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FDA Drug information

APO-VARENICLINE

Read time: 1 mins
Marketing start date: 18 Nov 2024
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Summary of product characteristics


Adverse Reactions

SIDE EFFECTS AND WHAT TO DO ABOUT THEM Whether you are taking medication to stop smoking or not, the following are symptoms you may feel: depressed, short-tempered, frustrated or angry, nervous, impatient; have difficulty concentrating. Your appetite may increase, and you may gain some weight. Like all medicines, APO-VARENICLINE can cause side effects, although not everybody gets them. The common side effects are mostly mild to moderate and these usually occur in the first weeks of treatment. Some of the most common side effects you should be aware of include: Nausea, vomiting Trouble sleeping Headache Abnormal dreams (vivid, unusual, or increased dreaming; rarely may include nightmares) Sleepiness, tiredness, dizziness Constipation, diarrhea, gas Mental Health Problems See “What is the most important information I should know about APO-VARENICLINE?” Stop taking APO-VARENICLINE if you experience severe or unusual feelings of agitation, aggression, depressed mood, hostility, hallucinations, or if you have thoughts of self-harm or harm to others. Tell your healthcare provider about your symptoms. Allergic Reactions Some people have allergic reactions to APO-VARENICLINE. Some of these allergic reactions can be life-threatening and include: swelling of the face, mouth (lips, gums, tongue), and throat can cause trouble breathing. If you have these symptoms, stop taking APO-VARENICLINE and seek immediate emergency medical attention. Serious Skin Reactions Some people can have serious skin reactions while taking APO-VARENICLINE. These can include rash, swelling, redness, and peeling of the skin. Some of these reactions can become life-threatening. If you have a rash with peeling skin, or blistering of the mouth, around the eyes or genitals, stop taking APO-VARENICLINE and seek immediate emergency medical attention. SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM Symptom/effect Talk to your healthcare professional Stop taking drug and get immediate medical help Only if severe In all cases Rare Allergic reaction redness, itching or swelling of your skin, hives, burning, stinging, swelling of the neck area, or any difficulty with breathing, not present before using this medicine √ Rare Serious skin reactions peeling of the skin, or rash combined with blisters around the mouth, eyes or genitals. √ Rare Mental Health Problems √ √ (if severe, or if involves potential for harm to self or others) Unknown Heart attack: chest pain often associated with left shoulder or jaw pain, feeling of constriction around chest and sweating √ Unknown Stroke: weakness and/or loss of sensation of limbs or face, difficulty speaking, clumsiness, visual loss √ Unknown Seizures : Loss of consciousness with uncontrollable shaking (convulsion) √ Unknown Sleepwalking √ (and stop taking APO-VARENICLINE) This is not a complete list of side effects. For any unexpected effects while taking APO-VARENICLINE, contact your doctor or pharmacist.

Adverse Reactions Table

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom/effectTalk to your healthcare professionalStop taking drug and get immediate medical help
Only if severeIn all cases
RareAllergic reaction redness, itching or swelling of your skin, hives, burning, stinging, swelling of the neck area, or any difficulty with breathing, not present before using this medicine√
RareSerious skin reactions peeling of the skin, or rash combined with blisters around the mouth, eyes or genitals.√
RareMental Health Problems√√ (if severe, or if involves potential for harm to self or others)
UnknownHeart attack: chest pain often associated with left shoulder or jaw pain, feeling of constriction around chest and sweating√
UnknownStroke: weakness and/or loss of sensation of limbs or face, difficulty speaking, clumsiness, visual loss√
UnknownSeizures: Loss of consciousness with uncontrollable shaking (convulsion)√
UnknownSleepwalking√ (and stop taking APO-VARENICLINE)

