Package Insert: Information for the User

Fluoxetina Viatris 20 mg Dispersible Tablets EFG

Fluoxetine Hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Fluoxetina Viatris belongs to a group of medications known as selective serotonin reuptake inhibitors (SSRIs).

This medication is indicated for the treatment of:

Adults:

• Severe depressive episodes.
• Symptoms of a condition called obsessive-compulsive disorder.
• Eating disorder bulimia nervosa: fluoxetina 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 after4 to6 sessions. Fluoxetina should be offered to children or young people with moderate to severe depression only in combination with a psychological therapy.

How fluoxetina 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 fluoxetina 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. If not treated, your condition cannot disappear and may become more severe and difficult 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 Viatris

• If you are allergic to fluoxetine or any of the other ingredients in this medication (listed in section 6).If you experience an allergic reaction (such as hives, 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 medications known as irreversible non-selective monoamine oxidase inhibitors (IMAOs), as this may cause a severe or life-threatening reaction (for example, iproniazid, which is used to treat depression).

The treatment with fluoxetine may only be initiated after 2 weeks of completing a treatment with an irreversible non-selective MAO inhibitor (for example, tranilcipromina).non-selectiveMAO inhibitor.

Do not take any irreversible non-selective MAO inhibitor for at least 5 weeks after stopping fluoxetine medication. If you have been prescribed fluoxetine for a long period of time and/or at a high dose, your doctor may consider the need to establish a longer interval before taking an MAO inhibitor. Examples of MAOIs include nialamide, iproniazid, selegiline, moclobemide, phenelzine, tranilcipromina, isocarboxazid, and toloxatone.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take fluoxetine:

• Develops skin eruptions or other allergic reactions (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 have heart disease.
• 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 the "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 have a history of mania or have experienced mania in the past; if you experience a manic episode, contact your doctor immediately, as you may need to discontinue fluoxetine treatment.
• If you have a history of bleeding disorders, if you develop unusual bleeding or bruising, or if you are pregnant (see "Pregnancy").
• If you are taking medications that affect blood clotting (see "Other medications and Fluoxetine Viatris").
• If you have epilepsy or seizures. If you have experienced seizures or experience an increase in their frequency, contact your doctor immediately; you may need to discontinue fluoxetine treatment.
• If you are receiving electroconvulsive therapy (ECT).
• If you are being treated with tamoxifen (used to treat breast cancer) (see "Other medications and Fluoxetine Viatris").
• If you begin to feel restless and cannot remain seated or be still (akathisia). Increasing your fluoxetine dose may worsen this.
• 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 slow heart rate at rest 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).
• If you are taking diuretics (tablets to urinate), especially if you are an elderly patient.
• If you have glaucoma (increased intraocular pressure).
• Some medications in the group to which fluoxetine belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (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 have thoughts of self-harm or suicide. This may increase when starting to take antidepressants, as all these medications take time to start working, usually around 2 weeks, although in some cases it may take longer.

You may be more likely to have these thoughts:

-If you have previously had thoughts of self-harm or suicide.

-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 disorders treated with antidepressants.

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

It may be helpful for you 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 if they think your depression or anxiety has worsened or if they are concerned about changes in your behavior.

Children and adolescents

Patients under 18 years old have a higher risk of adverse effects, such as attempts at suicide, suicidal thoughts, and hostility (primarily 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 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. However, if you are a patient under 18 years old, your doctor may prescribe fluoxetine for the treatment of moderate to severe 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 indicated above appear or worsen when patients under 18 years old are taking fluoxetine.

Fluoxetine should not be used in children under 8 years old.

Other medications and Fluoxetine Viatris

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

Do not take Fluoxetine Viatris with:

• Certain irreversible non-selective monoamine oxidase inhibitors (IMAOs), some of which are used to treat depression. Do not take non-selective MAO inhibitors with fluoxetine, as this may cause severe or life-threatening reactions (serotonin syndrome) (see "Do not take Fluoxetine Viatris"). MAO-B inhibitors (selegiline) may be taken with fluoxetine, provided your doctor closely monitors your treatment.
• 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 stopping fluoxetine medication. If you have been prescribed fluoxetine for a long period of time and/or at a high dose, your doctor may consider the need to establish a longer interval before taking an MAO inhibitor.
• Metoprololwhen used to treat heart failure, as this increases the risk of excessive slowing of the heart rate..

Fluoxetine may interact with other medications (interaction):

• Tamoxifen(used to treat breast cancer), as fluoxetine may alter the concentration of this medication in the blood and may reduce its effect. Your doctor should consider other antidepressant treatment options.
• Inhibitors of monoamine oxidase A (IMAO-A)including moclobemide, linezolid (an antibiotic), and chlorpromazine (also known as methylene blue, used to treat conjunctivitis, itching, and mild eye irritation): due to the risk of severe or life-threatening reactions (serotonin syndrome). Fluoxetine treatment may be initiated the day after completing a treatment with reversible MAO inhibitors, but your doctor may closely monitor your treatment and use a lower dose of the MAO-A inhibitor.
• Mequitazine(used to treat allergies); as taking this medication with fluoxetine may increase the risk of changes in heart activity.
• Fenitoin (a medication used to treat epilepsy), fluoxetine may increase the levels of this medication in the blood, so your doctor should carefully dose you with fenitoin when it is administered with fluoxetine and should perform more frequent checks.
• Lithium, buprenorphine,selegiline, St. John's Wort, tramadol(a pain reliever),triptans(for migraines)and tryptophan: there is an increased risk of mild serotonin syndrome if these medications are administered with fluoxetine. Your doctor should perform more frequent checks.
• Medications that may affect heart rate, for example,antiarrhythmic drugs of classes IA and III, antipsychotics(for example, phenothiazines, pimozide, haloperidol),tricyclic antidepressants, certainantimicrobial agents(for example, sparfloxacin, moxifloxacin, erythromycin IV, pentamidine),antimalarial treatment, particularly halofantrine or certainantihistamines(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), NSAIDs (such as ibuprofen, diclofenac), aspirinor other 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 if you start or stop taking fluoxetine while taking warfarin.
• Ciproheptadine(used to treat allergies); as it may reduce the effect of fluoxetine.
• Medicationsthat decrease sodium levels in the blood(including medications that cause increased urination desmopressin, carbamazepine, and oxcarbazepine); as these medications may increase the risk of sodium levels in the blood becoming too low when taken with fluoxetine.
• Antidepressantssuch as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs), bupropion,mefloquineorchloroquine(used to treat malaria),tramadol(used to treat intense pain) orantipsychoticssuch as phenothiazines or butyrophenones; as fluoxetine may increase the risk of seizures when taken with these medications.
• Flecainide, propafenone, nebivololorencainide(for heart problems),carbamazepine(for epilepsy),atomoxetineortricyclic antidepressants(for example,imipramine, desipramineandamitriptyline) orrisperidone(for schizophrenia); as fluoxetine may change the levels of these medications in the blood, your doctor may need to reduce your dose when they are administered with fluoxetine.

