Patient Information Leaflet

Fluoksetyna EGIS, 10 mg, hard capsules
Fluoksetyna EGIS, 20 mg, hard capsules
Fluoxetinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Fluoksetyna EGIS is and what it is used for
What you need to know before taking Fluoksetyna EGIS
How to take Fluoksetyna EGIS
Possible side effects
How to store Fluoksetyna EGIS
Contents of the pack and other information

1. What Fluoksetyna EGIS is and what it is used for

Fluoksetyna EGIS contains an active substance called fluoxetine, which belongs to a group of antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs).
Fluoksetyna EGIS is used to treat the following conditions:

Adults

Major depressive episodes
Obsessive-compulsive disorder (intrusive thoughts and compulsive behaviours)
Bulimia: Fluoksetyna EGIS is used in combination with psychotherapy to treat binge eating and purging (vomiting).

Children aged 8 years and older, and adolescents

Moderate to severe depressive episodes, when depressive symptoms do not improve after 4–6 sessions of psychotherapy. In children and adolescents with moderate to severe depression, Fluoksetyna EGIS should be used only in combination with psychological therapy.

How Fluoksetyna EGIS works
Everyone's brain produces a chemical called serotonin. People with depression, obsessive-compulsive disorder, and bulimia (psychogenic overeating) have lower levels of serotonin than others. The exact mechanism of action of Fluoksetyna EGIS and other SSRIs is not fully understood, but they may help by increasing the amount of serotonin in the brain.
Treating these conditions helps improve well-being. If left untreated, these conditions may not resolve, may worsen, and may become more difficult to treat.
Treatment may need to continue for several weeks or months to ensure symptoms have resolved.

2. Important information before using Fluoksetyna EGIS

When not to use Fluoksetyna EGIS:

if the patient is allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6); if the patient develops a rash or any other allergic reaction (such as itching, swelling of the lips or face, or shortness of breath), the medicine must be discontinued immediately and the doctor contacted;
if the patient is taking medicines known as non-selective, irreversible monoamine oxidase inhibitors (MAO inhibitors) (e.g. iproniazid, used in the treatment of depression), as this may lead to severe or even life-threatening adverse reactions. Treatment with Fluoksetyna EGIS may only be started at least 2 weeks after discontinuation of non-selective, irreversible MAO inhibitors. It is forbidden to use any irreversible, non-selective MAO inhibitors for at least 5 weeks after stopping Fluoksetyna EGIS. If Fluoksetyna EGIS has been prescribed for a prolonged period and (or) at a high dose, a longer washout period may need to be considered.
if the patient is taking metoprolol (used in the treatment of heart failure), as there is an increased risk of excessive slowing of the heart rate.

Warnings and precautions
Before starting treatment with Fluoksetyna EGIS, discuss this with your doctor or pharmacist. You should
inform your doctor if:

the patient has heart disease;
the patient develops fever, muscle stiffness, or tremor, or changes in mental status such as disorientation, irritability, or extreme agitation; these may be signs of serotonin syndrome or neuroleptic malignant syndrome. Although rare, these syndromes may be life-threatening; contact your doctor immediately, as discontinuation of fluoxetine may be necessary;
the patient is taking an opioid medicine—buprenorphine—for severe pain or other conditions. Using this medicine together with Fluoksetyna EGIS may lead to serotonin syndrome, a potentially life-threatening condition (see section "Fluoksetyna EGIS and other medicines");
the patient has mania (currently or in the past). In such cases, contact your doctor immediately, as discontinuation of fluoxetine may be necessary;
there has been a history of bleeding or bruising, or unusual bleeding occurs, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility");
the patient is taking medicines that affect blood clotting (see "Fluoksetyna EGIS and other medicines");
the patient has epilepsy (seizures) or an increased frequency of seizures; contact your doctor immediately. Discontinuation of fluoxetine may be necessary;
the patient is undergoing ECT (electroconvulsive therapy);
the patient is being treated with tamoxifen (used in the treatment of breast cancer) (see "Fluoksetyna EGIS and other medicines");
the patient experiences restlessness and inability to sit or stand still (akathisia). Increasing the dose of Fluoksetyna EGIS may worsen these symptoms;
the patient has diabetes (the doctor may need to adjust the dose of insulin or other antidiabetic medicine);
the patient has liver disease (the doctor may need to adjust the dose);
the patient has a slow heart rate at rest and (or) salt deficiency due to prolonged and severe diarrhoea, vomiting, or use of diuretics (water tablets);
the patient is being treated with diuretics (water tablets), especially elderly patients;
the patient has glaucoma (increased pressure in the eye).

Patients taking this medicine may experience weight loss, usually proportional to the body weight
before treatment.
Medicines such as Fluoksetyna EGIS (so-called SSRIs) may cause symptoms of
sexual dysfunction (see section 4). In some cases, these symptoms may persist
after stopping treatment.
Suicidal thoughts or worsening of depression or anxiety.
Patients with depression and (or) anxiety disorders may sometimes experience thoughts of self-harm or
suicide. This condition may worsen when patients first start taking antidepressants, and may
persist until the medicine begins to work fully, which usually occurs after about two weeks of treatment,
although sometimes later. Such thoughts are more common in patients who:

have previously had suicidal or self-harming thoughts;
are young adults. The risk of suicidal behaviour is higher in people under 25 years of age with psychiatric disorders who are treated with antidepressants. If the patient experiences thoughts of self-harm or suicide, they should contact their doctor or the nearest hospital immediately.

It may be helpful to inform family members or friends about the illness and ask them
to read this leaflet and inform you if they notice worsening of depression or anxiety, or other
behavioural changes of concern.
Children and adolescents aged 8 to 18 years
In patients under 18 years of age, there is an increased risk of adverse reactions such as suicide attempts,
suicidal thoughts, and hostility (mainly aggression, defiance, and anger) when taking medicines in this
group. Fluoksetyna EGIS may be used in children and adolescents aged 8 to 18 years only for the treatment of
moderate to severe depressive episodes (in combination with psychological therapy), but not for the treatment of other conditions.
There is limited information available on the long-term safety of fluoxetine in this
age group regarding growth, puberty, psychological and emotional development, and behaviour.
Nevertheless, the treating doctor may prescribe Fluoksetyna EGIS to patients under 18 years of age for the treatment of moderate to severe depressive episodes (together with psychotherapy) if they decide it is in the patient's best interest. If the prescription of this medicine for a patient under 18 years of age causes concern, discuss it with the doctor. If any of the above-mentioned symptoms develop or worsen in a patient under 18 years of age, inform the treating doctor immediately.
Fluoksetyna EGIS should not be used in children under 8 years of age.
Fluoksetyna EGIS and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not use Fluoksetyna EGIS with:

Non-selective, irreversible monoamine oxidase inhibitors (MAO inhibitors) used in the treatment of depression, as this may lead to severe or even fatal reactions (serotonin syndrome) (see section "When not to use Fluoksetyna EGIS"). Treatment with Fluoksetyna EGIS may be started at least 2 weeks after stopping irreversible, non-selective MAO inhibitors (e.g. tranylcypromine). Irreversible, non-selective MAO inhibitors should not be used for at least 5 weeks after stopping Fluoksetyna EGIS. If Fluoksetyna EGIS has been prescribed for a prolonged period and (or) at a high dose, the doctor may consider a longer washout period.
Metoprolol, if previously used in heart failure, as there is an increased risk of excessively slow heart rate.

Fluoksetyna EGIS may affect the action of other medicines, and other medicines may affect the action of
Fluoksetyna EGIS (interaction)

