Fluoxetine Generics

Patient Information Leaflet

Fluoxetina Generics 20 mg dispersible tablets

Fluoxetine
Generic medicine
Read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms appear to be the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Fluoxetina Generics is and what it is used for
2. What you need to know before taking Fluoxetina Generics
3. How to take Fluoxetina Generics
4. Possible side effects
5. How to store Fluoxetina Generics
6. Contents of the pack and other information

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

Fluoxetina Generics is an antidepressant that affects the central nervous system.
Fluoxetina Generics is used for:
Adults

• Depression
• Obsessive thoughts and actions
• Bulimia (binge-eating disorder)

Children and adolescents aged 8 years and older (only under specialist supervision):

• Moderate to severe major depressive disorder, when depression does not respond to psychotherapy after 4–6 sessions. Fluoxetina should be administered to a child or young person with moderate to severe major depressive disorder only in combination with psychological therapy.

Warning: Your doctor may have prescribed this medicine for a condition and/or at dosages different from those provided in the package leaflet. You must always follow the doctor's prescription and the instructions given on the packaging label.

2. What you need to know before taking Fluoxetina Generics

Do not take Fluoxetina Generics

• if you are allergic to fluoxetine or to any of the other ingredients of this medicine (listed in section 6).
• if you are currently taking any medicines specifically known as irreversible non-selective Monoamine Oxidase Inhibitors (MAOIs). An example of such medicines is iproniazid, used to treat depression.
• if you are currently taking the medicine metoprolol used to treat heart failure.

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

• if you have diabetes, because Fluoxetina Generics may increase or decrease blood glucose levels. You may need to adjust your dose of insulin or oral antidiabetic medication.
• if you have had seizures, suffer from epilepsy, or have reduced liver, kidney or heart function, or if you recently had a heart attack, inform your doctor, as you may require a lower dose of the medicine.
• if you have heart rhythm disorders known as QT prolongation (delayed electrical conduction that can be seen on an ECG, an electrical recording of heart activity), or a family history of such conditions.
• if you have any condition that makes you more susceptible to changes in heart rhythm (e.g. low levels of potassium or magnesium, slow heart rate).
• if you start feeling restless and unable to sit or stand still (akathisia). Increasing the dose of Fluoxetina Generics may worsen this condition.
• if you have or have had manic episodes.
• if you have a tendency to bleed.
• if you are taking tamoxifen (used to treat breast cancer) (see section 2 “Fluoxetina Generics and other medicines”).
• if you are taking other medicines or herbal remedies containing St. John’s Wort (Hypericum perforatum) (see section 2 “Fluoxetina Generics and other medicines”).
• if you are undergoing electroconvulsive therapy (ECT).
• if you have increased intraocular pressure (glaucoma).

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes have self-harming thoughts or suicidal ideation. These may increase when starting an antidepressant, as all such medicines require time to take effect—usually about two weeks, but sometimes longer.
You may experience such thoughts:

• if you have previously had suicidal ideation or self-harming thoughts.
• if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults under 25 years of age with psychiatric disorders treated with an antidepressant. If at any time you have self-harming thoughts or suicidal ideation, contact your doctor or go to hospital immediately.
  It may be helpful to explain to a relative or close friend that you are depressed and ask them to read this leaflet. You may wish to ask them to inform you if they think your depression is worsening or if they are concerned about changes in your behaviour.

If you develop an allergic reaction such as itching, rash, or swelling of the face, lips, tongue, and/or throat (sometimes with shortness of breath or difficulty swallowing), stop treatment with Fluoxetina Generics.
Contact your doctor if you develop symptoms such as high fever, muscle rigidity, confusion, and agitation (‘serotonin syndrome’ or “neuroleptic malignant syndrome”). You may need to stop treatment with Fluoxetina Generics.
Weight loss may occur during treatment with Fluoxetina Generics.

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). Fluoxetine should be used in children and adolescents aged 8 to 18 years only for the treatment of moderate to severe major depressive episodes (in combination with psychotherapy) and should not be used to treat other conditions.
For this age group, there is limited information available on the long-term safety of fluoxetine regarding growth, puberty, and mental, emotional, and behavioural development.
Nevertheless, your doctor may prescribe fluoxetine to patients under 18 years of age for the treatment of moderate to severe major depressive episodes in combination with psychotherapy, if they consider it the best option. If your doctor has prescribed fluoxetine to a patient under 18 years of age and you have questions, consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while patients under 18 years of age are taking fluoxetine.
Fluoxetine must not be used to treat children under 8 years of age.

