Package Leaflet: Information for the User

FLUOXETINE ALMUS 20 mg Hard Capsules EFG

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What is Fluoxetine Almus and what it is used for

2.What you need to know before taking Fluoxetine Almus

3. How to take Fluoxetine Almus

4. Possible side effects

5. Storage of Fluoxetine Almus

6. Contents of the pack and additional information

Fluoxetina Almus belongs to a group of medications known as selective serotonin reuptake inhibitors (SSRIs):

This medication is indicated for the treatment of:

Adults:

• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia nervosa: Fluoxetina Almus 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 after4 to6 sessions. Fluoxetina Almus should be offered to children or young people with moderate to severe depression only in combination with a psychological therapy.

Do not take Fluoxetina Almus:

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6). If you experience an allergic reaction such as itching, swelling of the face or lips, or difficulty breathing, stop taking the capsules immediately and contact your doctor.
• If you are taking other medications, known as irreversible non-selective monoamine oxidase inhibitors (IMAOs), as this may cause a severe or fatal adverse reaction (e.g. iproniazid, which is used to treat depression).
• If you are taking metoprolol (a medication used to treat heart problems), as this increases the risk of excessive slowing of the heart rate.

Treatment with fluoxetine may only be initiated after two weeks following the completion of a treatment with an irreversible non-selective MAO inhibitor.

Do not take any irreversible non-selective IMAO during at least five weeks after discontinuing medication with Fluoxetina Almus. If you have been prescribed Fluoxetina Almus 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluoxetina Almus.

Consult your doctor in the following cases:

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

• 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 fluoxetine.

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

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

• If you have heart disease.

• If you have a slow heart rate at rest and/or if you know you may have hyponatremia as a result of prolonged severe diarrhea and vomiting or the use of diuretics (diuretic tablets).

• If you are taking diuretics (diuretic tablets), especially if you are an elderly patient.

• If you have glaucoma (increased intraocular pressure).

• If you are receiving electroconvulsive therapy (ECT).

• 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 "Taking Fluoxetina Almus with other medications").

• If you are taking tamoxifen (used to treat breast cancer) (see "Taking Fluoxetina Almus with other medications").

• If you start to feel restless and cannot sit or stay still (akathisia). Increasing the dose of fluoxetine may worsen the effect.

• If you begin to experience fever, rigidity, or muscle twitching, changes in your mental state such as confusion, irritability, or 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, so contact your doctor immediately, as you may need to discontinue treatment with fluoxetine.

• If you are taking or have taken in the last 14 days another medication known as an irreversible non-selective monoamine oxidase inhibitor (IMAO) (see "Taking Fluoxetina Almus with other medications").

• Some medications in the group to which Fluoxetina Almus belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuing treatment.

Pregnancy*

If you take Fluoxetina Almus in the final stages 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 know that you are taking Fluoxetina Almus so they can advise you.

Thoughts of suicide 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 may increase when starting to take antidepressants, as all these medications need time to start working, usually around two weeks, but 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 young adults 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. It may be 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 can ask them if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Children and adolescents aged 8 to 18 years:

Patients under 18 years of age have a higher risk of adverse effects such as suicidal thoughts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medications. Fluoxetina Almus 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 regarding the long-term safety of Fluoxetina Almus in relation to growth, puberty, and cognitive, emotional, and behavioral development in this age group. However, your doctor may prescribe Fluoxetina Almus 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 Fluoxetina Almus 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 when patients under 18 years of age are taking Fluoxetina Almus.

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

Taking Fluoxetina Almus with other medications

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

Do not take Fluoxetina Almus with:

• Certain irreversible monoamine oxidase inhibitors (IMAOs), some of which are used to treat depression. Irreversible non-selective MAO inhibitors should not be used with Fluoxetina Almus as this may cause severe or fatal adverse reactions (serotonin syndrome), (see section "Do not take Fluoxetina Almus").

Treatment with Fluoxetina Almus should only be initiated at least 2 weeks after discontinuing an irreversible non-selective MAO inhibitor (e.g. tranilcipromina). Do not take any irreversible non-selective IMAO during at least 5 weeks after discontinuing medication with Fluoxetina Almus. If you have been prescribed Fluoxetina Almus 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.

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

This medication may interact with other medications (interaction):

• Tamoxifen(used to treat breast cancer); your doctor may consider a different antidepressant treatment as Fluoxetina Almus may change the levels of this medication in the blood and it cannot be ruled out that the effect of tamoxifen may be reduced.

