FLUOXETINE PHARMA COMBIX 20 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Fluoxetine Pharma Combix 20 mg hard capsules EFG

In this package leaflet

1. What Fluoxetine Pharma Combix is and what it is used for
2. Before taking Fluoxetine Pharma Combix
3. How to take Fluoxetine Pharma Combix
4. Possible side effects
5. Storage of Fluoxetine Pharma Combix
6. Additional information

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

Fluoxetine belongs to a group of medicines called selective serotonin reuptake inhibitor antidepressants (SSRIs):

This medicine is indicated for the treatment of:

Adults:

• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia nervosa: Fluoxetine is indicated 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 only be offered to children or young people with moderate to severe depression in combination with psychological therapy.

2. Before taking Fluoxetine Pharma Combix

Do not take Fluoxetine Pharma Combix

Do not take fluoxetine and inform your doctor or pharmacist:

• If you are allergic (hypersensitive) to fluoxetine or any of the other components of this medicine. An allergy can include rash, itching, swelling of the face or lips, or shortness of breath.
• If you are taking any medicine belonging to another type of medicine used to treat depression, known as non-selective monoamine oxidase inhibitors or reversible monoamine oxidase inhibitors type A (also called IMAO-A), a serious or life-threatening adverse reaction may occur.

Treatment with fluoxetine may only be started after two weeks after finishing treatment with an irreversible monoamine oxidase inhibitor (e.g., tranilcipromine).

However, treatment with fluoxetine can be started the day after finishing treatment with certain reversible monoamine oxidase inhibitors, known as reversible monoamine oxidase inhibitors type A (e.g., moclobemide).

Do not take any MAOI for at least five weeks after stopping medication with fluoxetine. If you have been prescribed fluoxetine for a long period and/or at a high dose, your doctor may consider the need for a longer interval before taking an MAOI. Examples of MAOIs are: nialamide, iproniazid, selegiline, moclobemide, phenelzine, tranilcipromine, isocarboxazid, and toloxatone.

Be careful with Fluoxetine Pharma Combix

Be careful with Fluoxetine Pharma Combix and inform your doctor or pharmacist if:

Use in children and adolescents from 8 to 18 years

Patients under 18 years have a higher risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritation) when taking this class of medicines. Fluoxetine 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 psychological therapy and should not be used for other indications in this age group.

Additionally, there is only limited information 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 when deemed necessary for the patient. If your doctor prescribes fluoxetine to a patient under 18 years 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 when patients under 18 years are taking fluoxetine.

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

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines (in the last 5 weeks), including those obtained without a prescription. This medicine may influence the action of other medicines (interaction). Interactions may occur with:

• Monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression). Non-selective MAOIs or MAOIs known as type A (such as moclobemide) should not be used with fluoxetine, as they can cause serious or fatal reactions (serotonin syndrome), see section "Do not take Fluoxetine Pharma Combix". MAOIs known as type B (Selegiline) can be used with fluoxetine, provided that your doctor carefully monitors the treatment.
• Lithium, tryptophan. There is an increased risk of serotonin syndrome if these medicines are administered with fluoxetine. When fluoxetine is administered in combination with lithium, your doctor should monitor you more frequently.
• Phenytoin (medicine used for epilepsy). Fluoxetine may increase the blood levels of this medicine, so your doctor should dose phenytoin more carefully when administered with fluoxetine and monitor you more frequently.
• Clozapine (used to treat some mental disorders), tramadol (for pain treatment), or tryptophans (for migraine treatment), there is an increased risk of hypertension.
• Flecainide or encainide (for heart problems), carbamazepine (for epilepsy), tricyclic antidepressants (e.g., imipramine, desipramine, and amitriptyline), because fluoxetine may change the blood levels of these medicines, so your doctor may need to reduce your dose when administered with fluoxetine.
• Warfarin or other medicines that affect blood coagulation; fluoxetine may alter the effect of these medicines in the blood. Your doctor will need to perform certain tests if you start or stop treatment with fluoxetine while taking warfarin.
• You should not start taking herbal preparations containing St. John's Wort (Hypericum perforatum) while being treated with fluoxetine, as it may increase the risk of adverse effects. If you start treatment with fluoxetine while taking St. John's Wort, stop taking it and inform your doctor at your next visit.

Taking Fluoxetine Pharma Combix with food and drinks

• Fluoxetine can be taken with or without food, as preferred.
• It is not advisable to consume alcohol while taking this medicine.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medicine.

Pregnancy

The information available to date does not indicate an increased risk when using this medicine during pregnancy. However, caution should be exercised when using it during pregnancy, especially during the last stage of pregnancy or just before delivery, as the following adverse effects have been reported in newborns: irritability, tremors, muscle weakness, persistent crying, difficulty feeding or sleeping.

If you take fluoxetine in the final stage of pregnancy, there may be an increased risk of excessive 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 to advise you accordingly.

