Patient Information Leaflet: Package Leaflet

Fluoxetine Viatris 20 mg Hard Capsules EFG

Read this leaflet carefully before you start to take 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 give it to others even if they have similar symptoms to you, 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.

The name of your medication is Fluoxetina Viatris 20 mg hard capsules EFG. It contains the active ingredient fluoxetine.

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

Fluoxetina Viatris is indicated for the treatment of:

Adults:

• Severe depressive episodes.
• Symptoms of a condition called obsessive-compulsive disorder (OCD).
• Eating disorder bulimia nervosa. This medication is indicated as a complement to psychotherapy for the reduction of binge eating and purging.

Children over 8 years and adolescents:

• 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 only in combination with a psychological therapy.

Do not takeFluoxetina 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, 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 metoprolol for the treatment of heart failure.
• If you are taking any medication known specifically as irreversible non-selective monoamine oxidase inhibitors (IMAOs),since it may cause a severe or fatal adverse reaction. An example is ipronazid, which is used to treat depression.

The treatment with fluoxetine may only be initiated after two weeks of completing a treatment with an IMAO irreversible (such as tranilcipromina).

Do not take any IMAO during at least 5 weeks after stopping the medication with fluoxetine. 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take fluoxetine:

• 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 interrupt the treatment with fluoxetine.
• If you have a history of mania. If you experience a manic episode, contact your doctor immediately, as you may need to interrupt the treatment with fluoxetine.
• If you have liver problems (your doctor may need to adjust your dose).
• If you have heart disease.

• If your resting heart rate is low and/or if you know you may have salt loss as a result of prolonged severe diarrhea and vomiting or the use of diuretics (medications to urinate).

• If you are recovering from a heart attack.
• If you are receiving electroconvulsive therapy (ECT).
• If you have diabetes, as your doctor may need to adjust your dose of diabetes medication.
• If you have a history of mental illness.
• If you have a history of bleeding disorders, if you develop unusual bleeding or bruising, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you have glaucoma (increased eye pressure).
• If you are taking other medications. See below, "Other medications and Fluoxetina Viatris".
• If you start to feel restless and cannot sit or stand still (akathisia). Increasing the dose of fluoxetine may worsen this condition.
• If you start to experience fever, muscle rigidity, or tremors, changes in your mental state such as confusion, irritability, and extreme agitation. If so, you may be at risk of what is called "serotonin syndrome" or "neuroleptic malignant syndrome".

Despite the fact that this syndrome is rare, it can be life-threatening, so contact your doctor immediately, as you may need to interrupt the treatment with fluoxetine.

Some medications in the group to which Fluoxetina Viatris belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

If you are unsure about what medications you are already taking, consult your doctor.

Thoughts of suicide and worsening of depression or anxiety

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may be stronger when you start taking antidepressants, as these medications take time to work, usually around two weeks, although sometimes the period is longer.

You are more likely to think this way:

• If you have had thoughts of harming yourself or committing suicide before.
• If you are a young adult. Clinical trial information has shown a higher risk of suicidal behavior in adults under 25 years old with psychiatric disorders being treated with an antidepressant.

If you have thoughts of harming yourself or committing suicide at any time,contact your doctor or go directly to a hospital.

Talking to a family member or friendwho is depressed or has an anxiety disorder, and asking them to read this leaflet, may be helpful. 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 aged 8 to 18

Children 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 type of medication. 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 to treat other conditions.

Additionally, there is only limited information about the long-term safety of fluoxetine in relation to growth, puberty, and cognitive, emotional, and behavioral development in this age group. However, your doctor may prescribe fluoxetine to patients under 18 years old for the treatment of moderate to severe depressive episodes in combination with psychological therapy if 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 want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years old taking fluoxetine.

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

Other medications and Fluoxetina Viatris

Inform your doctor or pharmacist what you are taking, have taken recently (in the last 5 weeks), or may need to take any other medication.

Do not take fluoxetine with:

• Certain irreversible non-selective monoamine oxidase inhibitors (IMAOs), some of which are used to treat depression. Do not use irreversible non-selective MAO inhibitors with fluoxetine, as they may cause severe or even fatal reactions (serotonin syndrome) (see "Do not take Fluoxetina Viatris"). The treatment with fluoxetine 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 during at least 5 weeks after stopping the medication with fluoxetine. 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 of 5 weeks before taking an irreversible non-selective MAO inhibitor.
• Metoprolol when used for heart failure; as it increases the risk of excessive slowing of heart rate.

