Fluoxetine Viatris 20 mg orodispersible tablets EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fluoxetina Viatris 20 mg dispersible tablets EFG

Fluoxetine hydrochloride

Read the entire leaflet carefully before you start taking 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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

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

This medicine is indicated for the treatment of:

Adults:

Severe depressive episodes.
Symptoms of a condition called obsessive-compulsive disorder.
Bulimia nervosa eating disorder: fluoxetine is indicated as an adjunct to psychotherapy for reducing binge eating and purging.

Children over 8 years of age and adolescents:

For moderate to severe depressive episodes, when 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.

How fluoxetine works

Everyone has a substance in the brain called serotonin. People who are depressed or have obsessive-compulsive disorder or bulimia nervosa have lower levels of serotonin than others. The exact way fluoxetine and other SSRIs work is not fully understood, but they may help by increasing serotonin levels in the brain.

Treating these conditions is important to help achieve improvement. If left untreated, your condition may not resolve and could become more severe and harder to treat.

You may need to be treated for several weeks or months to ensure you are symptom-free.

2. What you need to know before taking Fluoxetina Viatris

Do not take Fluoxetina Viatris

If you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you develop a rash or any other allergic reaction (such as itching, swelling of the face or lips, or difficulty breathing), stop taking the tablets immediately and contact your doctor as soon as possible.
If you are taking other medicines known as irreversible non-selective monoamine oxidase inhibitors (MAOIs), as this may cause a serious or even fatal adverse reaction (for example, iproniazid, used to treat depression).

Treatment with fluoxetine should only be started at least 2 weeks after stopping treatment with an irreversible non-selective MAOI (e.g., tranylcypromine).

Do not take any irreversible non-selective MAOI for at least five 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 before starting an MAOI. Examples of MAOIs include: nialamide, iproniazid, selegiline, moclobemide, phenelzine, tranylcypromine, isocarboxazid, and toloxatone.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking fluoxetine:

If you develop skin rashes or other allergic reactions (such as itching, swelling of the face or lips, or difficulty breathing), stop taking the dispersible tablets and contact your doctor immediately.
If you have heart disease.
If you start experiencing fever, muscle stiffness, or tremors, or changes in your mental state such as confusion, irritability, or extreme agitation; you may be experiencing "serotonin syndrome" or "neuroleptic malignant syndrome." Although rare, this condition can be life-threatening. Contact your doctor immediately, as you may need to discontinue treatment with fluoxetine.
If you have mania or have had mania in the past; if you experience a manic episode, contact your doctor immediately, as you may need to stop treatment with fluoxetine.
If you have a history of bleeding disorders, if you develop unusual bruising or bleeding, or if you are pregnant (see "Pregnancy").
If you are taking medicines that affect blood clotting (see "Other medicines and Fluoxetina Viatris").
If you have epilepsy or seizures. If you have had seizures or notice an increase in their frequency, contact your doctor immediately; you may need to stop treatment with fluoxetine.
If you are receiving electroconvulsive therapy (ECT).
If you are being treated with tamoxifen (used to treat breast cancer) (see "Other medicines and Fluoxetina Viatris").
If you start feeling restless and unable to sit still or remain motionless (akathisia). Increasing your fluoxetine dose may worsen this.
If you have diabetes, your doctor may need to adjust your insulin or other antidiabetic treatment.
If you have liver problems, your doctor may need to adjust your dose.
If you have a slow resting heart rate and/or if you know you may lose salts due to prolonged severe diarrhea, vomiting, or use of diuretics ("water pills").
If you are taking diuretics ("water pills"), especially if you are elderly.
If you have glaucoma (increased intraocular pressure).
Some medicines in the same class as fluoxetine (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of self-harm or suicide. These thoughts may increase when you first start taking antidepressants, as all these medicines take time to work—usually about two weeks, although sometimes longer.

You may be more likely to have such thoughts:

If you have previously had suicidal or self-harming thoughts.
If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in psychiatric patients under 25 years of age treated with antidepressants.

