Package leaflet: Information for the user anger) when they take this class of medicines. Fluoxetine should only be used in children Fluoxetine 60 mg capsules, hard and adolescents aged 8 to 18 years for fluoxetine hydrochloride the treatment of moderate to severe major depressive episodes (in combination with Read all of this leaflet carefully before you psychological therapy) and it should not be start taking this medicine because it contains used to treat other conditions. important information for you. • Additionally, only limited information - Keep this leaflet. You may need to read it concerning the long-term safety of fluoxetine again. on growth, puberty, mental, emotional and - If you have any further questions, ask your behavioural development in this age group doctor or pharmacist. is available. Despite this, and if you are a - This medicine has been prescribed for you patient under 18, your doctor may prescribe only. Do not pass it on to others. It may harm fluoxetine for moderate to severe major them, even if their signs of illness are the depressive episodes, in combination with same as yours. psychological therapy, because he/she - If you get any side effects, talk to your doctor decides that this is in your best interests. If or pharmacist. This includes any possible side your doctor has prescribed fluoxetine for a effects not listed in this leaflet. See section 4. patient under 18 and you want to discuss this, please go back to your doctor. You should What is in this leaflet: inform your doctor if any of the symptoms 1. What Fluoxetine is and what is used for listed above develop or worsen when patients 2. What you need to know before you take under 18 are taking fluoxetine. Fluoxetine 3. How to take Fluoxetine Fluoxetine should not be used in the treatment of 4. Possible side effects children under the age of 8 years. 5. How to store Fluoxetine 6. Contents of the pack and other information Other medicines and Fluoxetine Please tell your doctor or pharmacist if you are 1. What Fluoxetine is and what is used for taking or have recently taken or might take any other medicines. Fluoxetine contains fluoxetine which is one of a group of medicines called selective serotonin re- Do not take Fluoxetine with: uptake inhibitors (SSRI) . • Certain irreversible, non-selective monoamine oxidase inhibitors (MAOIs), This medicine is used to treat the following some used to treat depression. Irreversible, conditions: non-selective MAOIs must not be used with Adults: Fluoxetine as serious or even fatal reactions • Major depressive episodes (serotonin syndrome) can occur (see section • Obsessive-compulsive disorder “Do not take Fluoxetine”). • Bulimia nervosa: Fluoxetine is used alongside Treatment with Fluoxetine should only be started psychotherapy for the reduction of binge- at least 2 weeks after discontinuation of an eating and purging. irreversible, non-selective MAOI (for instance Children and adolescents aged 8 years and tranylcypromine). Do not take any irreversible, above: non-selective MAOIs for at least 5 weeks after Half Fold: 350 mm Moderate to severe major depressive disorder, if you stop taking Fluoxetine. If Fluoxetine has the depression does not respond to psychological been prescribed for a long period and/or at a high therapy after 4-6 sessions. Fluoxetine should be dose, a longer interval than 5 weeks may need to offered to a child or young person with moderate be considered by your doctor. to severe major depressive disorder only in • metoprolol when used for heart failure; combination with psychological therapy. there is an increased risk of your heart beat becoming too slow. Fluoxetine may How Fluoxetine works Everyone has a substance called serotonin affect the way the following medicines work in their brain. People who are depressed or (interaction): have obsessive-compulsive disorder or bulimia • tamoxifen (used to treat breast cancer); nervosa have lower levels of serotonin than because Fluoxetine may change the blood others. It is not fully understood how Fluoxetine levels of this drug, resulting in the possibility and other SSRIs work but they may help by of a reduction in the effect of tamoxifen, your increasing the level of