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Lexapro® (LEX-a-pro) Escitalopram oxalate (ES-sigh-talo-pram OX-a-late) Consumer Medicine Information (CMI)

What is in this leaflet sleep, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing. This leaflet contains answers to some Before you take it common questions about Lexapro. Lexapro corrects this chemical It does not contain all the information imbalance and may help relieve the symptoms of depression. When you must not take that is known about Lexapro. It does it not take the place of talking to your Lexapro may also be used to treat doctor or pharmacist. patients who may avoid and/or are Do not take Lexapro if you are All medicines have risks and fearful of social situations. allergic to it, to any medicine benefits. Your doctor has weighed Lexapro may also be used to treat containing escitalopram, or any of the risk of you using this medicine patients who have excessive the ingredients listed at the end of against the benefits he/she expects it and worry. this leaflet. will have for you. Lexapro may also be used to treat Symptoms of an allergic reaction If you have any concerns about irrational fears or obsessional may include shortness of breath, using this medicine, ask your behaviour (obsessive-compulsive wheezing or difficulty breathing, doctor or pharmacist. disorder). Obsessive-compulsive swelling of the face, lips, tongue or other parts of the body, or rash, Keep this leaflet with the medicine. disorder involves having both obsessions and compulsions. itching or hives on the skin. You may need to read it again. Obsessions are unwanted thoughts Do not take Lexapro at the same that occur . time as the following other Compulsions are the ongoing need to medicines: repeat certain actions as a result of • , a medicine used to What Lexapro is used these thoughts. for treat mental disorders Your doctor, however, may prescribe • monoamine oxidase inhibitors it for another purpose. Lexapro is used to treat depression. (MAOIs), such as , Ask your doctor if you have any and It belongs to a group of medicines questions about why it has been which are also used called selective prescribed for you. for the treatment of depression. inhibitors (SSRIs). They are thought to work by their actions on brain This medicine is only available with One day must elapse after you chemicals called amines which are a doctor's prescription. have finished taking involved in controlling mood. Lexapro is not addictive. However, if moclobemide before you start taking Lexapro. If you have taken Depression is longer lasting or more you suddenly stop taking it, you may any other MAOI you will need to severe than the "low moods" get side effects. wait 14 days. After stopping everyone has from time to time due Tell your doctor if you get any side Lexapro, you must allow 14 days to the stress of everyday life. It is effects after stopping Lexapro. before taking any MAOI thought to be caused by a chemical including moclobemide. imbalance in parts of the brain. This imbalance affects your whole body Taking Lexapro with MAOIs and can cause emotional and physical may cause a serious reaction with symptoms such as feeling low in a sudden increase in body spirit, loss of interest in activities, temperature, extremely high being unable to enjoy life, poor blood pressure and severe appetite or overeating, disturbed convulsions. Your doctor will

LEXAPRO 1 know when it is safe to start 3. you are breast-feeding or The effects of Lexapro in elderly Lexapro after the MAOI has been planning to breast-feed. patients are similar to that in other stopped. Do not take Lexapro if you are patients. Do not take it after the expiry date breast-feeding unless you and If you have not told your doctor printed on the pack. your doctor have discussed the about any of the above, tell them If you take it after the expiry date has risks and benefits involved. It is before you use Lexapro. passed, it may not work as well. The not recommended that you breast- expiry date refers to the last day of feed while taking Lexapro as it is Taking other medicines excreted in breast milk. the month. Tell your doctor if you are taking Do not take it if the packaging is 4. you have, or have had, the any other medicines, including any torn or shows signs of tampering. following medical conditions: that you buy without a • a tendency to bleed or bruise prescription from your pharmacy, Before you start to take easily supermarket or health food shop. it • diabetes Some medicines and Lexapro may interfere with each other. These Tell your doctor if: • heart disease, especially long QT include: 1. you have allergies to any other syndrome or other conduction • , a medicine helping to substances such as foods, disorders treat dependence preservatives or dyes. • conditions causing changes in the • medicines used to treat reflux and 2. you are pregnant or intend to levels of sodium, potassium or ulcers, such as cimetidine, become pregnant. magnesium in the blood (electrolytes) , esomeprazole and Medicines like Lexapro have been lansoprazole shown to reduce the quality of sperm • kidney disease • medicines known to prolong in animal studies. Theoretically, this • disease could affect fertility but impact on bleeding, e.g. aspirin or other • (manic non-steroidal anti-inflammatory human fertility has not been observed depression) drugs (NSAIDs) as yet with Lexapro. • a history of seizures or fits • ticlopidine and warfarin, Do not take Lexapro if you are medicines used to prevent blood pregnant unless you and your doctor • restlessness and/or a need to have discussed the risks and benefits move often clots involved. • eye problems, such as certain • mefloquine, an anti-malaria Make sure your doctor and/or kinds of glaucoma (increased medicine midwife know you are on Lexapro. pressure in the eye). • sumatriptan, used to treat When taken during , migraines particularly in the last three months 5. you are receiving • , used to relieve pain of pregnancy, medicines like electroconvulsive therapy. • medicines affecting the chemicals Lexapro may affect the general in the brain condition of your newborn baby and If you have any of the above medical • medicines that reduce the level of may increase the risk of a serious conditions, your doctor may perform sodium, potassium or magnesium condition in babies, called persistent additional tests, such as an ECG to in the blood, e.g. diuretics ('fluid pulmonary hypertension of the check your heart and blood tests to tablets') newborn (PPHN), making the baby check sodium, potassium and/or magnesium levels. breathe faster and appear bluish. • some heart medications, e.g.

