Package leaflet: Information for the user

Fluoxetine Vitabalans 20 mg enteric-coated tablets
Fluoxetine
Before using this medicine, read the entire leaflet carefully, as it contains
important information for you.

Keep this leaflet, so that you can read it again if necessary.
Consult your doctor or pharmacist if you need advice or further information.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, inform your doctor or pharmacist. This includes any possible adverse effects not listed in the leaflet. See section 4.

Leaflet contents:

What Fluoxetine Vitabalans is and what it is used for
Important information before taking Fluoxetine Vitabalans
How to take Fluoxetine Vitabalans
Possible side effects
How to store Fluoxetine Vitabalans
Contents of the pack and other information

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

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

Major depressive episodes
Obsessive-compulsive disorder (obsessive thoughts and compulsive behaviors)
Bulimia nervosa: Fluoxetine Vitabalans is used in conjunction with psychotherapy to reduce episodes of binge eating and decrease the frequency of purging behaviors.

Children over 8 years of age and adolescents:

Moderate to severe major depressive episodes, when there has been no response to psychotherapy after 4–6 therapeutic sessions. Fluoxetine Vitabalans should be given to children and young people suffering from moderate to severe depression only in combination with concurrent psychological therapy.

2. Important information before taking Fluoxetine Vitabalans

When not to use Fluoxetine Vitabalans

If the patient is allergic (hypersensitive) 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 metoprolol used in heart failure.
If the patient is currently taking other medicines known as reversible non-selective monoamine oxidase inhibitors (MAOIs), as serious, even fatal, adverse reactions may occur (e.g. iproniazid used in the treatment of depression).

Treatment with Fluoxetine Vitabalans should be started at least 2 weeks after discontinuation of irreversible MAO inhibitors (e.g. tranylcypromine).
Do not use any MAO inhibitors within 5 weeks after stopping treatment with Fluoxetine Vitabalans.
If Fluoxetine Vitabalans has been prescribed long-term and/or at high doses, the physician should consider the need for longer washout periods between treatments.

Warnings and precautions
Before starting treatment with Fluoxetine Vitabalans, discuss the following with your doctor:

If the patient develops a rash or other allergic reactions (such as itching, swelling of the lips or face, shortness of breath). The medicine should be stopped immediately and medical advice sought.
If the patient has epilepsy or experiences seizures. If a seizure occurs or seizure frequency increases, contact the doctor immediately. Discontinuation of Fluoxetine Vitabalans may be necessary.
If the patient has impaired liver or kidney function, heart problems, or has recently suffered a myocardial infarction, contact the doctor, as dose reduction may be required.
If the patient has experienced episodes of mania. If manic episodes occur, contact the doctor, as discontinuation of the medicine may be necessary.
If the patient has diabetes (adjustment of insulin or other antidiabetic medication dosage may be required).
If the patient has breast cancer and is being treated with tamoxifen.
If the patient has heart problems such as congenital heart defect (congenital long QT syndrome), irregular heartbeat, or
if the patient has a slow resting heart rate and/or salt deficiency due to prolonged, severe diarrhea and vomiting. If the patient feels restless or unable to sit or stand still (akathisia), these symptoms should be discussed with a doctor.
If the patient is undergoing electroconvulsive therapy.
If the patient has a history of bleeding disorders, or develops bruises or unusual bleeding, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility").
If the patient has increased intraocular pressure or risk of narrow-angle glaucoma.
If the patient develops fever, muscle stiffness or tremor, or changes in mental status such as confusion, agitation, or extreme restlessness. The patient may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Although these symptoms are rare, they may be life-threatening. Contact a doctor immediately, as discontinuation of Fluoxetine Vitabalans may be necessary.

Medicines such as Fluoxetine Vitabalans (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.

Suicidal thoughts and worsening of depression or anxiety symptoms
If the patient suffers from depression and/or anxiety disorder, they may occasionally have thoughts of self-harm or suicide. Such thoughts may occur more frequently at the beginning of treatment with antidepressants, as it takes time for these medicines to take effect, usually about 2 weeks, but sometimes longer.

Thoughts of self-harm or suicide are most likely to occur:

In patients who previously experienced suicidal thoughts or self-harm.
In young adults. Clinical trial data show an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric symptoms treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm at any time, they should contact their doctor immediately or go to hospital.
It may also be helpful to inform family members or close friends that the patient suffers from depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening of depressive or anxious symptoms or if they are concerned about changes in behaviour.

Children and adolescents aged 8 to 18 years
In patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiant behaviour, and anger) during treatment with this class of medicines. Fluoxetine Vitabalans should be used in children and adolescents aged 8 to 18 years only for the treatment of mild to moderate major depressive episodes (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 effects on growth, sexual maturation, and cognitive, emotional, and behavioural development in this age group. Nevertheless, a doctor may prescribe Fluoxetine Vitabalans to patients under 18 years of age for the treatment of mild to moderate major depressive episodes in combination with psychological therapy, if it is considered to be in their best interest. If Fluoxetine Vitabalans has been prescribed to a patient under 18 years of age and you have any concerns, please consult your doctor again. Inform the doctor if any of the above-mentioned symptoms develop or worsen during treatment with Fluoxetine Vitabalans in patients under 18 years of age.

Fluoxetine Vitabalans should not be used in children under 8 years of age.

Taking other medicines with Fluoxetine Vitabalans
Inform your doctor or pharmacist about all medicines you have recently taken (within the last 5 weeks), including those obtained without a prescription.

Do not take Fluoxetine Vitabalans with:

Certain MAO inhibitors (used in the treatment of depression). Irreversible, non-selective MAO inhibitors must not be used with Fluoxetine Vitabalans due to the risk of severe, sometimes fatal, adverse reactions (serotonin syndrome) (see section "When not to use Fluoxetine Vitabalans"). Treatment with Fluoxetine Vitabalans should be started at least 2 weeks after discontinuation of irreversible, non-selective MAO inhibitors (e.g. tranylcypromine). Do not take any irreversible, 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 at high doses, a longer washout period may be required.
Metoprolol used in heart failure; due to increased risk of bradycardia (slowing of the heart rate).

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

Tamoxifen (used in the treatment of breast cancer); because Fluoxetine Vitabalans may alter blood levels of the drug and reduced efficacy of tamoxifen cannot be excluded. The doctor may consider alternative antidepressant therapy.
Monoamine oxidase inhibitors (MAOI-A), including moclobemide, linezolid (as an antibiotic), and methylene blue (also known as methylthioninium chloride, used to treat drug- or chemical-induced methemoglobinemia): due to risk of severe, even fatal, adverse reactions (serotonin syndrome).
Lithium, selegiline, tramadol (a painkiller), buprenorphine, triptans (for migraine), tryptophan; increased risk of serotonin syndrome when used with Fluoxetine Vitabalans. The doctor may recommend more frequent monitoring.
Medicines affecting heart rhythm, e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarials, particularly halofantrine, certain antihistamines (astemizole, mizolastine), because using one or more of these medicines with Fluoxetine Vitabalans may increase the risk of changes in the electrical activity of the heart.
Mecamylamine, because 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 that increase urine output, used e.g. for high blood pressure, desmopressin (for nocturnal enuresis), carbamazepine, and oxcarbazepine); because these medicines may increase the risk of hyponatremia (low sodium levels in the blood) when used with Fluoxetine Vitabalans.
Phenytoin (an anticonvulsant); because Fluoxetine Vitabalans may affect blood levels of this medicine, the doctor may initiate phenytoin under supervision and perform monitoring tests when co-administered with Fluoxetine Vitabalans.
Flecainide, encainide, propafenone, nebivolol (used in heart conditions), phenytoin, carbamazepine, oxcarbazepine (anticonvulsants), atomoxetine (for attention deficit hyperactivity disorder), tricyclic antidepressants (e.g. imipramine, desipramine, amitriptyline), or risperidone; because Fluoxetine Vitabalans may alter blood levels of these medicines, the doctor may reduce the dose during co-administration.
Antidepressants such as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs), or bupropion, mefloquine or chloroquine (used in the treatment of malaria), tramadol (used for severe pain), or antipsychotics such as phenothiazine or butyrophenone derivatives; because Fluoxetine Vitabalans may increase the risk of seizures when used with these medicines.
Anticoagulants (such as warfarin), NSAIDs (such as ibuprofen, diclofenac), aspirin, and other medicines that may thin the blood (including clozapine, used in the treatment of certain psychiatric disorders). Fluoxetine Vitabalans may alter the effects of these medicines in the blood. Treatment with Fluoxetine Vitabalans may be initiated or interrupted during warfarin therapy, but the doctor will need to perform certain tests, adjust the dose, and monitor the patient more frequently.
Cyproheptadine (for allergies); because it may reduce the effect of Fluoxetine Vitabalans.
The patient should not take herbal preparations containing St. John's wort (Hypericum perforatum) while taking Fluoxetine Vitabalans, as this may increase the risk of adverse effects. If the patient is already taking St. John's wort preparations at the time of starting Fluoxetine Vitabalans therapy, they should stop taking them and inform the doctor at the next visit.

Taking Fluoxetine Vitabalans with food and drink
Fluoxetine Vitabalans may be taken during or between meals, according to patient preference.
Alcohol should be avoided during treatment with this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or plan to become pregnant, 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 no effect on human fertility has been observed to date.

Pregnancy
If a patient discovers she is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor immediately.
An increased risk of congenital heart defects has been observed in children whose mothers took Fluoxetine Vitabalans during the first few months of pregnancy. In the general population, 1 in 100 babies is born with a heart defect. In children whose mothers took Fluoxetine Vitabalans, this increases to 2 in 100. Together with the doctor, the patient may decide that gradually stopping the medicine is more beneficial if she is pregnant. However, depending on individual circumstances, the doctor may recommend continuing treatment with Fluoxetine Vitabalans.
Ensure that the midwife and/or doctor are aware that the patient is taking Fluoxetine Vitabalans.
Use of medicines such as Fluoxetine Vitabalans during pregnancy, particularly in the third trimester, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and cyanosis (bluish skin). These symptoms usually appear within the first 24 hours after birth. If such symptoms occur, inform the midwife and/or doctor immediately.
Caution should be exercised when using this medicine during pregnancy, especially in late pregnancy and shortly before delivery, as the following symptoms have been reported in newborns: irritability, tremor, muscle weakness, constant crying, and difficulties with sucking or sleeping.
Taking Fluoxetine Vitabalans near the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Fluoxetine Vitabalans, she should inform her doctor or midwife so appropriate advice can be provided.

Breastfeeding
Fluoxetine passes into breast milk and may cause adverse effects in infants. The patient may breastfeed if necessary. If a woman continues breastfeeding, the doctor should prescribe the lowest effective dose of Fluoxetine Vitabalans.

Driving and using machines
Fluoxetine Vitabalans may impair the ability to judge and coordinate. Do not drive, operate tools or machinery without consulting your doctor or pharmacist.

3. How to use Fluoxetine Vitabalans

This medicine should always be taken as directed by the doctor. If the patient has any doubts about
using the medicine, they should consult their doctor or pharmacist. Do not take more tablets than the
number recommended by the doctor.
The tablets should be swallowed with water. Do 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 after starting treatment. If needed, the dose may be gradually increased up 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 improvement immediately after the first dose of
antidepressant. This is normal, as symptom improvement in depression may take several weeks of
treatment. Patients suffering from 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 needed, the dose may be gradually increased up to a maximum of 3 tablets (60 mg)
per day. If no improvement occurs within 10 weeks, the doctor should re-evaluate the treatment
approach.

Children and adolescents aged 8 to 18 years with depression
Treatment should be initiated 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 a satisfactory response to treatment is achieved, the doctor will
consider whether continuing treatment beyond 6 months is necessary. If there is no improvement within
9 weeks, the doctor will consider whether further treatment is justified.

Elderly patients (over 65 years of age)
The doctor may increase the dose cautiously, and the daily dose should not exceed 2 tablets (40 mg). The
maximum daily dose is 3 tablets (60 mg).

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

If a dose of Fluoxetine Vitabalans is missed
Do not take a double (or increased) dose to make up for a missed dose. Take the next tablet at the usual
time.
Taking the medicine every day at the same time may help in remembering the regular dosing schedule.

Stopping Fluoxetine Vitabalans
Do not stop taking Fluoxetine Vitabalans without consulting your doctor, even if the patient feels
better. It is important that the patient continues taking the medicine.
The patient should ensure they have an adequate supply of tablets to maintain uninterrupted therapy.
After stopping the medicine, the patient may experience: dizziness, prickling or tingling sensations, sleep
disturbances (vivid dreams, nightmares, insomnia), restlessness or agitation, unusual tiredness or
weakness, anxiety, nausea and/or vomiting, tremor, headache.
In most patients, withdrawal symptoms are mild and resolve within a few weeks. If such symptoms
occur after stopping the medicine, the patient should contact their doctor.
To discontinue Fluoxetine Vitabalans, the doctor will recommend gradually reducing the dose over one
or two weeks. This approach helps reduce the risk of withdrawal symptoms.

If the patient has any further questions about the use of Fluoxetine Vitabalans, they should contact their
doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.

If the patient develops a rash or allergic reactions such as itching, swollen lips and (or) tongue, or wheezing and (or) shallow breathing, they should immediately stop taking the medicine and contact a doctor.
If the patient feels restless and unable to 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 experiences such sensations, they should contact a doctor.
If the patient experiences suicidal thoughts or self-harm ideation, they should immediately contact a doctor or go to hospital (see section 2). The doctor should be informed immediately if:
redness occurs on the skin or various skin reactions develop, or if blisters appear on the skin. These are rare symptoms.
a combination of symptoms occurs (known as serotonin syndrome), including unexplained fever with rapid breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation, or drowsiness;
the patient feels weakness, drowsiness, or confusion (mainly in elderly patients and elderly patients taking diuretics);
prolonged and painful erection occurs;
irritability and extreme agitation occur.

The following list includes adverse effects reported to date, presented according to frequency of occurrence:

Very common (occur in more than 1 in 10 people)

insomnia
headache
diarrhoea
nausea
fatigue

Common (occur in up to 1 in 10 people)

decreased appetite, weight loss
nervousness, anxiety
motor restlessness, attention disturbances
tension
reduced sexual drive or sexual disorders (including erectile dysfunction)
sleep disturbances, unusual dreams, tiredness or drowsiness
dizziness
taste disturbances
uncontrolled movements and tremor
blurred vision
rapid and irregular heartbeat
changes in the heart's electrical activity
flushing
yawning
indigestion, vomiting
dry mouth
rash, urticaria, itching
excessive sweating
joint pain
increased frequency of urination
unexplained vaginal bleeding
tremor, chills

Uncommon (occur in up to 1 in 100 people)

depersonalisation
disturbances in thinking
elevated mood
orgasmic disturbances
suicidal thoughts or self-harm ideation
bruxism (teeth grinding)
muscle spasms, involuntary movements, or disturbances in balance or coordination
memory disturbances
dilated (enlarged) pupils
tinnitus
low blood pressure
shortness of breath
nosebleeds
difficulty swallowing
hair loss
increased tendency to bruise
unexplained bruises or bleeding
cold sweats
difficulty urinating
sensation of cold or hot
malaise or unusual feeling of being unwell
psychomotor agitation (feeling of inner restlessness and an irresistible need to be constantly moving)

Rare (occur in up to 1 in 1,000 people)

decreased sodium concentration in blood
reduced platelet count, increasing the risk of bleeding or bruising
reduced white blood cell count, increasing susceptibility to various infections
serum sickness (delayed allergic reaction with rash, joint pain, fever, lymphatic swelling, shock, low blood pressure)
bizarre, wild behaviour
hallucinations
agitation
panic attacks
confusion
stuttering
aggression
serotonin syndrome
irregular heart rhythm
seizures
vasculitis (inflammation of blood vessels)
severe, sudden allergic reactions (shortness of breath, throat swelling, low blood pressure, gastrointestinal complaints, "racing" heart, dizziness, shock)
sudden and severe swelling of tissues in the neck, face, mouth, and (or) throat
severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis)
oesophageal pain
hepatitis (liver inflammation)
lung diseases
photosensitivity reactions
muscle pain
urinary disorders
galactorrhoea (milk secretion)
abnormal liver function tests
prolonged and painful erection

Unknown (frequency cannot be determined from available data)

Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection Pregnancy, breastfeeding and fertility in section 2.

Most of these adverse effects disappear during continued treatment.
Patients taking selective serotonin reuptake inhibitors (SSRIs), such as Fluoxetine Vitabalans, have an increased risk of bone fractures.
Children and adolescents (8–18 years): Fluoxetine Vitabalans may slow growth or delay sexual maturation.
Behaviours related to suicide (suicide attempts and suicidal thoughts) and hostility are observed more frequently in children and adolescents than in adult patients.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Fluoxetine Vitabalans

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack and blister after EXP. The expiry date refers to the last day of the mentioned month.
Do not use this medicine if there are visible signs of tablet damage.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Fluoxetine Vitabalans contains

The active substance is fluoxetine hydrochloride in an amount equivalent to 20 mg of fluoxetine.
The other ingredients 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, convex tablets with a score line, 9 mm in diameter.
The tablets may 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 Authorisation Holder
Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
Finland
Tel: +358 (3) 615600
Fax: +358 (3) 6183130

Manufacturer
Vitabalans Oy
Varastokatu 7-9
13500 Hämeenlinna
Finland

This medicinal product is authorised 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

Fluoxetine vitabalans