Prospecto: Information for the User

Fluoxetina Teva-Rimafar 20 mg Hard Capsules EFG

Fluoxetine Hydrochloride

1. What is Fluoxetina Teva-Rimafar and what is it used for

2. What you need to know before starting to take Fluoxetina Teva-Rimafar

3. How to take Fluoxetina Teva-Rimafar

4. Possible adverse effects

5. Storage of Fluoxetina Teva-Rimafar

6. Contents of the pack and additional information

Fluoxetina Teva-Rimafar contains the active ingredient fluoxetine which 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: Fluoxetine is indicated as a complement to psychotherapy for the reduction of binge eating and purging.

Older children and adolescents:

For moderate to severe depressive episodes, if there is no response to psychological therapy after4 to6 sessions. Fluoxetine should be offered to children or young people with moderate to severe depression only in combination with a psychological therapy.

How Fluoxetina Teva-Rimafar works

• Everyone has a substance called serotonin in their brain. 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.
• Treatment of these conditions is important to help improve. If not treated, your condition cannot disappear and may become more severe and harder to treat.

You may need to be treated for a few weeks or months to ensure you are free of symptoms.

Do not take Fluoxetina Teva-Rimafar

• if you are allergic to fluoxetine or any of the other ingredients in this medicine (listed in section 6).If you experience an allergic reaction (such as hives, itching, swelling of the face or lips, or difficulty breathing), stop taking the capsules immediately and contact your doctor as soon as possible..
• if you are taking other medicines known as irreversible non-selective monoamine oxidase inhibitors, as this may cause a serious or life-threatening reaction (for example, iproniazid used to treat depression).
• Fluoxetine Teva-Rimafar treatment can only be initiated after 2 weeks of completing a treatment with an irreversible non-selective MAO inhibitor.
• Do not takeany non-selective irreversible MAO inhibitor for at least 5 weeks after stopping treatment with Fluoxetine Teva-Rimafar. If you have been prescribed Fluoxetine Teva-Rimafar for a long period of time and/or a high dose, your doctor may consider a longer interval before taking an MAO inhibitor.
• if you are taking metoprolol (to treat heart failure), as this increases the risk of excessive slowing of the heart rate.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluoxetine Teva-Rimafar if you experience any of the following:

• If you have heart disease.
• If you begin to experience 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 "neuroleptic malignant syndrome." Despite the fact that this syndrome is rare, it can be life-threatening, so contact your doctor immediately, as you may need to discontinue treatment with fluoxetine.
• If you suffer from mania or have had mania in the past: if you experience a manic episode, contact your doctor immediately, as you may need to discontinue treatment with fluoxetine.
• If you have a history of bleeding disorders, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility") or experience unusual bleeding or bruising.
• If you have epilepsy or seizures. If you have had seizures or experience an increase in their frequency, contact your doctor immediately; you may need to discontinue treatment with fluoxetine.
• If you are receiving electroconvulsive therapy (ECT).
• If you are on long-term treatment with tamoxifen (used to treat breast cancer) (see "Taking Fluoxetine Teva-Rimafar with other medicines").
• If you begin to feel restless and cannot sit or stand still (akathisia). Increasing your fluoxetine dose may worsen it.
• 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 experience salt loss due to prolonged severe diarrhea and vomiting or the use of diuretics (diuretic tablets).
• If you are taking diuretics (diuretic tablets), especially if you are an elderly patient.
• Glaucoma (increased eye pressure).

Thoughts of suicide and worsening of depression or anxiety

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These may increase when you first start taking antidepressants, as all these medicines take time to start working, usually around 2 weeks, although sometimes a bit longer.

• You are more likely to think this way:
• 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.

You may find it helpful to tell a close relative or friend who is depressed or has an anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Children and adolescents aged 8 to 18 years

Young patients under 18 years have a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of 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 on the long-term safety of fluoxetine in relation to growth, puberty, and cognitive, emotional, and behavioral development in this age group. However, and if you are a patient under 18 years, your doctor may prescribe fluoxetine 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 this medicine to a patient under 18 years and wants to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when patients under 18 years are taking fluoxetine.

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

Sexual dysfunction

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

Taking Fluoxetine Teva-Rimafar with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Do not take Fluoxetine Teva-Rimafar with:

• certain irreversible non-selective monoamine oxidase inhibitors (MAOIs),some of which are used to treat depression.These MAOIs should not be used with fluoxetine as they may cause serious or even fatal reactions (serotonin syndrome), (see section “Do not take Fluoxetine Teva-Rimafar”).

Fluoxetine treatment should only be initiated at least 2 weeks after discontinuing an irreversible non-selective MAO inhibitor (for example, tranilcipromina.Do not takeany non-selective irreversible MAO inhibitor for at least 5 weeks after stopping treatment with Fluoxetine Teva-Rimafar. If you have been prescribed fluoxetine for a long period of time and/or a high dose, your doctor needs to consider the need for a longer interval before taking an MAO inhibitor.

• Metoprololwhen used to treat heart failure: as this increases the risk of excessive slowing of the heart rate.

Fluoxetine Teva-Rimafar may affect the action of other medicines (interaction):

• Tamoxifen(used to treat breast cancer); your doctor may need to consider a different antidepressant treatment because fluoxetine may change the levels of this medicine in the blood and it cannot be ruled out that the effect of tamoxifen is reduced,
• Monamine oxidase A inhibitors (MAO-A)), including moclobemide,linezolid(an antibiotic) andchlorpromazine(also called methylene blue used to treat methemoglobinemia
• induced by medicines or chemicals) due to the risk of serious or even fatal reactions (serotonin syndrome).You can start treatment with fluoxetine the day after finishing a treatment with reversible MAO inhibitors, but your doctor may monitor you closely and use a lower dose of the MAO-A inhibitor.
• Mequitazina (used to treat allergies); as taking this medicine with fluoxetine may increase the risk of changes in heart activity.
• Fenitoin(used to treat epilepsy): fluoxetine may increase the levels of this medicine in the blood, so your doctor will need to dose you more carefully and will need to monitor you more frequently
• Lithium, selegiline, St. John's Wort, tramadol, and buprenorphine(both for the treatment of intense pain);triptans(for the treatment of migraines) andtryptophan:there is an increased risk of mild serotonin syndrome if these medicines are administered with fluoxetine. Your doctor will monitor you more frequently.

• Medicines that can affect heart rhythm, e.g.,antiarrhythmic Class IA and III, antipsychotics(e.g., phenothiazines, pimozide, haloperidol),tricyclic antidepressants, someantimicrobial agents(e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine);malaria treatmentin particular halofantrine, someantihistamines(astemizol, mizolastina), as taking one or more of these medicines with fluoxetine may increase the risk of changes in heart activity.
• Anticoagulants(such as warfarin),NSAIDs(such as ibuprofen, diclofenac), aspirin, and other medicines that affect blood clotting (including clozapine, used to treat some mental disorders). Fluoxetine may alter the effect of these medicines on the blood. Your doctor will need to do some tests, adjust your dose, and monitor you more frequently if you start or stop taking fluoxetine while taking warfarin.
• Ciproheptadine(used to treat allergies), as it may reduce the effect of fluoxetine.
• Medicines that decrease sodium levels in the blood(including, diuretics that produce increased urine, desmopressin, carbamazepine, and oxcarbazepine), as the use of fluoxetine with these medicines may increase the risk of excessive decrease in sodium levels in the blood.

• Antidepressantssuch as antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion,mefloquineorchloroquine(used to treat malaria);tramadol(for the treatment of intense pain) orantipsychoticssuch as phenothiazines or butyrophenones; as taking fluoxetine with these medicines may increase the risk of seizures.

• Flecainide, encainide, propafenone, or nebivolol(for heart problems),carbamazepine(for epilepsy),atomoxetine ortricyclic antidepressants(e.g., imipramine, desipramine, and amitriptyline) orrisperidone(for schizophrenia) as fluoxetine may change the levels of these medicines in the blood, your doctor may need to reduce your dose when they are administered with fluoxetine.

Taking Fluoxetine Teva-Rimafar with food, drinks, and alcohol

Fluoxetine can be taken with or without food, as you prefer.

It is not recommended to take alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Studies in babies whose mothers took fluoxetine during the first months of pregnancy have described an increased 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.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Fluoxetine Teva-Rimafar 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 fluoxetine in the final 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 know that you are taking fluoxetine so they can advise you.

It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the potential risk. Therefore, you and your doctor may decide to gradually stop taking fluoxetine during pregnancy or before becoming pregnant. However, depending on your circumstances, your doctor may suggest that you continue taking fluoxetine.

Caution should be exercised when using during pregnancy, especially during the last stage of pregnancy or just before delivery, as the following effects have been reported in newborns: irritability, tremor, muscle weakness, persistent crying, difficulty breastfeeding or sleeping.

Breastfeeding

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.

Fertility

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

Driving and operating machinery

Medicines like fluoxetine can affect your judgment or coordination. Do not drive or operate machinery until you know how this medicine affects you.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not take more capsules than indicated by your doctor.

Adults

The recommended dose is:

• Depression: the initial recommended dose is 1 capsule (20 mg) per day. Your doctor may review and adjust your dose as necessary in the 3 to 4 weeks following the start of treatment. When necessary, this dose can be increased gradually up to a maximum of 3 capsules (60 mg) per day. The dose should be increased carefully to ensure that you receive the minimum effective dose. You may not feel better immediately when starting to take your medication for depression. This is common since there is no improvement in depressive symptoms 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 capsules (60 mg) per day.
• Obsessive-compulsive disorder: the recommended dose is 1 capsule (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 3 capsules (60 mg) per day. If no improvement is observed within 10 weeks, the treatment with fluoxetine should be reconsidered.

Use in children and adolescents from 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 increased carefully to ensure that you receive the minimum effective dose. Children with low weight may require lower doses. If you have a satisfactory response to treatment, your doctor should reevaluate the need to continue treatment after 6 months. If you have not improved in 9 weeks, treatment should be reconsidered.

Older adults

The dose increases made by your doctor should be carried out more carefully, and the daily dose should not generally exceed 40 mg (2 capsules). The maximum dose is 60 mg (3 capsules) per day.

Liver impairment

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

Administration form

Swallow the capsules with water. Do not crush them.

If you take more Fluoxetina Teva-Rimafar than you should

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

Take the packaging of fluoxetine with you.

Incaseofoverdoseoraccidental ingestionconsultyourdoctororpharmacistimmediatelyorcalltheToxicological Information Service,telephone915620420.

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

If you forgot to take Fluoxetina Teva-Rimafar

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 Teva-Rimafar

Do not stop taking fluoxetine unless your doctor has told you to, even if you start feeling better. It is essential that you continue taking your medication.

Make sure you do not run out of medication.

You may experience the following effects (withdrawal effects) when interrupting treatment with fluoxetine: dizziness, a sensation of pins and needles, sleep disturbances (intense dreams, nightmares, insomnia), a feeling of restlessness or agitation, unusual fatigue or weakness, anxiety, nausea, and/or vomiting, (feeling sick or being sick), tremors (instability), and headaches.

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

When interrupting treatment with fluoxetine, 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause 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 shortness of breath,stop taking the capsules and tell your doctor immediately.

• If you have thoughts of suicide or self-harm at any time, contact your doctor or go to the hospital immediately(see section 2).

• If you feel restless and feel like you cannot sit or stay still, you may be experiencing something called akathisia, and increasing your fluoxetine dose may make you feel worse. If you feel this way,consult your doctor.

• Tell your doctor immediatelyif your skin starts to redden or you experience any type of reaction or blisters appear, or if your skin starts to peel. This happens very rarely.

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

Some patients have experienced:

• A combination of symptoms (known as serotonin syndrome) that includes fever of unknown cause with an increase in breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation, or somnolence (rarely);
• Feeling weak, drowsy, or confused mainly in elderly patients and in people treated with diuretics (elderly patients);
• Prolonged and painful erection
• Irritability and extreme agitation
• Heart problems, such as rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm.

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

The following side effects have also been reported in patients treated with fluoxetine

Common (can affect up to 1 in 10 people)

• Loss of appetite, weight loss
• Nervousness, anxiety
• Restlessness, loss of concentration
• Sensation of nervous tension
• Decreased libido or sexual problems (including difficulty maintaining an erection during sexual activity)

• Sleep problems, unusual dreams, fatigue, or drowsiness
• Dizziness
• Alteration of taste
• Uncontrollable muscle tremors
• Blurred vision
• Sensation of rapid and irregular heartbeat
• Flush
• Yawning
• Indigestion, vomiting
• Dry mouth
• Urticaria, hives, itching
• Excessive sweating
• Joint pain
• Increased frequency of urination
• Unexplained vaginal bleeding
• Sensation of weakness, chills

• Feeling detached, distant from oneself
• Strange thoughts
• Euphoria

• Sexual problems, including orgasm problems, which may persist occasionally after treatment is stopped

• Thoughts of suicide or self-harm
• Grinding of teeth
• Muscle spasms, involuntary movements, or problems with balance or coordination
• Memory alterations
• Dilated pupils
• Noise in the ears
• Low blood pressure
• Difficulty breathing
• Nasal bleeding
• Difficulty swallowing
• Hair loss
• Increased tendency to bruise
• Unexplained bleeding or bruising
• Cold sweat
• Difficulty urinating
• Sensation of cold or heat
• Abnormal liver test results

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

• Low sodium levels in the blood
• Reduction in platelet count in the blood, which may increase the risk of bleeding or bruising,
• Reduction in white blood cell count
• Atypical, uncontrolled behavior
• Hallucinations
• Agitation
• Panic attacks
• Confusion
• Stammering
• Aggression
• Seizures
• Vasculitis (inflammation of a blood vessel)
• Quick swelling of tissues around the neck, face, mouth, and/or throat
• Esophageal pain (the tube that connects the mouth to the stomach)
• Heptatitis
• Lung problems
• Sensitivity to sunlight
• Muscle pain
• Urination problems
• Milk production

Frequency not known(cannot be estimated from available data)

Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see «Pregnancy, lactation, and fertility» in section 2 for more information.

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

In children and adolescents (8 to18 years)

In addition to the possible side effects mentioned above, fluoxetine may slow down growth or delay sexual maturation. Suicidal behaviors (suicide attempts and suicidal thoughts), hostility, mania, and nasal bleeding have also been frequently reported in children.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of in wastewater or trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of medications you no longer need. By doing so, you will help protect the environment.

Composition of Fluoxetina Teva-Rimafar

The active ingredient is fluoxetine in the form of hydrochloride. Each hard capsule contains 20 mg of fluoxetine.

The other components (excipients) are: pregelatinized cornstarch without gluten; anhydrous colloidal silica; magnesium stearate; talc.

The components of the gelatin capsule are: gelatin, water, erythrosine (E-127), quinoline yellow (E-104) and titanium dioxide (E-171).

Appearance of the product and content of the packaging

Fluoxetina Teva-Rimafar 20 mg hard capsules are presented in the form of hard yellow capsules.

Each package contains blisters of 14, 28 or 60 capsules.

Only some package sizes may be marketed.

Holder of the marketing authorization and manufacturer

Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing:

Teva Pharma, S.L.U. Polígono Malpica, c/C nº 4. 50016 Zaragoza. Spain

Last review date of this leaflet: April 2022

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/