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APO-Desvenlafaxine MR Tablets Contains the active ingredient desvenlafaxine (as benzoate) Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet Desvenlafaxine belongs to a class of • any of the ingredients listed at the medications called - end of this leaflet. This leaflet answers some common Noradrenaline Reuptake Inhibitors Some of the symptoms of an allergic questions about this medicine. It does (SNRIs). reaction may include: not contain all the available Serotonin and noradrenaline are • shortness of breath information. It does not take the chemical messengers that allow place of talking to your doctor or certain nerves in the brain to work. • wheezing or difficulty breathing pharmacist. This medicine increases the level of • swelling of the face, lips, tongue All medicines have risks and these two messengers. Experts think or other parts of the body benefits. Your doctor has weighed this is how it helps to restore your • rash, itching or hives on the skin the risks of you taking this medicine feeling of wellness. Do not take this medicine if you against the benefits they expect it Ask your doctor if you have any are taking other medications for will have for you. questions about why this medicine depression known as monoamine If you have any concerns about has been prescribed for you. oxidase inhibitors (MAOIs). taking this medicine, ask your Your doctor may have prescribed this Do not take desvenlafaxine even if doctor or pharmacist. medicine for another reason. you have stopped taking any MAOIs Keep this leaflet with the medicine. This medicine is available only with but have taken them within the last You may need to read it again. a doctor's prescription. 14 days. There is no evidence that this Do not take this medicine after the medicine is addictive. expiry date printed on the pack or if the packaging is torn or shows This medicine should not be used signs of tampering. What this medicine is in children or adolescents under 18 If it has expired or is damaged, return used for years of age. it to your pharmacist for disposal. The name of your medicine is APO- The safety and effectiveness of this If you are not sure whether you Desvenlafaxine MR Tablets. It medicine in this age group have not should start taking this medicine, contains the active ingredient been established. talk to your doctor. desvenlafaxine (as benzoate). It is used in the treatment and Before you start to take it prevention of relapse of depression. Tell your doctor if you have Depression can affect your whole Before you take this allergies to any other medicines, body and may cause emotional and medicine foods, preservatives or dyes. physical symptoms such as feeling low in spirit, being unable to enjoy When you must not take it Tell your doctor if you have or life, poor appetite or overeating, have had any of the following Do not take this medicine if you disturbed sleep, loss of sex drive, medical conditions: have an allergy to: lack of energy and feeling guilty over • a history of fits (seizures or • any medicine containing nothing. convulsions) desvenlafaxine or

APO-DESVENLAFAXINE MR TABLETS 1 • a personal history or family should be strictly as directed by your • drugs that affect serotonin levels history of bipolar disorder doctor. Symptoms of a relapse may e.g. , , • blood pressure problems occur if treatment is discontinued, fentanyl, , even if major depression was and pentazocine • (increased pressure in previously under control. the eye) • medicines for weight loss, Tell your doctor if you are including • a tendency to bleed more than currently , or you normal or you are taking a blood • medicines used to treat Attention plan to breastfeed. thinning medication Deficit Hyperactivity Disorder This medicine passes into breast milk (ADHD) such as • raised cholesterol or lipid levels and there is a possibility that the dexamphetamine and • problems with your kidneys or breastfed baby may be affected. lisdexamphetamine liver Do not take this medicine whilst • triptans (used to treat migraine) • problems with your heart breastfeeding until you and your • (used to treat infections) • low sodium levels in your blood doctor have discussed the risks and benefits involved. • drugs that affect your tendency to • or any other medical conditions. bleed, e.g., aspirin, NSAIDs, If you have not told your doctor Tell your doctor if you are warfarin. about any of the above, tell them currently pregnant or you plan to These medicines may be affected by before you start taking this become pregnant. desvenlafaxine or may affect how medicine. Do not take this medicine whilst well it works. You may need pregnant until you and your doctor Taking other medicines different amounts of your medicines, have discussed the risks and benefits or you may need to take different involved. Tell your doctor or pharmacist if medicines. you are taking any other Your doctor and pharmacist have One of these risks is that newborn medicines, including any that you more information on medicines to babies whose mothers have been get without a prescription from be careful with or avoid while taking this medicine may have your pharmacy, supermarket or taking this medicine. several problems including breathing health food shop. difficulties, seizures, lack of oxygen Some medicines and this one may in their blood, physical and/or Switching to this medicine interfere with each other. These behavioural problems, vomiting and from other : include: diarrhoea. Side effects from discontinuing • medications for depression If you take desvenlafaxine or similar medication may occur known as monoamine oxidase antidepressants mid to late in your if you are switched from other inhibitors (MAOIs) (such as , you may develop a antidepressants, including , and condition known as "pre-eclampsia", venlafaxine, to this medicine. Your ). which is characterised by persistent doctor may gradually reduce the dose high-blood pressure during or after Tell your doctor if you are of your initial antidepressant pregnancy. Symptoms of taking or have stopped taking medication to help reduce these side preeclampsia can include headaches, them within the last 14 days. effects. abdominal pain, shortness of breath Ask your doctor or pharmacist if or burning behind the sternum, you are unsure if you are taking nausea and vomiting, confusion, any of these medicines. heightened state of , and/or It is important that you do not How to take this visual disturbances such as take this medicine or medicines medicine oversensitivity to light, blurred similar to desvenlafaxine with vision, or seeing flashing spots or MAOIs or within 14 days of Follow all directions given to you auras. taking a MAOI, as this may by your doctor or pharmacist If you take desvenlafaxine or similar result in a serious life- carefully. antidepressants in the last month of threatening condition. They may differ from the your pregnancy, you may experience • any other medications for bipolar information contained in this leaflet. heavy bleeding during and/or after disorder, depression, anxiety, If you do not understand the delivery. obsessive-compulsive disorder or directions, ask your doctor or Continuing treatment with pre-menstrual dysphoric disorder, pharmacist for help. desvenlafaxine or similar including St John's wort antidepressants during pregnancy