Tamoxifen (used in the treatment of breast cancer): fluoxetine may reduce the effectiveness of tamoxifen. The treating doctor may consider using another antidepressant.
Monoamine oxidase inhibitors type A (MAO-A) (including moclobemide), linezolid (an antibiotic), and methylene blue chloride (also known as methylene blue, used in the treatment of methemoglobinemia) may lead to severe or even fatal reactions (serotonin syndrome). Treatment with fluoxetine may be started the next day after stopping reversible MAO inhibitors, but the doctor may decide to monitor the patient closely and use a lower dose of the reversible MAO inhibitor.
Mequitazine (used in the treatment of allergies): using this medicine with Fluoksetyna EGIS may increase the risk of changes in the electrical activity of the heart.
Phenytoin (used in the treatment of epilepsy); Fluoksetyna EGIS may affect blood levels of this active substance; the treating doctor will exercise caution when introducing phenytoin during fluoxetine treatment and will perform frequent monitoring.
Lithium (used in the treatment of manic depression), tryptophan (used in the treatment of conditions such as insomnia or depression), buprenorphine (used in the treatment of opioid addiction or severe pain), tramadol (a strong painkiller), triptans (used in the treatment of migraine), selegiline, St. John's wort: using these together with Fluoksetyna EGIS increases the risk of mild serotonin syndrome. The treating doctor will monitor the patient more frequently.
Medicines that may affect heart rhythm, e.g. antiarrhythmics of class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antibacterial medicines (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarials especially halofantrine, or some antihistamines (astemizole, mizolastine)—using these with Fluoksetyna EGIS may increase the risk of changes in the electrical activity of the heart.
Anticoagulants (such as warfarin), NSAIDs (such as ibuprofen, diclofenac), acetylsalicylic acid, and other medicines that may reduce blood clotting (including clozapine, used in the treatment of certain psychiatric disorders)—Fluoksetyna EGIS may alter the effect of these medicines on blood. If fluoxetine treatment is started or stopped while taking warfarin, the treating doctor may order specific tests, adjust the dose, and monitor the patient more frequently.
Cyproheptadine (used in the treatment of allergies): may reduce the effect of Fluoksetyna EGIS.
Medicines that lower sodium levels in the blood (including diuretics, desmopressin (used in the treatment of diabetes insipidus), carbamazepine and oxcarbazepine (used in the treatment of epilepsy).
Antidepressants such as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquine or chloroquine (used in the treatment of malaria), tramadol (used in the treatment of severe pain), or antipsychotics such as phenothiazines or butyrophenones; as fluoxetine may increase the risk of seizures when used with these medicines.
Flecainide, propafenone, nebivolol or encainide (used in the treatment of heart conditions), carbamazepine (an antiepileptic), atomoxetine, tricyclic antidepressants (e.g. imipramine, desipramine, amitriptyline), or risperidone (used in the treatment of certain psychiatric disorders)—fluoxetine may alter blood levels of these medicines; the treating doctor may reduce their dose when used with fluoxetine.

Using Fluoksetyna EGIS with food, drink, and alcohol
Fluoksetyna EGIS may be taken with or without food, as preferred.
Alcohol should be avoided during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
An increased risk of congenital heart defects has been observed in children whose mothers took this medicine during the first months of pregnancy. In the general population, about 1 in 100 newborns is born with a heart defect. If the mother took this medicine, this rate increases to 2 in 100 newborns.
Taking medicines such as fluoxetine during pregnancy, especially during the last three months,
may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and cyanosis. Symptoms usually appear within the first 24 hours after birth.
If such symptoms occur in the newborn, contact the doctor and (or) midwife immediately.
Use of this medicine during pregnancy is not recommended unless the potential benefits outweigh the risks. Therefore, the doctor may decide to gradually discontinue Fluoksetyna EGIS during pregnancy or before conception. However, the doctor may also decide to continue treatment with Fluoksetyna EGIS, depending on the circumstances.
Caution is advised, as symptoms such as irritability, tremor, muscle weakness, constant crying, feeding difficulties, or sleep disturbances have been reported in newborns whose mothers took fluoxetine, especially during the last 3 months of pregnancy or before delivery.
Taking Fluoksetyna EGIS towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Fluoksetyna EGIS, she should inform her doctor or midwife so appropriate advice can be provided.
Breastfeeding
This medicine passes into breast milk and may cause adverse effects in newborns. Breastfeeding is only permitted if absolutely necessary. If breastfeeding is continued, the treating doctor may recommend using a lower dose of this medicine.
Fertility
Animal studies have shown that fluoxetine may reduce semen quality. This could theoretically affect fertility, but no effect on fertility has been observed in humans to date.
Driving and operating machinery
Psychotropic medicines such as Fluoksetyna EGIS may impair the ability to assess situations and motor skills. Do not drive or operate machinery until the patient knows how Fluoksetyna EGIS affects them.
Fluoksetyna EGIS contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

3. How to take Fluoksetyna EGIS

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Do not take more capsules than your doctor has prescribed.
Swallow the capsules whole with water. Do not chew the capsules.

Adults
The recommended dose is:

Depression: the recommended dose is 20 mg per day (2 capsules of 10 mg or 1 capsule of 20 mg). Your doctor will assess the course of treatment and, if necessary, adjust the dose within 3 to 4 weeks after starting treatment. If needed, the dose may be gradually increased up to a maximum of 60 mg (3 capsules of 20 mg) per day. The dose should be increased cautiously to ensure the use of the lowest effective dose. Your condition may not improve immediately after starting the medicine. Initial effects of treatment may only become noticeable after some time, usually after several weeks of treatment. Patients with depression should be treated for at least 6 months.
Obsessive-compulsive disorder: the recommended dose is 20 mg (2 capsules of 10 mg or 1 capsule of 20 mg) per day. Your doctor will assess the course of treatment and, if necessary, adjust the dose after 2 weeks of treatment. If needed, the dose may be gradually increased up to a maximum of 60 mg (3 capsules of 20 mg) per day. If no improvement occurs within 10 weeks, your doctor will consider whether continued treatment with Fluoksetyna EGIS is justified.
Bulimia: the recommended dose is 60 mg (3 capsules of 20 mg) per day.

Use in children and adolescents
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 (1 capsule of 10 mg) per day. After 1 to 2 weeks, your doctor may increase the dose to 20 mg (2 capsules of 10 mg or 1 capsule of 20 mg) per day. The dose should be increased cautiously to ensure the use of the lowest effective dose. Children with lower body weight may require lower doses. If a satisfactory response to treatment is achieved, your doctor will evaluate the need for continuing treatment beyond 6 months. If there is no improvement within 9 weeks, your doctor will consider whether further treatment is justified.

Elderly patients
The dose should be cautiously and gradually increased, and the daily dose should generally not exceed 40 mg (2 capsules of 20 mg). The maximum daily dose is 60 mg (3 capsules of 20 mg) per day.

Hepatic impairment
If liver function is impaired or if other medicines are being taken that may affect fluoxetine, your doctor may prescribe lower doses or recommend administering this medicine every other day.

Taking more Fluoksetyna EGIS than prescribed

If you take too many capsules, seek immediate medical attention at the nearest emergency department (or call emergency services) or contact your doctor.
If possible, bring the packaging of Fluoksetyna EGIS with you. Symptoms of overdose may include nausea, vomiting, seizures, heart problems (such as irregular heartbeat and cardiac arrest), lung problems, and changes in mental state (ranging from agitation to coma).

Missing a dose of Fluoksetyna EGIS

If you miss a dose, do not be concerned. Take the next dose the following day at your usual time. Do not take a double dose to make up for a missed dose.
Taking the medicine at the same time each day may help you remember to take it regularly.

Stopping treatment with Fluoksetyna EGIS
Do not stop taking Fluoksetyna EGIS without consulting your doctor, even if your condition improves. It is important to continue taking the medicine as prescribed.
Ensure that you have enough capsules available.
After stopping Fluoksetyna EGIS, you may experience the following symptoms (withdrawal symptoms): dizziness, tingling or pricking sensations, sleep disturbances (vivid dreams, nightmares, insomnia), feelings of anxiety or agitation, unusual tiredness or weakness, anxiety, nausea/vomiting, tremors, headaches.
In most people, withdrawal symptoms associated with stopping Fluoksetyna EGIS are mild and resolve within a few weeks.
If you experience any symptoms after stopping treatment, contact your doctor.
When discontinuing Fluoksetyna EGIS, your doctor may recommend gradually reducing the dose over one or two weeks, which should reduce the likelihood of withdrawal symptoms.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

If thoughts of suicide or self-harm occur, you must contact your doctor immediately or go to hospital (see section 2).
If a rash or allergic symptoms such as itching, swelling of the lips/tongue, or wheezing/shortness of breath occur, stop taking the medicine immediately and contact your doctor without delay.
If the patient feels restless and unable to sit or stand still, they may be experiencing akathisia (a syndrome including intense restlessness, anxiety, irritability, and motor agitation); increasing the dose of Fluoxetine EGIS may worsen this condition. In such cases, you should contact your doctor.
Contact your doctor immediately if skin redness, various skin reactions, blisters, or skin peeling occur. These reactions are very rare.

The most common adverse reactions (very common adverse reactions, which may affect
more than 1 in 10 patients) are: insomnia, headache, diarrhoea, nausea, and fatigue.
In some patients, the following have been observed:

rarely - a combination of symptoms known as serotonin syndrome: fever with rapid breathing or increased heart rate, excessive sweating, muscle stiffness or tremor, confusion, extreme agitation, or drowsiness;
weakness, drowsiness, or confusion – mainly in elderly patients and in elderly patients taking diuretics;
prolonged or painful erection;
irritability or intense agitation;
heart-related problems such as fast or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate an abnormal heart rate.

If any of the above symptoms occur in the patient, inform the doctor immediately.
The following adverse reactions have been reported in patients taking Fluoksetyna EGIS:
Common (may occur in up to 1 in 10 patients)

loss of appetite, weight loss
nervousness, anxiety
motor restlessness, poor concentration
feeling of tension
reduced sexual drive or sexual problems (including difficulty maintaining erection during sexual activity and ejaculation problems)
sleep problems, unusual dreams, or drowsiness
dizziness
altered taste sensation
uncontrollable tremors
blurred vision
fast or irregular heartbeat
hot flushes
yawning
indigestion, vomiting
dry mouth
rash, urticaria, itching
excessive sweating
joint pain
increased frequency of urination
unexplained vaginal bleeding
malaise or chills

Uncommon (may occur in up to 1 in 100 patients)

feeling detached from oneself
unusual thoughts
overly elevated mood
difficulty achieving orgasm
suicidal thoughts or thoughts of self-harm
teeth grinding
muscle twitching, involuntary movements, or problems with balance and coordination
memory impairment
enlarged (dilated) pupils
tinnitus
low blood pressure
shortness of breath
nosebleeds
difficulty swallowing
intra-abdominal bleeding
unusual hair loss
increased tendency to bruise
unexplained bruises or bleeding
cold sweats
difficulty passing urine
sexual dysfunction
general malaise or unusual feelings
sensation of heat or cold

Rare (may occur in up to 1 in 1000 patients)

low blood sodium levels
decreased platelet count, which may increase the risk of bleeding and bruising
decreased white blood cell count
unusual behaviour
seeing, feeling, and hearing things that are not there (hallucinations)
agitation
panic attacks
confusion
stuttering
aggression
seizures
irregular heartbeat
phlebitis (vein inflammation)
blood vessel dilation (vasodilation)
rapid swelling of ankles, face, tongue, and (or) throat
oesophageal pain
sore throat and discomfort when swallowing
hepatitis (liver inflammation)
lung problems
photosensitivity (increased sensitivity to sunlight)
muscle pain
problems with urination
milk discharge from breast glands
increased blood prolactin (hormone) levels
bleeding from mucous membranes of mouth and nose

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

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

Bone fractures – an increased risk of bone fractures has been observed in patients taking this type of medicine.
Most of these adverse reactions resolve during continued treatment.
Adverse reactions in children and adolescents (8–18 years)
In addition to the possible adverse reactions listed above, Fluoxetine EGIS may slow growth and delay sexual maturation. Suicidal behaviour (suicide attempts and suicidal thoughts), hostility, mania, and nosebleeds are also frequently reported in children.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Fluoksetyna EGIS

Store below 30\°C. Keep in the original packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton and blister pack. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Fluoksetyna EGIS contains
Fluoksetyna EGIS, 10 mg, hard capsules
The active substance is 10 mg of fluoxetine in each capsule (as fluoxetine hydrochloride).
Fluoksetyna EGIS, 20 mg, hard capsules
The active substance is 20 mg of fluoxetine in each capsule (as fluoxetine hydrochloride).
Other ingredients:
Hard capsules, 10 mg: magnesium stearate, pregelatinized starch, lactose monohydrate (56.8 mg).
Capsule shell: iron oxide yellow (E 172), titanium dioxide (E 171), gelatin.
Hard capsules, 20 mg: magnesium stearate, pregelatinized starch, lactose monohydrate (56.8 mg).
Capsule shell: indigotine (E 132), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin.

What Fluoksetyna EGIS looks like and contents of the pack
Fluoksetyna EGIS, hard capsules, 10 mg
Yellow capsules (size 3), marked with "EGIS 412" printed on the cap, filled with white or almost white powder.
Fluoksetyna EGIS, hard capsules, 20 mg
Green capsules (size 3), filled with white or almost white powder.
Blister packs made of PVC/PVdC/Aluminium in cardboard boxes
14 capsules
28 capsules

Marketing Authorisation Holder
Egis Pharmaceuticals PLC
1106 Budapest, Keresztúri út 30-38
Hungary

Manufacturer
Egis Pharmaceuticals PLC
1165 Budapest, Bökenyföldi út 118-120
Hungary
Egis Pharmaceuticals PLC
9900 Körmend, Mátyás kir. u. 65
Hungary

For further information, please contact the local representative of the marketing authorisation holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Telephone number: +48 22 417 92 00

Fluoxetine egis