Package leaflet: Information for the user

FLUOXETINE EG 20 mg hard capsules

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 give it to other people, even if their symptoms are the same as yours, because it may 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

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

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

Fluoxetina EG belongs to a group of antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs).
For adults (aged 18 years and older), Fluoxetina EG is used to treat:
major depressive disorder (major depressive episodes);
obsessive-compulsive disorder (OCD);
bulimia nervosa (an eating disorder). Fluoxetina EG is used as an adjunct to psychotherapy to reduce frequent episodes of binge eating followed by compensatory behaviors.

Children and adolescents from 8 years of age:
moderate to severe major depression, when depression does not respond to psychological therapy after 4–6 sessions. Fluoxetina EG may be given to a child or adolescent with moderate to severe major depression only in combination with psychological therapy.

2. What you need to know before taking Fluoxetina EG

DO NOT take Fluoxetina EG
if you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in
section 6). An allergic reaction may present as skin rash, itching, swelling of the face or
lips, or difficulty breathing;
if you are taking or have recently taken a type of medicine called an irreversible non-selective monoamine oxidase inhibitor (also known as MAOI), such as iproniazid. MAOIs are also used to treat depression, Parkinson's disease, or infections. Your doctor will know whether other medicines you are taking belong to the MAOI class;
if you are taking a medicine called metoprolol used for heart failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluoxetina EG, especially if you have or have ever had any of the following conditions or diseases:
Skin rash or other allergic reactions (hypersensitivity). Fluoxetina EG may cause a serious type of allergic reaction called anaphylactic reaction. These reactions may affect the skin and certain internal organs (kidneys, liver, lungs). Symptoms include swelling of the face, lips, tongue, and throat, and difficulty breathing.
If you develop such a reaction, stop taking Fluoxetina EG immediately. Contact your doctor or go immediately to the nearest Emergency Department.
Seizures. Taking Fluoxetina EG may increase the risk of seizures. If you have previously experienced seizures, your doctor will start treatment with this medicine with particular caution and will determine the appropriate dose of Fluoxetina EG for you. See also section 3 “How to take Fluoxetina EG”.
You must not take Fluoxetina EG:
if you have an obsessive disorder that is not well controlled by medication (unstable).
You must stop treatment with Fluoxetina EG:
if you experience seizures for the first time;
if you have had seizures before, but they now begin to occur more frequently.
Your doctor must closely monitor your treatment with Fluoxetina EG:
if you suffer from epilepsy (a disorder causing seizures) but are taking medicines that prevent seizures.
Electroconvulsive therapy (ECT). Electroconvulsive therapy is used to treat depression. If you take fluoxetine while undergoing ECT treatment, seizures may last longer than usual. Therefore, you must inform your doctor that you are taking this medicine.
Mania (hyperactive behaviour or thoughts). If you have experienced episodes of mania, use Fluoxetina EG with caution. If a manic episode occurs, contact your doctor immediately, as it may be necessary to discontinue Fluoxetina EG.
Impaired liver or kidney function. You may need to take a lower dose of Fluoxetina EG if your liver is not functioning properly. A dose reduction may also be necessary if your kidneys are not working adequately. Your doctor will decide the dose and frequency at which you should take the medicine.
Concurrent treatment with tamoxifen (used to treat breast cancer). See "Other medicines and Fluoxetina EG".
Heart disease. Fluoxetina EG should be taken with caution if you have heart disease. Your doctor will decide whether you should take a lower dose.
Diuretics. When taking diuretics, especially if you are elderly, sodium levels in the blood may decrease.
Weight loss. Weight loss may occur during treatment with Fluoxetina EG.
Diabetes. Treatment with Fluoxetina EG may lower blood sugar levels too much; stopping the treatment may cause blood sugar levels to rise excessively. Your doctor may therefore need to adjust the dose of medicines used to treat diabetes.