Fluoxetine may interact with other medications, especially the following:

• Some medications known as irreversible non-selective monoamine oxidase A (IMAO-A) inhibitors, used to treat depression and Parkinson's disease, including moclobemide, linezolid (an antibiotic), and methionine chloride (also known as methylene blue, used to treat a blood disorder called methemoglobinemia): due to the risk of severe or even fatal adverse reactions (serotonin syndrome).
• Lithium, tryptophan, opioids (such as buprenorphine, tramadol), selegiline, St. John's Wort, or other medications known as triptans (such as sumatriptan, zolmitriptan);. These medications may interact with fluoxetine and you may experience symptoms such as involuntary muscle contractions, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when you experience these symptoms.
• Phenytoin (for epilepsy), as fluoxetine may modify the blood levels of this medication, your doctor may need to change the dose of phenytoin and monitor you more frequently when taking it with fluoxetine.
• Flecainide, propafenone, or nebivolol (for heart problems), atomoxetine (for attention deficit hyperactivity disorder, ADHD), carbamazepine (for epilepsy), risperidone (for mental illness), tricyclic antidepressants (such as imipramine, desipramine, and amitriptyline) as fluoxetine may change the blood levels of these medications, so your doctor may need to reduce the doses of these medications when administering fluoxetine.
• Tamoxifen (used to treat breast cancer), as fluoxetine may alter the blood concentration of this medication and may reduce the effectiveness of tamoxifen. Your doctor should consider other antidepressant options.
• Medications that affect heart rhythm (antiarrhythmics) such as procainamide, disopyramide, sotalol, antipsychotics (such as phenothiazines, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (such as ciprofloxacin, moxifloxacin, erythromycin administered intravenously, and pentamidine), antimalarial treatment (especially halofantrine), certain antihistamines used to treat allergies (astemizol and mizolastine)as taking one or more of these medications with fluoxetine may increase the risk of changes in heart activity.
• Mequitazine or ciproheptadine, medications used to treat allergies.
• Warfarin, NSAIDs, or other anticoagulants (including clozapine, used to treat certain mental disorders, and aspirin) as fluoxetine may alter the effects of these medications on 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.
• Medications that may decrease blood sodium levels, such as oxcarbazepine, used to treat epilepsy; desmopressin, used to treat certain hormonal problems; diuretics (medications that increase urine production).
• Medications that may increase the risk of seizures, such as other ISRS antidepressants (such as sertraline, citalopram, paroxetine), medications for nausea and vertigo (such as perphenazine, prochlorperazine, chlorpromazine), certain medications for mental illness called butyrophenones (such as benperidol, haloperidol), mefloquine or chloroquine (for malaria), or bupropion (for depression or nicotine dependence).

Fluoxetine Viatris and alcohol

You should avoid 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

There has been a reported increase in the risk of congenital defects in babies whose mothers took fluoxetine during the first months of pregnancy, particularly those affecting the heart. In the general population, approximately 1 in 100 babies is born with a heart defect. This number increased to 2 in 100 babies in mothers who took fluoxetine.

When fluoxetine is taken during pregnancy, particularly during 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), causing the baby to breathe faster and appear blue. These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, you should consult your midwife 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 you continue taking fluoxetine.

Caution should be exercised when using it 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, difficulty breastfeeding, or sleeping.

Taking fluoxetine during the final stages of pregnancy may increase the 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 fluoxetine to be able to advise you.

Breastfeeding

Fluoxetine passes into 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. Theoretically, this could affect fertility, but there has been no observed impact on human fertility.

Driving and operating machinery

Fluoxetine may affect your judgment or coordination. Do not drive or operate machinery without consulting your doctor or pharmacist.

Fluoxetine Viatris contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, such as lactose, consult with them before taking this medication.

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

Swallow the capsules with a glass of water. Do not chew the capsule.

Adults:

The recommended dose is:

- Severe depressive episodes:The recommended dose is 1 capsule (20 mg) per day.

If necessary, your doctor may review and adjust your dose at 3 or 4 weeks of starting treatment. When necessary, the dose can be gradually increased up to a maximum of 60 mg per day (3 capsules). The dose should be increased with caution to ensure that you receive the lowest effective dose. You may not feel improvement immediately after starting to take the medication for depression. This is common since depressive symptoms do not start to improve until after the first few weeks. Patients with depression should be treated for at least 6 months.

- Obsessive-compulsive disorder (OCD):The recommended dose is 1 capsule (20 mg) per day. If after 2 weeks there is no improvement, your doctor may gradually increase the dose up to the maximum recommended dose of 60 mg (3 capsules) per day. If in 10 weeks there is no perceived improvement, your doctor should reconsider treatment.

- Bulimia nervosa:The recommended dose is 3 capsules (60 mg) per day.

Older patients:

Your doctor will increase the dose with more caution and the daily dose should not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) per day.

