Fluoxetine Teva-Ratiopharm 20 mg dispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Fluoxetina Teva-ratiopharm 20 mg dispersible tablets EFG

fluoxetine

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Fluoxetina 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 (Fluoxetina Teva-ratiopharm is used in combination with psychotherapy to reduce binge eating and purging).

Children over 8 years of age and adolescents:

• For moderate to severe depressive episodes, when there is no response to psychological therapy after 4 to 6 sessions. Fluoxetina Teva-ratiopharm should be offered to children or adolescents with moderate to severe depression only in combination with psychological therapy.

How Fluoxetina Teva-ratiopharm works

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

Treating these conditions is important to help you get better. If left untreated, your illness may not resolve and may become more severe and harder to treat.

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

2. What you need to know before taking Fluoxetina Teva-ratiopharm

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, swelling of the face or lips, or difficulty breathing), stop taking the dispersible tablets and contact your doctor immediately,
• you are taking other medicines known as non-selective irreversible monoamine oxidase inhibitors (MAOIs), as a serious or even fatal adverse reaction may occur (e.g., iproniazid, used to treat depression),

Treatment with Fluoxetina Teva-ratiopharm may only be started 2 weeks after stopping treatment with a non-selective irreversible MAO inhibitor.

Do not take any non-selective irreversible MAOI for at least five weeks after stopping treatment with Fluoxetina Teva-ratiopharm. If you have been prescribed Fluoxetina Teva-ratiopharm for a long period of time and/or at a high dose, your doctor may consider the need for 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 heartbeat.

Warnings and precautions

Talk to your doctor or pharmacist before taking Fluoxetina Teva-ratiopharm if any of the following apply to you:

• heart disease,
• current or past mania,
• 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 seizures now or in the past,
• ongoing electroconvulsive therapy (ECT),
• ongoing 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 are known to lose salt due to prolonged severe diarrhoea, vomiting, or use of diuretics (water tablets),
• ongoing treatment with diuretics, especially if you are elderly,
• glaucoma (increased pressure in the eye),
• ongoing treatment with any other medicine (see “Other medicines and Fluoxetina Teva-ratiopharm”).

Contact your doctor if you experience any of the following during treatment:

• heart disease,
• appearance of bruises or unusual bleeding,
• development of fever, muscle stiffness or twitching, changes in mental state such as confusion, irritability, and extreme agitation; you may be experiencing a condition called “serotonin syndrome” or “neuroleptic malignant syndrome”. Although rare, this condition can be life-threatening, so contact your doctor immediately, as fluoxetine may need to be discontinued,
• if you experience a manic episode, contact your doctor immediately, as you may need to discontinue fluoxetine,
• if you have seizures or experience an increase in their frequency, contact your doctor immediately; you may need to stop treatment with fluoxetine,
• you start feeling restless and unable to 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 occasionally have suicidal thoughts or thoughts of self-harm. These thoughts may be more likely when starting antidepressants for the first time, as these medicines take time to work, usually about two weeks, although sometimes longer.

You are more likely to have such thoughts:

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

If at any time you have thoughts of suicide or self-harm, contact your doctor or go to hospital immediately.

It may be helpful to tell a close friend or family member that you are depressed or have an anxiety disorder and let them read this leaflet. Ask them to inform you if they think your depression or anxiety is worsening or if they are concerned about changes in your behaviour.

Children and adolescents aged 8 to 18 years

Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behaviour, 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.

In addition, there is only limited information on the long-term safety of Fluoxetina Teva-ratiopharm with regard to growth, puberty, and cognitive, emotional, and behavioural development in this age group.

However, if you are under 18 years of age, your doctor may still prescribe Fluoxetina Teva-ratiopharm for patients under 18 years for the treatment of moderate to severe depressive episodes in combination with psychological therapy if they consider it appropriate for your condition. If your doctor prescribes Fluoxetina Teva-ratiopharm to a patient under 18 years and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms mentioned above appear or worsen while patients under 18 years are taking Fluoxetina Teva-ratiopharm dispersible tablets.

Fluoxetina Teva-ratiopharm must not be used in children under 8 years of age.

Sexual dysfunction

Some medicines in the same group as fluoxetine (called SSRIs/SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medicines and Fluoxetina Teva-ratiopharm

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

Do not take Fluoxetina Teva-ratiopharm with

• certain non-selective irreversible monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Non-selective irreversible MAOIs must not be used with Fluoxetina Teva-ratiopharm, as they may sometimes cause serious or even fatal reactions (serotonin syndrome) (see section “Do not take Fluoxetina Teva-ratiopharm”).
• metoprolol when used to treat heart failure, as this increases the risk of excessive slowing of the heartbeat.

