Terry White Chemists Escitalopram
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Terry White Chemists Escitalopram Contains the active ingredient, escitalopram (as escitalopram oxalate) Consumer Medicine Information For a copy of a large print leaflet, What this medicine is Escitalopram corrects this chemical Ph: 1800 195 055 imbalance and may help relieve the used for symptoms of depression. The name of your medicine is Terry There is no evidence that White Chemists Escitalopram. It escitalopram is addictive. However, What is in this leaflet contains the active ingredient, if you suddenly stop taking it, you escitalopram (as escitalopram may get side effects. Read this leaflet carefully before oxalate). taking your medicine. Tell your doctor if you get any side It is used to treat: effects after stopping escitalopram. This leaflet answers some common • depression questions about escitalopram. • social anxiety disorder Use in children It does not contain all the available • general anxiety disorder information. It does not take the Do not give this medicine to a child • obsessive-compulsive disorder. or adolescent. place of talking to your doctor or pharmacist. Ask your doctor if you have any There is no experience with its use in questions about why this medicine children and adolescents under 18 The information in this leaflet was has been prescribed for you. Your years of age. last updated on the date listed on the doctor may have prescribed this last page. More recent information on medicine for another reason. this medicine may be available. This medicine is available only with Ask your doctor or pharmacist: a doctor's prescription. Before you take this • if there is anything you do not medicine understand in this leaflet, How it works • if you are worried about taking your medicine, or Escitalopram belongs to a group of When you must not take it medicines called Selective Serotonin • to obtain the most up-to-date Do not take this medicine if: Reuptake Inhibitors (SSRIs). information. Escitalopram and other SSRIs are You can also download the most up thought to help by increasing the to date leaflet from amount of serotonin in your brain. www.apotex.com.au. Depression is longer lasting or more All medicines have risks and severe than the "low moods" benefits. Your doctor has weighed everyone has from time to time due the risks of you using this medicine to the stress of everyday life. It is against the benefits they expect it thought to be caused by a chemical will have for you. imbalance in parts of the brain. This Pharmaceutical companies cannot imbalance affects your whole body give you medical advice or an and can cause emotional and physical individual diagnosis. symptoms such as feeling low in spirit, loss of interest in activities, Keep this leaflet with your being unable to enjoy life, poor medicine. appetite or overeating, disturbed You may want to read it again. sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing. Terry White Chemists Escitalopram Published by MIMS January 2015 1
• You are taking the following • You have had an allergic 2. You have or have had any other medicines: reaction to escitalopram, medical conditions, especially - pimozide, used to treat disorders citalopram or any of the the following: which affect the way you think, ingredients listed at the end of - mania, hypomania, bipolar feel or act this leaflet. disorder or any other conditions - monoamine oxidase inhibitors Symptoms of an allergic reaction which affect the way you think, (MAOIs), used to treat depression may include cough, shortness of feel or act (phenelzine, tranylcypromine, breath, wheezing or difficulty - epilepsy or convulsions, fits or moclobemide), Parkinson's breathing; swelling of the face, seizures (you should avoid taking Disease (selegiline) or infections lips, tongue, throat or other parts escitalopram if your epilepsy is (linezolid). of the body; rash, itching or hives not properly controlled; if it is Do not take escitalopram until 14 on the skin; fainting or hayfever- properly controlled your doctor days after stopping most MAOIs. like symptoms. will wish to watch you carefully The exception is the MAOI, If you think you are having an if you take escitalopram) moclobemide, where you may allergic reaction do not take - heart problems take escitalopram one whole day any more of the medicine and - liver problems after finishing taking contact your doctor - kidney problems moclobemide. Similarly, do not immediately or go to the - problems with blood clotting or take any MAOI until at least 14 Accident and Emergency abnormal bleeding, i.e. a days after stopping taking department at the nearest tendency to bleed or bruise easily escitalopram. hospital. - thoughts or actions relating to Taking escitalopram with MAOIs self-harm or suicide may cause a serious reaction with Before you start to take it - diabetes