FLUOXETINA 20 mg Hard Capsules

Зміст інструкції

1. Fluoxetina Mylan Generics 20 mg Hard Capsules
   1. What is Fluoxetina Mylan Generics and what is it used for
   2. What you need to know before taking Fluoxetina Mylan Generics
   3. How to take Fluoxetina Mylan Generics
   4. Possible side effects
   5. How to store Fluoxetina Mylan Generics
   6. Package Contents and Other Information

Fluoxetina Mylan Generics 20 mg Hard Capsules

Fluoxetine hydrochloride

Generic medicine
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• 1. What is Fluoxetina Mylan Generics and what it is used for
• 2. What you need to know before you take Fluoxetina Mylan Generics
• 3. How to take Fluoxetina Mylan Generics
• 4. Possible side effects
• 5. How to store Fluoxetina Mylan Generics
• 6. Contents of the pack and other information

1. What is Fluoxetina Mylan Generics and what is it used for

The name of the medicine is Fluoxetina Mylan Generics20 mg hard capsules. It contains the active ingredient
fluoxetine.
Fluoxetine belongs to a group of medicines called antidepressants, selective serotonin reuptake inhibitors (SSRIs).
Fluoxetina Mylan Generics can be used to treat the following conditions:
Adults

• Major depressive episodes.
• The symptoms of a disorder called Obsessive-Compulsive Disorder (OCD).
• The eating disorder bulimia nervosa. This medicine is used together with psychotherapy to reduce binge eating and purging behaviors.

Children and adolescents aged 8 years and over:

• Major depressive disorder from moderate to severe, if the depression does not respond to psychotherapy after 4-6 sessions, Fluoxetina must be administered to a child or young person with moderate to severe major depressive disorder onlyin combination with psychological therapy.

2. What you need to know before taking Fluoxetina Mylan Generics

Do not take Fluoxetina Mylan Generics:

• if you are allergic to fluoxetine or any of the ingredients of this medicine (listed in section 6). If you develop a skin rash or other allergic reactions (such as itching,swelling of the lips or face or shortness of breath), stop taking the capsules immediately andcontact your doctor immediately
• if you are already taking the medicine metoprolol used to treat heart failure
• if you are already taking any of the medicines specifically known as Non-selective irreversible Monoamine Oxidase Inhibitors (MAOIs)because serious or even fatal reactions may occur. An example of such medicines is iproniazide, used to treat depression.

Treatment with fluoxetine should only begin two weeks after stopping an irreversible MAOI.
(e.g. tranylcypromine).

You must notuse any MAOI for at least 5 weeks after stopping fluoxetine. If the
fluoxetine has been prescribed for a long period and/or at a high dose, the doctor will consider a longer
interval.

Warnings and precautions:
Talk to your doctor or pharmacist before taking Fluoxetina

• if you suffer from epilepsy or have seizures. If you have seizures or notice an increase in the frequency of seizures, contact your doctor immediately; it may be necessary to stop fluoxetine
• if you have experienced or have had manic episodes, if you have manic episodes, contact your doctor immediately because it may be necessary to stop fluoxetine
• if you have liver problems (the doctor may need to adjust the dose)
• if you have heart problems
• if you have a low resting heart rate and/or are aware that you may have a loss of salts as a result of severe diarrhea and vomiting or if you are using diuretics
• if you are recovering from a heart attack
• if you are undergoing electroconvulsive therapy (ECT)
• if you have diabetes, because the doctor may need to adjust the dose of your diabetes medicine
• if you have a history of mental illness
• if you have a history of bleeding disorders or the appearance of unusual bruising or bleeding
• if you have glaucoma (increased pressure inside the eye)
• if you are already taking other medicines. See below “Other medicines and Fluoxetina Mylan Generics”
• if you start to feel restless and cannot sit or stand still (akathisia). Increasing the dose of Fluoxetina may worsen the situation
• if you experience fever, muscle stiffness or tremor, changes in mental status, such as confusion, irritability and extreme agitation, you may be suffering from the so-called "serotonin syndrome" or "neuroleptic malignant syndrome". Although this syndrome is rare, it can lead to potentially life-threatening conditions; contact your doctor immediately, as it may be necessary to stop therapy with fluoxetine.

Medicines such as fluoxetine (so-called SSRIs/SNRIs) can cause symptoms of sexual dysfunction
(see section 4). In some cases, persistence of these symptoms has been observed after discontinuation of
treatment.
If you are unsure about the medicines you are already taking, talk to your doctor.

