Fluoksetina Egis

Package Leaflet: Information for the User

Fluoxetine EGIS, 10 mg, hard capsules

Fluoxetine EGIS, 20 mg, hard capsules

Fluoxetine

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

• 1. What is Fluoxetine EGIS and what is it used for
• 2. Before you take Fluoxetine EGIS
• 3. How to take Fluoxetine EGIS
• 4. Possible side effects
• 5. How to store Fluoxetine EGIS
• 6. Contents of the pack and other information

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

Fluoxetine EGIS contains the active substance fluoxetine, which belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Fluoxetine EGIS is used to treat the following conditions:

Adults

• Major depressive episodes
• Obsessive-compulsive disorder (recurrent thoughts and compulsive behaviors)
• Bulimia: Fluoxetine EGIS is used in conjunction with psychotherapy to treat binge eating and vomiting.

Children aged 8 and above and adolescents

• Depressive episodes of moderate to severe intensity, when symptoms of depression do not improve after 4-6 sessions of psychotherapy. In children and young people with depression of moderate to severe intensity, Fluoxetine EGIS can only be used in conjunction with psychological therapy.

How Fluoxetine EGIS works

The brain produces a substance called serotonin. People with depression, obsessive-compulsive disorder, and bulimia have lower levels of serotonin than others. The mechanism of action of Fluoxetine 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 mood. If left untreated, the condition may not improve, worsen, and become more difficult to treat. It may take several weeks or months of treatment to ensure that symptoms have improved.

2. Before you take Fluoxetine EGIS

When not to take Fluoxetine EGIS:

• If you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6);if you experience a rash or other allergic reaction (such as itching, swelling of the lips or face, or shortness of breath), you should stop taking this medicine and contact your doctor immediately;
• if you are taking medicines known as non-selective, irreversible monoamine oxidase inhibitors (MAOIs) (e.g., iproniazid, used to treat depression), as this may cause serious or life-threatening side effects. Treatment with Fluoxetine EGIS can only be started 2 weeks after stopping non-selective, irreversible MAOIs. Do nottake any non-selective, irreversible MAOIs for at least 5 weeks after stopping Fluoxetine EGIS. If Fluoxetine EGIS was prescribed for a longer period and/or in a higher dose, it may be necessary to consider a longer washout period.
• if you are taking metoprolol (used to treat heart failure), as there is an increased risk of excessively slow heart rate.

Warnings and precautions

Before starting treatment with Fluoxetine EGIS, discuss it with your doctor or pharmacist. You should tell your doctor if:

• you have heart disease;
• you have a fever, stiffness, or tremors, changes in mental status, such as disorientation, irritability, and extreme agitation; this may be a condition called serotonin syndrome or neuroleptic malignant syndrome. Although this condition is rare, it can have life-threatening consequences; you should contact your doctor immediately, as it may be necessary to stop taking fluoxetine;
• you have severe pain or other conditions treated with opioid medications - buprenorphine. Taking this medication with Fluoxetine EGIS may lead to serotonin syndrome, a potentially life-threatening condition (see "Fluoxetine EGIS and other medicines");
• you have mania (currently or in the past). In this case, you should contact your doctor immediately, as it may be necessary to discontinue fluoxetine;
• you have a history of bleeding or have recently experienced bruising or unusual bleeding, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• you are taking medications that affect blood clotting (see "Fluoxetine EGIS and other medicines");
• you have epilepsy (seizures) or have experienced an increase in seizure frequency, you should contact your doctor immediately. It may be necessary to discontinue fluoxetine;
• you are being treated with electroconvulsive therapy (ECT):
• you are being treated with tamoxifen (used to treat breast cancer) (see "Fluoxetine EGIS and other medicines");
• you experience restlessness and inability to sit or stand still (akathisia). Increasing the dose of Fluoxetine EGIS may worsen these conditions;
• you have diabetes (your doctor may need to adjust your insulin or other antidiabetic medication dose);
• you have liver disease (your doctor may need to adjust the dose);
• you have slow heart rate at rest and/or low levels of salts due to prolonged and severe diarrhea, vomiting, or use of diuretics (water pills);
• you are taking diuretics (water pills), especially in the elderly;
• you have glaucoma (increased pressure in the eye).

