Fluoxetine Viatris 20 mg hard capsules EFG: detailed information

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Fluoxetina Viatris 20 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

What Fluoxetina Viatris is and what it is used for
What you need to know before taking Fluoxetina Viatris
How to take Fluoxetina Viatris
Possible side effects
How to store Fluoxetina Viatris
Contents of the pack and other information

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

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

Fluoxetina Viatris belongs to a group of medicines 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).
Bulimia nervosa, an eating disorder. This medicine is indicated as an adjunct to psychotherapy for the reduction of binge eating and purging.

Children over 8 years of age 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 psychological therapy.

2. What you need to know before taking Fluoxetina Viatris

Do not take Fluoxetina Viatris:

If you are allergic to fluoxetine or to any of the other ingredients of this medicine (listed in section 6). If you develop a rash or any other type of allergic reaction (such as 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 medicines specifically known as irreversible non-selective monoamine oxidase inhibitors (MAOIs), as a serious or even fatal reaction may occur. An example is iproniazid, used to treat depression.

Treatment with fluoxetine may only be started at least two weeks after stopping treatment with an irreversible MAOI (such as tranylcypromine).

Do not take any MAOI for at least 5 weeks after stopping fluoxetine treatment. If you have been prescribed fluoxetine for a long period of time and/or at a high dose, your doctor may consider the need for a longer interval.

Warnings and precautions

Talk to your doctor or pharmacist before starting fluoxetine:

If you have epilepsy or seizures. If you experience seizures or an increase in their frequency, contact your doctor immediately: you may need to stop treatment with fluoxetine.
If you currently have or have previously had mania. If you experience a manic episode, contact your doctor immediately, as you may need to stop 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 due to severe prolonged diarrhoea, vomiting, or use of diuretics (water tablets).
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, develop unusual bruising or bleeding, or if you are pregnant (see "Pregnancy, breastfeeding and fertility").
If you have glaucoma (increased pressure in the eye).
If you are taking other medicines. See below, "Other medicines and Fluoxetina Viatris".
If you begin to feel restless and unable to sit or stand still (akathisia). Increasing the dose of fluoxetine may worsen this condition.
If you begin to experience fever, muscle stiffness, or tremors, or changes in your mental state such as confusion, irritability, and extreme agitation. In such cases, you may be experiencing what is known as "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 stop treatment with fluoxetine.

Some medicines in the same class as Fluoxetina Viatris (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

If you are unsure about which medicines you are currently taking, consult your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder

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

You are more likely to have such thoughts:

If you have previously had thoughts of harming yourself or of suicide.
If you are a young adult. Clinical trial data have shown a higher risk of suicidal behaviour in psychiatric patients under 25 years of age being treated with an antidepressant.

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

It may be helpful 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 to inform you if they think your depression or anxiety is worsening or if they are concerned about changes in your behaviour.

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 thoughts, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Fluoxetine should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe depressive episodes (in combination with psychological therapy) and should not be used to treat other conditions.

In addition, there is only limited information on the long-term safety of fluoxetine with regard to growth, puberty, and cognitive, emotional, and behavioural development in this age group. However, your doctor may prescribe fluoxetine 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 appropriate for the patient. If your doctor prescribes fluoxetine 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 while patients under 18 years of age are taking fluoxetine.

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

Other medicines and Fluoxetina Viatris

Tell your doctor or pharmacist if you are taking, have recently taken (within the last 5 weeks), or might need to take any other medicines.

Do not take fluoxetine with:

Certain irreversible non-selective monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Irreversible non-selective MAO inhibitors should not be used with fluoxetine, as serious or even fatal reactions (serotonin syndrome) may occur (see section "Do not take Fluoxetina Viatris"). Treatment with fluoxetine should only be started at least 2 weeks after discontinuation of an irreversible non-selective MAOI (e.g. tranylcypromine). Do not take any irreversible non-selective MAOI for at least 5 weeks after stopping fluoxetine treatment. If you have been prescribed fluoxetine for a long period of time and/or at a high dose, your doctor may consider the need for a longer interval than 5 weeks before taking an MAOI.
Metoprolol when used for heart failure, as it increases the risk of excessive slowing of the heartbeat.