Suicidal thoughts and worsening of depression and anxiety disorder.
If you are depressed and/or have anxiety disorders, you may sometimes think about harming yourself or killing yourself. These
thoughts may increase when you start taking antidepressants, as these medicines
take some time to work, usually about two weeks, but sometimes longer.
You are more likely to have these kinds of thoughts:

• If you have had thoughts of killing yourself or harming yourself in the past.
• If you are a young adult. Information from clinical studies has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant.

If you think about harming yourself or killing yourself, at any time, contact your doctor or go to hospital
immediately.
It may be helpful to tell a relative or close friendthat you are depressed or have an anxiety disorder, and
ask them to read this leaflet. You may ask them to tell you if they think your depression or
anxiety is getting worse, or if they are worried about changes in your behavior.

Children and adolescents aged between 8 and 18 years:
When taking this type of medicine, patients under 18 years of age have an increased
risk of adverse effects such as suicide attempt, suicidal ideation and hostility (essentially
aggression, oppositional behavior and anger).
Fluoxetina Mylan Generics should be used in children and adolescents aged between 8 and 18
years only for the treatment of moderate to severe major depressive episodes (in
association with psychotherapy) and should not be used to treat other conditions.
In addition, limited information is available in this age group regarding the long-term safety of Fluoxetina Mylan Generics on growth, puberty and mental, emotional and
behavioral development. Despite this, the doctor may prescribe Fluoxetina Mylan Generics to patients under
18 years of age for the treatment of moderate to severe major depressive episode in
association with psychotherapy, if he/she believes that this is the best solution for them. If the doctor
has prescribed Fluoxetina Mylan Generics to a patient under 18 years of age and you would like clarification, return
to the doctor. You should inform the doctor if any of the above symptoms appear or worsen,
when patients under 18 years of age are taking Fluoxetina Mylan Generics.
Fluoxetina Mylan Generics should not be used in the treatment of children under 8 years of age.

Other medicines and Fluoxetina Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken (up to 5 weeks ago) or
may take any other medicine.

Do not take Fluoxetina Mylan Generics with: some irreversible and non-selective inhibitors of
monoamine oxidase (MAOIs), used to treat depression. Irreversible non-
selective MAOIs should not be used with fluoxetine as serious or
even fatal reactions (serotonin syndrome) may occur (see section 2 “Do not take Fluoxetina Mylan
Generics”). Treatment with fluoxetine must be started strictly at least 2 weeks after
stopping an irreversible and non-selective MAOI (such as tranylcypromine). Do
not take any irreversible and non-selective MAOI for at least 5 weeks after you have stopped
taking fluoxetine. If fluoxetine has been prescribed for a long period and/or at high doses,
the doctor may need to consider a longer time interval of 5
weeks.

• metoprolol when used for heart failure; there is a risk that the heartbeat may become too slow.

Fluoxetine can affect how other medicines work (interaction), in particular the following:

• some medicines known as monoamine oxidase inhibitors (MAOIs, used to treat conditions such as depression and Parkinson's disease), including moclobemide, linezolid (an antibiotic) and methylthioninium chloride (also called methylene blue and used to treat a blood disease known as methemoglobinemia): due to the risk of serious or even fatal reactions (called serotonin syndrome)
• lithium, tryptophan, tramadol, selegiline, herbal remedy known as St John's Wort or medicines known as “triptans” (e.g. sumatriptan, zolmitriptan): there is an increased risk of serotonin syndrome when these drugs are taken with fluoxetine. The doctor will perform more frequent check-ups.
• phenytoin (for epilepsy): as Fluoxetine can affect the levels of this drug in the blood, the doctor may need to insert phenytoin with greater care and to perform check-ups when administered with fluoxetine.
• flecainide, propafenone or nebivolol (for heart problems), atomoxetine (for attention deficit hyperactivity disorder, ADHD), carbamazepine (for epilepsy), risperidone (for mental illnesses), tricyclic antidepressants (e.g. imipramine, desipramine and amitriptyline): as fluoxetine may eventually change the plasma levels of these medicines, the doctor may need to reduce the dose if administered with fluoxetine.
• tamoxifen (used to treat breast cancer): as fluoxetine can change the levels of this drug in the blood and a reduction in the effects of tamoxifen cannot be ruled out, the doctor may need to consider different antidepressant treatments.
• medicines that have an effect on the heart rhythm (antiarrhythmics) e.g. procainamide, disopyramide, sotalol, antipsychotics (e.g. phenothiazines, pimozide, haloperidol), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, moxifloxacin, erythromycin intravenously, pentamidine), anti-malarial treatments, in particular halofantrine, some antihistamines used to treat allergies (astemizole, mizolastine), because taking one or more of these medicines with fluoxetine may increase the risk of changes in the electrical activity of the heart.
• mequitazine or cyproheptadine, medicines used to treat allergies
• warfarin, NSAIDs or other drugs able to thin the blood (including clozapine, used to treat some mental disorders, and aspirin): fluoxetine can alter the effect of these drugs on the blood. If treatment with fluoxetine is started or stopped when taking warfarin, the doctor will need to perform some checks, modify the dose or monitor it more frequently.
• medicines that lower sodium levels in the blood, e.g. oxcarbazepine, used to treat epilepsy
• desmopressin, used to treat some types of hormonal problems, diuretics
• medicines that can increase the possibility of convulsions, such as other SSRI antidepressants (e.g. sertraline, citalopram, paroxetine), medicines used for nausea and dizziness (e.g. perphenazine, prochlorperazine, chlorpromazine), some medicines for mental illnesses called butyrophenones (e.g. benperidol, haloperidol), mefloquine or chloroquine (for malaria) or bupropion (for depression or nicotine dependence).

