FLUOXETINE TEVA-RATIOPHARM 20 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the Patient

Fluoxetine Teva-ratiopharm 20 mg Dispersible Tablets EFG

fluoxetine

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Fluoxetine Teva-ratiopharm dispersible tablets are and what they are used for
2. What you need to know before you take Fluoxetine Teva-ratiopharm dispersible tablets
3. How to take Fluoxetine Teva-ratiopharm dispersible tablets
4. Possible side effects
5. Storage of Fluoxetine Teva-ratiopharm dispersible tablets
6. Contents of the pack and other information

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

Fluoxetine Teva-ratiopharm 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 Teva-ratiopharm is used in combination with 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 Teva-ratiopharm should be offered to children and young people with moderate to severe depression only in combination with psychological therapy.

How Fluoxetine Teva-ratiopharm works

Everyone 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.

Treatment of 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-ratiopharm

Do not take Fluoxetine Teva-ratiopharm if

• you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you develop skin rash or other allergic reactions (such as itching, swelling of the face or lips or shortness of breath), stop taking the dispersible tablets and contact your doctor immediately,
• you are taking other medicines known as irreversible non-selective monoamine oxidase inhibitors (MAOIs), as a serious or life-threatening reaction may occur (e.g. iproniazid, used to treat depression),

Treatment with Fluoxetine Teva-ratiopharm may only be started after 2 weeks after finishing a treatment with an irreversible non-selective MAOI.

Do nottakeany irreversible non-selective MAOI for at least five weeks after stopping your treatment with Fluoxetine Teva-ratiopharm. If you have been prescribed Fluoxetine Teva-ratiopharm for a long period and/or at a high dose, your doctor may consider the need to set a longer interval before taking an MAOI.

• you are taking metoprolol (to treat heart failure) as it increases the risk of excessive slowing of heartbeats.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluoxetine Teva-ratiopharm if you have:

• heart disease,
• current or past mania,
• a history of bleeding disorders or if you are pregnant (see “Pregnancy, breastfeeding and fertility”),
• you are taking medicines that affect blood clotting (see “Other medicines and Fluoxetine Teva-ratiopharm”),
• epilepsy or seizures now or in the past,
• ongoing electroconvulsive therapy (ECT),
• ongoing treatment with tamoxifen (used to treat breast cancer) (see “Other medicines and Fluoxetine Teva-ratiopharm”),
• diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment dose),
• liver problems (your doctor may need to adjust your dose),
• you have a low resting heart rate and/or if you know you may have salt loss as a result of severe and prolonged diarrhea and vomiting or the use of diuretics (water tablets),
• ongoing treatment with diuretics, especially if you are an elderly patient,
• glaucoma (high pressure in the eye),
• ongoing treatment with any other medicine (see “Other medicines and Fluoxetine Teva-ratiopharm”. )

Consult your doctor if you experience any of the following during treatment

• heart disease,
• appearance of bruises or unusual bleeding,
• appearance of fever, stiffness or muscle tremors, changes in your mental state such as confusion, irritability and 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 fluoxetine may need to be discontinued,
contact your doctorimmediatelybecause you may need to stop taking fluoxetine,contact your doctor immediately; you may need to stop taking fluoxetine,
• you start to feel restless and cannot sit or stand still (akathisia). Increasing the dose of fluoxetine may worsen this effect.

Suicide/ suicidal thoughts or 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 thoughts may be greater when you first start taking antidepressants, as these medicines take time to work, usually about 2 weeks, but sometimes longer.

You are more likely to think this way:

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

It may be helpful to tell a relative or close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. 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 they take this class of medicines. Fluoxetine Teva-ratiopharm 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 conditions.

Furthermore, there is only limited information on the long-term safety of Fluoxetine Teva-ratiopharm in relation to growth, puberty, and cognitive, emotional and behavioural development in this age group.

However, if you are under 18 years, your doctor may prescribe Fluoxetine Teva-ratiopharm to patients under 18 years for the treatment of moderate to severe depressive episodes in combination with psychological therapy when he/she decides that it is the best for his/her patient. If your doctor prescribes Fluoxetine Teva-ratiopharm to a patient under 18 years and you wish to discuss this decision, please contact your doctor again. You should inform your doctor if any of the symptoms mentioned above appear or worsen when patients under 18 years are taking Fluoxetine Teva-ratiopharm dispersible tablets.

Fluoxetine Teva-ratiopharm 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/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Other medicines and Fluoxetine Teva-ratiopharm

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

Do not take Fluoxetine Teva-ratiopharm with

• certain irreversible non-selective monoamine oxidase inhibitors (MAOIs),some used to treat depression. Irreversible non-selective MAOIs should not be used with Fluoxetine Teva-ratiopharm as they can cause serious or life-threatening reactions (serotonin syndrome) (see section “Do not take Fluoxetine Teva-ratiopharm”).
• metoprololwhen used to treat heart failure, as it increases the risk of excessive slowing of heartbeats.

