FLUOXETINE VIATRIS 20 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Fluoxetine Viatris 20 mg Dispersible Tablets 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, 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 signs of illness are the same as yours.
• If you get 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 pack and other information

1. What is Fluoxetine Viatris and what is it used for
2. What you need to know before you take Fluoxetine Viatris
3. How to take Fluoxetine Viatris
4. Possible side effects
5. Storing Fluoxetine Viatris

1. Contents of the pack and further information

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

Fluoxetine Viatris belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).

This medicine is used for the treatment of:

Adults:

• Severe depressive episodes.
• Symptoms of a disease called 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 only be offered to children or young people with moderate to severe depression in combination with psychological therapy.

How fluoxetine works

Everyone 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 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 you take Fluoxetine Viatris

Do not take Fluoxetine Viatris

• If you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you experience a rash or other allergic reaction (such as itching, swelling of the face or lips or difficulty breathing), stop taking the tablets immediately and contact your doctor as soon as possible.

• If you are taking other medicines known as irreversible non-selective monoamine oxidase inhibitors (MAOIs), as a serious or life-threatening reaction may occur (e.g. iproniazid, which is used to treat depression).

Treatment with fluoxetine can only be started at least 2 weeks after stopping treatment with an irreversible non-selective MAOI (e.g. tranilcipromine).

Do nottake 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 to establish a longer interval before taking an MAOI. Examples of MAOIs are: nialamide, iproniazid, selegiline, moclobemide, phenelzine, tranilcipromine, isocarboxazide, and toloxatone.

• If you are taking metoprolol (for 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:

• Develops skin rashes or other allergic reactions (such as itching, swelling of the face or lips or difficulty breathing), stop taking the dispersible tablets and contact your doctor immediately.
• If you have heart disease.
• If you start to experience fever, muscle stiffness or tremors, changes in your mental state such as confusion, irritability, and extreme agitation; you may be suffering from “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 interrupt treatment with fluoxetine.
• If you suffer from mania or have suffered from mania in the past; if you have a manic episode, contact your doctor immediately, as you may need to interrupt treatment with fluoxetine.
• If you have a history of bleeding disorders, if you develop bruises or unusual bleeding or if you are pregnant (see “Pregnancy”).
• If you are taking medicines that affect blood clotting (see “Other medicines and Fluoxetine Viatris”).
• If you have epilepsy or convulsions. If you have had convulsions or experience an increase in the frequency of them, contact your doctor immediately; you may need to interrupt treatment with fluoxetine.
• If you are receiving electroconvulsive therapy (ECT).
• If you are being treated with tamoxifen (used to treat breast cancer) (see “Other medicines and Fluoxetine Viatris”).
• If you start to feel restless and cannot sit or stand still (akathisia). Increasing your dose of fluoxetine could make it worse.
• If you have diabetes, your doctor may need to adjust your insulin or other antidiabetic treatment.
• If you have liver problems, your doctor may need to adjust your dose.
• If you have a low resting heart rate and/or if you know you may have loss of salts as a result of severe prolonged diarrhea and vomiting or the use of diuretics (water tablets).
• If you are taking diuretics (water tablets), especially if you are an elderly patient.
• If you have glaucoma (increased eye pressure).
• Some medicines of the same group as fluoxetine (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These thoughts may be increased when you first start taking antidepressants, as all these medicines take time to start working, usually around two weeks, although in some cases it may be longer.

You will be more likely to have these thoughts:

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

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

It may be helpful for you to tell a relative or close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety has got worse, or if they are worried about changes in your behavior.

Children and adolescents

Patients under 18 years have an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Fluoxetine should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe 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 on the long-term safety of fluoxetine in relation to growth, puberty, and cognitive, emotional, and behavioral development in this age group. However, if you are under 18 years, your doctor may prescribe fluoxetine for the treatment of moderate to severe depressive episodes in combination with psychological therapy when decided it is the most suitable for the patient. If your doctor prescribes fluoxetine to a patient under 18 years and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms appear or worsen when patients under 18 years are taking fluoxetine.

