Package Leaflet: Information for the User

Fluoxetina Aurovitas 20mg Hard Capsules EFG

Fluoxetine Hydrochloride

Read this 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. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isFluoxetina Aurovitasand what it is used for

2. What you need to know before you start takingFluoxetina Aurovitas

3. How to takeFluoxetina Aurovitas

4. Possible side effects

5. Storage ofFluoxetina Aurovitas

6. Contents of the pack and additional information

Fluoxetina Aurovitascontains the active ingredient fluoxetine, which belongs to a group of medicines called 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.

Older children and adolescents:

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

How Fluoxetina Aurovitas works

Every person has a substance called serotonin in their brain. People who are depressed or have obsessive-compulsive disorder or bulimia nervosa have lower levels of serotonin than others. The exact way 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 improve your symptoms. If left untreated, your condition cannot disappear and may become more severe and harder to treat.

You may need to be treated for a few weeks or months to ensure you are free of symptoms.

Do not take Fluoxetina Aurovitas:

• If you are allergic to fluoxetine or any of the other ingredients of this medication (listed in section 6).If you experience a rash or other type of 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 medications, known as irreversible non-selective monoamine oxidase inhibitors (IMAOs), as it may cause a severe or fatal adverse reaction (for example, iproniazid used to treat depression).

Treatment with fluoxetine may only be initiated after 2 weeks following the completion of a treatment with an irreversible non-selective MAO inhibitor.

Do not takeany irreversible non-selective MAO inhibitor for at least 5 weeks after discontinuing fluoxetine medication. If you have been prescribed fluoxetine for a long period of time and/or at a high dose, your doctor may consider setting a longer interval.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take fluoxetine if you experience any of the following:

• If you have epilepsy or seizures. If you have had seizures or experience an increase in their frequency, contact your doctor immediately; you may need to discontinue fluoxetine treatment;
• If you suffer from mania or have had mania in the past; if you have a manic episode, contact your doctor immediately, as you may need to discontinue fluoxetine treatment;
• If you have diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment dose);
• If you have liver problems (your doctor may need to adjust your dose);
• If you have heart disease;
• If you have a slow resting heart rate and/or if you know you may have salt loss due to prolonged severe diarrhea and vomiting or the use of diuretics (tablets to urinate);
• Glaucoma (increased eye pressure).
• If you are taking diuretics (tablets to urinate), especially if you are an elderly patient;
• If you are receiving electroconvulsive therapy (ECT);
• If you have a history of bleeding disorders or if you develop unusual bleeding or bruisingor if you are pregnant (see “Pregnancy, breastfeeding and fertility”);
• If you are taking medications that affect blood clotting (see“Taking Fluoxetina Aurovitas with other medications”);
• If you are taking tamoxifen (used to treat breast cancer) (see"Taking Fluoxetina Aurovitas with other medications");
• If you start to feel restless and cannot sit or stay still (akathisia). Increasing your fluoxetine dose may worsen it;
• If you begin to experience fever, muscle stiffness, or tremors, changes in your mental state such as confusion, irritability, and extreme agitation, you may be experiencing a condition called “serotonin syndrome” or “neuroleptic malignant syndrome”. Although this syndrome is rare, it can be life-threatening,contact your doctor immediately, as you may need to discontinue fluoxetine treatment.
• If you are taking medications that contain buprenorphine. The use of these medications with fluoxetine may cause serotonin syndrome, a potentially fatal condition (see “Taking Fluoxetina Aurovitas with other medications”).
• Somemedications in the group to which fluoxetine belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after discontinuing treatment.

Thoughts of suicide and worsening of your depression or anxiety.

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. This may increase when starting to take antidepressants, as all these medications need time to begin to take effect, usually around 2 weeks, although sometimes longer.

You are more likely to think this way:

- If you have previously had suicidal thoughts or self-harm.

- If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults with psychiatric disorders, who were treated with antidepressants.

If you ever 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 friendwho is depressed or has an anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Children and adolescents (8 to 18 years):

Patients under 18 years old have a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this class of medications. Fluoxetine should only be used in children and adolescents aged 8 to 18 years 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.

