FLUOXETINE KERN PHARMA 20 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fluoxetine Kern Pharma 20 mg Hard Capsules EFG

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

1. What is Fluoxetine Kern Pharma and what is it used for

Fluoxetine Kern Pharma 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: as a complement to psychotherapy for the reduction of binge-eating and purging.

Children over 8 years and adolescents:

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

How fluoxetine 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.

Treating these conditions is important to help you improve. If left untreated, your illness may not disappear and may become more severe and more difficult to treat.

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

2. What you need to know before you take Fluoxetine Kern Pharma

Do not take Fluoxetine Kern Pharma

• If you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you experience a rash or other type of allergic reaction (such as itching, swelling of the face or lips or shortness of breath),stop taking the capsules immediately and contact your doctor as soon as possible.

• If you are taking other medicines, known as irreversible non-selective monoamine oxidase inhibitors (MAOIs), as a severe or life-threatening reaction may occur (e.g. iproniazide used to treat depression).

Treatment with Fluoxetine Kern Pharma may only be started after 2 weeks after finishing treatment with an irreversible non-selective MAOI.

Do not takeany irreversible non-selective MAOI for at least 5 weeks after stopping treatment with Fluoxetine Kern Pharma. If you have been prescribed Fluoxetine Kern Pharma for a long period and/or at a high dose, your doctor may consider the need for a longer interval before taking an MAOI.

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Fluoxetine Kern Pharma if you have:

• Heart disease;
• Epilepsy or seizures. If you have had seizures or experience an increase in the frequency of seizures, contact your doctor immediately; you may need to stop treatment with Fluoxetine Kern Pharma;
• Mania or have had mania in the past; if you have a manic episode, contact your doctor immediately, as you may need to stop treatment with Fluoxetine Kern Pharma;
• Diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment);
• Liver problems (your doctor may need to adjust your dose);
• Low resting heart rate and/or if you know you may have low salt levels in the blood as a result of severe prolonged diarrhea and vomiting or the use of diuretics (water tablets);
• You are taking diuretics (water tablets), especially if you are an elderly patient;
• You are receiving electroconvulsive therapy (ECT);
• You are being treated with tamoxifen (used to treat breast cancer) (see “Taking Fluoxetine Kern Pharma with other medicines”);
• You start to feel restless and cannot sit or stand still (akathisia). Increasing your dose of Fluoxetine Kern Pharma may make it worse;
• You have a history of bleeding disorders or if you develop bruising or unusual bleeding, or if you are pregnant (see “Pregnancy”);
• You are taking medicines that affect blood clotting (see “Taking Fluoxetine Kern Pharma with other medicines”);
• You start to experience fever, muscle stiffness or tremors, changes in your mental state such as confusion, irritability and extreme agitation, you may have a condition called “serotonin syndrome” or “neuroleptic malignant syndrome”. Although this syndrome is rare, it can be life-threatening, contact your doctor immediately, as you may need to stop treatment with Fluoxetine Kern Pharma;

• Glaucoma (increased eye pressure).

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. This may increase when you first start taking antidepressants, as all these medicines need time to start working, usually around 2 weeks, although sometimes a little longer.

You are more likely to think this way:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric conditions, who were treated with antidepressants.

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

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

Sexual dysfunction

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

Children and adolescents from 8 to 18 years

Patients under 18 years have an increased risk of side effects such as suicidal attempts, suicidal thoughts and hostility (mainly aggression, confrontational behavior and irritability) when taking this type of medicine. Fluoxetine Kern Pharma should only be used in children and adolescents from 8 to 18 years for the treatment of moderate to severe depressive episodes (in combination with psychotherapy), and should not be used for other indications in this age group.

Additionally, there is only limited information on the long-term safety of fluoxetine in relation to growth, puberty, and cognitive, emotional and behavioral development in this age group. However, your doctor may prescribe fluoxetine to patients under 18 years for the treatment of moderate to severe depressive episodes, in combination with psychotherapy, when they decide what is best for the patient. If your doctor prescribes Fluoxetine Kern Pharma to a patient under 18 years and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms appear or worsen when patients under 18 years are taking Fluoxetine Kern Pharma.

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

Other medicines and Fluoxetine Kern Pharma

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

Do not take Fluoxetine Kern Pharma with:

• Certain irreversible non-selective monoamine oxidase inhibitors (MAOIs),some of which are used to treat depression. Irreversible non-selective MAOIs should not be used with Fluoxetine Kern Pharma as they may cause serious or life-threatening reactions (serotonin syndrome), (see section “Do not take Fluoxetine Kern Pharma”).

Treatment with Fluoxetine Kern Pharma should only be started at least 2 weeks after discontinuation of an irreversible non-selective MAOI (e.g. tranylcypromine). Do not take any irreversible non-selective MAOI for at least 5 weeks after stopping treatment with Fluoxetine Kern Pharma. If you have been prescribed Fluoxetine Kern Pharma for a long period and/or at a high dose, your doctor may consider the need for a longer interval before taking an MAOI.

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

Fluoxetine Kern Pharma may affect the action of other medicines (interaction):

• Tamoxifen(used to treat breast cancer); your doctor may consider a different antidepressant treatment because Fluoxetine Kern Pharma may change the blood levels of this medicine and it cannot be ruled out that the effect of tamoxifen may be reduced.
• Monoamine oxidase A inhibitors (MAO-A)including moclobemide, linezolid (an antibiotic) and methylthioninium chloride (also known as methylthionine chloride, used to treat conjunctivitis, itching and mild eye irritation): due to the risk of serious or life-threatening reactions (called serotonin syndrome). Treatment with fluoxetine may be started the day after finishing treatment with reversible MAOIs, but your doctor may monitor you closely and use a lower dose of the MAOI medicine.
• Mequitazine(used to treat allergies); as taking this medicine with Fluoxetine Kern Pharma may increase the risk of changes in heart electrical activity.
• Lithium, selegiline, St. John's Wort, tramadol(for pain treatment), triptans(for migraine treatment) and tryptophan: there is an increased risk of mild serotonin syndrome if these medicines are given with Fluoxetine Kern Pharma. Your doctor will monitor you more frequently.
• Phenytoin(medicine used for epilepsy): Fluoxetine Kern Pharma may increase the blood levels of this medicine, so your doctor will need to monitor you more closely when Fluoxetine Kern Pharma is given with phenytoin and adjust the dose of phenytoin with more care.
• Medicines that may affect heart rhythm, such as Class IA and III antiarrhythmics, antipsychotics(e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents(e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), treatment for malaria, especially halofantrine, or some antihistamines(astemizole, mizolastine), as taking one or more of these medicines with Fluoxetine Kern Pharma may increase the risk of changes in heart electrical activity.
• Flecainide, propafenone, nebivolol or encainide(for heart problems), carbamazepine (for epilepsy treatment), atomoxetine or tricyclic antidepressants(e.g. imipramine, desipramine and amitriptyline), or risperidone(for schizophrenia treatment); as Fluoxetine Kern Pharma may change the blood levels of these medicines, it is possible that your doctor will need to reduce your dose when they are given with Fluoxetine Kern Pharma.
• Anticoagulants(such as warfarin), NSAIDs(such as ibuprofen, diclofenac), aspirinand other medicines that affect blood clotting(including clozapine, used to treat some mental disorders). Fluoxetine Kern Pharma 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 Kern Pharma while you are taking warfarin.
• Cyproheptadine(used to treat allergies); as it may reduce the effect of Fluoxetine Kern Pharma.
• Medicines that lower sodium levels in the blood(including, medicines that increase urine production, desmopressin, carbamazepine and oxcarbazepine); as the use of Fluoxetine Kern Pharma 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 strong pain treatment) or antipsychoticssuch as phenothiazines or butyrophenones; as the use of fluoxetine Kern Pharma with these medicines may increase the risk of seizures.

Taking Fluoxetine Kern Pharma with food, drinks and alcohol

• Fluoxetine Kern Pharma can be taken with or without food, as you prefer.
• It is not recommended to drink alcohol while taking this medicine.

Pregnancy, breast-feeding and fertility

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

Pregnancy

Talk to your doctor as soon as possible if you are pregnant, think you may be pregnant or are planning to have a baby.

In babies whose mothers took fluoxetine during the first months of pregnancy, there are studies that describe a higher risk of congenital heart defects. In the general population, approximately 1 in 100 babies are born with a heart defect. This probability increased to about 2 in 100 in babies whose mothers took fluoxetine.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like fluoxetine may increase the risk of a serious disease in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

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 newborns: irritability, tremors, muscle weakness, persistent crying and difficulty sleeping or feeding.

It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the potential risk. Therefore, you and your doctor may decide to stop taking fluoxetine Kern Pharma gradually 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 Kern Pharma.

If you take Fluoxetine Kern Pharma 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 this medicine so they can advise you.

Breast-feeding

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

Fertility

In animal studies, fluoxetine has been shown to reduce sperm quality. Theoretically, this could affect fertility, but it has not yet been observed to have an impact on human fertility.

Driving and using machines

Psychotropic medicines like Fluoxetine Kern Pharma may alter your judgment or coordination. Do not drive or use machinery until you know how Fluoxetine Kern Pharma affects you.

3. How to take Fluoxetine Kern Pharma

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

Swallow the capsules with water. Do not chew the capsules.

Adults:

The recommended dose is:

• Depression:the recommended dose is 1 capsule (20 mg) daily. Your doctor may review and adjust your dose if necessary within 3 to 4 weeks after starting treatment. When necessary, the dose can be gradually increased up to a maximum of 3 capsules (60 mg) daily. The dose should be carefully increased to ensure you receive the lowest effective dose. You may not feel better immediately after starting to take your medication for depression. This is common because improvement in depressive symptoms 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) daily.
• Obsessive-compulsive disorder:the recommended dose is 1 capsule (20 mg) daily. Your doctor may review and adjust the dose after two weeks of treatment. When necessary, the dose can be gradually increased up to a maximum of 3 capsules (60 mg) daily. If no improvement is observed within 10 weeks, treatment with fluoxetine should be reconsidered.

Use in children and adolescents from 8 to 18 years with depression:

Treatment should be initiated and supervised by a specialist. The initial dose is 10 mg/day (administer 2.5 ml of commercial presentations with the same active ingredient in oral solution at a concentration of 20 mg/5ml). After one or two 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 weight may require lower doses. Your doctor should reevaluate the need to continue treatment after 6 months. If you have not improved within 9 weeks, treatment should be reconsidered.

Elderly patients:

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

Hepatic impairment:

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

If you take more Fluoxetine Kern Pharma than you should

• If you take too many capsules, go to the emergency department of the nearest hospital or consult your doctor immediately.
• If possible, take the Fluoxetine Kern Pharma packaging with you.

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

If you forget to take Fluoxetine Kern Pharma

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

If you interrupt treatment with Fluoxetine Kern Pharma

• Do notstop taking this medication unless your doctor has indicated it, even if you start to feel better .It is important that you continue taking it.
• Make sure you do not run out of medication.

You may experience the following effects (withdrawal effects) when interrupting treatment with this medication: 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 (feeling sick or being sick), tremors (instability), and headache.

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

When interrupting treatment with this medication, your doctor will help you gradually reduce the dose over one to two weeks, which 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 adverse effects

Like all medications, Fluoxetine Kern Pharma can cause adverse effects, although not all people experience them.

• If you have suicidal thoughts or self-harm thoughts at any time, contact your doctor or go directly to the hospital(see section 2).
• If you experience skin rash or allergic reactions such as itching, swelling of the lips/tongue, or wheezing/shortness of breath, stop taking the capsulesand inform your doctor immediately.
• If you feel restless and feel like you cannot sit still or remain quiet, you may be suffering from something called akathisia, and increasing your dose of Fluoxetine Kern Pharma could make you feel worse. If you feel this way, consult your doctor.
• Talk to your doctor immediatelyif your skin starts to redden or presents any type of reaction or blisters, or if your skin begins to peel. This happens very rarely.

The most frequent adverse effects (very frequent adverse 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 includes fever of unknown cause with increased breathing or heart rate, sweating, muscle stiffness or tremors, 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 rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart rhythm.

If you experience any of the above adverse effects, you should contact your doctor immediately.

The following adverse effects have also been reported in patients taking fluoxetine:

Frequent(may affect up to 1 in 10 people)

• loss of appetite, weight loss
• nervousness, anxiety
• restlessness, lack of concentration
• feeling of nervous tension
• decreased sexual desire or sexual problems (including difficulty maintaining an erection during sexual activity)
• sleep disorders, abnormal dreams, fatigue, drowsiness
• dizziness
• altered sense of taste
• uncontrolled tremor movements
• blurred vision
• feeling of rapid and irregular heartbeats
• flushing
• yawning
• indigestion, vomiting
• dry mouth
• skin rash, hives, itching
• excessive sweating
• joint pain
• increased frequency of urination
• unexplained vaginal bleeding
• feeling of weakness or chills

Infrequent(may affect up to 1 in 100 people)

• feeling separated, distant from oneself
• strange thinking
• euphoria
• sexual problems, including orgasm problems, which may persist occasionally after treatment is discontinued
• suicidal thoughts or self-harm thoughts
• teeth grinding
• muscle spasms, involuntary movements, or problems with balance or coordination
• memory disorders
• dilated pupils
• ringing in the ears
• low blood pressure
• breathing difficulties
• nosebleeds
• difficulty swallowing
• hair loss
• increased tendency to bruise
• unexplained bruising or bleeding
• cold sweats
• difficulty urinating
• feeling of heat or cold
• liver test abnormalities

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

• low sodium levels in the blood
• reduced platelet count in the blood, which increases the risk of bleeding or bruising
• reduced white blood cell count
• atypically unrestrained behavior
• hallucinations
• agitation
• panic attacks
• confusion
• stuttering
• aggression
• seizures
• vasculitis (inflammation of a blood vessel)
• rapid swelling of tissues around the neck, face, mouth, and/or throat
• esophageal pain (the tube that connects the mouth to the stomach)
• hepatitis
• lung problems
• sensitivity to sunlight
• muscle pain
• urination problems
• breast milk production

Frequency not known(cannot be estimated from available data)

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

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

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

In children and adolescents (8 to 18 years)-In addition to the possible adverse 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's pharmacovigilance system: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fluoxetine Kern Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fluoxetine Kern Pharma

The active ingredientis fluoxetine in the form of hydrochloride.

The other ingredients(excipients) are: pregelatinized cornstarch.

The components of the gelatin capsule are: gelatin, titanium dioxide (E-171), quinoline yellow (E-104), and erythrosine (E-127).

Appearance of the product and package contents

Fluoxetine Kern Pharma 20 mg is presented in the form of white and orange capsules.

Each normal package contains aluminum/PVC blisters of 28 or 60 capsules.

Each clinical package contains aluminum/PVC blisters of 500 capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this leaflet: June 2024

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