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_{Packageleaflet:Informationforthe patient}

Fluoxetin Mylan 20 mg Dispersible Tablets

fluoxetine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

- Keep this leaflet. You may need to read it again.

- Ifyouhave any further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

- If you get any side effects talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Fluoxetin Mylan is and what it is used for

2. What you need to know before you take Fluoxetin Mylan

3. How to take Fluoxetin Mylan

4. Possible side effects

5. How to store Fluoxetin Mylan

_{6. Contents of the pack and other information}

1. WhatFluoxetin Mylan isand what it is used for

Fluoxetin Mylan is an antidepressant that influences the central nervoussystem. Fluoxetin Mylan is used for:

Adults

• _Depression

• _{Obsessive thoughts and obsessive actions}

• _{Bulimia (compulsive eating)}

Children and adolescents aged 8 years and above(Underspecialistsupervisiononly):

Note that the doctor may have prescribed this medicine for a different purpose and/or at a different dosage fromthatgiveninthepackageleaflet.Youmustalwaysfollowthedoctor’sprescription andthe instructions given on the label of the pack.

2. What you needto know before you take Fluoxetine Mylan

Do not use Fluoxetin Mylan:

Warningsandprecautions

Talk to your doctor or pharmacist before taking Fluoxetin Mylan:

• if you have diabetes, as Fluoxetin Mylan can raise or lower your blood sugar. The dose of your insulin or the antidiabetes medicines that you take by mouth may need to be adjusted.

• if you have had seizures, have epilepsy, reduced liver, kidney or heart function or have recently had a heart attack you must tell your doctor, because it may be necessary to prescribe a lower dose for you.

• if you have disturbances in heart rhythm called QT prolongation (delayed conduction of electrical signals which can be seen on an ECG, an electrical recording of the heart), or a family history of such conditions.

• if you suffer from any conditions that may make you more prone to experiencing changes in your heart beat (e.g. low blood potassium or magnesium levels, a slow heart beat)

• if you are starting to feel restless and cannot sit or stand still (akathisia). Increasing your dose of Fluoxetin Mylan may make this worse

• if you have or have had mania.

• if you have a tendency to bleed.

• if you are taking tamoxifen (used to treat breast cancer) (see section 2 below “Other medicines and Fluoxetin Mylan”);

• if you are taking other medicines or herbal preparations containing St. John’s wort (Hypericum perforatum) (see section 2 below “Other medicines and Fluoxetin Mylan).

• if you are receiving electro-convulsive shock treatment (ECT).

• if you have increased pressure in the eye (glaucoma)

Thoughts of suicide and worsening of your depression

If you are depressed you can sometimes have thoughts of harming or killing yourself. These may be

increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

- If you have previously had thoughts about killing or harming yourself.

- If you are a youngadult.

Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who weretreated with an antidepressant.

Ifyou have thoughts ofharmingorkillingyourselfat any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friendthat you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Ifyou get an allergic reaction such as itching, nettle rash or swelling of the face, lips, tongueand/or throat (sometimes with breathlessness or difficulties in swallowing) the treatment with Fluoxetin Mylan must be stopped.

Contactyourdoctorifyoudevelopsymptomssuchashighfever,muscletwitching,confusionand anxiety (‘serotonin syndrome’ or ‘neuroleptic malignant syndrome’). The treatment with Fluoxetin Mylan might need to be stopped.

Weight loss may occur during the treatment with Fluoxetin Mylan.

Children and adolescents aged 8 to 18 years

Patientsunder18yearsofagehaveanincreasedriskofside-effectssuchassuicideattempt,suicidal thoughtsandhostility(predominantlyaggression,oppositionalbehaviourandanger)whentakingthis classofmedicines.Fluoxetineshouldonlybeused inchildrenandadolescents aged8 to18yearsfor the treatment of moderate to severe major depressive episodes (in combination with psychological therapy); it should not be used to treat other conditions.

Onlylimitedinformation concerningthelong-termsafetyoffluoxetineongrowth,puberty,mental, emotionalandbehaviouraldevelopment inthis age groupisavailable.Despitethis,yourdoctormay prescribe fluoxetine forpatients under18 formoderatetoseveremajordepressiveepisode incombination withpsychologicaltherapybecausehe/shedecides thatthisisintheirbestinterests.Ifyourdoctorhas prescribedfluoxetinefora patientunder18yearsofageandyouwanttodiscussthis,pleasegobackto yourdoctor.Youshouldinformyourdoctor if any of the symptoms listed above develop or worsen when patients under 18 years of age are taking fluoxetine.