Suicidal thoughts and worsening of depression or anxiety disorder. If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts of harming yourself or of suicide. These thoughts may occur more frequently at the beginning of antidepressant therapy, as all these medicines take some time to work, usually two weeks, but sometimes longer.
These thoughts are more likely to occur in any of the following cases:
if you have previously had thoughts of suicide or self-harm;
if you are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with antidepressants.
If at any time you think about harming yourself or committing suicide, contact your doctor or go immediately to hospital.
It may be helpful to tell a close relative or friend that you are depressed or suffering from anxiety and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening or if they are concerned about any changes they observe in your behaviour.
Akathisia (inability to remain still) or psychomotor restlessness (a distressing sense of agitation and an overwhelming, constant need to move continuously). You may develop a distressing or unpleasant sense of restlessness and an overwhelming, constant need to move continuously. Often at the same time, you may be unable to sit still or stand still. This is more likely to occur during the first weeks of treatment. If you notice these symptoms, consult your doctor.
Bleeding (haemorrhage). When taking medicines such as Fluoxetina EG (SSRIs), abnormal skin bleeding may occur. This includes bruising and purpura, which appear as small spots or blue or purple patches under the skin. Bruising has been reported during treatment with fluoxetine, but only in rare cases.
You should pay particular attention:
if you are taking medicines that affect blood clotting, such as:
oral anticoagulants (e.g., warfarin);
clozapine (used in mental disorders);
a group of medicines used for mental disorders called phenothiazines;
most tricyclic antidepressants (e.g., amitriptyline, clomipramine);
acetylsalicylic acid (a painkiller);
non-steroidal anti-inflammatory drugs (NSAIDs);
current or past episodes of bleeding.
Other types of bleeding that occur rarely include:
vaginal bleeding;
bleeding from the digestive system (vomiting blood or blood in stools);
other types of bleeding from the skin or mucous membranes of the mouth or nose.
Withdrawal symptoms. When you stop taking Fluoxetina EG, withdrawal symptoms may occur, which are particularly common when stopping the medicine abruptly.
Withdrawal symptoms include:
dizziness;
disturbed sensations (tingling sensation like small pinpricks or needles);
sleep disturbances, including inability to sleep (insomnia) and vivid dreams;
agitation or anxiety;
nausea (feeling unwell) and/or vomiting;
tremor;
headache.
These symptoms are usually mild to moderate in intensity, although sometimes they can be severe. They typically appear during the first weeks after stopping treatment and generally improve within 2 weeks. However, they may persist for 2-3 months or longer. Inform your doctor if these symptoms become severe or interfere with your daily activities.
Increased pressure inside the eye (glaucoma). Dilated pupils (mydriasis) may develop. Use with caution. Consult your doctor.
Serotonin syndrome or events similar to Neuroleptic Malignant Syndrome. Serotonin syndrome or events similar to Neuroleptic Malignant Syndrome are caused by excessive release of one of the body's chemicals, serotonin. Symptoms of serotonin syndrome include:
hyperthermia (excessively high body temperature);
muscle rigidity;
myoclonus (involuntary muscle contractions);
rapid fluctuations in vital signs (sudden changes in heart rate, respiratory rate, or blood pressure);
changes in mental status including confusion, irritability, and extreme agitation up to delirium (racing thoughts, disordered speech, reduced consciousness), and loss of consciousness (coma) (see also section 4).
Serotonin syndrome and events similar to Neuroleptic Malignant Syndrome may occur during treatment with Fluoxetina EG but are more common with concomitant use of:
linezolid (an antibiotic);
other antidepressants;
L-tryptophan;
neuroleptics (medicines for mental disorders).
If you develop signs or symptoms of serotonin syndrome, contact your doctor immediately. The doctor will advise you which medicine to discontinue.
Treatment with monoamine oxidase inhibitors (MAOIs), some used to treat depression.
Serious and sometimes fatal adverse effects have been reported in patients treated with an SSRI in combination with an irreversible non-selective monoamine oxidase inhibitor.
These cases presented with features similar to serotonin syndrome. Therefore, Fluoxetina EG must not be used in combination with an irreversible non-selective MAOI. Due to the two-week duration of action of the latter, fluoxetine treatment should only be started two weeks after discontinuation of an irreversible non-selective MAOI. Similarly, at least five weeks must elapse after stopping Fluoxetina EG before starting treatment with an irreversible non-selective MAOI (see "Other medicines and Fluoxetina EG").
Medicines such as Fluoxetina EG (so-called selective serotonin reuptake inhibitors, SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Children and adolescents
Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking this class of medicines. Fluoxetina EG should only be used in children and adolescents aged 8 to 18 years to treat moderate to severe major depressive episodes (in combination with psychological therapy) and not for other indications.
Furthermore, there is limited long-term safety data on the effects of Fluoxetina EG on growth, puberty, and mental, emotional, and behavioural development in this age group.
However, your doctor may prescribe Fluoxetina EG to patients under 18 years of age for moderate to severe major depressive episodes in combination with psychological therapy if they consider it to be in the best interest of the patient. If your doctor has prescribed Fluoxetina EG to a patient under 18 years of age and you wish to discuss this, do not hesitate to do so. Inform your doctor if any of the above-mentioned symptoms appear or worsen in a patient under 18 years of age taking Fluoxetina EG.
Fluoxetina EG must not be used to treat children under 8 years of age.
Other medicines and Fluoxetina EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Also inform your doctor if you are taking or have recently taken any herbal preparations.
Note that fluoxetine remains in the body for a long time after stopping treatment: this means it may interact with other medicines up to 5 weeks after stopping treatment.
The following medicines may interact with or be affected by fluoxetine
Irreversible non-selective monoamine oxidase inhibitors (some used to treat depression, e.g., iproniazide). Serious and sometimes fatal adverse effects have been reported in patients treated with an SSRI in combination with an irreversible non-selective monoamine oxidase inhibitor.
These cases presented with features similar to serotonin syndrome. For symptoms of this interaction, see “Serotonin syndrome or events similar to Neuroleptic Malignant Syndrome” above:
Therefore:
Do not take Fluoxetina EG for at least 2 weeks after stopping treatment with an irreversible monoamine oxidase inhibitor (such as iproniazide).
Likewise, when switching from fluoxetine to a monoamine oxidase inhibitor, wait at least 5 weeks after the last dose of Fluoxetina EG before taking an MAOI. If Fluoxetina EG has been taken for a long time and/or at a high dose, a longer interval may be considered by the doctor.
Do not change your medicine without discussing it with your doctor.
Lithium, buprenorphine, buprenorphine/naloxone combination, tramadol, triptans, tryptophan, selegiline, linezolid, methylene blue (methylthioninium chloride), St. John’s wort (Hypericum perforatum); if these medicines are taken together with Fluoxetina EG, the risk of serotonin syndrome increases. When these medicines are taken with Fluoxetina EG, your doctor should perform more frequent checks. The doctor may reduce the dose of some medicines (e.g., MAOIs including linezolid, moclobemide, and methylene blue (methylthioninium chloride)) when taken with Fluoxetina EG, and close clinical monitoring may be required. Do not use any St. John’s wort preparations while taking Fluoxetina EG, as the combination may lead to an increase in adverse effects. If you are already using a St. John’s wort preparation when starting Fluoxetina EG treatment, stop taking St. John’s wort and inform your doctor at your next visit.
Phenytoin (for epilepsy); since Fluoxetina EG may affect blood levels of this medicine, your doctor must introduce phenytoin with extreme caution and perform frequent monitoring when administered together with Fluoxetina EG.
Clozapine (used to treat certain mental disorders), tramadol (a painkiller), or triptans (for migraine); there is an increased risk of hypertension (elevated blood pressure).
Flecainide and propafenone (for heart problems), nebivolol (to lower blood pressure and for heart problems), carbamazepine (for epilepsy), atomoxetine (for attention deficit hyperactivity disorder), tricyclic antidepressants (such as imipramine, desipramine, and amitriptyline), and risperidone (for mental disorders); since Fluoxetina EG may alter blood levels of these medicines, your doctor may need to reduce their dose when taken with Fluoxetina EG.
Tamoxifen (used to treat breast cancer); since fluoxetine may alter blood levels of this drug and a reduction in the effect of tamoxifen cannot be excluded, your doctor may consider alternative antidepressant treatments.
Mequitazine (used to treat allergies and rhinitis); because the risk of adverse events with mequitazine may be increased by fluoxetine.
Medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine), antimalarial treatments (especially halofantrine), and certain antihistamines (astemizole, mizolastine).
Medicines that affect blood clotting ability, such as oral anticoagulants, acetylsalicylic acid (a pain treatment medicine), and non-steroidal anti-inflammatory drugs (NSAIDs).
Cyproheptadine (used to treat allergic reactions).
Medicines that lower sodium levels in the blood (e.g., diuretics (water pills), desmopressin, carbamazepine, and oxcarbazepine).
Medicines that lower the seizure threshold, such as tricyclic antidepressants, other SSRIs, phenothiazines, butyrophenones, mefloquine, chloroquine, bupropion, tramadol.
Fluoxetina EG with food and alcohol
You may take Fluoxetina EG with or without food, as preferred.
You should avoid alcohol while taking this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
In newborns whose mothers took fluoxetine during the first months of pregnancy, there have been some reports showing an increased risk of birth defects, particularly those affecting the heart. In the general population, about 1 in 100 children are born with a heart defect. This increases to about 2 in 100 children in mothers who took fluoxetine. You and your doctor may decide it is best to gradually stop taking Fluoxetina EG during pregnancy. However, depending on the circumstances, your doctor may suggest it is better for you to continue taking Fluoxetina EG.
Ensure your midwife and/or doctor knows you are taking Fluoxetina EG. Medicines such as Fluoxetina EG, if taken during pregnancy, especially during the last three months of pregnancy, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.
Your doctor may decide you can take fluoxetine during pregnancy, but caution is advised, especially during the later stages of pregnancy and before labour begins. However, the following effects have been reported in newborns: irritability, tremor, hypotonia (low muscle tone), muscle weakness, persistent crying, difficulty sucking or sleeping.
If you take Fluoxetina EG near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking Fluoxetina EG so they can advise you on what to do.
Breastfeeding
Fluoxetine is excreted in breast milk and may cause adverse effects in newborns. You should breastfeed only if clearly necessary. If you continue breastfeeding, your doctor may prescribe a lower dose of fluoxetine.
Fertility
In animal studies, fluoxetine has been shown to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.

