Prospect: Information for the Patient

Fluoxetina Teva-ratiopharm 20 mg Dispersible Tablets EFG

fluoxetine

Read this prospect carefully before starting to take the medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyto you and should not be given to other people, even if they have the same symptomsas you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4

Fluoxetina Teva-ratiopharm contains the active ingredient fluoxetina whichbelongs 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 (Fluoxetina Teva-ratiopharm is used in combinationwith psychotherapy for the reduction of binge eating and purging).

Older children and adolescents (over 8 years):

• For moderate to severe depressive episodes, if there is no response to psychological therapy after4 to 6 sessions.Fluoxetina Teva-ratiopharmshould be offered to children or young people with moderate to severe depression only in combination with a psychological therapy.

How Fluoxetina Teva-ratiopharm works

Every person 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 fluoxetina and other SSRIs work is not fully understood, but they may help by increasing the levels of serotonin 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-ratiopharm if

• You are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6).If you develop skin rashes or other allergic reactions (such as itching, facial or lip swelling, 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 this may cause a serious or life-threatening adverse reaction (e.g., iproniazid, used to treat depression),

The treatment with Fluoxetina Teva-ratiopharm may only be initiated after 2 weeks following the completion of a treatment with an irreversible non-selective MAOI.

Do not takeany irreversible non-selective MAOI for at least five weeks after stopping the medication with Fluoxetina Teva-ratiopharm. If you have been prescribed Fluoxetina Teva-ratiopharmfor a long period of time 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 this increases the risk of excessive slowing of the heart rate.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluoxetina Teva-ratiopharm if you have any of the following:

• Heart disease,
• Mania in the present or past,
• 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 Fluoxetina Teva-ratiopharm”),
• Epilepsy or convulsions now or in the past,
• Continued electroconvulsive therapy (ECT),
• Continued treatment with tamoxifen (used to treat breast cancer) (see “Other medicines and Fluoxetina Teva-ratiopharm”),
• Diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment),
• Liver problems (your doctor may need to adjust your dose),
• You have a slow resting heart rate and/or if you know you may have hyponatremia as a result of prolonged severe diarrhea and vomiting or the use of diuretics (tablets to urinate),
• Continued treatment with diuretics, especially if you are an elderly patient,
• Glaucoma (high eye pressure),
• Continued treatment with any other medicine (see “Other medicines and Fluoxetina 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 twitching, changes in your mental state such as confusion, irritability, and extreme agitation; you may be experiencing a condition called “serotonin syndrome” or “neuroleptic malignant syndrome”.Although this syndrome is rare, it can be life-threatening, so contact your doctorimmediately, as fluoxetine may be discontinued,
• You have a manic episode,contact your doctorimmediatelyas you may need to discontinue fluoxetine,
• You have convulsions or experience an increase in their frequency,contact your doctor immediately; you may need to interrupt treatment with 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 depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have suicidal thoughts or self-harm. These thoughts may be more common when taking antidepressants for the first time, as these medicines take time to take effect, usually around two weeks, although sometimes it may be longer.

You may think more about this:

• If you have previously had suicidal thoughts or self-harm,
• If you are a young adult patient. Clinical trial information has shown an increased risk of suicidal behavior in patients under 25 years of age with psychiatric disorders treated with antidepressants.

If you ever have suicidal thoughts or self-harm,consult your doctor or go to the hospital immediately.

Telling someone you trustthat you are depressed or have an anxiety disorder and asking them to read this leaflet may be helpful. Ask them to tell you if they think your depression or anxiety is getting worse or if they are concerned about your changes in behavior.

Children and adolescents aged 8 to 18 years

Patients under 18 years of age have a higher risk of adverse effects such as suicidal thoughts, suicidal behavior, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Fluoxetina 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 to treat other conditions.

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

However, and if you are under 18 years of age, your doctor may prescribe Fluoxetina Teva-ratiopharm to patients under 18 years of age for the treatment of moderate to severe depressive episodes in combination with psychological therapy when they decide that it is in the best interest of their patient. If your doctor prescribes Fluoxetina Teva-ratiopharm to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above appear or worsen when patients under 18 years of age are taking Fluoxetina Teva-ratiopharm dispersible tablets.

