Package leaflet: information for the patient

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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What this Package Leaflet contains

What Fluoxetina Mylan Generics is and what it is used for
What you need to know before taking Fluoxetina Mylan Generics
How to take Fluoxetina Mylan Generics
Possible side effects
How to store Fluoxetina Mylan Generics
Contents of the pack and other information

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

The name of the medicine is Fluoxetina Mylan Generics 20 mg hard capsules. It contains the active substance
fluoxetine.
Fluoxetine belongs to a group of medicines called antidepressants, selective serotonin reuptake inhibitors (SSRIs).
Fluoxetina Mylan Generics can be administered to treat the following conditions:
Adults

Major depressive episodes.
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 behaviours.

Children and adolescents aged 8 years and older:

Moderate to severe major depressive disorder. If depression does not respond to psychotherapy after 4–6 sessions, Fluoxetina Mylan Generics should be given to a child or adolescent with moderate to severe major depressive disorder only in combination with psychological therapy.

2. What you should 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 and contact your doctor immediately
if you are already taking the medicine metoprolol used to treat heart failure
if you are already taking any medicines specifically known as irreversible non-selective Monoamine Oxidase Inhibitors (MAOIs), as serious or even fatal reactions may occur. An example of such medicines is iproniazid, used to treat depression.

Treatment with fluoxetine should only begin two weeks after stopping an irreversible MAOI (e.g. tranylcypromine).
You must not use any MAOI for at least 5 weeks after stopping fluoxetine. If fluoxetine has been prescribed for a long period and/or at a high dose, your doctor will consider a longer interval.

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

if you suffer from epilepsy or have seizures. If you experience convulsive seizures or notice an increased frequency of convulsive seizures, contact your doctor immediately; it may be necessary to discontinue fluoxetine
if you are experiencing or have previously experienced manic episodes; contact your doctor immediately if you have manic episodes, as it may be necessary to discontinue fluoxetine
if you have liver problems (your 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 lose salts due to severe diarrhoea and vomiting, or if you are taking diuretics
if you are recovering from a heart attack
if you are undergoing electroconvulsive therapy (ECT)
if you have diabetes, as your doctor may need to adjust your diabetes medication
if you have a history of mental illness
if you have a history of coagulation 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 feeling restless and unable to sit or stand still (akathisia). Increasing the dose of Fluoxetina may worsen this condition
if you develop fever, muscle stiffness or tremor, changes in mental status such as confusion, irritability, or extreme agitation, you may be experiencing 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 discontinuation of fluoxetine therapy may be necessary.

Medicines such as fluoxetine (known as SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after discontinuation of treatment.
If you are unsure about the medicines you are currently taking, discuss this with your doctor.

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

if you have previously had thoughts of suicide or self-harm
if you are a young adult. Data from clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go to hospital immediately.
It may be helpful to tell a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them to inform you if they believe your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Children and adolescents aged 8 to 18 years:
When taking this type of medicine, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger).
Fluoxetina Mylan Generics should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes (in combination with psychotherapy) and should not be used to treat other conditions.
Furthermore, only limited data are available regarding the long-term safety of Fluoxetina Mylan Generics on growth, puberty, and mental, emotional, and behavioural development in this age group. Nevertheless, your doctor may prescribe Fluoxetina Mylan Generics to patients under 18 years of age for the treatment of moderate to severe major depressive episodes in combination with psychotherapy, if he/she considers this to be the best option for them. If your doctor has prescribed Fluoxetina Mylan Generics to a patient under 18 years of age and you would like further clarification, please consult your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while patients under 18 years of age are taking Fluoxetina Mylan Generics.
Fluoxetina Mylan Generics must not be used to treat children under 8 years of age.

Other medicines and Fluoxetina Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken (within the last 5 weeks), or might take any other medicines.
Do not take Fluoxetina Mylan Generics with: certain irreversible non-selective monoamine oxidase inhibitors (MAOIs) used to treat depression. Irreversible non-selective MAOIs must 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 discontinuation of an irreversible non-selective MAOI (e.g. tranylcypromine). Do not take any irreversible non-selective MAOI for at least 5 weeks after stopping fluoxetine. If fluoxetine has been prescribed for a long period and/or at high doses, your doctor may need to consider a longer interval than 5 weeks.

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

Fluoxetine may affect how other medicines work (interaction), particularly the following:

