Package Insert: Information for the User

Fluoxetina VIR 20 mg Hard Capsules EFG

Fluoxetine Hydrochloride

In this package insert:

1. What Fluoxetina VIR is and for what it is used
2. Before taking Fluoxetina VIR
3. How to take Fluoxetina VIR
4. Possible adverse effects
5. Storage of Fluoxetina VIR
6. Additional information

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

This medication is indicated for the treatment of:

Adults:

• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia nervosa: Fluoxetina VIR 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. Fluoxetina VIR should be offered to children or young people with moderate to severe depression only in combination with a psychological therapy.

Do not take Fluoxetina VIR and inform your doctor or pharmacist:

If you are allergic (hypersensitive) to fluoxetine or to any of the other ingredients of Fluoxetina VIR. An allergy may include rash, itching, swelling on the face or lips, or shortness of breath.

• If you are taking any other type of medication used to treat depression and are known as non-selective monoamine oxidase inhibitors or reversible inhibitors of monoamine oxidase type A (also called IMAO-A), there may be a severe or fatal reaction.

The treatment with fluoxetine can only be initiated after two weeks of completing a treatment with an irreversible MAO inhibitor (for example, tranilcipromina).

However, treatment with fluoxetine can be initiated the day after completing a treatment with certain reversible MAO inhibitors, known as reversible MAO inhibitors called IMAO-A (for example, moclobemida).

Do not take any IMAO for at least five weeks after stopping the medication with Fluoxetina VIR. If you have been prescribed Fluoxetina VIR for a long period of time and/or at a high dose, your doctor may consider the need for a longer interval before taking an IMAO. Examples of IMAOs are: nialamida, iproniazida, selegelina, moclobemida, fenelcina, tranilcipromina, isocarboxacida, and toloxatona.

There has been an observed increase in the risk of bone fractures in patients treated with this type of medication.

Be especially careful with Fluoxetina VIR and inform your doctor or pharmacist if:

• You develop skin rashes or other allergic reactions (such as itching, swelling on the face or lips, or shortness of breath), stop taking the capsules and contact your doctor immediately.

• If you have epilepsy or have had seizures in the past, if you have seizures or experience an increase in their frequency, contact your doctor immediately, you may need to discontinue treatment with fluoxetine.

• If you have had mania in the past, if you have a manic episode, contact your doctor immediately, you may need to discontinue the use of fluoxetine.
• 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 heart disease.

• If you are taking diuretics, especially if you are an elderly patient.

• If you are receiving electroconvulsive therapy (ECT).

• If you have a history of bleeding disorders, if you develop hematomas or unusual bleeding, or if you are pregnant (see “Pregnancy”).

• If you are taking medications that affect blood clotting (see “Taking other medicines”).

• If you start experiencing fever, stiffness, or muscle spasms, changes in your mental state such as confusion, irritability, or extreme agitation, you may be experiencing a condition called serotonin syndrome or malignant neuroleptic syndrome. Although this syndrome is rare, it can be life-threatening, so contact your doctor immediately, the use of fluoxetine may be discontinued.

If you have suicidal thoughts or self-harm. Depression is associated with an increased risk of suicidal thoughts, self-harm, and suicide (suicide-related events). This risk may persist until the disease improves. Since it may take 3 to 4 weeks after starting treatment with fluoxetine for the improvement to occur, your doctor will closely monitor you at the beginning of treatment. Other psychiatric conditions for which Fluoxetina VIR is prescribed may also be associated with an increased risk of suicide-related events. Therefore, the same precautions should be taken when treating patients with other psychiatric disorders.

You may be more prone to having these types of 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 young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

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

Telling a family member or close friend that you are depressed or have an anxiety disorder and asking them to read this leaflet may be helpful. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behavior.

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

Use in children and adolescents aged 8 to 18:

Patients under 18 years of age have a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. Fluoxetina VIR should only be used in children and adolescents aged 8 to 18 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.

Furthermore, there is only limited information on the long-term safety of Fluoxetina VIR in relation to growth, puberty, and cognitive, emotional, and behavioral development in this age group. However, your doctor may prescribe Fluoxetina VIR to patients under 18 years of age 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 Fluoxetina VIR to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen in patients under 18 years of age taking Fluoxetina VIR.

Fluoxetina VIR should not be used to treat children under 8 years of age.