signs such as a sudden increase in - a decreased level of sodium in body temperature, very high Before you start taking this your blood blood pressure, rigid muscles, medicine, tell your doctor if: - restlessness and/or a need to nausea/vomiting and/or fits 1. You have allergies to: move often (akathisia) (convulsions). Your doctor will - any other medicines 3. You are currently pregnant or know when it is safe to start - any other substances such as you plan to become pregnant. escitalopram after the MAOI has foods, preservatives, lactose or There have been reports that been stopped. dyes. babies exposed to certain • The expiry date (EXP) printed on antidepressants during the third the pack has passed. trimester of pregnancy may • The packaging is torn, shows develop complications after birth. signs of tampering or it does not Do not take this medicine whilst look quite right. pregnant until you and your doctor have discussed the risks and benefits involved. 4. You are currently breast- feeding or you plan to breast- feed. It is not recommended that you breast-feed while taking this medicine because escitalopram passes into breast milk and may affect your baby. Do not take this medicine whilst breast-feeding until you and your doctor have discussed the risks and benefits involved. 5. You are receiving electroconvulsive therapy (ECT). 6. You are planning to have, or have very recently had, surgery or an anaesthetic. Terry White Chemists Escitalopram Published by MIMS January 2015 2
7. You are currently receiving or • antipsychotics, medicines used to How much to take are planning to receive dental treat psychoses, schizophrenia treatment. and other conditions which affect Your doctor will tell you how much the way you think, feel or act of this medicine you should take. 8. You are taking or are planning to (e.g. risperidone, thioridazine and This will depend on your condition take any other medicines. haloperidol) and whether you are taking any other This includes vitamins and medicines. supplements that are available • any other medicines affecting the from your pharmacy, supermarket chemicals in the brain The standard dose for this medicine or health food shop. • prochlorperazine, used to prevent is 10 mg per day. Your doctor may or treat severe nausea and increase your dose to 20 mg per day Some combinations of medicines may increase the risk of serious vomiting depending on how you respond to this medicine. side effects and are potentially life- • bupropion, a medicine helping to threatening. treat nicotine dependence Elderly people may need smaller Therefore some medicines MUST • mefloquine, an anti-malaria doses. The maximum dose for elderly NOT be taken with escitalopram. medicine people is 10 mg per day. These include: • some heart or blood pressure Patients with liver disease or with a • monoamine oxidase inhibitors, medications, e.g. dipyridamole, lack of certain liver enzymes may such as moclobemide, phenelzine, flecainide, propafenone, receive a lower initial dose of 5 mg tranylcypromine, selegiline and metoprolol daily for the first two weeks. Your linezolid • medicines known to prolong doctor may increase the dose to 10 • pimozide bleeding e.g. aspirin or other non- mg daily. (see also "When you must not take steroidal anti-inflammatory drugs Do not stop taking your medicine or it"). (NSAIDs) and anti-coagulants change your dosage without first (such as warfarin and ticlopidine), checking with your doctor. Some other medicines may interact which are used to prevent blood with escitalopram. clots How to take it These include: • medicines used to treat reflux and • tryptophan, contained in some ulcers, such as cimetidine, Swallow the tablets whole with a multivitamin and herbal omeprazole, esomeprazole and full glass of water. preparations lansoprazole Do not chew them. • sumatriptan, used to treat • imipramine and desipramine migraines types of antidepressants. When to take it • tramadol, a strong pain killer If you are taking any of these you • sumatriptan and similar may need a different dose or you Take escitalopram as a single dose, may need to take different medicines. either in the morning or in the medicines used to treat migraines evening. and cluster headaches Other medicines not listed above • St John's Wort (Hypericum may also interact with escitalopram. Take this medicine at the same perforatum), a herbal remedy time each day. Taking it at the same time each day • other medicines used to treat will have the best effect and will also depression, including SSRIs, help you remember when to take it. imipramine, clomipramine, How to take this nortriptyline and desipramine medicine It does not matter if you take it • lithium, used to treat mood before, with or after food. swings and some types of Follow carefully all directions depression given to you by your doctor. How long to take it for • any other medicines used to treat Their instructions may be different to Continue taking your medicine for anxiety, obsessive-compulsive the information in this leaflet. as long as your doctor tells you, disorder or pre-menstrual even if it takes some time before dysphoric disorder you feel any improvement in your condition. Make sure you have enough to last over weekends and holidays. Terry White Chemists Escitalopram Published by MIMS January 2015 3