If at any time you have thoughts of suicide or self-harm, contact your doctor or go directly to the 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 has worsened or if they are concerned about changes in your behavior.

Children and adolescents

Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, 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 for other indications in this age group.

Furthermore, there is only limited information available regarding the long-term safety of fluoxetine with respect to growth, puberty, and cognitive, emotional, and behavioral development in this age group. However, if you are under 18 years of age, your doctor may prescribe fluoxetine for the treatment of moderate to severe depressive episodes in combination with psychological therapy if they consider it appropriate. 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 must not be used in children under 8 years of age.

Other medicines and Fluoxetina Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Fluoxetina Viatris with:

Certain irreversible non-selective monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Non-selective MAOIs and MAO inhibitors known as type A MAOIs (such as moclobemide) must not be taken with fluoxetine, as this may cause serious or even fatal reactions (serotonin syndrome) (see section "Do not take Fluoxetina Viatris").
MAO inhibitors known as MAO-B inhibitors (selegiline) may be taken with fluoxetine, provided your doctor carefully monitors your treatment.
Treatment with fluoxetine should only be started at least 2 weeks after stopping 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 time and/or at a high dose, your doctor may consider the need for a longer interval before starting an MAOI.
Metoprolol when used for heart failure, as this increases the risk of excessive slowing of the heartbeat.

Fluoxetine may affect the action of other medicines (interactions):

Tamoxifen (used to treat breast cancer), as fluoxetine may alter blood levels of this medicine and a reduction in tamoxifen's effect cannot be ruled out. Your doctor should consider alternative antidepressant treatments.
Monoamine oxidase A inhibitors (MAO-A inhibitors) including moclobemide, linezolid (an antibiotic), and methylene blue chloride (also known as methylene blue, used to treat mild conjunctivitis, eye itching, and irritation): due to the risk of serious or even fatal adverse reactions (called serotonin syndrome). Fluoxetine treatment may be started the day after stopping reversible MAO inhibitors, but your doctor should carefully monitor you and may use a lower dose of the MAO-A inhibitor.
Mequitazine (used to treat allergies); as taking this medicine with fluoxetine may increase the risk of changes in the heart's electrical activity.
Phenytoin (a medicine used for epilepsy); fluoxetine may increase blood levels of this medicine, so your doctor should monitor and adjust phenytoin dosage more carefully when given with fluoxetine and perform more frequent check-ups.
Lithium, buprenorphine, selegiline, St. John's wort, tramadol (an analgesic), triptans (for migraine), and tryptophan: there is an increased risk of mild serotonin syndrome if these medicines are taken with fluoxetine. Your doctor should monitor you more frequently.
Medicines that may affect heart rhythm, for example, antiarrhythmics of classes IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine), antimalarial treatments, particularly halofantrine, or certain antihistamines (astemizole, mizolastine); taking one or more of these medicines with fluoxetine may increase the risk of changes in the heart's electrical activity.
Anticoagulants (such as warfarin), NSAIDs (such as ibuprofen, diclofenac), aspirin, or other medicines that affect blood clotting (including clozapine, used to treat certain mental disorders); fluoxetine may alter the effect of these medicines on blood. Your doctor will need to perform certain blood tests if you start or stop fluoxetine treatment while taking warfarin.
Cyproheptadine (used to treat allergies); as it may reduce the effect of fluoxetine.
Medicines that reduce blood sodium levels (including medicines that increase urination such as desmopressin, carbamazepine, and oxcarbazepine); as these medicines may increase the risk of abnormally low blood sodium levels when taken with fluoxetine.
Antidepressants such as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquine or chloroquine (used to treat malaria), tramadol (used to treat severe pain), or antipsychotics such as phenothiazines or butyrophenones; as fluoxetine may increase the risk of seizures when taken with these medicines.
Flecainide, propafenone, nebivolol, or encainide (for heart problems), carbamazepine (for epilepsy), atomoxetine, or tricyclic antidepressants (e.g., imipramine, desipramine, and amitriptyline) or risperidone (for schizophrenia); as fluoxetine may alter blood levels of these medicines, your doctor may need to reduce their dose when administered together with fluoxetine.

Taking Fluoxetina Viatris with food, drinks, and alcohol

Fluoxetine may be taken with or without food, as preferred.
Alcohol consumption is not recommended while taking this medicine.

Pregnancy, breastfeeding and fertility

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

Pregnancy

In babies whose mothers took fluoxetine during the first months of pregnancy, some studies have reported an increased risk of congenital defects affecting the heart. In the general population, approximately 1 in every 100 babies is born with a cardiac defect. This figure increased to about 2 in every 100 babies of mothers who took fluoxetine.

When taken during pregnancy, especially 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), which causes the baby to breathe faster and appear bluish in colour. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

If you take fluoxetine late in 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 so they can advise you appropriately.

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 individual circumstances, your doctor may advise that it is better for you to continue taking fluoxetine.

Caution should be exercised when taking fluoxetine during pregnancy, particularly during the last stage of pregnancy or shortly before delivery, as the following effects have been reported in newborn infants: irritability, tremor, muscle weakness, persistent crying, difficulty feeding or sleeping.

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.

Fertility

Animal studies have shown that fluoxetine reduces sperm quality. Reported cases in humans with SSRIs have indicated that the effect on sperm quality is reversible.

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

Driving and use of machines

Psychotropic medicines such as fluoxetine may affect your judgment or coordination. Do not drive or operate machinery until you know how fluoxetine affects you.

Fluoxetina Viatris contains sodium

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

3. How to take Fluoxetine Viatris

Follow exactly the dosing instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Do not take more tablets than prescribed by your doctor.

Swallow the tablets with half a glass of water or dissolved in half a glass of water, which should be swallowed immediately and completely. Do not chew them.

Adults:

The recommended dose is:

Depression: The recommended dose is 1 tablet (20 mg) daily. Your doctor may review and adjust your dose if necessary, within the first 3 to 4 weeks of starting treatment. When necessary, the dose may be gradually increased up to a maximum of 3 tablets (60 mg) daily. The dose should be increased carefully to ensure you receive the lowest effective dose. You may not feel better immediately when starting your antidepressant medication. This is common, as improvement in depressive symptoms 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 3 tablets (60 mg) daily.
Obsessive-compulsive disorder: The recommended dose is 1 tablet (20 mg) daily.

Your doctor may review and adjust the dose after two weeks of treatment. When necessary, the dose may be gradually increased up to a maximum of 3 tablets (60 mg) daily. If no improvement is observed within the following 10 weeks, your doctor will reconsider your treatment.

Children and adolescents aged 8 to 18 years with depression:

Treatment should be initiated and supervised by a specialist. The initial dose is 10 mg/day (administered as 2.5 ml of an oral fluoxetine solution formulation). After one or two weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased carefully to ensure you receive the lowest effective dose. Children with low body weight may require lower doses. If there is a satisfactory response to treatment, your doctor should re-evaluate the need to continue treatment after 6 months. If there is no improvement within 9 weeks, treatment should be reconsidered.

Elderly patients:

Dose increases prescribed by your doctor should be carried out more cautiously, and the daily dose should generally not exceed 2 tablets (40 mg). The maximum dose is 3 tablets (60 mg) daily.

Patients with liver problems:

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

If you take more Fluoxetine 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 91 562 04 20, stating the medicine and the amount ingested. If possible, bring the Fluoxetine Viatris packaging with you.

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

If you forget to take Fluoxetine Viatris

Do not worry if you miss a dose. Take the next dose the following day at your 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 Fluoxetine Viatris

Do not stop taking fluoxetine unless your doctor tells you to, even if you start to feel better. It is important that you continue taking your medicine.
Make sure you do not run out of medication.

You may experience the following effects (withdrawal symptoms) when stopping treatment with fluoxetine: 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 (feeling sick or being sick), tremors (shakiness), and headache.

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

When stopping treatment with fluoxetine, your doctor will help you gradually reduce the dose over one to two weeks—this will help reduce the likelihood of withdrawal effects.

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

4. Possible adverse effects

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

If you have suicidal thoughts or thoughts of self-harm at any time, contact your doctor or go directly to hospital (see section 2).
If you develop a skin rash or allergic reactions such as itching, swelling of the lips/tongue, or wheezing/shortness of breath, stop taking the tablets and inform your doctor immediately.
If you feel restless and feel as though you cannot sit still or remain motionless, you may be experiencing a condition called akathisia; increasing your fluoxetine dose could make you feel worse. If you feel this way, consult your doctor.
Contact your doctor immediately if your skin starts turning red, develops any kind of reaction, blisters form, or your skin begins to peel. This occurs very rarely.

The most common adverse effects (very common side effects that may affect more than 1 in 10 people) are insomnia, headache, diarrhoea, discomfort (nausea), and fatigue.

Some patients have experienced:

A combination of symptoms (known as "serotonin syndrome"), including fever of unknown cause with increased breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation, or drowsiness (only in rare cases).
Feeling weak, drowsy, or confused, mainly in elderly patients and in people (elderly) treated with diuretics.
Prolonged and painful erection.
Irritability and extreme agitation.
Heart problems, such as fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm function.

If you experience any of the adverse effects described above, inform your doctor immediately.

The following adverse effects have also been reported in patients taking fluoxetine:

Common (may affect up to 1 in 10 people)

Loss of appetite, weight loss.
Nervousness, anxiety.
Restlessness, difficulty concentrating.
Feeling of nervous tension.
Decreased sex drive or sexual problems (including difficulty maintaining an erection during sexual activity).
Sleep disturbances, abnormal dreams, tiredness, drowsiness.
Dizziness.
Altered sense of taste.
Uncontrollable trembling movements.
Blurred vision.
Sensation of rapid or irregular heartbeat.
Flushing.
Yawning.
Indigestion, vomiting.
Dry mouth.
Skin rash, hives, itching.
Excessive sweating.
Joint pain.
Increased frequency of urination.
Unexplained vaginal bleeding.
Feeling of weakness or chills.

Uncommon (may affect up to 1 in 100 people)

Feeling detached or distant from oneself.
Strange thoughts.
Euphoria.
Orgasm problems.
Suicidal thoughts or self-harm.
Teeth grinding.
Muscle spasms, involuntary movements, or problems with balance or coordination.
Memory disturbances.
Dilated pupils.
Ringing in the ears.
Low blood pressure.
Difficulty breathing.
Nosebleeds.
Difficulty swallowing.
Weight loss.
Increased tendency to bruise.
Unexplained bruising or bleeding.
Cold sweats.
Difficulty urinating.
Sensation of heat or cold.
Abnormal liver function tests.

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

Low levels of sodium in the blood.
Reduction in platelets in the blood, increasing the risk of bleeding or bruising.
Reduction in white blood cell count.
Uncharacteristically reckless behaviour.
Hallucinations.
Agitation.
Panic attacks.
Confusion.
Stuttering.
Aggressiveness.
Seizures.
Vasculitis (inflammation of a blood vessel).
Rapid swelling of tissues around the neck, face, mouth, and/or throat.
Pain in the oesophagus (the tube connecting the mouth to the stomach).
Hepatitis.
Lung problems.
Sensitivity to sunlight.
Muscle pain.
Urination problems.
Production of breast milk.

Frequency not known (cannot be estimated from available data)

Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see "Pregnancy" in section 2 for more information.

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

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

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 blister and cardboard carton after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Fluoxetine Viatris

The active substance is fluoxetine in the form of fluoxetine hydrochloride.

The other components are: microcrystalline cellulose, corn starch, crospovidone, anhydrous colloidal silica, magnesium stearate, sodium saccharin, and mint powder.

Appearance of the product and contents of the container

White, convex, oval dispersible tablets, marked with FL/20 on one side and G on the other, available in packs containing 14, 28, or 500 dispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Mylan Hungary Kft

Mylan utca 1

2900 Komárom

Hungary

Date of the most recent review of this leaflet: July 2023

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