Champix® tablets

Manufacturer:
Pfizer Canada Inc.

Generic Name:
varenicline

Product Illustration Form:
tablet

Route:
oral


Why is it prescribed?

Champix® tablets contains varenicline.

Varenicline is a medication used to help adults quit smoking.

 

Side Effects

Champix® tablets contains varenicline.

Along with its needed effects, varenicline may cause some unwanted or undesirable effects. When stopping to smoke, regardless of whether medication is used to help, the following symptoms may occur: depression, short-temperedness, frustration, anger, nervousness, lack of patience, difficulty with concentration, increased appetite and weight gain. Possible unwanted effects of taking varenicline are mild to moderate and usually occur in the first weeks of treatment. They include:

  • nausea
  • vomiting
  • trouble sleeping
  • headache
  • abnormal dreams
  • constipation
  • gas

Rarely:
  • Allergic reaction such as redness, itching or swelling of the skin, hives, burning, stinging, or any other skin problems, swelling of the neck area, or any difficulty with breathing, not present before using varenicline.

Serious post marketing neuropsychiatric adverse events have been reported including, depressed mood, agitiation, hostility, changes in behaviour, suicidal ideation and suicide as well as worsening of pre-exisiting psychiatric illness. If any of the above are observed varenicline should be discontinued and a healthcare provider contacted.
Patients with concomitant psychiatric conditions, even if well controlled, or with a history of psychiatric symptoms, should be diligently monitored.

 

Precautions and Warnings for Champix® tablets

Champix® tablets contains varenicline

The effects of changes in the body resulting from stopping smoking, with or without treatment with varenicline may alter the way other drugs work. Tell your doctor if you are taking insulin, asthma medications (eg. theophylline), blood thinners (eg. warfarin). The dose of these medications may need to be adjusted once you are smoke free. Tell the doctor if you are taking any other prescription or non prescription medications. A lower dose may need to be used if you have kidney problems. Varenicline may affect your mental alertness or physical coordination. Do not engage in potentially hazardous tasks, such as driving a car or operating dangerous machines until you are sure of the affect of varenicline on mental alertness or physical coordination. The safety and benefits of taking varenicline with other products for stopping smoking (eg. patches, gum, inhaler) have not been studied. Therefore, it is not recommended to take varencline with these products. Using these products with varenicline is not likely to increase your chance of stopping smoking and may increase side effects. Use is not recommended in the following situations::

  • allergy to varenicline or any component of the preparation
  • when also taking nicotine replacement therapy, such as patches, gum or inhaler. The combination may result in increased side effects.

    Caution is recommended in the following situations:

    • kidney problems
    • when taking insulin
    • when taking some asthma medications
    • when taking some blood thinners
    Use in pregnancy and breastfeeding:

    Consult your doctor if you suspect you are pregnant or breast feeding. Studies in animals has shown reproductive toxicity. Animal studies have shown that varenicline can be transferred to pups. It is not known whether varenicline is transferred to human milk.

     

    Patient Information

    You are more likely to quit smoking if you are motivated. Your doctor or pharmacist can help provide support or sources for information to help you quit.

    Before starting Champix® you should decide on a date in the second week of treatment when you will stop smoking. This allows the medication to build up in your body. You may continue to smoke during this time. If you “slip up” after your quit date keep trying as some people need a few weeks for Champix® to work best. Continuing to smoke after your quit date will lessen your chance of being successful.

     

    Directions for Use

    There are two dosing options for Champix®:

    • Option 1: Days 1-3: 0.5 mg tablet once daily. Days 4-7: 0.5mg twice daily. Day 8 and onwards: 0.5mg twice daily.
    • Option 2: Days 1-3: 0.5 mg tablet once daily. Days 4-7: 0.5mg twice daily. Day 8 and onwards: 1.0mg twice daily.

    You should take Champix® for 12 weeks. If you have stopped after this time your doctor may want to continue Champix® for additional weeks.

    Champix® may be taken with or without food. If you miss a dose, take it as soon as you remember if it is within a few hours of the missed dose. If a longer period of time has elapsed skip the dose and take the next dose at the usual time.

    Store tablets at room temperature (15-30 degrees C)

    Keep out of reach of children.

     

    Lung Diseases Treated with this Drug

    • nicotine addiction

     

    Need More Information?

    For more information contact your physician, pharmacist, other health care professional or for general questions call your local lung association.