Fluoxetine Pharma Combix 20 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fluoxetina Pharma Combix 20 mg hard capsules EFG

In this leaflet

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

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

Fluoxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs):

This medicine is indicated for the treatment of:

Adults:

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

Children over 8 years of age and adolescents:

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

2. Before taking Fluoxetina Pharma Combix

Do not take Fluoxetina Pharma Combix

Do not take fluoxetine and inform your doctor or pharmacist if:

• You are allergic (hypersensitive) to fluoxetine or any of the other ingredients of this medicine. An allergic reaction may include rash, itching, swelling of the face or lips, or difficulty breathing.
• You are taking any medicine belonging to another class of drugs also used to treat depression known as non-selective monoamine oxidase inhibitors or reversible inhibitors of monoamine oxidase type A (also called MAOI-A), as a serious or even fatal adverse reaction may occur.

Treatment with fluoxetine may only be started two weeks after stopping treatment with an irreversible MAO inhibitor (e.g. tranylcypromine).

However, treatment with fluoxetine may be started the day after stopping treatment with certain reversible MAO inhibitors, known as reversible MAO inhibitors called MAOI-A (e.g. moclobemide).

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

Take special care with Fluoxetina Pharma Combix

Take special care with Fluoxetina Pharma Combix and inform your doctor or pharmacist if:

• You develop skin rashes or other allergic reactions (such as itching, facial or lip swelling, or difficulty breathing), stop taking the capsules and contact your doctor immediately.
• You have epilepsy or have previously had seizures; if you experience seizures or an increase in their frequency, contact your doctor immediately, as you may need to discontinue fluoxetine treatment.
• You have previously experienced mania; if you have a manic episode, contact your doctor immediately, as you may need to discontinue fluoxetine.
• You have diabetes, as your doctor may need to adjust your insulin or other antidiabetic treatment dosage.
• You have liver problems (your doctor may need to adjust your dose).
• You have heart disease.
• You are taking diuretics, especially if you are elderly.
• You are receiving electroconvulsive therapy (ECT).
• You have a history of bleeding disorders, or if you develop unusual bruising or bleeding, or if you are pregnant (see "Pregnancy and breastfeeding").
• You are taking medicines that affect blood clotting (see section "Taking other medicines with Fluoxetina Pharma Combix").
• You begin to experience fever, muscle stiffness or twitching, 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, so contact your doctor immediately, as fluoxetine treatment may need to be discontinued.
• You have suicidal thoughts or thoughts of self-harm. Depression is associated with an increased risk of suicidal thoughts, self-harm, and suicide (suicide-related events). This risk may persist until the condition improves. Since it may take 3 to 4 weeks after starting fluoxetine treatment before improvement occurs, your doctor will closely monitor you at the beginning of treatment. Other psychiatric conditions for which fluoxetine is prescribed may also be associated with an increased risk of suicide-related events. Therefore, the same precautions should be taken when treating patients with other psychiatric disorders.

Use in 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 behavior, and irritability) when taking this type of medicine. Fluoxetine 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.

In addition, there is only limited information regarding the long-term safety of fluoxetine with respect to growth, puberty, and cognitive, emotional, and behavioral development in this age group. However, 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 they decide it is in the patient's best interest. If your doctor prescribes fluoxetine 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 when patients under 18 years of age are taking fluoxetine.

Fluoxetine must 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 (within the last 5 weeks) any other medicines, including those obtained without a prescription. This medicine may affect the action of other medicines (interaction). Interactions may occur with:

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

Taking Fluoxetina Pharma Combix with food and drink

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Available information to date does not indicate an increased risk when this medicine is used during pregnancy. However, caution should be exercised when using it during pregnancy, especially during the third trimester or shortly before delivery, as the following adverse effects have been reported in newborns: irritability, tremor, muscle weakness, persistent crying, difficulty feeding or sleeping.

If you take fluoxetine in the late 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 be aware that you are taking fluoxetine 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.

Driving and using machines

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

3. How to take Fluoxetina Pharma Combix

Follow exactly the instructions for administration of this medicine as given by your doctor.

Consult your doctor or pharmacist if you have any doubts.

The usual dose is:

• ?Depression: The recommended initial dose is 20 mg. Your doctor may review and adjust your dose as necessary within the first 3 to 4 weeks of starting treatment. When required, the dose may be gradually increased up to a maximum of 60 mg. 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 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 may be gradually increased up to a maximum of 60 mg. If no improvement is observed within 10 weeks, treatment with fluoxetine should be reconsidered.
• ?Children and adolescents aged 8 to 18 years with depression: Treatment should be initiated and supervised by a specialist. The initial dose is 10 mg/day. After one or two weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased carefully to ensure the patient remains on the lowest effective dose. Children with low body weight may require lower doses. Your doctor should re-evaluate the need for continued treatment after 6 months. If you have not improved, treatment should be reconsidered.

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

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

Method of administration

Swallow the capsules with water. Do not chew them.

If you take more Fluoxetina Pharma Combix than you should

• ?If you take too many capsules, go to the nearest hospital emergency department or contact your doctor immediately.
• ?If possible, bring the fluoxetine packaging with you.

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

Symptoms of overdose include: nausea, vomiting, seizures, cardiac problems (such as irregular heartbeat or cardiac arrest), respiratory problems, and changes in mental status ranging from agitation to coma.

If you forget to take Fluoxetina Pharma Combix

• ?Do not worry if you forget a dose. Take the next dose the following day at your usual time. Do not take a double dose to make up for missed doses.
• ?Taking your medicine at the same time each day may help you remember to take it regularly.

If you stop taking Fluoxetina Pharma Combix

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

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

You may experience the following effects when stopping treatment with fluoxetine: dizziness, tingling sensations like pins and needles, sleep disturbances (vivid dreams, nightmares, insomnia), feelings of restlessness or agitation, unusual tiredness or weakness, anxiety, nausea and/or vomiting, tremors (shakiness), and headache.

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

When discontinuing treatment with fluoxetine, your doctor will help you gradually reduce the dose over one to two weeks—this will help reduce the likelihood of withdrawal effects.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

• If you develop a skin rash or allergic reactions such as itching, swelling of the face or lips, or difficulty breathing, stop taking the capsules and tell your doctor immediately.
• If you feel restless and have an urge to keep moving or an inability to sit still, you may be experiencing a condition called akathisia; increasing your fluoxetine dose might make you feel worse. If you feel this way, consult your doctor.
• Contact your doctor immediately if your skin starts turning red and then blisters or begins to peel. This occurs very rarely.

Some patients have experienced:

• A combination of symptoms (known as serotonin syndrome), including fever of unknown cause with increased heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation, or drowsiness (only very rarely);
• Weakness, drowsiness, or confusion, mainly in elderly patients and in those treated with diuretics (elderly patients);
• Prolonged and painful erection.
• Irritability and extreme agitation.

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

If you experience any of the following symptoms and they bother you or persist over time, inform your doctor:

• General disorders: chills, light sensitivity, weight loss.
• Gastrointestinal system: diarrhea and stomach discomfort, vomiting, indigestion, difficulty swallowing, altered sense 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, seizures, extreme restlessness, hallucinations, unusually reckless behavior, confusion, agitation, anxiety, nervousness, difficulty concentrating and thinking clearly, panic attacks, or thoughts of suicide or self-harm.
• Genitourinary and reproductive system disorders: difficulty urinating, increased frequency of urination, sexual dysfunction, prolonged erections, and production of breast milk.

Frequency not known (cannot be estimated from available data): Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see section 2 “Pregnancy and breastfeeding” for more information.

• Respiratory system: sore throat, breathing difficulties. Pulmonary disorders (including inflammatory processes and various histopathological changes and/or fibrosis) have been reported rarely.
• Other: hair loss, yawning, blurred vision, unexplained bruising or bleeding, sweating, hot flushes, dizziness upon standing, muscle or joint pain, low blood sodium levels.

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

Additionally, in children and adolescents (8 to 18 years of age) – fluoxetine may reduce growth rate or delay sexual maturation.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluoxetine 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Additional information

Composition of Fluoxetina Pharma Combix

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

The other components are: pregelatinized maize starch and dimethicone. The components of the capsule shell are: quinoline yellow (E-104), erythrosine (E-127), indigo carmine (E-132) and gelatin.

Appearance of the product and contents of the pack

Fluoxetina Pharma Combix 20 mg is presented as hard capsules with a yellow body and a blue cap.

Each pack contains blisters with 14, 28, 56, 60 or 500 (hospital pack) hard capsules.

Only some pack sizes may be commercially available.

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 leaflet was approved in July 2025.

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