VARENICLINE PFIZER

(var-ren-ee-cline fi-zer) Varenicline tartrate Consumer Medicine Information

What is in this leaflet Although it is not recommended that Deciding to stop you smoke after your quit date, smoking This leaflet answers some common Varenicline Pfizer will reduce your questions about Varenicline Pfizer. It enjoyment of cigarettes if you do Varenicline Pfizer helps you give up smoke while on treatment. does not contain all the available smoking. Other things you need information. It does not take the include: How Varenicline Pfizer place of talking to your doctor or • willpower pharmacist. works • a quit plan All medicines have risks and Varenicline Pfizer contains the active benefits. Your doctor has weighed ingredient varenicline and works by • support from your family and the risks of you taking Varenicline blocking the effects of nicotine in friends Pfizer against the benefits it is your body. There are receptors for • counselling, advice or additional expected to have for you. nicotine in the brain. When cigarette support smoke is inhaled, nicotine attaches to If you have any concerns about • changes in your behaviour, so these receptors. This sends a message taking this medicine, ask your you avoid situations where you doctor or pharmacist. to a different part of the brain to are likely to smoke. release a chemical called dopamine. Keep this leaflet with the medicine. Dopamine gives a feeling of pleasure Most people are unable to quit You may need to read it again. which only lasts for a short time. The smoking without support. Your body wants to repeat this feeling doctor and pharmacist can give you reinforcing the need to keep advice, support and sources of smoking. It is believed that information to help you stop What Varenciline Varenicline Pfizer works by smoking. You can also get free Pfizer is used for activating these receptors and advice and support from Quitline by blocking nicotine from attaching to calling 0800 778 778 or online at www.quit.org.nz. Varenicline Pfizer is a medicine to them. Varenicline Pfizer does not help adults stop smoking. It can help contain nicotine and it is not to reduce craving and withdrawal addictive. symptoms that may happen while Ask your doctor if you have any you stop smoking. questions about why this medicine Before you take Varenciline Pfizer People giving up smoking are often has been prescribed for you. affected by nicotine withdrawal. Your doctor may have prescribed it Symptoms of nicotine withdrawal for another reason. When you must not take it can include craving for tobacco, Varenicline Pfizer is only available Do not take Varenicline Pfizer if irritability, frustration, feeling angry, with a doctor's prescription. you have an allergy to: sleep problems, depressed mood, • any medicine containing feeling anxious, difficulty Use in children varenicline tartrate concentrating, restlessness, decreased heart rate, increased appetite or Available information does not • any of the ingredients listed at the weight gain. Not everybody is support the use of this medicine in end of this leaflet. affected by symptoms of nicotine children under the age of 18 years. Some of the symptoms of an allergic withdrawal. reaction may include:

VARENICLINE PFIZER 1 • shortness of breath, wheezing or • mental health conditions such cessation therapies is not difficulty breathing as depression, thoughts of recommended. • swelling of the face, lips, tongue suicide or self-harm The safety and benefits of taking or other parts of the body • kidney problems Varenicline Pfizer in combination • rash, itching or hives on the skin. • repeated fits or convulsions with other medicines to stop smoking have not been studied. Do not take Varenicline Pfizer (epilepsy) after the expiry date printed on the Some people have reported Tell your doctor or pharmacist if pack or if the packaging is torn or convulsions or fits while taking you are taking any of the shows signs of tampering. Varenicline Pfizer. following: • If it has expired or is damaged, return • heart and blood vessel insulin it to your pharmacist for disposal. problems such as heart attack, • theophylline, a medicine used to Talk to your doctor if you are not chest pain or stroke. treat asthma sure whether you should take this Tell your doctor if you are • warfarin, a medicine used to thin medicine. pregnant, become pregnant or are the blood. breast-feeding. The effects of changes in your body Before you start to take it • it is not recommended that you resulting from stopping smoking, Tell your doctor if have or have take Varenicline Pfizer while you with or without Varenicline Pfizer, had feelings of low mood, anxiety, are pregnant or breast-feeding. may alter the way these medicines disturbances in thinking, emotional • if you plan to become pregnant, work. In some cases, an adjustment reactions or behaviour that has your treatment should be timed so of dose may be necessary. interfered or interferes with your that you have completed the Your doctor and pharmacist have everyday life. course before becoming pregnant. more information on medicines to be For some people, stopping smoking, If you have not told your doctor careful with or avoid while taking with or without treatment, has been about any of the above, tell this medicine. associated with changes in him/her before you start taking behaviour, thinking or mood that are Varenicline Pfizer. not typical for them e.g. developing Tell your doctor if you have suicidal thoughts or actions, anxiety, How to take allergies to any other medicines, panic, aggression, anger, mania, foods, preservatives or dyes. Varenciline Pfizer abnormal sensations, hallucinations, paranoia or confusion. Follow all directions given to you Taking other medicines Some people had these symptoms by your doctor or pharmacist when they began taking Varenicline Tell your doctor or pharmacist if carefully. Pfizer, and others developed them you are taking any other They may differ from the after several weeks of treatment or medicines, including: information in this leaflet. • all prescription medicines after stopping Varenicline Pfizer. If you do not understand the Your family and friends should be • all medicines, vitamins, herbal instructions on the pack, ask your asked to monitor any changes in your supplements or natural therapies doctor or pharmacist for help. behaviour, thinking or mood that are you buy without a prescription not typical for you e.g. if you from a pharmacy, supermarket, How to start develop suicidal thoughts or actions, naturopath or health food shop. There are 3 ways to quit smoking anxiety, panic, aggression, anger, This includes other medicines to help with Varenicline Pfizer: mania, abnormal sensations, you stop smoking such as: hallucinations, paranoia or confusion. 1. Choose a quit date when you • nicotine replacement therapy will stop smoking. Discuss with your doctor the (NRT), which includes patches, • Make a note of this date. You benefits and risks of taking gum, lozenges, sublingual tablets can write this date on the Varenicline Pfizer to decide if it is and inhalers (such as Nicorette, carton of the Initiation Pack as right for you. Nicabate, QuitX) a reminder. Tell your doctor if you have or • bupropion (e.g. Zyban). have had any of the following • Start taking Varenicline Pfizer Taking Varenicline Pfizer in medical conditions: 1 to 2 weeks (7 to 14 days) combination with other smoking before your quit date.

VARENICLINE PFIZER 2 • You can keep smoking during • Weeks 5 - 12: Take one light blue If you forget to take it this time. 1 mg tablet in the morning and If it is less than 6 hours before your one in the evening. • Make sure that you try to stop next dose, skip the dose you missed smoking on your quit date. If • Weeks 13 - 24: Take one light and take your next dose when you you slip-up and smoke, try blue 1 mg tablet in the morning are meant to. again. and one in the evening. Otherwise, take it as soon as you 2. Start taking Varenicline Pfizer. remember, and then go back to How to take it • Choose a quit date when you taking your medicine as you would will stop smoking between days Swallow the tablets whole with a normally. full glass of water. 8 and 35 of starting Varenicline Do not take a double dose to make Pfizer. up for the dose that you missed. When to take it • Make a note of this date. You If you are not sure what to do, ask can write this date on the Take your medicine at about the your doctor or pharmacist. carton of the Initiation Pack as same time each day. If you have trouble remembering a reminder. This will have the best effect and to take your medicine, ask your • Make sure that you try to stop help you remember when to take it. pharmacist for some hints. smoking on your quit date. If It does not matter if you take you slip-up and smoke, try Varenicline Pfizer before or after If you take too much again. food. (overdose) 3. Start taking Varenicline Pfizer. Some people find it helpful to take Immediately telephone your doctor • Reduce the number of Varenicline Pfizer with food. or contact the Poisons Information cigarettes you smoke each day Centre for advice (telephone 0800 during the first 12 weeks of How long to take it POISON or 0800 764 766), or go to taking Varenicline Pfizer. If options 1 or 2 are the selected Accident and Emergency at the • Stop smoking on the last day of way to quit smoking, take nearest hospital if you think that the 12 week treatment period. Varenicline Pfizer for 12 weeks. you or anyone else may have taken This is your quit date. too much Varenicline Pfizer. Do Your doctor may advise you to take this even if there are no signs of • Continue taking Varenicline Varenicline Pfizer for a further 12 discomfort or poisoning. Pfizer 1 mg tablets for a further weeks after your first treatment. This 12 weeks. may increase your chances of You may need urgent medical stopping in the long term. attention. How much to take If option 3 is the selected way to Take your tablets with you to Start with the white 0.5 mg tablet quit smoking, take Varenicline hospital. and then increase the dose up to Pfizer for 12 weeks. the light blue 1 mg tablet. You must then take Varenicline Starting with a low dose helps your Pfizer for an additional 12 weeks body get used to Varenicline Pfizer. (24 weeks in total). While you are taking Varenciline Pfizer If you have severe kidney disease If you do not stop smoking during your doctor may prescribe a different the first 12 weeks of treatment or if Make sure you try to stop smoking dose. you start smoking again after on your quit date. treatment, you can make another The usual dosage instructions are If you slip up and smoke, try again. listed below. attempt to stop smoking. • Days 1 - 3: Take one white However, before you make another Things you must do 0.5 mg tablet once a day. attempt, you should try to understand the reasons why your attempt to stop Stop taking Varenicline Pfizer and • Days 4 - 7: Take one white smoking failed, so that your next tell your doctor immediately if you 0.5 mg tablet in the morning and attempt has a better chance of or your family/friends notice one in the evening. success. agitation, hostility, depression or • Weeks 2 - 4: Take one light blue changes in behaviour, thinking, or 1 mg tablet in the morning and mood that are not typical for you, one in the evening. or you develop suicidal thoughts or actions, anxiety, panic, aggression,