Driving and using machines
This medicine may affect your ability to judge and your coordination. Do not drive or operate machinery unless your doctor or pharmacist has advised you that it is safe to do so.
Fluoxetina EG contains lactose (milk sugar)
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Fluoxetina EG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist. Do not take more capsules than prescribed by your doctor.
The usual dose is:
Adults
Treatment of major depressive episodes
The recommended dose is 1 capsule (20 mg) daily. If necessary, your doctor will reassess and adjust the
dosage for the individual patient after 3–4 weeks of treatment. When appropriate, the dose may be
gradually increased up to a maximum of 3 capsules (60 mg). However, any increase must be made with
extreme caution to ensure that the patient receives the lowest effective dose. When starting treatment with
an antidepressant, it is common not to feel better immediately; this is normal, as improvement in depressive
symptoms cannot occur until several weeks have passed. Patients with depression should be treated for at
least 6 months.
Treatment of obsessive-compulsive disorder (OCD)
The recommended dose is 1 capsule (20 mg) daily. If necessary, your doctor will reassess and adjust the
individual patient's dose after 2 weeks of treatment. When appropriate, the dose may be gradually
increased up to a maximum of 3 capsules (60 mg). If no improvement is observed within 10 weeks, the
appropriateness of continuing treatment with Fluoxetina EG should be reconsidered.
Treatment of bulimia nervosa
The recommended dose is 3 capsules (60 mg) daily.
Use in children and adolescents aged 8 to 18 years with depression
Treatment must be initiated and supervised by a specialist doctor. The starting dose is 10 mg daily
(administered as 2.5 ml of an oral liquid formulation containing fluoxetine). After one or two weeks, your
doctor may increase the dose to 20 mg daily. However, any increase must be made with extreme caution to
ensure that the patient receives the lowest effective dose.
Children with lower body weight may require lower doses. Your doctor must evaluate whether continued
treatment is necessary after 6 months. If no improvement is observed, the appropriateness of continuing
treatment should be reconsidered.
Elderly patients
If you are elderly, your doctor will increase the dose more cautiously, and the daily dose should generally not
exceed 40 mg. The maximum daily dose is 60 mg.
Hepatic impairment
If you have liver problems or are taking other medicines that may affect fluoxetine, your doctor may decide to
prescribe a lower dose or to have you take Fluoxetina EG on alternate days.
Method of administration
Swallow the capsules with water. Do not chew the capsules.