Patients taking this medicine may experience weight loss, usually proportional to their initial body weight. Medicines like Fluoxetine EGIS (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.

Suicidal thoughts or worsening of depression or anxiety.

In patients with depression and/or anxiety disorders, suicidal thoughts or self-harm may occur. This condition may worsen when the patient first starts taking antidepressants, and may persist until the medicine starts to work, usually within two weeks of treatment, although sometimes later. Such thoughts are more common in patients who:

• have had suicidal thoughts or self-harm before;
• are young adults. The risk of suicidal behavior in people under 25 with mental disorders treated with antidepressants is higher. If you experience suicidal thoughts or self-harm, you should contact your doctor or the nearest hospital immediately.

It may be helpful to inform your relatives or friends about your condition and ask them to read this leaflet and inform you if they notice any worsening of depression or anxiety, or other

worrisome changes in behavior.

Children and adolescents aged 8 to 18 years

In patients under 18 years, there is an increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger), when taking medicines of this class. Fluoxetine EGIS can only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe depressive episodes (in conjunction with psychological therapy), but not for the treatment of other conditions. There is limited information on the long-term safety of fluoxetine in this age group regarding growth, maturation, and cognitive and emotional development, as well as behavior. Nevertheless, your doctor may prescribe Fluoxetine EGIS to patients under 18 years for the treatment of moderate to severe depressive episodes (including psychological therapy) if they decide it is in the best interest of the patient. If your doctor prescribes this medicine to a patient under 18 years, and you have concerns, you should discuss them with your doctor. If any of the above symptoms develop or worsen in a patient under 18 years, you should inform your doctor. Fluoxetine EGIS should not be used to treat children under 8 years.

Fluoxetine EGIS and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Do not take Fluoxetine EGIS with:

• Non-selective, irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression, as they may cause serious or life-threatening reactions (serotonin syndrome) (see "When not to take Fluoxetine EGIS"). Treatment with Fluoxetine EGIS can only be started 2 weeks after stopping non-selective, irreversible MAOIs. Do not take any non-selective, irreversible MAOIs for at least 5 weeks after stopping Fluoxetine EGIS. If Fluoxetine EGIS was prescribed for a longer period and/or in a higher dose, it may be necessary to consider a longer washout period.
• Metoprolol, if used to treat heart failure, as there is an increased risk of excessively slow heart rate.

