Fluoxetine Almus 20 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

FLUOXETINE ALMUS 20 mg hard capsules EFG

Read the entire 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, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Fluoxetine Almus is 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. How to store Fluoxetine Almus
6. Contents of the pack and other information

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

Fluoxetina Almus belongs to a group of medicines known as selective serotonin reuptake inhibitor (SSRI) antidepressants.

This medicine is indicated for the treatment of:

Adults:

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

Children over 8 years and adolescents:

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

2. What you need to know before taking Fluoxetina Almus

Do not take Fluoxetina Almus:

• If you are allergic to the active substance or to any of the other components 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 non-selective irreversible monoamine oxidase inhibitors (MAOIs), as a serious or even fatal adverse reaction may occur (e.g. iproniazid, 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 the heartbeat.

Treatment with fluoxetine should only be started at least two weeks after stopping treatment with a non-selective irreversible MAOI.

Do not take any non-selective irreversible MAOI for at least five weeks after stopping 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 starting an MAOI.

Warnings and precautions

Talk to 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 notice an increase in their frequency, contact your doctor immediately, as you may need to stop treatment with fluoxetine.

• If you suffer from mania or have had manic episodes in the past; if you experience a manic episode, contact your doctor immediately, as you may need to discontinue fluoxetine treatment.

• 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 conditions.

• If you have a slow resting heart rate and/or if you know you may lose salt due to prolonged severe diarrhea, vomiting, or use of diuretics (water tablets).

• If you are taking diuretics (water tablets), especially if you are elderly.

• 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 unusual bruising or bleeding, or if you are pregnant (see "Pregnancy"*).

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

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

• If you start feeling restless and unable to sit still or remain motionless (akathisia). Increasing the dose of fluoxetine may worsen this effect.

• If 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, these conditions can be life-threatening, so contact your doctor immediately, as you may need to stop fluoxetine treatment.

• If you are taking or have taken within the last 14 days another medicine known as a non-selective irreversible monoamine oxidase inhibitor (MAOI) (see "Taking Fluoxetina Almus with other medicines").

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

Pregnancy*

If you take Fluoxetina Almus in the late stages of pregnancy, there is an increased risk of heavy vaginal bleeding shortly after childbirth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Fluoxetina Almus so they can advise you appropriately.

Suicidal thoughts 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. These thoughts may increase when starting antidepressants, as these medicines take time to work—usually about two weeks, although sometimes longer. You are more likely to have such thoughts:

• If you have previously had suicidal or self-harming thoughts.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with antidepressants.

If at any time you have thoughts of suicide or self-harm, contact your doctor immediately or go directly to the hospital. It may help to tell a close family member or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may also ask them whether they notice your depression or anxiety getting worse, or if they are concerned about changes in your behaviour.

Children and adolescents aged 8 to 18 years:

Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. 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.

In addition, there is only limited information on the long-term safety of Fluoxetina Almus with regard to growth, puberty, and cognitive, emotional, and behavioural 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 if they consider it appropriate. If your doctor prescribes Fluoxetina Almus to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms listed above appear or worsen while patients under 18 years of age are taking Fluoxetina Almus.

Fluoxetina Almus must not be used in children under 8 years of age.

Taking Fluoxetina Almus with other medicines

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

Do not take Fluoxetina Almus with:

• Certain monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Non-selective irreversible MAOIs must not be used with Fluoxetina Almus, as they may cause serious or even fatal reactions (serotonin syndrome) (see section "Do not take Fluoxetina Almus").

Treatment with Fluoxetina Almus should only be started at least two weeks after discontinuing a non-selective irreversible MAOI (e.g. tranylcypromine). Do not take any non-selective irreversible MAOI for at least five weeks after stopping 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 starting an MAOI.

• Metoprolol when used for heart failure; as it increases the risk of excessive slowing of the heartbeat.

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

• Tamoxifen (used to treat breast cancer); your doctor may consider an alternative antidepressant treatment because Fluoxetina Almus may alter blood levels of this medicine, and a reduced effect of tamoxifen cannot be ruled out.