Fluoxetine should not be used in the treatment of children under the age of 8 years.

Other medicines and Fluoxetin Mylan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Certain other medicines can affect or be affected by Fluoxetin Mylan. Please contact your doctor if you are taking any of the medicines listed below.

Do not take Fluoxetine with:

• certain irreversible, non-selective monoamine oxidase inhibitors (MAOIs), some used to treat depression. Irreversible, non-selective MAOIs must not be used with fluoxetine as serious or even fatal reactions (serotonin syndrome) can occur (see section ‘Do not take Fluoxetine’). Treatment with fluoxetine should only be started at least 2 weeks after discontinuation of an irreversible, non-selective MAOI (for instance tranylcypromine). Do not take any irreversible, non-selective MAOIs for at least 5 weeks after you stop taking fluoxetine. If fluoxetine has been prescribed for a long period and/or at a high dose, a longer interval than 5 weeks may need to be considered by your doctor.

• _metoprolol, used to treat heart failure (see also, “Do not take Fluoxetine”).

Fluoxetine may affect the way some other medicines work (interaction), especially the following:

• lithium (used to treat bipolar disorder), tryptophan (used to treat mental illness), selegiline (used for Parkinson’s disease), the herbal remedy St. John’s wort (used to treat depression), tramadol (a pain-killer) or medicines known as ‘triptans’ (e.g. sumatriptan, zolmitriptan) used to treat migraine; there is an increased risk of serotonin syndrome when these medicines are taken with fluoxetine

• blood-thinning medicine (e.g. warfarin)

• medicine for epilepsy (e.g. phenytoin or carbamazepine)

• medicine for pain and inflammation like acetylsalicylic acid and nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin, ibuprofen)

• certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine)

• anti-malarial treatment particularly halofantrine

• astemizole, mequitazine, cyproheptadine or mizolastine (antihistamines, used to treat allergic reactions)

• medicines used to treat heart problems (e,g, flecainide, propafenone, nebivolol),

• diuretics (water tablets), medicines used to treat high blood pressure

• medicines that affect the heart’s rhythm e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, antipsychotic drugs (e.g. pimozide, haloperidol, risperidone)

• tamoxifen (used to treat breast cancer); because fluoxetine may change the blood levels of this drug, resulting in the possibility of a reduction in the effect of tamoxifen, your doctor may need to consider prescribing a different antidepressant treatment.

• atomoxetine (used to treat attention-deficit hyperactivity disorder, ADHD)

• desmopressin, used to treat certain hormone problems that affect urination.

• medicines that can increase the chance of seizures, such as other SSRI antidepressants (e.g. sertraline, citalopram, paroxetine), certain medicines for mental illness called phenothiazines (e.g. perphenazine, chlorpromazine), certain medicines for mental illness called butyrophenones (e.g. benperidol, haloperidol), mefloquine or chloroquine (for malaria), or bupropion (for depression or nicotine dependence).

Fluoxetin Mylan with alcohol

The combination of Fluoxetin Mylan and alcohol is not recommended.

Pregnancy, breast-feeding and fertility

Ifyouarepregnantorbreast-feeding,thinkyoumaybepregnantorareplanningtohaveababy,askyour doctor or pharmacist for advice before taking this medicine.

Pregnancy

Inbabieswhosemotherstookfluoxetineduringthefirstfewmonthsofpregnancy,therehavebeensome studies suggesting an increased risk of birth defects, affecting the heart. In the general population, about 1 in100babiesarebornwithaheartdefect. Thisincreasedtoabout2in100babies inmotherswho took fluoxetine.

Whentakenduringpregnancy, particularlyinthelast3monthsofpregnancy,medicineslikefluoxetinemayincrease theriskofaserious conditioninbabies,called persistentpulmonaryhypertensionofthenewborn(PPHN),makingthebaby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.

It is preferable not to use fluoxetine during pregnancy unless the potential benefit outweighs the potential risk. Thus,you and your doctor may decide that it is better for you to gradually stop taking fluoxetine while youarepregnant.However,dependingonyourcircumstances,yourdoctormaysuggestthatitisbetter for you to keep taking fluoxetine.

Caution should be exercised when used duringpregnancy, especially during late pregnancy or just before giving birth since the following effects have been reported in new born children: irritability, tremor, muscle weakness, persistent crying, and difficulty in sucking or in sleeping.

Breast-feeding

Fluoxetineisexcretedinbreastmilkandcancausesideeffectsinbabies.Youshouldonlybreast-feedifit is clearly necessary. If breast-feeding is continued, your doctor may prescribe a lower dose of fluoxetine.

Fertility

Fluoxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.

Driving and using machines

FluoxetinMylan can impair judgement, thinking capacity and motor skills.This should be taken into account in situations where increased alertness is necessary, e.g. when driving or operating hazardous machinery.

3. Howto take FluoxetinMylan

Alwaystakethismedicineexactlyasyourdoctororpharmacisthastoldyou.Checkwithyourdoctoror pharmacist if you are not sure.

Fluoxetin Mylan dispersible tablets can be dissolved in a glass of water, or swallowed whole with or between meals. The score‑line is not intended for breaking the tablet.

Adults

Depression, obsessive thoughts and obsessive actions (OCD):

Therecommendeddoseis20mg-60 mg daily

Yourdoctorwillreviewandadjustyourdosageifnecessarywithin3to4weeksofthestartoftreatment. The dose should be increased carefully to ensure that you receive the lowest effective dose.

Bulimia nervosa:

The recommended dose is 60 mg daily

Use in children and adolescents aged 8 years and above with moderate to severe depression

Treatmentshouldbestartedandbesupervisedbyaspecialist.Thestartingdoseis10mgaday(givenas 2.5 mloffluoxetineliquid).After1to2weeks,yourdoctormayincreasethedoseto20 mgaday. The doseshouldbeincreasedcarefullytoensurethatyoureceivethelowesteffectivedose.Lowerweight childrenmayneedlowerdoses.Ifthereisasatisfactoryresponsetotreatment,yourdoctorshouldreview theneedforcontinuingtreatmentbeyond6months. Ifyouhavenotimprovedwithin9weeks,your doctor will reassess your treatment.

Patients with liver problems

If you suffer from liver impairment, the dosage may be reduced by your doctor.

Ifyou take moreFluoxetin Mylan than you should

If you have taken too much of this medicine you should contact your doctor or a hospital.

Signs of overdose:Nausea, vomiting, seizures, anxiety, restlessness, excessive cheerfulness, impaired heart function (e.g. arrhythmia and cardiac arrest) and impaired breathing.

Ifyou forget to take Fluoxetin Mylan

Ifyouforgettotakeadose,takeyournextdosethenextdayattheusualtime. Donottakeadoubledose to make up for a forgotten tablet.

IfyoustoptakingFluoxetin Mylan

Do not discontinue the treatment without consulting your doctor, even when you start to feel better.

If you stop taking Fluoxetin Mylan, withdrawal reactions can occur, e.g. sleep disturbances (vivid dreams, nightmares,inabilitytosleep), feelingrestlessoragitated,unusualtirednessorweakness,nausea, vomiting,shakiness,dizziness, headache,anxietyand abnormal sensation ofthe skinsuchasnumbness, tingling, pricking or burning (paraesthesia). These disorders are mild and temporary.

When your doctor decides you should stop taking Fluoxetin Mylan, he/she may choose to reduce the dose gradually over anumberofweeks.Ifyou experience sideeffects when the dose isreduced, your doctor may decide to reduce the dose more slowly.

Ifyou have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possibleside effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Ifyou experience any of the following side effects, stop taking your tablets and either tell your doctor immediately or go to your nearest hospitalemergency department:

Uncommon(may affect up to 1 in 100 people):

Rare (may affect up to 1 in 1,000 people):

- rash

- swollen face, tongue and/or pharynx, difficulty in swallowing, hives and difficulties in breathing (angioedema)

- sudden wheezing, fainting or difficulties in swallowing

- fever, rapid swelling of the tissues around the neck, face, mouth and/or throat, skin rash, enlargement of the lymph nodes (serum sickness).

• fits (convulsion)

• disturbances in heart rhythm called QT prolongation (delayed conduction of electrical signals which can be seen on an ECG, an electrical recording of the heart). In some people this can develop into a potentially serious heart condition known as Torsades de pointes. This can result in a very fast heartbeat causing a sudden loss of consciousness

• restlessness and an inability to sit or stand still, you may have akathisia; increasing your dose of Fluoxetin Mylan may make you feel worse.