Lactation

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

Driving and using machines

This medicine may affect your judgment or coordination. Do not drive or use machinery without consulting your doctor or pharmacist.

3. How to take Fluoxetine Pharma Combix

Follow the administration instructions of this medicine indicated by your doctor exactly.

Consult your doctor or pharmacist if you have any doubts.

The normal dose is:

• Depression: the recommended initial dose is 20 mg. Your doctor may review and adjust your dose as necessary in the 3 to 4 weeks following the start of treatment. When necessary, the dose can be gradually increased up to a maximum of 60 mg. The dose should be carefully increased to ensure that you receive the lowest effective dose. You may not feel better immediately when starting to take your medicine for depression. This is common, as 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 60 mg per day.
• Obsessive-compulsive disorder: the recommended dose is 20 mg per day. 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 60 mg. If you do not observe improvement within 10 weeks, treatment with fluoxetine should be reconsidered.
• Children and adolescents from 8 to 18 years with depression: treatment should be started 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 carefully increased to ensure that the patient is maintained with the lowest effective dose. Children with low weight may need lower doses. Your doctor should reevaluate the need to continue treatment after 6 months. If you have not improved, treatment should be reconsidered.

If you are an elderly patient, your doctor should carry out dose increases more carefully, and the daily dose should not generally exceed 40 mg. The maximum dose is 60 mg per day.

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

Method of administration

Swallow the capsules with water. Do not chew them.

If you take more Fluoxetine Pharma Combix 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 packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

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 forget to take Fluoxetine Pharma Combix

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

If you stop taking Fluoxetine Pharma Combix

Do not stop taking fluoxetine unless your doctor has told you to do so.It is important that you continue taking your medicine.

• Do not stop taking your medicine without asking your doctor first, even if you start to feel better.
• Make sure you do not run out of medicine.

You may experience the following effects when stopping treatment with fluoxetine: 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, tremors (instability), and headache.

Most people find that the symptoms that occur when stopping treatment with fluoxetine are moderate and disappear on their own 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 possibility of withdrawal effects.

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

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

• If you have a skin rash or allergic reactions such as itching, swelling of the face or lips, or shortness of breath, stop taking the capsules and tell your doctor immediately.
• If you feel restless and feel like you cannot sit still or stay still, you may be suffering from something called akathisia, and increasing your fluoxetine dose could make you feel worse. If you feel this way, consult your doctor.
• Talk to your doctor immediatelyif your skin starts to redden and then blisters or peels. This happens very rarely.

Some patients have suffered from:

• A combination of symptoms (known as serotonin syndrome) that include unexplained fever with increased heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation or drowsiness (only rarely);
• 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

If you suffer from any of the above-mentioned side effects, you should contact your doctor immediately.

If you suffer from any of the symptoms described below and they bother you or persist over time, tell your doctor:

• Generalized disorders: cooling, sensitivity to light, weight loss.
• Digestive system: diarrhea and stomach upset, vomiting, indigestion, difficulty swallowing or alteration of taste or dry mouth. Rarely, abnormalities in liver function tests have been reported, with very rare cases of hepatitis.
• Nervous system: headache, sleep disturbances or abnormal dreams, dizziness, loss of appetite, fatigue, euphoria, uncontrolled movements, convulsions, extreme agitation, hallucinations, atypically reckless behavior, confusion, agitation, anxiety, nervousness, inability to concentrate and think clearly, panic attacks, or thoughts of suicide or self-harm.
• Disorders of the urogenital and reproductive system: difficulty urinating, increased frequency of urination, sexual dysfunction, prolonged erections, and milk production.

Frequency not known (cannot be estimated from available data): abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see section 2 "Pregnancy and lactation" for more information.

• Respiratory system: sore throat, difficulty breathing. Rarely, pulmonary disorders (including inflammatory and varied histopathological processes and/or fibrosis) have been reported.
• Others: hair loss, yawning, blurred vision, unexplained bruising or bleeding, sweating, hot flashes, feeling of dizziness when standing up, muscle or joint pain, low sodium levels in the blood.

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

Additionally, in children and adolescents (8 years to 18 years)- fluoxetine may decrease growth or delay sexual maturation.

If you consider that any of the adverse effects you are suffering from are serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Fluoxetina Pharma Combix

Keep out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of Fluoxetina Pharma Combix

The active ingredient is fluoxetine. Each hard capsule contains 20 mg of fluoxetine.

The other components are: pregelatinized cornstarch and dimeticone. The components of the capsule are: quinoline yellow (E-104), erythrosine (E-127), indigotine (E-132), and gelatin.

Appearance of the Product and Packaging Content

Fluoxetina Pharma Combix 20 mg is presented in the form of hard capsules with a yellow body and a blue cap.

Each package contains blister packs with 14, 28, 56, 60, or 500 (clinical package) hard capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón

(Madrid) Spain

Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70, Polígono Industrial Urtinsa II,

28923 Alcorcón, Madrid

Spain

This prospectus was approved in July 2025

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