Fluoxetine Kern Pharma 20 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluoxetine Kern Pharma 20 mg hard capsules EFG

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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

What Fluoxetine Kern Pharma is and what it is used for
What you need to know before taking Fluoxetine Kern Pharma
How to take Fluoxetine Kern Pharma
Possible side effects
How to store Fluoxetine Kern Pharma
Contents of the pack and other information

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

Fluoxetina Kern Pharma 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: as an adjunct to psychotherapy for the reduction of binge eating and purging.

Children over 8 years of age and adolescents:

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 adolescents with moderate to severe depression only in combination with psychological therapy.

How fluoxetine 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 recover. If left untreated, your condition may not resolve and could 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 Kern Pharma

Do not take Fluoxetina Kern Pharma

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 type of 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 irreversible non-selective monoamine oxidase inhibitors (MAOIs), as this may cause a serious or even fatal reaction (e.g., iproniazid, used to treat depression).

Treatment with Fluoxetina Kern Pharma may only be started at least 2 weeks after stopping treatment with an irreversible non-selective MAOI.

Do not take any irreversible non-selective MAOI for at least five weeks after stopping Fluoxetina Kern Pharma. If you have been prescribed Fluoxetina Kern Pharma for a long period 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 (for the treatment of heart failure), as it increases the risk of excessive slowing of the heartbeat.

Warnings and precautions

Talk to your doctor or pharmacist before starting Fluoxetina Kern Pharma if any of the following apply to you:

If you have heart disease;
If you have epilepsy or seizures. If you experience seizures or an increase in their frequency, contact your doctor immediately; you may need to stop treatment with Fluoxetina Kern Pharma;
If you suffer from 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 Fluoxetina Kern Pharma;
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 severe prolonged diarrhea, vomiting, or use of diuretics (water tablets);
If you are taking diuretics (water tablets), especially if you are elderly;
If you are receiving electroconvulsive therapy (ECT);
If you are being treated with tamoxifen (used to treat breast cancer) (see "Taking Fluoxetina Kern Pharma with other medicines");
If you start feeling restless and unable to sit still or remain motionless (akathisia). Increasing your dose of Fluoxetina Kern Pharma could worsen this;
If you have a history of bleeding disorders or develop unusual bruising or bleeding, or if you are pregnant (see "Pregnancy");
If you are taking medicines that affect blood clotting (see "Taking Fluoxetina Kern Pharma with other medicines");
If you develop fever, muscle stiffness, tremors, or changes in mental status 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. Contact your doctor immediately, as you may need to stop treatment with Fluoxetina Kern Pharma;
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. This risk 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 thoughts or thoughts of self-harm.
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 you have any thoughts of suicide or self-harm at any time, contact your doctor immediately or go directly to the hospital.

You may find it helpful to tell a family member or close 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.

Sexual dysfunction

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

Children and adolescents aged 8 to 18

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. Fluoxetina Kern Pharma should only be used in children and adolescents aged 8 to 18 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 regarding the long-term safety of fluoxetine with respect to growth, puberty, and cognitive, emotional, and behavioural development in this age group. Nevertheless, your doctor may prescribe fluoxetine to patients under 18 years of age for the treatment of moderate to severe depressive episodes, in combination with psychological therapy, when it is considered appropriate. If your doctor prescribes Fluoxetina Kern Pharma to a patient under 18 years of age 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 of age are taking Fluoxetina Kern Pharma.

Fluoxetina Kern Pharma must not be used to treat children under 8 years of age.

Other medicines and Fluoxetina Kern Pharma

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

Do not take Fluoxetina Kern Pharma with:

Certain irreversible non-selective monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Irreversible non-selective MAOIs must not be used with Fluoxetina Kern Pharma, as they may cause serious or even fatal reactions (serotonin syndrome) (see section "Do not take Fluoxetina Kern Pharma").

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

Metoprolol when used for heart failure, as it increases the risk of excessive slowing of the heartbeat.

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

Tamoxifen (used to treat breast cancer); your doctor may consider an alternative antidepressant treatment because Fluoxetina Kern Pharma may alter blood levels of this medicine, and a reduction in the effectiveness of tamoxifen cannot be ruled out.
Monoamine oxidase A inhibitors (MAO-A), including moclobemide, linezolid (an antibiotic), and methylene blue chloride (also called methylene blue, indicated for mild conjunctivitis, eye itching, and irritation): due to the risk of serious or 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); because taking this medicine with Fluoxetina Kern Pharma may increase the risk of changes in the heart's 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 taken with Fluoxetina Kern Pharma. Your doctor will monitor you more frequently.
Phenytoin (a medicine used for epilepsy): Fluoxetina Kern Pharma may increase blood levels of this medicine, so your doctor will need to monitor and adjust your phenytoin dose more carefully when used with Fluoxetina Kern Pharma and will need to check you more frequently.
Medicines that may affect heart rhythm, for example, 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 such as halofantrine, or certain antihistamines (astemizole, mizolastine), as taking one or more of these medicines with Fluoxetina Kern Pharma may increase the risk of changes in the heart's electrical activity.
Flecainide, propafenone, nebivolol, or encainide (for heart problems), carbamazepine (for epilepsy), atomoxetine or tricyclic antidepressants (e.g., imipramine, desipramine, amitriptyline), or risperidone (for schizophrenia); since Fluoxetina Kern Pharma may alter blood levels of these medicines, your doctor may need to reduce their dose when administered together with Fluoxetina Kern Pharma.
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). Fluoxetina Kern Pharma 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 Fluoxetina Kern Pharma while taking warfarin.
Cyproheptadine (used to treat allergies); as it may reduce the effect of Fluoxetina Kern Pharma.
Medicines that lower blood sodium levels (including medicines that increase urine production, desmopressin, carbamazepine, and oxcarbazepine); as using Fluoxetina Kern Pharma with these medicines may increase the risk of excessive lowering of 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 strong pain), or antipsychotics such as phenothiazines or butyrophenones; as using fluoxetine with these medicines may increase the risk of seizures.