Fluoxetina Mylan Generics with alcohol
You should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning to have a baby,
talk to your doctor or pharmacist before taking this medicine.

Pregnancy
Regarding newborns whose mothers have taken fluoxetine during the first months of pregnancy, there
is data indicating an increased risk of birth defects, in particular concerning
the heart. In the general population, babies born with heart defects are about 1 in

• 100. This ratio increases to about 2 babies in 100, in mothers who have taken fluoxetine. Together with your doctor, you can decide whether it is more appropriate to gradually reduce the intake of fluoxetine during pregnancy. However, depending on the circumstances, the doctor may suggest whether or not to continue taking fluoxetine.

When taken during pregnancy, especially in the last 3 months of pregnancy, medicines such as
fluoxetine can increase the risk of a serious pediatric condition called persistent pulmonary hypertension in the newborn (PPHN), which involves accelerated breathing in the newborn and
the appearance of bluish skin. Usually, these symptoms appear during the first 24 hours after the birth of
the baby. Immediately inform the midwife and/or doctor if your baby should present these
symptoms.
It is preferable not to use fluoxetine during pregnancy unless the potential benefit
outweighs the potential risk. Therefore, together with your doctor you can decide to gradually
stop taking fluoxetine before or during the period of pregnancy. However, depending on the
circumstances, the doctor may suggest that it is better for you to continue taking fluoxetine.
Caution should be exercised when fluoxetine is used during pregnancy, especially
during the last stage of pregnancy or shortly before delivery as the following symptoms have been
reported in newborns: irritability, tremor, muscle weakness, persistent crying, difficulty
sucking or sleeping.

Breastfeeding
Fluoxetine is excreted in breast milk and can cause adverse reactions in babies. You should only breastfeed
if it is clearly necessary.

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

Driving and using machines
Fluoxetine can alter your ability to judge or coordinate. Do not drive or use machines without
the consent of your doctor or pharmacist.

Fluoxetina contains lactose
If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking
this medicine.

3. How to take Fluoxetina Mylan Generics

Take this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Swallow the capsules with a glass of water. Do not chew the capsules.

Adults
The recommended dose is:

Major depressive episodes: the recommended dose is 1 capsule (20 mg) per day. The doctor will review
and adjust the dose, if necessary, within 3 or 4 weeks of starting treatment. If necessary, the dose
may be gradually increased to a maximum dose of 60 mg per day (3 capsules). The dose must be
increased with caution to ensure you receive the minimum effective dose. You may not feel better
immediately when you start taking the medicine for depression. This is usual because an improvement in
depressive symptoms may not occur until after the first few weeks. The treatment should be
administered for at least 6 months.

Obsessive-Compulsive Disorder (OCD) -The recommended dose is 1 capsule (20 mg) of Fluoxetina per
day. If your condition does not improve after two weeks, the doctor may gradually increase the dose
to the maximum recommended dose of 60 mg per day (3 capsules). If no improvement is observed within 10
weeks, the doctor will reconsider the treatment.

Bulimia nervosa –The recommended dose is 3 capsules (60 mg) per day.

Elderly:
The doctor will increase the dose more cautiously and the daily dose should generally not exceed 2
capsules (40 mg). The maximum dose is 3 capsules (60 mg) per day.

Patients with liver problems
If you have liver problems or are using other medicines that may affect Fluoxetina, the doctor
will decide to prescribe a lower dose or tell you to take Fluoxetina on alternate days.

Use in children and adolescents aged 8 to 18 years with moderate to
severe depression
Treatment must be initiated and supervised by a specialist.
The initial dose is 10 mg per day (administered as 2.5 ml of Fluoxetina oral solution).
After one-two weeks, the dose may be increased to 20 mg per day. The dose must be increased with
caution to ensure that the minimum effective dose is received. Children with low body weight may
need lower doses. If there is a satisfactory response to treatment, the doctor should evaluate the
need to continue treatment after 6 months. If no improvements are noticed within 9 weeks, the
doctor will re-evaluate the treatment.

If you take more Fluoxetina Mylan Generics than you should

• If you take too many capsules, go immediately to the nearest emergency room or contact your doctor
• Bring the package of Fluoxetina Mylan Generics with you if you can.

The signs of overdose are: nausea, vomiting, seizures, heart problems (such as irregular heartbeat and cardiac arrest), lung problems and change in mental status ranging
from agitation to coma.

If you forget to take Fluoxetina Mylan Generics

• If you forget a dose, do not worry. Take the next dose the next day at the usual time. Do not take a double dose to make up for a missed capsule.
• Taking the medicine at the same time each day can help you remember to take it regularly.

If you stop taking Fluoxetina Mylan Generics

• Do not stoptaking Fluoxetina without asking your doctor first, even when you start to feel better. It is important that you continue to take the medicine.
• Make sure you do not run out of capsules.

You may notice the following effects (withdrawal syndrome) when you stop taking Fluoxetina:
dizziness, tingling sensations like pins and needles; sleep disturbances (vivid dreams, nightmares, inability to
sleep), feeling restless or agitated, unusual tiredness or weakness, anxiety, nausea/vomiting
(feeling sick or unwell), tremor, headache.
Most people find that the symptoms of Fluoxetina withdrawal are mild and
disappear within a few weeks. If you experience symptoms when stopping treatment, contact your
doctor.
When stopping fluoxetine, the doctor will help you reduce the dose slowly over one or two
weeks - this should help reduce the risk of a withdrawal syndrome.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If any of the following side effects occur, you must immediately inform your doctor or
go directly to the nearest hospital.
Uncommon(may affect up to 1 in 100 people)

• thoughts of self-harm or suicide, at any time (see section 2 “Suicidal thoughts and worsening of depression and anxiety disorder”).

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

• severe allergic reaction. These reactions can manifest as anaphylaxis (a severe form of allergic reaction) with symptoms such as:
• skin rash
• swelling of the face, lips, mouth, tongue or throat (angioedema)
• sudden wheezing, fainting or difficulty swallowing
• fever, rapid swelling of tissues around the neck, face, mouth and/or throat, skin rash, enlarged lymph nodes (serum sickness).
• if you feel agitated and cannot sit or stand still, you may have akathisia; increasing the dose of fluoxetine may make it feel worse.
• andskin rash, which may give rise to blisters, which appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), widespread rash with blisters and peeling of the skin, especially on the body surface, around the mouth, nose, eyes and genitals (toxic epidermal necrolysis, Stevens Johnson syndrome).
• seizures
• low levels of sodium in the blood, which can cause weakness and confusion, with muscle pain. This may be due to inappropriate secretion of vasopressin (ADH) a hormone that causes fluid retention in the body and dilution of 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 of the lungs, with difficulty breathing
• liver disorder with the following symptoms: nausea or vomiting, loss of appetite, general feeling of unwellness, fever, itching, yellowing of the skin and eyes, pale stools, dark urine
• a combination of symptoms (known as "serotonin syndrome") including unexplained fever with accelerated breathing or heart rate, sweating, muscle rigidity or tremor, confusion, irritability and extreme agitation or drowsiness
• prolonged and painful erection
• heart problems, such as a fast or irregular heartbeat, fainting, collapse or dizziness when standing up, which may indicate abnormal heart rate function.

Other possible side effects:

Very common: may affect more than 1 in 10 people

• difficulty sleeping (insomnia)
• headache
• diarrhea, feeling unwell (nausea)
• fatigue (tiredness), feeling abnormally tired

Common: may affect up to 1 in 10 people

• loss of appetite, weight loss
• nervousness, anxiety
• restlessness,
• difficulty concentrating
• feeling of tension
• decreased sexual desire or sexual problems (including difficulty maintaining an erection for sexual intercourse and problems with ejaculation)
• sleep disturbances, unusual dreams (including nightmares)
• tiredness or drowsiness
• dizziness
• altered taste
• tremulous involuntary movements
• blurred vision
• feeling of a fast and irregular heartbeat, other changes in the heart's electrical activity called QT prolongation, which can be observed with an ECG, an electrical recording of the heart's activity
• hot flushes
• yawning
• indigestion, vomiting
• dry mouth
• skin rash, hives, itching
• excessive sweating
• joint pain
• more frequent urination
• unexplained vaginal bleeding
• feeling shaken or having chills