As with other medicines for the Do not stop taking this medicine Do this even if there are no signs of treatment of these conditions, it may suddenly. discomfort or poisoning. You may take a few weeks before you feel any If you suddenly stop taking your need urgent medical attention. improvement. medicine, you may experience mild, If you take too much escitalopram, but usually temporary, symptoms you may get symptoms of Individuals will vary greatly in their such as dizziness, pins and needles, drowsiness, sleepiness, dizziness, response to escitalopram. electric shock sensations, sleeping high or low blood pressure, nausea Your doctor will check your progress problems (vivid dreams, nightmares, (feeling sick), vomiting, agitation or at regular intervals. inability to sleep), feeling anxious, tremor (shaking), fast or slow heart The length of treatment may vary for restless or agitated, headaches, beat or change in heart rhythm, each individual, but is usually at least feeling sick (nausea), vomiting, dilated pupils or, rarely, temporary 6 months. sweating, tremor (shaking), feeling paralysis or weakness of muscles, confused, feeling emotional or convulsions or coma. In some cases, your doctor may irritable, diarrhoea, visual decide that longer treatment is disturbances, or fast or irregular A condition called serotonin necessary. heartbeats. syndrome may occur, with high fever, agitation, confusion, trembling Occasionally the symptoms of When you have completed your depression or other psychiatric and abrupt contraction of muscles. course of treatment, the dose of conditions may include thoughts of escitalopram is gradually reduced harming yourself or committing over a couple of weeks rather than suicide. It is possible that these stopped abruptly. symptoms may continue or increase While you are taking until the full anti-depressant effect of Your doctor will tell you how to this medicine your medicine becomes apparent. reduce the dosage so that you help avoid getting side effects. You or anyone close to you or Things you must do caring for you should watch for these symptoms and tell your If you forget to take it People taking escitalopram may be doctor immediately or go to the more likely to think about killing If you missed a dose and remember nearest hospital if you have any themselves or actually trying to do in less than 12 hours, take it distressing thoughts or experiences so, especially when escitalopram is straight away, and then go back to during this initial period or at any taking it as you would normally. first started or the dose is changed. other time. Tell your doctor immediately if Otherwise, if you are more than 12 you have thoughts about killing Also contact your doctor if you hours late, skip the dose you yourself or if you are close to or experience any worsening of your missed and take the next dose care for someone using depression or other symptoms at any when you are meant to. escitalopram who talks about or time during your treatment. shows signs of killing him or Do not take a double dose to make herself. up for missed doses. Stopping Treatment This may increase the chance of you All mentions of suicide or violence Do not stop taking this medicine experiencing side effects. must be taken seriously. even if you begin to feel better. If you have trouble remembering Occasionally, the symptoms of Your doctor may decide that you to take your medicine, ask your depression may include thoughts of should continue to take it for some pharmacist for some hints to help suicide or self-harm. It is possible time, even when you have overcome you remember. that these symptoms continue or get your problem. For best effect, this worse until the full antidepressant medicine must be taken regularly. If you take too much effect of the medicine becomes (overdose) apparent. This is more likely to occur The underlying illness may persist if you are a young adult, i.e. 18 to 24 for a long time and if you stop your If you think that you or anyone years of age, and you have not used treatment too soon, your symptoms else may have taken too much of antidepressant medicines before. may return. this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital. Terry White Chemists Escitalopram Published by MIMS January 2015 4