Furthermore, there is only limited information available regarding the long-term safety of fluoxetine in relation to growth, puberty, and cognitive, emotional, and behavioral development in this age group. Despite this, and if you are a patient under 18 years old, your doctor may prescribe fluoxetine for the treatment of moderate to severe major depressive episodes, in combination with psychological therapy, when they decide it is in the best interest of the patient. If your doctor prescribes fluoxetine to a patient under 18 years old and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when patients under 18 years old are taking fluoxetine.

Fluoxetine should not be used to treat children under 8 years old.

Taking Fluoxetina Aurovitas with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take Fluoxetina Aurovitas with:

• Certainirreversible non-selective monoamine oxidase inhibitors (IMAOs),some of which are used to treat depression. Irreversible non-selective MAO inhibitors should not be used with fluoxetine as they may cause severe or even fatal reactions (serotonin syndrome), (see section “Do not take Fluoxetina Aurovitas”). Fluoxetine treatment should only be initiated at least 2 weeks after discontinuing an irreversible non-selective MAO inhibitor (for example, tranilcipromina). Do not take any irreversible non-selective MAO inhibitor for at least 5 weeks after discontinuing fluoxetine medication. If you have been prescribed fluoxetine for a long period of time and/or at a high dose, your doctor may consider setting a longer interval before taking an MAO inhibitor.
• Metoprololwhen used to treat heart failure; as it increases the risk of excessive slowing of heartbeats.

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

• Tamoxifen(used to treat breast cancer); your doctor may consider a different antidepressant treatment as fluoxetine may change the levels of this medication in the blood and it cannot be ruled out that the effect of tamoxifen may be reduced.
• Inhibitors of monoamine oxidase A (IMAO-A)including moclobemide, linezolid (an antibiotic) and chlorpromazine (also known as methylene blue used to treat methemoglobinemia): due to the risk of severe or even fatal adverse reactions (serotonin syndrome). Fluoxetine treatment may be initiated the day after completing a treatment with reversible MAO inhibitors, but your doctor may closely monitor you and use a lower dose of the IMAO-A medication.
• Mequitazine(used to treat allergies); as taking this medication with fluoxetine may increase the risk of changes in heart activity.
• Fenitoin(used to treat epilepsy); fluoxetine may modify the levels of this medication in the blood, so your doctor will need to adjust your dose of fenitoin when it is taken with fluoxetine and will need to monitor you more frequently.
• Lithium, selegiline, St. John's Wort, tramadol(for pain relief), buprenorphine,triptans(for migraine treatment)and tryptophan: there is an increased risk of mild serotonin syndrome if these medications are taken with fluoxetine. Your doctor will monitor you more frequently.
• Medications that may affect heart rhythm, for example,antiarrhythmic Class IA and III, antipsychotics(such as phenothiazine derivatives, pimozide, haloperidol),tricyclic antidepressants, someantimicrobial agents(such as esparfloxacino, moxifloxacino, intravenous erythromycin, pentamidine), particularly malaria treatment halofantrine or someantihistamines(astemizol, mizolastina), as taking one or more of these medications with fluoxetine may increase the risk of changes in heart activity.
• Anticoagulants(such as warfarin),AINEs(such as ibuprofen, diclofenac),aspirinandother medications that affect blood clotting(including clozapine, used to treat certain mental disorders). Fluoxetine may alter the effect of these medications on the blood. Your doctor will need to perform certain tests, adjust your dose, and monitor you more frequently if you start or stop taking fluoxetine while taking warfarin.
• Ciproheptadinas(used to treat allergies); as it may reduce the effect of fluoxetine.
• Medications that decrease sodium levels in the blood(including, medications that produce increased urine production, desmopressin, carbamazepine, and oxcarbazepine); as the use of fluoxetine with these medications may increase the risk of excessive decrease in sodium levels in the blood.
• Antidepressantssuch as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion,mefloquineorchloroquine(used to treat malaria),tramadol(for strong pain relief) orantipsychoticssuch as phenothiazines or butyrophenones; as the use of fluoxetine with these medications may increase the risk of seizures.
• Flecainida, propafenona, nebivololorencainida(for heart problems),carbamazepine(for epilepsy treatment),atomoxetineortricyclic antidepressants(such asimipramine,desipramineandamitriptyline) orrisperidona(for schizophrenia treatment); as fluoxetine may change the levels of these medications in the blood, your doctor may need to reduce your dose when they are taken with fluoxetine.

