Fluoxetin Polpharma

Leaflet accompanying the packaging: patient information

Fluoxetin Polpharma, 20 mg, hard capsules

Fluoxetine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• 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.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Fluoxetin Polpharma and what is it used for

Fluoxetin Polpharma belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs).
This medicine is used to treat the following conditions:
Adults

• Episodes of major depression.
• Obsessive-compulsive disorder (obsessive-compulsive neurosis).
• Bulimia (psychic overeating): the medicine is used in combination with psychotherapy to reduce the desire to overeat and vomit.

Children aged 8 and older and adolescents

• Depression of moderate to severe intensity, when there is no improvement after 4-6 sessions of psychotherapy. The medicine should be recommended to children and adolescents with moderate or severe depression only in combination with psychotherapy.

2. Important information before taking Fluoxetin Polpharma

When not to take Fluoxetin Polpharma

Treatment with fluoxetine can only be started 2 weeks after stopping irreversible MAOIs (e.g. tranylcypromine).
Treatment with fluoxetine can be started the next day after stopping reversible MAOIs of type A (e.g. moclobemide).
MAOIs should not be taken for at least 5 weeks after stopping Fluoxetin Polpharma. If Fluoxetin Polpharma has been taken for a long time and/or in a high dose, the doctor may consider a longer interval before starting treatment with MAOIs. MAOIs include: nialamide, iproniazid, selegiline, moclobemide, phenelzine, tranylcypromine, isocarboxazid, and toloxatone.

Warnings and precautions

Before starting treatment with Fluoxetin Polpharma, the patient should discuss it with their doctor.
Particular caution should be exercised when taking Fluoxetin Polpharma:

suicidal thoughts or self-harm. In patients with depression or anxiety disorders, suicidal thoughts or self-harm may occur. This condition may worsen when the patient first starts taking antidepressant medicines and may persist until the medicine starts to work, which usually happens after 2 weeks of treatment, although sometimes later. Such thoughts are more common in patients who:
• have had suicidal thoughts or self-harm in the past;
• are young adults. The risk of suicidal behavior in people under 25 with mental disorders treated with antidepressant medicines is higher. If the patient experiences self-harm or

suicidal thoughts they should contact their doctor or the nearest hospital immediately.
Hospital.
The patient may not be aware of the symptoms they are experiencing. Therefore, it may be helpful for friends or family members to observe changes in the patient's behavior during treatment and read this leaflet. If the patient's depressive or anxiety disorder worsens or if there are disturbing changes in behavior, the doctor should be contacted promptly or the patient should go to the nearest hospital.
In other mental disorders where Fluoxetin Polpharma is also used, the risk of suicidal incidents may also be increased. Therefore, during treatment of patients with other mental disorders, the same precautions should be taken as in the case of depression and bulimia.
Medicines like Fluoxetin Polpharma (so-called SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.

Children and adolescents

In patients under 18 taking antidepressant medicines of this class, the risk of suicidal behavior (attempts and suicidal thoughts) and hostility (mainly aggression, rebellious behavior, and anger) is increased. If the doctor considers it beneficial for the patient's health, the medicine can be used in children and adolescents aged 8 to 18 in combination with psychotherapy exclusively for the treatment of moderate or severe episodes of major depression.
Data on the long-term safety of Fluoxetin Polpharma in this age group, including effects on growth, maturation, and cognitive and emotional development, are limited; therefore, this medicine should not be used for other indications.
Fluoxetin Polpharma should not be used to treat children under 8 years of age.

Fluoxetin Polpharma and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
This medicine may affect the action of other medicines (interactions). Interactions may occur when taking:

• MAOIs (used to treat depression or Parkinson's disease)
• irreversible, non-selective monoamine oxidase inhibitors (e.g. iproniazid) should not be taken due to the risk of severe, potentially fatal side effects (serotonin syndrome) (see "When not to take Fluoxetin Polpharma");
• taking MAOIs of type A (including linezolid and methylthioninium chloride - methylthioninium blue) with fluoxetine may cause serotonin syndrome; if taking these medicines with fluoxetine is necessary, the doctor will closely monitor the patient's condition (see "When not to take Fluoxetin Polpharma");
• metoprolol (used to treat heart failure) (see "When not to take Fluoxetin Polpharma");
• lithium, tryptophan, selegiline, herbal medicines containing St. John's Wort, or medicines belonging to the triptan group (e.g. sumatriptan, zolmitriptan), opioid medicines (buprenorphine, tramadol). These medicines should not be taken with fluoxetine without prior consultation with a doctor. These medicines may interact with Fluoxetin Polpharma and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, body temperature above 38°C. If such symptoms occur, the doctor should be contacted - there is an increased risk of serotonin syndrome;

The doctor may recommend more frequent check-ups;

• phenytoin (an antiepileptic medicine); fluoxetine may affect the level of this medicine in the blood, and the doctor may introduce phenytoin more cautiously while the patient is taking fluoxetine and perform frequent check-ups;
• flecainide, propafenone, and nebivolol (medicines used to treat heart conditions), as well as atomoxetine (used to treat attention deficit hyperactivity disorder, ADHD), carbamazepine (used to treat epilepsy), and risperidone (used to treat mental disorders). Since fluoxetine may decrease the level of these medicines in the blood, the doctor may reduce their dose;
• medicines that may affect heart rhythm (prolongation of the QT interval):
• antiarrhythmic medicines of class IA and III
• antipsychotic medicines (e.g. phenothiazine derivatives, pimozide, haloperidol)
• tricyclic antidepressant medicines
• certain antibacterial medicines (such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine)
• antimalarial medicines, especially halofantrine
• certain antihistamine medicines used to treat allergies (astemizole, mizolastine);
• tamoxifen (used to treat breast cancer), as it may reduce the effect of tamoxifen; the doctor may consider treating with another antidepressant medicine;
• mequitazine (used to treat allergies);
• medicines that affect blood clotting (oral anticoagulants, such as warfarin, antiplatelet medicines, including acetylsalicylic acid, and nonsteroidal anti-inflammatory medicines); taking these medicines with fluoxetine increases the risk of bleeding - the doctor may order additional tests;
• cyproheptadine (used to treat allergies), as cases of reduced antidepressant effect of fluoxetine in combination with this medicine have been reported;
• medicines that cause decreased sodium levels in the blood (e.g. diuretics, desmopressin, carbamazepine, and oxcarbazepine). Hyponatremia is a side effect of fluoxetine, so taking fluoxetine with these medicines may further decrease sodium levels in the blood;
• medicines that lower the seizure threshold, such as tricyclic antidepressant medicines, other selective serotonin reuptake inhibitors (e.g. sertraline, citalopram, paroxetine), phenothiazine derivatives (e.g. perphenazine, prochlorperazine, chlorpromazine), butyrophenone derivatives (e.g. benperidol, haloperidol), mefloquine, or chloroquine (used to treat malaria), bupropion (used to treat depression), tramadol (a pain reliever). Taking fluoxetine with these medicines increases the risk of seizures.

Fluoxetin Polpharma with food, drink, and alcohol

The medicine can be taken with or without food.
Alcohol should not be consumed during treatment.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Children 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 children is born with heart defects. If the mother took fluoxetine, this rate increases to about 2 in 100. The patient and their doctor may decide to gradually stop taking fluoxetine during pregnancy. However, depending on the circumstances, the doctor may recommend continuing to take fluoxetine.
Taking medicines like Fluoxetin Polpharma during pregnancy, especially in the last three months, may increase the risk of a condition called persistent pulmonary hypertension in the newborn (PPHN). This condition is characterized by rapid breathing and cyanosis. These symptoms usually appear within the first day of life. If such symptoms occur in the newborn, the doctor and/or midwife should be contacted immediately.
Care should be taken, as newborns whose mothers took fluoxetine in the last three months of pregnancy have reported symptoms such as irritability, tremors, weakness, constant crying, feeding or sleeping problems.
Taking Fluoxetin Polpharma 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 Fluoxetin Polpharma, they should inform their doctor or midwife so that they can provide appropriate advice.
Breastfeeding
Fluoxetine is excreted in breast milk and may cause side effects in the baby.
Breastfeeding is only recommended if absolutely necessary. Breastfeeding women may be advised to take a lower dose of fluoxetine.
Fertility
In animal studies, fluoxetine has been shown to decrease sperm quality. This may theoretically affect fertility, although no effect on human fertility has been observed so far.

Driving and using machines

The medicine may affect mental processes and coordination. The patient should not drive vehicles or operate machines without consulting their doctor.

Fluoxetin Polpharma contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Fluoxetin Polpharma

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor should be consulted.

Adults

Depression
The recommended dose is 20 mg per day. If necessary, the doctor may change the dose of the medicine within the first 3 to 4 weeks of treatment. The dose can be gradually and cautiously increased to a maximum of 60 mg per day, ensuring that the smallest effective dose is used. The first effects of treatment may not be noticeable until after some time, usually after several weeks of treatment.
Patient with depression should take the medicine for at least 6 months.
Bulimia (psychic overeating )
The recommended dose is 60 mg per day.
Obsessive-compulsive disorder
The recommended dose is 20 mg per day. If necessary, the doctor may change the dose of the medicine after 2 weeks of treatment. The dose can be gradually increased to a maximum of 60 mg per day. If there is no improvement in the patient's condition within 10 weeks, the doctor should reconsider the use of Fluoxetin Polpharma.

Use in children and adolescents

Depression in children and adolescents aged 8 to 18
Treatment should be initiated and supervised by a specialist. The initial dose is 10 mg per day. The doctor may increase the dose to 20 mg per day after one or two weeks.
The dose should be increased cautiously, ensuring that the patient receives the smallest effective dose. Children with lower body weight may require a lower dose. If there is no improvement in the patient's condition within 6 months, the doctor will reconsider the use of Fluoxetin Polpharma.

Use in elderly patients (over 65 years of age)

In elderly patients, the dose should be increased with caution. The daily dose should not exceed 40 mg. The maximum dose is 60 mg per day.

Use in patients with liver function disorders

In case of liver function disorders or taking other medicines that may affect the action of fluoxetine, the doctor may recommend a lower dose or taking Fluoxetin Polpharma every other day.

Method of administration

The capsules should be swallowed with water. The capsules should not be chewed.

Taking a higher dose of Fluoxetin Polpharma than recommended

In case of taking too many capsules, the patient should go to the emergency room or the nearest hospital, or consult a doctor.
If possible, the patient should take the packaging of Fluoxetin Polpharma with them.
Symptoms of overdose include:

• nausea, vomiting, seizures;
• heart problems (such as arrhythmias and cardiac arrest);
• respiratory problems;
• changes in mental state - from agitation to coma.

Missing a dose of Fluoxetin Polpharma

If a dose is missed, the next dose should be taken the next day at the usual time. A double dose should not be taken to make up for the missed dose.
Taking the medicine at the same time every day helps to remember to take it.

Stopping treatment with Fluoxetin Polpharma

Treatment with Fluoxetin Polpharma should not be stopped without consulting a doctor, even if the patient's condition improves.
It is essential to continue taking the medicine without interruption. The patient should ensure that they never run out of medicine to continue treatment.
After stopping Fluoxetin Polpharma, the following symptoms may occur:

• dizziness, tingling, numbness;
• sleep disturbances (vivid dreams, nightmares, insomnia);
• psychomotor restlessness or agitation;
• fatigue or weakness, anxiety;
• nausea or vomiting;
• tremors, headaches.

In most people, any symptoms that occur after stopping Fluoxetin Polpharma are mild and resolve on their own within a few weeks. If symptoms occur after stopping treatment, the doctor should be contacted.
If the doctor decides to stop Fluoxetin Polpharma, they will recommend gradually reducing the dose over a period of 1 to 2 weeks to minimize the risk of withdrawal symptoms.
If the patient has any further doubts about taking this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, Fluoxetin Polpharma can cause side effects, although not everyone gets them.

The patient should stop taking the medicine and contact their doctor or go to the nearest hospital immediately:

The patient should also inform their doctor if they experience any of the following symptoms, especially if they persist or are severe:

• a combination of symptoms known as serotonin syndrome: fever with rapid breathing or heart rate, excessive sweating, muscle stiffness or tremors, disorientation, extreme agitation or drowsiness
• weakness, drowsiness, or disorientation - mainly in elderly patients and those taking diuretics (also in the elderly)
• prolonged and painful erections
• irritability and extreme agitation

Other side effects

Very common (occurring in more than 1 in 10 patients)

• insomnia (including early morning awakening, difficulty falling asleep, difficulty maintaining sleep)
• headaches
• diarrhea, nausea
• fatigue (including weakness)

Common (occurring in less than 1 in 10 patients but more than 1 in 100 patients)

• decreased appetite (including anorexia), weight loss
• anxiety, nervousness
• psychomotor restlessness, attention disturbances
• tension
• decreased libido (including loss of sexual desire), erectile dysfunction, ejaculation disorders
• sleep disturbances, unusual dreams (including nightmares), lethargy, drowsiness (including excessive drowsiness, sedation)
• dizziness, tremors
• taste disturbances
• blurred vision
• palpitations
• flushing of the face or other parts of the body (including hot flashes)
• yawning
• vomiting, nausea, dry mouth
• itching, hives, excessive sweating, rash
• joint pain
• frequent urination
• vaginal bleeding
• tremors, chills

Uncommon (occurring in less than 1 in 100 patients but more than 1 in 1,000 patients)

• disturbances of concentration and thinking (e.g. depersonalization), elevated mood, euphoric mood, abnormal thinking, orgasm disorders (including anorgasmia), involuntary grinding or clenching of the teeth
• hyperactivity, involuntary movements (dyskinesia), coordination disorders (ataxia), balance disorders, myoclonic muscle contractions (myoclonus), memory disturbances
• pupil dilation
• tinnitus
• hypotension
• shortness of breath
• nasal bleeding
• difficulty swallowing
• gastrointestinal bleeding (most commonly gum bleeding, vomiting blood, fresh blood in stool, rectal bleeding, bloody diarrhea, black stools, gastrointestinal bleeding from ulcers)
• hair loss, increased bruising, cold sweats
• muscle tremors
• urination difficulties
• sexual dysfunction
• unusual feeling, malaise, feeling of cold, feeling of heat
• abnormal liver function test results (increased transaminase activity, increased gamma-glutamyltransferase)

Rare (occurring in less than 1 in 1,000 patients but more than 1 in 10,000 patients)

• decreased platelet count, which increases the risk of bleeding or bruising (thrombocytopenia)
• decreased neutrophil count, which increases the risk of various infections (neutropenia)
• decreased white blood cell count (leukopenia)
• serum sickness
• inappropriate antidiuretic hormone secretion
• decreased sodium levels in the blood (hyponatremia)
• hallucinations, manic reactions (hypomania, mania), agitation
• confusion, stuttering, aggression
• seizures
• involuntary movements of the face and tongue (tardive dyskinesia)
• serotonin syndrome
• ventricular arrhythmias (including torsades de pointes), prolonged QT interval on ECG
• vasculitis, vasodilation
• pharyngitis
• pulmonary diseases
• hepatitis
• esophageal pain
• purpura
• photosensitivity reactions
• muscle pain
• urination difficulties, urination disorders
• galactorrhea
• increased prolactin levels in the blood (hyperprolactinemia)
• bleeding from the mucous membranes

Frequency not known (cannot be estimated from available data)

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

Children and adolescents (aged 8 to 18)

Taking fluoxetine in children and adolescents may slow down growth or delay sexual maturation.
Children often report nosebleeds.
In patients over 50 taking selective serotonin reuptake inhibitors and tricyclic antidepressant medicines, there is an increased risk of bone fractures. The mechanism of this effect is unknown.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Fluoxetin Polpharma

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.
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 Fluoxetin Polpharma contains

• The active substance of the medicine is fluoxetine. Each hard capsule contains 20 mg of fluoxetine (as fluoxetine hydrochloride).
• Other ingredients are: cornstarch, lactose monohydrate, magnesium stearate - which make up the capsule core, and gelatin, titanium dioxide (E 171), indigo carmine (E 132), yellow quinoline (E 104) - which make up the capsule shell.

What Fluoxetin Polpharma looks like and what the packaging contains

The medicine is in the form of hard capsules, green and white in color.
The packaging contains 30 capsules.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Date of last revision of the leaflet: