FLUOXETINE ALMUS 20 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

FLUOXETINE ALMUS 20 mg hard capsules EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Fluoxetine Almus and what is it used for
2. What you need to know before you take Fluoxetine Almus
3. How to take Fluoxetine Almus
4. Possible side effects
5. Storing Fluoxetine Almus
6. Contents of the pack and other information

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

Fluoxetine Almus belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs):

This medicine is indicated for the treatment of:

Adults:

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

2. What you need to know before you take Fluoxetine Almus

Do not take Fluoxetine Almus:

• If you are allergic to the active substance or to any of the other ingredients of this medicine (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 medicines, known as irreversible non-selective monoamine oxidase inhibitors (MAOIs), as a severe or life-threatening reaction may occur (e.g. iproniazid, which is used to treat depression).
• If you are taking metoprolol (a medicine used to treat heart problems), as it increases the risk of excessive slowing of heartbeats.

Treatment with fluoxetine may only be started at least 2 weeks after discontinuation of an irreversible non-selective MAOI.

Do not take any irreversible non-selective MAOI for at least 5 weeks after stopping treatment with Fluoxetine Almus. If you have been prescribed Fluoxetine Almus for a long period and/or at a high dose, your doctor may consider the need for a longer interval before taking an MAOI.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Fluoxetine Almus.

Consult your doctor in the following cases:

• If you suffer from epilepsy or convulsions. If you have had convulsions or experience an increase in the frequency of them, contact your doctor immediately, as you may need to discontinue treatment with fluoxetine.

• If you suffer from mania or have suffered from mania in the past; if you experience 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 problems.

• If you have a low resting heart rate and/or if you know you may have salt loss as a result of severe prolonged diarrhea and vomiting or the use of diuretics (water pills).

• If you are taking diuretics (water pills), especially if you are an elderly patient.

• If you have glaucoma (increased eye pressure).

• If you are receiving electroconvulsive therapy (ECT).

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

• If you are taking medicines that affect blood clotting (see "Taking Fluoxetine Almus with other medicines")

• If you are taking tamoxifen (used to treat breast cancer) (see "Taking Fluoxetine Almus with other medicines")

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

• If you start to experience fever, stiffness or muscle tremors, changes in your mental state such as confusion, irritability or extreme agitation, you may have 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 medicine known as an irreversible non-selective monoamine oxidase inhibitor (MAOI) (see "Taking Fluoxetine Almus with other medicines").

• Some medicines of the same group as Fluoxetine Almus (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Pregnancy*

If you take Fluoxetine Almus during the late stage 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 know that you are taking Fluoxetine Almus so they can advise you.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, since these medicines all take time to start working, usually about two weeks, but sometimes longer. You are more likely to think this way:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to hospital straight away. It might be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Children and adolescents aged 8 to 18 years:

Patients under 18 years have an increased risk of side effects such as suicide attempts, suicidal thoughts and hostility (predominantly aggression, confrontational behaviour and irritability) when taking this class of medicines. Fluoxetine 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.

Furthermore, there is only limited information on the long-term safety of Fluoxetine Almus in relation to growth, puberty, and cognitive, emotional and behavioural development in this age group. Nevertheless, your doctor may prescribe Fluoxetine Almus to patients under 18 years for the treatment of moderate to severe depressive episodes in combination with psychological therapy when they decide that it is the best option for the patient. If your doctor prescribes Fluoxetine Almus 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 above symptoms appear or worsen when patients under 18 years are taking Fluoxetine Almus.

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

Taking Fluoxetine Almus with other medicines

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

Do not take Fluoxetine Almus with:

• Certain monoamine oxidase inhibitors (MAOIs),some of which are used to treat depression. Irreversible non-selective MAOIs should not be used with Fluoxetine Almus as they can cause serious or life-threatening reactions (serotonin syndrome), (see section "Do not take Fluoxetine Almus").

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

• Metoprololwhen used for heart failure; as it increases the risk of excessive slowing of heartbeats.