certain medicines known as monoamine oxidase inhibitors (MAOIs, used to treat conditions such as depression and Parkinson’s disease), including moclobemide, linezolid (an antibiotic), and methylene blue chloride (also known as methylene blue and used to treat a blood disorder called methaemoglobinaemia): due to the risk of serious or even fatal reactions (called serotonin syndrome)
lithium, tryptophan, tramadol, selegiline, St. John’s wort (an herbal remedy), or medicines known as "triptans" (e.g. sumatriptan, zolmitriptan): there is an increased risk of serotonin syndrome when these medicines are taken with fluoxetine. Your doctor will perform more frequent check-ups.
phenytoin (for epilepsy): since fluoxetine may affect blood levels of this medicine, your doctor may need to monitor phenytoin more closely 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, amitriptyline): since fluoxetine may alter plasma levels of these medicines, your doctor may need to reduce the dose when administered with fluoxetine.
tamoxifen (used to treat breast cancer): since fluoxetine may alter blood levels of this medicine and a reduction in the effects of tamoxifen cannot be excluded, your doctor may consider alternative antidepressant treatments.
medicines that affect heart rhythm (antiarrhythmics) e.g. procainamide, disopyramide, sotalol; antipsychotics (e.g. phenothiazines, pimozide, haloperidol); tricyclic antidepressants; certain antimicrobials (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine); antimalarial treatments, particularly halofantrine; certain 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 heart's electrical activity.
mequitazine or cyproheptadine, medicines used to treat allergies
warfarin, NSAIDs, or other medicines that thin the blood (including clozapine, used to treat certain mental disorders, and aspirin): fluoxetine may alter the effect of these medicines on blood. If treatment with fluoxetine is started or stopped while taking warfarin, your doctor will need to perform certain checks, adjust 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 certain hormonal problems, diuretics
medicines that may increase the risk of seizures, such as other SSRI antidepressants (e.g. sertraline, citalopram, paroxetine), medicines used for nausea and dizziness (e.g. perfenazine, prochlorperazine, chlorpromazine), certain 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 and alcohol
You should avoid drinking alcohol while taking this medicine.

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

Pregnancy
Data are available regarding newborns whose mothers took fluoxetine during the first months of pregnancy, indicating an increased risk of birth defects, particularly heart defects. In the general population, about 1 in 100 babies are born with heart defects. This rate increases to about 2 in 100 babies in mothers who took fluoxetine. Together with your doctor, you may decide whether it is preferable to gradually reduce fluoxetine intake during pregnancy. However, depending on the circumstances, your doctor may advise continuing or discontinuing fluoxetine.

When taken during pregnancy, especially during the last 3 months, medicines such as fluoxetine may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and a bluish skin colour in the newborn. Symptoms usually appear within the first 24 hours after birth. Inform your midwife and/or doctor immediately if your baby shows 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 may decide to gradually discontinue fluoxetine before or during pregnancy. However, depending on the circumstances, your doctor may suggest it is better for you to continue taking fluoxetine.
Caution should be exercised when fluoxetine is used during pregnancy, especially during the last trimester or shortly before delivery, as the following symptoms have been reported in newborns: irritability, tremor, muscle weakness, persistent crying, difficulty feeding or sleeping.

Breastfeeding
Fluoxetine is excreted in breast milk and may cause adverse reactions in infants. You should breastfeed only if clearly necessary. If breastfeeding is continued long-term, your doctor may prescribe a lower dose of fluoxetine.

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

Driving and using machines
Fluoxetine may affect your judgment or coordination. Do not drive or operate machinery without the consent of your doctor or pharmacist.

Fluoxetina contains lactose
If your doctor has told you 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 directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
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) daily. Your doctor will review and adjust the dose if necessary within 3 or 4 weeks after starting treatment. If needed, the dose may be gradually increased up to a maximum of 60 mg daily (3 capsules). The dose should be increased cautiously to ensure you receive the lowest effective dose. You may not feel better immediately when you start taking the medicine for depression. This is usual, as improvement in depressive symptoms may not occur until after the first few weeks. Treatment should be continued for at least 6 months.

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

Bulimia nervosa: The recommended dose is 3 capsules (60 mg) daily.

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

Patients with liver problems
If you have liver problems or are taking other medicines that may affect fluoxetine, your doctor will decide whether to prescribe a lower dose or advise you to take fluoxetine every other day.

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 daily (administered as 2.5 ml of fluoxetine oral solution).
After one to two weeks, the dose may be increased to 20 mg daily. The dose should be increased cautiously to ensure the lowest effective dose is administered. Children with low body weight may require lower doses. If there is a satisfactory response to treatment, your doctor should evaluate the need to continue treatment after 6 months. If no improvement is observed within 9 weeks, your 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 department or contact your doctor.
Take the Fluoxetina Mylan Generics packaging with you if possible.

Signs of overdose include: nausea, vomiting, seizures, cardiac disturbances (such as irregular heartbeat and cardiac arrest), lung problems, and changes in mental status ranging from agitation to coma.

If you forget to take Fluoxetina Mylan Generics

If you miss a dose, do not worry. Take the next dose the following 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 may help you remember to take it regularly.

If you stop taking Fluoxetina Mylan Generics

Do not stop taking fluoxetine without first consulting your doctor, even if you start to feel better. It is important that you continue taking the medicine.
Make sure you do not run out of capsules.

