Fluoxetine Eg Stada

Italy
Brand name Fluoxetine Eg Stada
Form tablets, orodispersible
Active substance / Dosage
FLUOXETINE HYDROCHLORIDE
Prescription type Prescription only
ATC code
N06AB03
Registration number 034667
Manufacturer EG S.P.A.
Fluoxetine Eg Stada tablets, orodispersible

Table of Contents

Patient Information Leaflet

FLUOXETINE EG STADA 20 mg orodispersible tablets

Generic medicine
Please read all of this leaflet carefully before you take 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, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What FLUOXETINA EG STADA is and what it is used for

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

  • Major depressive episodes.
  • Obsessive-compulsive disorder.
  • Bulimia nervosa: FLUOXETINA EG STADA is used in combination with psychotherapy to reduce binge eating and purging behaviors.

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 EG STADA should be prescribed to a child or young person with moderate to severe major depressive disorder only in combination with psychotherapy.

How FLUOXETINA EG STADA works
In every individual, the brain contains a substance called serotonin. People who are depressed, or who have obsessive-compulsive disorder or bulimia nervosa, have lower levels of serotonin compared to others.
The exact way in which FLUOXETINA EG STADA and other SSRIs work is not fully understood, but they may help by increasing the level of serotonin in the brain. Treating these medical conditions is important to help you feel better. If left untreated, your condition may persist and may become worse and more difficult to treat.
To ensure that symptoms do not return, treatment may need to continue for several weeks or months.

2. What you should know before taking FLUOXETINA EG STADA

Do not take FLUOXETINA EG STADA if

  • you are allergic to fluoxetine 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, or shortness of breath), stop taking the tablets immediately and contact your doctor immediately.
  • you are taking other medicines known as irreversible and non-selective monoamine oxidase inhibitors (MAOIs), as serious or even fatal reactions may occur (e.g. iproniazid used to treat depression). Treatment with FLUOXETINA EG STADA must not begin until at least 2 weeks after stopping treatment with an irreversible and non-selective MAOI. Do not take any irreversible and non-selective MAOI for at least 5 weeks after stopping FLUOXETINA EG STADA. If FLUOXETINA EG STADA has been prescribed for a long period of time and/or at high doses, your doctor should consider a longer interval.
  • you are taking metoprolol (for 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 FLUOXETINA EG STADA if any of the
following apply to you:

  • heart problems;
  • development of fever, muscle stiffness or tremor, or changes in mental state such as confusion, irritability, or extreme agitation; you may be experiencing so-called “serotonin syndrome” or “neuroleptic malignant syndrome”. Although this syndrome is rare, it may lead to conditions potentially life-threatening; contact your doctor immediately, as it may be necessary to stop taking FLUOXETINA EG STADA;
  • if you have or have previously had episodes of mania; if you experience an episode of mania, contact your doctor immediately, as it may be necessary to stop taking FLUOXETINA EG STADA;
  • tendency to bleed or bruise easily, or if you are pregnant [see section “Pregnancy, breastfeeding and fertility”];
  • currently undergoing treatment with medicines that improve blood fluidity (see “Other medicines and FLUOXETINA EG STADA”);
  • epilepsy or seizures. If you have a seizure (convulsions) or experience an increase in the frequency of seizures, contact your doctor immediately; it may be necessary to stop taking FLUOXETINA EG STADA;
  • undergoing electroconvulsive therapy (ECT);
  • currently undergoing treatment with tamoxifen (used to treat breast cancer) (see “Other medicines and FLUOXETINA EG STADA”);
  • you start feeling restless and unable to sit still or remain still (akathisia). Increasing the dose of FLUOXETINA EG STADA may worsen this condition;
  • diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment dosage);
  • liver problems (your doctor may need to adjust your dosage);
  • low resting heart rate and/or if you are aware that you may have a deficiency of salts due to severe and prolonged diarrhoea and vomiting (feeling unwell) or as a result of taking diuretics (water tablets);
  • currently taking diuretics (water tablets), especially if you are elderly;
  • glaucoma (increased pressure inside the eye);
  • you are taking medicines containing buprenorphine. Using these medicines together with FLUOXETINA EG STADA may lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and FLUOXETINA EG STADA").

