Fluoxetine Vitabalans

Leaflet accompanying the packaging: patient information

Fluoxetine Vitabalans 20 mg coated tablets

Fluoxetine

Before taking the medicine, read the entire leaflet carefully, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor or pharmacist if you need advice or additional information.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, you should tell your doctor or pharmacist. This also applies to possible side effects not listed in the leaflet. See section 4.

Table of contents of the leaflet:

• 1. What is Fluoxetine Vitabalans and what is it used for
• 2. Important information before taking Fluoxetine Vitabalans
• 3. How to take Fluoxetine Vitabalans
• 4. Possible side effects
• 5. How to store Fluoxetine Vitabalans
• 6. Contents of the packaging and other information

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

Fluoxetine Vitabalans contains fluoxetine, which belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRI).
This medicine is indicated for the treatment of:
Adults:

• Episodes of major depression
• Obsessive-compulsive disorders (obsessive thinking and behavior)
• Bulimia nervosa: Fluoxetine Vitabalans is used in conjunction with psychotherapy to alleviate episodes of binge eating and reduce the frequency of purging behaviors.

Children over 8 years old and adolescents:

• Episodes of major depression of moderate to severe course, if there is no response to psychotherapy after 4-6 therapeutic sessions. Fluoxetine Vitabalans should be administered to children and young people suffering from moderate to severe depression onlyin combination with concurrent psychological therapy.

2. Important information before taking Fluoxetine Vitabalans

When not to take Fluoxetine Vitabalans

• If the patient has been diagnosed with an allergy (hypersensitivity) to fluoxetine or any of the other ingredients of this medicine (listed in section 6). Allergic reactions include rash, itching, swelling of the face or tongue, and shortness of breath.
• If the patient is taking other medicines known as reversible non-selective monoamine oxidase inhibitors, as severe, even life-threatening, side effects may occur (e.g., iproniazid used in the treatment of depression).

Therapy with Fluoxetine Vitabalans should be started after at least 2 weeks have passed since the end of treatment with non-reversible MAO inhibitors (e.g., tranylcypromine).
Do nottake any MAO inhibitors before 5 weeks have passed since the end of treatment with Fluoxetine Vitabalans.
If Fluoxetine Vitabalans has been prescribed for long-term use and/or in high doses, the doctor should consider the need for longer breaks between treatments.

Warnings and precautions

Before starting treatment with Fluoxetine Vitabalans, you should discuss the following with your doctor:

• If the patient experiences a rash or other allergic reactions (such as itching, swelling of the mouth or face, or shortness of breath). You should stop taking the medicine and contact your doctor immediately.
• If the patient has epilepsy or experiences seizures. If a seizure occurs or the frequency of seizures increases, you should contact your doctor immediately. It may be necessary to discontinue Fluoxetine Vitabalans.
• If the patient has liver or kidney function disorders, heart problems, or has recently had a heart attack, you should contact your doctor, as it may be necessary to reduce the prescribed dose of the medicine.
• If the patient has experienced episodes of mania. If the patient experiences manic episodes, you should contact your doctor, as it may be necessary to discontinue the medicine.
• If the patient has diabetes (it may be necessary to adjust the dose of insulin or other antidiabetic medicines).
• If the patient has breast cancer and is being treated with tamoxifen.
• If the patient has heart problems, such as congenital heart defects (congenital long QT syndrome), irregular heartbeat, or
• if the patient experiences slow heart rate at rest and/or low sodium levels due to prolonged, severe diarrhea and vomiting. If the patient feels anxious or cannot stand or sit still (akathisia). If such symptoms occur, you should consult your doctor.
• If the patient is undergoing electroconvulsive therapy.
• If the patient has a history of bleeding disorders or if the patient develops bruising or unusual bleeding or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility").
• If the patient has increased intraocular pressure or risk of glaucoma with a narrow angle of filtration.
• If the patient experiences fever, muscle stiffness, or tremors, changes in mental state such as confusion, agitation, and extreme excitement. The patient may be suffering from serotonin syndrome or malignant neuroleptic syndrome. Although these symptoms are rare, they can potentially be life-threatening. You should contact your doctor immediately, as it may be necessary to discontinue Fluoxetine Vitabalans.

Medicines such as Fluoxetine Vitabalans (so-called SSRI or SNRI) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.