serotonin in the brain. doctor may need to consider prescribing a different treatment. Treating these conditions is important to help you • monoamine oxidase inhibitors A (MAOI-A) get better. If it’s not treated, your condition may including moclobemide, linezolid (an not go away and may become more serious and antibiotic) and methylthioninium chloride more difficult to treat. (also called used for the treatment of medicinal or chemical product You may need to be treated for a few weeks induced methemoglobinemia): due to or months to ensure that you are free from the risk of serious or even fatal reactions symptoms. (called serotonin syndrome). Treatment with fluoxetine can be started the day after 2. What you need to know before you take stopping treatment with reversible MAOIs but Fluoxetine the doctor may wish to monitor you carefully Do not take Fluoxetine if you are: and use a lower dose of the MAOI-A drug. • allergic to fluoxetine or any of the other • mequitazine (for ); because taking ingredients of this medicine (listed in section this drug with Fluoxetine may increase the 6). If you develop a rash or other allergic risk of changes in the electrical activity of the reactions (like itching, swollen lips or face heart. or shortness of breath), stop taking the • phenytoin (for ); because Fluoxetine capsules straight away and contact your may influence the blood levels of this drug, doctor immediately. your doctor may need to introduce phenytoin • taking other medicines known as irreversible, more carefully and carry out check-ups when non-selective monoamine oxidase inhibitors given with Fluoxetine. (MAOIs), since serious or even fatal reactions • lithium, selegiline, St. John’s Wort, can occur (e.g. iproniazid used to treat (a painkiller), buprenorphine, depression) triptans (for migraine) and tryptophan; there is an increased risk of mild serotonin Treatment with Fluoxetine should only be started syndrome when these drugs are taken with at least 2 weeks after discontinuation of an Fluoxetine. Your doctor will carry out more irreversible, non-selective MAOI. frequent check-ups. Do not take any irreversible, non-selective • medicines that may affect the heart’s rhythm, MAOIs for at least 5 weeks after you stop taking e.g. Class IA and III antiarrhythmics, Fluoxetine. If Fluoxetine has been prescribed (e.g. for a long period and/or at a high dose, a longer derivatives, pimozide, ), interval needs to be considered by your doctor. antidepressants, certain antimicrobial (e.g. sparfloxacin, moxifloxacin, • taking metoprolol (to treat heart failure) since agents erythromycin IV, pentamidine), there is an increased risk of your heart beat anti-malaria particularly halofantrine or certain becoming too slow. treatment (, ), Warnings and precautions because taking one or more of these drugs Talk to your doctor or with Fluoxetine may increase the risk of pharmacist before taking changes in the electrical activity of the heart. Fluoxetine if any of the • Anti-coagulants (such as warfarin), NSAID following applies to you (such as ibruprofen, diclofenac), aspirin and • heart problems; other medicines which can thin the blood • appearance of fever, muscle (including , used to treat certain stiffness or , changes mental disorders). Fluoxetine may alter the in your mental state like effect of these medicines on the blood. If confusion, irritability and Fluoxetine treatment is started or stopped extreme agitation; you may when you are taking warfarin, your doctor suffer from the so-called will need to perform certain tests, adjust your “serotonin syndrome” or dose and check on you more frequently. “neuroleptic malignant • (for allergies); because it syndrome”. Although this may reduce the effect of Fluoxetine. syndrome occurs rarely it • drugs that lower sodium levels in the may result in potentially blood (including, drug that causes increase in life threatening conditions; urination, desmopressin, and contact your doctor ); because these drugs may immediately, since increase the risk of sodium levels in the blood Fluoxetine might need to be discontinued. becoming too low when taken with Fluoxetine. • If you are taking buprenorphine-containing • anti-depressants such as tricyclic anti- medicinal products. The use of these depressants, other selective serotonin medicines together with Fluoxetine can lead reuptake inhibitors (SSRIs) or bupropion, to serotonin syndrome, a potentially life- mefloquine or chloroquine (used to treat threatening condition (see “Other medicines malaria), tramadol (used to treat severe pain) and Fluoxetine”). or anti-psychotics such as • mania now or in the past; if you have a manic or butyrophenones; because Fluoxetine may episode, contact your doctor immediately increase the risk of seizures when taken with because Fluoxetine might need to be these medicines. discontinued; • flecainide, propafenone, nebivolol • history of bleeding disorders or appearance or encainide (for heart problems), of bruises or unusual bleeding, or if you are carbamazepine (for epilepsy), atomoxetine pregnant (see ‘, breast-feeding and or tricyclic antidepressants (for example fertility’); , and ) • ongoing treatment with medicines that thin the or (for schizophrenia); because blood (see ‘Other medicines and Fluoxetine’); Fluoxetine may possibly change the blood • epilepsy or fits. If you have a fit (seizures) or levels of these medicines, your doctor may experience an increase in seizure frequency, need to lower their dose when administered contact your doctor immediately; Fluoxetine with Fluoxetine. might need to be discontinued; Some medicines may increase the side effects • ongoing ECT (electro-convulsive therapy); of Fluoxetine and may sometimes cause • ongoing treatment with tamoxifen (used to very serious reactions. Do not take any other treat breast cancer) (see ‘Other medicines medicines whilst taking Fluoxetine without first and Fluoxetine’); talking to your doctor, especially: • starting to feel restless and cannot sit or • buprenorphine-containing medical products. stand still (akathisia). Increasing your dose of These medicines may interact with Fluoxetine Fluoxetine may make this worse; and you may experience symptoms such as • diabetes (your doctor may need to adjust involuntary, rhythmic contractions of muscles, your dose of insulin or other antidiabetic including the muscles that control movement treatment); of the eye, agitation, hallucinations, coma, • liver problems (your doctor may need to excessive sweating, tremor, exaggeration adjust your dosage); of reflexes, increased muscle tension, body • low resting heart-rate and/or if you know that temperature above 38°C. Contact your doctor you may have salt depletion as a result of when experiencing such symptoms. prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water Fluoxetine with food, drink and tablets); • You can take Fluoxetine with or without food, • ongoing treatment with diuretics (water whatever you prefer. tablets), especially if you are elderly; • You should avoid alcohol while you are taking • glaucoma (increased pressure in the eye). this medicine. • Medicines like fluoxetine (so called SSRIs/ Pregnancy, breast-feeding and fertility SNRIs) may cause symptoms of sexual If you are pregnant or breast-feeding, think you dysfunction (see section 4). In some cases, may be pregnant or are planning to have a baby, these symptoms have continued after ask your doctor or pharmacist for advice before stopping treatment. taking this medicine. Thoughts of suicide and worsening of your Pregnancy depression or anxiety disorder Talk to your doctor as soon as possible if you are If you are depressed and/or have anxiety pregnant, if you might be pregnant, or if you are disorders you can sometimes have thoughts planning to become pregnant. of harming or killing yourself. These may be increased when first starting antidepressants, In babies whose mothers took fluoxetine during since these medicines all take time to work, the first few months of pregnancy, there have usually about two weeks but sometimes longer. been some studies describing an increased risk of birth defects, affecting the heart. In the general You may be more likely to think like this: population, about 1 in 100 babies are born with - If you have previously had thoughts about a heart defect. This increased to about 2 in 100 killing or harming yourself. babies in mothers who took