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warnings and cautions
WARNINGS AND PRECAUTIONS BEFORE you use APO-VARENICLINE talk to your healthcare provider if you: - have experienced depression or any other mental health problems. Your healthcare provider will monitor you for new or worsened emotional or behavioral problems during treatment with APO-VARENICLINE. - have any problems with your kidneys, as you may need a lower dose of APO-VARENICLINE. - have heart or blood vessel (cardiovascular) problems. - have a history of seizures. - have any other medical conditions. - are pregnant, are breastfeeding or plan to become pregnant (see “Pregnancy” and “Breastfeeding” below). - have diabetes. APO-VARENICLINE can potentially affect your blood sugar regulation, and you may need to monitor your blood sugar more often. If you notice changes, discuss this with your healthcare provider. The effects of changes in your body resulting from stopping smoking, with or without treatment with APO-VARENICLINE, may alter the way other drugs work. Tell your healthcare provider about all your other medicines, including prescription and nonprescription medicines, vitamins and herbal supplements. Especially, tell your healthcare provider if you take: Insulin Asthma medicines (theophylline) Blood thinner (warfarin) as an adjustment of the dose of these medicines may be necessary once you are smoke-free. Mental Health Symptoms See “What is the most important information I should know about APO-VARENICLINE?” Pregnancy Talk to your healthcare provider if you are pregnant or planning to become pregnant. You should not take APO-VARENICLINE while you are pregnant. It is unknown if APO-VARENICLINE will harm your unborn baby. It is best to stop smoking before you get pregnant. Breastfeeding You should ask your healthcare provider for advice before taking any medication, including APO-VARENICLINE, if you are breastfeeding, as the medicine may pass into breast milk. APO-VARENICLINE is not recommended for use in children under 18 years of age. Accidental Injury, including while Driving, Operating Machinery Do not engage in potentially hazardous tasks, such as driving a car or operating dangerous machines, until you know how APO-VARENICLINE may affect you. In some cases, people have reported sleepiness, dizziness, blackouts, seizures or difficulty concentrating while driving. Seizures Tell your healthcare provider if you have experienced seizures or have epilepsy before you start APO-VARENICLINE treatment. Some people have reported seizures while taking varenicline, both with and without a history of seizures. Heart or Stroke Events New or worse heart or blood vessel (cardiovascular) problems have been reported in people taking varenicline, primarily in those who already have cardiovascular problems. From the information available to date, it is not possible to determine whether APO-VARENICLINE increases the risk of heart or stroke events. Tell your healthcare provider if you have any changes in cardiovascular symptoms during treatment with APO-VARENICLINE. Get emergency medical help right away if you have symptoms of a heart attack, including any of the following: Chest discomfort (uncomfortable pressure, squeezing, fullness or pain) that lasts more than a few minutes, or that goes away and comes back. Pain or discomfort in one or both arms, back, neck, jaw or stomach. Shortness of breath, sweating, nausea, vomiting, or feeling lightheaded associated with chest discomfort. Get emergency medical help right away if you have symptoms of a stroke, including any of the following: Weakness - Sudden loss of strength or sudden numbness in the face, arm or leg even if temporary. Trouble speaking - Sudden difficulty speaking or understanding or sudden confusion, even if temporary. Vision problems - Sudden trouble with vision, even if temporary. Headache - Sudden severe and unusual headache. Dizziness - Sudden loss of balance, especially with any of the above signs. Sleepwalking Sleepwalking has been reported in patients taking APO-VARENICLINE, and may sometimes lead to behaviour that is harmful to you or other people or property. Stop taking APO-VARENICLINE and tell your healthcare provider if you start sleepwalking.
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
<table frame="box" rules="all"><tbody><tr><th colspan="5"><content styleCode="bold">SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM</content></th></tr><tr><td colspan="2"><content styleCode="bold">Symptom/effect</content></td><td align="center" colspan="2"><content styleCode="bold">Talk to your healthcare professional</content></td><td align="center" rowspan="2" valign="top"><content styleCode="bold">Stop taking drug and get immediate medical help</content></td></tr><tr><td/><td rowspan="1"/><td align="center"><content styleCode="bold">Only if severe</content></td><td align="center"><content styleCode="bold">In all cases</content></td></tr><tr><td valign="top"><content styleCode="bold">Rare</content></td><td><content styleCode="bold">Allergic reaction</content> 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</td><td/><td/><td align="center" valign="top">√</td></tr><tr><td valign="top"><content styleCode="bold">Rare</content></td><td><content styleCode="bold">Serious skin reactions </content> peeling of the skin, or rash combined with blisters around the mouth, eyes or genitals.</td><td/><td/><td align="center" valign="top">√</td></tr><tr><td><content styleCode="bold">Rare</content></td><td><content styleCode="bold">Mental Health Problems</content></td><td/><td align="center">√</td><td align="center"><content styleCode="bold">√ (if severe, or if involves potential for harm to self or others)</content></td></tr><tr><td><content styleCode="bold">Unknown</content></td><td><content styleCode="bold">Heart attack:</content> chest pain often associated with left shoulder or jaw pain, feeling of constriction around chest and sweating</td><td/><td/><td align="center" valign="top"><content styleCode="none">√</content></td></tr><tr><td><content styleCode="bold">Unknown</content></td><td><content styleCode="bold">Stroke: </content> weakness and/or loss of sensation of limbs or face, difficulty speaking, clumsiness, visual loss</td><td/><td/><td align="center" valign="top">√</td></tr><tr><td><content styleCode="bold">Unknown</content></td><td><content styleCode="bold">Seizures</content>: Loss of consciousness with uncontrollable shaking (convulsion)</td><td/><td/><td align="center" valign="top">√</td></tr><tr><td><content styleCode="bold">Unknown</content></td><td>Sleepwalking</td><td/><td align="center">√ (and stop taking APO-VARENICLINE)</td><td/></tr></tbody></table>