Package leaflet: Information for the patient

FLUOXETINA FIDIA 20 mg hard capsules, mg soluble tablets, mg/5 ml oral solution

Fluoxetine hydrochloride
Equivalent medicine
Please read all of 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 they have the same symptoms as yours, because 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.

Contents of this leaflet:

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

1. What FLUOXETINA FIDIA is and what it is used for

FLUOXETINA FIDIA contains the active substance fluoxetine hydrochloride, which belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs).
This medicine is used to treat the following conditions:
Adults:

major depressive episodes;
obsessive-compulsive disorder, a behavioural disorder characterised by obsessive and repetitive thoughts;
bulimia nervosa, an eating disorder. In this case, it is indicated in combination with psychotherapy to reduce binge eating and purging behaviour.

Children and adolescents aged 8 years and older:

moderate to severe major depressive disorder, when depression does not respond to psychotherapy after 4–6 sessions. FLUOXETINA FIDIA should be prescribed to a child or young person with moderate to severe major depressive disorder only in combination with psychotherapy.

2. What you need to know before taking FLUOXETINE FIDIA

Do not take FLUOXETINE FIDIA

if you are allergic to fluoxetine hydrochloride or to any of the other 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, and shortness of breath ), stop taking the medicine immediately and contact your doctor immediately;
if you are taking other medicines used to treat depression, known as irreversible and non-selective monoamine oxidase inhibitors (MAOIs), as serious and sometimes fatal reactions may occur (e.g. iproniazid used to treat depression).

Treatment with fluoxetine must be started at least 2 weeks after stopping treatment
with an irreversible and non-selective MAOI.
Do not start therapy with an MAOI for at least 5 weeks after discontinuing treatment with
FLUOXETINE FIDIA.

if you are taking metoprolol (for the treatment of heart failure), as there is an increased risk that your heart rate may become too slow.

Warnings and precautions
Talk to your doctor or pharmacist before taking FLUOXETINE FIDIA if you are in any of the following
situations:

if you experience a skin reaction or other manifestations of an allergic nature. In this case, stop taking the medicine immediately and contact your doctor immediately;
if you suffer or have suffered from seizures. If you have a seizure or notice an increase in the frequency of seizures, contact your doctor immediately; it may be necessary to discontinue this medicine;
if you suffer or have previously suffered from mood and behavioural disorders (mania/hypomania). If you experience an episode of mania, contact your doctor immediately, as it may be necessary to discontinue this medicine;
if you have liver or kidney problems, your doctor may decide to adjust the dosage;
if you have heart problems;
if you have diabetes, your doctor may decide to adjust your insulin dose or other antidiabetic treatment;
if you develop an urge to keep moving constantly (akathisia), which may occur during the first weeks of treatment. A dosage adjustment may be indicated;
if you notice the appearance of bleeding skin lesions, bruising (ecchymoses), or pinpoint red spots (purpura), or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”);
if you are taking other medicines that improve blood fluidity (see section “Other medicines and FLUOXETINE FIDIA”);
if you are undergoing or are already receiving electroconvulsive therapy (ECT);
if you are being treated with tamoxifen (used to treat breast cancer) (see section “Other medicines and FLUOXETINE FIDIA”);
if you have a low resting heart rate and/or if you are aware that you may have a salt deficiency as a result of severe and prolonged diarrhoea and vomiting (feeling unwell) or due to the use of diuretics (water tablets);
if you are currently being treated with diuretics (water tablets), especially if you are elderly;
if you have glaucoma (increased pressure inside the eye);
if you are being treated with buprenorphine (with or without naloxone). Using these medicines together with Fluoxetina Fidia may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and Fluoxetina Fidia”).

