FLUOXETINA 20 mg Hard Capsule

Зміст інструкції

1. Fluoxetina Accord 20 mg hard capsules
   1. What Fluoxetina Accord is and what it is used for
   2. What you need to know before taking Fluoxetina Accord
2. Fluoxetina Accord is started or stopped while taking warfarin, the doctor will
   1. How to take Fluoxetina Accord
   2. Possible side effects
   3. How to store Fluoxetina Accord
   4. Package contents and other information

Fluoxetina Accord 20 mg hard capsules

Equivalent medicine
Read this leaflet carefully before taking this medicine as it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others,
even if they have the same symptoms as you, as it could be
harmful.
If you experience any side effects, including those not listed in
this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Fluoxetina Accord hard capsules contain fluoxetina, which is an antidepressant medicine
belonging to the class of selective serotonin reuptake inhibitors (SSRIs).
This medicine is used for the treatment of the conditions indicated below.

Adults

• Episodes of major depressive disorder
• Obsessive-compulsive disorder (a mental disorder mostly characterized by intrusive and repetitive thoughts, which result in compulsive behavior and mental acts that the person feels obliged to perform).
• Bulimia nervosa (eating disorder): Fluoxetina Accord 20 mg capsules are used together with psychotherapy to reduce binge eating and purging behavior.

Children and adolescents aged 8 years and over

• Moderate to severe major depressive disorder, if the depression does not respond to psychotherapy after 4-6 sessions.

Fluoxetina Accord 20 mg capsules must be administered to children or adolescents suffering
from moderate to severe major depressive disorder onlyin combination with
psychotherapy.
How Fluoxetina works
Every individual has, in their brain, a substance called serotonin. People who
are depressed, or have obsessive-compulsive disorder, or bulimia nervosa, have lower
levels of serotonin compared to other individuals. It is not fully understood how
fluoxetina and other SSRIs work, but they may provide help by increasing the level of
serotonin in the brain.
Treatment of the aforementioned pathological conditions is important to help you feel
better. If left untreated, your pathological condition may persist and may become even more
severe and more difficult to treat. To be sure you no longer have symptoms, 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 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 capsules and contact your doctor immediately.
• are taking other medicines known as non-selective irreversible monoamine oxidase inhibitors (MAOIs), as serious, or even fatal reactions may occur (e.g. iproniazid used to treat depression).

Treatment with Fluoxetina Accord capsules should only be started 2 weeks after
stopping treatment with a non-selective irreversible MAOI.

Do nottake any non-selective irreversible MAOI for at least 5 weeks after you have
stopped taking Fluoxetina Accord capsules. If Fluoxetina Accord capsules have been
prescribed to you for a long period of time and/or at high doses, your doctor
should consider a longer interval.

• are taking metoprolol (for the treatment of heart failure) as there is an increased risk that your heartbeat may become too slow. Warnings and precautionsConsult your doctor or pharmacist before taking Fluoxetina Accord if you think that any of the following conditions apply to you:
• heart problems;
• development of fever, muscle stiffness or tremor, changes in mental status such as confusion, irritability and extreme agitation; you may be affected by the so-called "serotonin syndrome" or "neuroleptic malignant syndrome". Although this syndrome is rare, it can lead to conditions potentially dangerous to the patient's life; contact your doctor immediately, as it may be necessary to stop taking Fluoxetina Accord.
• if you have had or currently have episodes of mania; if you have an episode of mania, contact your doctor immediately as it may be necessary to stop taking Fluoxetina Accord;
• history of bleeding disorders or bruising or unusual bleeding;
• current treatment with medicines that improve blood fluidity (see 'Other medicines and Fluoxetina Accord');
• suffer from 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 Accord;
• treatment with ECT (electroconvulsive therapy);
• current treatment with tamoxifen (used to treat breast cancer) (see 'Other medicines and Fluoxetina Accord');
• begin to feel restless and cannot sit still or remain calm (akathisia). Increasing the dose of fluoxetine may worsen the situation;
• diabetes (your doctor may need to adjust your insulin dosage or other antidiabetic treatment);
• 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 salt deficiency as a result of severe and prolonged diarrhoea and vomiting (feeling unwell) or following the use of diuretics (water tablets);
• current treatment with diuretics (water tablets), especially if you are elderly;
• glaucoma (increased pressure inside the eye);
• If you have suicidal thoughts or a worsening of your depression or anxiety disorder.If you have depression and/or anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These thoughts may be increased when you first start taking antidepressants, as all these medicines take time to work, usually about two weeks, but sometimes longer.

You are more likely to have these thoughts:

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

It may be helpful to tell a family member or close friendthat you are
may ask them to tell you if they think your depression or anxiety is getting worse or if
they are worried 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 (essentially aggression, oppositional behaviour and anger) following the intake of 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 association with psychotherapy) and should not be used in other indications.
In addition, limited information is available in this age group regarding the long-term safety of Fluoxetina Accord capsules on growth, puberty and mental, emotional and behavioural development. Despite this, the doctor
may prescribe Fluoxetina Accord capsules to patients under 18 years of age for the
treatment of moderate to severe major depressive episodes in
association with psychotherapy, if they believe this is the best solution. If the doctor
has prescribed Fluoxetina Accord capsules to a patient under 18 years of age and you wish to
clarify, return to the doctor. Inform the doctor if any of the
symptoms listed above appear or worsen in patients under 18 years of age who are taking
Fluoxetina Accord capsules.
Fluoxetina Accord capsules should not be used for the treatment of children under 8 years of age.

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

Do not take Fluoxetina Accord with:

• some non-selective irreversible monoamine oxidase inhibitors (MAOIs), some used to treat depression. Non-selective irreversible 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 be started strictly at least 2 weeks after stopping a non-selective irreversible MAOI (such as tranylcipromine). Do not takeany non-selective irreversible MAOI for at least 5 weeks after you have stopped taking 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 of more than 5 weeks. Metoprololwhen used for heart failure; there is an increased risk that your heartbeat may become too slow.

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

• tamoxifen(used to treat breast cancer); as Fluoxetina Accord can change the levels of this medicine in the blood, resulting in a possible decrease in the effect of tamoxifen, your doctor may need to consider prescribing another antidepressant treatment.
• Monoamine oxidase inhibitors Type A (MAOI-Type A)including moclobemide, linezolid (an antibiotic) and methylthioninium chloride (also called methylene blue and used for the symptomatic acute treatment of methemoglobinemia induced by drugs or chemicals: due to the risk of serious or even fatal reactions (called serotonin syndrome). Treatment with fluoxetine can be started the day after stopping treatment with a reversible MAOI but your doctor may decide to subject you to careful monitoring and use a lower dose of an MAOI-Type A.
• mequitazine(used for allergic reactions); as taking this medicine with Fluoxetina Accord may increase the risk of changes in the heart's electrical activity.
• phenytoin(for epilepsy); as Fluoxetina Accord can affect the levels of this medicine in the blood, when given with Fluoxetina Accord your doctor may need to administer phenytoin with greater care and perform checks.
• 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 developing mild serotonin syndrome. Your doctor will perform checks more frequently.
• medicines that can alter the heart rhythm, e.g. antiarrhythmics of
• Class IA and III, antipsychotics(e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants,someantibacterialagents(e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), treatment against malariaand in particular halofantrine or some antihistamines (astemizole, mizolastine), because taking one or more of these medicines with Fluoxetina Accord 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 medicinesthat can improve blood fluidity

of the blood(including clozapine, used to treat some mental disorders). Fluoxetina
Accord can alter the effect of these medicines on the blood. If treatment with

Fluoxetina Accord is started or stopped while taking warfarin, the doctor will

need to perform some tests, adjust the dosage and subject you to more frequent checks.

• ciproheptadine(used for allergic manifestations); as it may reduce the effect of Fluoxetina Accord.
• medicines that lower sodium levels in the blood(including medicines that cause increased urine output, desmopressin, carbamazepine and oxcarbazepine); as these medicines may increase the risk that sodium levels in the blood become too low when taken in association with Fluoxetina Accord.
• antidepressantssuch 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 in association with these medicines.
• flecainide, propafenone, nebivolol or encainide(for heart disorders), carbamazepine(for epilepsy), atomoxetineor tricyclic antidepressants(for example imipramine, desipramine and amitriptyline) or risperidone(for schizophrenia); as Fluoxetina Accord may in some way alter the levels of these medicines in the blood, the doctor may need to lower their dosage when administered with Fluoxetina Accord.

Fluoxetina Accord with food, drinks and alcohol

• You can take Fluoxetina Accord independently of meals, as you prefer.
• You should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Inform your doctor as soon as possible if you are pregnant, if you may be pregnant, or if you intend to plan a pregnancy.
There is data indicating an increased risk of birth defects, in particular concerning the heart, in newborns whose mothers had taken fluoxetine during the first months of pregnancy. In the general population, children born with heart defects are about 1 in 100. This ratio increases to about 2 children in 100, in mothers who had taken fluoxetine. Together with your doctor, you can decide to gradually discontinue taking Fluoxetina Accord during the period of pregnancy. However, depending on the circumstances, the doctor may suggest continuing, or not, taking Fluoxetina Accord.
When taken during pregnancy, especially in the last three months of pregnancy, drugs such as Fluoxetine may increase the risk of a serious condition in children, called persistent pulmonary hypertension of the newborn (PPHN), which causes the child to breathe faster and appear bluish. These symptoms usually appear within the first 24 hours after the birth of the child. If this happens to your child, you should immediately contact your midwife and/or doctor.
Caution is advised when taken during pregnancy, especially during the final period of pregnancy or immediately 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 eliminated in breast milk and may cause adverse effects in infants.
Breastfeeding should only be carried out if clearly necessary. If you continue breastfeeding, your doctor may prescribe you a lower dose of fluoxetine.

Fertility
Fluoxetine, in studies on animals, 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 alter your judgment or coordination skills. Do not drive and do not use tools or machinery until you are aware of how Fluoxetina Accord affects you.

3. How to take Fluoxetina Accord

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. Do not take more medicine than your doctor has prescribed. 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) per day. If necessary, your doctor will review and adjust the dosage within 3-4 weeks of starting treatment. If appropriate, the dosage may be gradually increased to a maximum of 3 capsules (60 mg) per day. The dose should be increased with caution to ensure that you receive the lowest effective dose. It is possible that you may not feel an immediate improvement at the beginning of treatment for depression. This is normal, as an improvement in the symptoms of depression may only appear 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) per day.
• Obsessive compulsive disorder:the recommended dose is 1 capsule (20 mg) per day. If necessary, your doctor will review and adjust the dosage after 2 weeks of therapy. If appropriate, the dosage may be gradually increased to a maximum of 3 capsules (60 mg) per day. If you do not notice any improvements within the first 10 weeks, your doctor will reconsider your treatment.

Use in children and adolescents aged between 8 and 18 years with
depression
Treatment must be started and supervised by a specialist. The initial dose is 10 mg per day.
After one or two weeks, your doctor may increase the dose to 20 mg per day. The dose should
be increased with caution to ensure that you receive the lowest effective dose. Children with low body weight may need lower doses. Your doctor should
assess the need to continue treatment beyond 6 months. If no improvements are noticed, the treatment should be re-evaluated.

Elderly
Your doctor will be more cautious when increasing the dose and the daily dosage should not
generally exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) per day.

Hepatic insufficiency
If you have liver problems or are taking other medicines that may interfere with
Fluoxetina Accord capsules, your doctor may decide to prescribe you a lower dose or
tell you to take Fluoxetina Accord capsules every two days.

If you take more Fluoxetina Accord than you should

• If you take too much, go to the Emergency Room of the nearest hospital or tell your doctor immediately.
• If possible, bring the Fluoxetina Accord package with you. The symptoms of an overdose include: nausea, vomiting, convulsions, heart disorders (such as irregular heartbeat and cardiac arrest), lung disorders and changes in mental status ranging from agitation to coma.

If you forget to take Fluoxetina Accord:

• If you forget to take a dose, do not worry. 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 every day at the same time can help you remember to take it regularly.

If you stop taking Fluoxetina Accord 20 mg capsules

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

When you stop taking Fluoxetina Accord capsules, you may notice the following effects:
dizziness, tingling sensations like pins and needles, sleep disturbances (vivid dreams, nightmares,
insomnia), feeling restless or agitated, unusual fatigue or weakness,
feeling anxious, nausea and/or vomiting (feeling sick or unwell), tremor
(shaking), headache.
Most people report that all symptoms that occur
when stopping Fluoxetina Accord capsule therapy are mild and
disappear spontaneously within a few weeks. If you should observe the appearance of
symptoms when stopping treatment, contact your doctor.
When you stop taking Fluoxetina Accord capsules, your doctor will help you reduce the dose
slowly over one or two weeks. This should help reduce the likelihood of
the appearance of withdrawal effects.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

• If you have thoughts of harming yourself or of suicide at any time, seekimmediate medical attention or go immediately to the hospital(see section 2).
• If you develop a skin rash or an allergic reaction, such as itching, swelling of the lips/tongue or difficulty breathing/shortness of breath, stoptakingFluoxetina Accord capsules immediately and consult your doctor immediately.
• If you feel a sensation of restlessness and are unable to sit still or remain immobile, you may have a condition called akathisia; an increase in the dose of Fluoxetina Accord capsules may make you feel worse. If you experience these sensations, contact your doctor.
• Report to your doctor immediatelyif your skin begins to redden, develops a mottled skin reaction or begins to blister or peel. This occurrence is very rare.

The most common side effects (very common side effects that may affect more than 1 in 10 people) are insomnia, headache, diarrhea, feeling of disgust (nausea) and fatigue.
Some patients have experienced:

• a combination of symptoms (known as “serotonin syndrome”) including unexplained fever with a rapid heart rate and breathing, sweating, muscle rigidity or tremors, confusion, extreme agitation or drowsiness (rarely);
• weakness, drowsiness or confusion, especially in elderly people and people (elderly) being treated with diuretics (water tablets);
• a prolonged and painful erection;
• irritability and extreme agitation.
• heart problems, such as a fast or irregular heartbeat, fainting, collapse or dizziness when standing up, which may indicate abnormal heart function.

Ifyou experienceanyof theabove side effects, informyour doctor immediately.
The following side effects have been reported in patients taking Fluoxetina Accord
capsules:

Common (may affect up to 1 in 10 people)

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

Not common (may affect up to 1 in 100 people)

• feeling detached from oneself
• strange thoughts
• excessively elevated mood
• problems with orgasm
• thoughts of suicide or self-harm
• teeth grinding
• muscle contraction, 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 sweat
• difficulty urinating
• feeling of hot or cold
• changes in liver function tests

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

• low levels of salt in the blood
• decreased platelets in the blood, which increases the risk of bleeding or bruising
• decreased white blood cells
• unusual uncontrolled behavior
• hallucinations
• agitation
• panic attacks
• confusion
• ·stuttering
• aggression
• convulsions
• 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 or water to the stomach
• hepatitis
• lung problems
• sensitivity to sunlight
• muscle pain
• problems with urination

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 (8-18 years of age)-In addition to the possible side
effects listed above, fluoxetine may slow growth and possibly delay
sexual maturation. Behaviors related to suicide (suicide attempt and suicidal thoughts), hostile attitude, mania and nosebleeds have also been commonly reported in children.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
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 Fluoxetina Accord

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the
pack after “Exp.”. The expiry date refers to the last day of that month.
Do not store the capsules at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 ingredient is fluoxetine hydrochloride. Each capsule contains 22.4 mg of fluoxetine
hydrochloride, equivalent to 20 mg of fluoxetine.
The other ingredients are: pregelatinized corn starch, purified talc, colloidal anhydrous
silica and magnesium stearate.
Capsule shell components: quinoline yellow (E104), erythrosine (E127),
indigo carmine (E132), titanium dioxide (E171) and gelatin.
Printing ink contains: shellac (E904), black iron oxide (E 172), propylene glycol and
ammonium hydroxide.

Description of the appearance of Fluoxetina Accord hard capsules and package contents
Fluoxetina Accord capsule is constituted by hard capsules. Each capsule contains 20 mg of
fluoxetine.
The capsules are light green opaque / standard opaque yellow, hard gelatin, with the
inscription “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. Blisters of 10,
14, 20, 28, 30, 50, 56, 60, 70, 90, 98 and 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization 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 Member States of the European Economic Area
under the following denominations:
Member State
Name
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 Hard Capsule