Fluoxetina EG may be administered as a single dose or in divided doses, with or without food.
If you take more Fluoxetina EG than you should
If you have taken too many capsules, go immediately to the nearest Emergency Room or contact your doctor
without delay.
Bring the Fluoxetina EG packaging with you, if possible.
Symptoms of overdose include: nausea, vomiting, seizures, cardiac problems (irregular heartbeat and cardiac
arrest), respiratory problems, and altered mental status ranging from agitation to coma.
Information for the doctor on overdose management is provided at the end of this leaflet.
If you forget to take Fluoxetina EG
If you miss a dose, do not be concerned. Take the next dose at the usual time the following day.
Do not take a double dose to make up for the missed dose.
Taking the medicine at the same time each day helps you remember to take it regularly.
If you stop taking Fluoxetina EG
DO NOT stop taking this medicine without first consulting your doctor, even if you start to feel better. It is
important to continue taking the medicine as prescribed.
Make sure you do not run out of capsules.
When stopping treatment with Fluoxetina EG, the following effects may occur: dizziness;
tingling sensations such as small pinpricks or needle stabs; sleep disturbances (vivid dreams, nightmares,
insomnia); feeling restless or agitated; unusual tiredness or weakness; anxiety; nausea/vomiting (feeling unwell
or sick); tremor; headache.
Most patients have reported that all symptoms occurring after discontinuation of Fluoxetina EG were mild
and resolved on their own within a few weeks. If you experience any symptoms when stopping treatment,
consult your doctor.
When discontinuing Fluoxetina EG, your doctor may help you gradually reduce the dose over one or two
weeks to minimize the risk of withdrawal-related effects.
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 everybody will experience them.
Contact your doctor immediately if:
you develop a skin rash or an allergic reaction, such as itching, swelling of the lips/tongue, or wheezing/shortness of breath. Stop taking the capsules immediately;
you feel restless and are unable to sit or stand still: you may have a condition called akathisia. Increasing the dose of Fluoxetina EG may worsen these sensations;
your skin starts to become red or you develop a different skin reaction, or your skin begins to blister or peel. This is very rare.