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

• tamoxifen(used to treat breast cancer); as Fluoxetine Teva-ratiopharm may change the levels of this medicine in the blood and cannot exclude a reduction in the effect of tamoxifen, your doctor may need to consider different treatments with antidepressants,
• monoamine oxidase A inhibitors (MAO-A),including moclobemide, linezolid (an antibiotic) and methylene blue (also known as methylthioninium chloride, used to treat high levels of methaemoglobin in the blood): due to the risk of serious and life-threatening reactions (called serotonin syndrome). Treatment with fluoxetine may be started the day after finishing a treatment with reversible MAOIs, but your doctor may need to monitor you closely and use a lower dose of the MAOI medicine,
• mequitazine(used to treat allergies); as taking this medicine with Fluoxetine Teva-ratiopharm may increase the risk of changes in heart activity,
• phenytoin(for epilepsy), as Fluoxetine Teva-ratiopharm may increase the levels of this medicine in the blood, so your doctor will need to adjust your phenytoin dose more carefully and monitor you more frequently,
• lithium, selegiline, St John's Wort, tramadol and buprenorphine(both for severe pain), triptans(for migraine) and tryptophan;there is an increased risk of mild serotonin syndrome if these medicines are given with Fluoxetine Teva-ratiopharm. Your doctor will need to monitor you more frequently.
• medicines that may affect heart rhythm, e.g. antiarrhythmics Class IA and III, antipsychotics(e.g. phenothiazine derivatives, pimozide, haloperidol); tricyclic antidepressants, some antimicrobial agents(e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarial treatmentin particular halofantrine or some antihistamines(astemizole, mizolastine) as taking one or more of these medicines with Fluoxetine Teva-ratiopharm may increase the risk of changes in heart activity,
• anticoagulants(such as warfarin), NSAIDs(such as ibuprofen, diclofenac), acetylsalicylic acidand other medicines that have an effect on 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 frequently if you start or stop treatment with fluoxetine while taking warfarin,
• cypheptadine(for allergies) may reduce the effect of Fluoxetine Teva-ratiopharm,
• medicines that may affect 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 excessively low sodium levels in the blood,
• antidepressantssuch as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquineor chloroquine(used to treat malaria), tramadol(for severe pain) or antipsychoticssuch as phenothiazines or butyrophenones; as the use of fluoxetine with these medicines may increase the risk of seizures,
• flecainide, propafenone, nebivololor encainide(for heart problems), carbamazepine(for epilepsy), atomoxetineor tricyclic antidepressants(e.g. imipramine, desipramineand amitriptyline) or risperidone(for schizophrenia); as Fluoxetine Teva-ratiopharm 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-ratiopharm with food, drinks and alcohol

Fluoxetine Teva-ratiopharm 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

In babies whose mothers took fluoxetine during the first months of pregnancy, there have been some studies that describe a higher risk of congenital defects affecting the heart. In the general population, about 1 in 100 babies are born with heart defects. This increases to about 2 in 100 babies in mothers who took fluoxetine. When taking medicines like fluoxetine during pregnancy, particularly in the last 3 months, there is an increased risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe rapidly and appear blue. These symptoms usually appear during the first 24 hours after birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the potential risk. Therefore, your doctor and you may decide that it is better to gradually reduce the intake of fluoxetine during pregnancy or before becoming pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to 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 and difficulty sleeping or feeding.

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 that they can advise you.

Breastfeeding

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

Fertility

Fluoxetine has been shown to reduce sperm quality in animal studies. In theory, this could affect fertility, but this has not yet been observed in humans.

Driving and using machines

Psychotropic medicines like Fluoxetine Teva-ratiopharm may affect your judgment or coordination. Do not drive or use machinery until you know how Fluoxetine Teva-ratiopharm affects you.

Fluoxetine Teva-ratiopharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Fluoxetina Teva-ratiopharm

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

Adults

The recommended dose is:

• Depression

The recommended dose is 20 mg per day. Your doctor may review and adjust your dose if necessary within 3 to 4 weeks after starting treatment. If necessary, the dose can be gradually increased up to a maximum of 60 mg per day. The dose should be increased carefully 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 the first few weeks of treatment. Patients with depression should be treated for at least 6 months.

• Bulimia nervosa

The recommended dose is 60 mg per day.

• Obsessive-compulsive disorder

The recommended dose is 20 mg per day. Your doctor may review and adjust the dose after 2 weeks of treatment. If necessary, the dose can be gradually increased up to a maximum of 60 mg per day. If there is no improvement within 10 weeks, your doctor will reconsider your treatment.