This medicine may affect the action of other medicines (interaction):

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

• Monoamine oxidase A inhibitors (MAO-A)including moclobemide, linezolid (an antibiotic) and methylthioninium chloride (also known as methylthioninium chloride, used to treat conjunctivitis, itching and mild eye irritation): due to the risk of serious or life-threatening reactions (serotonin syndrome). Treatment with fluoxetine can be started the day after finishing treatment with reversible MAOIs, but your doctor may monitor you closely and use a lower dose of the MAOI-A medicine.

• MAO-B inhibitors(Selegiline) can be used with Fluoxetine Almus provided your doctor monitors you closely.

• Lithium(for the treatment of mental disorders), tramadol(for the treatment of pain), triptans(for the treatment of migraine) and tryptophan: there is an increased risk of mild serotonin syndrome if these medicines are given with Fluoxetine Almus. Your doctor will monitor you more frequently.

• Phenytoin(a medicine used for epilepsy), Fluoxetine Almus may increase the levels of this medicine in the blood, so your doctor will need to monitor you more closely and adjust the dose of phenytoin more carefully.

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

• Medicines that may affect the heart rhythm, such as

• antiarrhythmics Class IA and III, antipsychotics(e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents(e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), treatment for malaria, particularly halofantrine, or some antihistamines(astemizole, mizolastine), as taking one or more of these medicines with Fluoxetine Almus may increase the risk of changes in the electrical activity of the heart.
• Mequitazine(used to treat allergy and rhinitis)

• Flecainide, propafenone, nebivololor encainide(for heart problems), carbamazepine(for the treatment of epilepsy), atomoxetine(for attention deficit hyperactivity disorder) or tricyclic antidepressants(e.g. imipramine, desipramineand amitriptyline) or risperidone(for the treatment of schizophrenia); as Fluoxetine Almus may change the levels of these medicines in the blood, it is possible that your doctor will need to reduce the dose when they are given with Fluoxetine Almus.

• Medicines that have effects on blood clotting such as oral anticoagulants(warfarin), NSAIDs(such as ibuprofen, diclofenac, acetylsalicylic acid) and other medicines that have effects on blood clotting(including clozapine, used to treat some mental disorders). Fluoxetine Almus may alter the effect of these medicines in the blood. Your doctor will need to perform certain tests, adjust the dose and monitor you more frequently if you start or stop treatment with Fluoxetine Almus while taking oral anticoagulants.
• Cyproheptadine(used to treat allergies); as it may reduce the effect of Fluoxetine Almus.

• Do not start taking herbal preparations containing St. John's Wort (Hypericum perforatum) while you are being treated with Fluoxetine Almus, as it may increase the risk of side effects. If you start treatment with Fluoxetine Almus while you are taking St. John's Wort, stop taking it and tell your doctor at your next visit.

• Medicines that decrease sodium levels in the blood(including, medicines that increase urine production, desmopressin, carbamazepine and oxcarbazepine); as the use of Fluoxetine Almus with these medicines may increase the risk of a significant decrease in sodium levels in the blood.

• Medicines that may decrease the convulsive threshold (e.g. tricyclic antidepressants, other SSRIs, phenothiazines, butyrophenones, mefloquine, chloroquine, bupropion, tramadol).

Taking Fluoxetine Almus with food, drinks and alcohol

• Fluoxetine Almus can be taken with or without food, as you prefer.
• It is not recommended to drink alcohol while taking this medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There are reports suggesting that babies whose mothers took fluoxetine during the first few months of pregnancy may have an increased risk of congenital heart defects. In the general population, about 1 in 100 babies are born with a heart defect. This increased to about 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. Therefore, you and your doctor may decide that while you are pregnant it is better that you 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 knows that you are taking Fluoxetine Almus. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Fluoxetine Almus may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

Caution should be exercised when used during pregnancy, especially during the last stage of pregnancy or just before delivery, as the following effects have been reported in newborn babies: irritability, tremors, muscle weakness, persistent crying, and difficulty sleeping or feeding.

Breast-feeding

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

Fertility

In animal studies, fluoxetine has been shown to reduce sperm quality. This may theoretically affect fertility, but it has not yet been observed in human fertility.

Driving and using machines

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

3. How to take Fluoxetina Almus

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 if necessary 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 carefully increased to ensure that you receive the lowest effective dose. You may not feel better immediately after 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 no improvement is observed within 10 weeks, treatment should be reconsidered.

Use in children and adolescents from 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 carefully increased to ensure that the patient maintains the lowest effective dose. Children with low weight may need lower doses. Your doctor should reassess the need to continue treatment after 6 months. If you have not improved, treatment should be reconsidered.

Elderly patients:

If you are an elderly patient, any 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.

Hepatic impairment:

If you have a liver problem or are using other medication that may affect fluoxetine, your doctor will decide whether 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 emergency department of the nearest hospital 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, heart problems (such as irregular heartbeats or cardiac arrest), lung problems, and changes in mental state ranging from excitement to coma.

If you forget to take Fluoxetina Almus

• 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 interrupt treatment with Fluoxetina Almus

Do not stop taking Fluoxetina Almus unless your doctor has indicated it. It is important 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, 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 interrupting treatment with Fluoxetina Almus 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 Fluoxetina Almus, 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 Fluoxetina Almus, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Fluoxetina Almus can have side effects, although not all people experience them.

• If you have suicidal thoughts or self-harm at any time, contact your doctor or go directly to the hospital (see section 2).
• If you experience 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 quiet, you may be experiencing something called akathisia, and increasing your dose of Fluoxetina Almus could make you feel worse. If you feel this way, consult your doctor.
• Talk to your doctor immediately if 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 unexplained fever with increased heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation or drowsiness (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;

• 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 above side effects, you should contact your doctor immediately.

The following side effects have also been reported in patients treated with Fluoxetina 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
• feeling of nervous tension
• decreased sexual desire or sexual problems (including difficulty maintaining an erection during sexual activity and ejaculation problems)
• sleep disorders, abnormal dreams, fatigue, drowsiness
• dizziness
• altered sense of taste
• uncontrollable tremors
• blurred vision
• feeling of rapid and irregular heartbeats (palpitations)
• 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 of being detached, distant from oneself (depersonalization)
• strange thoughts
• euphoria
• suicidal thoughts or self-harm behaviors
• orgasm problems
• teeth grinding (bruxism)
• memory disorders
• restlessness, need to move
• muscle spasms, involuntary movements, or balance and coordination problems
• dilated pupils
• ringing in the ears
• low blood pressure
• breathing difficulties
• nasal bleeding
• gastrointestinal bleeding
• difficulty swallowing
• hair loss
• increased bruising
• cold sweats
• difficulty urinating
• sexual dysfunction

• general discomfort
• feeling of cold or heat

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

• low sodium levels in the blood
• reduced platelet count 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, lymph node inflammation, and/or flu-like symptoms (serum sickness)
• low sodium levels in the blood, in some cases caused by the syndrome of inadequate antidiuretic hormone secretion.
• atypically reckless behavior
• hallucinations
• agitation
• panic attacks
• feeling of confusion
• aggressive behavior
• stuttering
• seizures
• inability to remain still
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia)
• serotonin syndrome
• irregular heartbeat
• vasculitis (inflammation of a blood vessel)
• vasodilation
• pharyngitis (inflammation of the throat)
• lung problems (pulmonary inflammation and fibrosis)
• esophageal pain (the tube that connects the mouth to the stomach)
• hepatitis
• rapid swelling of the tissues around the neck, face, mouth, and/or throat
• bleeding under the skin
• sensitivity to sunlight
• purple or red spots on the skin (purpura)
• severe skin reactions that can produce rash, skin redness, blisters in the mouth, lips, or eyes, skin peeling, fever (possible signs of erythema multiforme) that can progress to Stevens-Johnson syndrome or toxic epidermal necrolysis.
• muscle pain
• urination problems
• high levels of the hormone prolactin, milk production
• painful and prolonged erection of the penis
• bleeding from the mucous membranes
• abnormal liver function tests

Frequency not known(cannot be estimated from the available data)

• abundant 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 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 decrease growth or delay sexual maturation. Suicidal thoughts and behaviors, hostility, mania, and nosebleeds have been frequently reported in children.

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Fluoxetina Almus

Keep this medication out of sight and reach of children.

Do not use Fluoxetina Almus after the expiration date that appears on the carton. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Content of the leaflet and additional information

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 silicon dioxide; 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 packaging content

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

They are available in packs of 14, 28, or 60 capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

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

Date of the last revision of this leaflet: December 2020

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