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

• Tamoxifen (used to treat breast cancer), fluoxetine may reduce the effect of tamoxifen. Your doctor may consider treating you with another antidepressant.
• Monoamine oxidase inhibitors type A (MAO-A) (including moclobemide), linezolid (an antibiotic), and methylthioninium chloride (also known as methylene blue, used to treat methemoglobinemia), may cause serious or life-threatening reactions (serotonin syndrome). Treatment with fluoxetine can be started the day after stopping reversible MAOIs, but your doctor may decide to monitor you closely and use a lower dose of reversible MAOI.
• Mequtazine (used to treat allergies): taking this medicine with Fluoxetine EGIS may increase the risk of changes in heart rhythm.
• Phenytoin (used to treat epilepsy); Fluoxetine EGIS may affect the level of this active substance in the blood; your doctor will be cautious when introducing phenytoin while you are taking fluoxetine and will perform frequent checks.
• Lithium (used to treat manic depression), tryptophan (used to treat conditions such as insomnia or depression), buprenorphine (used to treat opioid dependence or severe pain), tramadol (a strong painkiller), triptan (used to treat migraines), selegiline, or St. John's Wort: taking these medicines with Fluoxetine EGIS may increase the risk of developing a mild serotonin syndrome. Your doctor will monitor you more closely.
• Medicines that may affect heart rhythm, such as anti-arrhythmic medicines class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin given intravenously, pentamidine), or certain antihistamines (astemizole, mizolastine) - taking these medicines with Fluoxetine EGIS may increase the risk of changes in heart rhythm.
• Anticoagulant medicines (such as warfarin), non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac), acetylsalicylic acid, and other medicines that may affect blood clotting (including clozapine, used to treat certain mental disorders) - Fluoxetine EGIS may affect the action of these medicines on the blood. If you start or stop taking fluoxetine while taking warfarin, your doctor may order specific tests, adjust the dose, and monitor you more closely.
• Cyproheptadine (used to treat allergies): may reduce the effect of Fluoxetine EGIS.
• Medicines that lower sodium levels in the blood (including diuretics, desmopressin (used to treat diabetes insipidus), carbamazepine, and oxcarbazepine (used to treat epilepsy)).
• Antidepressant medicines, such as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs), or bupropion, mefloquine, or chloroquine (used to treat malaria), tramadol (used to treat severe pain), or antipsychotic medicines, such as phenothiazines or butyrophenones; as fluoxetine may increase the risk of seizures when taking these medicines
• Flecainide, propafenone, nebivolol, or encainide (used to treat heart conditions), carbamazepine (an antiepileptic medicine), atomoxetine, or tricyclic antidepressants (e.g., imipramine, desipramine, and amitriptyline) or risperidone (used to treat certain mental disorders) - fluoxetine may affect the level of these medicines in the blood; your doctor may reduce their dose when given with fluoxetine.

Taking Fluoxetine EGIS with food, drink, and alcohol

Fluoxetine EGIS can be taken with or without food. You should avoid alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, you should consult your doctor or pharmacist before taking this medicine. PregnancyThere is an increased risk of congenital heart defects 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 like fluoxetine during pregnancy, especially in the last three months, may increase the risk of a condition called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and bluish discoloration. These symptoms usually appear within the first day of life. If such symptoms occur in a newborn, you should contact your doctor or midwife immediately. This medicine should not be used during pregnancy unless the potential benefits outweigh the risks. In this case, your doctor may decide to gradually stop Fluoxetine EGIS during pregnancy or before becoming pregnant. However, your doctor may also recommend continuing to take Fluoxetine EGIS, depending on the circumstances. You should be cautious, as newborns whose mothers took fluoxetine, especially in the last three months of pregnancy or before delivery, have reported symptoms such as irritability, tremors, weakness, constant crying, difficulty feeding, or sleeping. Taking Fluoxetine EGIS at the end of pregnancy may increase the risk of severe postpartum hemorrhage, which occurs shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Fluoxetine EGIS, you should inform your doctor or midwife so that they can provide you with appropriate advice. BreastfeedingThis medicine passes into breast milk and may cause side effects in newborns. Breastfeeding is only recommended if absolutely necessary. If breastfeeding continues, your doctor may recommend a lower dose of this medicine. FertilityAnimal studies have shown that fluoxetine may decrease sperm quality. This may theoretically affect fertility, but so far, no effect on fertility has been observed in humans.

Driving and using machines

Psychotropic medicines, such as Fluoxetine EGIS, may impair your judgment and affect your ability to drive or operate machinery. You should not drive or operate machinery until you know how Fluoxetine EGIS affects you.

Fluoxetine EGIS contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Fluoxetine EGIS

Always take this medicine exactly as your doctor or pharmacist has told you.If you are not sure, ask your doctor or pharmacist. Do not take more capsules than your doctor has recommended. The capsules should be swallowed with water. Do not chew the capsules.