If you or someone you know or Tell your doctor immediately if Tell your doctor if, for any reason, care for demonstrates any of the you become pregnant. If you are a you have not taken your medicine following warning signs of suicide- woman of child-bearing age, you exactly as prescribed. related behaviour while taking should avoid becoming pregnant Otherwise your doctor may think that escitalopram, contact a doctor while taking escitalopram. it was not effective and change your immediately, or even to go to the Make sure your midwife and/or treatment unnecessarily. nearest hospital for treatment: doctor know you are taking Tell your doctor if you feel this • thoughts or talk of death or escitalopram. When taken during medicine is not helping your suicide pregnancy, particularly in the last 3 condition. • thoughts or talk of self-harm or months of pregnancy, medicines like If you are being treated for harm to others escitalopram may increase the risk of depression, be sure to discuss with a serious condition in babies, called • any recent attempts of self-harm your doctor any problems you may persistent pulmonary hypertension of • increase in aggressive behaviour, have and how you feel, especially the newborn (PPHN), making the irritability or agitation any feelings of severe sadness, baby breathe faster and appear • worsening of depression. thoughts of suicide, bursts of unusual bluish. These symptoms usually energy, anger or aggression, or if you Follow your doctor's instructions. begin during the first 24 hours after become particularly agitated or Do not stop taking this medicine or the baby is born. If this happens to restless. change the dose without consulting your baby you should contact your your doctor, even if you experience midwife and/or doctor immediately. Tell your doctor immediately if increased anxiety at the beginning you have any suicidal thoughts or of treatment. Low Sodium other mental/mood changes. At the beginning of treatment, some Some people (especially older people or those taking diuretics/water Make sure you have enough tablets patients may experience increased tablets) may experience a lack of to last over weekends and holidays. anxiety, which will disappear during continued treatment. sodium in the blood when taking this medicine. Tell your doctor if you get Things you must not do Tell your doctor immediately if a headache or start to feel sick, you experience symptoms such as restless, irritated, confused or Do not: restlessness or difficulty sitting or • Give this medicine to anyone fatigued or if you vomit or have fits, standing still. muscle weakness or spasms. else, even if their symptoms seem These symptoms can also occur similar to yours. during the first weeks of treatment. Tell your doctor that you are taking this medicine if: • Take your medicine to treat any Contact your doctor as soon as other condition unless your possible if you suddenly experience • you are about to be started on any doctor or pharmacist tells you to. an episode of mania. new medicine • Stop taking your medicine, or Some people with bipolar disorder • you are breast-feeding or are change the dosage, without first (manic depression) may enter into a planning to breast-feed checking with your doctor. manic phase. Symptoms of mania • you are about to have any blood include lots of rapidly changing tests Do not let yourself run out of thoughts or ideas, exaggerated gaiety, medicine over the weekend or on • you are going to have surgery or holidays. being much more physically active an anaesthetic or are going into Suddenly stopping escitalopram may and much more restless. hospital. cause unwanted discontinuation Sometimes you may not know that Your doctor may occasionally do symptoms, such as dizziness, you are manic, so it may be helpful tests to make sure the medicine is headache and nausea. Your doctor to have a friend or relative watch working and to prevent side effects. will tell you when and how over you for any possible signs of escitalopram should be discontinued. Go to your doctor regularly for a change in your behaviour. You doctor will gradually reduce the check-up. Visit your doctor regularly so they amount you are using, usually over a can check on your progress. Tell any other doctors, dentists and period of one to two weeks, before pharmacists who are treating you stopping completely. that you take this medicine. Terry White Chemists Escitalopram Published by MIMS January 2015 5
