Fluoxetine Vir 20 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fluoxetina VIR 20 mg hard capsules EFG

Fluoxetine hydrochloride

In this leaflet:

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

1. What Fluoxetina Vir is and what it is used for

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

This medicine is indicated for the treatment of:

Adults:

• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia nervosa: Fluoxetina Vir is indicated as an adjunct to psychotherapy for the reduction of binge eating and purging episodes.

Children over 8 years of age and adolescents:

• Moderate to severe depressive episodes, when there is no response to psychological therapy after 4 to 6 sessions. Fluoxetina Vir should be offered to children or adolescents with moderate to severe depression only in combination with psychological therapy.

2. Before taking Fluoxetine VIR

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

If you are allergic (hypersensitive) to fluoxetine or to any of the other components of Fluoxetine VIR. An allergic reaction may include rash, itching, swelling of the face or lips, or difficulty breathing.

• If you are taking any medicine belonging to another type of medicines also used to treat depression, known as non-selective monoamine oxidase inhibitors or reversible monoamine oxidase inhibitors type A (also called MAOI-A), a serious or even fatal adverse reaction may occur.

Treatment with fluoxetine may only be started at least two weeks after stopping treatment with an irreversible MAO inhibitor (e.g. tranylcypromine).

However, treatment with fluoxetine may be started the day after stopping treatment with certain reversible MAO inhibitors, known as reversible MAO inhibitors called MAOI-A (e.g. moclobemide).

Do not take any MAOI for at least five weeks after stopping treatment with Fluoxetine VIR. If you have been prescribed Fluoxetine VIR for a long period of time and/or at a high dose, your doctor may consider the need for a longer interval before starting an MAOI. Examples of MAOIs are: nialamide, iproniazid, selegiline, moclobemide, phenelzine, tranylcypromine, isocarboxazid and toloxatone.

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Take special care with Fluoxetine VIR and inform your doctor or pharmacist if:

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

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

• If you have previously experienced mania, and have a manic episode, contact your doctor immediately; you may need to discontinue fluoxetine.

• If you have diabetes, your doctor may need to adjust your insulin or other antidiabetic treatment dosage.

• 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 elderly.

• If you are receiving electroconvulsive therapy (ECT).

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

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

• If you start experiencing fever, muscle stiffness or twitching, changes in mental state such as confusion, irritability, or extreme agitation, you may be experiencing a condition known as serotonin syndrome or neuroleptic malignant syndrome. Although rare, this syndrome can be life-threatening, so contact your doctor immediately; fluoxetine treatment may need to be discontinued.

If you have suicidal thoughts or thoughts of 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 condition improves. Since it may take 3 to 4 weeks after starting fluoxetine treatment before improvement occurs, your doctor will closely monitor you at the beginning of treatment. Other psychiatric conditions for which Fluoxetine 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 are more likely to have these types of thoughts:

• If you have previously had thoughts of ending your life or harming yourself.
• If you are a young adult.

Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

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

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

Some medicines in the group to which Fluoxetine VIR belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Use in children and adolescents aged 8 to 18 years:

Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this class of medicines. Fluoxetine VIR 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.

Furthermore, there is only limited information regarding the long-term safety of Fluoxetine VIR with respect to growth, puberty, and cognitive, emotional, and behavioural development in this age group. However, your doctor may prescribe Fluoxetine VIR to patients under 18 years of age for the treatment of moderate to severe depressive episodes in combination with psychological therapy when they consider it appropriate for the patient. If your doctor prescribes Fluoxetine VIR to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms mentioned above appear or worsen when patients under 18 years of age are taking Fluoxetine VIR.

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

Taking other medicines with Fluoxetine VIR

Inform your doctor or pharmacist if you are taking or have recently taken (within the last 5 weeks) any other medicines, including those obtained without a prescription. This medicine may affect the action of other medicines (interaction). Interactions may occur with:

• Monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression). Non-selective MAO inhibitors and MAO inhibitors known as MAOI-A (e.g. moclobemide) must not be used with Fluoxetine VIR, as serious or even fatal reactions (serotonin syndrome) may occur (see section "Do not take Fluoxetine VIR"). MAO inhibitors known as MAOI-B (selegiline) may be used with Fluoxetine VIR provided your doctor carefully monitors your treatment.