VARENICLINE PFIZER 3 anger, mania, abnormal sensations, Things to be careful of Stop taking Varenicline hallucinations, paranoia or Be careful driving or operating Pfizer if... confusion. machinery until you know how Stop taking Varenicline Pfizer and All mentions of suicide or violence Varenicline Pfizer affects you. tell your doctor immediately if you must be taken seriously. These are Varenicline Pfizer may cause or your family/friends notice very serious side effects. You may dizziness and sleepiness in some agitation, hostility, depression or need urgent medical attention or people. If you have any of these changes in behaviour, thinking, or hospitalisation. symptoms, do not drive, operate mood that are not typical for you, It is not known whether these machinery or do anything else that or you develop suicidal thoughts or changes are related to Varenicline could be dangerous. actions, anxiety, panic, aggression, Pfizer as it is known that mood anger, mania, abnormal sensations, Be careful if drinking alcohol while changes can also be due to the effects hallucinations, paranoia or you are taking this medicine. of stopping smoking. confusion. There have been reports of increased If you have existing heart or blood Some people have had changes in feelings of being drunk while taking vessel problems, tell your doctor as behaviour, thinking or mood that are Varenicline Pfizer. Drinking alcohol soon as possible if you notice any not typical for them when they start while taking Varenicline Pfizer may changes in symptoms while taking taking Varenicline Pfizer. These may also increase your risk of Varenicline Pfizer. include suicidal thoughts or actions, experiencing changes to your anxiety, panic, aggression, anger, Your doctor may check your blood behaviour, thinking or mood that are mania, abnormal sensations, pressure and blood glucose levels not typical for you e.g. developing hallucinations, paranoia or confusion. from time to time to make sure you suicidal thoughts or actions, anxiety, have not developed any unwanted panic, aggression, anger, mania, These symptoms have occurred in side effects. abnormal sensations, hallucinations, people with previous mental health It is important to keep all of your paranoia or confusion. problems, as well as those with no doctor's appointments so that your previous history. progress can be checked. Tell your doctor if... If you are about to be started on any new medicine, remind your Side effects Tell your doctor or pharmacist if doctor and pharmacist that you you have nausea (feel sick) while are taking Varenicline Pfizer. Tell your doctor or pharmacist as taking Varenicline Pfizer and it soon as possible if you do not feel worries you. Tell any other doctors, dentists and well while you are you are taking Around 3 in 10 people experience pharmacists who treat you that Varenicline Pfizer. you are taking this medicine. nausea, usually starting in the first Giving up smoking with or without week. Most people who have nausea If you are going to have surgery, treatment can cause various are able to keep taking the medicine. tell the surgeon or anaesthetist that symptoms. These could include Some people find it helpful to take you are taking this medicine. changes of mood, sleeplessness, Varenicline Pfizer with food. It may affect other medicines used difficulty concentrating, decreased Ask your doctor or pharmacist for during surgery. heart rate, increased appetite or advice if you notice any of the weight gain. This medicine helps If you become pregnant while following and they worry you: taking this medicine, tell your many people give up smoking, but it • stomach or bowel problems doctor immediately. may have unwanted side effects in some people. All medicines can have − constipation Things you must not do side effects. You may need medical − diarrhoea attention if you get some of the side Do not take Varenicline Pfizer to effects. − feeling bloated treat any other complaints unless − indigestion your doctor tells you to. Do not be alarmed by the following lists of side effects. − wind Do not give your medicine to You may not experience any of them. − nausea, vomiting anyone else, even if they are also trying to stop smoking. Ask your doctor or pharmacist to − stomach discomfort answer any questions you may • dry mouth, toothache have. • headache

VARENICLINE PFIZER 4 • dizziness muscles and generally feeling Do not store Varenicline Pfizer or • sleep problems unwell any other medicine in the • bathroom or near a sink. − difficulty sleeping breathing problems Do not leave it on a window sill or − − wheezing sleepiness in the car. − abnormal dreams − difficulty breathing Heat and dampness can destroy some − • feeling tired, fatigue shortness of breath medicines. • swelling of the face, lips, mouth, • signs and symptoms of a cold Keep it where children cannot tongue, throat, hands or feet • change in appetite, weight gain reach it. Some people have reported • changes in taste A locked cupboard at least one-and-a swelling of parts of their face and half metres above the ground is a • muscle or joint pain. body after taking Varenicline good place to store medicines. These are the more common side Pfizer. effects of Varenicline Pfizer. They • chest pain, which may spread to Disposal are usually mild. the neck and shoulders, numbness Return your unwanted medicines or weakness of the arms or legs, to your pharmacy for safe disposal. Tell your doctor as soon as headache, dizziness and possible if... confusion, visual disturbance, Your doctor may tell you to stop difficulty swallowing, slurred taking this medicine or the expiry Tell your doctor as soon as possible speech or loss of speech, collapse date may have passed. if you notice any of the following: • abnormal or fast heartbeat • trembling, fits or convulsions • blood in vomit. • problems with your vision or pain in your eyes This list includes very serious side Product description effects. You may need urgent • red blood in stools medical attention or hospitalisation. What it looks like • stomach pain Very serious side effects are rare. Varenicline Pfizer is available in 2 • excessive thirst, having a dry Tell your doctor or pharmacist if strengths: mouth and skin, passing large you notice anything else that is amounts of urine. making you feel unwell. • Varenicline Pfizer 0.5 mg tablets are white, film-coated, modified This list includes serious side effects Other side effects not listed above capsular shaped tablets marked which may require medical attention. may occur in some people. Some of "Pfizer" on one side and "CHX these side effects (for example, 0.5" on the other. Go to hospital if... changes in blood pressure or blood • Varenicline Pfizer 1 mg tablets Tell your doctor immediately or go sugar levels) can only be found when are light blue, film-coated, to Accident and Emergency at your doctor does tests to check your modified capsular shaped tablets, your nearest hospital and stop progress. marked "Pfizer" on one side and taking Varenicline Pfizer if you "CHX 1.0" on the other. experience any of the following: • self-harm or thoughts of self- Packs Available harm After taking Varenciline Pfizer The following packs are available: • changes in behaviour, thinking or mood that are not typical for you • Initiation pack to start treatment, e.g. if you develop suicidal Storage contains 11 x 0.5 mg tablets and 42 x 1 mg tablets thoughts or actions, anxiety, Keep your tablets in the pack until panic, aggression, anger, mania, it is time to take them. • Continuation pack containing 56 abnormal sensations, If you take the tablets out of the pack x 1 mg tablets to continue hallucinations, paranoia or they may not keep well. treatment. confusion Keep your tablets in a cool dry • rash or sudden severe itchy Ingredients place where the temperature stays swellings on the skin below 30°C. Active Ingredients • severe painful red blisters on the skin with chills, fever, aching

VARENICLINE PFIZER 5 Varenicline Pfizer 0.5 mg tablets contain the equivalent of 0.5 mg of varenicline. Varenicline Pfizer 1 mg tablets contain the equivalent of 1 mg of varenicline. Inactive Ingredients Each tablet of Varenicline Pfizer contains the following inactive ingredients: • Cellulose - microcrystalline • Calcium hydrogen phosphate • Croscarmellose sodium • Silica-colloidal anhydrous • Magnesium stearate • Opadry Blue (1 mg tablet), Opadry White (0.5 mg tablet) and Opadry Clear. Varenicline Pfizer is gluten free.

Supplier Pfizer New Zealand Limited PO Box 3998 Auckland, New Zealand. Toll Free Number: 0800 736 363.

This leaflet was prepared in October 2018.

© Pfizer Australia Pty Ltd 2018.

VARENICLINE PFIZER 6