You may experience the following effects (withdrawal syndrome) when stopping fluoxetine: dizziness, tingling sensations like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feelings of restlessness or agitation, unusual tiredness or weakness, anxiety, nausea/vomiting (feeling unwell or being unwell), tremor, headache.
Most people find that fluoxetine discontinuation symptoms are mild and disappear within a few weeks. If you experience symptoms when stopping treatment, contact your doctor.
When stopping fluoxetine, your doctor will help you gradually reduce the dose over one or two weeks—this should help reduce the risk of withdrawal syndrome.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, you must inform your doctor immediately or go directly to the nearest hospital.
Uncommon (may affect up to 1 in 100 people)

thoughts of harming yourself or of 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 may present 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, swollen lymph nodes (serum sickness).
if you feel restless and are unable to sit or stand still, you may have akathisia; increasing the dose of fluoxetine may make you feel worse.
s kin rash, which may lead to blistering, appearing as target-like lesions of small size (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), widespread rash with blisters and skin peeling, particularly on body surfaces, around the mouth, nose, eyes and genitals (toxic epidermal necrolysis, Stevens-Johnson syndrome).
seizures
lower than normal levels of sodium in the blood, which may cause weakness and confusion, with muscle pain. This may be due to inappropriate secretion of vasopressin (ADH), a hormone causing fluid retention in the body and dilution of the blood, thereby reducing sodium levels
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 illness, fever, itching, yellowing of the skin and eyes, pale stools, dark urine
a combination of symptoms (known as "serotonin syndrome") including unexplained fever with rapid breathing or rapid heartbeat, sweating, muscle stiffness or tremor, confusion, irritability and extreme agitation or drowsiness
prolonged and painful erection
heart problems, such as rapid or irregular heartbeat, fainting, collapse or dizziness when standing, which may indicate abnormal heart rhythm.

Other possible side effects:
Very common: may affect more than 1 in 10 people

difficulty sleeping (insomnia)
headache
diarrhoea, feeling unwell (nausea)
tiredness (fatigue), unusual feeling of tiredness

Common: may affect up to 1 in 10 people

loss of appetite, weight loss
nervousness, anxiety
restlessness
difficulty concentrating
feeling tense
reduced sexual desire or sexual problems (including difficulty maintaining an erection during sexual intercourse and ejaculation problems)
sleep disturbances, unusual dreams (including nightmares)
tiredness or drowsiness
dizziness
altered taste
involuntary tremors
blurred vision
sensation of rapid or irregular heartbeat, other changes in the heart's electrical activity known as QT prolongation, which can be seen on 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 shaky 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
orgasm problems
teeth grinding
muscle contractions, involuntary movements or problems with balance or coordination
enlarged (dilated) pupils
low blood pressure
shortness of breath
difficulty swallowing
gastrointestinal bleeding
hair loss
increased tendency to bruise
cold sweats
painful urination
sensation of feeling hot or cold
general feeling of illness or abnormality
increased liver enzymes observed in laboratory tests.

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

atypical, wild behaviour
seeing, sensing 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 tube carrying food or water to your stomach
sensitivity to sunlight
milk production from the breast
increased level of prolactin (a hormone) in the blood
problems urinating
sore throat and difficulty swallowing
muscle pain
bruises
unexplained bruising or 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 listed symptoms and they bother you, or last for some 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:

slowed growth and possible delay in sexual maturation
The following side effects have been commonly observed in children and adolescents:
behavioural changes, such as tendency to act without thinking, anger and irritability
mood changes, including aggression and agitation
self-harming or suicidal thoughts or suicide attempt
nosebleeds.

Reporting of side effects If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 stated on the pack, blister, or bottle after the word EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via 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 substance is fluoxetine hydrochloride.
Each capsule contains fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.
The other components are lactose (see section 2 “Fluoxetina contains lactose”), maize starch,
anhydrous colloidal silica, talc, magnesium stearate, gelatin, shellac, sodium lauryl sulfate, macrogol,
ammonium hydroxide, brilliant blue (E133), quinoline yellow (E104), erythrosine (E127), indigotine (E132),
titanium dioxide (E171) and black iron oxide (E172).

Description of the appearance of Fluoxetina Mylan Generics and the contents of the pack
Fluoxetina is a hard capsule with a light green opaque body and a purple opaque cap, printed in black ink with “FL20” on the body and “  ” on the cap.
Fluoxetina is available in HDPE bottles with a polypropylene screw cap (with a pressure-sensitive seal) 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 Milano - Italy

Responsible manufacturer 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 EEA Member States under the following names:
Austria: Fluoxetin ‘Arcana’ 20mg – Kapseln
Belgium: Fluoxetine Mylan 20mg harde capsules
Denmark: Fluoxetine Mylan
France: Fluoxétine Mylan 20 mg, gélule
Germany: Fluoxetin dura 20mg
Greece: Fluoxetine Mylan CAP 20mg/CAP
Ireland: Gerozac 20mg Capsules hard
Italy: Fluoxetina Mylan Generics
Luxembourg: Fluoxetine Mylan 20mg harde capsules
Netherlands: Fluoxetine Mylan 20mg, capsules
Portugal: Fluoxetina Mylan
United Kingdom: Fluoxetine Capsules 20mg
Spain: Fluoxetina Mylan 20 mg capsulas

Fluoxetine Mylan Generics