FLUOXETINE Aurovitas 20 mg Hard Capsules

Introduction

Package Leaflet: Information for the User

Fluoxetine Aurovitas 20mg hard capsules EFG

Fluoxetine hydrochloride

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Fluoxetine Aurovitas and what it is used for
2. What you need to know before you take Fluoxetine Aurovitas
3. How to take Fluoxetine Aurovitas
4. Possible side effects
5. Storing Fluoxetine Aurovitas
6. Package contents and further information

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

Fluoxetine Aurovitas contains the active substance 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 a complement to psychotherapy for the reduction of binge-eating and purging.

Children over 8 years 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 young people with moderate to severe depression onlyin combination with psychological therapy.

How Fluoxetine Aurovitas works

Every person has a substance in their brain called serotonin. People who are depressed or have obsessive-compulsive disorder or bulimia nervosa have lower levels of serotonin than others. It is not fully understood how fluoxetine and other SSRIs work, but they may help by increasing the levels of serotonin in the brain.

Treating these conditions is important to help you improve. If left untreated, your illness may not disappear and may become more severe and more difficult to treat.

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

2. What you need to know before taking Fluoxetine Aurovitas

Do not take Fluoxetine Aurovitas:

• If you are allergic to fluoxetine or any of the other components 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 shortness of breath), 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 (MAOIs), as a severe or life-threatening reaction may occur (e.g., iproniazide, used to treat depression).

Treatment with fluoxetine may only be started after 2 weeks after finishing treatment with an irreversible non-selective MAOI.

Do not takeany irreversible non-selective MAOI for at least 5 weeks after stopping fluoxetine medication. If you have been prescribed fluoxetine for a long period and/or at a high dose, your doctor may consider the need for 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 the frequency of seizures, contact your doctor immediately; you may need to discontinue treatment with fluoxetine;
• If you suffer from mania or have suffered from mania in the past; if you experience a manic episode, contact your doctor immediately, as you may need to discontinue treatment with fluoxetine;
• 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 disease;
• If you have a low resting heart rate and/or if you know you may have salt loss as a result of severe prolonged diarrhea and vomiting or the use of diuretics (water pills);
• Glaucoma (increased eye pressure).
• If you are taking diuretics (water pills), 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 bruising or unusual bleeding or if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• If you are taking medications that affect blood coagulation (see "Taking Fluoxetine Aurovitas with other medications");
• If you are being treated with tamoxifen (used to treat breast cancer) (see "Taking Fluoxetine Aurovitas with other medications");
• If you start to feel restless and cannot sit still or be quiet (akathisia). Increasing your dose of fluoxetine 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 suffering from 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 treatment with fluoxetine.
• If you are taking medications containing buprenorphine. The use of these medications with fluoxetine may cause serotonin syndrome, a potentially life-threatening disease (see "Taking Fluoxetine Aurovitas with other medications").
• Some medications in the same group as fluoxetine (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is discontinued.

Suicidal thoughts and worsening of your depression or anxiety disorder.

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. This can increase when you start taking antidepressants, as all these medications need time to start working, usually around two weeks, although sometimes a bit longer.

You are more likely to think this way:

• If you have had suicidal thoughts or self-harm in the past.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were treated with antidepressants.

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

You may find it helpful to tell a family member or close friendthat you are depressed or have 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 old):

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

Additionally, there is only limited information regarding the long-term safety of fluoxetine in relation to growth, puberty, and cognitive, emotional, and behavioral 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, when they decide it is most convenient for the patient. If your doctor prescribes fluoxetine to a patient under 18 years of age 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 when patients under 18 years of age are taking fluoxetine.

Fluoxetine should not be used in the treatment of children under 8 years of age.

Taking Fluoxetine Aurovitas with other medications

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

Do not take Fluoxetine Aurovitas with:

• Certain irreversible non-selective monoamine oxidase inhibitors (MAOIs),some of which are used to treat depression. Irreversible non-selective MAOIs should not be used with fluoxetine as they can cause severe or life-threatening reactions (serotonin syndrome) (see section "Do not take Fluoxetine Aurovitas"). Treatment with fluoxetine should only be started at least 2 weeks after discontinuation of an irreversible non-selective MAOI (e.g., tranycypromine). Do not take any irreversible non-selective MAOI for at least 5 weeks after stopping fluoxetine medication. If you have been prescribed fluoxetine for a long period and/or at a high dose, your doctor may consider the need for a longer interval before taking an MAOI.
• Metoprololwhen used for heart failure; as it increases the risk of excessive slowing of heartbeats.