• Inhibitors of monoamine oxidase A (IMAO-A)including moclobemide, linezolid (an antibiotic) and chlorpromazine (also known as methylene blue indicated for the treatment of conjunctivitis, itching, and mild eye irritation): due to the risk of severe or fatal adverse reactions (serotonin syndrome). Fluoxetine treatment 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.

• MAO inhibitors known as IMAO-B(Selegiline) may be used with Fluoxetina Almus as long as your doctor closely monitors your treatment.

• Lithium(used to treat mental disorders),tramadol(used to treat pain),triptans(used to treat migraines) andtryptophan: there is an increased risk of mild serotonin syndrome if these medications are taken with Fluoxetina Almus. Your doctor will perform more frequent checks.

• Fenitoin(used to treat epilepsy), Fluoxetina Almus may increase the levels of this medication in the blood, so your doctor will need to carefully dose you with fenitoin and perform more frequent checks.

• Clozapine(used to treat some mental disorders),tramadol(used to treat pain) ortriptans(used to treat migraines), there is an increased risk of hypertension.

• Medications that may affect heart rhythm, for example,

• Flecainida, propafenona, nebivololorencainida(used to treat heart problems),carbamazepina(used to treat epilepsy),atomoxetine(used to treat attention deficit hyperactivity disorder) ortricyclic antidepressants(e.g.imipramina,desipraminaandamitriptilina) orrisperidona(used to treat schizophrenia); as Fluoxetina Almus may change the levels of these medications in the blood, your doctor may need to reduce your dose when they are taken with Fluoxetina Almus.

• Medications that may affect blood clotting, such as oral anticoagulants(warfarina),NSAIDs(such as ibuprofen, diclofenac, acetylsalicylic acid)andother medications that may affect blood clotting(including clozapine, used to treat some mental disorders). Fluoxetina Almus may alter the effect of these medications on the blood. Your doctor will need to perform certain tests, adjust your dose, and perform more frequent checks if you start or stop treatment with Fluoxetina Almus while taking oral anticoagulants.
• Ciproheptadinas(used to treat allergies); as it may reduce the effect of Fluoxetina Almus.

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

• Medications that decrease sodium levels in the blood(including medications that increase urine production, desmopressin, carbamazepina, and oxcarbazepina); as the use of Fluoxetina Almus with these medications may increase the risk of excessive decrease in sodium levels in the blood.

• Medications that may decrease the seizure threshold (e.g. tricyclic antidepressants, other ISRSs, phenothiazines, butyrophenones, mefloquine, chloroquine, bupropion, tramadol).

Taking Fluoxetina Almus with food, drinks, and alcohol

• Fluoxetina Almus 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

Babies whose mothers took fluoxetine during the first months of pregnancy have been reported to 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 around 2 in 100 in babies whose mothers took fluoxetine. It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the potential risk. You and your doctor may decide that while you are pregnant, it is better to gradually stop taking fluoxetine. 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 Fluoxetina Almus. When taken during pregnancy, particularly in the last 3 months of pregnancy, medications like Fluoxetina Almus may increase the risk of a serious condition in newborns 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.

There should be caution when using 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.

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 is no observed impact on human fertility.

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 this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults:

The recommended dose is:

• Depression: the initial recommended dose is 20 mg. Your doctor may review and adjust your dose as needed in the 3 to 4 weeks following the start of treatment. When necessary, the dose can be increased gradually 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 increased gradually up to a maximum of 60 mg. If no improvement is observed within 10 weeks, the treatment 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. 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.

Older adults:

If you are an older adult, 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.

Liver impairment:

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

Method of administration

Swallow the capsules with water. Do not chew them.

If you take more Fluoxetina Almus than you should

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562 04 20.

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

If you forgot to take Fluoxetina Almus

• 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 Almus

Do not stop taking Fluoxetina Almus 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 to feel better.
• Make sure you do not run out of medication.

You may experience the following effects when interrupting treatment with Fluoxetina Almus: dizziness, a sensation of pins and needles, sleep disturbances (intense dreams, nightmares, insomnia), a feeling of restlessness or agitation, unusual fatigue or weakness, anxiety, nausea, and/or vomiting, tremors (instability), and headaches.

Most people find that the symptoms that occur when stopping treatment with Fluoxetina Almus are moderate and resolve on their own within a few weeks. If you experience these symptoms when stopping your treatment, consult your doctor.

When stopping treatment with Fluoxetina Almus, 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 other questions about the use of Fluoxetina Almus, ask your doctor or pharmacist.

Like all medicines, Fluoxetine Almusmay cause 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 face or lips, or difficulty breathing, 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 fluoxetine Almus 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 includes fever of unknown cause with increased heart rate, sweating, muscle rigidity or tremor, confusion, extreme agitation or somnolence (only rarely);

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

• Prolonged and painful erection;

• Irritability and extreme agitation;

• Heart problems, such as rapid or irregular heartbeat, 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 treated with fluoxetine Almus:

Very common(may affect more than 1 in 10 people)

• Insomnia
• Headache
• Diarrhea, feeling of discomfort (nausea)
• Fatigue

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 libido or sexual problems (including difficulty maintaining an erection during sexual activity and ejaculation problems)
• Changes in sleep, abnormal dreams, fatigue, somnolence
• Dizziness
• Alteration of taste
• Uncontrollable tremors
• Blurred vision
• Sensation of rapid and irregular heartbeats (palpitations)
• 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 (derealization)
• Strange thoughts
• Euphoria
• Thoughts or behaviors of suicide or self-harm
• Sexual dysfunction
• Bruxism (teeth grinding)
• Memory alterations
• Restlessness, need to move
• Muscle spasms, involuntary movements, or balance or coordination problems
• Dilated pupils
• Tinnitus (ringing in the ears)
• Low blood pressure
• Difficulty breathing
• Nasal bleeding
• Gastrointestinal bleeding
• Difficulty swallowing
• Hair loss
• Increased appearance of bruises
• Cold sweat
• Difficulty urinating
• Sexual dysfunction

- General discomfort

- Feeling cold or hot

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

• Low sodium levels in the blood
• Reduction of platelets in the blood, which increases the risk of bleeding or bruising
• Decrease in white blood cells (neutropenia, leucopenia)
• Allergic reaction
• Skin rash, with or without itching, fever, joint pain, muscle pain, swollen lymph nodes, and/or symptoms similar to the flu (serum sickness) that may progress to Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Low sodium levels in the blood, in some cases caused by the syndrome of inappropriate antidiuretic hormone secretion.
• Atypical, uncontrolled behavior
• Alucinations
• Agitation
• Panic attacks
• Sensation of confusion
• Aggressive behavior
• Stuttering
• Seizures
• Inability to remain still
• Uncontrollable movements of the mouth, tongue, and limbs (buccoglossal syndrome)
• Serotonin syndrome
• Irregular heartbeat
• Vasculitis (inflammation of a blood vessel)
• Vasodilation
• Pharyngitis (inflammation of the throat)
• Pulmonary problems (pulmonary inflammation and fibrosis)
• Esophageal pain (the tube that connects the mouth to the stomach)
• Heptatitis
• Quick swelling of the tissues around the neck, face, mouth, and/or throat
• Bleeding under the skin
• Sensitivity to sunlight
• Red or purple spots on the skin (purpura)
• Severe skin reactions that may cause rash, skin redness, blisters in the mouth, lips, or eyes, skin peeling, fever (possible signs of erythema multiforme) that may progress to Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Muscle pain
• Urination problems
• High levels of prolactin hormone, milk production
• Prolonged and painful erection of the penis
• Mucosal bleeding
• Abnormal liver function tests

Unknown frequency(cannot be estimated from available data)

• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see «Pregnancy»* in section 2 for more information.

Fractures:A higher risk of bone fractures has been observed in patients taking this type of medication.

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

Other side effects in children and adolescents (8 to 18 years)

In addition to the possible side effects mentioned above, fluoxetine may slow down growth or delay sexual maturation. Frequent reports have been made of children experiencing thoughts and behaviors of suicide, hostility, mania, and nasal bleeding.

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 Vigilance of Medicinal Products for Human Use: https://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 Fluoxetina Almus after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, askyour pharmacist how to dispose of the packaging and medicines you no longer need. In this way,you will help protect the environment.

Composition of Fluoxetina Almus

The active ingredient of this medication is fluoxetine in the form of hydrochloride. Each hard capsule contains 20 mg of fluoxetine (as fluoxetine hydrochloride).

The other components (excipients) are: pregelatinized cornstarch without gluten; anhydrous colloidal silica; magnesium stearate; talc.

The components of the gelatin capsule are: gelatin, water, erythrosine (E-127), quinoline yellow (E-104) and titanium dioxide (E-171).

Appearance of the product and contents of the package

Fluoxetina Almus 20 mg hard capsules are presented in the form of hard yellow capsules.

They are presented in packages of 14, 28 or 60 capsules.Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Responsible for manufacturing:

Teva Pharma, S.L.U., Malpica Industrial Estate, c/C nº 4. 50016 Zaragoza Spain

Date of the last review of this package leaflet: December 2020

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