Fluoxetina EG may cause the following side effects:

Very common side effects (may affect more than 1 in 10 people):
difficulty sleeping (insomnia);
headache;
loose stools (diarrhoea), feeling unwell (nausea);
mental or physical tiredness (fatigue).

Common side effects (may affect up to 1 in 10 people):
loss of appetite;
weight loss;
anxiety, nervousness;
feeling tense;
restlessness;
sleep disturbances (sleep disorders), for example, abnormal dreams;
feeling tired (drowsiness);
poor concentration (attention disorders), dizziness, lethargy;
altered taste (dysgeusia);
tremor (trembling);
blurred vision;
awareness of heartbeat (palpitations);
sudden flushing of the face (hot flushes);
yawning;
feeling unwell (vomiting), indigestion (dyspepsia);
dry mouth;
rash, hives, itching;
excessive sweating (hyperhidrosis);
joint pain (arthralgia);
frequent urination;
unexplained vaginal bleeding (gynaecological haemorrhage);
sexual problems, including difficulty maintaining an erection for sexual activity (erectile dysfunction), premature or delayed ejaculation (ejaculation disorders), reduced sexual desire (decreased libido);
feeling of chills.

Uncommon side effects (may affect up to 1 in 100 people):
feeling detached from oneself (depersonalisation);
strange thoughts (abnormal thinking);
abnormally elevated mood (elevated mood, euphoria);
orgasm problems;
teeth grinding (bruxism);
thoughts of self-harm or suicide (suicidal ideation) and suicidal behaviour;
distressing restlessness with a constant urge to move (psychomotor agitation);
muscle spasms (myoclonus), involuntary movements (dyskinesia), or problems with balance (balance disorders) or coordination (ataxia);
dilation of the pupils (mydriasis);
difficulty remembering things (memory impairment);
ringing in the ears (tinnitus);
low blood pressure (hypotension);
shortness of breath (dyspnoea);
nosebleeds (epistaxis);
difficulty swallowing (dysphagia);
intestinal bleeding (gastrointestinal haemorrhage);
hair loss (alopecia);
increased tendency to bruise;
cold sweats;
difficulty urinating (dysuria);
sexual performance problems (sexual dysfunction);
general discomfort (malaise), feeling unwell, feeling cold, feeling hot.