• Lithium, tryptophan: there is an increased risk of serotonin syndrome if these medicines are taken with Fluoxetine VIR. When fluoxetine is administered together with lithium, your doctor should monitor you more frequently.

• Phenytoin (a medicine used for epilepsy): Fluoxetine VIR may increase blood levels of this medicine, so your doctor should carefully adjust your phenytoin dosage when administered with Fluoxetine VIR and monitor you more frequently.

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

• Flecainide or encainide (for heart problems), carbamazepine (for epilepsy treatment), tricyclic antidepressants (e.g. imipramine, desipramine, amitriptyline), because Fluoxetine VIR may alter blood levels of these medicines, so your doctor may need to reduce their dosage when taken with Fluoxetine VIR.

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

• Do not start taking herbal preparations containing St. John's wort (Hypericum perforatum) while being treated with Fluoxetine VIR, as this may lead to an increase in adverse effects. If you are taking St. John's wort when starting treatment with Fluoxetine VIR, stop taking it and inform your doctor at your next visit.

Taking Fluoxetine VIR with food and drinks

• Fluoxetine VIR can be taken with or without food, as preferred.

• Alcohol consumption is not recommended while taking this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Pregnancy

Current information does not indicate an increased risk when this medicine is used 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 feeding or sleeping.

In babies whose mothers took fluoxetine during the first months of pregnancy, reports suggest a higher risk of congenital heart defects. In the general population, approximately 1 in every 100 babies is born with a heart defect. This risk increased to about 2 in every 100 in babies whose mothers took fluoxetine. You and your doctor may decide that it is better to gradually discontinue fluoxetine during pregnancy. However, depending on your circumstances, your doctor may recommend continuing fluoxetine.

Ensure that your midwife and/or doctor know that you are taking FLUOXETINE VIR. Medicines such as FLUOXETINE VIR, when taken during pregnancy, particularly during the last 3 months, 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 appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take Fluoxetine VIR in the late 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 be aware that you are taking Fluoxetine VIR so they can advise you accordingly.

Breastfeeding

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

Animal studies have shown that fluoxetine reduces sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

Driving and use of machines

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

3. How to take Fluoxetina Vir

Follow exactly the dosing instructions for Fluoxetina VIR provided by your doctor. Consult your doctor or pharmacist if you have any questions. The usual dose is:

• Depression: The recommended initial dose is 20 mg. Your doctor may review and adjust your dose as necessary within the first 3 to 4 weeks of starting treatment. If needed, the dose may be gradually increased up to a maximum of 60 mg. The dose should be carefully increased to ensure you receive the lowest effective dose. You may not feel immediate improvement when starting your antidepressant medication. This is common, as symptom improvement typically 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. If necessary, the dose may be gradually increased up to a maximum of 60 mg. If no improvement is observed within 10 weeks, treatment with Fluoxetina VIR should be reconsidered.

• 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. After one or two weeks, your doctor may increase the dose to 20 mg/day. The dose should be carefully increased to ensure the patient remains on the lowest effective dose. Children with low body 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, dose increases by your doctor should be made more cautiously, and the daily dose generally should not exceed 40 mg. The maximum dose is 60 mg per day.

If you have liver problems or are taking other medications that may affect fluoxetine, your doctor will decide whether to prescribe a lower dose or instruct you to take Fluoxetina VIR on alternate days.

Method of administration

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 immediately to the nearest hospital emergency department or contact your doctor right away.

• If possible, bring the Fluoxetina VIR packaging with you.

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

Symptoms of overdose include: nausea, vomiting, seizures, cardiac problems (such as irregular heartbeat or cardiac arrest), respiratory problems, and changes in mental status ranging from agitation to coma.

If you forget to take Fluoxetina VIR

• Do not worry if you miss a dose. Take your next dose the following day at the usual time. Do not take a double dose to make up for missed doses.

• Taking your medication at the same time each day may help you remember to take it regularly.

If you stop taking Fluoxetina VIR

Do not stop taking Fluoxetina VIR unless your doctor has instructed you to do so. It is important that you continue taking your medication.

• Do not stop taking your medication without first consulting your doctor, even if you begin to feel better.

• Make sure you do not run out of medication.

You may experience the following symptoms when stopping treatment with Fluoxetina VIR: dizziness, tingling sensations like pins and needles, sleep disturbances (vivid dreams, nightmares, insomnia), feelings of restlessness or agitation, unusual tiredness or weakness, anxiety, nausea and/or vomiting, tremors (shakiness), and headache.

Most people find that symptoms occurring when stopping Fluoxetina VIR are mild and resolve on their own within a few weeks. If you experience these symptoms when discontinuing treatment, consult your doctor.

When stopping treatment with Fluoxetina VIR, 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 further questions about the use of Fluoxetina VIR, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Fluoxetina VIR may have adverse effects, although not everyone experiences them.

• If you develop a skin rash or allergic reactions such as itching, swelling of the face or lips, or difficulty breathing, stop taking the capsules and inform your doctor immediately.

• If you feel restless and as though you cannot sit still or remain motionless, you may be experiencing a condition called akathisia; increasing your dose of Fluoxetina VIR could worsen this. If you feel this way, consult your doctor.

• Contact your doctor immediately if your skin starts to redden and then blisters or begins to peel off. This occurs very rarely.

Some patients have experienced:

• A combination of symptoms (known as serotonin syndrome) including fever of unknown cause with increased heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation, or drowsiness (only very rare);

• Feeling of weakness, drowsiness, or confusion, mainly in elderly patients and those treated with diuretics (elderly);

• Prolonged and painful erection.

• Irritability and extreme agitation.

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

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

• General disorders: feeling cold, light sensitivity, weight loss.

• Gastrointestinal system: diarrhea and stomach discomfort, vomiting, indigestion, difficulty swallowing, altered sense 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, uncontrolled movements, seizures, extreme restlessness, hallucinations, unusually reckless behavior, confusion, agitation, anxiety, nervousness, inability to concentrate and think clearly, panic attacks, or thoughts of suicide or self-harm.

• Urogenital and reproductive system disorders: difficulty urinating, increased frequency of urination, sexual dysfunction, prolonged erections, and production of breast milk. Frequency not known: heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see «Pregnancy»1 in section 2 for more information.

• Respiratory system: sore throat, breathing difficulties. Pulmonary changes (including inflammatory processes and various histopathological processes and/or fibrosis) have been reported rarely.

• Other: hair loss, yawning, blurred vision, unexplained bruising or bleeding, sweating, hot flushes, dizziness upon standing, muscle or joint pain, low levels of sodium in the blood.

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

Additionally, in children and adolescents (8 to 18 years of age) – fluoxetine may reduce growth or delay sexual maturation.

If you notice any adverse effects not listed in this leaflet, or if you experience any of the described side effects severely, inform your doctor or pharmacist.

5. Storage of Fluoxetine VIR

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Fluoxetine VIR after the expiry date stated on the packaging or on the blister, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition of Fluoxetina VIR:

The active substance is fluoxetine; each hard capsule contains 20 mg of fluoxetine. The other components (excipients) are: pregelatinized corn starch and dimethicone. The capsule components are: quinoline yellow (E-104), erythrosine (E-127), indigo carmine (E-132), and gelatin.

Appearance of the product and contents of the package

Fluoxetina VIR is presented as hard capsules with a yellow body/blue cap. It is available in packages containing 14, 28 or 60 hard capsules. Clinical pack with 500 hard capsules.

Marketing Authorization Holder and Manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

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

This leaflet was approved in December 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es