• Monoamine oxidase A inhibitors (MAO-A inhibitors), including moclobemide, linezolid (an antibiotic), and methylene blue chloride (also known as methylene blue, indicated for mild conjunctivitis, eye itching, and irritation): due to the risk of serious or even fatal adverse reactions (called serotonin syndrome). Treatment with fluoxetine may be started the day after stopping a reversible MAO inhibitor, but your doctor may monitor you closely and use a lower dose of the MAO-A inhibitor.

• Monoamine oxidase inhibitors known as MAO-B inhibitors (selegiline) may be used with Fluoxetina Almus provided your doctor monitors your treatment closely.

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

• Phenytoin (a medicine used for epilepsy): Fluoxetina Almus may increase blood levels of this medicine, so your doctor should monitor and adjust the dose of phenytoin more carefully.

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

• Medicines that may affect heart rhythm, for example:

• Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarial treatments such as halofantrine, or certain antihistamines (astemizole, mizolastine), as taking one or more of these medicines with Fluoxetina Almus may increase the risk of changes in the heart's electrical activity.

• Mequitazine (used to treat allergy and rhinitis)

• Flecainide, propafenone, nebivolol, or encainide (for heart problems), carbamazepine (for epilepsy), atomoxetine (for attention deficit hyperactivity disorder), or tricyclic antidepressants (e.g. imipramine, desipramine, and amitriptyline) or risperidone (for schizophrenia); since Fluoxetina Almus may alter blood levels of these medicines, your doctor may need to reduce their dose when used together with Fluoxetina Almus.

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

• Cyproheptadine (used to treat allergies); as it may reduce the effect of Fluoxetina Almus.

• You should not start taking herbal preparations containing St. John's wort (Hypericum perforatum) while being treated with Fluoxetina Almus, as this may increase the risk of adverse effects. If you are currently taking St. John's wort when starting Fluoxetina Almus, stop taking it and inform your doctor at your next visit.

• Medicines that reduce sodium levels in the blood (including medicines that increase urine output, desmopressin, carbamazepine, and oxcarbazepine); as using Fluoxetina Almus with these medicines may increase the risk of excessive reduction in blood sodium levels.

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

Taking Fluoxetina Almus with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Reports suggest that babies whose mothers took fluoxetine during the first months of pregnancy may have an increased risk of congenital heart defects. In the general population, approximately 1 in 100 babies is born with a heart defect. This risk 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 it is better to gradually stop taking fluoxetine during pregnancy. However, depending on your individual circumstances, your doctor may recommend continuing fluoxetine treatment.

Ensure that your midwife and/or doctor knows you are taking Fluoxetina Almus. Medicines such as Fluoxetina Almus, when taken during pregnancy, particularly during the last three months, 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 appear blue. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

Caution should be exercised when using this medicine during pregnancy, especially during the late stages or just before delivery, as the following effects have been reported in newborns: irritability, tremors, muscle weakness, persistent crying, and difficulty feeding or sleeping.

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.

Fertility

Animal studies have shown that fluoxetine may reduce sperm quality. This could theoretically affect fertility, but no impact on human fertility has been observed so far.

Driving and use of machines

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

3. How to take Fluoxetina Almus

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults:

The recommended 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 necessary, 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 usually 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 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 the patient remains on the lowest effective dose. Children with low body weight may require lower doses. Your doctor should re-evaluate 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, dose increases should be made more cautiously, and the daily dose should generally not exceed 40 mg. The maximum dose is 60 mg per day.

Hepatic impairment:

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 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 contact your doctor immediately.
• If possible, bring the Fluoxetina Almus packaging with you.

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

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 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 missed doses.
• Taking your medicine at the same time each day may help you remember to take it regularly.

