Fluoxetine Aurovitas 20 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluoxetina Aurovitas 20mg hard capsules EFG

Fluoxetine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Fluoxetina Aurovitas contains the active substance fluoxetine, which belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs).

This medicine is indicated for the treatment of:

Adults:

• Major depressive episodes.
• Obsessive-compulsive disorder.
• Bulimia nervosa: fluoxetine is indicated as an adjunct to psychotherapy for the reduction of binge eating and purging.

Children over 8 years of age and adolescents:

For moderate to severe depressive episodes, when there is no response to psychological therapy after 4 to 6 sessions. Fluoxetine should be offered to children or adolescents with moderate to severe depression only in combination with psychological therapy.

How Fluoxetina Aurovitas works

Everyone has a substance in the brain called serotonin. People who are depressed or 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 serotonin levels in the brain.

Treating these conditions is important to help you get better. If left untreated, your condition may not resolve and could become more severe and more difficult to treat.

You may need to be treated for several weeks or months to ensure that you are symptom-free.

2. What you need to know before taking Fluoxetina Aurovitas

Do not take Fluoxetina Aurovitas:

• If you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you develop a rash or any other allergic reaction (such as itching, swelling of the face or lips, or difficulty breathing), stop taking the capsules immediately and contact your doctor as soon as possible.
• If you are taking other medicines known as non-selective irreversible monoamine oxidase inhibitors (MAOIs), as this may cause a serious or even fatal adverse reaction (for example, iproniazid, used to treat depression).

Treatment with fluoxetine should only be started at least 2 weeks after stopping treatment with a non-selective irreversible MAOI.

Do not take any non-selective irreversible MAOI for at least five weeks after stopping fluoxetine treatment. If you have been prescribed fluoxetine for a long period of time and/or at a high dose, your doctor may consider a longer interval.

• If you are taking metoprolol (to treat heart failure), as this increases the risk of excessive slowing of the heartbeat.

Warnings and precautions

Talk to your doctor or pharmacist before taking fluoxetine if any of the following apply to you:

• If you have epilepsy or seizures. If you experience seizures or an increase in their frequency, contact your doctor immediately; you may need to stop fluoxetine treatment.
• If you suffer from mania or have had manic episodes in the past; if you experience a manic episode, contact your doctor immediately, as you may need to stop fluoxetine treatment.
• If you have diabetes (your doctor may need to adjust your insulin or other antidiabetic medication dose).
• If you have liver problems (your doctor may need to adjust your dose).
• If you have heart conditions.
• If you have a slow resting heart rate and/or if you know you may have salt loss due to prolonged severe diarrhoea, vomiting, or use of diuretics (water tablets).
• Glaucoma (increased eye pressure).
• If you are taking diuretics (water tablets), especially if you are elderly.
• If you are receiving electroconvulsive therapy (ECT).
• If you have a history of bleeding disorders, or if you develop unusual bruising or bleeding, or if you are pregnant (see "Pregnancy, breastfeeding and fertility").
• If you are taking medicines that affect blood clotting (see “Taking Fluoxetina Aurovitas with other medicines”).
• If you are being treated with tamoxifen (used to treat breast cancer) (see "Taking Fluoxetina Aurovitas with other medicines").
• If you start feeling restless and unable to sit still or remain still (akathisia). Increasing your fluoxetine dose may worsen this.
• If you begin to experience fever, muscle stiffness, or tremors, or changes in mental state such as confusion, irritability, and extreme agitation, you may be experiencing a condition called “serotonin syndrome” or “neuroleptic malignant syndrome.” Although rare, this condition can be life-threatening; contact your doctor immediately, as you may need to stop fluoxetine treatment.
• If you are taking medicines containing buprenorphine. Using these medicines together with fluoxetine may cause serotonin syndrome, a potentially fatal condition (see “Taking Fluoxetina Aurovitas with other medicines”).
• Some medicines in the same class as fluoxetine (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These thoughts may increase when starting antidepressants, as all these medicines take time to become effective, usually about two weeks, although sometimes longer.

You are more likely to have such thoughts:

• If you have previously had suicidal or self-harming thoughts.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with antidepressants.

If at any time you have thoughts of suicide or self-harm**, contact your doctor or go directly to the hospital.**

You may find it helpful to tell a family member 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 8 to 18):

Patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Fluoxetine should only be used in children and adolescents aged 8 to 18 for the treatment of moderate to severe major depressive episodes (in combination with psychological therapy), and should not be used for other indications in this age group.

In addition, there is only limited information on the long-term safety of fluoxetine with regard to growth, puberty, and cognitive, emotional, and behavioural development in this age group. Nevertheless, if you are a patient under 18 years of age, your doctor may prescribe fluoxetine for the treatment of moderate to severe major depressive episodes, in combination with psychological therapy, if they decide it is appropriate for you. If your doctor prescribes fluoxetine to a patient under 18 and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms mentioned above appear or worsen while patients under 18 are taking fluoxetine.

Fluoxetine must not be used in children under 8 years of age.

Taking Fluoxetina Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Fluoxetina Aurovitas with:

• Certain non-selective irreversible monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Non-selective irreversible MAOIs must not be used with fluoxetine, as this may cause serious or even fatal reactions (serotonin syndrome) (see section “Do not take Fluoxetina Aurovitas”). Treatment with fluoxetine should only be started at least 2 weeks after stopping a non-selective irreversible MAOI (e.g., tranylcypromine). Do not take any non-selective irreversible MAOI for at least 5 weeks after stopping fluoxetine treatment. If you have been prescribed fluoxetine for a long time and/or at a high dose, your doctor may consider a longer interval before taking an MAOI.
• Metoprolol when used for heart failure, as it increases the risk of excessive slowing of the heartbeat.

Fluoxetine may affect the action of other medicines (interaction):

• Tamoxifen (used to treat breast cancer); your doctor may consider a different antidepressant treatment because fluoxetine may alter blood levels of this medicine and a reduced effect of tamoxifen cannot be ruled out.
• Monoamine oxidase inhibitors A (MAO-A), including moclobemide, linezolid (an antibiotic), and methylene blue chloride (also called methylene blue, used to treat methaemoglobinaemia): due to the risk of serious or even fatal adverse reactions (called serotonin syndrome). Treatment with fluoxetine may be started the day after stopping reversible MAO inhibitors, but your doctor may monitor you closely and use a lower dose of the MAO-A inhibitor.
• Mequitazine (used to treat allergies); as taking this medicine with fluoxetine may increase the risk of changes in the heart's electrical activity.
• Phenytoin (used for epilepsy); fluoxetine may alter blood levels of this medicine, so your doctor should monitor phenytoin levels more carefully when given with fluoxetine and perform more frequent check-ups.
• Lithium, selegiline, St. John’s wort, tramadol (for pain treatment), buprenorphine, triptans (for migraine treatment), and tryptophan: there is an increased risk of mild serotonin syndrome if these medicines are taken with fluoxetine. Your doctor will monitor you more frequently.
• Medicines that may affect heart rhythm, for example, Class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarial treatments such as halofantrine, or some antihistamines (astemizole, mizolastine), as taking one or more of these medicines with fluoxetine may increase the risk of changes in the heart's electrical activity.
• Anticoagulants (such as warfarin), NSAIDs (such as ibuprofen, diclofenac), aspirin, and other medicines that affect blood clotting (including clozapine, used to treat some mental disorders). Fluoxetine may alter the effect of these medicines on blood. Your doctor will need to perform certain blood tests, adjust your dose, and monitor you more frequently if you start or stop fluoxetine treatment while taking warfarin.
• Cyproheptadine (used to treat allergies); as it may reduce the effect of fluoxetine.
• Medicines that reduce sodium levels in blood (including diuretics, desmopressin, carbamazepine, and oxcarbazepine); as using fluoxetine with these medicines may increase the risk of excessive reduction in blood sodium levels.
• Antidepressants such as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquine or chloroquine (used to treat malaria), tramadol (for strong pain), or antipsychotics such as phenothiazines or butyrophenones; as using fluoxetine with these medicines may increase the risk of seizures.
• 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 fluoxetine may alter blood levels of these medicines, your doctor may need to reduce their dose when given together with fluoxetine.

Some medicines may increase the side effects of fluoxetine and may sometimes cause very serious reactions. Do not take any other medicine while taking fluoxetine without first consulting your doctor, especially:

• Medicines containing buprenorphine. These medicines may interact with fluoxetine and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.

Taking Fluoxetina Aurovitas with food, drinks, and alcohol

• Fluoxetine may be taken with or without food, as preferred.
• It is not advisable to drink alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Talk to your doctor as soon as possible if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Studies in babies whose mothers took fluoxetine during the first months of pregnancy have reported an increased risk of congenital heart defects. In the general population, approximately 1 in 100 babies are born with a heart defect. This risk increased to about 2 in 100 in babies whose mothers took fluoxetine.

Medicines such as fluoxetine, when taken during pregnancy, particularly during the last three months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the potential risk. Therefore, you and your doctor may decide to gradually discontinue fluoxetine during pregnancy or before becoming pregnant. However, depending on your circumstances, your doctor may advise that it is better for you to continue taking fluoxetine.

Caution should be exercised when using fluoxetine during pregnancy, especially during the last stage of pregnancy or just before delivery, as the following effects have been reported in newborns: irritability, tremors, muscle weakness, persistent crying, and difficulty feeding or sleeping.

If you take Fluoxetina Aurovitas in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Fluoxetina Aurovitas so they can advise you appropriately.

Breastfeeding

Fluoxetine is excreted in breast milk and may cause adverse effects in infants. You should only continue breastfeeding if absolutely 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 may affect fertility, but no impact on human fertility has been observed so far.

Driving and use of machines

Psychotropic medicines such as fluoxetine may impair judgment or coordination. Do not drive or operate machinery until you know how fluoxetine affects you.

Fluoxetina Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially “sodium-free.”

3. How to take Fluoxetina Aurovitas

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Do not take more capsules than indicated by your doctor.

Swallow the capsules with water. Do not chew the capsules.

Adults:

The recommended dose is:

• Depression: the recommended dose is 1 capsule (20 mg) daily. Your doctor may review and adjust your dose if necessary within the first 3 to 4 weeks of treatment. When needed, the dose may be gradually increased up to a maximum of 3 capsules (60 mg) daily. The dose should be carefully increased to ensure you receive the lowest effective dose. You may not feel better immediately when starting your antidepressant medication. This is common, as improvement in depressive symptoms usually does not occur until after the first few weeks of treatment. Patients with depression should be treated for a period of 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. Your doctor may review and adjust the dose after two weeks of treatment. When necessary, the dose may be gradually increased up to a maximum of 3 capsules (60 mg) daily. If no improvement is observed within the following 10 weeks, your doctor will reconsider your treatment.

Use in children and adolescents aged 8 to 18 years with depression:

Treatment should be initiated and supervised by a specialist. The initial dose is 10 mg/day (administered as 2.5 ml of fluoxetine oral solution).

After one or two weeks, your doctor may increase the dose to 20 mg/day. The dose should be carefully increased to ensure you receive the lowest effective dose. Children with low body weight may require lower doses. If there is a satisfactory response to treatment, your doctor should reevaluate the need to continue treatment after 6 months. If you have not improved within 9 weeks, your doctor should reconsider the treatment.

Elderly patients:

Dose increases prescribed by your doctor should be carried out more cautiously, 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 medications that may interact with fluoxetine, your doctor may decide to prescribe a lower dose or instruct you to take fluoxetine on alternate days.

If you take more Fluoxetina Aurovitas than you should

• If you take too many capsules, go to the nearest hospital emergency department or contact your doctor immediately.
• If possible, bring the Fluoxetina Aurovitas packaging with you.

Symptoms of overdose include: nausea, vomiting, seizures, cardiac problems (such as irregular heartbeat or cardiac arrest), respiratory problems, and changes in mental status ranging from agitation to coma.

If you forget to take Fluoxetina Aurovitas

Do not worry if you forget to take a dose. Take the next dose the following day at the usual time. Do not take a double dose to make up for missed doses.

Taking your medicine at the same time each day may help you remember to take it regularly.

If you stop taking Fluoxetina Aurovitas

• Do not stop taking fluoxetine unless your doctor has instructed you to do so, even if you start to feel better. It is important that you continue taking your medicine.
• Make sure you do not run out of capsules.

You may experience the following effects (withdrawal symptoms) when stopping treatment with fluoxetine: dizziness, tingling sensations like pins and needles, sleep disturbances (intense dreams, nightmares, insomnia), feelings of restlessness or agitation, unusual tiredness or weakness, anxiety, nausea and/or vomiting (feeling sick or being sick), tremors (shakiness), and headache.

Most people find that symptoms occurring when stopping fluoxetine are mild and disappear within a few weeks. If you experience these symptoms when stopping your treatment, consult your doctor.

When stopping treatment with fluoxetine, your doctor will help you gradually reduce the dose over one to two weeks—this will help reduce the likelihood of withdrawal effects.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

• If you have thoughts of suicide or self-harm at any time, contact your doctor or go directly to hospital (see section 2).
• If you develop a skin rash or allergic reactions such as itching, swelling of the lips/tongue, or wheezing/shortness of breath, stop taking the capsules and inform your doctor immediately.
• If you feel restless and as though you cannot sit still or remain motionless, you may be experiencing a condition called akathisia; increasing your fluoxetine dose might make you feel worse. If you feel this way, consult your doctor.
• Contact your doctor immediately if your skin begins to redden or shows any reaction, develops blisters, or starts to peel. This occurs very rarely.

The most common effects (very common adverse effects that may affect more than 1 in 10 people) are insomnia, headache, diarrhoea, discomfort (nausea), and fatigue.

Some patients have experienced:

• A combination of symptoms (known as "serotonin syndrome") including fever of unknown cause with increased breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation, or drowsiness (only in rare cases);
• Weakness, drowsiness, or confusion, mainly in elderly patients and in people treated with diuretics (elderly patients);
• Prolonged and painful erection;
• Irritability and extreme agitation;
• Heart problems, such as fast or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm function.

If you experience any of the adverse effects described above, inform your doctor immediately.

The following adverse effects have also been reported in patients taking fluoxetine:

Common (may affect up to 1 in 10 people)

• loss of appetite, weight loss
• nervousness, anxiety
• restlessness, difficulty concentrating
• feeling of nervous tension
• decreased sexual desire or sexual problems (including difficulty maintaining an erection during sexual activity)
• sleep disturbances, abnormal dreams, tiredness, drowsiness
• dizziness
• altered sense of taste
• uncontrollable tremor-like 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 of weakness or chills

Uncommon (may affect up to 1 in 100 people)

• feeling detached from oneself
• unusual thinking
• euphoria
• orgasm problems
• suicidal thoughts or self-harm
• teeth grinding
• muscle spasms, involuntary movements, or problems with balance or coordination
• memory disturbances
• dilated pupils
• ringing in the ears
• low blood pressure
• difficulty breathing
• nosebleeds
• difficulty swallowing
• hair loss
• increased tendency to bruise
• unexplained bruising or bleeding
• cold sweats
• difficulty urinating
• sensation of heat or cold
• abnormalities in liver function tests

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

• low levels of sodium in the blood
• reduction in platelets in the blood, increasing the risk of bleeding or bruising
• reduction in white blood cell count
• unusually reckless 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 oesophagus (the tube connecting the mouth to the stomach)
• hepatitis
• lung problems
• sensitivity to sunlight
• muscle pain
• urinary problems
• milk production

Frequency not known (cannot be estimated from available data):

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

Bone fractures:

An increased risk of bone fractures has been observed in patients taking this type of medicine. Most of these adverse effects tend to disappear with continued treatment.

In children and adolescents (8 to 18 years) – In addition to the possible adverse effects mentioned above, fluoxetine may reduce growth or delay sexual maturation. Suicidal behaviour (suicide attempts and suicidal thoughts), hostility, mania, and nosebleeds have also been frequently reported in children.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluoxetine Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Fluoxetina Aurovitas

• The active substance is fluoxetine hydrochloride. Each hard capsule contains 22.357 mg of fluoxetine hydrochloride, equivalent to 20 mg of fluoxetine.

• The other components are:

Capsule contents: Pregelatinized starch (corn starch).

Capsule shell: Yellow iron oxide (E172), patent blue V (E131), titanium dioxide (E171), gelatin, sodium lauryl sulfate.

Printing ink: Shellac (E904), black iron oxide (E172), potassium hydroxide (E525).

Appearance of the product and contents of the container

Hard capsule.

Size "4" hard gelatin capsules, opaque green cap/yellow body, filled with white to off-white powder, printed in black ink with "J" on the opaque green cap and "96" on the yellow body.

Fluoxetina Aurovitas capsules are available in PVC/PVdC-aluminum foil blisters and high-density polyethylene (HDPE) bottles with polypropylene cap and induction-sealed liner.

Blister packs: 14, 20, 28, 30, 50, 56, 60, 90 and 98 hard capsules.

Bottles: 250 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus No 19, Venda Nova

2700-487 Amadora

Portugal

This medicinal product is authorized in the European Economic Area member states under the following names:

Belgium: Fluoxetin AB 20 mg harde capsules

Netherlands: Fluoxetine Aurobindo 20 mg, harde capsules

Poland: Fluoxetine Aurovitas

Portugal: Fluoxetina Aurovitas

Spain: Fluoxetina Aurovitas 20 mg cápsulas duras EFG

Date of latest revision of this leaflet: September 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)