Fluoxetine Accord: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluoxetina Accord 20 mg hard capsules

Generic medicine
Please 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their
symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your
doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:

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

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

Fluoxetina Accord hard capsules contain fluoxetine, which is an antidepressant medicine belonging to the class of selective serotonin reuptake inhibitors (SSRIs).
This medicine is used to treat the following conditions:
Adults

Major depressive disorder episodes
Obsessive-compulsive disorder (a mental disorder mostly characterized by intrusive and repetitive thoughts leading to compulsive behaviors and mental acts that the person feels compelled to perform)
Bulimia nervosa (an eating disorder): Fluoxetina Accord 20 mg capsules are 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 Accord 20 mg capsules should be administered to children or adolescents with moderate to severe major depressive disorder only in combination with psychotherapy.

How Fluoxetina works
Each individual has a substance in the brain called serotonin. People who are depressed, or who have obsessive-compulsive disorder or bulimia nervosa, have lower levels of serotonin than others. The exact way in which fluoxetine and other SSRIs work is not fully understood, but they may help by increasing the level of serotonin in the brain.

Treating the above-mentioned medical conditions is important to help you feel better. If left untreated, your condition may persist and may become even more severe and more difficult to treat. To ensure that your symptoms do not return, treatment may need to continue for several weeks or months.

2. What you need to know before taking Fluoxetina Accord

Do not take Fluoxetina Accord if you:

are allergic to fluoxetine or any of the excipients of this medicine (listed in section 6). If you develop a rash or other allergic reactions (such as itching, swelling of the lips or face, or shortness of breath), stop taking the capsules and contact your doctor immediately.
are taking other medicines known as non-selective, irreversible monoamine oxidase inhibitors (MAOIs), as serious, even fatal, reactions may occur (e.g. iproniazid used to treat depression).

Treatment with Fluoxetina Accord capsules must only be started 2 weeks after
discontinuation of treatment with an irreversible, non-selective MAOI.
Do not take any irreversible, non-selective MAOI for at least 5 weeks after stopping
Fluoxetina Accord capsules. If Fluoxetina Accord capsules have been prescribed for a long
period of time and/or at high doses, your doctor should consider a longer interval.

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 Accord if you think any of the conditions listed below apply to you:

heart problems;
develop fever, muscle stiffness, or tremor, or changes in mental status such as confusion, irritability, or extreme agitation; you may be experiencing a condition known as “serotonin syndrome” or “neuroleptic malignant syndrome.” Although rare, this syndrome can lead to potentially life-threatening conditions; contact your doctor immediately, as it may be necessary to discontinue Fluoxetina Accord.
have or have had episodes of mania; if you experience a manic episode, contact your doctor immediately, as it may be necessary to discontinue Fluoxetina Accord;
history of bleeding disorders, bruising, or unusual bleeding;
are currently being treated with medicines that improve blood fluidity (see 'Other medicines and Fluoxetina Accord');
have epilepsy or seizures. If you have a seizure (convulsions) or experience an increase in seizure frequency, contact your doctor immediately; it may be necessary to discontinue Fluoxetina Accord;
are undergoing electroconvulsive therapy (ECT);
are currently taking tamoxifene (used to treat breast cancer) (see 'Other medicines and Fluoxetina Accord');
begin to feel restless and unable to sit still or remain still (akathisia). Increasing the dose of fluoxetine may worsen this condition;
have diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment);
have liver problems (your doctor may need to adjust your dose);
have a 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 due to the use of diuretics (water tablets);
are currently taking diuretics (water tablets), especially if you are elderly;
have glaucoma (increased pressure inside the eye);
If you have suicidal thoughts or worsening depression or anxiety disorder. If you suffer from depression and/or an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These thoughts may increase when starting antidepressant therapy for the first time, as all these medicines require time to take effect, usually about two weeks, but sometimes longer.

You are more likely to have these thoughts:

If you have previously had suicidal or self-harming thoughts.
If you are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with antidepressants. If you experience thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.

You may find it helpful to tell a family member or close friend that you are
depressed or suffering from 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 8 to 18 years
Patients under 18 years of age have a higher 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 Accord capsules 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 for other indications.
Furthermore, only limited data are available regarding the long-term safety of Fluoxetina
Accord capsules on growth, puberty, and mental, emotional, and behavioural development in
this age group. Nevertheless, your doctor may prescribe Fluoxetina Accord capsules 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 Fluoxetina Accord capsules to a patient under 18 years of age and you require
clarification, consult your doctor again. Inform your doctor if any of the symptoms listed
above appear or worsen in patients under 18 years of age taking Fluoxetina Accord capsules.
Fluoxetina Accord capsules must not be used to treat children under 8 years of age.

Other medicines and Fluoxetina Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Do not take Fluoxetina Accord with:

certain non-selective, irreversible monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Irreversible, non-selective MAOIs must not be used with Fluoxetina Accord, as serious or even fatal reactions (serotonin syndrome) may occur (see section “Do not take Fluoxetina Accord”). Treatment with Fluoxetina Accord must begin strictly at least 2 weeks after discontinuation of an irreversible, non-selective MAOI (e.g. tranylcypromine). Do not take any irreversible, non-selective MAOI for at least 5 weeks after stopping Fluoxetina Accord. If Fluoxetina Accord 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.

Fluoxetina Accord may affect the action of the following medicines (interaction):

Tamoxifene (used to treat breast cancer); since Fluoxetina Accord may alter blood levels of this medicine, potentially reducing tamoxifene’s effectiveness, your doctor may consider prescribing another antidepressant.
Monoamine oxidase inhibitors Type A (MAO-A inhibitors), including moclobemide, linezolid (an antibiotic), and methylene blue (used for acute symptomatic treatment of drug- or chemical-induced methaemoglobinaemia); due to the risk of serious or even fatal reactions (called serotonin syndrome). Fluoxetina Accord treatment may be started the day after discontinuation of a reversible MAOI, but your doctor may decide to monitor you closely and use a lower dose of the MAO-A inhibitor.
Mequitazine (used for allergic conditions); as taking this medicine with Fluoxetina Accord may increase the risk of changes in heart electrical activity.
Phenytoin (for epilepsy); since Fluoxetina Accord may affect blood levels of this medicine, your doctor may need to administer phenytoin more carefully and perform monitoring when given with Fluoxetina Accord.
Lithium, selegiline, St. John’s Wort (Hypericum perforatum), tramadol (a painkiller), triptans (for migraine), and tryptophan; when these medicines are taken with Fluoxetina Accord, there is an increased risk of 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, some antibacterial agents (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine), antimalarial treatments, particularly halofantrine, or certain antihistamines (astemizole, mizolastine), because taking one or more of these medicines with Fluoxetina Accord may increase the risk of changes in heart 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 Accord may alter the effect of these medicines on blood. If treatment with Fluoxetina Accord is started or stopped while you are taking warfarin, your doctor will need to perform tests, adjust your dose, and monitor you more frequently.
Cyproheptadine (used for allergic conditions); as it may reduce the effect of Fluoxetina Accord.
Medicines that lower blood sodium levels (including those causing increased urine output, desmopressin, carbamazepine, and oxcarbazepine); as these medicines may increase the risk of low blood sodium levels when taken with Fluoxetina Accord.
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; as Fluoxetina Accord may increase the risk of seizures when taken with these medicines.
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); as Fluoxetina Accord may alter blood levels of these medicines, your doctor may need to reduce their dosage when administered with Fluoxetina Accord.

Fluoxetina Accord with food, drinks, and alcohol

You may take Fluoxetina Accord regardless of meals, as preferred.
You should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor as soon as possible if you are pregnant, may be pregnant, or are planning a pregnancy.
Data are available indicating an increased risk of birth defects, particularly heart defects, in newborns whose mothers took fluoxetine during the first months of pregnancy. In the general population, about 1 in 100 babies are born with heart defects. This rate increases to about 2 in 100 babies in mothers who took fluoxetine. Together with your doctor, you may decide to gradually discontinue Fluoxetina Accord during pregnancy. However, depending on the circumstances, your doctor may recommend continuing or discontinuing Fluoxetina Accord.

When taken during pregnancy, particularly during the last three months, medicines like Fluoxetina 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 appear within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

Caution is advised when taking this medicine during pregnancy, especially during the late stages of pregnancy or just before delivery, as the following effects have been reported in newborns: irritability, tremor, muscle weakness, persistent crying, and difficulty sucking or sleeping.

Breastfeeding
Fluoxetine is excreted in breast milk and may cause adverse effects in infants. Breastfeeding should only be performed if clearly necessary. If you continue breastfeeding, your doctor may prescribe a lower dose of fluoxetine.

Fertility
Fluoxetine has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed.

Driving and using machines:
This medicine may affect your ability to judge or coordinate. Do not drive or operate tools or machinery until you know how Fluoxetina Accord affects you.

3. How to take Fluoxetina Accord

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Do not take more medicine than prescribed by your doctor.
Swallow the capsules whole with a glass of water. Do not chew the capsules.

Adults
The recommended dose is as follows:

Depression: The recommended dose is 1 capsule (20 mg) daily. If necessary, your doctor will review and adjust the dosage within 3–4 weeks after starting treatment. If appropriate, the dose may be gradually increased up to a maximum of 3 capsules (60 mg) daily. The dose should be increased cautiously to ensure you receive the lowest effective dose. It is normal not to experience immediate improvement at the beginning of treatment for depression. Improvement in depressive symptoms may only become evident 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 capsules (60 mg) daily.
Obsessive-compulsive disorder: The recommended dose is 1 capsule (20 mg) daily. If necessary, your doctor will review and adjust the dosage after 2 weeks of treatment. If appropriate, the dose may be gradually increased up to a maximum of 3 capsules (60 mg) daily. If no improvement is observed within the first 10 weeks, your doctor will reconsider your 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.
After one or two weeks, your doctor may increase the dose to 20 mg daily. The dose should be increased cautiously to ensure you receive the lowest effective dose. Children with low body weight may require lower doses. Your doctor must evaluate the need to continue treatment beyond 6 months. If no improvement is observed, treatment should be reassessed.

Elderly
Your doctor will exercise greater caution when increasing the dose, and the daily dose should generally not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) daily.

Hepatic impairment
If you have liver problems or are taking other medicines that may interact with Fluoxetina Accord capsules, your doctor may decide to prescribe a lower dose or advise you to take Fluoxetina Accord capsules every other day.

If you take more Fluoxetina Accord than you should

If you take too much, go immediately to the nearest hospital emergency department or contact your doctor without delay.
If possible, bring the Fluoxetina Accord bottle with you. Symptoms of overdose may include: nausea, vomiting, seizures, cardiac disturbances (such as irregular heartbeat and cardiac arrest), respiratory problems, and changes in mental state ranging from agitation to coma.

If you forget to take Fluoxetina Accord:

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 each day may help you remember to take it regularly.

If you stop taking Fluoxetina Accord 20 mg capsules

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

When you stop taking Fluoxetina Accord capsules, you may experience the following effects:
dizziness, tingling sensations like pins and needles, sleep disturbances (vivid dreams, nightmares, insomnia), feeling restless or agitated, unusual tiredness or weakness, feeling anxious, nausea and/or vomiting (feeling unwell), tremor (shakiness), headache.
Most people report that symptoms occurring upon discontinuation of Fluoxetina Accord capsules are mild and resolve spontaneously within a few weeks. If you notice any symptoms when stopping treatment, contact your doctor.
When you stop taking Fluoxetina Accord capsules, your doctor will help you gradually reduce the dose over a period of one or two weeks. This should help reduce the likelihood of withdrawal 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 gets them.

If you have thoughts of harming yourself or of suicide at any time, seek immediate medical help or go immediately to a hospital (see section 2).
If you develop a rash or an allergic reaction, such as itching, swelling of the lips/tongue, or difficulty breathing/shortness of breath, stop taking Fluoxetina Accord capsules immediately and contact your doctor immediately.
If you feel restless and unable to sit or stay still, you may be experiencing a condition called akathisia; increasing the dose of Fluoxetina Accord capsules could make you feel worse. If you experience these symptoms, contact your doctor.
Contact your doctor immediately if your skin becomes red, develops a mottled rash, or starts blistering or peeling. This is very rare.

The most common side effects (very common side effects that may affect more than 1 in 10 patients) are insomnia, headache, diarrhoea, feeling sick (nausea), and tiredness.
Some patients have experienced:

a combination 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 (only rarely);
weakness, drowsiness, or confusion, particularly in elderly patients and in patients (especially elderly) taking diuretics (water tablets);
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.

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

loss of appetite, weight loss
nervousness, anxiety
restlessness, poor concentration
feeling tense
reduced sex drive or sexual problems (including difficulty maintaining an erection for sexual activity)
sleep problems, unusual dreams, tiredness or drowsiness
dizziness
altered taste
uncontrollable shaking movements
blurred vision
sensations of rapid or irregular heartbeat
hot flushes
yawning
indigestion, vomiting
dry mouth
rash, hives, itching
excessive sweating
joint pain
more frequent urination
unexplained vaginal bleeding
sensation of trembling or chills

Uncommon (may affect up to 1 in 100 patients)

feeling detached from oneself
strange thoughts
excessively elevated mood
orgasm problems
thoughts of suicide or self-harm
teeth grinding
muscle contractions, involuntary movements, or problems with balance or coordination
reduced memory
enlarged (dilated) pupils
ringing in the ears
low blood pressure
shortness of breath
nosebleeds
difficulty swallowing
hair loss
increased tendency to bruise
unexplained bruising or bleeding
cold sweats
difficulty urinating
sensation of feeling hot or cold
changes in liver function tests

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

low levels of sodium in the blood
decreased platelet count in the blood, increasing the risk of bleeding or bruising
decreased 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 carrying food or water to the stomach
hepatitis
lung problems
sensitivity to sunlight
muscle pain
problems urinating

Bone fractures – An increased risk of bone fractures has been observed in patients taking this type of medicine.
Most of these side effects tend to disappear with continued treatment.
In children and adolescents (aged 8–18 years) – In addition to the possible side effects listed above, fluoxetine may slow growth and possibly delay sexual maturation. Suicidal behaviour (suicide attempts and suicidal thoughts), hostility, 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, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluoxetine Accord

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the packaging following "Exp.". The expiry date refers to the last day of that month.
Do not store the capsules above 30°C.
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 Accord 20 mg capsules contain
The active substance is fluoxetine hydrochloride. Each capsule contains 22.4 mg of fluoxetine hydrochloride, equivalent to 20 mg of fluoxetine.
The other components are: pregelatinized maize starch, purified talc, anhydrous colloidal silicon dioxide and magnesium stearate.
Capsule shell components: quinoline yellow (E104), erythrosine (E127), indigo carmine (E132), titanium dioxide (E171) and gelatin.
The printing ink contains: shellac (E904), black iron oxide (E172), propylene glycol and ammonium hydroxide.

Description of the appearance of Fluoxetina Accord hard capsules and pack sizes
Fluoxetina Accord capsules are hard capsules. Each capsule contains 20 mg of fluoxetine.
The capsules are opaque light green / opaque standard yellow, hard gelatin capsules, with the imprint “BJ” on the cap and “F20” on the body, containing a white to off-white powder.
Fluoxetina Accord 20 mg capsules are packaged in PVC/aluminum blisters. Blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 70, 90, 98 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

This medicinal product is authorised in the European Economic Area Member States under the following names:

| Member State | Medicinal Product Name | |------------------|----------------------------| | Italy | Fluoxetina Accord 20 mg hard capsules | | Portugal | Fluoxetina Accord | | Spain | Fluoxetina Apotex 20 mg hard capsules EFG | | Sweden | Fluoxetine Accord 20 mg Capsule, hard |