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

• Tamoxifen(used to treat breast cancer); your doctor may consider a different antidepressant treatment because fluoxetine may change the blood levels of this medication and it cannot be ruled out that the effect of tamoxifen may be reduced.
• Monoamine oxidase A inhibitors (MAO-A)including moclobemide, linezolid (an antibiotic), and methylthioninium chloride (also called methylene blue, used to treat methemoglobinemia): due to the risk of severe and life-threatening adverse reactions (called serotonin syndrome). Treatment with fluoxetine can be started the day after finishing treatment with reversible MAOIs, but your doctor may perform close monitoring and use a lower dose of the MAOI-A medication.
• Mequitazine(used to treat allergies); as taking this medication with fluoxetine may increase the risk of changes in heart electrical activity.
• Phenytoin(used for epilepsy); fluoxetine may change the blood levels of this medication, so your doctor will need to dose phenytoin more carefully when administered with fluoxetine and will need to 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 medications are administered with fluoxetine. Your doctor will perform more frequent check-ups.
• Medications that can affect heart rhythm, such as antiarrhythmic Class IA and III, antipsychotics(e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents(e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), malaria treatment, particularly halofantrine, or some antihistamines(astemizole, mizolastine), as taking one or more of these medications with fluoxetine may increase the risk of changes in heart electrical activity.
• Anticoagulants(such as warfarin), NSAIDs(such as ibuprofen, diclofenac), aspirin, and other medications that affect blood coagulation(including clozapine, used to treat some mental disorders). Fluoxetine may alter the effect of these medications in the blood. Your doctor will need to perform certain tests, adjust your dose, and perform more frequent check-ups if you start or stop fluoxetine treatment while taking warfarin.
• Cyproheptadine(used to treat allergies); as it may reduce the effect of fluoxetine.
• Medications that decrease sodium levels in the blood(including diuretics, 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, mefloquineor chloroquine(used to treat malaria), tramadol(for pain treatment) or antipsychoticssuch as phenothiazines or butyrophenones; as the use of fluoxetine with these medications may increase the risk of seizures.
• Flecainide, propafenone, nebivololor encainide(for heart problems), carbamazepine(for epilepsy treatment), atomoxetineor tricyclic antidepressants(e.g., imipramine, desipramine, and amitriptyline) or risperidone(for schizophrenia treatment); as fluoxetine may change the blood levels of these medications, it is possible that your doctor will need to decrease your dose when administered with fluoxetine.

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

• Medications containing buprenorphine. These medications may interact with fluoxetine, and you may experience symptoms such as involuntary muscle contractions, including muscles that control 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 Fluoxetine Aurovitas with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

In babies whose mothers took fluoxetine during the first months of pregnancy, there are studies that describe a higher risk of congenital defects affecting the heart. In the general population, approximately 1 in 100 babies are born with a heart defect. This probability increased to about 2 in 100 in babies whose mothers took fluoxetine.

When taken during pregnancy, particularly in the last 3 months, medications like fluoxetine may increase the risk of a serious disease in babies 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 stop taking fluoxetine gradually 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 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 sucking or sleeping.

If you take Fluoxetine Aurovitas in the final stage 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 know that you are taking Fluoxetine Aurovitas to advise you accordingly.

Breastfeeding

Fluoxetine is excreted in breast milk and may cause adverse effects in children. You should only continue breastfeeding if it is 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 could affect fertility, but it has not yet been observed in human fertility.

Driving and using machines

Psychotropic medications like fluoxetine may alter judgment or coordination. Do not drive or use machinery until you know how fluoxetine affects you.

Fluoxetine Aurovitas contains sodium

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

3. How to take Fluoxetina Aurovitas

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 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 3 to 4 weeks after starting treatment. When necessary, the dose can be gradually increased up to a maximum of 3 capsules (60 mg) daily. The dose should be carefully increased to ensure that you receive the lowest effective dose. You may not feel better immediately after starting to take your medication for depression. This is common since there is no improvement in depressive symptoms 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 can be gradually increased up to a maximum of 3 capsules (60 mg) daily. If no improvement is observed within 10 weeks, your doctor will reconsider your treatment.

