FLUOXETINE TEVA-RIMAFAR 20 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fluoxetine Teva-Rimafar 20 mg hard capsules EFG

Fluoxetine hydrochloride

Contents of the pack

1. What is Fluoxetine Teva-Rimafar and what is it used for
2. What you need to know before you take Fluoxetine Teva-Rimafar
3. How to take Fluoxetine Teva-Rimafar
4. Possible side effects
5. Storing Fluoxetine Teva-Rimafar
6. Contents of the pack and other information

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

Fluoxetine Teva-Rimafar contains the active substance fluoxetine, which belongs to a group of medicines called 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.

Children over 8 years and adolescents:

For moderate to severe depressive episodes, if there is no response to psychological therapy after 4 to 6 sessions. Fluoxetine should only be offered to children or young people with depression of moderate to severe degree in combination with psychological therapy.

How Fluoxetine Teva-Rimafar works

• Every person has a substance in their brain called serotonin. People who are depressed or have obsessive-compulsive disorder or bulimia nervosa have lower levels of serotonin than others. It is not fully understood how fluoxetine and other SSRIs work, but they may help by increasing the levels of serotonin in the brain.
• Treating these conditions is important to help you improve. If left untreated, your illness may not disappear and may become more severe and more difficult to treat.

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

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

Do not take Fluoxetine Teva-Rimafar

• if you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you experience a rash or other allergic reaction (such as itching, swelling of the face or lips or shortness of breath), 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 (MAOIs), as a severe or life-threatening reaction may occur (e.g. iproniazide used to treat depression).
• Treatment with Fluoxetine Teva-Rimafar may only be started after 2 weeks after stopping treatment with an irreversible non-selective MAOI.
• Do not takeany irreversible non-selective MAOI for at least 5 weeks after stopping treatment with Fluoxetine Teva-Rimafar. If you have been prescribed fluoxetine for a long period and/or at a high dose, your doctor may consider the need for a longer interval before taking an MAOI.
• if you are taking metoprolol (for heart failure), as it increases the risk of excessive slowing of heartbeats.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with Fluoxetine Teva-Rimafar if you:

• have heart disease.
• start to experience fever, stiffness or muscle tremors, changes in your mental state such as confusion, irritability or extreme agitation, you may be suffering from a condition called "serotonin syndrome" or "neuroleptic malignant syndrome". Although this syndrome is rare, it can be life-threatening, so contact your doctor immediately, as you may need to stop treatment with fluoxetine.
• have a history of mania or have had mania in the past: if you have a manic episode, contact your doctor immediately, as you may need to stop treatment with fluoxetine.
• have a history of bleeding disorders, or if you are pregnant (see "Pregnancy, breastfeeding and fertility") or experience bruising or bleeding.
• have epilepsy or convulsions. If you have had convulsions or experience an increase in the frequency of convulsions, contact your doctor immediately; you may need to stop treatment with fluoxetine.
• are receiving electroconvulsive therapy (ECT).
• are being treated with tamoxifen (used to treat breast cancer) (see "Taking Fluoxetine Teva-Rimafar with other medicines").
• start to feel restless and cannot sit or stand still (akathisia). Increasing your dose of fluoxetine may make it worse.
• have diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment).
• have liver problems (your doctor may need to adjust your dose).
• have a low heart rate at rest and/or if you know you may have salt loss as a result of severe prolonged diarrhea and vomiting or the use of diuretics (water pills).
• are taking diuretics (water pills), especially if you are an elderly patient.
• have glaucoma (increased eye pressure).

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, as all these medicines take time to start working, usually around about 2 weeks, but sometimes 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 (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to hospital straight away.

You may find it helpful to tell a relative or close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Children and adolescents aged 8 to 18 years

Patients under 18 years have an increased risk of side effects such as suicide attempts, suicidal thoughts and hostility (predominantly aggression, confrontational behaviour and irritability) when taking this class of medicines. 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 on the long-term safety of fluoxetine in relation to growth, puberty, and cognitive, emotional, and behavioural development in this age group. Despite this, 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 that it is the best option for the patient. If your doctor prescribes this medicine to a patient under 18 years and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms occur or worsen when patients under 18 years are taking fluoxetine.

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

Sexual dysfunction

Some medicines of the same group as fluoxetine (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Taking Fluoxetine Teva-Rimafar with other medicines

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

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 must not be takenwith fluoxetine as they can cause serious or even life-threatening reactions (serotonin syndrome) (see section "Do not take Fluoxetine Teva-Rimafar").

Treatment with fluoxetine should only be started at least 2 weeks after stopping treatment with an irreversible non-selective MAOI (e.g. tranilcipromine). Do not takeany irreversible non-selective MAOI during at least 5 weeks after stopping treatment with Fluoxetine Teva-Rimafar. If you have been prescribed fluoxetine for a long period and/or at a high dose, your doctor may need to consider the need for a longer interval before taking an MAOI.

• Metoprololwhen used for heart failure: as it increases the risk of excessive slowing of heartbeats.

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 may be reduced.
• Monoamine oxidase inhibitors type A (MAO-A),including moclobemide, linezolid(an antibiotic) and methylene blue(also known as methylthioninium chloride, used to treat drug-induced or chemical-induced methemoglobinemia) due to the risk of serious and potentially life-threatening reactions (called serotonin syndrome). Treatment with fluoxetine may be started the day after stopping treatment with a reversible MAOI, but your doctor may need to monitor you closely and use a lower dose of the MAOI.
• Mequitazine (used to treat allergies); as taking this medicine with fluoxetine may increase the risk of changes in heart activity.
• Phenytoin(used for epilepsy): fluoxetine may increase the levels of this medicine in the blood, so your doctor will need to monitor you more closely and adjust the dose of phenytoin more frequently.
• Lithium, selegiline, St. John's Wort, tramadol and buprenorphine(both for the treatment of severe pain); triptans(for the treatment of migraine) and tryptophan:there is an increased risk of serotonin syndrome if these medicines are given with fluoxetine. Your doctor will monitor you more closely.

• Medicines that may affect the heart rhythm, e.g. anti-arrhythmics Class IA and III, antipsychotics(e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents(e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine); malaria treatmentin particular halofantrine, some antihistamines(astemizole, mizolastine), 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 in the blood. Your doctor will need to perform certain tests, adjust your dose and monitor you more closely if you start or stop treatment with fluoxetine while taking warfarin.
• Cyproheptadine(used to treat allergies), as it may reduce the effect of fluoxetine.
• Medicines that lower sodium levels in the blood(including, medicines that increase urine production, desmopressin, carbamazepine and oxcarbazepine), as the use of fluoxetine with these medicines may increase the risk of a significant decrease in sodium levels in the blood.

• Antidepressantssuch as other SSRIs or bupropion, mefloquineor chloroquine(used to treat malaria); tramadol(for the treatment of severe pain) or antipsychoticssuch as phenothiazines or butyrophenones; as the use of fluoxetine with these medicines may increase the risk of convulsions.

• Flecainide, encainide, propafenone or nebivolol(for heart problems), carbamazepine(for the treatment of epilepsy), atomoxetine or tricyclic antidepressants(e.g. imipramine, desipramine and amitriptyline) or risperidone(for the treatment of schizophrenia) as fluoxetine may change the levels of these medicines in the blood, it is possible that your doctor will need to reduce your dose when they are given 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 drink alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Studies have shown that babies whose mothers took fluoxetine during the first few months of pregnancy have a higher risk of congenital heart defects than the general population. In the general population, about 1 in 100 babies are born with a heart defect. This risk increased to about 2 in 100 in babies whose mothers took fluoxetine.

When taken during pregnancy, particularly in the last 3 months, medicines like Fluoxetine Teva-Rimafar may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during 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 be aware 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 stop taking fluoxetine gradually 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 used during pregnancy, especially during the last stage of pregnancy or just before delivery, as the following effects have been reported in newborn babies: irritability, tremors, muscle weakness, persistent crying, difficulty sleeping or feeding.

Breastfeeding

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

Fertility

Animal studies have shown that fluoxetine reduces sperm quality. This could theoretically affect fertility, but the impact on human fertility has not been observed yet.

Driving and using machines

Psychotropic medicines like fluoxetine may affect your judgment or coordination. Do not drive or use machinery until you know how this medicine affects you.

3. How to take Fluoxetina Teva-Rimafar

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 prescribed 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 if necessary within 3 to 4 weeks after starting treatment. When necessary, the dose can be gradually increased up to a maximum of 3 capsules (60 mg) per day. The dose should be carefully increased to ensure that you receive the lowest effective dose. You may not feel better immediately after starting to take your medication for depression. This is common because there is no improvement in depressive symptoms until after a few weeks have passed since the start 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 2 weeks of treatment. When necessary, the dose can be gradually increased up to a maximum of 3 capsules (60 mg) per day. If there is no improvement within 10 weeks, 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 carefully increased to ensure that you receive the lowest effective dose. Children with low weight may need lower doses. If there is a satisfactory response to treatment, your doctor should reassess the need to continue treatment after 6 months. If you have not improved within 9 weeks, treatment should be reconsidered.

Elderly patients

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.

Hepatic impairment

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

Method of administration

Swallow the capsules with water. Do not chew 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.

If possible, take the fluoxetine packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20.

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

If you forget to take Fluoxetina Teva-Rimafar

Do not worry if you forget to take a dose. Take the next dose the following day at the usual time. Do not take a double dose to make up for forgotten doses.

Taking your medication at the same time every day can help you remember to take it regularly.

If you stop treatment with Fluoxetina Teva-Rimafar

Do not stop taking fluoxetine unless your doctor has told you to do so, even if you start to feel better. It is important that you continue taking your medication.

Make sure you do not run out of medication.

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

Most people find that the symptoms that occur when stopping treatment with fluoxetine are mild and disappear on their own 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 possibility of withdrawal effects.

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

4. Possible side effects

Like all medications, this medication 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 suicidal thoughts or thoughts of 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 still or stay still, you may have something called akathisia, and increasing your dose of fluoxetine could make you feel worse. If you feel this way, consult your doctor.

• Talk to your doctor immediatelyif your skin starts to redden or shows any kind of reaction or blisters, or if your skin starts to peel. This happens very rarely.

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

Some patients have experienced:

• A combination of symptoms (known as serotonin syndrome) that include unexplained fever with increased breathing or heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation or drowsiness (rarely);
• Feeling of weakness, drowsiness, or confusion, 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, you should inform your doctor immediately.

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

Common (may affect up to 1 in 10 people)

• loss of appetite, weight loss
• nervousness, anxiety
• restlessness, loss of concentration
• feeling of nervous tension
• decreased sexual desire or sexual problems (including difficulty maintaining an erection during sexual activity)

• sleep problems, unusual dreams, fatigue, or drowsiness
• dizziness
• alteration of taste
• uncontrollable tremor movements
• blurred vision
• feeling of rapid and irregular heartbeats
• flushing
• yawning
• indigestion, vomiting
• dry mouth
• skin rash, hives, itching
• excessive sweating
• joint pain
• increased frequency of urination
• unexplained vaginal bleeding
• feeling of weakness, chills

Uncommon (may affect up to 1 in 100 people)

• feeling detached, distant from oneself
• strange thoughts
• euphoria

• sexual problems, including orgasm problems, which may persist occasionally after stopping treatment

• 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
• breathing difficulties
• nosebleeds
• difficulty swallowing
• hair loss
• increased tendency to bruise
• unexplained bleeding or bruising
• cold sweats
• difficulty urinating
• feeling of cold or heat
• liver test abnormalities

Rare (may 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
• atypically reckless behavior
• hallucinations
• agitation
• panic attacks
• confusion
• stuttering
• aggression
• seizures
• vasculitis (inflammation of a blood vessel)
• rapid swelling of the tissues around the neck, face, mouth, and/or throat
• esophageal pain (the tube that connects the mouth to the stomach)
• hepatitis
• lung problems
• sensitivity to sunlight
• muscle pain
• urination problems
• milk production

Frequency not known(cannot be estimated from the available data)

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

Bone 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 to 18 years)

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

Reporting side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fluxoetina Teva-Rimafar

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated 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 household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package contents and additional information

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 ingredients (excipients) are: pregelatinized cornstarch without gluten; anhydrous colloidal silicon dioxide; 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 package contents

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.

Marketing authorization holder and manufacturer

Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta.

28108 Alcobendas, Madrid (Spain)

Manufacturer:

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

Date of the last revision of this leaflet: April 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/