Fluxemed

Package Leaflet: Information for the Patient

Fluxemed, 20 mg, Hard Capsules

Fluoxetine

Eight Important Things You Should Know About Fluxemed

• Fluxemed is used to treat depression and anxiety disorders. Like all medicines, it can cause unexpected side effects. Therefore, it is essential to discuss the benefits and potential risks of treatment with your doctor before starting treatment.
• Fluoxetine will not work immediately. In some patients taking antidepressants, symptoms may worsen before they improve. Your doctor should see you again after a few weeks of starting treatment. You should tell your doctor if you do not feel better. See section 3, How to take Fluxemed.
• Fluoxetine is not intended for use in children and adolescents under 18 years of age. See section 2, Children and adolescents from 8 to 18 years.
• Some people with depression or anxiety may think about self-harm or suicide. If you feel worse or have thoughts of self-harm or suicide, you should see your doctor or go to the hospital immediately. See section 2.
• 2. Suicidal thoughts and worsening of depression or anxiety disorders.
• Do not stop taking fluoxetine without talking to your doctor first. If you suddenly stop taking fluoxetine or miss a dose, you may experience withdrawal symptoms. See section 3, Stopping Fluxemed.
• If you feel anxious or have a feeling that you cannot sit still, you should tell your doctor. Increasing the dose of fluoxetine may worsen these feelings. See section 4, Possible side effects.
• Taking certain medicines with fluoxetine can cause problems. You may need to talk to your doctor. See section 2, Fluxemed and other medicines.
• If you are pregnant or planning to become pregnant, you should talk to your doctor. See section 2, Pregnancy, breastfeeding, and fertility.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for you.

• You should keep this leaflet to be able to read it again if necessary.
• If you have any doubts, you should talk to your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 those not listed in this leaflet, you should tell your doctor or pharmacist.

Table of Contents of the Leaflet:

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

1. What is Fluxemed and what is it used for

Fluoxetine is one of a group of medicines called selective serotonin reuptake inhibitors (SSRIs) with antidepressant effects.

Fluxemed is used to treat:

Adults:

• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia. Fluxemed is used in conjunction with psychotherapy to reduce the urge to binge eat and induce vomiting.

Children and adolescents from 8 years and older:

• 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, Fluxemed should only be used in combination with concurrent psychological therapy.

How Fluxemed works

Everyone has a substance in the brain called serotonin. People who experience depression or obsessive-compulsive disorder or bulimia have lower serotonin levels than others. It is not fully understood how fluoxetine and other SSRIs work, but it is known that they can help increase serotonin levels in the brain.

Treating these disorders is essential to improve the patient's quality of life. If treatment is not started, the patient's condition may not improve and may even become more severe and difficult to treat.

To ensure that the patient is free from symptoms, treatment may be necessary for several weeks or months.

2. Important information before taking Fluxemed

When not to take Fluxemed

If a rash or other allergic reaction occurs (such as itching, swelling of the lips or face, or difficulty breathing), you should stop taking the medicine immediately and contact your doctor.

Treatment with Fluxemed should be started at least 2 weeks after stopping irreversible, non-selective MAOIs.

You should nottake any of the irreversible, non-selective MAOIs for the next 5 weeks after stopping Fluxemed. If fluoxetine has been taken for a long time and/or in high doses, your doctor may decide to extend the time between treatments.

Warnings and precautions

Before starting Fluxemed, you should discuss with your doctor or pharmacist if you have any of the following conditions:

• heart disease;
• fever, muscle stiffness, or tremors, changes in mental state, such as disorientation, irritability, and extreme agitation; This may be a condition called serotonin syndrome or neuroleptic malignant syndrome. Although these syndromes are rare, they can have life-threatening consequences; you should contact your doctor immediately, as it may be necessary to stop fluoxetine treatment;
• mania, currently or in the past; if a manic episode occurs, you should contact your doctor immediately, as it may be necessary to stop fluoxetine;
• history of bleeding disorders, bruising, or unusual bleeding, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• you are taking medicines that thin the blood (see section 2, Fluxemed and other medicines);
• epilepsy or seizures. If you have seizures or an increased frequency of seizures, you should contact your doctor immediately, as it may be necessary to stop fluoxetine;
• you are undergoing electroconvulsive therapy (ECT);
• you are taking tamoxifen (used to treat breast cancer) (see section 2, Fluxemed and other medicines);
• feeling restless and unable to sit still (akathisia). Increasing the dose of fluoxetine may worsen these feelings;
• diabetes (your doctor may need to adjust the dose of insulin or other antidiabetic medicines);
• liver disease (the dose of Fluxemed may need to be adjusted);
• low resting heart rate and/or low sodium levels in the blood due to prolonged severe diarrhea and vomiting or the use of diuretics (water pills);
• you are taking diuretics, especially if you are elderly;
• glaucoma (increased pressure in the eye).

Suicidal thoughts and worsening of depression or anxiety disorders

• People with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the start of treatment with antidepressants, as these medicines usually start working after 2 weeks, sometimes later. The occurrence of such symptoms is more likely if:
• you have had suicidal thoughts or self-harm in the past;
• you are a young adult; data from clinical trials indicate an increased risk of suicidal behavior in people under 25 with mental disorders who are being treated with antidepressants.
• If you have suicidal thoughts or thoughts of self-harm, you should contact your doctor or go to the hospital immediately.
• It may be helpful to inform your relatives or friends aboutyour depression or anxiety disorder and ask them to read this leaflet. You may want to ask your relatives or friends to tell you if they notice that your depression or anxiety has worsened or if you have any disturbing changes in your behavior.

Medicines like Fluxemed (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents (from 8 to 18 years)

Patients under 18 years of age taking medicines of this class are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and signs of anger). In children and adolescents from 8 to 18 years, Fluxemed should only be used for the treatment of moderate or severe major depressive episodes (in combination with psychological therapy) and should not be used for the treatment of other conditions.

If your doctor has prescribed Fluxemed for a patient under 18 years of age, and you have any concerns, you should talk to your doctor. If any of the above symptoms develop or worsen in patients under 18 years of age taking Fluxemed, you should tell your doctor.

Additionally, as yet, there is no data on the long-term safety of Fluxemed in this age group regarding growth, maturation, and cognitive and behavioral development. Nevertheless, if you are under 18 years of age, your doctor may prescribe Fluxemed for moderate or severe major depressive episodes, in combination with psychological therapy, if your doctor decides that it is in your best interest.

Fluxemed should not be used to treat children under 8 years of age.

Fluxemed and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Do not take Fluxemed with:

• Certain irreversible, non-selective monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Irreversible, non-selective MAOIs should not be taken with fluoxetine, due to the risk of severe or life-threatening reactions (serotonin syndrome) (see section 2, When not to take Fluxemed). Fluoxetine treatment should be started at least 2 weeks after stopping irreversible, non-selective MAOIs (e.g., tranylcypromine). You should not starttaking any irreversible, non-selective MAOIs for at least 5 weeks after stopping fluoxetine. If fluoxetine has been prescribed for a longer period and/or in high doses, your doctor may decide to extend the time between treatments.
• Metoprolol, used to treat heart failure; there is an increased risk of slow heart rate.

Fluxemed may affect the action of the following medicines (interaction):

• Tamoxifen(used to treat breast cancer); as fluoxetine may change the levels of this medicine in the blood, which may reduce the effect of tamoxifen, your doctor may consider prescribing a different antidepressant.
• Monoamine oxidase inhibitors A (MAO-A inhibitors), including moclobemide, linezolid (an antibiotic), and methylthioninium chloride (also known as methylthioninium chloride, used to treat methemoglobinemia caused by a medicine or other chemical), due to the risk of severe or life-threatening reactions (serotonin syndrome). Fluoxetine treatment can be started the day after stopping reversible MAOIs, but your doctor may want to monitor you closely and use lower doses of MAO-A inhibitors.
• Mequtazine(used to treat allergies); as taking this medicine with fluoxetine may increase the risk of changes in heart rhythm.
• Phenytoin(an antiepileptic medicine); as fluoxetine may affect the levels of this medicine in the blood, your doctor may need to adjust the dose of phenytoin and monitor you more closely if it is taken with fluoxetine.
• Lithium, selegiline, St. John's Wort, tramadol(a painkiller), triptans(used to treat migraines), and tryptophan; there is an increased risk of mild serotonin syndrome when these medicines are taken with fluoxetine. Your doctor will monitor you more closely.
• Medicines that may affect heart rate, such as anti-arrhythmic medicines of class IA and III, antipsychotic medicines(e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines(e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarial medicines, especially halofantrine, or certain antihistamines(astemizole, mizolastine), as fluoxetine taken with one or more of these medicines may increase the risk of changes in heart rhythm.

Fluxemed may interact with:

• Anticoagulant medicines(such as warfarin), NSAIDs(non-steroidal anti-inflammatory medicines, such as ibuprofen, diclofenac), aspirin, and other medicines that thin the blood(including clozapine, used to treat certain mental disorders). Fluoxetine may affect the action of these medicines in the blood. If fluoxetine treatment is started or stopped while taking warfarin, your doctor will need to perform certain tests to adjust the dose and monitor you more closely.
• Cyproheptadine(used to treat allergies); as it may reduce the effect of fluoxetine.
• Medicines that lower sodium levels in the blood(including medicines that increase urine production, desmopressin, carbamazepine, and oxcarbazepine); as these medicines may increase the risk of low sodium levels in the blood when taken with fluoxetine.
• Antidepressant medicines, such as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs), or bupropion, mefloquineor chloroquine(used to treat malaria), tramadol(used to treat severe pain), or antipsychotic medicines, such as phenothiazine derivatives or butyrophenone; as fluoxetine may increase the risk of seizures when taken with these medicines.
• Flecainide, propafenone, nebivolol, or encainide(used to treat heart conditions), carbamazepine(an antiepileptic medicine), atomoxetine, or tricyclic antidepressants(e.g., imipramine, desipramine, amitriptyline), or risperidone(used to treat schizophrenia); as fluoxetine may affect the levels of these medicines in the blood, your doctor may reduce the dose of these medicines if they are taken with fluoxetine.

Fluxemed with food, drink, and alcohol

• Fluxemed can be taken with or without food, depending on your preference.
• You should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, you should talk to your doctor or pharmacist before taking this medicine.

Pregnancy

You should tell your doctor as soon as possible if you are pregnant, think you may be pregnant, or plan to become pregnant.

In children whose mothers took fluoxetine during the first few months of pregnancy, some studies have shown an increased risk of congenital malformations, particularly heart defects. In the general population, about 1 in 100 babies is born with a heart defect. This number increases to 2 in 100 in children whose mothers took fluoxetine.

If medicines like fluoxetine are taken during pregnancy, especially during the last 3 months, there is an increased risk of a condition called persistent pulmonary hypertension in the newborn, which causes the baby to breathe faster than normal and turn blue. These symptoms usually occur within the first 24 hours after birth. If your baby experiences these symptoms, you should tell your doctor or midwife immediately.

It is recommended that this medicine not be taken during pregnancy unless the potential benefits to the mother outweigh the potential risks to the baby. You may, in consultation with your doctor, gradually stop taking Fluxemed when you are pregnant or planning to become pregnant. However, depending on the circumstances, your doctor may suggest continuing to take Fluxemed.

Due to the effects described in newborns, such as irritability, tremors, decreased muscle tone, persistent crying, and sleep disturbances, caution should be exercised, especially in the late stages of pregnancy or immediately before delivery.

Taking Fluxemed at the end of pregnancy may increase the risk of severe bleeding from the uterus, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Fluxemed, you should inform your doctor or midwife so that they can give you appropriate advice.

Breastfeeding

Fluoxetine passes into breast milk and may cause side effects in breastfed babies. Breastfeeding can continue, but only if necessary. If breastfeeding continues, your doctor may prescribe a lower dose of fluoxetine.

Fertility

In animal studies, fluoxetine has been shown to reduce sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

Psychotropic medicines, such as fluoxetine, may impair your judgment or coordination. You should not drive or operate machinery until you are sure that Fluxemed does not affect you.

3. How to take Fluxemed

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should 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:

The recommended dose is:

• Depression:the recommended dose is 1 capsule (20 mg) per day.

Your doctor will assess and adjust the dose if necessary within 3-4 weeks of starting treatment. If necessary, the dose can be gradually increased to a maximum of 3 capsules (60 mg) per day. Dose adjustments should be made cautiously, aiming to maintain the lowest effective dose. You may not feel better immediately after starting treatment for depression. This is a normal reaction, as improvement in depressive symptoms may only be seen after several weeks. Patients with depression should be treated for at least 6 months.

• Bulimia (binge eating):the recommended dose is 3 capsules (60 mg) per day.
• Obsessive-compulsive disorder:the recommended dose is 1 capsule (20 mg) per day.

Your doctor will assess and adjust the dose if necessary within 2 weeks of starting treatment. If necessary, the dose can be gradually increased to a maximum of 3 capsules (60 mg) per day. If no improvement is seen within 10 weeks, your doctor will consider the appropriateness of fluoxetine treatment.

Children and adolescents from 8 to 18 years with depression:

Treatment should be started and monitored under the supervision of a specialist.

The initial dose is 10 mg/day.

After 1-2 weeks, your doctor may increase the dose to 20 mg/day. Dose adjustments should be made cautiously, aiming to maintain the lowest effective dose. Children with low body weight may require a lower dose. If the response to treatment is satisfactory, your doctor will assess the need to continue treatment for more than 6 months. If there is no improvement within 9 weeks, your doctor should reassess the appropriateness of fluoxetine treatment.

Elderly:

Your doctor will increase the dose with caution, and the daily dose should not normally exceed 2 capsules (40 mg) per day.

The recommended maximum dose is 3 capsules (60 mg) per day.

Patients with liver impairment:

In patients with liver impairment or taking other medicines that may affect fluoxetine, your doctor may reduce the dose of Fluxemed or recommend taking fluoxetine every other day.

Overdose of Fluxemed

• In case of overdose, you should go to the nearest hospital emergency department or contact your doctor immediately.
• You should take the Fluxemed packaging with you, if possible.

Symptoms of overdose include: nausea, vomiting, seizures, heart problems (e.g., irregular heartbeat and cardiac arrest), lung problems, and changes in mental state, ranging from agitation to coma.

Missed dose of Fluxemed

• If you miss a dose, you should not worry. You should take the next dose the next day at the usual time. 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 Fluxemed

• You should notstop taking Fluxemed without talking to your doctor first, even if you start to feel better. It is essential to continue taking the medicine.
• You should make sure you have enough capsules to continue treatment.

You may experience the following reactions (withdrawal symptoms) when stopping Fluxemed: dizziness, tingling sensation, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety or agitation, unusual tiredness or weakness, feeling unwell; nausea and/or vomiting (nausea or malaise), tremors (seizures), headaches.

In most people, any symptoms that occur after stopping Fluxemed are mild and go away within a few weeks. If you experience withdrawal symptoms after stopping treatment, you should talk to your doctor.

When stopping Fluxemed, your doctor will help you reduce the dose gradually over one or two weeks – this should reduce the risk of withdrawal symptoms.

If you have any doubts about taking this medicine, you should talk to your doctor or pharmacist.

4. Possible side effects

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

If you have suicidal thoughts or thoughts of self-harm, you should contact your doctor or go to the hospital immediately(see section 2, When not to take Fluxemed). If a rash or allergic reactions occur (such as itching, swelling of the lips or face, or difficulty breathing), you should stop taking the capsules immediately and contact your doctor.

If you experience anxiety or a feeling that you cannot sit still, these may be symptoms of akathisia; increasing the dose of Fluxemed may worsen your condition. In this case, you should contact your doctor.

If you experience redness of the skin or various skin reactions or blisters and the skin starts to peel, you should tell your doctor immediately. This condition is very rare.

In some patients, the following have occurred:

• Several symptoms at the same time (known as serotonin syndrome), including fever of unknown origin with rapid breathing or heart rate, excessive sweating, muscle stiffness or tremors, disorientation, extreme agitation or drowsiness (rarely).
• Feeling weak, drowsy, or disoriented, mainly in elderly people and those taking diuretics.
• Prolonged and painful erections.
• Irritability and extreme agitation.
• Heart problems, such as fast or irregular heartbeat, fainting, falling, or dizziness when changing position, which may indicate abnormal heart function.

If you experience any of the above side effects, you should tell your doctor immediately.

Additionally, the following side effects have been reported in patients taking Fluxemed:

Very common (may affect more than 1 in 10 people):

• Difficulty sleeping or insomnia, Headache, Diarrhea, Nausea, Fatigue.

Common (may affect up to 1 in 10 people):

• Lack of appetite, weight loss, Anxiety, nervousness, Restlessness, decreased ability to concentrate, Feeling tense, Decreased sex drive or sexual dysfunction (including difficulty maintaining an erection during sexual activity), Sleep disturbances, unusual dreams, Dizziness, Disturbances of taste, Involuntary, brief movements, Blurred vision, Feeling of rapid, irregular heartbeat, Redness of the face or other parts of the body, Yawning, Nausea, Vomiting, Dryness of the mouth, Rash, hives, itching, Excessive sweating, Joint pain, Frequent urination, Unexplained bleeding from the reproductive organs, Shaking, chills.

Uncommon (may affect up to 1 in 100 people):

• Feeling of being detached from oneself,
• Strange thinking,
• Abnormally high mood,
• Disturbances of orgasm,
• Thoughts of suicide or self-harm,
• Teeth grinding (bruxism),
• Muscle tremors, involuntary movements, or disturbances of balance or coordination,
• Memory disturbances (memory problems),
• Pupil dilation,
• Ringing in the ears,
• Low blood pressure,
• Shortness of breath,
• Nosebleeds,
• Difficulty swallowing,
• Hair loss,
• Increased tendency to bruise,
• Unexplained bruising or bleeding,
• Cold sweats,
• General feeling of being unwell,
• Feeling cold or hot,
• Abnormal liver function test results.

Rare (may affect up to 1 in 1,000 people):

• Low sodium levels in the blood,
• Decreased platelet count, which may increase the risk of bleeding or bruising,
• Decreased white blood cell count,
• Abnormal or insane behavior,
• Hallucinations,
• Agitation,
• Panic attacks,
• Disorientation,
• Stuttering,
• Aggression,
• Seizures,
• Vasculitis (inflammation of blood vessels),
• Sudden, severe swelling of the tissues of the neck, face, mouth, and/or throat,
• Pain in the esophagus (the tube that carries food or water to the stomach),
• Hepatitis (inflammation of the liver),
• Lung problems,
• Sensitivity to sunlight,
• Muscle pain,
• Difficulty urinating,
• Milk production.

Frequency not known:

Severe bleeding from the uterus, occurring shortly after delivery (postpartum hemorrhage), see additional information in section 2, "Pregnancy, breastfeeding, and fertility".

Bone fractures- patients taking medicines of this class have been observed to have an increased risk of bone fractures.

If you experience any of these symptoms, you should tell your doctor or pharmacist.

Most of the above side effects usually go away during treatment.

In children and adolescents (from 8 to 18 years):

In addition to the above side effects, Fluxemed may slow growth and possibly delay sexual maturation. In children, the following have also been reported: suicidal behavior (suicidal attempts and thoughts), hostility, mania, and nosebleeds.

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 181 C, 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 Fluxemed

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 moisture.

Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. You should 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 Fluxemed contains

The active substance is fluoxetine hydrochloride, equivalent to 20 mg of fluoxetine.

The other ingredients are maize starch.

The capsule shell contains gelatin, brilliant blue (E 133), titanium dioxide (E 171), yellow iron oxide (E 172). The ingredients of the printing ink are activated carbon and shellac (E 904).

What Fluxemed looks like and contents of the pack

Fluxemed is a greenish-white hard capsule, marked with the letters FLX/MIL, and is available in blister packs containing 30 capsules.

Marketing authorization holder and manufacturer:

PRO.MED. CS. Praha a.s., Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Polska

Fluxemed

Date of revision of the leaflet:29.04.2021