Medicines such as FLUOXETINA EG STADA (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction
(see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
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 treatment with antidepressants, as these medicines require a period of time to become effective, usually about 2 weeks but sometimes longer.
You may be more likely to have these thoughts:

  • if you have previously had thoughts of suicide or self-harm.
  • if you are a young adult. Data from clinical trials 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 immediately to hospital. You may find it helpful to tell a relative or close 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 think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Children and adolescents aged between 8 and 18 years
When taking this type of medicine, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostile behaviour (especially aggressive, oppositional, and angry behaviour).
FLUOXETINA EG STADA should be used in children and adolescents aged between 8 and 18 years only for the treatment of moderate to severe major depressive episodes (in combination with psychotherapy) and should not be used to treat other conditions.
Furthermore, in this age group, there is only limited information available regarding the long-term safety of fluoxetine on growth, puberty, and mental, emotional, and behavioural development. Nevertheless, in patients under 18 years of age, your doctor may prescribe FLUOXETINA EG STADA 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 FLUOXETINA EG STADA for a patient under 18 years of age and you require clarification, consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with FLUOXETINA EG STADA in patients under 18 years of age.
FLUOXETINA EG STADA must not be used to treat children under 8 years of age.
Other medicines and FLUOXETINA EG STADA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take FLUOXETINA EG STADA 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 FLUOXETINA EG STADA, as serious or even fatal reactions (serotonin syndrome) may occur (see section “Do not take FLUOXETINA EG STADA”). Treatment with FLUOXETINA EG STADA must begin strictly at least 2 weeks after stopping an irreversible and non-selective MAOI (e.g. tranylcypromine). Do not take any irreversible and non-selective MAOI for at least 5 weeks after stopping FLUOXETINA EG STADA. If FLUOXETINA EG STADA 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 an increased risk that your heart rate may become too slow;
  • medicines containing buprenorphine. These medicines may interact with FLUOXETINA EG STADA and symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C may occur. Contact your doctor if you experience such symptoms. FLUOXETINA EG STADA may affect the mechanism of action of the following medicines (interaction):
  • tamoxifen (used to treat breast cancer); since FLUOXETINA EG STADA may alter blood levels of this medicine, potentially reducing the effectiveness of tamoxifen, your doctor may consider prescribing another antidepressant;
  • monoamine oxidase inhibitors Type A (MAOI-Type A) including moclobemide, linezolid (an antibiotic), and methylene blue chloride (also known as methylene blue, used for acute symptomatic treatment of drug- or chemical-induced methemoglobinemia, for local treatment of skin infections such as plaque psoriasis, acne vulgaris, and herpes labialis, and as a diagnostic agent for renal function to calculate glomerular filtration rate): due to the risk of serious or even fatal reactions (called serotonin syndrome). Treatment with fluoxetine may be started the day after stopping a reversible MAOI, but your doctor may decide to monitor you closely and use a lower dose of an MAOI-Type A;
  • mequitazine (used for allergic manifestations); because taking this medicine with FLUOXETINA EG STADA may increase the risk of changes in the heart's electrical activity;
  • phenytoin (for epilepsy); since FLUOXETINA EG STADA may affect blood levels of this medicine, your doctor may need to administer phenytoin more carefully and perform checks when given with FLUOXETINA EG STADA;
  • lithium, selegiline, St. John's wort, tramadol (a painkiller), triptans (for migraine), and tryptophan; when these medicines are taken with FLUOXETINA EG STADA, there is an increased risk of developing a mild serotonin syndrome. Your doctor will perform more frequent checks;
  • medicines that may alter heart rhythm, e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarial treatment, particularly halofantrine, or certain antihistamines (astemizole, mizolastine), because taking one or more of these medicines with FLUOXETINA EG STADA may increase the risk of changes in the heart's electrical activity;
  • anticoagulants (such as warfarin), NSAIDs (non-steroidal anti-inflammatory drugs - such as ibuprofen, diclofenac), aspirin, and other medicines that may improve blood fluidity (including clozapine, used to treat certain mental disorders). FLUOXETINA EG STADA may alter the effect of these medicines on blood. If treatment with FLUOXETINA EG STADA is started or stopped while taking warfarin, your doctor will need to perform tests, adjust the dosage, and monitor you more frequently;
  • cyproheptadine (used for allergic manifestations); because it may reduce the effect of FLUOXETINA EG STADA;
  • medicines that lower sodium levels in the blood (including medicines that increase urine output, desmopressin, carbamazepine, and oxcarbazepine); because these medicines may increase the risk of low sodium levels in the blood when taken together with FLUOXETINA EG STADA;
  • antidepressants such as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquine or chloroquine (used to treat malaria), tramadol (used to treat severe pain), or antipsychotics such as phenothiazines or butyrophenones; because FLUOXETINA EG STADA may increase the risk of seizures when taken in combination with these medicines;
  • flecainide, propafenone, nebivolol, or encainide (for heart disorders), carbamazepine (for epilepsy), atomoxetine, or tricyclic antidepressants (e.g. imipramine, desipramine, and amitriptyline) or risperidone (for schizophrenia); because FLUOXETINA EG STADA may in some way alter blood levels of these medicines, your doctor may need to reduce their dosage when administered with FLUOXETINA EG STADA.

FLUOXETINA EG STADA with food, drinks and alcohol
You may take FLUOXETINA EG STADA regardless of meals, as preferred.
You should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor as soon as possible if you are or might be pregnant, or if you are planning a pregnancy.
In newborns whose mothers took fluoxetine during the first months of pregnancy, some studies have reported an increased risk of congenital heart defects. In the general population, about 1 in 100 newborns is born with a heart defect. This figure increases to about 2 in 100 in mothers who took fluoxetine.
When taken during pregnancy, especially during the last 3 months, medicines such as FLUOXETINA EG STADA may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the newborn to have rapid breathing and a bluish skin colour. These symptoms usually appear within the first 24 hours after birth. If this occurs in the newborn, contact your midwife and/or doctor immediately.
It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the potential risk. Therefore, together with your doctor, you may decide to gradually discontinue FLUOXETINA EG STADA before or during pregnancy.
However, depending on the circumstances, your doctor may recommend that it is better for you to continue taking FLUOXETINA EG STADA.
Caution is advised when taking this medicine during pregnancy, especially during the late stages of pregnancy or shortly before delivery, as the following effects have been reported in newborns: irritability, tremor, muscle weakness, persistent crying, difficulty sucking or sleeping.
If you take FLUOXETINA EG STADA 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 STADA so they can advise you on what to do.
Breastfeeding
Fluoxetine is excreted in breast milk and may cause adverse effects in newborns. Breastfeeding should only be undertaken if clearly necessary. If breastfeeding is continued, your doctor may prescribe a lower dose of fluoxetine.
Fertility
In animal studies, fluoxetine has been shown to reduce sperm quality.
Theoretically, this could affect fertility, but the impact on human fertility has not yet been observed.
Driving and using machines
Medicines that act on mental function, such as FLUOXETINA EG STADA, may impair judgment or coordination. Do not drive or operate machinery until you are aware of how FLUOXETINA EG STADA affects you.
FLUOXETINA EG STADA contains sorbitol
This medicine contains 6.71 mg of sorbitol per tablet.
FLUOXETINA EG STADA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take FLUOXETINA EG STADA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Do not take more tablets than your doctor has prescribed.
Allow the tablet to dissolve in the mouth, or dissolve it in half a glass of water and swallow immediately and
completely. Do not chew the tablets.

Adults
The recommended dose is:

  • Depression: The recommended dose is 1 tablet (20 mg) daily. If necessary, your doctor will review and adjust the dosage within 3–4 weeks after starting treatment. If required, the dose may be gradually increased up to a maximum of 3 tablets (60 mg) daily. The dose should be increased cautiously to ensure you receive the lowest effective dose. You may not notice immediate improvement at the beginning of treatment for depression. This is normal, as symptom improvement in depression may only occur after the first few weeks of therapy. Patients with depression should be treated for at least 6 months.
  • Bulimia nervosa: The recommended dose is 3 tablets (60 mg) daily.
  • Obsessive-compulsive disorder: The recommended dose is 1 tablet (20 mg) daily. If necessary, your doctor will review and adjust the dosage after 2 weeks of treatment. If required, the dose may be gradually increased up to a maximum of 3 tablets (60 mg) daily. If no improvement is observed within the first 10 weeks, your doctor will reassess the treatment.

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 an oral fluoxetine solution).
After 1–2 weeks, your doctor may increase the dose 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 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
Your doctor will exercise greater caution when increasing the dose, and the daily dosage should generally not exceed 2 tablets (40 mg). The maximum dose is 3 tablets (60 mg) daily.

Hepatic impairment
If you have a liver disorder or are taking another medicine that may interact with FLUOXETINA EG STADA, your doctor may decide to prescribe a lower dose or provide instructions to take FLUOXETINA EG STADA on alternate days.

If you take more FLUOXETINA EG STADA than you should
If you take too many tablets, go immediately to the nearest hospital emergency department or contact your doctor right away. If possible, bring the FLUOXETINA EG STADA package with you.
Symptoms of overdose may include: nausea, vomiting, seizures, cardiac disturbances (such as irregular heartbeat and cardiac arrest), respiratory disturbances, and variable changes in mental status ranging from agitation to coma.

If you forget to take FLUOXETINA EG STADA
If you miss a dose, do not worry. Take the next dose at your 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 every day may help you remember to take it regularly.