Suicidal thoughts and worsening of depression or anxiety symptoms

If the patient suffers from depression and/or anxiety, they may sometimes think about self-harm or suicide. Such thoughts may occur more frequently at the beginning of treatment with antidepressant medicines, as it takes time for these medicines to start working, usually around 2 weeks, but sometimes longer.
Thoughts of self-harm or suicide are most likely to occur:

• In patients who have previously experienced suicidal thoughts or self-harm.
• In young adults. Data from clinical trials show an increased risk of suicidal behavior in adults under 25 years old with psychiatric symptoms who were treated with antidepressant medicines.

If the patient experiences suicidal thoughts or thoughts of self-harm at any time, they should
contact their doctor immediately or go to the hospital.
It may also be helpful to inform relatives or close friendsthat the patient is suffering from depression or anxiety and ask them to read the contents of this leaflet. The patient may ask them to inform them if they notice that the symptoms of depression or anxiety have worsened or if they are concerned about changes in their behavior.

Children and adolescents from 8 to 18 years old

In patients under 18 years old, the risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and anger) is increased during treatment with this class of medicines. Fluoxetine Vitabalans should be used in children and adolescents from 8 to 18 years old for the treatment of episodes of major depression of mild to moderate severity (in combination with psychological therapy) and should not be used for the treatment of other conditions.
Additionally, there is limited data available on the long-term safety of Fluoxetine Vitabalans and its impact on growth, pubertal development, mental, emotional, and behavioral development in this age group. Nevertheless, the doctor may prescribe Fluoxetine Vitabalans to patients under 18 years old for the treatment of episodes of major depression of mild to moderate severity in combination with psychological therapy, considering that it is in their best interest. If the doctor has prescribed Fluoxetine Vitabalans to a patient under 18 years old, and you have any doubts, please consult your doctor again. You should inform your doctor if the above symptoms develop or worsen during treatment with Fluoxetine Vitabalans in patients under 18 years old.
Fluoxetine Vitabalans should not be used for the treatment of children under 8 years old.

Taking other medicines with Fluoxetine Vitabalans

You should inform your doctor or pharmacist about all medicines taken recently (within the last 5 weeks), including those that are available without a prescription.
You should not take Fluoxetine Vitabalans with:

• certain MAO inhibitors (used in the treatment of depression). Non-reversible, non-selective MAO inhibitors should not be taken with Fluoxetine Vitabalans due to the possibility of severe, sometimes life-threatening, side effects (serotonin syndrome) (see section "When not to take Fluoxetine Vitabalans"). Treatment with Fluoxetine Vitabalans should be started at least 2 weeks after discontinuing non-reversible, non-selective MAO inhibitors (e.g., tranylcypromine). Do nottake any non-reversible, non-selective MAO inhibitors for at least 5 weeks after stopping Fluoxetine Vitabalans. If Fluoxetine Vitabalans has been prescribed for long-term use and/or in high doses, it may be necessary to consider a longer break from treatment.
• metoprolol used in heart failure; due to the increased risk that the heart will start beating slower.

Fluoxetine Vitabalans may affect the action of other medicines (cause interactions), particularly the following medicines:

• tamoxifen (used in the treatment of breast cancer); as Fluoxetine Vitabalans may change the concentration of the medicine in the blood and it cannot be ruled out that the action of tamoxifen may be reduced. The doctor may consider introducing another antidepressant therapy.
• monoamine oxidase inhibitors (MAOI-A), including moclobemide, linezolid (as an antibiotic), and methylthioninium chloride (also known as methylthioninium chloride, used to reduce methemoglobinemia caused by exposure to medicinal and chemical products): due to severe, even life-threatening, side effects (serotonin syndrome).
• lithium, selegiline, tramadol (pain reliever), buprenorphine, triptan (for migraine), tryptophan; there is an increased risk of serotonin syndrome during treatment with Fluoxetine Vitabalans. The doctor may recommend more frequent check-ups.
• medicines that affect heart rhythm, such as arrhythmia medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tri

cycle antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), antimalarial medicines, especially halofantrine, certain antihistamines (astemizole, mizolastine), as taking one or more of these medicines with Fluoxetine Vitabalans may increase the risk of changes in the electrical activity of the heart

• mequitazine, as Fluoxetine Vitabalans may increase the risk of changes in the electrical activity of the heart
• medicines that lower sodium levels in the blood (including diuretics used, e.g., for high blood pressure, and desmopressin for nocturnal enuresis), carbamazepine, and oxcarbazepine; as these medicines may increase the risk of reduced sodium levels in the blood during treatment with Fluoxetine Vitabalans
• phenytoin (antiepileptic medicine); as Fluoxetine Vitabalans may affect the concentration of this medicine in the blood, the doctor may introduce phenytoin under supervision and perform check-ups when administered with Fluoxetine Vitabalans
• flecainide, encainide, propafenone, nebivolol (used in heart diseases), phenytoin, carbamazepine, oxcarbazepine (antiepileptic medicine), atomoxetine (for attention deficit hyperactivity disorder) (tricyclic antidepressants, e.g., imipramine, desipramine, and amitriptyline), or risperidone, as Fluoxetine Vitabalans may potentially change the concentration of these medicines in the blood, the doctor may reduce the dose when taking Fluoxetine Vitabalans.
• antidepressant medicines, such as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRI), or bupropion, mefloquine, or chloroquine (used in the treatment of malaria), tramadol (used in the treatment of severe pain), or antipsychotic medicines, such as phenothiazine derivatives or butyrophenone; as Fluoxetine Vitabalans may increase the risk of seizures when taken with these medicines.
• anticoagulant medicines (such as warfarin), non-steroidal anti-inflammatory medicines (NSAIDs, such as ibuprofen, diclofenac), aspirin, and other medicines that may thin the blood (including clozapine, used in the treatment of certain mental disorders). Fluoxetine Vitabalans may change the action of these medicines in the blood. Treatment with Fluoxetine Vitabalans can be started or stopped during warfarin treatment, the doctor will need to perform certain tests, adjust the dose, and check the patient's condition more frequently.
• cyproheptadine (allergy); as it may reduce the action of Fluoxetine Vitabalans
• The patient should not take herbal preparations containing St. John's Wort while taking Fluoxetine Vitabalans, as it may result in increased risk of side effects. If the patient is already taking preparations containing St. John's Wort when starting treatment with Fluoxetine Vitabalans, they should stop taking these preparations and inform their doctor during the next visit.

Taking Fluoxetine Vitabalans with food and drink

Fluoxetine Vitabalans can be taken during or between meals, depending on the patient's preference.
Alcohol should be avoided during treatment with Fluoxetine Vitabalans.

Pregnancy, breastfeeding, and fertility

In case of pregnancy or breastfeeding, suspected pregnancy, or planning to become pregnant, you should consult your doctor or pharmacist before taking this medicine.
Fertility
Animal studies have shown that fluoxetine reduces sperm quality. This may theoretically affect fertility, but so far, no effect on human fertility has been observed.
Pregnancy
If the patient becomes pregnant, they may be pregnant, or plan to become pregnant, they should consult their doctor immediately.
In children whose mothers took Fluoxetine Vitabalans during the first few months of pregnancy, an increased risk of congenital heart defects has been observed. In the general population, 1 in 100 children is born with a heart defect. In children whose mothers took Fluoxetine Vitabalans, this number increases to 2 in 100. Together with the doctor, the patient can decide that it is more beneficial to gradually stop taking the medicine if they are pregnant. However, depending on the circumstances, the doctor may suggest that it is more beneficial to continue treatment with Fluoxetine Vitabalans.
The patient should ensure that the midwife and/or doctor are aware that they are taking Fluoxetine Vitabalans.
Taking medicines like Fluoxetine Vitabalans during pregnancy, especially in the last trimester, may increase the risk of a serious condition in children, namely persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and bluish discoloration of the baby. These symptoms usually occur within the first 24 hours after birth. If symptoms occur, the patient should immediately inform the midwife and/or doctor.
Caution should be exercised when taking Fluoxetine Vitabalans during pregnancy, especially during late pregnancy and just before delivery, as the following symptoms have been reported in newborns: irritability, tremors, weakness, constant crying, and difficulty sleeping or feeding.
Taking Fluoxetine Vitabalans at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Fluoxetine Vitabalans, they should inform their doctor or midwife so that they can provide appropriate advice.
Breastfeeding
Fluoxetine passes into breast milk and may cause side effects in children. The patient can breastfeed if necessary. If the woman continues to breastfeed, the doctor should prescribe the smallest effective dose of Fluoxetine Vitabalans.

Driving and using machines

Fluoxetine Vitabalans may impair judgment and coordination. The patient should not drive vehicles, use tools, or operate machinery without consulting their doctor or pharmacist.

3. How to take Fluoxetine Vitabalans

The patient should always take this medicine exactly as prescribed by their doctor. If the patient has any doubts about taking the medicine, they should consult their doctor or pharmacist. The patient should not take more tablets than prescribed by their doctor.
The tablets should be swallowed with water. The patient should not chew the tablets.

Adults

Depression
The recommended dose is 1 tablet (20 mg) per day. The dose may be adjusted if necessary, within 3 to 4 weeks of starting treatment. If necessary, the dose may be gradually increased to a maximum of 3 tablets (60 mg) per day. The dose should be increased cautiously to ensure that the patient receives the lowest effective dose. The patient will not feel an improvement immediately after taking the first dose of the medicine for depression. This is normal, as the improvement of depressive symptoms may occur after several weeks of treatment. Patients with depression should be treated for at least 6 months.
Bulimia nervosa
The recommended dose is 3 tablets (60 mg) per day.
Obsessive-compulsive disorder
The recommended dose is 1 tablet (20 mg) per day. The dose may be adjusted if necessary, 2 weeks after starting treatment. If necessary, the dose may be gradually increased to a maximum of 3 tablets (60 mg) per day. If there is no improvement within 10 weeks, the doctor should re-evaluate the treatment.

Children and adolescents from 8 to 18 years old with depression

Treatment should be started and supervised by a specialist doctor. The initial dose is 10 mg per day. After 1 or 2 weeks of treatment, the doctor may increase the dose to 20 mg per day. The dose should be increased cautiously to ensure that the patient receives the lowest effective dose. Children with low body weight may require lower doses. If there is a satisfactory response to treatment, the doctor will consider the need to continue treatment for more than 6 months. If there is no improvement within 9 weeks, the doctor will consider the appropriateness of further treatment.

Patients over 65 years old

The doctor may increase the dose with caution, and the daily dose should not exceed 2 tablets (40 mg). The maximum daily dose is 3 tablets (60 mg).

Liver function disorders

If the patient has liver problems or is taking other medicines that may affect the action of Fluoxetine Vitabalans, the doctor may prescribe a lower dose or recommend taking the medicine every other day.

Taking more than the recommended dose of Fluoxetine Vitabalans

If the patient has taken too many tablets, they should go to the nearest hospital, emergency department, or contact their doctor. The patient should take the packaging of Fluoxetine Vitabalans with them if possible.
Symptoms of overdose include nausea, vomiting, seizures, heart problems (irregular heartbeat and cardiac arrest), lung problems, and changes in mental state ranging from agitation to coma.

Missing a dose of Fluoxetine Vitabalans

The patient should not take a double dose (or increased dose) to make up for a missed dose. The patient should take the next tablet at the usual time.
Taking the medicine every day at the same time may help remember the regular treatment schedule.

Stopping treatment with Fluoxetine Vitabalans

The patient should not stop taking Fluoxetine Vitabalans without consulting their doctor, even if they feel better. It is important for the patient to continue taking the medicine.
The patient should have a sufficient supply of tablets to ensure continuity of treatment.
After stopping treatment with Fluoxetine Vitabalans, the patient may experience: dizziness, tingling sensation like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), restlessness or agitation, unusual fatigue or weakness, anxiety, nausea, and/or vomiting, tremors, headache.
In most patients, withdrawal symptoms are mild and transient, lasting a few weeks. If the patient experiences similar symptoms after stopping the medicine, they should contact their doctor.
To stop taking Fluoxetine Vitabalans, the doctor will recommend gradually reducing the dose over 1 or 2 weeks. This will help minimize the risk of withdrawal symptoms.
If the patient has any further questions about taking Fluoxetine Vitabalans, they should contact their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fluoxetine Vitabalans can cause side effects, although not everybody gets them.

• If the patient experiences a rash or allergic reactions such as itching, swollen mouth and/or tongue, or wheezing and/or breathlessness, they should stop taking the medicine and contact their doctor immediately.
• If the patient feels anxious and cannot sit or stand still, they may be suffering from akathisia; increasing the dose of Fluoxetine Vitabalans may worsen the patient's condition. If the patient has similar feelings, they should contact their doctor.
• If the patient experiences suicidal thoughts or self-harm, they should contact their doctor immediately or go to the hospital(see section 2). The patient should immediately inform their doctorif:
• redness or various skin reactions occur or blisters appear on the skin. These are rare symptoms.
• a combination of symptoms (known as serotonin syndrome) occurs, including unexplained fever with faster breathing or heart rate, sweating, stiffness or tremors, confusion, extreme excitement or drowsiness;
• the patient feels weak, sleepy, or confused (mainly in elderly patients and patients taking diuretics);
• a prolonged and painful erection occurs;
• irritability and extreme excitement occur.

The following list of side effects is presented according to the frequency of occurrence:
Very common(occurring in more than 1 in 10 patients)

• insomnia
• headache
• diarrhea
• nausea
• fatigue

Common(occurring in no more than 1 in 10 patients)

• decreased appetite, weight loss
• nervousness, anxiety
• restlessness, attention disturbances
• tension
• decreased sexual desire or sexual dysfunction (including erectile dysfunction)
• sleep disturbances, unusual dreams, fatigue, or drowsiness
• dizziness
• taste disturbances
• involuntary movements and tremors
• blurred vision
• rapid and irregular heartbeat
• changes in the electrical activity of the heart
• redness
• yawning
• indigestion, vomiting
• dry mouth
• rash, hives, itching
• excessive sweating
• joint pain
• increased urination
• unexplained vaginal bleeding
• shakiness, chills

Uncommon(occurring in no more than 1 in 100 patients)

• depersonalization
• thought disturbances
• elevated mood
• orgasm disturbances
• suicidal thoughts or self-harm
• teeth grinding
• muscle spasms, involuntary movements, or balance and coordination disturbances
• memory disturbances
• dilated pupils
• ringing in the ears
• low blood pressure
• shortness of breath
• nosebleeds
• difficulty swallowing
• hair loss
• increased tendency to bruise
• unexplained bruising or bleeding
• cold sweats
• difficulty urinating
• feeling cold or hot
• feeling unwell or unusual
• psychomotor hyperactivity (feeling of inner restlessness and an irresistible need to be in constant motion)

Rare(occurring in no more than 1 in 1000 patients)

• low sodium levels in the blood
• decreased platelet count, which increases the risk of bleeding or bruising
• decreased white blood cell count, which increases the susceptibility to various infections
• serum sickness-like reaction (delayed allergic reaction with rash, joint pain, fever, lymph node swelling, shock, low blood pressure, and gastrointestinal symptoms)
• unusual, wild behavior
• hallucinations
• excitement
• panic attacks
• confusion
• stuttering
• aggression
• serotonin syndrome
• abnormal heart rhythm
• seizures
• vasculitis
• severe, sudden allergic reactions (shortness of breath, swelling in the throat, low blood pressure, gastrointestinal symptoms, "racing" heart, dizziness, shock)
• severe swelling of the tissues in the neck, face, mouth, and/or throat
• severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis)
• esophageal pain
• liver inflammation
• lung disease
• allergic reactions to light
• muscle pain
• urination disturbances
• galactorrhea
• abnormal liver function tests
• prolonged and painful erections

Unknown(frequency cannot be estimated from the available data)

• severe postpartum hemorrhage, occurring shortly after delivery (postpartum hemorrhage), see additional information in the subsection Pregnancy, breastfeeding, and fertility in section 2.

Most of these side effects are transient and disappear during continued treatment.
In patients taking selective serotonin reuptake inhibitors (SSRI), such as Fluoxetine Vitabalans, there is an increased risk of bone fragility.
Children and adolescents (8-18 years old): Fluoxetine Vitabalans may slow growth or delay pubertal development. Suicidal behavior (attempts and thoughts) and hostility are more commonly observed in children and adolescents than in adult patients.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Fluoxetine Vitabalans

The medicine should be stored out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not take this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month stated.
Do not take this medicine if there are visible signs of tablet damage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fluoxetine Vitabalans contains

• The active substance of the medicine is fluoxetine hydrochloride in an amount equivalent to 20 mg of fluoxetine. The other ingredients of the medicine are: Tablet core: microcrystalline cellulose, pregelatinized starch, colloidal anhydrous silica, magnesium stearate. Tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172), indigo carmine (E 132), and black iron oxide (E 172).

What Fluoxetine Vitabalans looks like and contents of the pack

What Fluoxetine Vitabalans tablets look like:
Light green, round, biconvex tablets with a dividing line, 9 mm in diameter.
The tablets can be divided into two equal parts.
Pack sizes:
Fluoxetine Vitabalans 20 mg: 10, 20, 30, 60, and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland
Phone: +358 (3) 615600
Fax: +358 (3) 6183130

Manufacturer

Vitabalans Oy
Varastokatu 7-9
13500 Hämeenlinna
Finland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Fluoxetine Vitabalans (Czech Republic, Denmark, Estonia, Finland, Hungary, Latvia, Lithuania, Norway, Poland, Slovakia, Sweden)
Fluoxetin Vitabalans (Germany)
Fluoksetin Vitabalans (Slovenia)

Date of revision of the text: 2021-11-12