Taking Fluoxetina Kern Pharma with food, drinks, and alcohol

Fluoxetina Kern Pharma may be taken with or without food, according to your preference.
Alcohol consumption is not recommended while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

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

Medicines like fluoxetine, when taken during pregnancy—particularly during the last three 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 with your baby, contact your midwife and/or doctor immediately.

Caution should be exercised when using this medicine during pregnancy, especially during the late stages of pregnancy or just before delivery, as the following effects have been reported in newborns: irritability, tremors, muscle weakness, persistent crying, and difficulty feeding 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 discontinue Fluoxetina Kern Pharma during pregnancy or before becoming pregnant. However, depending on your circumstances, your doctor may advise that it is better for you to continue taking Fluoxetina Kern Pharma.

If you take Fluoxetina Kern Pharma late in 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 aware that you are taking this medicine 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

Animal studies have shown that fluoxetine reduces sperm quality. This could theoretically affect fertility, but no impact on human fertility has been observed so far.

Driving and using machines

Psychotropic medicines such as Fluoxetina Kern Pharma may impair judgment or coordination. Do not drive or operate machinery until you know how Fluoxetina Kern Pharma affects you.

3. How to take Fluoxetina Kern Pharma

Follow exactly the instructions for administration of this medicine provided by your doctor or pharmacist. If in 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 the first 3 to 4 weeks of treatment. When necessary, the dose may be gradually increased up to a maximum of 3 capsules (60 mg) daily. 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 typically 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 may 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 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 oral solution formulations with the same active substance at a concentration of 20 mg/5 ml). After one or two weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased carefully to ensure the patient remains on the lowest effective dose. Children with low body 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 prescribed by your doctor should be carried out more cautiously, and the daily dose should generally not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) daily.

Hepatic impairment:

If you have liver problems or are taking other medications that may interact with this medicine, your doctor will decide whether to prescribe a lower dose or advise you to take fluoxetine on alternate days.

If you take more Fluoxetina Kern Pharma than you should

If you take too many capsules, go immediately to the nearest hospital emergency department or contact your doctor without delay.
If possible, bring the Fluoxetina Kern Pharma packaging with you.

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 agitation to coma.

If you forget to take Fluoxetina Kern Pharma

Do not worry if you forget a dose. Take your next dose the following day at the 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 Kern Pharma

Do not stop taking this medicine unless instructed by your doctor, even if you begin to feel better. It is important that you continue taking it.
Make sure you do not run out of medicine.

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

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

When discontinuing treatment with this medicine, your doctor will help you gradually reduce the dose over one to two weeks, which 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, Fluoxetina Kern Pharma may produce adverse effects, although not everyone experiences them.

If at any time you have suicidal thoughts or thoughts of self-harm, contact your doctor or go directly to the hospital (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 capsules and inform your doctor immediately.
If you feel restless and as though you cannot sit still or remain motionless, you may be experiencing a condition called akathisia; increasing your dose of Fluoxetina Kern Pharma could worsen this. If you feel this way, consult your doctor.
Contact your doctor immediately if your skin begins to redden or shows any kind of reaction, blisters appear, or your skin 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, diarrhea, 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 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 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 function.

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

The following adverse 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, difficulty concentrating
feeling of nervous tension
decreased sexual desire or sexual problems (including difficulty maintaining an erection during sexual activity)
sleep disturbances, abnormal dreams, tiredness, drowsiness
dizziness
altered sense of taste
uncontrollable trembling 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 or chills

Uncommon (may affect up to 1 in 100 people)

feeling detached or distant from oneself
strange thoughts
euphoria
sexual problems, including orgasm disorders, occasionally persisting after discontinuation of treatment
thoughts of suicide or 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
unexplained bruising or bleeding
cold sweats
difficulty urinating
sensation of heat or cold
abnormalities in liver function tests

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

low sodium levels in the blood
reduction in platelets in the blood, increasing the risk of bleeding or bruising
reduction in white blood cell count
unusually uninhibited 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
pain in the esophagus (the tube connecting the mouth to the stomach)
hepatitis
lung problems
sensitivity to sunlight
muscle pain
problems with urination
milk production

Frequency not known (cannot be estimated from available data)

Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see "Pregnancy" 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) – In addition to the possible adverse effects mentioned above, fluoxetine may reduce growth or delay sexual maturation. Suicidal behavior (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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluoxetine Kern Pharma

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.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, 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 Fluoxetine Kern Pharma

The active substance is fluoxetine in the form of hydrochloride.

The other components (excipients) are: pregelatinized corn starch.

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 contents of the pack

Fluoxetine Kern Pharma 20 mg is presented as white and orange capsules.

Each standard pack contains aluminum/PVC blisters with 28 or 60 capsules.

Each hospital pack contains aluminum/PVC blisters with 500 capsules.

Only certain pack 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 most recent review of this leaflet: June 2024

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