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

Other medicines and Fluoxetina Teva-ratiopharm

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

Do not take Fluoxetina 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 Fluoxetina Teva-ratiopharm as they may cause serious or even fatal reactions (serotonin syndrome)(see section “Do not take Fluoxetina Teva-ratiopharm”).
• Metoprololwhen used to treat heart failure, as this increases the risk of excessive slowing of the heart rate.

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

• Tamoxifen(used to treat breast cancer); as Fluoxetina Teva-ratiopharm may change the blood levels of this medicine and it cannot be ruled out that there is a reduction in the effect of tamoxifen, your doctor may need to consider different antidepressant treatments,
• Inhibitors of monoamine oxidase A(MAO-A), including moclobemide, linezolid (an antibiotic) and chlorpromazine (also known as methylene blue, used to treat high levels of methemoglobin in the blood): due to the risk of serious or even fatal adverse reactions (serotonin syndrome). Treatment with fluoxetine may be initiated the day after completing a treatment with reversible MAO inhibitors, but your doctor may closely monitor you and use a lower dose of the MAO-A inhibitor,
• Mequitazine(used to treat allergies); as taking this medicine with Fluoxetina Teva-ratiopharm may increase the risk of changes in heart activity,
• Fenitoin(for epilepsy), as Fluoxetina Teva-ratiopharm may increase the blood levels of this medicine, 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 severe pain),triptans(for migraines) andtryptophan;there is an increased risk of mild serotonin syndrome if these medicines are taken with Fluoxetina Teva-ratiopharm. Your doctor will need to monitor you more frequently.
• Medicines that may 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 or someantihistamines(astemizol, mizolastina) as taking one or more of these medicines with Fluoxetina Teva-ratiopharm may increase the risk of changes in heart activity,
• Anticoagulants(such as warfarin),NSAIDs(such as ibuprofen, diclofenac),aspirinandothermedicines that affect blood clotting(including clozapine, used to treat certain mental disorders). Fluoxetine may alter the effect of these medicines on 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,
• Ciproheptadine(for allergies) may reduce the effect of Fluoxetina Teva-ratiopharm,
• Medicines that may affect sodium levels in the blood(including medicines that produce increased urination, desmopressin, carbamazepine, and oxcarbazepine); as the use of Fluoxetina with these medicines may increase the risk of excessive decreaseof sodium levels in the blood,
• Antidepressantssuch as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion,mefloquineorchloroquine(used to treat malaria),tramadol(for severe pain) orantipsychoticssuch as phenothiazines or butyrophenones; as the use of fluoxetine with these medicines may increase the risk of convulsions,
• Flecainide, propafenone, nebivololorencainide(for heart problems),carbamazepine(for epilepsy),atomoxetineortricyclic antidepressants(e.g.imipramine,desipramineandamitriptyline) orrisperidone(for schizophrenia); as Fluoxetina Teva-ratiopharm may change the blood levels of these medicines, your doctor may need to reduce your dose when they are taken with fluoxetine.

Taking Fluoxetina Teva-ratiopharm with food, drinks, and alcohol

Fluoxetina Teva-ratiopharm 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

In babies whose mothers took fluoxetine during the first months of pregnancy, there have been some studies that describe an increased risk of congenital heart defects. 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 may be an increased risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe rapidly and appear blue. These symptoms usually appear within the first 24 hours after birth. If this happens to your baby, 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 your fluoxetine dose 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 using during pregnancy, especially in the last stage of pregnancy or just before delivery, as the following effects have been reported in newborn babies: irritability, tremor, muscle weakness, persistent crying, and difficulty breastfeeding or sleeping.

Taking fluoxetine in the final stage of pregnancy may increase the risk of excessive bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking fluoxetine to be able to advise you.

Breastfeeding

Fluoxetine is excreted in breast milk and may cause adverse effects in babies. You should only continue breastfeeding if 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 there is no evidence of its impact on human fertility.

Driving and operating machinery

Medicines like Fluoxetina Teva-ratiopharm mayalter your judgment or coordination. Do not drive or operate machineryuntil you know how Fluoxetina Teva-ratiopharm affects you.

Fluoxetina Teva-ratiopharm contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Do not take more tablets than those indicated 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 as needed within 3 to 4 weeks after starting treatment. If necessary, this 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 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 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 two weeks of treatment. If necessary, the dose can be gradually increased up to a maximum of 60 mg per day. If no improvement is observed within 10 weeks, your doctor will reconsider your treatment.