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

Certain medicines known as monoamine oxidase A inhibitors (MAO-A), used to treat depression and Parkinson's disease, including moclobemide, linezolid (an antibiotic), and methylene blue chloride (also called methylene blue, used to treat a blood disorder known as methemoglobinemia): due to the risk of serious and even fatal adverse reactions (called serotonin syndrome).
Lithium, tryptophan, opioids (e.g., buprenorphine, tramadol), selegiline, St. John's wort, or other medicines known as triptans (e.g., sumatriptan, zolmitriptan). These medicines may interact with fluoxetine, and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.
Phenytoin (for epilepsy), as fluoxetine may alter blood levels of this medicine; your doctor may need to adjust the dose of phenytoin and should monitor you when it is taken with fluoxetine.
Flecainide, propafenone, or nebivolol (for heart problems), atomoxetine (for attention deficit hyperactivity disorder, ADHD), carbamazepine (for epilepsy), risperidone (for mental illnesses), tricyclic antidepressants (e.g., imipramine, desipramine, and amitriptyline), as fluoxetine may alter blood levels of these medicines, so your doctor may need to reduce their doses when fluoxetine is administered.
Tamoxifen (used to treat breast cancer), as fluoxetine may alter blood concentrations of this medicine and a reduction in the effect of tamoxifen cannot be ruled out. Your doctor should consider other antidepressant treatment options.
Medicines that affect heart rhythm (antiarrhythmics), e.g., procainamide, disopyramide, sotalol; antipsychotics (e.g., phenothiazines, pimozide, haloperidol); tricyclic antidepressants; certain antibiotics (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, and pentamidine); antimalarial treatments (especially halofantrine); certain antihistamines used to treat allergies (astemizole and mizolastine), as taking one or more of these medicines with fluoxetine may increase the risk of changes in the heart's electrical activity.
Mequitazine or cyproheptadine, medicines 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 medicines on blood. Your doctor will need to perform certain blood tests, adjust your dose, and monitor you more frequently if you start or stop fluoxetine treatment while taking warfarin.
Medicines that reduce sodium levels in the blood, e.g., oxcarbazepine, used to treat epilepsy; desmopressin, used for certain hormonal problems; diuretics (medicines that increase urine production).
Medicines that may increase the risk of seizures, such as other SSRI antidepressants (e.g., sertraline, citalopram, paroxetine), medicines for nausea and dizziness (e.g., perfenazine, prochlorperazine, chlorpromazine), certain medicines for mental illnesses called butyrophenones (e.g., benperidol, haloperidol), mefloquine or chloroquine (for malaria), or bupropion (for depression or nicotine dependence).

Taking Fluoxetina Viatris with alcohol

You should avoid alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

When fluoxetine is taken during pregnancy, particularly during the last 3 months, medicines 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 begin within the first 24 hours after birth. If this happens to your baby, you must 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 discontinue fluoxetine during pregnancy or before becoming pregnant. However, depending on your circumstances, your doctor may suggest it is better for you to continue taking fluoxetine.

Caution should be exercised when using fluoxetine during pregnancy, especially during the third trimester or just before delivery, as the following effects have been reported in newborns: irritability, tremors, muscle weakness, persistent crying, difficulty feeding or sleeping.

If you take fluoxetine 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 informed that you are taking fluoxetine so they can advise you accordingly.

Breastfeeding

Fluoxetine passes into 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.

Fertility

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

Driving and using machines

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

Fluoxetina Viatris contains lactose

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

3. How to take Fluoxetina Viatris

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in 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) daily.

If necessary, your doctor may review and adjust your dose after 3 or 4 weeks of starting treatment. When considered necessary, the dose may be gradually increased up to a maximum of 60 mg daily (3 capsules). The dose should be increased carefully to ensure you receive the lowest effective dose. You may not feel immediate improvement after starting the medication for depression. This is common, as depressive symptoms do not usually begin 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) daily. If there is no improvement after 2 weeks, your doctor may gradually increase the dose up to the maximum recommended dose of 60 mg (3 capsules) daily. If no improvement is observed within 10 weeks, your doctor should reconsider the treatment.
Bulimia nervosa: the recommended dose is 3 capsules (60 mg) daily.

Elderly patients:

Your doctor will increase the dose more cautiously, and the daily dose must not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) daily.

Patients with liver problems:

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

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

Treatment must be initiated and supervised by a specialist.

The initial dose is 10 mg daily. After one or two weeks, your doctor may increase the dose to 20 mg daily. The dose should be increased carefully to ensure the patient remains on the lowest effective dose. Children with low body weight may require lower doses. If a satisfactory response to treatment is achieved, your doctor should re-evaluate the need to continue treatment after 6 months. If no improvement is observed within 9 weeks, your doctor should reconsider your treatment.

If you take more Fluoxetina Viatris than you should

In case of overdose or accidental ingestion, go immediately to the nearest hospital emergency department, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Fluoxetina Viatris

If you miss a dose, do not worry. 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 medicine at the same time each day may help you remember to take it regularly.

If you stop taking Fluoxetina Viatris

Do not stop treatment with fluoxetine without first consulting your doctor, even if you start to feel better. It is important that you continue taking your medication.
Make sure you do not run out of capsules.

At the end of your treatment with fluoxetine, you may experience the following symptoms (withdrawal symptoms): dizziness, tingling sensations, sleep disturbances (vivid dreams, nightmares, insomnia); feeling restless or agitated, unusual tiredness or weakness, anxiety, nausea/vomiting (feeling sick or being sick), tremors (shakiness), and headaches.

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

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

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

4. Possible adverse effects

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

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

Uncommon (may affect up to 1 in 100 people)

Thoughts of harming yourself or of suicide at any time (see section 2, "Suicidal thoughts and worsening of depression or anxiety disorder").

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

Severe allergic reactions. These reactions may occur as anaphylaxis (a severe form of allergic reaction) with symptoms such as:
Itching.
Swelling of the face, lips, mouth, tongue, or throat (angioedema).
Sudden wheezing, fainting, or difficulty swallowing.
- Fever, rapid swelling of tissues around the neck, face, mouth, and/or throat, skin rash, swollen lymph nodes (serum sickness).
- If you feel restless and unable to stay still, you may have akathisia; increasing the dose of fluoxetine may make you feel worse.
- Skin rash, blisters resembling small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme).
- Widespread rash with blisters and peeling of the skin, particularly around body surfaces, mouth, nose, eyes, and genitals (toxic epidermal necrolysis, Stevens-Johnson syndrome).
- Seizures (fits).
- Low sodium levels in the blood, which may lead to weakness and muscle wasting. This may be due to a disturbance in the secretion of antidiuretic hormone, a hormone that causes the body to retain water, thereby diluting the blood and reducing sodium levels.
- Frequent infections with fever, chills, sore throat, or mouth ulcers (reduction in the number of white blood cells).
- Lung problems, scarring and thickening of the lungs with shortness of breath.
- Liver problems with the following signs: feeling unwell, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes (jaundice), pale stools, dark urine.
- A combination of symptoms (known as "serotonin syndrome") including fever of unknown cause with increased breathing or pulse rate, sweating, muscle stiffness or tremors, confusion, irritability, extreme agitation, or drowsiness.
- Prolonged and painful erection.
Heart problems, such as rapid or irregular heartbeat, fainting, falls, dizziness upon standing, which may indicate abnormal heart rhythm function.

Other possible adverse effects

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

Difficulty sleeping (insomnia).
Headache.
Diarrhea, stomach discomfort (nausea).
Tiredness (fatigue), 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).
Trouble sleeping, abnormal dreams (including nightmares).
Tiredness or drowsiness.
Dizziness.
Altered sense of taste.
Uncontrollable tremors.
Blurred vision.
Fast and irregular heartbeat; other changes in the heart's electrical activity known as QT prolongation, which can be seen on an ECG, a test that records the heart's electrical activity.
Hot flushes.
Yawning.
Indigestion, vomiting.
Dry mouth.
Rash, hives, itching.
Excessive sweating.
Joint pain.
Increased frequency of urination.
Vaginal bleeding of unknown cause.
Feeling agitated, chills.

Uncommon (may affect up to 1 in 100 people)

Feeling detached or distant from oneself.
Memory problems.
Strange thoughts.
Euphoria.
Ringing in the ears (tinnitus).
Nosebleeds.
Problems with orgasm.
Teeth grinding.
Muscle twitching, 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.
Pain when urinating.
Sensation of cold or heat.
General discomfort/abnormal feeling.
Increased liver enzymes in a blood test.

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

Unusually uninhibited behavior.
Seeing, feeling, or hearing things that do not exist (hallucinations).
Agitation.
Panic attacks.
Aggression.
Confusion.
Stuttering or stammering.
Inflammation of blood vessels (vasculitis).
Dilation of blood vessels.
Pain in the esophagus, the part of the digestive tract that carries food or water to the stomach.
Sensitivity to sunlight.
Milk production from the breasts.
Increased level of prolactin (a hormone) in the blood.
Urinary disturbances.
Sore throat and discomfort when swallowing.
Muscle pain.
Bruising.
Bruising or bleeding without apparent cause.
Difficulty urinating.
Bleeding from mucous membranes lining areas such as the mouth and nose.

Frequency not known (cannot be estimated from available data)

Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage). For more information, see Pregnancy, breastfeeding and fertility in section 2.

Bone fractures: an increased risk of bone fractures has been observed in patients taking this type of medicine.

If you experience any of the listed symptoms and they are troublesome or persist over time, inform your doctor or pharmacist.

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

Adverse effects in children and adolescents (8 to 18 years of age)

The following adverse effects were observed only in children and adolescents:

Delay in growth or possible delay in sexual maturation.

The following adverse effects were frequently observed in children and adolescents:

Changes in behavior such as acting without thinking, anger, and irritability.
Changes in mood such as aggression and agitation.
Thoughts of self-harm or suicide, or suicide attempts.
Nosebleeds.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluoxetine Viatris

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container, blister pack, or bottle after EXP or CAD. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Fluoxetine Viatris

The active substance is fluoxetine hydrochloride.

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

The other components are: lactose (see section 2, “Fluoxetine Viatris contains lactose”), corn starch, anhydrous colloidal 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 black iron oxide (E172).

Nature of the product and contents of the pack

Fluoxetine Viatris is presented as hard gelatin capsules with a light green opaque body and a purple opaque cap, printed in black ink with “FL20” on the body and “?” on the cap.

Fluoxetine Viatris is available in high-density polyethylene (HDPE) bottles with a polypropylene child-resistant screw cap containing 7, 10, 14, 20, 28, 30, 50, 60, 90 and 100 hard capsules.

Fluoxetine 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 certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

McDermott Laboratories Ltd. t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland

Viatris Sante
360 Avenue Henri Schneider
69330 Meyzieu
France

Mylan B.V.
Krijgsman 20
1186 DM Amstelveen
The Netherlands

EUROPEENNE DE PHARMACOTECHNIE - EUROPHARTECH
Rue Henri Matisse
63370 LEMPDES
France

Mylan Hungary Kft/Mylan Hungary Ltd
Mylan utca 1
2900, Komárom
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised in the European Economic Area (EEA) member states under the following names:

Germany Fluoxetin dura 20 mg
Austria Fluoxetin ‘Arcana’ 20 mg – Kapseln
Belgium Fluoxetine Mylan 20 mg harde capsules
Denmark Fluoxetine Mylan
Spain Fluoxetina Viatris 20 mg hard capsules EFG
France Fluoxétine Viatris 20 mg, gélule
Greece Fluoxetine/Mylan CAP 20 mg/CAP
Ireland Gerozac 20 mg Capsules hard
Italy Fluoxetina Mylan Generics
Luxembourg Fluoxetine Mylan 20 mg harde capsules
The Netherlands Fluoxetine Mylan 20 mg, capsules
Portugal Fluoxetina Mylan
United Kingdom Fluoxetine Capsules 20 mg

Date of the most recent review of this leaflet: July 2021

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