Stop taking this medicine immediately and inform your doctor if you experience fever,
muscle stiffness or tremor, changes in your mental state such as confusion, irritability and extreme
agitation. These may be symptoms of a condition called serotonin syndrome or neuroleptic malignant
syndrome, which, although rare, can lead to potentially life-threatening conditions.
Medicines such as FLUOXETINE FIDIA (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) can cause symptoms of sexual dysfunction (see
section 4). In some cases, these symptoms have been observed to persist after discontinuation of treatment.
Suicidal thoughts and worsening of your depression or anxiety disorder
During the first few weeks or immediately after starting treatment, especially
if you suffer from other mental health problems (psychiatric disorders), you may have self-harming thoughts and think about harming yourself or committing suicide. For this reason, your doctor should monitor you closely, particularly at the beginning of treatment or when the dose is increased, if you have previously experienced these disorders, or if you are young (under 25 years of age). Inform your doctor immediately if you experience these symptoms or if someone caring for you notices changes in your behaviour.
It may be helpful to inform a relative or close friend that you suffer from depression or 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 worsening or if they are concerned about any 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 thoughts and hostility
(especially aggressive, oppositional and angry behaviour). FLUOXETINE FIDIA 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. In addition, only limited information is available regarding the long-term safety of FLUOXETINE FIDIA in this age group with respect to growth, puberty, and mental, emotional and behavioural development. Nevertheless, and in patients under 18 years of age, your doctor may prescribe FLUOXETINE FIDIA for the treatment of moderate to severe major depressive episodes in combination with psychotherapy if they consider this to be the best option for you. If your doctor has prescribed FLUOXETINE FIDIA to a patient under 18 years of age and you wish to clarify, consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with FLUOXETINE FIDIA in patients under 18 years of age.
Fluoxetina Fidia must not be used to treat children under 8 years of age.
Other medicines and FLUOXETINE FIDIA
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
This medicine may affect the action of other medicines.
Do not take FLUOXETINE FIDIA with:

certain irreversible and non-selective monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Irreversible and non-selective MAOIs must not be used with FLUOXETINE FIDIA as serious or even fatal reactions (serotonin syndrome) may occur (see section “Do not take FLUOXETINE FIDIA”). Treatment with FLUOXETINE FIDIA must be started strictly at least 2 weeks after discontinuation of an irreversible and non-selective MAOI (such as tranylcypromine). Do not take any irreversible and non-selective MAOI for at least 5 weeks after stopping FLUOXETINE FIDIA. If FLUOXETINE FIDIA 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, as there is an increased risk that your heart rate may become too slow;

Take this medicine with caution and inform your doctor if you are taking:

other medicines used to treat depression, such as monoamine oxidase inhibitors (MAOIs). Type A MAOIs (such as moclobemide, linezolid and methylene blue chloride) must not be used in combination with this medicine (see section "Do not take FLUOXETINE FIDIA"). Type B MAOIs (such as selegiline) may be used with FLUOXETINE FIDIA provided your doctor closely monitors you, as serious and sometimes fatal reactions (serotonin syndrome) may occur (see section “Warnings and precautions”);
buprenorphine (with or without naloxone). These medicines may interact with Fluoxetina Fidia and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, fever above 38°C. Contact your doctor if these symptoms occur.
tamoxifen (used to treat breast cancer); since FLUOXETINE FIDIA may alter blood levels of this medicine, potentially reducing the effectiveness of tamoxifen, your doctor may consider prescribing another antidepressant;
mequitazine (used for allergic manifestations); as taking this medicine with FLUOXETINE FIDIA may increase the risk of changes in the heart's electrical activity;
medicines used to treat epilepsy such as phenytoin;
medicines used to treat mental disorders such as clozapine, lithium and tryptophan;
tramadol, a medicine used to treat pain;
medicines used for chronic headaches (triptans);
medicines containing lithium, selegiline, St. John's wort (Hypericum perforatum) used to treat mental disorders;
medicines used for heart problems such as flecainide and encainide;
anticoagulants (e.g. warfarin), NSAIDs such as ibuprofen and diclofenac, aspirin or other medicines used to thin the blood;
electroconvulsive therapy (ECT);
medicines that may alter heart rhythm, e.g. class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, butyrophenones such as haloperidol), tricyclic antidepressants such as bupropion, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine), mefloquine and chloroquine for malaria treatment, and particularly halofantrine or certain antihistamines (astemizole, mizolastine);
cyproheptadine (used for allergic manifestations);
medicines that lower sodium levels in the blood (including medicines that increase urine output, desmopressin, carbamazepine and oxcarbazepine);
flecainide, propafenone, nebivolol or encainide (for heart conditions), carbamazepine (for epilepsy), atomoxetine or tricyclic antidepressants (e.g. imipramine, desipramine and amitriptyline) or risperidone (for schizophrenia);