If you stop taking FLUOXETINA EG STADA
Do not stop taking FLUOXETINA EG STADA without first consulting your doctor, even if you start to feel better. It is important that you take the medicine continuously.
Make sure you do not run out of tablets.
When stopping FLUOXETINA EG STADA, you may experience the following effects (withdrawal symptoms): dizziness; tingling sensations like pins and needles; sleep disturbances (vivid dreams, nightmares, difficulty falling asleep); feeling restless or agitated; unusual tiredness or weakness; feeling anxious; nausea/vomiting; tremor; headache.
Most people report that any symptoms occurring when stopping FLUOXETINA EG STADA are mild and disappear within a few weeks. If you notice any symptoms when stopping treatment, contact your doctor.
When you stop taking FLUOXETINA EG STADA, your doctor will help you gradually reduce the dose over one or two weeks—this should help reduce the likelihood of withdrawal effects.

If you have any questions about how to use 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 at any time you have thoughts of harming yourself or of suicide, contact your doctor or go to hospital immediately (see section 2).
  • If you develop a rash or an allergic reaction such as itching, swelling of the lips or tongue, difficulty breathing, or shortness of breath, stop taking the tablets immediately and inform 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 EG STADA could make you feel worse. If you experience these sensations, contact your doctor.
  • Contact your doctor immediately if your skin becomes red, if you develop a different skin reaction, or if your skin starts to blister or peel. This occurrence is very rare.

The most common side effects (very common side effects which may affect more than 1 in 10 people) 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 heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation, or drowsiness (rarely only);
  • feeling weak, drowsy, or confused, especially in elderly people and in people (elderly) taking diuretics (tablets for urination);
  • prolonged and painful erection;
  • irritability and extreme agitation;
  • heart problems, such as a fast or irregular heartbeat, fainting, collapse, or dizziness when standing, which may indicate abnormal heart rhythm;
  • heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage) (frequency not known); see section 2 “Pregnancy, breastfeeding and fertility” for further information.

If you experience any of the side effects listed above, inform your doctor immediately.
The following side effects have also been reported in patients taking FLUOXETINA EG STADA:
Common (may affect up to 1 in 10 people)

  • 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;
  • involuntary movements;
  • blurred vision;
  • sensation of fast or irregular heartbeat;
  • flushing;
  • yawning;
  • indigestion, vomiting;
  • dry mouth;
  • 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 people)

  • feeling detached from oneself;
  • strange thoughts;
  • abnormally elevated mood;
  • sexual problems, including orgasm problems, occasionally persisting after stopping treatment;
  • suicidal thoughts or thoughts of self-harm;
  • teeth grinding;
  • muscle contraction, involuntary movements, or problems with balance or coordination;
  • reduced memory;
  • dilated pupils;
  • ringing in the ears;
  • low blood pressure;
  • shortness of breath;
  • nosebleeds;
  • difficulty swallowing;
  • hair loss;
  • increased tendency to bruise;
  • appearance of unexplained bruises or bleeding;
  • cold sweating;
  • difficulty passing urine;
  • sensation of feeling hot or cold;
  • abnormalities in liver function tests.

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

  • low levels of sodium in the blood;
  • reduced platelet count in the blood, increasing the risk of bleeding or bruising;
  • reduced white blood cells in the blood;
  • 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 that carries food and water to the stomach;
  • hepatitis;
  • lung problems;
  • sensitivity to sunlight;
  • muscle pain;
  • problems with urination;
  • milk secretion from the breast.

Bone fractures – an increased risk of bone fractures has been observed in patients taking this type of medicine.
Most of these side effects are likely to disappear with continued treatment.
Children and adolescents (8–18 years) – In addition to the possible side effects listed above, FLUOXETINA EG STADA may slow growth and possibly delay sexual maturation.
Suicidal behaviour (suicide attempt and suicidal thoughts), hostile behaviour, mania, and nosebleeds have also 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. 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 FLUOXETINE EG STADA

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.
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 pack and other information

What FLUOXETINA EG STADA contains

  • The active substance is fluoxetine hydrochloride. Each tablet contains 20 mg of fluoxetine (as fluoxetine hydrochloride).
  • The other components are: microcrystalline cellulose, sodium saccharin, mannitol, sorbitol (E420), anise flavour, mint flavour, colloidal silicon dioxide, maize starch, sodium stearyl fumarate, povidone.

Description of the appearance of FLUOXETINA EG STADA and pack contents
Pack containing 12 or 28 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
SPECIAL PRODUCT’S LINE S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR), Italy