Things to be careful of • feeling or being sick, reflux, • flu-like symptoms, runny or diarrhoea or loose bowel motions, blocked nose, sneezing, facial Be careful when driving or constipation, indigestion, stomach pressure or pain, coughing or sore operating machinery until you pain or discomfort, wind, throat know how this medicine affects burping, hiccups, problems Tell your doctor as soon as possible you. swallowing, sore mouth, tongue if you notice any of the following. This medicine may cause nausea, or throat, haemorrhoids (piles) fatigue, drowsiness, sight problems These may be serious side effects. or dizziness in some people, • dry mouth, feeling thirsty You may need medical attention. especially early in the treatment. If increased saliva, taste disturbance • becoming nervous, confused, you have any of these symptoms, do • fatigue, sleepiness or drowsiness, yawning, sleeping difficulties, forgetful, unable to concentrate, not drive, operate machinery, or do agitated, confused, panicky or anything else that could be strange or terrifying dreams anxious dangerous. • teeth grinding or clenching • feeling restless or unable to sit Avoid alcohol while you are taking • increased or decreased appetite, still this medicine. weight loss • stomach pain with nausea and It is best not to drink alcohol while • excessive and/or abnormal vomiting of blood, or blood in the you are being treated for depression. movements bowel movements • increased muscle tension, muscle You should be aware that people • aggression, worsening of over 50 years of age who take twitching depression antidepressants have an increased • sexual problems, painful erection, • general swelling or swollen risk of having a bone fracture. prostate problems hands, ankles, feet or face or eye • symptoms of hyperglycaemia area due to fluid build-up (high blood sugar): feeling • problems speaking hungry, thirsty and/or frequent or • feelings of not being part of your Possible side effects excessive urination; body, or in a daze • problems with eyes or eyesight • feeling sick or unwell with weak Tell your doctor as soon as possible • dizziness when you stand up muscles or feeling confused if you do not feel well while you are suddenly, due to low blood (these symptoms may be signs of taking escitalopram or if you have pressure a rare condition as a result of low any questions or concerns. • unable to tolerate alcohol levels of sodium in the blood, Do not be alarmed by the following • menstrual irregularities, period which may be caused by lists of side effects. You may not pain, breast pain, unusual vaginal antidepressants and occurs experience any of them. All bleeding especially in elderly women) medicines can have side effects. • loss of bladder control unusual increased tendency to bleed, Sometimes they are serious, but most hair loss or thinning develop bruises or broken bones of the time, they are not. • tingling or numbness of the hands • passing more or less urine than Tell your doctor if you notice any or feet normal, or problems when of the following: • breast enlargement or unusual urinating, or bladder infection • feeling tired and weak (fatigued), secretion of breast milk in men or • abnormal liver function tests hot flushes, fever, feeling unwell, women (increased amount of liver shaking or tremors, migraine, • mild rash, or itching or prickling enzymes) headache, or giddiness of the skin • flushing, varicose veins • muscle, back, bone, nerve or joint • acne, eczema, dermatitis, dry • infection in any part of your body pain, stiffness, weakness or skin, psoriasis or other skin • dizziness cramps, decrease or loss of touch problem • agitation, anxiety, feeling tense or other senses • pain of any type and restless, tired, drowsy, lack of • increased or decreased sensitivity • ringing or other persistent noise energy, irritable, problems to outside stimuli in the ears, problems hearing or sleeping, headache, nausea and earache tingling or numbness of the hands • increased or decreased sweating and feet after stopping • bruises escitalopram. • osteoporosis • tooth or jaw problems Terry White Chemists Escitalopram Published by MIMS January 2015 6
If you experience any of the • jaundice (yellowing of the skin Keep your medicine in a cool dry following, stop taking your and/or eyes), with or without place where the temperature will medicine and contact your doctor other signs of hepatitis or liver stay below 30°C. immediately or go to the Accident problems (loss of appetite, and Emergency department at Do not store your medicine, or any tiredness, feeling or being sick, other medicine, in the bathroom, your nearest hospital. dark urine, stomach pain or or near a sink. These are very serious side effects. swelling, confusion, Do not leave it on a window-sill or You may need urgent medical unconsciousness) in the car. Heat and dampness can attention or hospitalisation. • feeling paranoid, panicky, or destroy some medicines. • seizures, tremors, movement "high" or having mood swings or disorders (involuntary feeling more depressed or in a Keep this medicine where children trance cannot reach it. movements of the muscles or A locked cupboard at least one-and- being unco-ordinated) • thoughts of suicide or attempting a-half metres above the ground is a • coma (unconsciousness) suicide or self-harm good place to store medicines. • a collection of symptoms • sudden, severe breathing including weight gain (despite problems Disposal loss of appetite), feeling and • sudden weakness or numbness of being sick, muscle weakness and the face, arms or legs, especially If your doctor tells you to stop irritability on one side, slurred speech taking this medicine, or it has • severe rash, with blisters and/ or Other side effects not listed above passed its expiry date, your excessive peeling of skin and also pharmacist can dispose of the may also occur in some people. possibly severe blisters and remaining medicine safely. bleeding in the lips, eyes, mouth, Allergic reactions nose and genitals • a sudden increase in body If you think you are having an temperature, very high blood allergic reaction to escitalopram, Product description pressure, rigid muscles, do not take any more of this nausea/vomiting and/or fits medicine and tell your doctor (convulsions). These symptoms immediately or go to the Accident What Terry White Chemists and Emergency department at Escitalopram looks like may be signs of a rare condition your nearest hospital. called Serotonin Syndrome. • Neuroleptic Malignant Syndrome Symptoms of an allergic reaction New formulation (a serious reaction to some may include some or all of the following: Terry White Chemists Escitalopram medicines with a sudden increase tablets are available in the following in body temperature, extremely • cough, shortness of breath, strengths: high blood pressure and severe wheezing or difficulty breathing convulsions) • swelling of the face, lips, tongue, • 10 mg tablets: white to off-white, • fast, slow or irregular heartbeat, throat or other parts of the body oval, biconvex, film-coated tablets with "C4" embossed on high blood pressure • rash, itching or hives on the skin one side and a notch break-line • palpitations, fainting or chest pain • fainting on the other side. or tightness • hayfever-like symptoms • 20 mg tablets: white to off-white, • abnormal bleeding oval, biconvex, film-coated • kidney pain, difficulty in passing tablets with "C3" embossed on urine, dark coloured urine or one side and a notch break-line blood in the urine Storage and disposal on the other side. • a collection of symptoms Blister packs of 28 tablets. including fever, sore throat, swollen glands, mouth ulcers, Storage * Not all strengths may be available. unusual bleeding or bruising Keep your medicine in its original under the skin packaging until it is time to take it. Old Formulation • mania (mood of excitement, over- If you take your medicine out of its APO-Escitalopram tablets come in activity and uninhibited original packaging, it may not keep the following strengths: behaviour or aggression), well. hallucinations (hearing, seeing or feeling things that are not there) Terry White Chemists Escitalopram Published by MIMS January 2015 7
• 5 mg tablets: white, round, • croscarmellose sodium biconvex, film-coated tablets, • butylated hydroxyanisole engraved "APO" on one side, • hypromellose "ESC" over "5" on the other side. • hydroxypropylcellulose • 10 mg tablets: white, round, • macrogol 8000 biconvex, film-coated tablets, engraved "APO" on one side, • titanium dioxide. "ESC" over score "10" on the This medicine is gluten-free, sucrose- other side. free, tartrazine-free and free of other • 15 mg tablets: white, round, azo dyes. biconvex, film-coated tablets, engraved "APO" on one side, Australian Registration "ESC" over score "15" on the Numbers other side. • 20 mg tablets: white, round, New formulation biconvex, film-coated tablets, engraved "APO" on one side, • Terry White Chemists "ESC" over score "20" on the Escitalopram 10 mg tablets other side. (blister pack): AUST R 213725. Blister packs of 28 tablets. • Terry White Chemists Escitalopram 20 mg tablets Ingredients (blister pack): AUST R 213726. New formulation • Terry White Chemists Escitalopram 5 mg tablets Each tablet contains, 10 mg, or 20 Blister pack: AUST R 146029. mg of escitalopram (as oxalate) as the active ingredient. • Terry White Chemists Escitalopram 10 mg tablets It also contains the following inactive Blister pack: AUST R 146031. ingredients: • Terry White Chemists • microcrystalline cellulose Escitalopram 15 mg tablets • colloidal anhydrous silica Blister pack: AUST R 146036. • hypromellose • Terry White Chemists • magnesium stearate Escitalopram 20 mg tablets • croscarmellose sodium Blister pack: AUST R 146038. • purified talc • macrogol 400 Sponsor • titanium dioxide. Apotex Pty Ltd This medicine is gluten-free, lactose 16 Giffnock Avenue free, sucrose-free, tartrazine-free and Macquarie Park NSW 2113 free of other azo dyes. This leaflet was last updated in: August 2014. Old formulation Each tablet contains 5 mg, 10 mg, 15 mg or 20 mg of escitalopram (as escitalopram oxalate) as the active ingredient. It also contains the following inactive ingredients: • microcrystalline cellulose • lactose • magnesium stearate Terry White Chemists Escitalopram Published by MIMS January 2015 8
You can also read