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 1 or 2 weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased carefully to ensure that the patient remains on 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 after 9 weeks, your doctor should reassess your treatment.

Elderly patients

Your doctor will increase the dose more carefully, and the daily dose should not generally exceed 40 mg. The maximum dose is 60 mg 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 tell you how to use Fluoxetina Teva-ratiopharm on alternate days.

Method of administration

Swallow half a tablet or one tablet with a glass of water or dissolve it in half a glass of water. The resulting suspension should be taken immediately and in its entirety.

The tablet can be divided into equal doses.

If you take more Fluoxetina Teva-ratiopharm than you should

If you take too many dispersible tablets, go to the emergency department of the nearest hospital or consult your doctor immediately. If possible, take the Fluoxetina Teva-ratiopharm packaging with you.

You can also call the Toxicology Information Service Phone: 91 562 04 20.

The 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 excitement to coma.

If you forget to take Fluoxetina Teva-ratiopharm

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-ratiopharm

Do notstop taking Fluoxetina Teva-ratiopharm without first asking 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 medication.

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

Most people find that the symptoms that occur when stopping treatment with Fluoxetina Teva-ratiopharm are mild and disappear within a few weeks. If you experience these symptoms when stopping your treatment, consult your doctor.

When stopping treatment with Fluoxetina Teva-ratiopharm, 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 thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the hospital immediately(see section 2).
• If you experience a skin rash or allergic reactions such as itching, swelling of the lips/tongue, or wheezing/shortness of breath, stop taking the dispersible tablets and tell your doctor immediately.
• If you feel restless and feel like you cannot sit still or remain quiet, you may be experiencing akathisia, and increasing your dose of Fluoxetina Teva-ratiopharm could make you feel worse. If you feel this way, consult your doctor.
• Talk to your doctor immediatelyif your skin starts to redden or develops a skin reaction or blisters appear on your skin or it peels. This happens 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 fever of unknown cause with increased heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation or drowsiness (rarely)
• feeling of weakness, drowsiness, or confusion mainly in the elderly and in patients 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 above side effects, you should contact 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 tense
• decreased sexual desire or sexual problems (including difficulty maintaining an erection during sexual activity)
• sleep problems, unusual dreams, fatigue, or drowsiness
• dizziness
• altered sense of taste
• uncontrollable tremors

• blurred vision
• feeling of rapid and irregular heartbeat
• hot flashes
• yawning
• indigestion, vomiting
• dry mouth
• rash, hives, itching
• excessive sweating
• joint pain
• increased frequency of urination
• unexplained vaginal bleeding
• feeling of tremors or chills

Uncommon (may affect up to 1 in 100 people)

• feeling of detachment from oneself
• strange thoughts
• abnormally elevated mood
• sexual problems, including orgasm problems, which may persist occasionally after treatment is discontinued
• suicidal thoughts or self-harm
• teeth grinding
• muscle contractions, involuntary movements, or balance or coordination problems
• memory impairment
• dilated pupils
• ringing in the ears
• low blood pressure
• breathing difficulties
• nosebleeds
• difficulty swallowing
• hair loss
• increased bruising
• gastrointestinal bleeding
• cold sweats
• difficulty urinating
• feeling of general discomfort
• abnormal sensation
• feeling of cold or heat
• liver test abnormalities

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

• low blood salt levels
• reduced platelet count in the blood, which may increase the risk of bleeding or bruising
• reduced white blood cell count
• atypical wild behavior
• hallucinations
• agitation
• panic attacks
• confusion
• stuttering
• aggression
• seizures
• vasculitis (inflammation of blood vessels)

• rapid swelling of tissues around the neck, mouth, and/or throat
• esophageal pain
• throat inflammation
• hepatitis
• lung problems
• sensitivity to sunlight
• skin bleeding
• muscle pain
• urination problems
• breast milk production
• mucosal bleeding

Frequency not known(cannot be estimated from available data)

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

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

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

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 effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fluoxetina Teva-ratiopharm

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

Do not use this medication after the expiration date shown on the blister pack and carton after EXP. 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 through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Fluoxetina Teva-ratiopharm

• The active ingredient is fluoxetine

Each dispersible tablet contains 20 mg of fluoxetine (as hydrochloride).

• The other ingredients are:

Microcrystalline cellulose, sodium croscarmellose, magnesium stearate, colloidal silicon dioxide.

Appearance and packaging of the product

Fluoxetina Teva-ratiopharm 20 mg dispersible tablets are presented as round, scored tablets. Each carton contains blisters of 10, 14, 28, 30, 60, and 100 dispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143-Blaubeuren (Germany)

Date of last revision of this leaflet:May 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/64443/P_64443.html