Effective Time

20230126

Version

3

Spl Product Data Elements

APO-VARENICLINE VARENICLINE APO-VARENICLINE APO-VARENICLINE MICROCRYSTALLINE CELLULOSE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE HYPROMELLOSE 2910 (5 MPA.S) HYDROXYPROPYL CELLULOSE (110000 WAMW) TRIACETIN TITANIUM DIOXIDE VARENICLINE TARTRATE VARENICLINE APO;VAR;0;5 Capsule-Shaped APO-VARENICLINE APO-VARENICLINE MICROCRYSTALLINE CELLULOSE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE HYPROMELLOSE 2910 (5 MPA.S) HYDROXYPROPYL CELLULOSE (110000 WAMW) TRIACETIN TITANIUM DIOXIDE VARENICLINE TARTRATE VARENICLINE FD&C BLUE NO. 2 Capsule-Shaped APO;VAR;1 APO-VARENICLINE VARENICLINE VARENICLINE TARTRATE VARENICLINE MICROCRYSTALLINE CELLULOSE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE HYPROMELLOSE 2910 (5 MPA.S) HYDROXYPROPYL CELLULOSE (110000 WAMW) TRIACETIN TITANIUM DIOXIDE Capsule-Shaped APO;VAR;0;5 APO-VARENICLINE VARENICLINE MICROCRYSTALLINE CELLULOSE ANHYDROUS DIBASIC CALCIUM PHOSPHATE MAGNESIUM STEARATE HYPROMELLOSE 2910 (5 MPA.S) HYDROXYPROPYL CELLULOSE (110000 WAMW) TRIACETIN TITANIUM DIOXIDE VARENICLINE TARTRATE VARENICLINE FD&C BLUE NO. 2 Capsule-Shaped APO;VAR;1 Chantix0.5mg56count Chantix0.5mgimage Chantix1mg56count Chantix1mgimage Chantixcontinuationpack Chantixstarterpack Containerlabel0.5mg56count containerlabel1mg56count Vareniclinecontinuationpack Vareniclinestarterpack Apo0.5mgimage Apo1mgimage barcode1.jpg barcode2.jpg barcode3.jpg barcode4.jpg chantixstructure.jpg apotexstructure.jpg pfizerlogo.jpg chantixfigure1.jpg chantixfigure2.jpg chantixfigure3.jpg chantixmed1.jpg chantixmed2.jpg chantixmed3.jpg chantixmed4.jpg chantixstorage.jpg chantixtable1.jpg chantixtable2.jpg chantixtable3.jpg chantixtable4.jpg chantixtable5.jpg chantixtable6.jpg chantixtable7.jpg chantixtable8.jpg chantixtable9.jpg chantixtable10.jpg chantixtable11.jpg chantixtable12.jpg chantixtable13.jpg chantixtable14.jpg chantixtable15.jpg chantixtable16.jpg chantixtable17.jpg chantixtable18.jpg chantixtable19.jpg chantixtabledose.jpg chantixmed5.jpg Apofigure2.jpg Apofigure3.jpg Apomed1.jpg Apomed2.jpg Apomed3.jpg Apotable.jpg Apotable1.jpg Apotable5.jpg Apotable6.jpg Apotable7.jpg Apotable8.jpg Apotable8a.jpg Apotable9.jpg Apotable11.jpg Apotable12.jpg Apotable13.jpg Apotable14.jpg apodose1.jpg

Brand Name

APO-VARENICLINE

Generic Name

VARENICLINE

Product Ndc

60505-4765

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL Apo-Varenicline Tablets 0.5 mg 56 tablets bottle label 60505-4765

Spl Patient Package Insert Table

DayDose
Day 1 to 3Take one white APO-VARENICLINE 0.5 mg tablet once a day.
Day 4 to 7Take one white APO-VARENICLINE 0.5 mg tablet twice a day, once in the morning and once in the evening, at about the same time each day.

Storage And Handling

HOW TO STORE IT Store APO-VARENICLINE at room temperature (15°C to 30°C). Keep out of the reach and sight of children. Reporting Side Effects You can report any suspected side effects associated with the use of health products to Health Canada by: • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or • Calling toll-free at 1-866-234-2345. NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage And Handling Table

Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

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