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 pack and other information

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

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

• Adults
• Major depressive episodes
• Obsessive-compulsive disorder (recurrent, intrusive thoughts and compulsions to perform specific rituals)
• Bulimia: Fluoxetine EGIS is used in conjunction with psychotherapy to treat binge-eating and vomiting.

Children and adolescents aged 8 and above

• Depressive episodes of moderate to severe intensity, when the symptoms of depression do not improve after 4-6 sessions of psychotherapy. In children and adolescents with moderate to severe depression, Fluoxetine EGIS should 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 reactions (such as itching, swelling of the mouth 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 high doses, a longer washout period may be considered.
• 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 this 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 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 stop taking 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 had an increase in seizure frequency, you should contact your doctor immediately. It may be necessary to stop taking 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 oral hypoglycemic medication dose);
• you have liver disease (your doctor may need to adjust your dose);
• you have slow heart rate at rest and/or low salt levels due to prolonged and severe diarrhea, vomiting, or diuretic use;
• you are being treated with diuretics (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.

Patients with depression and/or anxiety disorders may sometimes experience suicidal thoughts or self-harm. This may worsen when the patient first starts taking antidepressants, and may persist until the medicine starts to work, usually after 2 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 self-harm or suicidal thoughts, 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

In patients under 18, 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 should only be used in children and adolescents aged 8 to 18 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 behavioral development. However, your doctor may prescribe Fluoxetine EGIS to patients under 18 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 and you have concerns, you should discuss this with your doctor. If any of the above symptoms develop or worsen in patients under 18, you should inform your doctor.

Fluoxetine EGIS and other medicines

Tell your doctor or pharmacist about all the 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 serious or life-threatening reactions (serotonin syndrome) may occur (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 high doses, your doctor may 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), as serious or life-threatening reactions (serotonin syndrome) may occur. 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 the 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 exercise caution 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 addiction or severe pain), tramadol (a strong pain reliever), 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 your condition more closely.
• Medicines that may affect heart rhythm, such as anti-arrhythmic medicines class IA and III, antipsychotic medicines (e.g., phenothiazines, 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 medicines (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 fluoxetine treatment is started or stopped 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, as preferred. You should avoid alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. PregnancyThere have been reports of 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 babies is born with a heart defect. If the mother takes this medicine, this rate increases to 2 in 100 babies. 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 3 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 there is 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 prescribe 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 ability to assess situations and affect your motor skills. You should not drive or operate machinery until you know how Fluoxetine EGIS affects you.

Fluoxetine EGIS contains lactose

If you have been diagnosed with 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. AdultsThe 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 your progress and adjust the dose if necessary within 3 to 4 weeks of starting treatment. If necessary, 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 smallest effective dose. Your mood may not improve immediately after starting treatment. The first effects of treatment may only be 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 your progress and adjust the dose if necessary after 2 weeks of treatment. If necessary, the dose may be gradually increased up 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 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 to continue 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 exceed 40 mg (2 capsules of 20 mg) in general. The maximum daily dose is 60 mg (3 capsules of 20 mg) per day. Renal impairmentIf there are liver disorders or 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 immediately go to the nearest emergency department (or call emergency services) or contact your doctor.
• If possible, take the Fluoxetine EGIS packaging 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).

Missed dose of Fluoxetine EGIS

• If you miss 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 the missed dose.
• Taking the 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, difficulty sleeping), restlessness or agitation, unusual fatigue 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 1 or 2 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 immediately contact your doctor or go to the hospital(see section 2).
• In case of a rash or allergic reactions such as itching, swelling of the lips/tongue, or wheezing/shortness of breath, you should immediately stop taking the medicine and contact your doctor.
• If you feel restless and unable to 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 this, you should contact your doctor.
• You should immediately contact your doctorif 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 people) are insomnia, headaches, diarrhea, nausea, and fatigue. Some patients have 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;
• weakness, drowsiness, or disorientation - 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 immediately tell your doctor.

Patients taking Fluoxetine EGIS have reported the following side effects:

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

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

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

• feeling detached from oneself
• unusual thoughts
• excessive mood elevation
• difficulty achieving orgasm
• suicidal thoughts or self-harm
• teeth grinding
• 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 malaise/unusual feelings
• feeling hot or cold
• increased liver enzyme activity in blood tests.

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

• 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, hearing, or feeling things that are not there (hallucinations)
• agitation
• panic attacks
• confusion
• stuttering
• aggression
• seizures
• irregular heartbeat
• vein inflammation
• vasodilation
• rapid swelling of the ankles, face, and/or throat
• esophageal pain and discomfort when swallowing
• liver inflammation
• 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 reported 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)

In addition to 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 have also been 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 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. 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 that are no longer needed. 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 of fluoxetine (as fluoxetine hydrochloride) per capsule. Fluoxetine EGIS, 20 mg, hard capsules The active substance is 20 mg of fluoxetine (as fluoxetine hydrochloride) per capsule. The other ingredients are: Hard capsules, 10 mg:magnesium stearate, cornstarch, lactose monohydrate (56.8 mg). Capsule shell: yellow iron oxide (E 172), titanium dioxide (E 171), gelatin. Hard capsules, 20 mg:magnesium stearate, cornstarch, 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