Fluoxetine should not be used in children under 8 years.

Other medicines and Fluoxetine Viatris

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

Do not take Fluoxetine Viatris with:

• Certain irreversible non-selective monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Non-selective MAOIs or MAOIs known as MAOI type A (such as moclobemide) should not be taken with fluoxetine, as serious or life-threatening reactions may occur (serotonin syndrome) (see section “Do not take Fluoxetine Viatris”). MAOIs known as MAOI-B (selegiline) may be taken with fluoxetine, provided your doctor monitors the treatment carefully.
• Fluoxetine treatment should only be started at least 2 weeks after stopping an irreversible non-selective MAOI (e.g. tranilcipromine). Do nottake 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 to establish a longer interval before taking an MAOI.
• Metoprololwhen used for heart failure, as it increases the risk of excessive slowing of heartbeats.

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

• Tamoxifen(used to treat breast cancer), as fluoxetine may alter the blood concentration of this medicine and a reduction in the effect of tamoxifen cannot be ruled out. Your doctor should consider other treatment options for depression.
• Monoamine oxidase inhibitors A (MAOI-A)including moclobemide, linezolid (an antibiotic), and methylthioninium chloride (also known as methylene blue, indicated for the treatment of conjunctivitis, itching, and mild eye irritation): due to the risk of serious or life-threatening reactions (serotonin syndrome). Treatment with fluoxetine can be started the day after stopping treatment with reversible MAOIs, but your doctor may monitor the treatment carefully and use a lower dose of the MAOI-A medicine.
• Mequitazine(used to treat allergies); as taking this medicine with fluoxetine may increase the risk of changes in heart electrical activity.
• Phenytoin (a medicine used for epilepsy), fluoxetine may increase the blood levels of this medicine, so your doctor will need to prescribe phenytoin with more caution when given with fluoxetine and will need to monitor you more frequently.
• Lithium, buprenorphine, selegiline, St. John's Wort, tramadol(a painkiller), triptans(for migraine) and tryptophan: there is an increased risk of mild serotonin syndrome if these medicines are given with fluoxetine. Your doctor will need to monitor you more frequently.
• Medicines that may affect heart rhythm, such as anti-arrhythmics of classes IA and III, antipsychotics(e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents(e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), antimalarial treatment, particularly halofantrine, or certain antihistamines(astemizole, mizolastine), as taking one or more of these medicines with fluoxetine may increase the risk of changes in heart electrical activity.
• Anticoagulants (such as warfarin), NSAIDs (such as ibuprofen, diclofenac), aspirinor other medicines that affect blood clotting (including clozapine, used to treat certain mental disorders); fluoxetine may alter the effect of these medicines in the blood. Your doctor will need to perform certain tests 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 lower blood sodium levels(including desmopressin, carbamazepine, and oxcarbazepine); as these medicines may increase the risk of low blood sodium levels when taken with fluoxetine.
• Antidepressantssuch as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs), or bupropion, mefloquineor chloroquine(used to treat malaria), tramadol(used to treat severe pain), or antipsychoticssuch as phenothiazines or butyrophenones; as fluoxetine may increase the risk of convulsions when taken with these medicines.
• Flecainide, propafenone, nebivololor encainide(for heart problems), carbamazepine(for epilepsy), atomoxetineor tricyclic antidepressants(e.g. imipramine, desipramine, and amitriptyline) or risperidone(for schizophrenia); as fluoxetine may change the blood levels of these medicines, your doctor may need to reduce your dose when given with fluoxetine.

Taking Fluoxetine Viatris with food, drinks, and alcohol

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

In babies whose mothers took fluoxetine during the first months of pregnancy, there have been some studies describing 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 figure increased to about 2 in 100 babies of mothers who took fluoxetine.

When taken during pregnancy, especially in the last 3 months, medicines like fluoxetine may increase the risk of a serious disease in babies called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and turn blue. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take fluoxetine in the final 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 know that you are taking fluoxetine to be able to advise you.

It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the potential risk. Therefore, you and your doctor can 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 taking fluoxetine during pregnancy, especially during the last stage of pregnancy or just before delivery, as the following effects have been reported in newborn babies: irritability, tremors, muscle weakness, persistent crying, difficulty sleeping or feeding.

Breast-feeding

Fluoxetine is excreted in breast milk and may cause side effects in the child. You should only continue breast-feeding if it is absolutely necessary. If you continue breast-feeding, your doctor may prescribe a lower dose of fluoxetine.

Fertility

Animal studies have shown that fluoxetine reduces sperm quality. Cases reported in humans with some SSRIs have shown that the effect on sperm quality is reversible.

Theoretically, this could affect fertility, but it has not yet been observed to have an impact on human fertility.

Driving and using machines

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

Fluoxetine Viatris contains sodium

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

3. How to Take Fluoxetina Viatris

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist. Do not take more tablets than prescribed by your doctor.

Swallow the tablets with half a glass of water or dissolved in half a glass of water, which should be swallowed immediately and completely. Do not chew them.

Adults:

The recommended dose is:

• Depression: the recommended dose is 1 tablet (20 mg) per day. 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 tablets (60 mg) per day. 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 because 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 tablets (60 mg) per day.

• Obsessive-Compulsive Disorder: the recommended dose is 1 tablet (20 mg) per day.

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 tablets (60 mg) per day. If there is no improvement within 10 weeks, your doctor will reconsider your treatment.

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 a fluoxetine oral solution). After one or two weeks, your doctor may increase the dose up 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 there is no improvement within 9 weeks, treatment should be reconsidered.

Elderly Patients:

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

Patients with Liver Problems:

If you have a liver problem or are taking other medication that may affect fluoxetine, your doctor will decide whether to prescribe a lower dose or instruct you on how to take fluoxetine every other day.

If You Take More Fluoxetina Viatris Than You Should

In case of overdose or accidental ingestion, go to the emergency department of the nearest hospital, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. If possible, take the Fluoxetina Viatris packaging with you.

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

If You Forget to Take Fluoxetina Viatris

• 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 Viatris

• Do notstop taking fluoxetine unless your doctor has indicated it, even if you start to feel better. It is important that you continue taking your medication.
• Make sure you do not run out of medication.

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 thoughts 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 wheezing/shortness of breath, stop taking the tablets 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 type of reaction or blisters, or 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"), which 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 (of advanced age) treated with diuretics.
• 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 detached, distant from oneself.
• Strange thoughts.
• Euphoria.
• Orgasm problems.
• Suicidal thoughts or self-harm thoughts.
• Teeth grinding.
• Muscle spasms, involuntary movements, or problems with balance or coordination.
• Memory disorders.
• Dilated pupils.
• Noise in the ears.
• Low blood pressure.
• Breathing difficulties.
• Nosebleeds.
• Difficulty swallowing.
• Weight loss.
• Increased tendency to bruise.
• Unexplained bruising or bleeding.
• Cold sweat.
• 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.
• Aggressiveness.
• 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" 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.

Other Adverse Effects in Children and Adolescents (from 8 to 18 years)

In addition to those mentioned above, fluoxetine may decrease growth or delay sexual maturation. Suicidal behaviors (suicide attempts and suicidal thoughts), hostility, mania, and nosebleeds have also been frequently reported in children.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 Viatris

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the carton after "CAD" or "EXP". 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 the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of 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 Viatris

The active ingredient is fluoxetine in the form of fluoxetine hydrochloride.

The other components are: microcrystalline cellulose, cornstarch, crospovidone, anhydrous colloidal silica, magnesium stearate, sodium saccharin, and peppermint powder.

Appearance of the Product and Package Contents

They are dispersible tablets, white, convex, oval, marked with FL/20 on one side and G on the other, presented in packages containing 14, 28, or 500 dispersible tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Mylan Hungary Kft

Mylan utca 1

2900 Komárom

Hungary

Date of Last Revision of this Prospectus:July 2023

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