Fluoxetina Generics and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interact with Fluoxetina Generics or be affected by it. Contact your doctor if you are taking any of the following medicines:

• certain irreversible non-selective monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Irreversible non-selective MAOIs must not be used with fluoxetine because serious or even fatal reactions (serotonin syndrome) may occur (see section “Do not take Fluoxetina Generics”). Treatment with Fluoxetina Generics must begin strictly at least 2 weeks after stopping 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 consider a longer interval than 5 weeks.
• metoprolol when used for heart failure (see also “Do not take Fluoxetina Generics”).

Fluoxetine may affect the action of the following medicines (interaction), particularly:

• certain medicines known as monoamine oxidase inhibitors (MAOIs), including moclobemide, linezolid (an antibiotic), and methylene blue (also known as methylthioninium chloride, used to treat a blood disorder called methemoglobinemia): due to the risk of serious or even fatal reactions (called serotonin syndrome). Treatment with fluoxetine may be started the day after stopping treatment with a reversible MAOI, but your doctor may decide to monitor you closely and use a lower dose of an MAO-A type inhibitor.
• lithium (used to treat bipolar disorder), tryptophan (used to treat certain mental disorders), selegiline (used for Parkinson’s disease), the herbal remedy St. John’s Wort (used to treat depression), tramadol (a painkiller), 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 medicines (e.g. warfarin).
• medicines for epilepsy (e.g. phenytoin or carbamazepine).
• painkillers and anti-inflammatory medicines such as acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin, ibuprofen).
• certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine).
• anti-malarial treatments, 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, medicines used to treat high blood pressure.
• medicines that affect heart rhythm, e.g. Class IA and III antiarrhythmics.
• tricyclic antidepressants.
• antipsychotic medicines (e.g. pimozide, haloperidol, risperidone).
• tamoxifen (used to treat breast cancer), because fluoxetine may alter blood levels of this medicine, potentially reducing the effectiveness of tamoxifen; your doctor may need to consider prescribing another antidepressant.
• atomoxetine (used to treat Attention Deficit Hyperactivity Disorder, ADHD).
• desmopressin, used to treat certain hormonal disorders affecting urination.
• medicines that may increase the risk of seizures, such as other SSRI antidepressants (e.g. sertraline, citalopram, paroxetine), medicines used for mental illnesses (e.g. perphenazine, chlorpromazine), certain antipsychotics known as butyrophenones (e.g. benperidol, haloperidol), mefloquine or chloroquine (for malaria), or bupropion (for depression or nicotine dependence).

Fluoxetina Generics and alcohol
The combination of Fluoxetina Generics and alcohol is not recommended.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist for advice before taking this medicine.

Pregnancy:
There are some studies in 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 malformations. This risk increases to about 2 in 100 babies in mothers who took fluoxetine.
When taken during pregnancy, especially during the last three months, medicines such as Fluoxetina Generics 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 baby. 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 advise that it is better for you to continue taking fluoxetine.
Caution should be exercised when fluoxetine is used during pregnancy, especially during the third trimester or shortly before delivery, as the following symptoms have been reported in newborns: irritability, tremors, muscle weakness, persistent crying, feeding or sleeping difficulties.

Breastfeeding
Fluoxetine is excreted in breast milk and may cause adverse effects in infants. You should breastfeed only if clearly necessary. If breastfeeding is continued, 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
Fluoxetina Generics may impair judgment, thinking, and motor skills. This should be taken into account in situations requiring increased mental alertness, such as driving or operating dangerous machinery.

3. How to take Fluoxetina Generics

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Fluoxetina Generics dispersible tablets can be dissolved in a glass of water or swallowed whole, with or
without food. The score line is not intended for dividing the tablet.
Adults
Depression, obsessive thoughts and actions (OCD, Obsessive-Compulsive Disorder):
The recommended dose is 20 mg – 60 mg/day.
Your doctor will review and adjust your dosage, if necessary, within 3 or 4 weeks after starting treatment. The
dose should be increased carefully to ensure you receive the lowest effective dose.
Bulimia nervosa:
The recommended dose is 60 mg/day.
Use in children and adolescents aged 8 years and older 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 Fluoxetina 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 achieved. Children with low body weight may require lower doses. If a satisfactory response to treatment is observed, your doctor should evaluate the need to continue treatment after 6 months. If no improvement is seen within 9 weeks, your doctor will re-evaluate the treatment.
Patients with liver problems
If you have impaired liver function, your doctor may reduce your dosage.
If you take more Fluoxetina Generics than you should
If you have taken too much of this medicine, you must contact your doctor or a hospital.
Signs of overdose: nausea, vomiting, seizures, anxiety, restlessness, excessive euphoria, impaired cardiac
function (e.g. arrhythmia and cardiac arrest), and breathing difficulties.
If you forget to take Fluoxetina Generics
If you forget to take a dose, take the next dose at your usual time the following day. Do not take a double
dose to make up for the missed tablet.
If you stop taking Fluoxetina Generics
Do not stop treatment without consulting your doctor, even if you start to feel better.
If you discontinue treatment with Fluoxetina Generics, withdrawal symptoms may occur, such as sleep
disturbances (vivid dreams, nightmares, inability to sleep), feelings of restlessness or agitation, unusual
tiredness or weakness, nausea, vomiting, unsteadiness, dizziness, headache, anxiety, and sensory disturbances
such as numbness, tingling, pricking, or burning sensations (paraesthesia). These symptoms are generally mild and temporary.
When your doctor decides that you should stop taking Fluoxetina Generics, they may choose to gradually reduce
the dose over several weeks. If undesirable effects occur during dose reduction, your doctor may decide to taper the dose more slowly.
If you have any further 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 everybody gets them.
If you experience any of the following side effects, stop taking the tablets and contact your doctor immediately or go to the nearest hospital emergency department:
Uncommon (may affect up to 1 in 100 people):

