Fluoxetine Aurovitas

Leaflet accompanying the packaging: information for the user

Fluoxetine Aurovitas, 20 mg, hard capsules

Fluoxetine

EIGHT IMPORTANT THINGS TO KNOW ABOUT FLUOXETINE

Fluoxetine treats depression and anxiety disorders.

Like all medicines, it can have side effects. It is essential to consider the benefits of treatment and the possible side effects before starting treatment with your doctor.

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 years).
Fluoxetine will not work immediately.Some patients taking antidepressants feel worse before they feel better. The doctor should see the patient again after a few weeks of starting treatment. If treatment does not improve, the doctor should be informed. See section 3, How to take Fluoxetine Aurovitas.

Some people with depression feel anxious or have thoughts of self-harm

or suicide.If the patient starts to feel worse or has thoughts of self-harm or suicide, they should contact their doctor or go to the hospital.See section 2. Do not stop taking fluoxetine without consulting a doctor.Stopping the medication abruptly or missing a dose can cause withdrawal symptoms. See section 3 for more information.

If the patient feels anxious and cannot sit still or stand still,

they should inform their doctor.Increasing the dose of fluoxetine may worsen these feelings. See section 4, Possible side effects.
Taking certain other medications with fluoxetine can cause problems.The patient may need to consult their doctor. See section 2, Fluoxetine Aurovitas and other medicines.
If the patient is pregnant or plans to become pregnant, they should consult their doctor.See section 2, Pregnancy, breastfeeding, and fertility.

It is essential to read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The patient should keep this leaflet to read it again if necessary.
• If the patient has any doubts, they should consult their doctor or pharmacist.
• This medicine has been prescribed specifically for the patient. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

The active substance of Fluoxetine Aurovitas is fluoxetine, which is one of a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs).
This medicine is used to treat the following conditions:
Adults:

• Episodes of major depression
• Obsessive-compulsive disorder
• Bulimia: Fluoxetine Aurovitas is used in conjunction with psychotherapy to reduce the urge to binge eat and induce vomiting.

Children and adolescents aged 8 and older:

• Moderate to severe depressive episodes, if the depression does not respond to psychological therapy after 4-6 sessions. Fluoxetine Aurovitas should be used in children or young people with moderate to severe depressive episodes only in conjunction with psychotherapy.

How Fluoxetine Aurovitas works

Everyone has a substance in the brain called serotonin. People who experience depression or obsessive-compulsive disorder or bulimia have lower levels of serotonin than others.
It is not fully understood how Fluoxetine Aurovitas and other SSRIs work, but it is known that they can help increase serotonin levels in the brain.
Treating these conditions is essential to improve the patient's quality of life. If treatment is not started, the patient's condition may not improve and may become more severe and difficult to treat.
It may be necessary to treat for several weeks or months to ensure the patient is free from symptoms.

2. Important information before taking Fluoxetine Aurovitas

When not to take Fluoxetine Aurovitas:

• if the patient is allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). In case of rash or other allergic reactions (such as itching, swelling of the lips or face, or shortness of breath), the patient should stop taking the medicine immediately and contact their doctor.
• if the patient is taking other medicines known as irreversible, non-selective monoamine oxidase inhibitors (MAOIs) (e.g., iproniazid used to treat depression), due to the risk of severe or even life-threatening reactions.

Treatment with Fluoxetine Aurovitas should be started at least 2 weeks after stopping irreversible, non-selective MAOIs.
Do not takeany irreversible, non-selective MAOIs for at least 5 weeks after stopping Fluoxetine Aurovitas. If Fluoxetine Aurovitas has been prescribed for a longer period or in a higher dose, the doctor may consider a longer interval.

• if the patient is taking metoprolol (a medicine used to treat heart failure), as there is an increased risk of excessively slow heart rate.

