Prospect: information for the user

LURAMON 20 mg hard capsules

Hydrochloride of fluoxetine

In this prospect:

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

LURAMON belongs to a group of medications known as selective serotonin reuptake inhibitor antidepressants (SSRIs):

This medication is indicated for the treatment of:

Adults:

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

Children over 8 years and adolescents:

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

Do not take LURAMON and inform your doctor or pharmacist:

If you are allergic (hypersensitive) to fluoxetine or to any of the other components of LURAMON. An allergy may include rash, itching, swelling on the face or lips, or shortness of breath.

• If you are taking any medication belonging to another type of medication that is also used to treat depression and are known as non-selective monoamine oxidase inhibitors or reversible inhibitors of monoamine oxidase type A (also called IMAO-A), a severe or fatal adverse reaction may occur.

The treatment with fluoxetine can only be initiated after two weeks of completing a treatment with an irreversible MAO inhibitor (for example, tranilcipromina).

However, treatment with fluoxetine can be initiated the day after completing a treatment with certain reversible MAO inhibitors, known as reversible MAO inhibitors called IMAO-A (for example, moclobemida).

Do not take any IMAO for at least five weeks after discontinuing LURAMON medication. If you have been prescribed LURAMON for a long period of time and/or at a high dose, your doctor may consider the need for a longer interval before taking an IMAO. Examples of IMAOs are: nialamida, iproniazida, selegelina, moclobemida, fenelcina, tranilcipromina, isocarboxacida, and toloxatona.

An increased risk of bone fractures has been observed in patients treated with this type of medication.

Be especially careful with LURAMON and inform your doctor or pharmacist if:

• You develop skin rashes or other allergic reactions (such as itching, swelling on the face or lips, or shortness of breath), stop taking the capsules and contact your doctor immediately.

• If you have epilepsy or have had seizures in the past, if you have seizures or experience an increase in their frequency, contact your doctor immediately, you may need to discontinue treatment with fluoxetine.

• If you have had mania in the past, if you have a manic episode, contact your doctor immediately, you may need to discontinue the use of fluoxetine.

• If you have diabetes, your doctor may need to adjust your insulin or other antidiabetic treatment dose.

• If you have liver problems (your doctor may need to adjust your dose).

• If you have heart disease.

• If you are taking diuretics, especially if you are an elderly patient.

• If you are receiving electroconvulsive therapy (ECT).

• If you have a history of bleeding disorders, if you develop hematomas or unusual bleeding or if you are pregnant (see "Pregnancy").

• If you are taking medications that affect blood clotting (see "Taking other medications").

• If you start experiencing fever, stiffness, or muscle spasms, changes in your mental state such as confusion, irritability, or extreme agitation, you may be experiencing a condition called serotonin syndrome or malignant neuroleptic syndrome. Although this syndrome is rare, it can be life-threatening, so contact your doctor immediately, the use of fluoxetine may be discontinued.

• If you have suicidal thoughts or 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 disease improves. Since it may take 3 to 4 weeks after starting treatment with fluoxetine for improvement to occur, your doctor will closely monitor you at the start of treatment. Other psychiatric conditions for which LURAMON 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. You may be more prone to having these types of thoughts:

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

• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

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

Telling a family member or close friend that you are depressed or have an anxiety disorder and asking them to read this leaflet may be helpful. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behavior.

Some medications in the group to which LURAMON belongs (called ISRS/IRSN)

may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms

persist after treatment is discontinued.

Use in children and adolescents aged 8 to 18:

Children under 18 years of age have a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. LURAMON 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 available on the long-term safety of LURAMON in relation to growth, puberty, and cognitive, emotional, and behavioral development in this age group. However, your doctor may prescribe LURAMON 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 best interest of the patient. If your doctor prescribes LURAMON to a patient under 18 years of age 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 in patients under 18 years of age taking LURAMON.

LURAMON should not be used to treat children under 8 years of age.

Taking other medications with LURAMON:

Inform your doctor or pharmacist if you are taking or have recently taken other medications (in the last 5 weeks), including those purchased without a prescription. This medication may interact with other medications (interaction). Interactions may occur with:

• Non-selective monoamine oxidase inhibitors (MAO) or reversible monoamine oxidase inhibitors known as IMAO type A (such as moclobemida), which should not be used with LURAMON as they may cause severe or fatal reactions (serotonin syndrome), see "Do not take LURAMON". Reversible MAO inhibitors known as IMAO-B (selegilina) may be used with LURAMON, provided your doctor closely monitors your treatment.

• Lithium, tryptophan: there is an increased risk of serotonin syndrome if these medications are administered with LURAMON. When fluoxetine is administered in combination with lithium, your doctor should perform more frequent checks.

• Phenobarbital (used to treat epilepsy), LURAMON may increase the levels of this medication in the blood, so your doctor should dose you more carefully when taking LURAMON and phenobarbital together and should perform more frequent checks.

• Clozapine (used to treat certain mental disorders), tramadol (for pain relief), or tryptophans (for migraine treatment), there is an increased risk of hypertension.

• Flecainide or encainide (for heart problems), carbamazepine (for epilepsy treatment), tricyclic antidepressants (such as imipramine, desimpramine, and amitriptyline), because LURAMON may change the levels of these medications in the blood, your doctor may need to reduce your dose when taking LURAMON with these medications.

• Warfarin or other medications that affect blood clotting; LURAMON may alter the effect of these medications on the blood. Your doctor will need to perform certain tests if you start or stop taking LURAMON while taking warfarin.

• Do not start taking herbal preparations containing St. John's Wort (Hypericum perforatum) while taking LURAMON, as it may cause an increase in adverse effects. If you start taking LURAMON and are already taking St. John's Wort, stop taking it and inform your doctor at your next visit.

Taking LURAMON with food and drinks:

• LURAMON can be taken with or without food, as you prefer.

• It is not recommended to consume alcohol while taking this medication.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking a medication.

Pregnancy

Information obtained to date does not indicate an increased risk when using this medication 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, tremor, muscle weakness, persistent crying, difficulty breastfeeding or sleeping.

There have been reports of an increased risk of congenital heart defects in babies whose mothers took fluoxetine during the first months of pregnancy. 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. You and your doctor can decide whether to stop taking fluoxetine while pregnant or to gradually taper off the medication. However, depending on your circumstances, your doctor may suggest that you continue taking fluoxetine.

Make sure your midwife and/or doctor know that you are taking LURAMON. When taken during pregnancy, especially in the last 3 months of pregnancy, medications like LURAMON 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 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.

Taking LURAMON in the final stages of pregnancy may increase the 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 LURAMON 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.

Animal studies have shown that fluoxetine reduces sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not been observed so far.

Driving and operating machinery:

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

Follow exactly the administration instructions of LURAMON provided by your doctor. 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 needed within 3 to 4 weeks after starting treatment. When necessary, the dose can be gradually increased up to a maximum of 60 mg. 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 there is no improvement in depressive symptoms 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, the treatment with LURAMON should be reconsidered.

• Children and adolescents aged 8 to 18 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 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, treatment should be reconsidered.

If you are elderly, the dose increases made by your doctor should be carried out 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 LURAMON on alternate days.

Administration method

Swallow the capsules with water. Do not chew them.

If you take more LURAMON than you should

• If you take too many capsules, go to the nearest hospital emergency service or consult your doctor immediately.

• Take the LURAMON 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 medication and the amount ingested.

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

If you forgot to take LURAMON

• Do not worry if you forgot to take a dose. Take the next dose the following 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 LURAMON

Do not stop taking LURAMON unless your doctor has told you to.It is essential that you continue taking your medication.

• Do not stop taking your medication without first asking your doctor, even if you start feeling better.

• Make sure you do not run out of medication.

You may experience the following effects when interrupting treatment with LURAMON: dizziness, pins-and-needles sensation, sleep disturbances (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 interrupting treatment with LURAMON are moderate and disappear on their own within a few weeks. If you experience these symptoms when interrupting your treatment, consult your doctor.

When interrupting treatment with LURAMON, 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 LURAMON, ask your doctor or pharmacist.

Like all medications, LURAMON may have side effects, although not everyone will experience 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 or stay still, you may be experiencing something called akathisia, and increasing your LURAMON dose may make you feel worse. If you feel this way,consult your doctor.

• Tell your doctor immediatelyif your skin starts to redden and then blisters or peels. This happens very rarely.

Some patients have experienced:

• A combination of symptoms (known as serotonin syndrome) that include fever of unknown cause with increased heart rate, sweating, muscle rigidity or tremors, confusion, extreme agitation or somnolence (rarely);

• Feeling weak, drowsy, or confused mainly in the elderly and in people treated with diuretics (elderly);

• Prolonged and painful erection.

• Irritability and extreme agitation

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

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

• Generalized disorders: Chills, sensitivity to light, weight loss.

• Digestive system: Diarrhea and stomach discomfort, 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, involuntary movements, convulsions, extreme restlessness, hallucinations, atypical uninhibited behavior, confusion, agitation, anxiety, nervousness, inability to concentrate and think clearly, panic attacks, or suicidal or self-harm thoughts.

• Urinary and reproductive system disorders: Difficulty urinating, increased frequency of urination, sexual dysfunction, prolonged erections, and milk production.Unknown frequency: Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

• Respiratory system: Sore throat, difficulty breathing. Rarely, pulmonary abnormalities (including inflammatory processes and various histopathological processes and/or fibrosis) have been reported.

• Other: Hair loss, yawning, blurred vision, unexplained bruises or bleeding, sweating, hot flashes, feeling dizzy when standing up, muscle or joint pain, low sodium levels in the blood.

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

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

If you notice side effects not mentioned in this leaflet or if you experience one of the side effects described in a severe manner, inform your doctor or pharmacist.

No special conservation conditions are required.

Keep out of the reach and sight of children.

Do not use LURAMON after the expiration date appearing on the packaging or blister, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of unused packaging and medicines. This will help protect the environment.

Composition of LURAMON:

The active ingredient is fluoxetine, each capsule contains 20 mg of fluoxetine. The other components (excipients) are: pregelatinized cornstarch and dimethicone. The capsule components are: quinoline yellow (E-104), erythrosine (E-127), indigotin (E-132), and gelatin.

Appearance of the product and contents of the package

LURAMON is presented in the form of hard capsules with a yellow body and blue cap. It is presented in packages of 14, 28, 30, or 56 hard capsules. Clinical package with 500 hard capsules.

Holder of the marketing authorization and 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 December 2020

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