FLUOXETINE FIDIA with food, drinks and alcohol
Do not drink alcohol during treatment with this medicine. You may take FLUOXETINE FIDIA
regardless of meals.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary, as it may
cause serious problems in your baby.
When taken during pregnancy, particularly during the last three months, medicines such as
FLUOXETINE FIDIA 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. If this occurs in your baby, you must contact your midwife and/or doctor immediately.
If you have taken this medicine during the late stages of pregnancy, your baby may show
irritability, tremor, altered muscle tone (hypotonia), persistent crying, difficulty sleeping or feeding.
If you take Fluoxetina Fidia near the end of pregnancy, there may be an increased risk of
heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders
(easy bleeding). Inform your doctor or midwife that you are taking Fluoxetina Fidia so they can advise you on what to do.
FLUOXETINE FIDIA is excreted in breast milk and this may cause problems for the baby.
If treatment with FLUOXETINE FIDIA is considered necessary, discontinuation of breastfeeding should be considered; however, if breastfeeding is continued, the lowest effective dose of fluoxetine should be prescribed.
This medicine may affect sperm quality. This effect disappears upon discontinuation of
treatment (see section “Possible side effects”).
Driving and use of machinery
This medicine may impair your ability to drive or operate machinery because it may reduce your
judgment and reactivity in dangerous situations. Therefore, be cautious before driving or operating machinery.
FLUOXETINE FIDIA 20 mg dispersible tablets contain 6.7 mg of sorbitol.
FLUOXETINE FIDIA 20 mg/5 ml oral solution contains 3.15 g of sorbitol.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, talk to your doctor before you (or your child) take this medicine.
FLUOXETINE FIDIA 20 mg/5 ml oral solution
This medicine contains 2.5 mg of benzoic acid per dose.
Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age (see Pregnancy, breastfeeding and fertility).
FLUOXETINE FIDIA 20 mg dispersible tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take FLUOXETINA FIDIA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
FLUOXETINA FIDIA may be administered as a single dose or in divided doses, with or without food.
Your doctor will adjust the dose according to your individual needs. Do not change the dose without first consulting your doctor
(see section “If you stop taking FLUOXETINA FIDIA”).

Treatment of major depressive episodes
The recommended dose for adults and elderly patients is 20 mg daily.
If necessary, your doctor will review and adjust the dosage within 3 weeks after starting treatment. The dose
may be increased up to a maximum of 60 mg daily. Dose adjustments should be made carefully to ensure that you receive the lowest effective dose.
You may not feel better immediately at the beginning of treatment for depression. This is usually because improvement in depressive symptoms may not occur until after the first few weeks.
Patients with depression should be treated for at least 6 months.

Treatment of obsessive-compulsive disorder
The recommended dose for adults and elderly patients is 20 mg daily.
If no improvement is observed after 2 weeks, your doctor may reassess the dosage as necessary. The dose may be gradually increased up to a maximum of 60 mg daily. Dose adjustments should be made carefully to ensure that you receive the lowest effective dose.
If no improvement is observed within 10 weeks, your doctor will reconsider your treatment.

Treatment of bulimia nervosa
The recommended dose for adults and elderly patients is 60 mg daily.

Use in children and adolescents aged 8 to 18 years with depression:
Treatment must be initiated and supervised by a specialist. The initial dose is 10 mg daily
(administered as 2.5 ml of FLUOXETINA FIDIA oral solution). After 1–2 weeks, your doctor may
increase the dose to 20 mg daily. The dose should be increased cautiously to ensure that the lowest effective dose is administered. Children with low body weight may require lower doses. If a satisfactory response to treatment is achieved, your doctor will reassess the need to continue treatment beyond 6 months. If no improvement occurs within the first 9 weeks, your doctor will reconsider the treatment.