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

• tamoxifen (used to treat breast cancer); as Fluoxetina Teva-ratiopharm may alter blood levels of this medicine and a reduction in tamoxifen’s effect cannot be ruled out, your doctor may need to consider alternative antidepressant treatments,
• monoamine oxidase A inhibitors (MAO-A), including moclobemide, linezolid (an antibiotic), and methylene blue chloride (also called methylene blue, used to treat high levels of methaemoglobin in the blood): due to the risk of serious or even fatal adverse reactions (called serotonin syndrome). Treatment with fluoxetine may be started the day after stopping treatment with reversible MAO inhibitors, but your doctor may monitor you closely 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 the heart's electrical activity,
• phenytoin (for epilepsy), as Fluoxetina Teva-ratiopharm may increase blood levels of this medicine, so your doctor should monitor phenytoin dosing more carefully and perform more frequent check-ups,
• 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 taken with Fluoxetina Teva-ratiopharm. Your doctor should perform more frequent check-ups.
• medicines that may affect heart rhythm, e.g., Class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol); tricyclic antidepressants, some antimicrobial agents (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarial treatments, particularly halofantrine, or some antihistamines (astemizole, mizolastine), as taking one or more of these medicines with Fluoxetina Teva-ratiopharm may increase the risk of changes in the heart's electrical activity,
• anticoagulants (such as warfarin), NSAIDs (such as ibuprofen, diclofenac), acetylsalicylic acid, and other medicines that affect blood clotting (including clozapine, used to treat certain mental disorders). Fluoxetine may alter the effect of these medicines on blood. Your doctor will need to perform certain blood tests, adjust your dose, and monitor you more frequently if you start or stop treatment with fluoxetine while taking warfarin,
• cyproheptadine (for allergies) may reduce the effect of Fluoxetina Teva-ratiopharm,
• medicines that may affect blood sodium levels (including medicines that increase urine output, desmopressin, carbamazepine, and oxcarbazepine); as using Fluoxetina Teva-ratiopharm with these medicines may increase the risk of excessively low blood sodium levels,
• antidepressants such as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquine or chloroquine (used to treat malaria), tramadol (for treating severe pain), or antipsychotics such as phenothiazines or butyrophenones; as using fluoxetine with these medicines may increase the risk of seizures,
• flecainide, propafenone, nebivolol, or encainide (for heart problems), carbamazepine (for epilepsy), atomoxetine, or tricyclic antidepressants (e.g., imipramine, desipramine, and amitriptyline) or risperidone (for treating schizophrenia); as Fluoxetina Teva-ratiopharm may alter blood levels of these medicines, your doctor may need to reduce their dose when administered together with fluoxetine.

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

Fluoxetina Teva-ratiopharm may be taken with or without food, as preferred.

It is not advisable 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 become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Some studies have reported a slightly increased risk of congenital heart defects in babies whose mothers took fluoxetine during the first months of pregnancy. 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 medicines such as fluoxetine are taken during pregnancy, particularly in the last 3 months, there may be an increased risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe rapidly and appear bluish. 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, you and your doctor may decide it is best to gradually reduce fluoxetine intake during pregnancy or before becoming pregnant. However, depending on your circumstances, your doctor may advise that it is better for you to continue taking fluoxetine.

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

If you take fluoxetine in the late 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 informed that you are taking fluoxetine so they can advise you accordingly.

Breastfeeding

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

Fertility

Fluoxetine has been shown to reduce sperm quality in animal studies. In theory, this could affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines

Psychotropic medicines such as Fluoxetina Teva-ratiopharm may impair judgment or coordination. Do not drive or operate machinery until 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”.

3. How to take Fluoxetina Teva-ratiopharm

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in 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 daily. Your doctor may review and adjust your dose if necessary within the first 3 to 4 weeks after starting treatment. If needed, the dose may be gradually increased up to a maximum of 60 mg daily. The dose should be increased carefully to ensure you receive the lowest effective dose. You may not feel immediate improvement when starting your antidepressant medication. This is common, as symptom improvement typically does not occur 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 daily.

• Obsessive-compulsive disorder

The recommended dose is 20 mg daily. Your doctor may review and adjust the dose after two weeks of treatment. If necessary, the dose may be gradually increased up to a maximum of 60 mg daily. 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 carefully increased to ensure the patient remains on the lowest effective dose. Children with low body 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 after 9 weeks, your doctor should reevaluate your treatment.