fluoxetine. - If you are a young adult. Information from clinical trials has shown an increased risk of When taken during pregnancy, particularly in suicidal behaviour in adults aged less than 25 the last 3 months of pregnancy, medicines like years with psychiatric conditions who were fluoxetine may increase the risk of a serious treated with an antidepressant. condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the If you have thoughts of harming or killing yourself baby breathe faster and appear bluish. These at any time, contact your doctor or go to a symptoms usually begin during the first 24 hours hospital straight away. after the baby is born. If this happens to your You may find it helpful to tell a relative or baby you should contact your midwife and/or close friend that you are depressed or have an doctor immediately. anxiety disorder, and ask them to read this leaflet. It is preferable not to use this treatment during You might ask them to tell you if they think your pregnancy unless the potential benefit outweighs depression or anxiety is getting worse, or if they the potential risk. Thus, you and your doctor may are worried about changes in your behaviour. decide to gradually stop taking Fluoxetine Children and adolescents (aged 8 to 18 years): while you are pregnant or before being • Patients under 18 have an increased risk pregnant. However, depending on your of side-effects such as suicide attempt, circumstances, your doctor may suggest suicidal thoughts and hostility (predominantly that it is better for you to keep taking

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Version: 01 Date & Time: 15.12.2020 & 2.30 PM Submission Code: N13529 Half Fold: 350 mm 350 Fold: Half this medicine,askyourdoctororpharmacist. If youhaveanyfurtherquestionsontheuseof withdrawal effects. weeks -thisshouldhelpreducethechanceof you toreduceyourdoseslowlyoveroneortwo When stoppingFluoxetine,yourdoctorwillhelp stop treatment,contactyourdoctor. weeks. Ifyouexperiencesymptomswhen Fluoxetine aremildanddisappearwithinafew Most peoplefindthatanysymptomsonstopping tremor (shakiness);. nausea/vomiting (feelingsickorbeingsick); unusual tirednessorweakness;feelinganxious; inability tosleep);feelingrestlessoragitated; sleep disturbances(vividdreams,nightmares, ; tinglingfeelingslikepinsandneedles; effects) whenyoustoptakingFluoxetine: You maynoticethefollowingeffects (withdrawal • • If youstoptakingFluoxetine • • If youforgettotakeFluoxetine mental conditionrangingfromagitationtocoma. and cardiacarrest),lungproblemschangein seizures, heartproblems(likeirregularbeat nausea, vomiting, include: Symptoms ofoverdose • is 3capsules(60mg)daily. exceed 2capsules(40mg). The maximumdose caution andthedailydoseshouldgenerallynot Your doctorwillincreasethedosewithmore Elderly: will reassessyourtreatment. have notimprovedwithin9weeks,yourdoctor continuing treatmentbeyond6months.Ifyou to treatment,yourdoctorwillreviewtheneedfor lower doses.Ifthereisasatisfactoryresponse effective dose.Lowerweightchildrenmayneed carefully toensurethatyoureceivethelowest dose to20mg/day. The doseshouldbeincreased After 1to2weeks,yourdoctormayincreasethe as 2.5mloffluoxetineoralsolution). (given by aspecialist. The startingdoseis10mg/day Treatment shouldbestartedandsupervised years withdepression: Use inchildrenandadolescentsaged8to18 • • • The recommendeddoseis: Adults: not chewthecapsules. Swallow thecapsuleswithadrinkofwater. Do you. Do nottakemorecapsulesthanyourdoctortells doctor orpharmacistifyouarenotsure. or pharmacisthastoldyou.Checkwithyour Always takethismedicineexactlyasyourdoctor • • • • Some patientshavehad: sick (nausea)andfatigue. 