Taking other medicines with Fluoxetina VIR:

Inform your doctor or pharmacist if you are taking or have taken other medications (in the last 5 weeks), including those purchased without a prescription. This medication may interact with other medications (interaction). Interactions may occur with:

• Non-selective monoamine oxidase inhibitors (MAO) or reversible monoamine oxidase inhibitors known as IMAO type A (such as moclobemida), which should not be used with Fluoxetina VIR as they may cause severe or fatal reactions (serotonin syndrome), see section “Do not take Fluoxetina VIR”. Reversible MAO inhibitors known as IMAO-B (selegilina) may be used with Fluoxetina VIR if your doctor closely monitors your treatment.

• Lithium, tryptophan: there is an increased risk of serotonin syndrome if these medications are administered with Fluoxetina VIR. When fluoxetine is administered in combination with lithium, your doctor should perform more frequent checks.

• Phenobarbital (used to treat epilepsy), Fluoxetina VIR may increase the levels of this medication in the blood, so your doctor should dose you more carefully when taking Fluoxetina VIR and Phenobarbital, and should perform more frequent checks.

• Clozapine (used to treat certain mental disorders), tramadol (for pain relief), or tryptophans (for migraine treatment), there is an increased risk of hypertension.

• Flecainide or encainide (for heart problems), carbamazepine (for epilepsy treatment), tricyclic antidepressants (such as imipramine, desimpramine, and amitriptyline), because Fluoxetina VIR may change the levels of these medications in the blood, so your doctor may need to reduce your dose when taking Fluoxetina VIR.

• Warfarin or other medications that affect blood clotting; Fluoxetina VIR may alter the effect of these medications on the blood. Your doctor will need to perform certain tests if you start or stop treatment with Fluoxetina VIR while taking warfarin.

• You should not start taking herbal preparations containing St. John's Wort (Hypericum perforatum) while taking Fluoxetina VIR as it may cause an increase in adverse effects. If you start taking Fluoxetina VIR and are already taking St. John's Wort, stop taking it and inform your doctor at your next visit.

Taking Fluoxetina VIR with food and drinks:

• Fluoxetina VIR can be taken with or without food, as you prefer.

• It is not recommended to consume alcohol while taking this medication.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking a medication.

Pregnancy

The information obtained to date does not indicate an increased risk when using this medication during pregnancy. However, caution should be exercised when using it during pregnancy, especially during the last stage of pregnancy or just before delivery, as the following adverse effects have been reported in newborns: irritability, tremors, muscle weakness, persistent crying, difficulty breastfeeding or sleeping.

In babies whose mothers took fluoxetine during the first months of pregnancy, there have been reports of a higher risk of congenital heart defects. In the general population, approximately 1 in 100 babies are born with a heart defect. This probability increased to around 2 in 100 in those babies whose mothers took fluoxetine. You and your doctor can decide whether it is best to stop taking fluoxetine while pregnant or to continue taking it. However, depending on your circumstances, your doctor may suggest that you continue taking fluoxetine.

Make sure your midwife and/or doctor know that you are taking FLUOXETINA VIR. When taken during pregnancy, especially in the last 3 months of pregnancy, medications like FLUOXETIA VIR may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

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

Lactation

Fluoxetine is excreted in breast milk and may cause adverse effects in infants. You should only continue breastfeeding if absolutely necessary. If you continue breastfeeding, your doctor may prescribe a lower dose of fluoxetine.

Studies in animals have shown that fluoxetine reduces sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not been observed so far.

Driving and operating machinery:

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

Follow exactly the administration instructions of Fluoxetina VIR from your doctor. Consult your doctor or pharmacist if you have any doubts. The normal dose is:

• Depression: the recommended initial dose is 20 mg. 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 60 mg. The dose should be increased carefully to ensure that you receive the lowest effective dose. You may not feel better immediately when starting to take your medication for depression. This is common since improvement in depressive symptoms does not occur until after the first few weeks of treatment. Patients with depression should be treated for a period of at least 6 months.

• Bulimia nervosa: the recommended dose is 60 mg per day.

• Obsessive-compulsive disorder: the recommended dose is 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 60 mg. If you do not observe improvement within 10 weeks, the treatment with Fluoxetina VIR should be reconsidered.

• Children and adolescents aged 8 to 18 with depression: Treatment should be initiated and supervised by a specialist. The initial dose is 10 mg/day. After one or two weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased carefully to ensure that the patient remains on the lowest effective dose. Children with low weight may require lower doses. Your doctor should reevaluate the need to continue treatment after 6 months. If you have not improved, treatment should be reconsidered.

If you are elderly, the dose increases made by your doctor should be carried out more carefully, and the daily dose should not generally exceed 40 mg. The maximum dose is 60 mg per day.

