a full glass of water, after eating.

Varenicline is intended to be used in combination with quit-smoking education and counselling. There are 3 different approaches to setting a date to quit smoking (the "quit date"). Talk to your doctor or pharmacist about which method would be best for you.

  • In the fixed quit approach, start treatment with varenicline 1 to 2 weeks before the date you have set to quit smoking and continue for 12 weeks.
  • In the flexible quit approach, start taking varenicline, then set a date to quit smoking between weeks 2 and 5 after the start of treatment. Treatment should be continued for 12 weeks. For those who succeed in quitting smoking during this time, an additional 12 weeks of treatment may be recommended by your doctor to reduce the risk that they will start smoking again.
  • In the gradual quit approach, start taking varenicline and decrease smoking with a goal to quit smoking by the end of 12 weeks. If you are able to, you may quit smoking at any time before the end of 12 weeks. Continue taking varenicline for an additional 12 weeks, to make up a total of 24 weeks of treatment.

Your doctor may suggest that you gradually decrease the dose of varenicline as you stop the medication, to reduce the risk of you starting to smoke again.

People who fail to quit smoking during the first 12-week treatment are encouraged to try again once they have identified and addressed the factors that may have caused them to have trouble quitting.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, and it is within a few hours of the missed dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you are allergic to varenicline or any ingredients of the medication.

Do not take varenicline if you are using nicotine replacement therapy such as patches, gum or the nicotine inhaler. Combining varenicline and nicotine replacement therapy may cause more side effects than with varenicline alone and is unlikely to improve your chances of quitting.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • diarrhea
  • difficulty concentrating
  • dizziness
  • flatulence (passing gas)
  • headache
  • nausea
  • sleep disturbance (difficulty sleeping or abnormal dreams)
  • unusual tiredness or weakness
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • signs of mental changes (e.g., changes in behaviour, changes in mood, hallucinations, thinking about harming self or others)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

Stop taking the medication and seek immediate medical attention if any of the following occur:



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