Flufenamic acid

Package leaflet: Information for the patient

Fluxemed, 20 mg, hard capsules
Fluoxetine
Eight important facts patients should know about Fluxemed

• Fluxemed is used to treat depression and anxiety disorders. Like all medicines, it may cause unexpected side effects. Therefore, it is important that the doctor and patient consider the benefits of treatment versus possible adverse effects before starting therapy.
• Fluoxetine does not work immediately. In some patients taking antidepressants, symptoms may worsen before they start to feel better. The doctor should schedule a follow-up visit a few weeks after starting treatment. Inform 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 aged 8 to 18.
• Some people with depression or anxiety may have thoughts about self-harm or suicide. If you feel worse or have thoughts about self-harm or suicide, seek immediate medical help by contacting your doctor or going to a hospital. See section 2. Suicidal thoughts and worsening of depression or anxiety disorders.
• Do not stop taking fluoxetine without first discussing it with your doctor. If you suddenly stop taking fluoxetine or miss a dose, withdrawal symptoms may occur. See section 3. Stopping Fluxemed.
• If you feel restless or have a sense that you cannot sit or stand still, inform your doctor. Increasing the dose of fluoxetine may worsen these sensations. See section 4. Possible side effects.
• Taking certain medicines together with fluoxetine may cause problems. You may need to consult your doctor. See section 2. Fluxemed and other medicines.
• If you are pregnant or planning to become pregnant, talk to your doctor. See section 2. Pregnancy, breastfeeding and fertility.

Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Fluxemed is and what it is used for
2. What you need to know 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 Fluxemed is and what it is used for

Fluoxetine belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs), which have antidepressant properties.
Fluxemed is used to treat:
Adults:

• Major depressive episodes
• Obsessive-compulsive disorder (OCD)
• Bulimia nervosa. Fluxemed is used in addition to psychotherapy to reduce episodes of binge eating and self-induced vomiting.

Children and adolescents aged 8 years and older:

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

How Fluxemed works
Everyone has a substance in the brain called serotonin. People experiencing depression, obsessive-compulsive disorder, or bulimia often have lower levels of serotonin than others. The exact mechanism of action of fluoxetine and other SSRIs is not fully understood, but it is known that they may help by increasing serotonin levels in the brain.
Treating these conditions is very important to improve the patient's quality of life. Without treatment, the patient's condition may not improve and could worsen, becoming more severe and harder to treat.
To ensure full recovery from symptoms, treatment may need to continue for several weeks or months.

2. Important information before taking Fluxemed

When not to take Fluxemed

• if the patient is allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If a rash or another allergic reaction occurs (such as itching, swelling of the lips or face, or difficulty breathing), stop taking the medicine immediately and contact a doctor.
• if the patient is taking metoprolol (a medicine used to treat heart failure), as there is an increased risk of developing a slow heart rate.
• if the patient is taking other medicines known as irreversible, non-selective monoamine oxidase inhibitors (MAOIs) (e.g. iproniazid used to treat depression), as a severe reaction may occur, which could even be fatal.

Treatment with Fluxemed should be started no earlier than at least 2 weeks after discontinuing treatment with irreversible, non-selective MAO inhibitors.
Do not use any of the irreversible, non-selective MAO inhibitors for at least 5 weeks after stopping treatment with Fluxemed. If fluoxetine has been used long-term and (or) at high doses, the doctor may decide to extend the interval between treatments.
Warnings and precautions
Before starting to take Fluxemed, discuss this with your doctor or pharmacist if any of the following apply to the patient:

• heart disease;
• fever, muscle stiffness, or tremors, changes in mental state such as confusion, irritability, or extreme agitation; these may be symptoms of serotonin syndrome or neuroleptic malignant syndrome. Although these syndromes are rare, they may have life-threatening consequences; contact a doctor immediately, as treatment with fluoxetine may need to be discontinued;
• current or past episodes of mania; if a manic episode occurs, contact a doctor immediately, as it may be necessary to discontinue fluoxetine;
• history of bleeding disorders, bruising, or unusual bleeding, or if the patient is pregnant (see "Pregnancy, breastfeeding and effect on fertility");
• the patient is taking medicines that thin the blood (see section 2. Fluxemed and other medicines);
• epilepsy or seizures. If the patient experiences seizures or an increase in seizure frequency, contact a doctor immediately, as discontinuation of fluoxetine may be necessary;
• the patient is undergoing electroconvulsive therapy (ECT);
• the patient is taking tamoxifen (used to treat breast cancer) (see section 2. Fluxemed and other medicines);
• feelings of restlessness and inability to sit still or remain motionless (akathisia). Increasing the dose of fluoxetine may worsen this condition;
• diabetes (the doctor may need to adjust the dose of insulin or other antidiabetic medicines);
• liver disease (a dose adjustment of the medicine may be necessary);
• low resting heart rate and (or) salt deficiency due to prolonged severe diarrhea and vomiting or due to diuretic use (water tablets);
• the patient is taking diuretics (water tablets), especially if the patient is elderly;
• glaucoma (increased pressure in the eye).

Suicidal thoughts and worsening of depression or anxiety disorders

• Patients with depression and (or) anxiety disorders may sometimes experience thoughts of self-harm or suicide. These symptoms or behaviors may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working. The occurrence of such symptoms is more likely if:
  • the patient has previously had suicidal thoughts or self-harming behavior;
  • the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders who are treated with antidepressants.
• If the patient experiences suicidal thoughts or thoughts of self-harm, seek immediate medical help by contacting a doctor or going to a hospital.
• It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask for help from relatives or friends and ask them to inform the patient if they notice worsening depression or anxiety, or concerning changes in behavior.

Medicines such as Fluxemed (so-called SSRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Children and adolescents (aged 8 to 18 years)
Patients under 18 years of age taking medicines of this class are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behavior, and anger). In children and adolescents aged 8 to 18 years, Fluxemed should be used only for the treatment of moderate to severe episodes of major depression (in combination with psychological therapy) and should not be used to treat other conditions.
If a doctor has prescribed Fluxemed to a patient under 18 years of age, and the patient has any doubts, they should consult the prescribing doctor. If any of the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Fluxemed, this should be reported to the doctor.
Furthermore, there are currently no data on the long-term safety of Fluxemed use in this age group regarding growth, puberty, cognitive development, and behavioral development. Nevertheless, if the patient is under 18 years of age, the doctor may prescribe Fluxemed for moderate to severe episodes of major depression, in combination with psychological therapy, if the doctor decides it is in the patient's best interest.
Fluxemed should not be used to treat children under 8 years of age.
Fluxemed and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not take Fluxemed together with:

• Certain irreversible, non-selective monoamine oxidase inhibitors (MAOIs), some used to treat depression. Irreversible, non-selective MAOIs should not be taken together with fluoxetine due to the risk of severe or even fatal reactions (serotonin syndrome) (see section 2. When not to take Fluxemed). Treatment with fluoxetine should be started at least 2 weeks after discontinuation of irreversible, non-selective MAOIs (e.g. tranylcypromine). Do not start treatment with any irreversible, non-selective MAOIs for at least 5 weeks after stopping fluoxetine. If fluoxetine has been prescribed for long-term treatment and (or) at a high dose, the doctor may recommend waiting longer than 5 weeks.
• Metoprolol, used to treat heart failure; there is an increased risk of excessive slowing of the heart rate.