These symptoms usually begin flecainide, propafenone, Do not give Lexapro to a child or during the first 24 hours after the metoprolol adolescent. baby is born. If this happens to your • Antiarrhythmic medicines, used There is no experience with its use in baby, you should contact your doctor to treat irregular heartbeats, e.g. children or adolescents under 18 and/or midwife immediately. , disopyramide, years old. If used during pregnancy Lexapro sotalol Lexapro can be given to elderly should never be stopped abruptly. • Antifungal medicines e.g. patients over 65 years of age with a Ask your doctor or pharmacist for fluconazole, voriconazole reduced dose. advice before taking any medicine. • Some antibiotics, e.g. azithromycin, clarithromycin,

LEXAPRO 2 erythromycin, roxithromycin, It is recommended that patients with The underlying illness may persist amphotericin, gentamicin liver disease receive an initial dose of for a long time and if you stop your • medicines, used to 5 mg daily for the first two weeks. treatment too soon, your symptoms relieve the symptoms of allergy Your doctor may increase the dose to may return. (such as hay ) or colds and 10 mg daily. Do not stop taking this medicine 'flu, e.g. terfenadine, loratadine, Your doctor may have prescribed a suddenly. different dose. If Lexapro is stopped suddenly you • , an amino-acid Ask your doctor or pharmacist if may experience mild, but usually • used to treat mood swings you are unsure of the correct dose temporary, symptoms such as and some types of depression for you. , pins and needles, electric shock sensations, sleep disturbances • , a class of They will tell you exactly how much (vivid dreams, inability to sleep), medicines used to treat certain to take. feeling anxious or agitated, mental and emotional conditions, Follow the instructions they give headaches, feeling sick (nausea), e.g. , thioridazine and you. vomiting, sweating, tremor (shaking), If you take the wrong dose, Lexapro feeling confused, feeling emotional • , e.g. may not work as well, and your or irritable, diarrhoea, visual , condition may not improve. disturbances, or fast or irregular • St John's Wort (Hypericum heartbeats. perforatum), a herbal remedy How to take it When you have completed your • any other medicines used to treat Swallow the tablets whole with a course of treatment, the dose of seizures, depression, anxiety, full glass of water. Lexapro is gradually reduced over a couple of weeks rather than stopped obsessive-compulsive disorder or Do not chew them. pre-menstrual dysphoric disorder abruptly. These medicines may be affected by When to take it Your doctor will tell you how to reduce the dosage so that you do not Lexapro or may affect how well it Take Lexapro as a single dose get these unwanted effects. works. You may need to use different either in the morning or in the amounts of your medicines or take evening. different medicines. Your doctor will If you forget to take it Take Lexapro with or without advise you. If you miss a dose and remember food. Some combinations of medicines in less than 12 hours, take it may increase the risk of serious side How long to take it straight away, and then go back to effects and are potentially life taking it as you would normally. Continue to take Lexapro even if it threatening. Otherwise, if it is almost time for takes some time before you feel any Your doctor or pharmacist has more your next dose, skip the dose you improvement in your condition. information on medicines to be missed and take the next dose careful with or avoid while taking As with other medicines for the when you are meant to. treatment of these conditions it may Lexapro. Do not take a double dose to make take a few weeks before you feel any up for the dose you have missed. improvement. If you are not sure what to do, ask Individuals will vary greatly in their your doctor or pharmacist. How to take it response to Lexapro. Your doctor will check your progress at regular If you have trouble remembering How much to take intervals. when to take your medicine, ask your pharmacist for hints. The duration of treatment may vary Your doctor will decide what dose for each individual but is usually at you will receive. If you take too much least 6 months. The standard dose for this medicine (overdose) In some cases, the doctor may decide is 10 mg per day. This may be that longer treatment is necessary. Immediately telephone your increased by your doctor to 20 mg doctor, or the Poisons Information Continue taking your medicine for per day. Centre (Tel: 0800 764 766) or go to as long as your doctor tells you, The recommended maximum dose in Accident and Emergency at your even if you begin to feel better. elderly patients is 10 mg per day. nearest hospital, if you think you

