Fluoxetine Teva-Rimafar 20 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fluoxetina Teva-Rimafar 20 mg hard capsules EFG

Fluoxetine hydrochloride

Package leaflet

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

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

Fluoxetina Teva-Rimafar contains the active substance fluoxetine, which belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs):

This medicine is indicated for the treatment of:

Adults:

• Major depressive episodes.
• Obsessive-compulsive disorder.
• Bulimia nervosa: Fluoxetine is indicated as an adjunct to psychotherapy for reducing binge eating and purging episodes.

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. Fluoxetine should be offered to children or young people with moderate to severe depression only in combination with psychological therapy.

How Fluoxetina Teva-Rimafar 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 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 improve your symptoms. If left untreated, your condition may not resolve and may become more severe and more difficult 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-Rimafar

Do not take Fluoxetina Teva-Rimafar

• if you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you develop a rash or any other allergic reaction (such as itching, swelling of the face or lips, or difficulty breathing), stop taking the capsules immediately and contact your doctor as soon as possible.
• if you are taking other medicines known as non-selective irreversible monoamine oxidase inhibitors (MAOIs), as this may cause a serious or even fatal adverse reaction (e.g., iproniazid, used to treat depression).
• Treatment with Fluoxetina Teva-Rimafar may only be started at least 2 weeks after stopping treatment with a non-selective irreversible MAOI.
• Do not take any non-selective irreversible MAOI for at least five weeks after stopping Fluoxetina Teva-Rimafar. If you have been prescribed Fluoxetina Teva-Rimafar for a long period of time and/or at a high dose, your doctor may consider the need for a longer interval before starting an MAOI.
• if 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-Rimafar if any of the following apply to you:

• If you have heart disease.
• If you develop fever, muscle stiffness, or muscle twitching, or changes in your mental state such as confusion, irritability, or extreme agitation, you may be experiencing a condition called “serotonin syndrome” or “neuroleptic malignant syndrome.” Although rare, this condition can be life-threatening, so contact your doctor immediately, as you may need to stop treatment with fluoxetine.
• If you have mania or have had mania in the past: if you experience a manic episode, contact your doctor immediately, as you may need to stop treatment with fluoxetine.
• If you have a history of bleeding disorders, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”) or develop unusual bruising or bleeding.
• If you have epilepsy or seizures. If you have had seizures or notice an increase in their frequency, contact your doctor immediately; you may need to stop treatment with fluoxetine.
• If you are receiving electroconvulsive therapy (ECT).
• If you are on long-term treatment with tamoxifen (used to treat breast cancer) (see “Taking Fluoxetina Teva-Rimafar with other medicines”).
• If you start feeling restless and unable to sit or stand still (akathisia). Increasing your dose of fluoxetine could worsen this.
• If you have diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment).
• If you have liver problems (your doctor may need to adjust your dose).
• If you have a slow resting heart rate and/or if you know you may have salt loss due to prolonged severe diarrhea, vomiting, or use of diuretics (water tablets).
• If you are taking diuretics (water tablets), especially if you are elderly.
• Glaucoma (increased eye pressure).

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These thoughts may increase when you first start taking antidepressants, as all 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 young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

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

You may find it helpful to tell a close family member or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may 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 ideation, and hostility (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Fluoxetine should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe depressive episodes in combination with psychological therapy, and should not be used for other indications in this age group.

Furthermore, there is only limited information on the long-term safety of fluoxetine with regard to growth, puberty, and cognitive, emotional, and behavioural development in this age group. Nevertheless, if you are a patient under 18 years of age, your doctor may prescribe fluoxetine for the treatment of moderate to severe depressive episodes in combination with psychological therapy if they consider it appropriate. If your doctor prescribes this medicine to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms mentioned above appear or worsen while patients under 18 years of age are taking fluoxetine.

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

Sexual dysfunction

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

Taking Fluoxetina Teva-Rimafar with other medicines

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-Rimafar with:

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

Treatment with fluoxetine should only be started at least two weeks after discontinuing a non-selective irreversible MAOI (e.g., tranylcypromine). Do not take any non-selective irreversible MAOI for at least 5 weeks after stopping Fluoxetina Teva-Rimafar. If you have been prescribed fluoxetine for a long time and/or at a high dose, your doctor will need to consider whether a longer interval is necessary before starting an MAOI.

• Metoprolol when used for heart failure: as this increases the risk of excessive slowing of the heartbeat.

Fluoxetina Teva-Rimafar may affect the action of other medicines (interactions):

• Tamoxifen (used to treat breast cancer); your doctor may need to consider a different antidepressant, as fluoxetine may alter blood levels of this medicine and a reduction in tamoxifen’s effect cannot be ruled out.
• Monoamine oxidase A inhibitors (MAO-A inhibitors), including moclobemide, linezolid (an antibiotic), and methylthioninium chloride (also known as methylene blue, used to treat drug- or chemical-induced methemoglobinemia), due to the risk of serious and even fatal adverse reactions (called serotonin syndrome). Treatment with fluoxetine may be started the day after stopping a reversible MAO inhibitor, 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 fluoxetine may increase the risk of changes in the heart’s electrical activity.
• Phenytoin (used for epilepsy): fluoxetine may increase blood levels of this medicine, so your doctor will need to monitor and adjust your phenytoin dose more carefully and perform more frequent check-ups.
• Lithium, selegiline, St. John’s wort, tramadol, and buprenorphine (both for severe pain); triptans (for migraine treatment); and tryptophan: there is an increased risk of mild serotonin syndrome if these medicines are taken with fluoxetine. Your doctor will 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; some antihistamines (astemizole, mizolastine), as taking one or more of these medicines with fluoxetine may increase the risk of changes in the heart’s electrical activity.
• Anticoagulants (such as warfarin), NSAIDs (such as ibuprofen, diclofenac), aspirin, and other medicines 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 blood tests, adjust your dose, and monitor you more frequently if you start or stop taking fluoxetine while on warfarin.
• Cyproheptadine (used to treat allergies), as it may reduce the effect of fluoxetine.
• Medicines that reduce sodium levels in the blood (including medicines that increase urine production, desmopressin, carbamazepine, and oxcarbazepine), as using fluoxetine with these medicines may increase the risk of excessive reduction in blood sodium levels.
• Antidepressants such as other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquine or chloroquine (used to treat malaria); tramadol (for severe pain); or antipsychotics such as phenothiazines or butyrophenones; as using fluoxetine with these medicines may increase the risk of seizures.
• Flecainide, encainide, propafenone, or nebivolol (for heart problems), carbamazepine (for epilepsy), atomoxetine or tricyclic antidepressants (e.g., imipramine, desipramine, amitriptyline), or risperidone (for schizophrenia), as fluoxetine may alter blood levels of these medicines, and your doctor may need to reduce their dose when co-administered with fluoxetine.

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

Fluoxetine may be taken with or without food, as preferred.

Alcohol intake is not recommended 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

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

Medicines such as Fluoxetina Teva-Rimafar, when taken during pregnancy, particularly during the last 3 months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

If you take fluoxetine late in pregnancy, you may have 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 appropriately.

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

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

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

Animal studies have shown that fluoxetine reduces sperm quality. This could theoretically affect fertility, but no effect on human fertility has been observed to date.

Driving and using machines

Psychotropic medicines such as fluoxetine may impair judgment or coordination. Do not drive or operate machinery until you know how this medicine affects you.

3. How to take Fluoxetina Teva-Rimafar

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not take more capsules than those prescribed by your doctor.

Adults

The recommended dose is:

• Depression: The recommended initial dose is 1 capsule (20 mg) per day. Your doctor may review and adjust your dose if necessary within the first 3 to 4 weeks of starting treatment. When required, the dose may be gradually increased up to a maximum of 3 capsules (60 mg) per day. The dose should be increased carefully to ensure you receive the lowest effective dose. You may not feel better immediately when starting your antidepressant medication. This is common, as improvement in depressive symptoms usually does not occur until after the first few weeks of treatment. Patients with depression should be treated for a period of at least 6 months.
• Bulimia nervosa: The recommended dose is 3 capsules (60 mg) per day.
• Obsessive-compulsive disorder: The recommended dose is 1 capsule (20 mg) per day. Your doctor may review and adjust the dose after two weeks of treatment. When necessary, the dose may be gradually increased up to a maximum of 3 capsules (60 mg) per day. If no improvement is observed within the following 10 weeks, treatment with fluoxetine should be reconsidered.

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 one or two weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased carefully to ensure you receive the lowest effective dose. Children with low body weight may require lower doses. If a satisfactory response to treatment is observed, your doctor should reevaluate the need for continuing treatment after 6 months. If you have not improved within 9 weeks, treatment should be reconsidered.

Elderly patients

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

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 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 immediately to the nearest hospital emergency department or contact your doctor right away.

If possible, bring the fluoxetine packaging with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or 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-Rimafar

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-Rimafar

Do not stop taking fluoxetine unless your doctor has instructed 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 medicine.

You may experience the following effects (withdrawal symptoms) when stopping treatment with fluoxetine: 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 (feeling sick or being sick), tremors (shakiness), and headache.

Most people find that symptoms occurring when stopping fluoxetine treatment are mild and resolve spontaneously 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 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 develop a skin rash or allergic reactions such as itching, swelling of the face or lips, or difficulty breathing, stop taking the capsules and tell your doctor immediately.

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

• If you feel restless and as though you cannot sit still or remain motionless, you may be experiencing a condition called akathisia; increasing your fluoxetine dose might make you feel worse. If you feel this way, consult your doctor.

• Contact your doctor immediately if your skin begins to redden or develops any kind of reaction, blisters, or starts to peel. This occurs very rarely.

The most common 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 breathing or increased heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation, or drowsiness (only in rare cases);
• 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 fast or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.

If you experience any of the adverse effects described above, you must inform 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 of nervous tension;
• 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 tremor-like movements;
• blurred vision;
• sensation of rapid or irregular heartbeat;
• 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 or distant from oneself;
• strange thoughts;
• euphoria;
• sexual problems, including orgasm-related issues, occasionally persisting after discontinuation of treatment;
• suicidal thoughts or thoughts of 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;
• difficulty breathing;
• nosebleeds;
• difficulty swallowing;
• hair loss;
• increased tendency to bruise;
• bleeding or bruising without explanation;
• cold sweats;
• difficulty urinating;
• sensation of feeling hot or cold;
• 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;
• unusually uncontrolled behaviour;
• hallucinations;
• agitation;
• panic attacks;
• confusion;
• stuttering;
• aggressiveness;
• seizures;
• vasculitis (inflammation of a blood vessel);
• rapid swelling of tissues around the neck, face, mouth, and/or throat;
• pain in the oesophagus (the tube connecting the mouth to the stomach);
• hepatitis;
• lung problems;
• sensitivity to sunlight;
• muscle pain;
• problems with urination;
• milk production (galactorrhea).

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.

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 thoughts), 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluxoetina Teva-Rimafar

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

Do not use this medicine after the expiry date stated on the 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluoxetina Teva-Rimafar

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

The other components (excipients) are: pregelatinized maize starch 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 contents of the container

Fluoxetina Teva-Rimafar 20 mg hard capsules are presented as yellow hard capsules.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Manufacturer:

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

Date of the latest revision of this leaflet: April 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/