Warnings and precautions

Before starting Fluoxetine Aurovitas, the patient should discuss the following with their doctor or pharmacist:

• epilepsy or seizures. If the patient has seizures or an increased frequency of seizures, they should contact their doctor immediately; it may be necessary to stop taking Fluoxetine Aurovitas;
• current or past mania; if a manic episode occurs, the patient should contact their doctor immediately, as it may be necessary to stop taking Fluoxetine Aurovitas;
• diabetes (the doctor may need to adjust the insulin or other antidiabetic medication dose);
• liver problems (the doctor may need to adjust the dose);
• heart problems;
• 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);
• glaucoma (increased eye pressure);
• ongoing treatment with diuretics (water pills), especially in the elderly;
• ongoing electroconvulsive therapy (ECT);
• pre-existing bleeding disorders or bruising or bleeding or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility");
• ongoing treatment with blood-thinning medicines (see "Fluoxetine Aurovitas and other medicines");
• ongoing treatment with tamoxifen (used to treat breast cancer) (see "Fluoxetine Aurovitas and other medicines");
• feeling anxious and unable to sit or stand still (akathisia). Increasing the dose of Fluoxetine Aurovitas may worsen the patient's condition;
• the occurrence of fever, muscle stiffness, or tremors, changes in mental status, such as confusion, agitation, and extreme excitement; the patient may be suffering from a condition called serotonin syndrome or neuroleptic malignant syndrome. Although these symptoms are rare, they can lead to life-threatening conditions; the patient should contact their doctor immediately, as it may be necessary to stop taking Fluoxetine Aurovitas;
• if the patient is taking medicines containing buprenorphine. Taking these medicines with Fluoxetine Aurovitas can lead to serotonin syndrome, a potentially life-threatening condition (see "Fluoxetine Aurovitas and other medicines").
• Medicines like fluoxetine (SSRIs/SNRIs) can cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and (or) worsening of depression or anxiety

Patients with depression and (or) anxiety disorders may sometimes have thoughts of self-harm or suicide. These thoughts may worsen when starting antidepressant treatment, as it takes some time for the medicine to start working, usually around two weeks, but sometimes longer.
It is more likely to occur:

• If the patient has had suicidal thoughts or self-harm in the past.
• If the patient is a young adult. Data from clinical trials indicate an increased risk of suicidal behavior in people under 25 with mental disorders treated with antidepressants.

If the patient thinks about self-harm or suicide, they should contact their doctor or go to the hospital.
It may be helpful to inform relatives or friendsabout the depression or anxiety disorder and ask them to read this leaflet. The patient can ask them to tell them if they notice that their depression or anxiety has worsened or if there are worrying changes in their behavior.
Children and adolescents( aged 8 to 18 years)

• In patients under 18 years of age, there is an increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and signs of anger) when taking medicines of this class. In children and adolescents aged 8 to 18 years, Fluoxetine Aurovitas should be used to treat moderate or severe major depressive episodes (in conjunction with psychological therapy) and should not be used to treat other conditions.
• Additionally, there is limited information on the long-term use of fluoxetine in this age group regarding growth, maturation, and psychological, emotional, and behavioral development. Nevertheless, if the patient is under 18 years of age, the doctor may prescribe fluoxetine for moderate or severe major depressive episodes, in conjunction with psychological therapy, if the doctor decides it is in the patient's best interest. If the doctor has prescribed fluoxetine to a patient under 18 years of age and this raises concerns, the patient should contact the doctor. The patient should inform their doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking fluoxetine.

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

Fluoxetine Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

Do not take Fluoxetine Aurovitas 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 Aurovitas due to the risk of severe or even life-threatening reactions (serotonin syndrome) (see "When not to take Fluoxetine Aurovitas"). Treatment with Fluoxetine Aurovitas should be started at least 2 weeks after stopping irreversible, non-selective MAOIs (e.g., tranylcypromine). Do not startany irreversible, non-selective MAOIs for at least 5 weeks after stopping Fluoxetine Aurovitas. If Fluoxetine Aurovitas has been prescribed for a longer period or in a higher dose, the doctor may consider a longer interval.
• metoprolol used to treat heart failure; there is an increased risk of excessively slow heart rate.

Fluoxetine Aurovitas may affect the action of the following medicines (interaction):

• tamoxifen(used to treat breast cancer); as Fluoxetine Aurovitas may change the levels of this medicine in the blood, which may reduce the effect of tamoxifen, the doctor may consider prescribing another 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 medicinal product or other chemical substance

chemically): due to the risk of severe, potentially life-threatening reactions (serotonin syndrome). Fluoxetine treatment can be started the day after stopping reversible MAOIs, but the doctor may want to monitor the patient's condition carefully and use smaller doses of MAO-A inhibitors.