If you have a liver problem or are using other medication that may affect fluoxetine, your doctor will decide to prescribe a lower dose or instruct you on how to use Fluoxetina VIR on alternate days.

Administration method

Swallow the capsules with water. Do not chew them.

If you take more Fluoxetina VIR than you should

• If you take too many capsules, go to the nearest hospital emergency service or consult your doctor immediately.

• Take the Fluoxetina VIR packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to take Fluoxetina VIR

• 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 VIR

Do not stop taking Fluoxetina VIR unless your doctor has told you to.It is essential that you continue taking your medication.

• Do not stop taking your medication without first asking your doctor, even if you start feeling better.

• Make sure you do not run out of medication.

You may experience the following effects when interrupting treatment with Fluoxetina VIR: dizziness, pins-and-needles sensation, sleep disturbances (intense dreams, nightmares, insomnia), restlessness or agitation, unusual fatigue or weakness, anxiety, nausea, and/or vomiting, tremors (instability), and headaches.

Most people find that the symptoms that occur when interrupting treatment with Fluoxetina VIR are moderate and resolve on their own within a few weeks. If you experience these symptoms when interrupting your treatment, consult your doctor.

When interrupting treatment with Fluoxetina VIR, 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 doubts about the use of Fluoxetina VIR, ask your doctor or pharmacist.

Like all medications, Fluoxetina VIR may have side effects, although not everyone will experience them.

• If you have a skin rash or allergic reactions such as itching, swelling of the face or lips, or difficulty breathing, stop taking the capsules and tell 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 Fluoxetina VIR dose may make you feel worse. If you feel this way,consult your doctor.

• Tell your doctor immediatelyif your skin starts to redden and then blisters or peels. This happens very rarely.

Some patients have experienced:

• A combination of symptoms (known as serotonin syndrome) that include fever of unknown cause with increased heart rate, sweating, muscle rigidity or tremor, confusion, extreme agitation or somnolence (rarely);

• Feeling weak, drowsy, or confused, mainly in the elderly and in people treated with diuretics (elderly);

• Prolonged and painful erection.

• Irritability and extreme agitation

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

If you experience any of the symptoms described below and they bother or persist over time, inform your doctor:

• Generalized disorders: Chills, sensitivity to light, weight loss.

• Digestive system: Diarrhea and stomach discomfort, vomiting, indigestion, difficulty swallowing or alteration of taste or dry mouth. Rarely, abnormalities in liver function tests have been reported, with very rare cases of hepatitis.

• Nervous system: Headache, sleep disturbances or abnormal dreams, dizziness, loss of appetite, fatigue, euphoria, involuntary movements, convulsions, extreme restlessness, hallucinations, atypical behavior, confusion, agitation, anxiety, nervousness, inability to concentrate and think clearly, panic attacks, or thoughts of suicide or self-harm.

• Urinary and reproductive system disorders: Difficulty urinating, increased frequency of urination, sexual dysfunction, prolonged erections, and milk production. Unknown frequency:Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy"1 in section 2 for more information.

• Respiratory system: Sore throat, difficulty breathing. Rarely, pulmonary changes (including inflammatory processes and varied histopathological processes and/or fibrosis) have been reported.

• Other: Hair loss, yawning, blurred vision, unexplained bruises or bleeding, sweating, hot flashes, feeling dizzy when standing up, muscle or joint pain, low sodium levels in the blood.

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

Additionally, in children and adolescents (8 years to 18 years)- fluoxetine may slow growth or delay sexual maturation.

If you notice side effects not mentioned in this leaflet or if you experience one of the side effects described in a severe form, inform your doctor or pharmacist.

No requires special conservation conditions.

Keep out of reach and sight of children.

Do not use Fluoxetina VIR after the expiration date that appears on the packaging or in the blister, after CAD. The expiration date is the last day of the month indicated.

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

Composition of Fluoxetina VIR:

The active ingredient is fluoxetine, each capsule contains 20 mg of fluoxetine. The other components (excipients) are: pregelatinized cornstarch and dimethicone. The capsule components are: quinoline yellow (E-104), erythrosine (E-127), indigotin (E-132), and gelatin.

Appearance of the Product and Contents of the Package

Fluoxetina VIR is presented in the form of hard capsules with a yellow body and blue cap. It is presented in packages of 14, 28, or 60 hard capsules. Clinical package with 500 hard capsules.

Holder of the Marketing Authorization and Manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/. Laguna 66-68-70 28923 ALCORCÓN (Madrid) España

Tel.: 91 486 29 90Fax: 91 486 29 91

This leaflet was approved in December 2020

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