Uncommon: may affect up to 1 in 100 people

• feeling detached from oneself
• memory problems
• strange thoughts
• abnormally elevated mood
• ringing in the ears
• nosebleeds
• problems with orgasm
• teeth grinding
• muscle contractions, involuntary movements or problems with balance or coordination
• enlarged pupils (dilated)
• low blood pressure
• shortness of breath
• difficulty swallowing
• gastrointestinal bleeding
• hair loss
• increased tendency to bruise
• cold sweat
• painful urination
• feeling of hot or cold
• general feeling of unwellness/abnormal
• increased liver enzymes observed in laboratory tests.

Rare: May affect up to 1 in 1,000 people

• atypical wild behavior
• seeing, perceiving or hearing things that do not exist (hallucinations)
• agitation
• panic attacks
• aggression
• confusion
• stuttering
• inflammation of blood vessels (vasculitis)
• dilation of blood vessels
• pain in the duct that carries food or water to your stomach
• sensitivity to sunlight
• production of milk from the breasts
• increased level of prolactin (a hormone) in the blood
• problems with urination
• sore throat and difficulty swallowing
• muscle pain
• bruising
• ecchymosis or unexplained bleeding
• difficulty urinating
• bleeding from mucous membranes in areas such as the mouth and nose.

Bone fractures- an increased risk of bone fractures has been observed in patients taking this
type of medicine.
If you experience any of the symptoms listed and if they bother you, or last for a certain time, inform
your doctor or pharmacist.
Most of these side effects may disappear with continued treatment.

Additional side effects in children and adolescents (8-18 years)
The following side effects have been observed only in children and adolescents

• slowing of growth and possible delay in sexual maturity The following side effects have been commonly observed in children and adolescents
• changes in behavior, such as a tendency to act without thinking, anger and irritation
• changes in mood, including aggression and agitation
• self-harming or suicidal thoughts or attempts
• nosebleeds.

Reporting of side effectsIf you get any side effect, even if not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Fluoxetina Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging, on the blister or on the bottle
after the wording EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Fluoxetina Mylan Generics contains
The active ingredient is fluoxetine hydrochloride.
Each capsule contains fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.
The other ingredients are lactose (see section 2 “Fluoxetina contains lactose”), corn starch,
anhydrous colloidal silica, talc, magnesium stearate, gelatin, shellac, sodium lauryl sulfate, macrogol,
ammonium hydroxide, brilliant blue (E133), quinoline yellow (E104), erythrosine (E127), indacotina (E132),
titanium dioxide (E171) and black iron oxide (E172).

Description of the appearance of Fluoxetina Mylan Generics and package contents
Fluoxetina is a hard capsule with a light green opaque body and an opaque purple cap printed with
black ink “FL20” on the body and “  ” on the cap.
Fluoxetina is available in HDPE bottles with a polypropylene screw cap (with a pressure-sensitive
tamper-evident closure) containing 7, 10, 14, 20, 28, 30, 50, 60, 90 and 100 hard capsules.
Fluoxetina is also available in PVC / PVDC / Al blister packs containing 7, 10, 12, 14, 20, 28, 30,
50, 60, 90 and 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A., Via Vittor Pisani, 20 - 20124 Milan - Italy

Manufacturer responsible for batch release
McDermott Laboratories Ltd. trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road
Dublin 13, Ireland
Generics [UK] Ltd.
Station Close, Potters Bar
Hertfordshire, EN6 1TL, UK
Mylan sas
Zac des Gaulnes10,
Boulevard de Lattre de Tassigny,
69330 Meyzieu
France

This medicinal product is authorised in the Member States of the EEA under the following denominations:
Austria: Fluoxetin ‘Arcana’ 20mg – Capsules
Belgium: Fluoxetine Mylan 20mg hard capsules
Denmark: Fluoxetine Mylan
France: Fluoxétine Mylan 20 mg, capsule
Germany: Fluoxetin dura 20mg
Greece: Fluoxetine Mylan CAP 20mg/CAP
Ireland: Gerozac 20mg Hard Capsules
Italy: Fluoxetina Mylan Generics
Luxembourg: Fluoxetine Mylan 20mg hard capsules
Netherlands: Fluoxetine Mylan 20mg, capsules
Portugal: Fluoxetina Mylan
United Kingdom: Fluoxetine Capsules 20mg
Spain: Fluoxetina Mylan 20 mg capsules