Elderly patients

Your doctor will increase the dose more cautiously, and the daily dose should generally not exceed 40 mg. The maximum dose is 60 mg daily.

Hepatic impairment

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

Method of administration

Swallow half a tablet or one whole tablet with a glass of water, or dissolve it in half a glass of water. The resulting suspension should be swallowed completely and immediately.

The tablet may 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 department or contact your doctor immediately. If possible, bring the Fluoxetina Teva-ratiopharm packaging with you.

You may also call the Toxicology Information Service at telephone number: 91 562 04 20.

Symptoms of overdose include: nausea, vomiting, seizures, cardiac problems (such as irregular heartbeat or cardiac arrest), respiratory problems, and changes in mental status ranging from agitation 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 your usual time. Do not take a double dose to make up for missed doses.

Taking your medicine at the same time each day may help you remember to take it regularly.

If you stop taking Fluoxetina Teva-ratiopharm

Do not stop taking Fluoxetina Teva-ratiopharm without first consulting 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 medicine.

You may experience the following effects (withdrawal syndrome) when stopping treatment with Fluoxetina Teva-ratiopharm: dizziness, tingling sensations like pins and needles, sleep disturbances (vivid dreams, nightmares, insomnia), feelings of restlessness or agitation, unusual tiredness or weakness, anxiety, nausea and/or vomiting, tremors (shakiness), and headache.

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

When discontinuing treatment with Fluoxetina Teva-ratiopharm, your doctor will help you gradually reduce the dose over one to two weeks—this will help reduce the likelihood of withdrawal effects.

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

4. Possible adverse effects

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

• If you have thoughts of harming yourself or of suicide at any time, contact your doctor or go to a hospital immediately (see section 2).
• If you develop a skin rash or allergic reactions such as itching, swelling of the lips/tongue, or wheezing/shortness of breath, stop taking the dispersible tablets and tell your doctor immediately.
• If you feel restless and as though you cannot sit still or remain motionless, you may be experiencing akathisia; increasing your dose of Fluoxetina Teva-ratiopharm could make you feel worse. If you feel this way, consult your doctor.
• Speak to your doctor immediately if your skin begins to redden or you develop a skin reaction, blisters, or peeling of the skin. This occurs rarely.

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

Some patients have experienced:

• a combination of symptoms (known as “serotonin syndrome”) including fever of unknown cause with increased heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation, or drowsiness (only rarely);
• feeling weak, drowsy, or confused, mainly in elderly patients and those treated with diuretics (elderly patients);
• prolonged and painful erection;
• irritability and extreme agitation;
• heart problems, such as fast or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.

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

The following adverse 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, difficulty concentrating;
• feeling tense;
• decreased sexual desire or sexual problems (including difficulty maintaining an erection during sexual activity);
• sleep problems, unusual dreams, tiredness or drowsiness;
• dizziness;
• altered sense of taste;
• uncontrollable tremors;
• blurred vision;
• sensation of fast or irregular heartbeat;
• hot flushes;
• 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 detached from oneself;
• strange thoughts;
• abnormally elevated mood;
• sexual problems, including orgasm disorders, occasionally persisting after discontinuation of treatment;
• suicidal thoughts or thoughts of self-harm;
• teeth grinding;
• muscle contractions, involuntary movements, or problems with balance or coordination;
• memory impairment;
• dilated pupils;
• ringing in the ears;
• low blood pressure;
• difficulty breathing;
• nosebleeds;
• difficulty swallowing;
• hair loss;
• increased tendency to bruise;
• gastrointestinal bleeding;
• cold sweats;
• difficulty urinating;
• general feeling of discomfort;
• abnormal sensation;
• feeling of cold or heat;
• abnormalities in liver function tests.

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

• low levels of sodium in the blood;
• reduction in platelets in the blood, which may increase the risk of bleeding or bruising;
• reduction in 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;
• pain in the tube carrying food and water to the stomach (oesophagus);
• throat inflammation;
• hepatitis;
• lung problems;
• sensitivity to sunlight;
• skin bleeding;
• muscle pain;
• urinary problems;
• production of breast milk;
• bleeding from mucous membranes.

Frequency not known (cannot be estimated from available data)

• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); 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 medicine.

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

In children and adolescents (8 to 18 years of age)

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluoxetine Teva-ratiopharm

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and outer packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Fluoxetina Teva-ratiopharm

• The active substance is fluoxetine.

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

• The other components are:

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

Appearance of the medicinal product and contents of the container

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

Only some 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, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren (Germany)

Date of the most recent revision of this leaflet: May 2021

Detailed and up-to-date information on this medicinal product 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/64443/P_64443.html