• high fever, muscle twitching, confusion and anxiety. These symptoms could be a sign of so called “serotonin syndrome”

• skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with dark ring around the edge) (erythema multiforme), widespread rash with blisters and peeling skin, particularly around the body surface, mouth, nose, eyes and genitals (toxic epidermal necrolysis, Stevens-Johnson syndrome)

• prolonged and painful erection

Other possible side effects

Very common (may affect more than 1 in 10 people):

• difficulty sleeping (insomnia)

• headache

• diarrhoea

• feeling sick (nausea)

• tiredness (fatigue), feeling unusually weak

Common (may affect up to 1 in 10 people):

• loss of appetite, weight loss

• nervousness, anxiety

• restlessness

• poor concentration

• feeling tense

• decreased sex drive or sexual problems (including difficulty maintaining an erection for sexual activity)

• sleep problems, unusual dreams (including nightmares)

• tiredness or sleepiness

• dizziness

• change in taste

• uncontrollable shaking movements

• blurred vision

• rapid and irregular heartbeat sensations, other changes to the electrical activity of the heart called QT prolongation , which can be seen on an ECG, an electrical recording of the heart.

• flushing

• yawning

• indigestion, vomiting

• dry mouth

• rash, hives (urticaria), itching

• excessive sweating

• joint pain

• passing urine more frequently

• unexplained vaginal bleeding

• feeling shaky or chills

Uncommon (mayaffectupto 1 in 100 people):

• feeling detached from yourself

• memory problems

• abnormally high mood

• ringing in the ears

• nose bleeds

• orgasm problems

• teeth grinding

• muscle twitching, involuntary movements or problems with balance or coordination

• enlarged (dilated) pupils

• low blood pressure

• shortness of breath

• difficulty swallowing

• abdominal bleeding

• hair loss

• increased tendency to bruising

• cold sweat

• pain when passing urine

• feeling hot or cold

• generally feeling unwell/abnormal

• increase in liver enzymes seen in a blood test

Rare(may affect up to 1 in 1,000 people):

• a lower than normal level of sodium in the blood, which may make you feel weak and confused with aching of muscles. This may be due to inappropriate ADH secretion, a hormone that causes the body to retain water and dilute the blood, reducing the amount of sodium

• frequent infections with fever, chills, sore throat or mouth ulcers (reduced number of white blood cells)

• lung problems, scarring and thickening in the lungs with shortness of breath

• liver disease with the following signs; feeling or being sick, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine

• low levels of salt in the blood

• untypical wild behaviour

• seeing, feeling or hearing things that are not there (hallucinations)

• agitation

• panic attacks

• confusion

• stuttering or stammering

• inflammation of a blood vessel (vasculitis)

• widening of blood vessels

• pain in the tube that takes food or water to your stomach

• sensitivity to sunlight

• producing breast milk

• high prolactin levels in the blood

• sore throat and discomfort when swallowing

• muscle pain

• unexplained bruising or bleeding

• difficulty passing urine

• problems urinating

• bleeding from the mucosal lining of areas such as the mouth and nose

Not known (frequency cannot be estimated from the available data)

Bonefractures-Anincreasedriskofbonefractureshasbeenobservedinpatientstakingthistypeof medicine.

Side effects in children and adolescents (8-18 years)

In addition to the possible side effects listed above, fluoxetine may slow growth or possibly delay sexual maturity. Suicide-related behaviours (suicide attempt and suicidal thoughts), hostility, mania and nose bleeds were also commonly reported in children.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly viathe national reporting system listed in Appendix V.By reporting sideeffects, you can help provide more information on the safety of this medicine.

5. How to storeFluoxetin Mylan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, blisters or bottle label after EXP. The expirydate refers to the last day of that month.

Do not store above 25°C

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contentsof the pack and other information

What Fluoxetin Mylan contains:

The active substance is fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.

The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, maize starch, crospovidone, saccharin sodium, magnesium stearate and peppermint powder.

What Fluoxetin Mylan looks like and contents of the pack

Your medicine is a dispersible tablet; it is a white, oval-shaped tablet marked “FL|20” on one side and “G” on the other.

Your medicine is available in plastic bottles with screw caps of 30, 100, 250 and 500 tablets or in blisters containing 7,12, 14, 28 and 30 tablets, as well as blisters of 30x1 and 100x1 unit-dose tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

[To be completed nationally]

This leaflet was last revised in

2016-11-11