• thoughts of harming yourself or of suicide (see section 2 “Suicidal thoughts and worsening of depression”).

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

• an allergic reaction. These reactions may occur as anaphylaxis (a severe form of allergic reaction) with symptoms such as:
• skin rash
• swelling of the face, tongue and/or throat, difficulty swallowing, hives, and breathing difficulties (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)
• seizures
• disturbances in heart rhythm known as QT prolongation (delayed conduction of electrical signals, which can be seen on an electrocardiogram (ECG), an electrical recording of heart activity). In some people, this may progress to a potentially serious heart condition known as “Torsades de pointes”. This may cause a very rapid heartbeat leading to sudden loss of consciousness
• if you feel restless and unable to sit or stand still, you may have akathisia; increasing the dose of Fluoxetina Generics may make you feel worse
• high fever, muscle rigidity, confusion, and anxiety. These symptoms could be signs of a condition known as “serotonin syndrome ”.
• skin 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 peeling of the skin, particularly on body surfaces and around the 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 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
• decreased sexual desire or sexual problems (including difficulty maintaining an erection for sexual intercourse)
• sleep disturbances, unusual dreams (including nightmares)
• tiredness or drowsiness
• dizziness
• altered taste
• involuntary tremulous movements
• blurred vision
• sensation of rapid or irregular heartbeat, another change in the heart's electrical activity called QT prolongation, which may be observed on an ECG, an electrical recording of heart 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
• dilated pupils (enlarged)
• 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 being unwell/abnormal
• increased liver enzymes observed in laboratory tests.

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

• lower than normal levels of sodium in the blood, which may cause weakness, confusion, and 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 breathing difficulties
• liver disorder with the following signs: feeling unwell, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), pale stools, dark urine
• low levels of salts in the blood
• atypical wild behaviour
• 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 tube (oesophagus) that carries food or water to the stomach
• sensitivity to sunlight
• milk production from the breast
• increased level of prolactin (a hormone) in the blood
• sore throat and difficulty swallowing
• muscle pain
• bruising
• unexplained ecchymoses or bleeding
• difficulty urinating
• bleeding from mucous membranes in areas such as the mouth and nose.

Not known (frequency cannot be estimated from the available data)
Bone fractures - An increased risk of bone fractures has been observed in patients taking this type of medicine.

Side effects in children and adolescents (8-18 years)
In addition to the side effects listed above, fluoxetine may slow growth or possibly delay sexual maturation. Suicidal-related behaviours (suicide attempts and suicidal thoughts), hostility, mania, and nosebleeds have been commonly reported in children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps provide more information on the safety of this medicine.

5. HOW TO STORE FLUOXETINE GENERICS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, blister, or bottle label, following the term "EXP".
The expiry date refers to the last day of the 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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Fluoxetina Generics contains:
The active substance is fluoxetine hydrochloride, equivalent to 20 mg of fluoxetine.
The other components are microcrystalline cellulose, anhydrous colloidal silica, maize starch, crospovidone,
sodium saccharin, magnesium stearate and peppermint powder.

Description of the appearance of Fluoxetina Generics and contents of the pack
The medicine is available as dispersible tablets. These are white, oval-shaped tablets, marked “FL|20” on one side and “G” on the other.
The medicine is available in plastic bottles with screw caps containing 30, 100, 250 and 500 tablets, or in blisters containing 7, 12, 14, 28 and 30 tablets, as well as in unit-dose blisters of 30x1 and 100x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
MYLAN S.P.A
VIA VITTOR PISANI, 20
20124 MILAN
ITALY

Batch release
Generics (UK) Ltd.
Station Close, Potters Bar, Hertfordshire, EN6 1TL – United Kingdom
McDermott Laboratories Ltd (t/a Gerard Laboratories Ltd)
35-36 Baldoyle Industrial Estate, Grange Road, Dublin 13 - Ireland
Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1
Hungary