Elderly patients:
Your doctor will exercise greater caution when increasing the dose, and the daily dose should generally not exceed 40 mg. The maximum dose is 60 mg daily.

Hepatic impairment:
If you have liver disease or are taking another medicine that could interact with FLUOXETINA FIDIA, your doctor may decide to prescribe a lower dose or advise you to take FLUOXETINA FIDIA on alternate days.

Instructions for using FLUOXETINA FIDIA:
Hard capsules: swallow the capsule whole without chewing.
Soluble tablets: swallow the tablet whole without chewing, or dissolve the tablet in water and dilute to taste.
Oral solution: draw up the prescribed dose using the oral dosing syringe provided in the package.

If you take more FLUOXETINA FIDIA than you should
In case of accidental overdose or ingestion of an excessive amount of FLUOXETINA FIDIA, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose include nausea, vomiting, seizures, heart problems (cardiovascular dysfunction ranging from asymptomatic arrhythmia to cardiac arrest), respiratory problems (pulmonary dysfunction), and mental disturbances ranging from agitation to coma. Death has occurred very rarely.

If you forget to take FLUOXETINA FIDIA
Do not take a double dose to make up for the missed tablet.

If you stop taking FLUOXETINA FIDIA
Do not stop treatment with FLUOXETINA FIDIA suddenly or without first discussing it with your doctor.
When stopping treatment with this medicine, the following withdrawal symptoms may occur: dizziness, sensory disturbances such as tingling in the arms and legs (paraesthesiae) and electric shock sensations, sleep disturbances such as inability to fall asleep (insomnia) and vivid dreams, agitation or anxiety, nausea and vomiting, headache, tremor, confusion, sweating, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances.
These symptoms usually appear within the first few days after stopping treatment and generally resolve within 2 weeks, although in some individuals they may persist longer (2–3 months or more).
Abrupt discontinuation should be avoided. When you stop taking FLUOXETINA FIDIA, your doctor will help you gradually reduce the dose over 1 or 2 weeks, which should help reduce the likelihood of withdrawal symptoms.
If you experience any of these symptoms when stopping treatment, contact your doctor.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions occur mainly at the beginning of treatment and usually disappear later.
If during treatment you think about harming yourself or have suicidal thoughts, contact your doctor immediately and stop taking the medicine.

If you develop a skin rash or an allergic reaction such as itching, swelling of the lips or tongue, difficulty breathing, or shortness of breath, stop taking the medicine immediately and contact your doctor immediately.
If you feel restless and unable to sit still or remain motionless, you may be experiencing a condition called akathisia; increasing the dose of FLUOXETINA FIDIA might worsen this feeling. If you experience these symptoms, contact your doctor.
Contact your doctor immediately if your skin becomes red, if you develop another skin reaction, or if your skin starts to blister or peel. This occurrence is very rare.

The most common adverse reactions (very common side effects affecting more than 1 in 10 patients) are insomnia, headache, diarrhoea, nausea, and fatigue.
Some patients have experienced:

a group of symptoms (known as "serotonin syndrome") including unexplained fever with rapid breathing and increased heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation, or drowsiness (rarely only);
feelings of weakness, drowsiness, or confusion, especially in elderly patients and in patients (particularly elderly) taking diuretics (water tablets);
prolonged and painful erection;
irritability and extreme agitation;
heart problems such as increased or irregular heart rate, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.

If you experience any of the adverse reactions listed above, inform your doctor immediately.
Other adverse reactions that may occur include:
Common (may affect up to 1 in 10 patients)

loss of appetite, weight loss
nervousness, anxiety
restlessness, poor concentration
feeling tense
reduced sexual desire and sexual problems (including difficulty maintaining an erection during sexual activity)
sleep problems, unusual dreams, tiredness or drowsiness
dizziness
altered taste
uncontrolled movements
blurred vision
sensation of rapid or irregular heartbeat
flushing
yawning
indigestion, vomiting
dry mouth
skin rash, hives, itching
excessive sweating
joint pain
increased frequency of urination
unexplained vaginal bleeding
feeling unable to stand or chills