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

• Tamoxifen (used to treat breast cancer); since fluoxetine may alter the blood concentration of this medicine, potentially reducing its effectiveness, the doctor may consider prescribing an alternative antidepressant.
• Monoamine oxidase A inhibitors (MAO-A inhibitors), including moclobemide, linezolid (an antibiotic), and methylene blue (also known as methylthioninium chloride, used to treat drug- or chemical-induced methemoglobinemia): due to the risk of severe, even fatal reactions (known as serotonin syndrome). Treatment with fluoxetine may be started the day after stopping reversible MAO inhibitors, but the doctor may wish to monitor the patient closely and use lower doses of MAO-A inhibitors.
• Mequitazine (used to treat allergies); as co-administration with fluoxetine may increase the risk of changes in the electrical activity of the heart.
• Phenytoin (an anticonvulsant); since fluoxetine may affect the blood concentration of this medicine, the doctor may consider gradual introduction of phenytoin and perform control tests when used concomitantly with fluoxetine.
• Lithium, selegiline, St. John's wort, tramadol (a painkiller), triptans (used to treat migraine), and tryptophan; there is an increased risk of mild serotonin syndrome when these medicines are taken together with fluoxetine. The doctor may order more frequent monitoring.
• Medicines that may affect heart rate, e.g. class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarials, especially halofantrine, or certain antihistamines (astemizole, mizolastine),

because fluoxetine taken together with one or more of these medicines may increase the risk of changes in the electrical activity of the heart.

• Anticoagulants (such as warfarin), NSAIDs (non-steroidal anti-inflammatory drugs, such as ibuprofen, diclofenac), acetylsalicylic acid, and other medicines that may thin the blood (including clozapine, used to treat certain psychiatric disorders). Fluoxetine may interfere with the action of these medicines in the blood. If treatment with fluoxetine is started or stopped while taking warfarin, the doctor will need to perform certain tests to adjust the dose and conduct more frequent monitoring.
• Cyproheptadine (used to treat allergies); as it may reduce the effect of fluoxetine.
• Medicines that reduce sodium levels in the blood (including those causing increased urine output, desmopressin, carbamazepine, and oxcarbazepine); as these medicines may increase the risk of low blood sodium levels when used together with fluoxetine.
• Antidepressants, 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 antipsychotics, such as phenothiazine or butyrophenone derivatives; as fluoxetine may increase the risk of seizures when taken together with these medicines.
• Flecainide, propafenone, nebivolol, or encainide (used for heart conditions), carbamazepine (an anticonvulsant), atomoxetine, or tricyclic antidepressants (e.g. imipramine, desipramine, and amitriptyline) or risperidone (used in schizophrenia); as fluoxetine may alter the blood concentration of these medicines, the doctor may reduce their dose if used concomitantly with fluoxetine.

Fluxemed with food, drink, and alcohol

• Fluxemed may be taken with food or between meals, depending on preference.
• Alcohol should be avoided during treatment with this medicine.

Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor as soon as possible if you are pregnant, suspect you may be pregnant, or plan to become pregnant.
Studies in children whose mothers took fluoxetine during the first few months of pregnancy have shown an increased risk of congenital malformations, particularly affecting the heart. In the general population, about 1 in 100 babies is born with a heart defect. This number increases to 2 in 100 in babies whose mothers took fluoxetine.
If medicines such as fluoxetine are used during pregnancy, especially during the last three months, there is an increased risk of the newborn developing a condition called persistent pulmonary hypertension, which causes the baby to breathe faster than normal and appear blue. These symptoms usually occur within the first 24 hours after birth. If the baby shows such symptoms, inform the doctor or midwife immediately.
It is recommended not to use this medicine during pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus. The patient may, in consultation with the doctor, gradually discontinue Fluxemed if she is pregnant or planning pregnancy. However, depending on the circumstances, the doctor may suggest continuing treatment with Fluxemed.
Due to effects observed in newborns, such as irritability, tremor, reduced muscle tone, persistent crying, and feeding and sleep disturbances, caution should be exercised, especially in the late stages of pregnancy or immediately before delivery.
Taking Fluxemed late in 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 Fluxemed, she should inform her doctor or midwife so they can provide appropriate advice.
Breastfeeding
Fluoxetine passes into breast milk and may cause adverse effects in breastfed infants. Breastfeeding should only be continued if absolutely necessary. If breastfeeding is continued, the doctor may recommend a lower dose of fluoxetine.
Fertility
Animal studies have shown that fluoxetine reduces semen quality. This may theoretically affect fertility, although no effect on human fertility has been observed to date.
Driving and operating machinery
Psychotropic medicines such as fluoxetine may impair judgment or coordination. Do not drive or operate machinery until the patient knows how Fluxemed affects them.

3. How to take Fluxemed

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

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

Your doctor will assess and, if necessary, adjust the dose within 3–4 weeks of starting
treatment. If needed, the dose may be gradually increased up to a maximum of 3 capsules (60 mg)
daily. Dose adjustments should be made cautiously, aiming to maintain the lowest effective dose.
Patients may not feel better immediately after starting treatment for depression. This is a common
response, as improvement in depressive symptoms may take several weeks. Patients with
depression should be treated for at least 6 months.

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

Your doctor will assess and, if necessary, adjust the dose within 2 weeks of starting treatment. If
needed, the dose may be gradually increased up to a maximum of 3 capsules (60 mg) daily. If no
improvement is observed within 10 weeks, your doctor will consider whether continued fluoxetine
treatment is appropriate.
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 daily.
After 1–2 weeks, your doctor may increase the dose to 20 mg daily. 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 whether
treatment should continue beyond 6 months. If no improvement occurs within 9 weeks, your doctor
should re-evaluate the appropriateness of treatment.
Elderly patients:
Your doctor will increase the dose with particular caution, and the daily dose should generally not
exceed 2 capsules (40 mg) daily.
The recommended maximum dose is 3 capsules (60 mg) daily.
Patients with impaired liver function:
In patients with impaired liver function or those taking other medicines that may affect fluoxetine’s
action, your doctor may reduce the dose or recommend taking fluoxetine every other day.
Taking more Fluxemed than recommended

• If you take too many capsules, go immediately to the nearest hospital emergency department or contact your doctor without delay.
• Bring 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.
If you miss a dose of Fluxemed

• If you miss a dose, do not be alarmed. Take your next dose at the usual time the following day. 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 Fluxemed

• Do not stop taking Fluxemed without first consulting your doctor, even if you start to feel better. It is important that you continue taking the medicine as prescribed.
• Make sure you have enough capsules to continue your treatment.

The following reactions (withdrawal symptoms) may occur after stopping Fluxemed: dizziness,
tingling sensations, sleep disturbances (intense dreams, nightmares, insomnia), anxiety or agitation,
unusual tiredness or weakness, feelings of anxiety; nausea and/or vomiting (nausea or general
malaise), tremor (seizures), headaches.
In most people, any symptoms after stopping Fluxemed are mild and resolve within a few weeks. If
withdrawal symptoms occur after stopping treatment, contact your doctor.
When discontinuing Fluxemed, your doctor will help you gradually reduce the dose over one or two
weeks—this should reduce the risk of withdrawal effects.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

• If suicidal thoughts or urges to self-harm occur, seek immediate medical attention or go to hospital (see section 2. When not to take Fluxemed).
• If a rash or allergic reactions occur, such as itching, swelling of the lips or tongue, wheezing or shortness of breath, stop taking the capsules immediately and contact your doctor without delay.
• If psychomotor agitation or an inability to sit still or remain in one place occurs, these may be symptoms of akathisia; increasing the dose of Fluxemed may worsen the condition. In such cases, contact your doctor.
• If skin redness, various skin reactions, blisters or skin peeling occur, contact your doctor immediately. This reaction is very rare.

In some patients, the following have been reported:

• Several symptoms occurring together (known as serotonin syndrome), including fever of unknown cause with increased breathing or heart rate, excessive sweating, muscle stiffness or tremor, confusion, extreme agitation or drowsiness (rare).
• Feeling of weakness, drowsiness or disorientation, mainly in elderly patients and in elderly patients taking diuretics.
• Prolonged and painful erection.
• Irritability and extreme agitation.
• Heart problems such as rapid or irregular heartbeat, fainting, collapse or dizziness upon standing, which may indicate abnormal heart function.

If any of the above adverse reactions occur, contact your doctor immediately.
The following adverse reactions have also been reported in patients taking Fluxemed:
Very common (may affect more than 1 in 10 people):

• Difficulty falling asleep or insomnia,
• Headache,
• Diarrhoea, nausea,
• Fatigue.

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

• Loss of appetite, weight loss,
• Anxiety, nervousness,
• Psychomotor agitation, reduced concentration ability,
• Feeling of tension,
• Reduced sexual drive or sexual dysfunction (including difficulty maintaining erection during sexual activity),
• Sleep disturbances, unusual dreams,
• Dizziness,
• Taste disturbances,
• Uncontrolled, brief movements,
• Blurred vision,
• Sensation of fast or irregular heartbeat,
• Flushing of the face or other parts of the body,
• Yawning,
• Indigestion, vomiting,
• Dryness of the oral mucosa,
• Rash, urticaria, itching,
• Excessive sweating,
• Joint pain,
• Frequent urination,
• Unexplained vaginal bleeding,
• Tremor, chills.

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

• Feeling detached from oneself,
• Strange thinking,
• Abnormally elevated mood,
• Orgasmic disturbances,
• Suicidal thoughts or self-harming behaviour,
• Teeth grinding (bruxism),
• Muscle tremor, involuntary movements or disturbances in balance or motor coordination,
• Forgetfulness (memory impairment),
• Pupil dilation (mydriasis),
• Tinnitus,
• Low blood pressure,
• Shortness of breath,
• Nosebleeds,
• Difficulty swallowing,
• Hair loss,
• Increased tendency to bruise,
• Unexplained bruises or bleeding,
• Cold sweats,
• General malaise,
• Sensation of cold or heat,
• Abnormal liver function test results.

Rare (may affect up to 1 in 1000 people):

• Low sodium levels in the blood,
• Decreased platelet count, increasing the risk of bleeding or bruising,
• Decreased white blood cell count,
• Unusual or bizarre behaviour,
• Hallucinations,
• Agitation,
• Panic attacks,
• Disorientation,
• Stuttering,
• Aggression,
• Seizures,
• Vasculitis (inflammation of blood vessels),
• Sudden swelling of neck, facial, oral and/or throat tissues,
• Pain in the oesophagus (the tube through which food or water passes to the stomach),
• Hepatitis (liver inflammation),
• Lung problems,
• Photosensitivity (increased sensitivity to sunlight),
• Muscle pain,
• Difficulty passing urine,
• Galactorrhoea (milk production).

Frequency not known:
Severe vaginal bleeding shortly after childbirth (postpartum haemorrhage), see additional information under section “Pregnancy, breastfeeding and fertility” in section 2.
Bone fractures – patients taking medicines in this class have shown an increased risk of bone fractures.
If any of the symptoms listed above occur, inform your doctor or pharmacist.
Most of the adverse reactions listed above usually resolve during treatment.

In children and adolescents (aged 8 to 18 years):
In addition to the adverse reactions listed above, Fluxemed may slow growth and possibly delay sexual maturation. In children, suicidal behaviour (suicidal attempts and suicidal thoughts), hostility, mania and nosebleeds have also been frequently reported.

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 of Monitoring of Adverse Drug Reactions, 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
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Fluxemed

Keep this medicine 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:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Fluxemed contains
The active substance is fluoxetine hydrochloride, in an amount equivalent to 20 mg of fluoxetine.
The other ingredient of the medicine is pregelatinized corn starch.
The capsule shell contains gelatin, brilliant blue (E 133), titanium dioxide (E 171), and yellow iron oxide (E 172).
The printing ink ingredients are propylene glycol (E 1520), black iron oxide (E 172), and shellac (E 904).

What Fluxemed looks like and contents of the pack
Fluxemed is a greenish-white, size 2, gelatin capsule, marked with the letters FLX/MIL. It is available in blister packs containing 30 capsules.

Marketing Authorisation Holder and Manufacturer:
PRO.MED. CS. Praha a.s., Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland Fluxemed