LEXAPRO 3 or anyone else may have taken too warning signs of -related Do not take Lexapro to treat any much Lexapro. behaviour while taking Lexapro. other complaints unless your Do this even if there are no signs of Tell your doctor immediately, or doctor tells you to. discomfort or poisoning. even go to the nearest hospital for Do not stop taking Lexapro, or treatment: You may need urgent medical lower the dosage, without checking • attention. thoughts or talk of death or with your doctor. suicide Symptoms of an overdose may Do not let yourself run out of • include dizziness, low blood thoughts or talk of self-harm or medicine over the weekend or on pressure, nausea (feeling sick), harm to others holidays. vomiting, agitation, tremor (shaking) • any recent attempts of self-harm Suddenly stopping Lexapro may and rarely convulsions and coma. • increase in aggressive behaviour, cause unwanted discontinuation or agitation symptoms such as dizziness, headache and nausea. Your doctor Do not stop taking this medicine or will tell you when and how Lexapro While you are taking it change the dose without consulting should be discontinued. Your doctor your doctor, even if you experience will gradually reduce the amount you increased anxiety at the beginning Things you must do are using, usually over a period of of treatment. one to two weeks, before stopping If you are about to be started on At the beginning of treatment, some completely. any new medicine, remind your patients may experience increased doctor and pharmacist that you anxiety which will disappear during Things to be careful of are taking Lexapro. continued treatment. Be careful driving or operating Tell any other doctors, dentists and Tell your doctor immediately if machinery until you know how pharmacists who treat you that you experience symptoms such as Lexapro affects you. you are taking this medicine. restlessness or difficulty in sitting It may cause nausea, fatigue and or standing still. If you become pregnant while dizziness in some people, especially taking Lexapro, tell your doctor These symptoms can occur during early in the treatment. If you have immediately. the first weeks of treatment. any of these symptoms, do not drive, Persons taking Lexapro may be Contact your doctor as soon as operate machinery, or do anything more likely to think about killing possible if you suddenly experience else that could be dangerous. themselves or actually trying to do an episode of . Avoid while you are taking so, especially when Lexapro is first Some patients with bipolar disorder this medicine. started, or the dose is changed. Tell (manic depression) may enter into a It is not advisable to drink alcohol your doctor immediately if you manic phase. This is characterised by while you are being treated for have thoughts about killing profuse and rapidly changing ideas, depression. yourself or if you are close to or exaggerated gaiety and excessive care for someone using Lexapro physical activity. who talks about or shows signs of killing him or herself. Sometimes you may be unaware of the above-mentioned symptoms and Side effects All mentions of suicide or violence therefore you may find it helpful to must be taken seriously. ask a friend or relative to help you to All medicines may have some Occasionally, the symptoms of observe the possible signs of change unwanted side effects. Sometimes depression may include thoughts of in your behaviour. they are serious, but most of the time suicide or self-harm. It is possible Medicines like Lexapro may cause they are not. Your doctor has that these symptoms continue or get symptoms of weighed the risks of using this worse until the full (see section "Side effects"). medicine against the benefits he/she effect of the medicine becomes expects it will have for you. apparent. This is more likely to occur In some cases, these symptoms have Tell your doctor or pharmacist as if you are a young adult, i.e. 18 to 24 continued after stopping treatment. soon as possible if you do not feel years of age, and you have not used well while you are taking Lexapro. antidepressant medicines before. Things you must not do It helps most people with depression, Do not give the tablets to anyone Patients and care givers should pay (social else, even if they have the same attention for any of the following phobia), generalised anxiety disorder condition as you.