Uncommon (may affect up to 1 in 100 patients)

feeling detached from oneself
strange thoughts
excessively elevated mood
orgasm problems
suicidal thoughts or thoughts of self-harm
teeth grinding
muscle contraction, involuntary movements, or problems with balance or coordination
memory impairment
dilated pupils
ringing in the ears
low blood pressure
shortness of breath
nosebleeds
difficulty swallowing
hair loss
increased tendency to bruise
appearance of bruises or unexplained bleeding
cold sweating
difficulty passing urine
sensation of feeling hot or cold
abnormal liver function tests

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

suicidal ideation/behaviour
restlessness and need to keep moving (akathisia)
low sodium levels in the blood
reduced platelet count in the blood, increasing the risk of bleeding or bruising
reduced white blood cell count
unusual, uncontrolled behaviour
hallucinations
agitation
panic attacks
confusion
stuttering
aggression
seizures
vasculitis (inflammation of a blood vessel)
rapid swelling of tissues around the neck, face, mouth, and/or throat
pain in the tube allowing food and water to pass into the stomach (oesophagus)
hepatitis
lung problems
sensitivity to sunlight
muscle pain
problems with urination
milk secretion from the breasts

Not known (frequency cannot be estimated from available data)

Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, "Pregnancy, breastfeeding and fertility", for further information

Bone fractures – An increased risk of bone fractures has been observed in patients taking this type of medicine.
Most of these adverse reactions are likely to disappear with continued treatment.
Children and adolescents (8–18 years): In addition to the possible adverse reactions listed above, FLUOXETINA FIDIA may slow growth and possibly delay sexual maturation. Suicidal-related behaviours (suicide attempt and suicidal thoughts), hostility, mania, and nosebleeds have also been commonly reported in children.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store FLUOXETINE FIDIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “EXP”.
The expiry date refers to the last day of that month.
Hard capsules: Store below 30 °C.
Oral solution: The product must be used within 15 days after first opening the bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What FLUOXETINA FIDIA Contains
FLUOXETINA FIDIA 20 mg hard capsules

The active substance is fluoxetine hydrochloride. Each capsule contains 22.36 mg of fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.
The other components are: pregelatinized starch, colloidal silicon dioxide, magnesium stearate.
Capsule shell constituents: quinoline yellow (E104), erythrosine (E127), titanium dioxide (E171), gelatin.

FLUOXETINA FIDIA 20 mg dispersible tablets

The active substance is fluoxetine hydrochloride. Each tablet contains 22.36 mg of fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.
The other components are: microcrystalline cellulose, sodium saccharin, mannitol, sorbitol, anise flavour, peppermint flavour, colloidal silicon dioxide, modified starch 1500, sodium stearyl fumarate, polyvinylpyrrolidone.

FLUOXETINA FIDIA 20 mg/5 ml oral solution

The active substance is fluoxetine hydrochloride. 5 ml of oral solution contain 22.36 mg of fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.
The other components are: benzoic acid, sorbitol 70% solution, glycerin, mint flavour, purified water.

Description of the Appearance of FLUOXETINA FIDIA and Contents of the Pack
Hard capsules – Box containing 12 or 28 hard capsules of 20 mg.
Dispersible tablets – Box containing 28 dispersible tablets of 20 mg.
Oral solution – 60 ml bottle. The bottle has a child-resistant closure to protect against tampering by children.

Marketing Authorization Holder
FIDIA Farmaceutici S.p.A. — Via Ponte della Fabbrica, 3/A — 35031 Abano Terme (PD).

Manufacturers
FLUOXETINA FIDIA 20 mg hard capsules and 20 mg dispersible tablets
Fidia Farmaceutici S.p.A. - Via Ponte della Fabbrica, 3/A - Abano Terme (PD).
FLUOXETINA FIDIA 20 mg dispersible tablets and 20 mg/5 ml oral solution
Consorzio Farmaceutico e Biotecnologico Bioprogress s.r.l. - Strada Paduni 240 - 03012 Anagni (FR).

Fluoxetine Fidia