APO-DESVENLAFAXINE MR TABLETS 2 How much to take Make sure you have enough to last It may affect other medicines used over weekends and holidays. during surgery. Your doctor will tell you how much of this medicine you should take. If you become pregnant or start to If you forget to take it This will depend on your condition breastfeed while taking this and whether you are taking any other If it is less than 12 hours until your medicine, tell your doctor medicines. next dose, skip the missed dose and immediately. The usual dose is 50 mg taken once take your next dose at the usual If you are about to have any blood daily with or without food. time. tests, tell your doctor that you are taking this medicine. If you have kidney problems, you Otherwise, take it as soon as you may need a lower dose of remember and then go back to It may interfere with the results of desvenlafaxine. taking your medicine as you would some tests. normally. Keep all your doctor's How to take it Do not take a double dose to make appointments so that your progress up for missed doses. Swallow the tablets whole with a can be checked. full glass of water. This may increase the chance of you Your doctor may do some tests from experiencing side effects. time to time to make sure the Do not divide, crush, chew or place medicine is working and to prevent the tablets in water. If you have trouble remembering to take your medicine, ask your unwanted side effects. Do not be concerned if you see a pharmacist for some hints to help tablet 'shell' in your faeces after Always discuss any questions you you remember. taking this medicine. have about this medicine with your doctor. As the tablet travels the length of If you take too much Take this medicine exactly as your your gastrointestinal tract, the active (overdose) ingredient desvenlafaxine is slowly doctor has prescribed. released. The tablet 'shell' remains Immediately telephone your doctor Watch carefully for signs that your undissolved and is eliminated in your or the Poisons Information Centre depression is getting worse, faeces. Therefore, even though, you (telephone 13 11 26) for advice or especially in the first few weeks of may see a tablet 'shell' in your faeces, go to Accident and Emergency at treatment or if your dose has your dose of desvenlafaxine has been the nearest hospital, if you think changed. that you or anyone else may have absorbed. Sometimes people with depression taken too much of this medicine. can experience a worsening of their Do this even if there are no signs of When to take it depressive symptoms. This can discomfort or poisoning. Take your medicine at about the happen even when taking an You may need urgent medical same time each day. antidepressant. attention. Taking it at the same time each day Tell your doctor there is the will have the best effect. It will also potential for a false positive help you remember when to take it. urinary drug screen while on this medicine. It does not matter if you take this While you are taking medicine before or after food. this medicine Tell your doctor immediately if you experience any of the following How long to take it for symptoms, especially if they are Things you must do severe, you have not had these Continue taking your medicine for If you are about to be started on symptoms before, or they happen as long as your doctor tells you. any new medicine, remind your very suddenly: Although you may begin to feel doctor and pharmacist that you • anxiety or agitation better after two weeks, it may take are taking this medicine. several weeks before you feel much • panic attacks Tell any other doctors, dentists, better. It is important to give this • difficulty sleeping and pharmacists who treat you medicine time to work. that you are taking this medicine. • irritability This medicine helps to control your If you are going to have surgery, • aggressiveness condition but does not cure it, so it is tell the surgeon or anaesthetist that • hostility or impulsiveness important to keep taking your you are taking this medicine. medicine even if you feel well. • restlessness