• mexiletine(used to treat allergies); when taking this medicine with Fluoxetine Aurovitas, the risk of changes in heart rhythm may increase.
• phenytoin(an antiepileptic medicine); as Fluoxetine Aurovitas may affect the levels of this medicine in the blood, the doctor may need to adjust the dose of phenytoin and perform regular checks if it is taken with Fluoxetine Aurovitas.
• lithium, selegiline, St. John's Wort, tramadol(painkillers), buprenorphine, triptans(used to treat migraines), and tryptophan; there is an increased risk of mild serotonin syndrome when these medicines are taken with Fluoxetine Aurovitas. The doctor will perform more frequent checks.
• medicines that may affect heart rate, 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, intravenous erythromycin, pentamidine), antimalarial medicines, especially halofantrine, or certain antihistamines(astemizole, mizolastine), as Fluoxetine Aurovitas taken with one or more of these medicines may increase the risk of changes in heart rhythm.
• blood-thinning medicines(such as warfarin), NSAIDs(non-steroidal anti-inflammatory medicines, such as ibuprofen, diclofenac), aspirin, and other medicines that may thin the blood(including clozapine, used to treat certain mental disorders). Fluoxetine Aurovitas may affect the action of these medicines in the blood. If Fluoxetine Aurovitas treatment is started or stopped while taking warfarin, the doctor will need to perform certain tests to adjust the dose and perform more frequent checks.
• cyproheptadine(used to treat allergies); as it may reduce the effect of Fluoxetine Aurovitas.
• 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 Aurovitas.
• antidepressants, 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 Aurovitas 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 Aurovitas may affect the levels of these medicines in the blood, the doctor may reduce their dose if taken with Fluoxetine Aurovitas.

Some medicines may increase the side effects of Fluoxetine Aurovitas, and sometimes cause severe reactions. While taking Fluoxetine Aurovitas, the patient should not take other medicines without consulting their doctor, especially:

• medicines containing buprenorphine. These medicines may interact with Fluoxetine Aurovitas and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and fever above 38°C. If the patient experiences these symptoms, they should contact their doctor.

Fluoxetine Aurovitas can be taken with food or between meals, depending on the patient's preference.

• The patient should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should contact their doctor if they are pregnant, think they may be pregnant, or plan to have a baby.
In infants whose mothers took fluoxetine during the first few months of pregnancy, some studies have shown an increased risk of congenital heart defects. In the general population, about 1 in 100 children is born with a heart defect. This risk increases to about 2 in 100 children in mothers taking fluoxetine.
If treatment is started during pregnancy, especially during the last 3 months of pregnancy, medicines like fluoxetine may increase the risk of a severe condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and turn blue (cyanosis). If these symptoms occur in the baby, the patient should contact the midwife and (or) doctor immediately.
It is recommended not to take this medicine during pregnancy unless the potential benefits to the mother outweigh the potential risk to the baby. The patient may, in consultation with their doctor, gradually stop taking Fluoxetine Aurovitas when pregnant or planning a pregnancy. However, depending on the circumstances, the doctor may suggest continuing to take Fluoxetine Aurovitas.
Care should be taken when using during pregnancy, especially in late pregnancy or shortly before delivery, as the following symptoms have been reported in newborn babies: irritability, tremors, weakness, constant crying, and difficulty feeding or sleeping.
Taking Fluoxetine Aurovitas at the end of pregnancy may increase the risk of severe bleeding from the vagina, occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Fluoxetine Aurovitas, they should inform their doctor or midwife so they can provide appropriate advice.
Breastfeeding
Fluoxetine passes into breast milk and may cause side effects in infants. The patient can breastfeed only if it is absolutely necessary. If breastfeeding continues, the doctor may recommend a lower dose of fluoxetine.
Fertility
Animal studies have shown that fluoxetine reduces sperm quality. It may theoretically have a harmful effect on fertility, but this has not been observed in humans.

Driving and using machines

Psychotropic medicines, such as fluoxetine, can impair judgment or coordination. The patient should not drive or operate machinery until they are sure what effect Fluoxetine Aurovitas has on them.