10) areinsomnia,,diarrhoea,feeling side effects that mayaffect morethan1userin The mostfrequentsideeffects (verycommon • • • • effects, althoughnoteverybodygetsthem. Like allmedicines,thismedicinecancauseside essentially ‘sodium-free’. sodium (23mg)pereachcapsule,thatistosay This medicinecontainslessthan1mmol Fluoxetine containsSodium affects you. use machineryuntilyouknowhowFluoxetine your judgmentorco-ordination.Donotdrive Psychotropic drugssuchasfluoxetinemayaffect Driving andusingmachines has notbeenobservedasyet. could affect fertility, butimpactonhumanfertility of sperminanimalstudies. Theoretically, this Fluoxetine hasbeenshowntoreducethequality Fertility lower doseoffluoxetine. feeding iscontinued,yourdoctormayprescribea breast-feed ifitisclearlynecessary. Ifbreast- cause sideeffects inbabies. You shouldonly Fluoxetine isexcretedinbreastmilkandcan Breast-feeding advise you. aware thatyouaretakingFluoxetinesotheycan disorders. Your doctorormidwifeshouldbe especially ifyouhaveahistoryofbleeding of heavyvaginalbleedingshortlyafterbirth, pregnancy theremaybeanincreasedrisk If youtakeFluoxetineneartheendofyour crying, anddifficulty insuckingorsleeping. irritability, tremor, muscleweakness,persistent effects havebeenreportedinnewb or justbeforegivingbirthsincethefollowing pregnancy, especiallyduringlatepregnancy Caution shouldbeexercisedwhenusedduring 3. 4. Make sureyoudonotrunoutof capsules. your medicine. better. Itisimportantthatyoukeeptaking your doctorfirst,evenwhenyoustarttofeel withoutasking Do not stoptakingFluoxetine regularly. day mayhelpyoutoremembertakeit Taking timeeach atthesame youmedicine forgotten dose. Do nottakeadoubledosetomakeupfor next dosethedayatusualtime. If youmissadose,donotworry. Take your can. Take thepackofFluoxetinewithyouif reconsider yourtreatment. is notedwithin10weeks,yourdoctorwill capsules (60mg)daily. Ifnoimprovement gradually increaseduptoamaximumof3 treatment. Ifrequired,thedosagecanbe your dosageifnecessaryafter2weeksof daily. Your doctorwillreviewandadjust recommended doseis1capsule(20mg) disorder: The Obsessive-compulsive 3 capsules(60mg)daily. Bulimia nervosa: The recommendeddoseis be treatedforatleast6months. few weeks.Patientswithdepressionshould symptoms maynotoccuruntilafterthefirst because animprovementindepressive your medicinefordepression. This isusual better immediatelywhenyoufirststarttaking lowest effective dose. You maynotfeel carefully toensurethatyoureceivethe (60 mg)daily. The doseshouldbeincreased increased uptoamaximumof3capsules If required,thedosagecanbegradually within 3to4weeksofthestarttreatment. review andadjustyourdosageifnecessary 1 capsule(20mg)daily. Your doctorwill Depression: doseis The recommended irritability and extremeagitation; irritability and painfulerection; prolonged and tablets); in (elderly)peopletakingdiuretics(water confusion mostlyinelderlypeopleand or ofweakness,drowsiness feelings (only rarely); confusion, extremeagitationorsleepiness sweating, musclestiffness ortremor, fever withfasterbreathingorheartrate, “serotonin syndrome”)includingunexplained ofsymptoms(knownas a combination This isveryrare. reaction oryourskinstartstoblisterpeel. starts toturnredoryoudevelopavariedskin Tell yourdoctor immediatelyifyourskin feel likethis,contactyourdoctor. of Fluoxetinemaymakeyoufeelworse.If you mayhaveakathisia;increasingyourdose sitorstandstill, If youfeelrestlessandcannot doctor immediately. capsules straightawayandtellyour shortness ofbreath,stoptakingthe as itching,swollenlips/tongueorwheezing/ such If yougetarashorallergicreaction to ahospitalstraightaway(seeSection2). yourself atanytime,contactyourdoctororgo If youhavethoughtsofharmingorkilling How totakeFluoxetine Possible side effects • than youshould If youtakemoreFluoxetine Fluoxetine everyotherday. a lowerdoseortellyoutouse doctor maydecidetoprescribe might affect Fluoxetineyour are usingothermedicationthat If youhavealiverproblemor Liver impairment: away. or tellyourdoctorstraight department (orcasualty) nearest hospitalemergency capsules, gotoyour If youtaketoomany orn children: The leafletwaslastrevisedin07/2021. United Kingdom Ruislip HA46QD West EndRoad Ares Block,OdysseyBusinessPark Milpharm Limited or Malta Birzebbugia, BBG3000 HF26, HalFarIndustrialEstate, APL SwiftServices(Malta)Limited Manufacturer United Kingdom Ruislip HA46QD West EndRoad Ares Block,OdysseyBusinessPark Milpharm Limited Holder Marketing Authorization Not allpacksizesmaybemarketed. Bottle pack:28and500capsules,hard capsules, hard Blister pack:5,7,10,14,20,28,30,56and60 HDPE bottlepackwith PVC/PVdC -Aluminiumfoilblisterpackand Fluoxetine 60mgcapsulesare cap and‘95’ onyellowbodywithblackink. powder andimprintedwith‘J’ onopaquegreen gelatin capsulefilledwithwhitetooff-white Opaque greencap/yellowbody, size“1”hard Capsule, hard. the pack What Fluoxetinelookslikeandcontentsof oxide (E172),potassiumhydroxide. Printing ink sodium laurylsulfate. blue V(E131),titaniumdioxide(E171),gelatin, Capsule shell anhydrous starch), cellulosemicrocrystalline,silicacolloidal Capsule contents The otheringredientsare: hydrochloride equivalentto60mgofFluoxetine Each hardcapsulecontains67.072mgfluoxetine The activesubstanceisfluoxetinehydrochloride. What Fluoxetinecontains measures willhelpprotecttheenvironment. throw awaymedicinesyounolongeruse. These or householdwaste. Ask yourpharmacisthowto Do notthrowawayanymedicinesviawastewater storage conditions This medicinedoesnotrequireanyspecial expiry datereferstothelastdayofthatmonth. which isstatedonthelabel,cartonafterEXP. The Do nottakethismedicineaftertheexpirydate children. Keep thismedicineoutofthesightandreach more informationonthesafetyofthismedicine. By reportingsideeffects youcanhelpprovide Store. or AppleApp search forMHRA Yellow CardintheGoogle Play Scheme at:www.mhra.gov.uk/yellowcard report sideeffects directlyviathe Yellow Card side effects notlistedinthisleaflet. You canalso pharmacist ornurse. This includesanypossible If yougetanysideeffects, talktoyourdoctor, Reporting ofsideeffects reported inchildren. mania andnosebleedswerealsocommonly (suicide attemptandsuicidalthoughts),hostility, delay sexualmaturity. Suicide-relatedbehaviors above, Fluoxetinemayslowgrowthorpossibly In additiontothepossiblesideeffects listed In childrenandadolescents(8-18years)– with continuedtreatment. Most ofthesesideeffects arelikelytodisappear this typeofmedicines. fractures hasbeenobservedinpatientstaking Bone fractures • available data) Not known • • • • • • hepatitis • • • • fits • • stuttering • Confusion • • agitation • hallucinations • • • • Rare (mayaffect upto1in1,000people) • • • • • • • • • • • • • • • • • • • • • Uncommon (mayaffect upto1in100people) • • • • • • • • • yawning • flushing • • • • • dizziness • • • • • • Common (mayaffect upto1in10people) reported inpatientstakingfluoxetine: The followingsideeffects havealsobeen should tellyourdoctorimmediately. If youhaveanyoftheabovesideeffects, • 6. 5. more information. breast-feeding andfertilityinsection2for (postpartum haemorrhage),seePregnancy, afterbirth bleedingshortly Heavy vaginal milk producing breast problems urinating muscle pain sensitivity tosunlight lung problems your stomach pain inthetubethattakesfoodorwaterto face, mouthand/orthroat ofthetissuesaroundneck, rapid swelling vessel) ofablood vasculitis (inflammation aggression panic attacks behaviour untypical wild bloodcellcount reduction inwhite risk ofbleedingorbruising increases platelets,which reduction inblood low levelsofsaltintheblood testresults abnormal liver cold feeling hotor difficulty passingurine cold sweat bruising orbleeding unexplained tobruising increased tendency hairloss difficulty swallowing nosebleeds shortness ofbreath low bloodpressure ears ringing inthe pupils enlarged (dilated) memory impairment problems withbalanceorco-ordination movementsor muscle twitching,involuntary teeth grinding yourself thoughts ofsuicideorharming orgasm problems mood abnormally high strange thinking fromyourself feeling detached orchills feeling shaky vaginal bleeding unexplained morefrequently passing urine joint pain excessive sweating itching rash, urticaria, dry mouth indigestion, vomiting sensations heartbeat rapid andirregular blurred vision shakingmovements uncontrollable change intaste sleepiness tirednessor unusualdreams, sleep problems, sexual activity) (including difficulty maintaininganerectionfor problems driveorsexual decreased sex feeling tense poorconcentration restlessness, anxiety nervousness, not feelinghungry, weightloss functioning oftheheartrate. upon standingwhichmayindicateabnormal heart rate,fainting,collapsingordizziness suchasfast or irregular heart problems, information Contents of thepackandother How tostore Fluoxetine : Shellac,propyleneglycol,blackiron (cannotbeestimatedfromthe : Ironoxideyellow(E172),patent -anincreasedriskofbone : Starchpregelatinised(maize polypropylene closure. available inclear or

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