APO-DESVENLAFAXINE MR TABLETS 3 • overactivity or uninhibited • abnormal dreams orgasm – sometimes lasting even behaviour • diarrhoea after you have stopped taking desvenlafaxine • other unusual changes in • excessive sweating behaviour • nervousness or anxiety • visual impairment • thoughts of . • feeling jittery or irritable • high blood pressure Tell your doctor immediately if • difficulty thinking or working Slowly reducing the amount of this you have any thoughts about medicine being taken reduces the • yawning suicide or doing harm to yourself. possibility of these effects occurring. • disturbances in concentration Warning signs of suicide In some people this may need to • fainting or dizziness after occur over periods of months or standing up If you or someone you know is longer. showing the following warning • fatigue signs, contact your doctor or a Things to be careful of • rapid heart beat mental health advisor right away • chills or go to the nearest hospital for Be careful when driving or treatment. operating machinery until you • headache know how this medicine affects • excessive sweating All thoughts or talk about suicide or you. It may make you feel drowsy. violence are serious. These include: • hot flushes Avoid drinking alcohol while you • thoughts or talk about death or are taking this medicine. • rash suicide • weight loss or weight gain • thoughts or talk about self-harm • blurred vision or doing harm to others • ringing in the ears • any recent attempts of self-harm Side effects • altered taste, dry mouth. • an increase in aggressive Tell your doctor or pharmacist as behaviour, irritability or agitation. Tell your doctor as soon as possible soon as possible if you do not feel if you notice any of the following: well while you are taking this Things you must not do • muscle spasms, stiffness, medicine. weakness or movement disorders Do not take this medicine to treat All medicines can have side effects. • abnormal facial movements such any other complaints unless your Sometimes they are serious but most as tongue thrusting, repetitive doctor tells you to. of the time they are not. chewing, jaw swinging, or Do not give your medicine to Do not be alarmed by the following grimacing anyone else, even if they have the lists of side effects. You may not • a feeling of apathy or not caring same condition as you. experience any of them. about things Do not stop taking your medicine Ask your doctor or pharmacist to • feeling detached from yourself or lower the dosage without answer any questions you may checking with your doctor. have. • hallucinations, confusion Your doctor may want to slowly Tell your doctor or pharmacist if • agitation decrease your dose of this medicine you notice any of the following and • unusually overactive to help avoid side effects. Side they worry you: effects are known to occur when • problems with breathing, people stop taking this medicine, • nausea or vomiting shortness of breath especially when they suddenly stop • loss of appetite • bleeding or bruising more easily therapy. • diarrhoea than normal Some of these side effects include: • constipation • numbness or pins and needles • headache • difficulty passing urine • sensitivity to sunlight. • nausea • difficulty sleeping, abnormal The above list includes serious side • dizziness sleepiness or abnormal dreams effects that may require medical attention. Serious side effects are • tiredness • sexual function problems such as rare. • irritability decreased sex drive, delayed ejaculation, problems achieving If any of the following happen, tell • anxiety erection or difficulties achieving your doctor immediately or go to

APO-DESVENLAFAXINE MR TABLETS 4 Accident and Emergency at your Storage and disposal Ingredients nearest hospital: Each modified release tablet contains • palpitations, shortness of breath, Storage 50 mg or 100 mg of desvenlafaxine intense chest pain, or irregular benzoate as the active ingredient. heartbeats Keep your medicine in its original packaging until it is time to take it. It also contains the following inactive • severe upper abdominal pain ingredients: If you take your medicine out of its • swollen and tender abdomen original packaging it may not keep • Microcrystalline cellulose, • fever well. • purified talc, • rise or decrease in blood pressure Keep your medicine in a cool dry • stearic acid, – you may experience headache, place where the temperature will • colloidal anhydrous silica, blurred vision, palpitations, stay below 25°C. confusion or loss of • magnesium stearate, Do not store your medicine, or any consciousness, or sometimes you other medicine, in the bathroom or • hypromellose may not experience any of these near a sink. Do not leave it on a • OPADRY® II complete film symptoms. It is important to keep window sill or in the car. coating system 85F94487 PINK your routine doctor's (PI No. 106952) for 50 mg appointments so that your blood Heat and dampness can destroy some tablets, pressure can be checked seizures medicines. ® or fits. Keep this medicine where children • OPADRY II complete film coating system 85F94527 PINK • symptoms of sudden fever with cannot reach it. (PI No. 106953) for 100 mg sweating, rapid heartbeat and A locked cupboard at least one-and- tablets. muscle stiffness, which may lead a-half metres above the ground is a to loss of consciousness good place to store medicines. This medicine is gluten-free, lactose- free, sucrose-free, tartrazine-free and • symptoms of an allergic reaction free of other azo dyes. including cough, shortness of Disposal breath, wheezing or difficulty If your doctor tells you to stop Sponsor breathing; swelling of the face, taking this medicine or the expiry lips, tongue, throat or other parts date has passed, ask your Apotex Pty Ltd of the body; rash, itching or hives pharmacist what to do with any 16 Giffnock Avenue on the skin. medicine that is left over. Macquarie Park NSW 2113 The above list includes very serious Australia side effects. You may need urgent medical attention or hospitalisation. Tel: +61 2 8877 8333 These side effects are very rare. Product description Web: www1.apotex.com/au Tell your doctor or pharmacist if you notice anything that is making What APO-Desvenlafaxine APO is a registered trade mark of you feel unwell. MR Tablet looks like Apotex Inc. Other side effects not listed above 50 mg Tablet may occur in some patients. Light pink, biconvex, round shaped, This leaflet was last updated in Some of these side effects (for film coated tablets debossed with December 2019. example, increase in blood pressure, "DV" on one side and "50" on the increase in blood cholesterol, other side. AUST R 218307. changes to liver function, protein in 100 mg Tablet the urine) can only be found when your doctor does tests from time to Reddish-orange, biconvex, round time to check your progress. shaped, film coated tablets, debossed with "DV" on one side and "100" on the other side. AUST R 227802. Available in blister packs of 7, 14 and 28 tablets. * Not all strengths and/or pack sizes may be available.

APO-DESVENLAFAXINE MR TABLETS 5