Fluoxetine Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Fluoxetine Aurovitas

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are not sure, they should ask their doctor or pharmacist.
The patient should not take more capsules than their doctor has recommended.
The capsules should be swallowed with water. The patient should not chew the capsules.
Adults:
The recommended dose is:

• Depression:The recommended dose is 1 capsule (20 mg) per day. The doctor will assess 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 3 capsules (60 mg) per day. The dose should be increased slowly to achieve effective treatment at the lowest possible dose. The patient may not feel better immediately after starting treatment for depression. This is a normal reaction, as improvement in depressive symptoms may occur only after several weeks. Patients with depression should be treated for at least 6 months.
• Bulimia:The recommended dose is 3 capsules (60 mg) per day.
• Obsessive-compulsive disorder:The recommended dose is 1 capsule (20 mg) per day. The doctor will assess and adjust the dose if necessary after 2 weeks of treatment. If necessary, the dose may be gradually increased to a maximum of 3 capsules (60 mg) per day. If there is no improvement within 10 weeks, the doctor will consider the appropriateness of continuing treatment.

Use in children and adolescents aged 8 to 18 years with depression:

Treatment should be started and supervised by a specialist doctor. The initial dose is 10 mg/day (given as 2.5 ml of fluoxetine oral solution).
After 1 to 2 weeks, the doctor may increase the dose to 20 mg/day. The dose should be increased slowly to achieve effective treatment at the lowest possible dose. Children with a lower body weight may require lower doses. If the response to treatment is satisfactory, the doctor will assess the need to continue treatment for more than 6 months. If there is no improvement within 9 weeks, the doctor should reassess the appropriateness of treatment.
Elderly patients:
The doctor will increase the dose with caution, and the daily dose should not exceed 2 capsules (40 mg) in general. The maximum dose is 3 capsules (60 mg) per day.

Patients with liver function disorders:

If the patient has liver problems or is taking other medicines that may affect Fluoxetine Aurovitas, the doctor may prescribe a lower dose of Fluoxetine Aurovitas or recommend taking the medicine every other day.

Taking more than the recommended dose of Fluoxetine Aurovitas

• If the patient takes too many capsules, they should go to the nearest hospital emergency department or contact their doctor immediately.
• The patient should take the packaging of Fluoxetine Aurovitas with them if possible.
• Symptoms of overdose include nausea, vomiting, seizures, heart problems (such as irregular heartbeat and cardiac arrest), lung problems, and changes in mental status, ranging from agitation to coma.

Missing a dose of Fluoxetine Aurovitas

• If the patient misses a dose, they should take the next dose the next day at the usual time. The patient should not take a double dose to make up for the missed dose.
• Taking the medicine at the same time every day can help the patient remember to take it regularly.

Stopping Fluoxetine Aurovitas treatment

• The patient should not stop taking Fluoxetine Aurovitas without consulting their doctor first, even if they start to feel better. It is essential to continue taking the medicine.
• The patient should ensure they have enough capsules to continue treatment.

The patient may experience the following reactions (withdrawal symptoms) after stopping Fluoxetine Aurovitas: dizziness, tingling sensation, sleep disturbances (intense dreams, nightmares, insomnia), anxiety or agitation, unusual tiredness or weakness, feeling unwell; nausea and (or) vomiting (nausea or discomfort), tremors (seizures), headaches.
In most people, any symptoms that occur after stopping Fluoxetine Aurovitas are mild and disappear within a few weeks. If withdrawal symptoms occur after stopping treatment, the patient should contact their doctor.
When stopping Fluoxetine Aurovitas, the doctor will help reduce the dose gradually over one or two weeks – this should reduce the risk of withdrawal symptoms.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

• If the patient thinks about self-harm or suicide, they should contact their doctor or go to the hospital (see section 2).
• If the patient experiences a rash or allergic reactions, such as itching, swelling of the lips and (or) tongue or shortness of breath, they should stop taking the capsules and inform their doctor immediately.
• If the patient feels anxious and cannot sit still or stand still, this may be akathisia; increasing the dose of Fluoxetine Aurovitas may worsen the patient's condition. If the patient has similar feelings, they should contact their doctor.
• The patient should inform their doctor immediatelyif their skin turns red or they experience various skin reactions or blisters or peeling skin. These are very rare reactions.