Patients with liver problems:

If you have a liver problem or are taking any other medication that may interact with fluoxetine, your doctor should decide whether to prescribe a lower dose or indicate that you take fluoxetine on alternate days.

Use in children and adolescents from 8 to 18 years with moderate to severe depression:

Treatment should be initiated and supervised by a specialist.

The initial dose is 10 mg per day. After one or two weeks, your doctor may increase the dose up to 20 mg per day. The dose should be increased carefully to ensure that the patient remains on the lowest effective dose. Children with low weight may need lower doses. If there is a satisfactory response to treatment, your doctor should reevaluate the need to continue treatment after 6 months. If no improvement is seen in 9 weeks, your doctor should reconsider treatment.

If you take more Fluoxetine Viatris than you should

In case of overdose or accidental ingestion, go to the nearest hospital emergency room, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

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

If you forgot to take Fluoxetine Viatris

• If you forgot a dose, do not worry. Take your next dose the next day at the usual time. 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 Fluoxetine Viatris

• Do notinterrupt treatment with fluoxetine without first consulting your doctor, 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.

When you finish your treatment with fluoxetine, you may experience the following symptoms (withdrawal symptoms): dizziness, tingling, sleep disturbances (intense dreams, nightmares, insomnia); feeling restless or agitated, unusual fatigue or weakness, anxiety, nausea/vomiting (feeling sick or being sick), tremors (unsteadiness), and headaches.

Most people find that the symptoms that appear when stopping treatment with fluoxetine are moderate and disappear within a few weeks. If you experience any symptoms when stopping treatment, inform your doctor.

When stopping treatment with fluoxetine, your doctor will gradually reduce the dose over one or two weeks. This should help reduce the likelihood of withdrawal symptoms.

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

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

If you experience any of the following side effects, you must inform your doctor immediately or go to the nearest hospital.

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

• Severe allergic reactions. These reactions can appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as:

-Itching.

-Swelling of the face, lips, mouth, tongue, or throat (angioedema).

-Sudden onset of wheezing, fainting, or difficulty swallowing.

• High fever, rapid swelling of tissues around the neck, face, mouth, and/or throat, skin rash, inflammation of lymph nodes (serum sickness).
• If you are agitated and unable to remain still, you may experience akathisia, and increasing the fluoxetine dose may make you feel worse.
• Rash on the skin, blisters, which appear like small targets (dark centers surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).
• Generalized rash with blisters and skin peeling, particularly around the body surface, mouth, nose, eyes, and genitals (toxic epidermal necrolysis, Stevens-Johnson syndrome).
• Seizures.
• Low sodium levels in the blood, which can lead to weakness and muscle dystrophy. This may be due to an alteration in the secretion of the antidiuretic hormone, a hormone that causes the body to retain water, diluting the blood and reducing the amount of sodium.
• Frequent infections with fever, chills, sore throat, or mouth ulcers (decreased white blood cell count).
• Pulmonary problems, scarring, and thickening of the lungs with shortness of breath.
• Hepatic problems with the following signs: feeling sick, loss of appetite, general feeling of discomfort, fever, itching, yellowing of the skin and eyes, light-colored stools, dark-colored urine.
• Combination of symptoms (known as "serotonin syndrome") that includes fever of unknown cause with an acceleration of breathing or pulse, sweating, muscle rigidity or tremors, confusion, irritability, and extreme agitation or somnolence.
• Prolonged and painful erection.

• Cardiac problems, such as rapid or irregular heartbeat, fainting, falls, dizziness when standing up that may indicate abnormal heart rhythm.

Other possible side effects

Very common(may affect more than 1 in 10 people)

-Difficulty sleeping (insomnia).

-Headache.

-Diarrhea, nausea.

-Fatigue (weakness), feeling unusually weak.

Common(may affect up to 1 in 10 people)

-Loss of appetite, weight loss.

-Nervousness, anxiety.

-Restlessness.

-Difficulty concentrating.

-Tension.

-Decreased sexual desire or sexual problems (difficulty maintaining an erection during sexual activity and ejaculation problems).

-Difficulty sleeping, abnormal dreams (including nightmares).

-Fatigue or drowsiness.

-Dizziness.

-Alteration of taste.

-Uncontrollable tremors.

-Blurred vision.

-Rapid heartbeat and irregular heartbeat; other changes in heart electrical activity called QT prolongation, which can be seen on an ECG, a test that records heart electrical activity.

-Hot flashes.

-Yawning.

-Indigestion, vomiting.

-Dry mouth.

-Hives, urticaria, itching.

-Excessive sweating.

-Joint pain.

-Increased frequency of urination.

-Unexplained vaginal bleeding.

-Sensation of agitation, chills.

Rare(may affect up to 1 in 100 people)

-Feeling detached, distant from oneself.

-Memory problems.