Taking Fluoxetine Viatris with food, drinks, and alcohol

• Fluoxetine may 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 taking this medication.

Pregnancy

Infants whose mothers took fluoxetine during the first months of pregnancy have had some studies describing an increased risk of congenital heart defects. In the general population, approximately 1 in 100 babies are born with a heart defect. This figure increased to around 2 in 100 babies of mothers who took fluoxetine.

When taken during pregnancy, especially 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 causes the baby to breathe faster and turn blue. These symptoms usually begin within the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

Fluoxetine taken in the final stages of pregnancy may increase the risk of excessive bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking fluoxetine 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 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 taking fluoxetine during pregnancy, especially in the last stage of pregnancy or just before delivery, as there have been reports of the following effects in newborns: irritability, tremors, muscle weakness, persistent crying, difficulty breastfeeding, or difficulty sleeping.

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

Studies in animals have shown that fluoxetine reduces sperm quality.Reports in humans with certain SSRIs have shown that the effect on sperm quality is reversible.

Theoretically, this may affect fertility, but there has been no observed impact on human fertility.

Driving and operating machinery

Medications like fluoxetine can affect your judgment or coordination. Do not drive or operate machinery until you know how fluoxetine affects you.

Fluoxetine Viatris contains sodium

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

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

Swallow the tablets with half a glass of water or dissolved in half a glass of water, which must 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 as needed, in the 3 to 4 weeks following the start of treatment. When necessary, the dose can be increased gradually up to a maximum of 3 tablets (60 mg) per day. The dose should be increased carefully to ensure that you receive the minimum effective dose. You may not feel better immediately when 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 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 increased gradually up to a maximum of 3 tablets (60 mg) per day. If no improvement is observed in the 10 weeks following, your doctor will reconsider your treatment.

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 a fluoxetine oral solution). 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 minimum 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, treatment should be reconsidered.

Older patients:

The dose increases made 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 another medication that may affect fluoxetine, your doctor will decide to prescribe a lower dose or instruct you on how to take fluoxetine on alternate days.

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, orcallthe Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. If possible, bring the packaging of Fluoxetina Viatris with you.

The symptoms of overdose include: nausea, vomiting, convulsions, 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 Viatris:

• Do not worry if you forgot to take a dose. Take the next dose the following day at the usual time. Do not take a double dose to compensate for the missed doses.
• Taking your medicine at the same time every day may help you remember to take it regularly.

If you interrupt treatment with Fluoxetina Viatris:

• Do notstop taking fluoxetine unless your doctor has told you to, even if you start to feel better. It is essential to 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, a sensation of pins and needles, sleep disturbances (intense dreams, nightmares, insomnia), a feeling of 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 medications, this medication may produce 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 face/hives/lack of breathing,stop taking the tablets 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, and increasing your fluoxetine dose may make you feel worse. If you feel this way,consult your doctor..
• Talk to your doctor immediatelyif your skin starts to redden or you experience any type of reaction or blisters appear or 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, discomfort (nausea) and fatigue.

Some patients have experienced:

• A combination of symptoms (known as "serotonin syndrome"), which 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, drowsy or confused, 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 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 sex drive 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.
• Flushing.
• Yawning.
• 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 detached, 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.
• Weight loss.
• Increase in bruising tendency.
• Unexplained bruises or 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, uncontrolled behavior.
• Hallucinations.
• Agitation.
• Panic attacks.
• Confusion.
• Stammering.
• Aggression.
• Seizures.
• Vasculitis (inflammation of a blood vessel).
• Fast swelling of tissues around the neck, face, mouth and/or throat.
• Esophageal pain (the tube that connects the mouth to the stomach).
• Hepatitis.
• Lung problems.
• Sensitivity to sunlight.
• Muscle pain.
• Urination problems.
• Milk production.

Unknown frequency(cannot be estimated from available data)

• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" 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.

Other side effects in children and adolescents (8 to 18 years)

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

Reporting 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 Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not usethis medicationafter the expiration date that appears on the blister pack and on the cardboard box after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

This medicationdoes not require special storage conditions.

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

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 content of the container

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

Only some container sizes may be commercially marketed.

Marketing authorization holder

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing

McDermott Laboratories Ltd. t/a Gerard Laboratories

310/36 Baldoyle Industrial Estate, Grange Road

Dublín 13

Ireland

Or

Mylan Hungary Kft

Mylan utca 1

2900 Komárom

Hungary

Last review date of this leaflet:July 2023

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