The most common side effects (very common side effects that may occur in more than 1 in 10 people) are insomnia, headaches, diarrhea, nausea (nausea), and fatigue.
Some patients have experienced:

• a syndrome of symptoms (known as "serotonin syndrome"), including unexplained fever with rapid breathing or heart rate, sweating, muscle stiffness, or tremors, disorientation, extreme excitement or drowsiness (rarely);
• feeling weak, sleepy, and disoriented, mainly in elderly people and people (including the elderly) taking diuretics (water pills);
• prolonged and painful erections;
• irritability and extreme excitement;
• heart problems, such as rapid or irregular heartbeat, fainting, dizziness, or lightheadedness, which may indicate an abnormal heart rhythm.

If the patient experiences any of the above side effects, they should inform their doctor immediately.

The following side effects have also been reported in patients taking fluoxetine:
Common(may affect up to 1 in 10 people)

• loss of appetite, weight loss
• nervousness, feeling anxious
• irritability, poor concentration
• feeling tense
• decreased sex drive or sexual problems (including difficulty maintaining an erection during sexual activity)
• sleep disturbances, unusual dreams, fatigue, or drowsiness
• dizziness
• change in taste
• uncontrolled trembling
• blurred vision
• rapid and irregular heartbeat
• flushing
• yawning
• indigestion, vomiting
• dry mouth
• rash, hives, itching
• excessive sweating
• joint pain
• more frequent urination
• unexplained vaginal bleeding
• feeling shaky or having chills

Uncommon(may affect up to 1 in 100 people)

• feeling detached from oneself
• strange thoughts
• unusually good mood
• problems with orgasm
• thoughts of suicide or self-harm
• grinding teeth
• muscle contractions, involuntary movements, or problems with balance or coordination
• memory problems
• dilated pupils
• 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
• difficulty urinating
• feeling hot or cold
• 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 increases the risk of bleeding or bruising
• decreased white blood cell count
• abnormal, primary behaviors
• hallucinations
• agitation
• panic attacks
• disorientation
• stuttering
• aggression
• seizures
• inflammation of blood vessels (vasculitis)
• sudden, severe swelling of the tissues of the neck, face, mouth, and (or) throat
• esophageal pain (the tube that carries food or water to the stomach)
• liver inflammation
• lung problems
• sensitivity to sunlight
• muscle pain
• urination problems
• breast milk production

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

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

Bone fractures- an increased risk of bone fractures has been observed in patients taking medicines of this type. Most of these side effects disappear during continued treatment.
Additional side effects in children and adolescents (aged 8 to 18 years)- in addition to the above side effects, Fluoxetine Aurovitas may slow down the child's growth or possibly delay sexual maturation. Suicidal behavior (suicidal attempts and suicidal thoughts), hostility, mania, and nosebleeds are also commonly observed in children.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Fluoxetine Aurovitas

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the label, carton, and blister after: Expiry date. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fluoxetine Aurovitas contains

The active substance is fluoxetine hydrochloride.
Each hard capsule contains 22.357 mg of fluoxetine hydrochloride, equivalent to 20 mg of fluoxetine ( Fluoxetine).
The other ingredients are:
Caplet core: Corn starch, microcrystalline cellulose, colloidal anhydrous silica.
Caplet shell: Yellow iron oxide (E 172), patent blue V (E 131), titanium dioxide (E 171), gelatin, sodium lauryl sulfate, purified water.
Ink: Shellac ,black iron oxide (E 172).

What Fluoxetine Aurovitas looks like and contents of the pack

Hard capsule
A green and yellow capsule, size "4", filled with a white to almost white powder, and printed with "J" on the green cap and "96" on the yellow body with black ink.
Fluoxetine Aurovitas, 20 mg, hard capsules are available in transparent PVC/PVDC/Aluminum blister packs and HDPE bottles with a desiccant plug and a PP cap.
Blister packs:14, 20, 28, 30, 50, 56, 60, 90, and 98 hard capsules.
Bottle:250 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

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

Belgium:
Fluoxetin AB 20 mg hard capsules
Netherlands:
Fluoxetine Aurobindo 20 mg, hard capsules
Poland:
Fluoxetine Aurovitas
Portugal:
Fluoxetina Aurovitas
Spain:
Fluoxetina Aurovitas 20 mg hard capsules EFG

Date of last revision of the leaflet: 07/2021