-Strange thoughts.

-Euphoria.

-Tinnitus.

-Nasal bleeding.

-Sexual problems.

-Grinding of teeth.

-Muscle fasciculations, involuntary movements, or problems with balance and coordination.

-Dilated pupils.

-Low blood pressure.

-Difficulty breathing.

-Difficulty swallowing.

-Abdominal bleeding.

-Hair loss.

-Increased tendency to bruise.

-Cold sweats.

-Painful urination.

-Sensation of cold or heat.

-General feeling of discomfort/abnormal.

-Increased liver enzymes in a blood test.

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

-Unusually uncontrolled behavior.

-Seeing, feeling, or hearing things that do not exist (hallucinations).

-Agitation.

-Panic attacks.

-Aggression.

-Confusion.

-Stammering or stuttering.

-Inflammation of blood vessels (vasculitis).

-Dilation of blood vessels.

-Pain in the esophagus, part of the digestive tube that carries food or water to the stomach.

-Sensitivity to sunlight.

-Milk production in the breasts.

-Increased level of prolactin (a hormone) in the blood.

-Urinary problems.

-Painful throat and swallowing difficulties.

-Muscle pain.

-Hematomas.

-Hematomas or bleeding without apparent cause.

-Difficulty urinating.

-Bleeding from mucous membranes that cover areas such as the mouth and nose.

Unknown frequency(cannot be estimated from available data)

• Heavy vaginal bleeding shortly after giving birth (postpartum hemorrhage. For more information, seePregnancy, breastfeeding, and fertilityin section 2.

Fractures:an increased risk of fractures has been observed in patients taking this type of medication.

If you experience any of the symptoms listed and they are bothersome, or if they persist for some time, inform your doctor or pharmacist.

Most of these side effects tend to disappear with continued treatment.

Side effects in children and adolescents (8 to 18 years)

The following side effects were only observed in children and adolescents

• Delayed growth or possible delay in sexual maturation.

The following side effects were frequently observed in children and adolescents

• Changes in behavior such as acting without thinking, irritability, and anger.
• Changes in mood such as aggression and agitation.
• Thoughts of self-harm or suicide or attempted suicide.
• Nasal bleeding.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Pharmacovigilance 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 medication.

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, blister pack, or bottle after CAD or EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

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 point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fluoxetina Viatris

The active ingredient is hydrochloride of fluoxetine.

Each capsule contains hydrochloride of fluoxetine equivalent to 20 milligrams (mg) of fluoxetine.

The other components are: lactose, (see section 2 “Fluoxetina Viatris contains lactose”), cornstarch, colloidal anhydrous silica, talc, magnesium stearate, gelatin, shellac, sodium lauryl sulfate, propylene glycol, ammonium hydroxide, brilliant blue (E133), quinoline yellow (E104), erythrosine (E127), indigo carmine (E132), titanium dioxide (E171) and iron oxide black (E172).

Appearance of the product and contents of the package

Fluoxetina Viatrisis presented in the form of hard gelatin capsules with a light green opaque body and a light purple opaque cap, and they have “FL20” printed in black ink on the body and “?” on the cap.

Fluoxetina Viatris is available in high-density polyethylene (HDPE) bottles with a polypropylene safety closure containing 7, 10, 14, 20, 28, 30, 50, 60, 90 and 100 hard capsules.

Fluoxetina Viatris is also available in PVC/PVDC/Aluminum blisters containing 7, 10, 12, 14, 20, 28, 30, 50, 60, 90 and 100 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

or

Viatris Sante

360 Avenue Henri Schneider

69330 Meyzieu

France

or

Mylan B.V.

Krijgsman 20,

1186 DM Amstelveen

Netherlands

or

EUROPEENNE DE PHARMACOTECHNIE - EUROPHARTECH

Rue Henri Matisse

63370 LEMPDES

France

or

Mylan Hungary Kft/Mylan Hungary Ltd

Mylan utca 1

2900, Komárom

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

GermanyFluoxetin dura 20 mg

AustriaFluoxetin ‘Arcana’ 20 mg – Kapseln

BelgiumFluoxetine Mylan 20 mg harde capsules

DenmarkFluoxetine Mylan

SpainFluoxetina Viatris 20 mg cápsulas duras EFG

FranceFluoxétine Viatris 20 mg, gélule

GreeceFluoxetine/MylanCAP 20 mg/CAP

IrelandGerozac 20 mg Capsules hard

ItalyFluoxetina Mylan Generics

LuxembourgFluoxetine Mylan 20 mg harde capsules

NetherlandsFluoxetine Mylan 20 mg, capsules

PortugalFluoxetina Mylan

United KingdomFluoxetine Capsules 20 mg

Last review date of this leaflet:July 2021

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