Adults

• Depression:the recommended dose is 20 mg per day (2 capsules of 10 mg or 1 capsule of 20 mg). Your doctor will assess your progress and adjust the dose if necessary within 3 to 4 weeks of starting treatment. If necessary, the dose may be gradually increased 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 smallest effective dose. Your mood may not improve immediately after starting treatment. The first effects of treatment may be felt only 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 your progress and adjust the dose if necessary after 2 weeks of treatment. If necessary, the dose may be gradually increased to a maximum of 60 mg (3 capsules of 20 mg) per day. If there is no improvement within 10 weeks, your doctor will consider the appropriateness of continuing treatment with Fluoxetine EGIS.
• 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 The treatment should be started 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 smallest effective dose. Children with lower body weight may require lower doses. If there is a satisfactory response to treatment, your doctor will assess the need for continued treatment for more than 6 months. If there is no improvement within 9 weeks, your doctor will consider the appropriateness of continuing treatment. ElderlyThe dose should be increased cautiously, and the daily dose should not usually exceed 40 mg (2 capsules of 20 mg). The maximum daily dose is 60 mg (3 capsules of 20 mg) per day. Impaired liver functionIf you have liver disease or are taking other medicines that may affect fluoxetine, your doctor may prescribe lower doses or recommend taking this medicine every other day.

Overdose of Fluoxetine EGIS

• If you take more capsules than you should, you should contact your doctor or the nearest emergency department (or emergency services) immediately.
• If possible, take the package of Fluoxetine EGIS with you. Symptoms of overdose include nausea, vomiting, seizures, heart problems (such as irregular heartbeat and cardiac arrest), lung problems, changes in mental status (from agitation to coma).

Forgot to take Fluoxetine EGIS

• If you forget to take a dose, do not worry. Take the next dose at the usual time the next day. Do not take a double dose to make up for a forgotten dose.
• Taking your medicine at the same time every day can help you remember to take it regularly.

Stopping treatment with Fluoxetine EGIS

Do not stop taking Fluoxetine EGIS without consulting your doctor, even if you feel better. It is important to continue taking the medicine. Make sure you have enough capsules. After stopping Fluoxetine EGIS, you may experience the following symptoms (withdrawal symptoms): dizziness, tingling, numbness, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness or agitation, unusual tiredness or weakness, anxiety, nausea/vomiting, tremors, headaches. In most people, withdrawal symptoms from Fluoxetine EGIS are mild and go away within a few weeks. If you experience any symptoms after stopping treatment, you should contact your doctor. When stopping Fluoxetine 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 taking this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

• In case of suicidal thoughts or self-harm, you should contact your doctor immediately or go to the hospital(see section 2).
• In case of a rash or allergic reactions such as itching, swelling of the lips or tongue, or wheezing, you should stop taking the medicine and contact your doctor immediately.
• If you feel restless and cannot sit or stand still, you may have akathisia (a condition characterized by feelings of intense anxiety, agitation, and restlessness); increasing the dose of Fluoxetine EGIS may worsen this condition. If you experience such symptoms, you should contact your doctor.
• You should contact your doctor immediatelyif you experience redness of the skin, various skin reactions, blisters, or peeling. These reactions are very rare.

The most common side effects (very common side effects that may occur in more than 1 in 10 patients) are insomnia, headaches, diarrhea, nausea, and fatigue. In some patients, the following have been reported:

• rarely - a combination of symptoms known as serotonin syndrome: fever with rapid breathing or heart rate, excessive sweating, stiffness or tremors, disorientation, extreme agitation or drowsiness;
• feeling weak, sleepy, or disoriented - mainly in elderly patients and patients (elderly) taking diuretics;
• prolonged or painful erections;
• irritability or extreme agitation;
• heart problems, such as rapid or irregular heartbeat, fainting, or dizziness when standing up, which may indicate abnormal heart rhythm.

If you experience any of the above symptoms, you should contact your doctor immediately.

Patient reports with Fluoxetine EGIS include the following side effects:

Frequent(may occur in up to 1 in 10 patients)

• loss of appetite, weight loss
• nervousness, anxiety
• restlessness, poor concentration
• feeling tense
• decreased libido or sexual dysfunction (including problems with maintaining an erection during sexual activity and problems with ejaculation)
• sleep disturbances, unusual dreams, or drowsiness
• dizziness
• change in taste
• uncontrolled tremors
• blurred vision
• rapid or irregular heartbeat
• hot flashes
• yawning
• indigestion, vomiting
• dry mouth
• rash, hives, itching
• excessive sweating
• joint pain
• increased urination
• unexplained vaginal bleeding
• feeling unwell or having chills

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

• feeling detached from oneself
• unusual thoughts
• being overly cheerful
• difficulty achieving orgasm
• suicidal thoughts or self-harm
• grinding teeth
• muscle tremors, involuntary movements, or balance and coordination problems
• memory problems
• dilated pupils
• ringing in the ears
• low blood pressure
• shortness of breath
• nosebleeds
• difficulty swallowing
• abdominal bleeding
• unusual hair loss
• increased tendency to bruise
• unexplained bruising or bleeding
• cold sweats
• difficulty urinating
• sexual dysfunction
• general feeling of being unwell or unusual
• feeling hot or cold
• increased liver enzyme activity in blood tests.

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

• low sodium levels in the blood
• decreased platelet count, which may increase the risk of bleeding and bruising
• decreased white blood cell count
• abnormal behavior
• seeing, feeling, or hearing things that are not there (hallucinations)
• agitation
• panic attacks
• confusion
• stuttering
• aggression
• seizures
• irregular heartbeat
• inflammation of the veins
• vasodilation (widening of blood vessels)
• rapid swelling of the ankles, face, and/or throat
• esophageal pain and discomfort when swallowing
• inflammation of the liver
• lung problems
• increased sensitivity to sunlight
• muscle pain
• urination problems
• breast milk production
• increased prolactin levels in the blood
• bleeding from the mucous membranes of the mouth and nose

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

• severe postpartum hemorrhage, which occurs shortly after delivery (see additional information in the "Pregnancy, breastfeeding, and fertility" section in point 2).

Bone fractures -patients taking this type of medicine have an increased risk of bone fractures. Most of these side effects go away during continued treatment.

Side effects in children and adolescents (8-18 years)

Aside from the possible side effects listed above, Fluoxetine EGIS may slow growth and delay sexual maturation. Suicidal behavior (suicidal attempts and thoughts), hostility, mania, and nosebleeds are also commonly reported in children.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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, you can help provide more information on the safety of this medicine.

5. How to store Fluoxetine EGIS

Store in a temperature below 30°C. Store in the original package 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. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fluoxetine EGIS contains

Fluoxetine EGIS, 10 mg, hard capsules The active substance is 10 mg fluoxetine (as fluoxetine hydrochloride) per capsule. Fluoxetine EGIS, 20 mg, hard capsules The active substance is 20 mg fluoxetine (as fluoxetine hydrochloride) per capsule. The other ingredients are: Hard capsules, 10 mg:magnesium stearate, maize starch, lactose monohydrate (56.8 mg). Capsule shell: yellow iron oxide (E 172), titanium dioxide (E 171), gelatin. Hard capsules, 20 mg:magnesium stearate, maize starch, lactose monohydrate (56.8 mg). Capsule shell: indigo carmine (E 132), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin.

What Fluoxetine EGIS looks like and contents of the pack

Fluoxetine EGIS, hard capsules, 10 mg Yellow capsules (size 3), with "EGIS 412" printed on the cap, filled with white or off-white powder. Fluoxetine EGIS, hard capsules, 20 mg Green capsules (size 3), filled with white or off-white powder. PVC/PVdC/Aluminum blisters in a cardboard box 14 capsules 28 capsules

Marketing authorization 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 more information, contact your local representative of the marketing authorization holder: EGIS Polska Sp. z o.o. ul. Komitetu Obrony Robotników 45 D 02-146 Warsaw Phone: +48 22 417 92 00

Date of last revision of the leaflet: