Package Insert: Information for the User

Fluoxetina Kern Pharma 20 mg Hard Capsules EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as 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 package insert. See section 4.

Fluoxetina Kern Pharma contains the active ingredient 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.

Older children and adolescents (over 8 years):

• 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 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 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 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 Kern Pharma

• If you are allergic to fluoxetine or any of the other ingredients of this medication (listed in section 6).If you experience an allergic reaction (such as hives, 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 medications, known as irreversible non-selective monoamine oxidase inhibitors (IMAOs), as this may cause a severe or fatal reaction (for example, iproniazid, which is used to treat depression).

The treatment with Fluoxetina Kern Pharma may only be initiated after 2 weeks of completing a treatment with an irreversible non-selective MAO inhibitor.

Do not takeany IMAOirreversible non-selectivefor at least five weeks after stopping the medication with Fluoxetina Kern Pharma. If you have been prescribed Fluoxetina Kern Pharma for 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 IMAO.

• If 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 Kern Pharma if you experience any of the following:

• If you have heart disease;
• If you have epilepsy or seizures. If you have had seizures or experience an increase in their frequency, contact your doctor immediately; you may need to discontinue treatment with Fluoxetina Kern Pharma;
• If you suffer from mania or have had mania in the past; if you have a manic episode, contact your doctor immediately, as you may need to discontinue treatment with Fluoxetina Kern Pharma;
• If you have diabetes (your doctor may need to adjust your insulin or other antidiabetic medication);
• If you have liver problems (your doctor may need to adjust your dose);
• If you have a slow heart rateat rest and/or if you know you may have salt loss as a result of prolonged severe diarrhea and vomiting or the use of diuretics (tablets to urinate);
• If you are taking diuretics (tablets to urinate), especially if you are an elderly patient;
• If you are receiving electroconvulsive therapy (ECT);
• If you are being treated with tamoxifen (used to treat breast cancer) (see “Fluoxetina Kern Pharma with other medications”);
• If you start to feel restless and cannot sit or stay still (akathisia). Increasing your dose of Fluoxetina Kern Pharma may worsen it;
• If you have a history of bleeding disorders or if you develop unusual bleeding or bruising, or if you are pregnant (see “Pregnancy”);
• If you are taking medications that affect blood clotting (see “Fluoxetina Kern Pharma with other medications”);
• If you begin to experience fever, muscle stiffness, or tremors, 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,contact your doctor immediately, as you may need to discontinuetreatment with Fluoxetina Kern Pharma;

• Glaucoma (increased eye pressure).

Thoughts of suicide and worsening of your depression or anxiety

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. This may increase when starting to take antidepressants, as all these medications need time to start working, usually around two weeks, although sometimes longer.

You are more likely to think this way:

- If you have previously had thoughts of suicide or self-harm.

- 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 illnesses, who were treated with antidepressants.

If you ever have thoughts of suicide or self-harm,contact your doctor or go directly to the hospital.

You may find it helpful to tell a family member or close friendwho is depressed or has an anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they think your depressionor anxiety is getting worse, or if they are concerned about changes in your behavior.

Sexual dysfunction

Some medications in the group to which Fluoxetina Kern Pharma belongs (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents aged 8 to 18 years

Children under 18 years have a higher risk of adverse effects such as suicidal behavior, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this class of medications. Fluoxetina Kern Pharma 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.

Additionally, there is only limited information available regarding 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 psychological therapy, if they decide it is in the best interest of the patient. If your doctor prescribes Fluoxetina Kern Pharma to a patient under 18 years 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 are taking Fluoxetina Kern Pharma.

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

Other medications and Fluoxetina Kern Pharma

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

Do not take Fluoxetina Kern Pharma with:

• Certainirreversible non-selective monoamine oxidase inhibitors (IMAOs),some of which are used to treat depression. Do not use IMAO irreversible non-selective with Fluoxetina Kern Pharma as this may cause severe or even fatal reactions (serotonin syndrome), (see section “Do not take Fluoxetina Kern Pharma”).

The treatment with Fluoxetina Kern Pharma should only be initiated at least 2 weeks after discontinuing an irreversible non-selective MAO inhibitor (for example, tranilcipromina). Do not take any IMAO irreversible non-selective for at least 5 weeks after stopping the medication with Fluoxetina Kern Pharma. If you have been prescribed Fluoxetina Kern Pharma for 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 IMAO.

• Metoprololwhen used to treat heart failure; as this increases the risk of excessive slowing of the heart rate.

Fluoxetina Kern Pharma may affect the action of other medications (interaction):

• Tamoxifen(used to treat breast cancer); your doctor may consider a different antidepressant treatment as Fluoxetina Kern Pharma may change the blood levels of this medication and it cannot be ruled out that the effect of tamoxifen is reduced.
• Inhibitors of monoamine oxidase A (IMAO-A)including moclobemide, linezolid (an antibiotic) and methionine chloride (also known as methylene blue, used to treat conjunctivitis, itching, and mild eye irritation): due to the risk of severe or even fatal reactions (serotonin syndrome). Fluoxetina Kern Pharma 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 IMAO-A medication.
• Mequitazina(used to treat allergies); as taking this medication with Fluoxetina Kern Pharma may increase the risk of changes in heart activity.
• Lithium,selegiline, St. John's Wort, tramadol(for pain relief),triptans(for migraine treatment) andtryptophan: there is an increased risk of mild serotonin syndrome if these medications are administered with Fluoxetina Kern Pharma.Your doctor will perform more frequent reviews.
• Fenitoin(a medication used to treat epilepsy): Fluoxetina Kern Pharma may increase the blood levels of this medication, so your doctor will need to carefully dose you with fenitoin when it is administered with Fluoxetina Kern Pharma and will need to perform more frequent reviews.
• Medications that may affect heart rhythm, for example,Class IA and III antiarrhythmics,antipsychotics(for example, phenothiazine derivatives, pimozide, haloperidol),tricyclic antidepressants, someantimicrobials(for example, ciprofloxacin, moxifloxacin, intravenous erythromycin, pentamidine), particularly malaria treatment halofantrine or someantihistamines(astemizol, mizolastina), as taking one or more of these medications with Fluoxetina Kern Pharma may increase the risk of changes in heart activity.
• Flecainida,propafenona,nebivolol or encainida(for heart problems), carbamazepine (for epilepsy treatment),atomoxetine ortricyclic antidepressants(for example imipramine, desipramine, and amitriptyline),orrisperidona(for schizophrenia treatment); as Fluoxetina Kern Pharma may change the blood levels of these medications, your doctor may need to reduce your dose when they are administered with Fluoxetina Kern Pharma.
• Anticoagulants(such as warfarin),AINEs(such as ibuprofen, diclofenac),aspirinandother medications that affect blood clotting(including clozapine, used to treat some mental disorders).Fluoxetina Kern Pharma may alter the effect of these medications on the blood. Your doctor will need to perform certain testsadjust your dose and perform more frequent reviews if you start or stop treatmentwith Fluoxetina Kern Pharma while taking warfarin.
• Ciproheptadinas(used to treat allergies); as it may reduce the effect of Fluoxetina Kern Pharma.
• Medications that decrease blood sodium levels(including, medications that increase urine production, desmopressin, carbamazepine, and oxcarbazepine); as the use of Fluoxetina Kern Pharma with these medications may increase the risk of excessive decrease in blood sodium levels.
• Antidepressantssuch as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion,mefloquinaorcloroquina(used to treat malaria),tramadol(for strong pain relief) orantipsychoticssuch as phenothiazines or butyrophenones; as the use of fluoxetine Kern Pharma with these medications may increase the risk of seizures.

Fluoxetina Kern Pharma with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Studies in babies whose mothers took fluoxetine during the first months of pregnancy have described an increased risk of congenital heart defects. In the general population, approximately 1 in 100 babies are born with a heart defect. This probability increased to around 2 in 100 in those babies whose mothers took fluoxetine.

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

Use with caution when used during pregnancy,especially in 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 breastfeeding or sleeping.

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 stop taking fluoxetine Kern Pharma during pregnancy or before becoming pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to continue taking Fluoxetina Kern Pharma.

If you take Fluoxetina Kern Pharma in the final stage of pregnancy, there may be an increased risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking this medication to be able to advise you.

Lactation

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

Fertility

In animal studies, fluoxetine has been shown to reduce sperm quality. Theoretically, this may affect fertility, but there has been no observed impact on human fertility.

Driving and operating machinery

Medications like Fluoxetina Kern Pharma canalter your judgment or coordination.Do not drive or operate machinery until you know how Fluoxetina Kern Pharma affects you.

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 indicated 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 as needed within 3 to 4 weeks after starting treatment. When necessary, the dose can be increased gradually up to a maximum of 3 capsules (60 mg) daily. 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 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 increased gradually up to a maximum of 3 capsules (60 mg) daily. If no improvement is observed within 10 weeks, the 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 (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 increased carefully to ensure that 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 in 9 weeks, treatment should be reconsidered.

Older adults:

The dose increases made 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.

Liver impairment:

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

If you take more Fluoxetina 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.
• Take the packaging of Fluoxetina Kern Pharma with you.

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

If you forgot to take Fluoxetina Kern Pharma

• 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 Kern Pharma

• Do notstop taking this medication unless your doctor has told you to, even if you start feeling better..It is essential 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, a sensation of pins and needles, sleep disturbances (intense dreams, nightmares, insomnia), restlessness or agitation, unusual fatigue or weakness, anxiety, nausea, and/or vomiting (feeling sick or being sick), tremors (unsteadiness), and headache.

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

When stopping treatment with this medication, your doctor will help you reduce the dose gradually over one to two weeks, which 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 medications, Fluoxetina Kern Pharma may produce side effects, although not everyone will experience them.

• If you have any thoughts of suicide or self-harm at any time,contact your doctor or go directly to the hospital(see section 2).
• If you have a skin rash or allergic reactions such as itching, swelling of the lips/tongue or throat/breathing difficulties,stop taking the capsulesand inform your doctor immediately.
• If you feel restless and feel like you cannot sit or stay still, you may be experiencing something called akathisia, so increasing your dose of Fluoxetina Kern Pharma may make you feel worse. If you feel this way,consult your doctor.
• Inform your doctor immediatelyif your skin starts to redden or presents any type of reaction or blisters appear or if your skin starts to peel. This happens very rarely.

The most common side effects (very common side effects that can 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 withan increase in breathing or heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation or somnolence (only in rare cases);
• Feeling weak, drowsy or confused mainly inolder patientsand in people treated with diuretics (older patients);
• Prolonged and painful erection;
• Irritability and extreme agitation;
• Heart problems, such as rapid or irregular heart rate, fainting, collapse or dizziness when standing up, which may indicate abnormal heart rhythm.

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

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

Common(may affect up to 1 in 10 people)

• Loss of appetite, weight loss
• Nervousness, anxiety
• Restlessness, lack of concentration
• Sensation of nervous tension
• Decreased sex drive or sexual problems (including difficulty maintaining an erection during sexual activity)
• Sleep disturbances, abnormal dreams, fatigue, somnolence
• Dizziness
• Alteration of taste
• Uncontrollable tremors
• Blurred vision
• Sensation of rapid and irregular heartbeats
• Flush
• Yawns
• Indigestion, vomiting
• Dry mouth
• Skin rash, urticaria, itching
• Excessive sweating
• Joint pain
• Increased frequency of urination
• Unexplained vaginal bleeding
• Sensation of weakness or chills

Uncommon(may affect up to 1 in 100 people)

• Feeling detached, distant from oneself
• Strange thoughts
• Euphoria
• Sexual problems, including orgasm problems, persisting occasionally after treatment is stopped
• Thoughts of suicide or self-harm
• Grinding teeth
• Muscle spasms, involuntary movements or problems with balance or coordination
• Memory alterations
• Dilated pupils
• Noise in the ears
• Low blood pressure
• Difficulty breathing
• Nasal bleeding
• Difficulty swallowing
• Hair loss
• Increase in tendency to bruise
• Bruises or bleeding without explanation
• Cold sweat
• Difficulty urinating
• Sensation of heat or cold
• Abnormalities in liver tests

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

• Low sodium levels in the blood
• Reduction in platelet count in the blood, which increases the risk of bleeding or bruising
• Reduction in white blood cell count
• Atypical behavior
• Delusions
• Agitation
• Panic attacks
• Confusion
• Stammering
• Aggression
• Seizures
• Vasculitis (inflammation of a blood vessel)
• Quick swelling of tissues around the neck, face, mouth and/or throat
• Esophageal pain (the tube that connects the mouth to the stomach)
• Heptatitis
• Lung problems
• Sensitivity to sunlight
• Muscle pain
• Urination problems
• Milk production

Frequency not known(cannot be estimated from available data)

• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see “Pregnancy” in section 2 for more information

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

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

In children and adolescents (8 to 18 years)-Aside from the possible side effects mentioned above, fluoxetine may decrease growth or delay sexual maturation. Suicidal behaviors (suicide attempts and suicidal thoughts), hostility, mania, and nasal bleeding have also been reported frequently in children.

Reporting 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 the Spanish System for the Pharmacovigilance of Medicines for Human Use: 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 packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fluoxetina Kern Pharma

Theactive ingredientis fluoxetine in the form of hydrochloride.

The other components(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 content of the packaging

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

Each standard 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 commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72- Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Date of the last review of this leaflet: June 2024

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