Some medications may increase the side effects of fluoxetine and, in some cases, may cause severe reactions. Do not take any other medication while taking fluoxetina without consulting your doctor, especially:

- Medications that contain buprenorphine. These medications may interact with fluoxetine and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. Contact your doctor if you experience these symptoms.

Taking Fluoxetina Aurovitas with food, drinks, and alcohol

• Fluoxetine can be taken with or without food, as you prefer.
• It is not recommended to consume alcohol while taking this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Babies whose mothers took fluoxetine during the first months of pregnancy have been studied, and there is a higher risk of congenital heart defects. In the general population, approximately 1 in 100 babies are born with a heart defect. This probability increased to around 2 in 100 in those babies whose mothers took fluoxetine.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medications like fluoxetine may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby is born. 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 stop taking fluoxetine during pregnancy or before becoming pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to continue taking fluoxetine.

Caution should be exercised when using it during pregnancy, especially in 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 breastfeeding or sleeping.

If you take Fluoxetina Aurovitas in the final stage of pregnancy, there may be an increased risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Fluoxetina Aurovitas to be able to advise you.

Lactation

Fluoxetine is excreted in breast milk and may cause adverse effects in infants. You should only continue breastfeeding if absolutely necessary. If you continue breastfeeding, 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 there is no observed impact on human fertility yet.

Driving and operating machinery

Psychotropic medications like fluoxetine may affect your judgment or coordination. Do not drive or operate machinery until you know how fluoxetine affects you.

Fluoxetina Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Do not take more capsules than those 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 as needed in the 3 to 4 weeks following the start of treatment. When necessary, the dose may be increased gradually up to a maximum of 3 capsules (60 mg) daily. The dose should be increased carefully to ensure that you receive the lowest effective dose. You may not feel better immediately when starting to take your medication for depression. This is common since improvement in depressive symptoms 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 increased gradually up to a maximum of 3 capsules (60 mg) daily. If no improvement is observed in the 10 weeks following, 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 the fluoxetine oral solution presentation).

After one or two weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased carefully to ensure that you receive the lowest effective dose. Children with low 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 in 9 weeks, your doctor should reconsider treatment.

Older patients:

The dose increases made by your doctor should be carried out more carefully, and the daily dose should not generally exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) daily.

Liver impairment:

If you have a liver problem or are using another medication that may interact with fluoxetine, your doctor may decide to prescribe a lower dose or instruct you on how to use 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 consult your doctor immediately.
• If you can, bring the Fluoxetina Aurovitas packaging with you.

The symptoms of overdose include: nausea, vomiting, seizures, cardiac problems (such as irregular heartbeats or cardiac arrest), respiratory problems, and changes in mental state ranging from excitement to coma.

If you forgot to take Fluoxetina Aurovitas

Do not worry if you forgot to take a dose. Take the next dose at the usual time the next day. Do not take a double dose to compensate for the missed doses.

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

If you interrupt treatment with Fluoxetina Aurovitas

• Do notstop taking fluoxetine unless your doctor has told you to, even if you start feeling better. It is essential that you continue taking your medication.
• Make sure you do not run out of capsules.

You may experience the following effects (withdrawal effects) when interrupting treatment with fluoxetine: dizziness, a sensation of pins and needles, sleep disturbances (intense dreams, nightmares, insomnia), restlessness or agitation, unusual fatigue or weakness, anxiety, nausea, and/or vomiting (feeling sick or being sick), tremors (unsteadiness), and headaches.

Most people find that the symptoms that occur when stopping treatment with fluoxetine are moderate 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 other questions about the use of this medication, ask your doctor or pharmacist.