If you stop taking Fluoxetina Almus

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

You may experience the following effects when stopping treatment with Fluoxetina Almus: 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 Fluoxetina Almus are mild and resolve spontaneously within a few weeks. If you experience these symptoms when stopping 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 further questions about the use of Fluoxetina Almus, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Fluoxetina Almus can have adverse effects, although not everyone will experience them.

• If at any time you have suicidal thoughts or thoughts of self-harm, contact your doctor or go directly to hospital (see section 2).
• 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 inform your doctor immediately.
• If you feel restless and feel unable to sit still or remain motionless, you may be experiencing a condition called akathisia; increasing your dose of Fluoxetina Almus could worsen this. If you feel this way, consult your doctor.
• Contact your doctor immediately if your skin starts to redden and then blisters or begins to peel off. This occurs very rarely.

Some patients have experienced:

• A combination of symptoms (known as serotonin syndrome) including unexplained fever 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 people treated with diuretics (elderly patients);

• Prolonged and painful erection;

• Irritability and extreme agitation;

• Heart problems, such as fast or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm function.

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

The following adverse effects have also been reported in patients treated with Fluoxetina Almus:

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

• insomnia
• headache
• diarrhoea, feeling unwell (nausea)
• fatigue

Common (may affect up to 1 in 10 people)

• loss of appetite, weight loss
• nervousness, anxiety
• restlessness, difficulty concentrating
• feeling of nervous tension
• decreased sexual desire or sexual problems (including difficulty maintaining an erection during sexual activity and ejaculation problems)
• sleep disturbances, abnormal dreams, tiredness, drowsiness
• dizziness
• altered sense of taste
• uncontrollable tremors
• blurred vision
• sensation of rapid or irregular heartbeat (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 detached or distant from oneself (depersonalization)
• strange thoughts
• euphoria
• suicidal or self-harming thoughts and behaviours
• orgasm problems
• teeth grinding (bruxism)
• memory disturbances
• restlessness, need to move around
• muscle spasms, involuntary movements, or problems with balance or coordination
• dilated pupils
• ringing in the ears
• low blood pressure
• breathing difficulty
• nosebleeds
• gastrointestinal bleeding
• difficulty swallowing
• hair loss
• increased tendency to bruise
• cold sweats
• difficulty urinating
• sexual dysfunction
• general malaise
• sensation of feeling cold or hot

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

• low sodium levels in the blood
• reduction in blood platelets, increasing 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 flu-like symptoms (serum sickness)
• low sodium levels in the blood, in some cases caused by syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• unusually uninhibited behaviour
• hallucinations
• agitation
• panic attacks
• feeling confused
• aggressive behaviour
• 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)
• lung problems (lung inflammation and fibrosis)
• pain in the oesophagus (the tube connecting the mouth to the stomach)
• hepatitis
• rapid swelling of 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 may cause rash, redness of the skin, blisters in the mouth, lips or eyes, peeling of the skin, fever (possible signs of erythema multiforme), which may progress to Stevens-Johnson syndrome or toxic epidermal necrolysis
• muscle pain
• problems urinating
• elevated levels of prolactin hormone, milk production
• painful and persistent penile erection
• mucosal bleeding
• abnormal liver function tests

Frequency not known (cannot be estimated from available data)

• heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); 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 medicine.

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

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

In addition to the possible adverse effects mentioned above, fluoxetine may reduce growth or delay sexual maturation. Suicidal thoughts and behaviours, hostility, mania, and nosebleeds have been frequently reported in children.

Reporting of adverse effects

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

5. Storage of Fluoxetine Almus

Keep this medicine out of the sight and reach of children.

Do not use Fluoxetine Almus after the expiry date stated on the carton. The expiry date is the last day of the month indicated.

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

6. Package leaflet contents and additional information

Composition of Fluoxetina Almus

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

The other components (excipients) are: pregelatinized maize starch, gluten-free; anhydrous colloidal silicon dioxide; magnesium stearate; talc.

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

Appearance of the product and contents of the container

Fluoxetina Almus 20 mg hard capsules are presented as 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

Telephone: 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 most recent review of this leaflet: December 2020

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