Use in 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. 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 require lower doses. If there is 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, your doctor should reevaluate your treatment.

Older 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.

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 tell you how to use Fluoxetina Teva-ratiopharm on alternate days.

Method of administration

Swallow half a tablet or a tablet with a glass of water or dissolve it in half a glass of water. The resulting suspension should be ingested entirely and immediately.

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 nearest hospital emergency service or consult your doctor immediately. If you can, bring the Fluoxetina Teva-ratiopharm package with you.

You can also call the Toxicological Information Service Telephone: 91 562 04 20.

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

If you forgot to take Fluoxetina Teva-ratiopharm

Do not worry if you forgot to take a dose. Take the next dose the next 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-ratiopharm

Do notstop taking Fluoxetina Teva-ratiopharm without first asking your doctor, even if you start to feel better. It is essential to continue taking your medication. Make sure you do not run out of medication.

You may experience the following effects (withdrawal syndrome) when interrupting treatment with Fluoxetina Teva-ratiopharm: 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, tremors (unsteadiness), and headaches.

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

When interrupting treatment with Fluoxetina Teva-ratiopharm, your doctor will help you gradually reduce the dose over a period of one to two weeks - this will help reduce the likelihood 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 thoughts of harming yourself or suicidal thoughts at any time, contact your doctor or go to the hospital immediately (see section 2).
• If you have a skin rash or allergic reactions such as itching, swelling of the lips/tongue or throat/shortness of breath, stop taking the dispersible tablets and tell your doctor immediately.
• If you feel restless and feel like you cannot sit or stay still, you may be experiencing akathisia, and increasing your fluoxetine Teva-ratiopharm dose may make you feel worse. If you feel this way, consult your doctor.
• Contact your doctor immediately if your skin starts to redden or develops a skin reaction or blisters or peels on your skin. This happens 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 increased heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or somnolence (only rarely)
• feeling weak, drowsy, or confused mainly in the elderly and in people treated with diuretics (elderly patients);
• prolonged and painful erection
• irritability and extreme agitation
• heart problems, such as rapid or irregular heart rhythm, fainting, collapses, or dizziness when standing up, which may indicate abnormal heart rhythm function.

If you experience any of the side effects described above, contact 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
• feeling tense
• decreased libido or sexual problems (including difficulty maintaining an erection during sexual activity)
• sleep problems, unusual dreams, fatigue, or somnolence
• dizziness
• alteration of taste
• involuntary tremors

• blurred vision
• feeling of rapid and irregular heartbeat
• headaches
• yawns
• indigestion, vomiting
• dry mouth
• skin rash, urticaria, itching
• excessive sweating
• joint pain
• increased frequency of urination
• unexplained vaginal bleeding
• feeling of tremors or chills

Uncommon (can affect up to 1 in 100 people)

• feeling of detachment from oneself
• strange thoughts
• abnormally elevated mood
• sexual problems, including problems with orgasm, which may persist occasionally after treatment is stopped
• suicidal thoughts or self-harm
• grinding of teeth
• muscle contractions, involuntary movements, or problems with balance or coordination
• memory deterioration
• dilated pupils
• tinnitus
• low blood pressure
• difficulty breathing
• nasal bleeding
• difficulty swallowing
• hair loss
• increased appearance of bruises
• gastrointestinal bleeding
• chills
• difficulty urinating
• general feeling of discomfort
• abnormal sensation
• feeling of cold or heat
• abnormalities in liver tests

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

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

• rapid swelling of tissues around the neck, mouth, and/or throat
• pain in the tube that carries food and water to the stomach
• inflammation of the throat
• hepatitis
• lung problems
• sensitivity to sunlight
• bleeding of the skin
• muscle pain
• urination problems
• production of milk
• bleeding of mucous membranes

Frequency not known(cannot be estimated from available data)

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

Fractures of bones: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 to18 years)

In addition to the possible side effects mentioned above, fluoxetine may reduce 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the blister pack and 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 through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fluoxetina Teva-ratiopharm

• The active ingredient is fluoxetine

Each dispersible tablet contains 20 mg of fluoxetine (in the form of hydrochloride).

• The other components are:

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

Appearance of the product and content of the packaging

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

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing:

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143-Blaubeuren (Germany)

Last review date of this leaflet:May 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the carton 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