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

• If you have any thoughts of suicide or self-harm at any time, contact your doctor or go directly to the hospital (see section 2).
• If you have a skin rash or allergic reactions such as itching, swelling of the lips/tongue or hives/shortness of breath, stop taking the capsules and inform your doctor immediately.
• If you feel restless and feel like you cannot sit or stay still, you may be experiencing something called akathisia, so increasing your fluoxetine dose may make you feel worse. If you feel this way, consult your doctor.
• Inform your doctor immediately if your skin starts to redden or presents any type of reaction or if blisters appear or if your skin starts to peel. This happens very rarely.

The most common side effects (very common side effects that can affect more than 1 in 10 people) are insomnia, headache, diarrhea, nausea and fatigue.

Some patients have experienced:

• A combination of symptoms (known as "serotonin syndrome") that includes fever of unknown cause with an increase in breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or somnolence (only in rare cases);
• Feeling weak, somnolence 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 rapid or irregular heart rate, fainting, collapse or dizziness when standing up, which may indicate abnormal heart rhythm.

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

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

Frequent(can affect up to 1 in 10 people)

• Loss of appetite, weight loss
• Nervousness, anxiety
• Restlessness, lack of concentration
• Sensation of nervous tension
• Decreased libido or sexual problems (including difficulty maintaining an erection during sexual activity)
• Sleep disturbances, abnormal dreams, fatigue, somnolence
• Dizziness
• Alteration of taste
• Uncontrollable tremors
• Blurred vision
• Sensation of rapid and irregular heartbeats
• Flush
• Yawns
• Indigestion, vomiting
• Dry mouth
• Skin rash, urticaria, itching
• Excessive sweating
• Joint pain
• Increased frequency of urination
• Unexplained vaginal bleeding
• Sensation of weakness or chills

Rare(can affect up to 1 in 100 people)

• Feeling distant from oneself
• Strange thoughts
• Euphoria
• Sexual problems
• Thoughts of suicide or self-harm
• Grinding teeth
• Muscle spasms, involuntary movements or problems with balance or coordination
• Memory alterations
• Dilated pupils
• Noise in the ears
• Low blood pressure
• Difficulty breathing
• Nasal bleeding
• Difficulty swallowing
• Hair loss
• Increase in the tendency to bruise
• Bruises or unexplained bleeding
• Cold sweat
• Difficulty urinating
• Sensation of heat or cold
• Abnormal liver test results

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

• Low sodium levels in the blood
• Reduction in platelet count in the blood, which increases the risk of bleeding or bruising
• Reduction in white blood cell count
• Atypical behavior
• Alucinations
• Agitation
• Panic attacks
• Confusion
• Stammering
• Aggression
• Seizures
• Vasculitis (inflammation of a blood vessel)
• Quick swelling of tissues around the neck, face, mouth and/or throat
• Esophageal pain (the tube that connects the mouth to the stomach)
• Heptatitis
• Lung problems
• Sensitivity to sunlight
• Muscle pain
• Urination problems
• Milk production

Unknown frequency(cannot be estimated from available data):

• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, lactation and fertility" in section 2 for more information.

Fractures:

In patients taking this type of medication, an increased risk of bone fractures has been observed. Most of these side effects tend to disappear with continued treatment.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Fluoxetina Aurovitas

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

• The other components are:

Hard capsule content:Pregelatinized starch (cornstarch), microcrystalline cellulose, anhydrous colloidal silica.

Capsule coatings:Yellow iron oxide (E172), Patent Blue V (E131), titanium dioxide (E171), gelatin, sodium lauryl sulfate.

Printing ink:Lacquer, iron oxide black (E172).

Appearance of the product and contents of the package

Hard capsule.

Hard gelatin capsules of size “4”, green opaque/yellow filled with powder (white to off-white) and marked with black ink with “J” on the green opaque cap and “96” on the yellow body.

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

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

Bottles:250 hard capsules.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area under the following names:

Belgium: Fluoxetin AB 20 mg hard capsules

Netherlands: Fluoxetine Aurobindo 20 mg, hard capsules

Poland: Fluoxetine Aurovitas

Portugal: Fluoxetina Aurovitas

Spain: Fluoxetina Aurovitas 20 mg hard capsules EFG

Last review date of this leaflet: July 2021

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