LEXAPRO 4 and obsessive-compulsive disorder, patients taking this type of After taking it but it may have unwanted side effects medicine* in a few people. These may be serious side effects of Storage The side effects of Lexapro are, in Lexapro. You may need urgent general, mild and disappear after a medical attention. Keep Lexapro tablets in the blister pack until it is time to take them. short period of time. Tell your doctor immediately, or Tell your doctor if you notice any go to Accident and Emergency at If you take the tablets out of the box of the following and they worry your nearest hospital, if you notice or the blister pack, they may not keep you: any of the following: well. • decreased appetite or loss of • Thoughts of harming yourself or Keep Lexapro tablets in a cool dry appetite thoughts of suicide, see also place where the temperature stays below 30°C. • dry mouth section "Things you must do"* • Do not store it or any other • diarrhoea serious allergic reaction medicine in the bathroom, near a (symptoms of an allergic reaction • nausea (feeling sick) sink, or on a window-sill. may include swelling of the face, • sleeplessness lips, mouth or throat which may Do not leave it in the car. • fatigue, sleepiness or drowsiness, cause difficulty in swallowing or Heat and damp can destroy some yawning breathing, or hives) medicines. • increased sweating • high fever, agitation, confusion, Keep it where children cannot • sexual disturbances (decreased trembling and abrupt contractions reach it. sexual drive; problems with of muscles A locked cupboard at least one-and- ejaculation or erection; women (these symptoms may be signs of a-half metres above the ground is a may experience difficulties a rare condition called serotonin good place to store medicines. achieving orgasm) syndrome) * Tell your doctor as soon as possible • mania (i.e.: elevated mood and Disposal if you notice any of the following: associated symptoms) * If your doctor tells you to stop • agitation, confusion, panic • hallucinations taking Lexapro, or the medicine attacks*, anxiety, restlessness* • seizures, tremors, movement has passed its expiry date, ask your • dizziness disorders (involuntary pharmacist what to do with any that is left over. • dizziness when you stand up due movements of the muscles) * to low blood pressure* • fast, irregular heart beat with Return any unused medicine to your pharmacist. • a fast heart rate or decrease in feelings of dizziness, faintness, heart rate or irregular heart beat loss of consciousness or difficulty breathing • low sodium levels in the blood (the symptoms are feeling sick These are very serious side effects. Product description and unwell with weak muscles or You may need urgent medical attention or hospitalisation. feeling confused) * What it looks like • abnormal liver function tests *The side effects marked with an (increased amounts of liver asterisk (*) are a number of rare side Lexapro comes in two types of tablets: enzymes in the blood) * effects that are known to occur with medicines that work in a similar way • Lexapro 10 mg film-coated • difficulties urinating* to Lexapro. tablets - oval, white, scored and • unusual secretion of breast milk* Tell your doctor if you notice marked with "E" and "L" on each • Bleeding disorders including skin anything else that is making you side of the score on one side of and mucous bleeding (e.g. feel unwell. the tablet bruising*) and a low level of Other side effects not listed above • Lexapro 20 mg film-coated blood platelets* may occur in some people. tablets - oval, white, scored and • rash, itching, patches of marked with "E" and "N" on each Do not be alarmed by this list of circumscribed swellings side of the score on one side of possible side effects. • An increased risk of bone the tablet You may not experience any of them. fractures has been observed in A box contains 28 tablets.

LEXAPRO 5 Ingredients Active ingredient(s): • Lexapro 10 mg tablets - 10 mg escitalopram (as oxalate) per tablet • Lexapro 20 mg tablets - 20 mg escitalopram (as oxalate) per tablet

Inactive ingredients (tablets): • microcrystalline cellulose • croscarmellose sodium • opadry OY-S28849 (contains: hypromellose, macrogol 400, titanium dioxide). • magnesium stearate • colloidal anhydrous silica • purified talc Lexapro does not contain lactose, gluten, sucrose, tartrazine or any other azo dyes.

Manufacturer/Sponsor Lexapro is made by H. A/S, Denmark. Distributed in New Zealand by: Pharmacy Retailing t/a Healthcare Logistics, 58 Richard Pearse Drive, Mangere, Auckland 2022 Phone: 0800 540 555

This leaflet was prepared on 02 July 2020

"Lexapro" is the registered trademark of H. Lundbeck A/S.

LEXAPRO 6