Rare side effects (may affect up to 1 in 1,000 people):
reduced platelet count in the blood, increasing the risk of bleeding or bruising (thrombocytopenia);
low number of certain white blood cells (neutropenia);
decreased number of white blood cells (leucopenia);
allergic reaction (anaphylactoid);
rash with or without itching, together with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms (serum sickness);
low blood sodium levels (hyponatraemia), including serum sodium levels below 110 mmol/l. This may, in some cases, be due to the so-called syndrome of inappropriate antidiuretic hormone secretion. This is more likely to occur if you are elderly or taking diuretic tablets. Symptoms usually improve when treatment is stopped;
extremely elevated mood, energy, and unusual thought patterns (mania), persistently euphoric or irritable mood (hypomania);
seeing or hearing things that are not there (hallucinations);
agitation;
panic attacks;
confusion;
stuttering (dysphemia);
aggression;
seizures;
inability to stay still (akathisia, see section 2. "Warnings and precautions");
uncontrolled movements of the mouth, tongue, and limbs (buccoglossal syndrome);
serotonin syndrome, a reaction caused by excess serotonin, a chemical in the body (for symptoms, see section 2. "Warnings and precautions");
potentially fatal irregular heartbeat (ventricular arrhythmia including torsade de pointes), abnormalities in the heart's ECG trace (prolonged QT interval on electrocardiogram);
inflammation of blood vessels (vasculitis);
widening of blood vessels (vasodilation);
sore throat (pharyngitis);
lung disorders, including lung inflammation and fibrosis (formation of scar tissue in the lungs). Shortness of breath may occur before these signs of illness;
pain in the throat (oesophageal pain);
rapid swelling of tissues around the neck, face, mouth, and/or throat (angioedema);
bleeding under the skin (ecchymosis);
sensitivity to light (photosensitivity);
small purple or red spots on the skin (purpura);
severe, life-threatening skin reactions, including rash, skin redness, blisters on lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), which may progress to Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome);
muscle pain (myalgia);
inability to urinate (urinary retention), urinary disorders;
persistent painful erection (priapism);
high levels of a hormone called prolactin (hyperprolactinaemia), excessive production of breast milk (galactorrhoea);
bleeding from mucous membranes (mucosal haemorrhage);
yellowing of the skin and whites of the eyes, signs of impaired liver function/hepatitis;
abnormal liver function tests (increased transaminases, increased gamma-glutamyltransferase).

The frequency of the following side effects is unknown (frequency cannot be estimated from the available data):
reduced sensitivity to touch or sensation (hypoesthesia);
hoarseness (dysphonia);
burning or numbness sensation in the mouth (glossodynia);
burning pain and red skin (erythromelalgia);
difficulty concentrating;
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 "Pregnancy, breastfeeding and fertility" for further information.

Other possible side effects:
An increased risk of bone fractures has been observed in patients taking this type of medicine.

Withdrawal symptoms
These occur particularly if treatment with fluoxetine is stopped abruptly. Symptoms include:
tingling (paraesthesia), tremor, headache;
sleep disturbances (including insomnia and vivid dreams), asthenia, agitation, anxiety;
dizziness, feeling unwell and/or malaise
(see also section 3. "If you stop taking Fluoxetina EG").

Use in children and adolescents under 18 years of age
In clinical studies conducted in a paediatric population, the following additional side effects were reported:
suicidal ideation and behaviour, and hostility;
manic reactions, including euphoric mood, increased energy, and unusual patterns of thinking (mania), and persistently euphoric or irritable mood (hypomania);
growth delay (poor increase in height and weight);
delayed sexual maturation or sexual dysfunction;
reduced levels of alkaline phosphatase.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not store Fluoxetina EG at temperatures above 30°C.
Store the capsules in their original blister packs and in the outer carton to protect them from light and moisture.
Do not dispose of medicines 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 EG contains
The active substance is fluoxetine (as hydrochloride).
Each 20 mg fluoxetine capsule contains 20 mg of fluoxetine.
The other components inside the capsule are:
monohydrate lactose;
microcrystalline cellulose;
magnesium stearate;
anhydrous colloidal silica.
The capsule shell is composed of:
gelatin;
titanium dioxide (E171);
yellow iron oxide (E172).

Description of the appearance of Fluoxetina EG and pack contents
Fluoxetina EG 20 mg hard capsules are opaque ivory-colored capsules.
Fluoxetina EG 20 mg hard capsules are available in blisters made of plastic and aluminum foil.
Pack sizes are available in blisters containing 12, 14, 20, 28, 30, 48, 50, 98, and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milano, Italy

Manufacturer
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
DOPPEL Farmaceutici S.r.l., Via Volturno 48 – Quinto De’ Stampi, 20089 Rozzano (Milan), Italy
STADA M&D SRL, Str. Trascăului, nr 10, RO-401135, Turda (Romania)

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria: Fluoxetina STADA 20 mg Kapseln
Germany: Fluoxetin STADA 20 mg Hartkapseln
Italy: Fluoxetina EG 20 mg capsule rigide

The following information is intended exclusively for healthcare professionals

Management of overdose
Treatment should include general symptomatic and supportive measures, along with monitoring of cardiac symptoms and vital signs. No specific antidotes are known.
Forced diuresis, dialysis, hemoperfusion, and blood transfusion are unlikely to be beneficial.
Activated charcoal, which may be used with sorbitol, may be as effective or more effective than emesis or gastric lavage.
When managing an overdose, consider the possibility of multiple drug ingestion.
In some patients who have taken excessive amounts of tricyclic antidepressants, a longer period of careful medical observation may be required if they are currently taking or have recently taken fluoxetine.

Fluoxetine EG