Use in children and adolescents from 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 carefully increased to ensure that you receive the lowest effective dose. Children with low weight may need lower doses. If there is a satisfactory response to treatment, your doctor should reassess the need to continue treatment after 6 months. If you have not improved within 9 weeks, your doctor should reconsider treatment.

Elderly patients:

Dose increases 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.

Hepatic impairment:

If you have a liver problem or are using other 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 emergency department of the nearest hospital or consult your doctor immediately.
• If you can, bring the Fluoxetina Aurovitas package with you.

The symptoms of overdose include: nausea, vomiting, seizures, heart problems (such as irregular heartbeat or cardiac arrest), lung problems, and changes in mental state ranging from excitement 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 forgotten doses.

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

If you interrupt treatment with Fluoxetina Aurovitas

• Do notstop taking fluoxetine unless your doctor has indicated it, even if you start to feel 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, sensation of tingling similar to pinpricks or needles, sleep disorders (intense dreams, nightmares, insomnia), feeling of restlessness or agitation, unusual fatigue or weakness, anxiety, nausea and/or vomiting (feeling sick or being sick), tremors (instability), and headache.

Most people find that the symptoms that occur when interrupting treatment with fluoxetine are moderate and disappear within a few weeks. If you experience these symptoms when interrupting your treatment, consult your doctor.

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

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

• If you have suicidal thoughts or self-harm at any time, contact your doctor or go directly to the hospital (see section 2).
• If you experience 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 feel like you cannot sit still or stay quiet, you may be suffering from something called akathisia, and increasing your fluoxetine dose could make you feel worse. If you feel this way, consult your doctor.
• Talk to your doctor immediatelyif your skin starts to redden or presents any reaction or blisters, or if your skin begins to peel. This happens very rarely.

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

Some patients have experienced:

• A combination of symptoms (known as "serotonin syndrome") that includes unexplained fever with increased breathing or heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation or drowsiness (only in rare cases);
• Feeling of 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 rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm.

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

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

Frequent(may affect up to 1 in 10 people)

• Lack of appetite, weight loss
• Nervousness, anxiety
• Restlessness, lack of concentration
• Feeling of nervous tension
• Decreased sexual desire or sexual problems (including difficulty maintaining an erection during sexual activity)
• Sleep disorders, abnormal dreams, fatigue, drowsiness
• Dizziness
• Alteration of taste
• Uncontrolled tremor movements
• Blurred vision
• Feeling of rapid and irregular heartbeats
• Flushing
• 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 distant from oneself
• Strange thinking
• Euphoria
• Orgasm problems
• Suicidal thoughts or self-harm
• Teeth grinding
• Muscle spasms, involuntary movements, or problems with balance or coordination
• Memory disorders
• Dilated pupils
• Ringing in the ears
• Low blood pressure
• Breathing difficulties
• Nosebleeds
• Difficulty swallowing
• Hair loss
• Increased tendency to bruising
• Unexplained bruising or bleeding
• Cold sweats
• Difficulty urinating
• Feeling of heat or cold
• Liver test abnormalities

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

• Low sodium levels in the blood
• Reduced platelet count in the blood, which increases the risk of bleeding or bruising
• Reduced white blood cell count
• Atypically reckless behavior
• 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 esophagus (the tube that connects the mouth to the stomach)
• Hepatitis
• Lung problems
• Sensitivity to sunlight
• Muscle pain
• Urination problems
• Milk production

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

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

Bone fractures:

In patients taking this type of medication, an increased risk of bone fractures has been observed. 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 decrease growth or delay sexual maturation. Suicidal behavior (suicide attempts and suicidal thoughts), hostility, mania, and nosebleeds have also been frequently reported in children.

Reporting adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Fluoxetina Aurovitas

Keep this medication out of sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

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.

• Other components are:

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

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

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

Appearance of the product and package contents

Hard capsule.

Hard gelatin capsules of size "4", opaque green/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 (HDPE) bottles with a polypropylene closure and an induction-sealed liner.

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

Bottles:250 hard capsules.

Only some package 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

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medication 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

Date of the last revision of this leaflet: July 2021

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)