Fluoxetine aurovitas: detailed information

Package leaflet: Information for the user

Fluoxetine Aurovitas, 20 mg, hard capsules
Fluoxetinum
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT FLUOXETINE
Fluoxetine treats depression and anxiety disorders.
Like any medicine, it may have side effects. It is important that before starting treatment,
the doctor and patient consider the benefits of treatment versus the possible unwanted
effects.
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 does not work immediately. Some patients taking antidepressants may feel
worse before they start to feel better. The doctor should see the patient again a few
weeks after starting treatment. Inform the doctor if there is no improvement with treatment. See section 3, How to take Fluoxetine Aurovitas.
Some people who have depression may experience anxiety 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 hospital immediately. See section 2.
Do not stop taking fluoxetine without consulting your doctor. Stopping the
medicine suddenly or missing doses may lead to withdrawal symptoms. See section 3 for further information.
If the patient feels restless and unable to sit 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 medicines with fluoxetine may cause problems. It may be necessary
to consult a doctor. See section 2, Fluoxetine Aurovitas and other medicines.
If the patient is pregnant or planning to become pregnant, she should consult her doctor. See section 2, Pregnancy, breastfeeding and fertility.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further 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 the same.
If the patient experiences any side effects, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Contents of the leaflet

What Fluoxetine Aurovitas is and what it is used for
What you need to know before taking Fluoxetine Aurovitas
How to take Fluoxetine Aurovitas
Possible side effects
How to store Fluoxetine Aurovitas
Contents of the pack and other information

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

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

Major depressive episodes
Obsessive-compulsive disorder
Bulimia: Fluoxetine Aurovitas is used in addition to psychotherapy to reduce the urge to binge eat and to induce vomiting.

Children and adolescents aged 8 years and older:

Moderate to severe depressive disorder when 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 disorder only in combination with psychotherapy.

How Fluoxetine Aurovitas works
Everyone has a substance in the brain called serotonin. People who experience depression,
obsessive-compulsive disorder, or bulimia have lower levels of serotonin than others.
The exact way in which Fluoxetine Aurovitas and other SSRIs work is not fully understood, but it is known
that they may help by increasing the level of serotonin in the brain.
Treating these disorders is very important to improve the patient's quality of life. If treatment is not
started, the patient's condition may not improve and may even become worse and more difficult to
treat.
To ensure the patient is free of symptoms, treatment may need to continue for several
weeks or months.

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). If a rash or other allergic reaction occurs (such as itching, swelling of the lips or face, or difficulty breathing), the medicine must be stopped immediately and the doctor contacted at once.
if the patient is taking other medicines known as irreversible, non-selective monoamine oxidase inhibitors (enzymes called MAO inhibitors) (e.g. iproniazid used in the treatment of depression), due to the risk of severe or even fatal reactions.

Treatment with Fluoxetine Aurovitas should be started at least 2 weeks after discontinuation of irreversible, non-selective MAO inhibitors.
Do not use any irreversible, non-selective MAO inhibitors for at least 5 weeks after stopping Fluoxetine Aurovitas. If Fluoxetine Aurovitas has been prescribed for long-term treatment and/or at a higher dose, the doctor may decide that a longer interval after stopping Fluoxetine Aurovitas is appropriate.

if metoprolol (a medicine used to treat heart failure) is being used, as there is an increased risk of developing a slow heart rate.

Warnings and precautions
Before starting treatment with Fluoxetine Aurovitas, discuss with your doctor or pharmacist if any of the following apply to the patient:

epilepsy or seizures. If the patient experiences seizures or an increase in their frequency, they should contact the doctor immediately; discontinuation of Fluoxetine Aurovitas may be necessary;
current or past episodes of mania; if a manic episode occurs, the patient should contact the doctor immediately, as discontinuation of Fluoxetine Aurovitas may be required;
diabetes (the doctor may adjust the dose of insulin or other antidiabetic medicines);
liver problems (the doctor may adjust the dose);
heart problems;
low resting heart rate and/or low salt levels in the body due to prolonged severe diarrhoea and vomiting or due to diuretic use (water tablets);
glaucoma (increased pressure in the eye);
ongoing treatment with diuretics (water tablets), especially if the patient is elderly;
ongoing treatment with electroconvulsive therapy (ECT);
pre-existing bleeding disorders, bruising or haemorrhagic spots, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility");
ongoing treatment with medicines that thin the blood (see section "Fluoxetine Aurovitas with other medicines");
ongoing treatment with tamoxifen (used in the treatment of breast cancer) (see section "Fluoxetine Aurovitas with other medicines");
feeling restless and unable to sit or stand still (akathisia). Increasing the dose of Fluoxetine Aurovitas may worsen this condition;
development of fever, muscle stiffness or tremor, changes in mental state such as confusion, irritability or extreme agitation; the patient may be suffering from a condition known as serotonin syndrome or neuroleptic malignant syndrome. Although these symptoms are rare, they may lead to potentially life-threatening conditions; the patient should contact the doctor immediately, as treatment with Fluoxetine Aurovitas may need to be discontinued;
if the patient is taking medicines containing buprenorphine. Taking these medicines together with Fluoxetine Aurovitas may lead to serotonin syndrome, a potentially life-threatening condition (see section "Fluoxetine Aurovitas with other medicines").
Medicines such as fluoxetine (so-called SSRI/SNRI) may cause sexual dysfunction (see section 4). In some cases, these symptoms may 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 may increase at the beginning of antidepressant treatment, as it takes some time before these medicines start to work, usually about two weeks, but sometimes longer.
Such thoughts are more likely to occur:

if the patient has previously had thoughts of suicide or self-harm;
if the patient is a young adult. Clinical trial data indicate an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders treated with antidepressant medicines.

If the patient has thoughts of self-harm or suicide, they should contact the doctor immediately or go to hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform the patient if they notice worsening depression or anxiety, or concerning changes in behaviour.

Children and adolescents (aged 8 to 18 years)

In patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger) when taking medicines in this class. In children and adolescents aged 8 to 18 years, Fluoxetine Aurovitas 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.
Additionally, there is limited information on the long-term use of fluoxetine in this age group regarding growth, puberty, and psychological, emotional, and behavioural development. Nevertheless, if the patient is under 18 years of age, the doctor may prescribe fluoxetine 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. If fluoxetine has been prescribed to a patient under 18 years of age and this causes concern, contact the prescribing doctor. Inform the 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Fluoxetine Aurovitas together with:

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

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

tamoxifen (used in the treatment of breast cancer); since Fluoxetine Aurovitas 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 in the treatment of methemoglobinemia induced by a medicinal product or other chemical substance): due to the risk of severe, even fatal reactions (known as serotonin syndrome). Fluoxetine treatment may be started the day after stopping reversible MAO inhibitors, but the doctor may wish to monitor the patient and use lower doses of MAO-A inhibitors cautiously.
mequitazine (used to treat allergies); when taken with Fluoxetine Aurovitas, this medicine may increase the risk of changes in the electrical activity of the heart;
phenytoin (an anticonvulsant medicine); since Fluoxetine Aurovitas may affect the blood concentration of this medicine, the doctor may consider it necessary to introduce phenytoin gradually and perform control tests when used concomitantly with Fluoxetine Aurovitas;
lithium, selegiline, St. John's wort, tramadol (a painkiller), buprenorphine, triptans (used to treat migraine), and tryptophan; there is an increased risk of mild serotonin syndrome when these medicines are taken together with Fluoxetine Aurovitas. The doctor will order more frequent monitoring.
medicines that may affect heart rate, e.g. antiarrhythmics of class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarial medicines, especially halofantrine, or certain antihistamines (astemizole, mizolastine), since Fluoxetine Aurovitas 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 in the treatment of certain psychiatric disorders). Fluoxetine Aurovitas may interfere with the action of these medicines in the blood. If treatment with Fluoxetine Aurovitas is started or stopped during warfarin therapy, 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 Aurovitas;
medicines that lower blood sodium levels (including medicines that increase urine output, desmopressin, carbamazepine, and oxcarbazepine); as these medicines may increase the risk of low blood sodium levels when used together with Fluoxetine Aurovitas;
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 Aurovitas may increase the risk of seizures when taken together with these medicines;
flecainide, propafenone, nebivolol, or encainide (used in heart conditions), carbamazepine (an anticonvulsant), atomoxetine, or tricyclic antidepressants (e.g. imipramine, desipramine, and amitriptyline) or risperidone (used in schizophrenia); as Fluoxetine Aurovitas may likely alter the blood concentration of these medicines, the doctor may reduce their dose when used concomitantly with Fluoxetine Aurovitas.

Some medicines may worsen the side effects of Fluoxetine Aurovitas and sometimes cause very severe reactions. During treatment with Fluoxetine Aurovitas, do not take other medicines without prior consultation with the doctor, especially:

medicines containing buprenorphine. These medicines may interact with Fluoxetine Aurovitas and cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, and body temperature above 38°C. If the patient experiences such symptoms, contact the doctor.

Fluoxetine Aurovitas with food, drink and alcohol

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

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The patient should contact her doctor if she is pregnant, suspects she may be pregnant, or is planning to have a baby.
Studies in infants whose mothers took fluoxetine during the first few months of pregnancy have shown an increased risk of congenital malformations affecting the heart. In the general population, about 1 in 100 babies is born with a heart defect. This risk increases to about 2 in 100 babies of mothers taking fluoxetine.
If treatment is continued during pregnancy, especially during the last 3 months, medicines such as fluoxetine may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue (cyanotic). These symptoms usually occur within the first 24 hours after birth. If these symptoms occur in the baby, contact the midwife and/or doctor immediately.
It is recommended not to use this medicine during pregnancy unless the potential benefits to the mother outweigh the potential risks to the baby. The patient may, in consultation with her doctor, gradually discontinue Fluoxetine Aurovitas if she is pregnant or planning pregnancy. However, depending on the circumstances, the doctor may suggest continuing treatment with Fluoxetine Aurovitas.
Caution should be exercised during use in pregnancy, especially in late pregnancy or shortly before delivery, as newborns have reported the following symptoms: irritability, tremor, muscle weakness, constant crying, and difficulties with sucking or sleeping.
Taking Fluoxetine Aurovitas towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Fluoxetine Aurovitas, she should inform her doctor or midwife so they can provide appropriate advice.

Breastfeeding
Fluoxetine passes into human milk and may cause adverse effects in infants. The patient may breastfeed only if absolutely necessary. If breastfeeding is continued, the doctor may recommend using 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 no effect on human fertility has been observed so far.

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 Fluoxetine Aurovitas affects them.

Fluoxetine Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Fluoxetine Aurovitas

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Do not take more capsules than prescribed by your doctor.
Swallow the capsules with water. Do not chew the capsules.

Adults:
The recommended dose is:

Depression: The recommended dose is 1 capsule (20 mg) daily. Your doctor will assess and adjust the dose if necessary, within 3 to 4 weeks after starting treatment. If required, the dose may be gradually increased up to a maximum of 3 capsules (60 mg) daily. The dose should be increased slowly to achieve effective treatment at the lowest possible dose. You may not feel better immediately after starting treatment for depression. This is a normal response, as improvement in depressive symptoms may take several weeks. Patients with depression should be treated for at least 6 months.
Bulimia: 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 adjust the dose if necessary after 2 weeks of treatment. If required, the dose may be gradually increased up to a maximum of 3 capsules (60 mg) daily. If there is no improvement within 10 weeks, your doctor will consider whether continued treatment is justified.

Use in children and adolescents aged 8 to 18 years with depression:
Treatment should be initiated and supervised by a specialist doctor. The initial dose is
10 mg/day (administered as 2.5 ml of fluoxetine oral solution).
After 1 to 2 weeks, your 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 lower body weight may require lower doses. If the response to treatment is satisfactory, your doctor will evaluate the need for continuing treatment beyond 6 months. If no improvement occurs within 9 weeks, your doctor should reassess the justification for continuing treatment.

Elderly patients:
Your doctor will increase the dose more cautiously, and the daily dose should generally not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) daily.

Patients with impaired liver function:
If you have liver impairment or are taking other medicines that may affect Fluoxetine Aurovitas, your doctor may prescribe a lower dose of Fluoxetine Aurovitas or recommend taking the medicine every other day.

Taking more Fluoxetine Aurovitas than prescribed

If you take too many capsules, go immediately to the nearest hospital emergency department or contact your doctor without delay.
You should bring the Fluoxetine Aurovitas 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.

Missing a dose of Fluoxetine Aurovitas

If you miss a dose, take the next dose at your 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 Fluoxetine Aurovitas

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

The following reactions (withdrawal symptoms) may occur after stopping Fluoxetine Aurovitas: dizziness, tingling sensations, sleep disturbances (intense dreaming, nightmares, inability to sleep), anxiety or agitation, unusual tiredness or weakness, feeling restless; nausea and (or) vomiting (nausea or feeling unwell), tremor (shaking), headache.
In most people, any symptoms after stopping Fluoxetine Aurovitas are mild and resolve within a few weeks. If withdrawal symptoms occur after stopping treatment, contact your doctor.
When discontinuing Fluoxetine Aurovitas, 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 further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

If the patient has thoughts of self-harm or suicide, they should immediately contact their doctor or go to hospital (see section 2).
If the patient develops a rash or allergic reactions such as itching, swelling of the lips and (or) tongue, or wheezing and (or) shortness of breath, the patient must immediately stop taking the capsules and seek medical advice without delay.
If the patient feels restless and unable to sit still or remain calm, this may indicate akathisia; increasing the dose of Fluoxetine Aurovitas may worsen the patient's condition. If the patient experiences such symptoms, they should contact their doctor.
The patient should immediately inform their doctor if their skin becomes red or develops various skin reactions, or if blisters appear on the skin or the skin begins to peel. These are very rare reactions.

The most common side effects (very common side effects, which may affect more than 1 in 10 people) are insomnia, headache, diarrhoea, nausea and fatigue.
Some patients have experienced:

a group of symptoms (known as "serotonin syndrome"), including unexplained fever with rapid breathing or pulse, sweating, muscle stiffness or tremor, confusion, extreme agitation or drowsiness (rare);
weakness, drowsiness and disorientation, mainly in elderly patients and patients (including elderly patients) taking diuretics (water tablets);
prolonged and painful erection;
irritability and extreme agitation;
heart problems such as fast or irregular heartbeat, fainting, dizziness or lightheadedness when standing, which may indicate an abnormal heart rhythm.

If any of the above side effects occur, the doctor must be informed 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
agitation, poor concentration
feeling tense
reduced sex drive or sexual problems (including difficulty maintaining an erection during sexual activity)
sleep disturbances, unusual dreams, fatigue or drowsiness
dizziness
altered taste
uncontrollable trembling
blurred vision
fast and irregular heartbeat
flushing
yawning
indigestion, vomiting
dry mouth
rash, hives, itching
excessive sweating
joint pain
increased frequency of urination
unexplained vaginal bleeding
feeling shaky or chills

Uncommon (may affect up to 1 in 100 people)

feeling detached from oneself
strange thoughts
unnaturally elevated mood
problems with orgasm
thoughts of suicide or self-harm
teeth grinding
muscle spasms, involuntary movements, or problems with balance or coordination
memory impairment
enlarged (dilated) pupils
ringing in the ears
low blood pressure
shortness of breath
nosebleeds
difficulty swallowing
hair loss
increased tendency to bruise
unexplained bruises or bleeding
cold sweats
difficulty passing urine
sensation of heat or cold
abnormal liver function test results

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

low blood sodium levels
reduced platelet count, increasing the risk of bleeding or bruising
reduced white blood cell count
unusual, impulsive behaviours
hallucinations
agitation
panic attacks
confusion
stammering
aggression
seizures
vasculitis (inflammation of blood vessels)
sudden swelling of tissues in the neck, face, mouth and (or) throat
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
problems with urination
milk production in the breasts

Frequency not known (cannot be estimated from available data)

Severe vaginal bleeding shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2.

Bone fractures – increased risk of bone fractures has been observed in patients taking medicines of this type. Most of these side effects diminish during continued treatment.
Additional side effects in children and adolescents (aged 8 to 18 years) – in addition to the side effects listed above, Fluoxetine Aurovitas may slow a child's growth or potentially delay sexual maturation. Suicidal behaviour (suicide attempts and suicidal thoughts), hostility, mania and nosebleeds have also been frequently observed in children.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 authorisation holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Fluoxetine Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, and blister pack
after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply to this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures 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 (Fluoxetinum).
The other ingredients are:
Capsule contents: Pregelatinized maize starch.
Capsule shell: Iron oxide yellow (E 172), patent blue V (E 131), titanium dioxide (E 171), gelatin, sodium lauryl sulfate, purified water.
Printing ink: Shellac (E 904), iron oxide black (E 172), potassium hydroxide (E 525).

What Fluoxetine Aurovitas looks like and contents of the pack
Hard capsule
A gelatin capsule with an opaque green cap and a yellow body, size “4”, filled with white to almost white powder, printed with “J” on the opaque green cap and “96” on the yellow body using black ink.

Fluoxetine Aurovitas 20 mg capsules are available in transparent PVC/PVDC/Aluminium blister packs and in HDPE bottles with a sealing liner and PP screw 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 Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area under the following names:
Belgium: Fluoxetin AB 20 mg harde capsules
Netherlands: Fluoxetine Aurobindo 20 mg, harde capsules
Poland: Fluoxetine Aurovitas
Portugal: Fluoxetina Aurovitas
Spain: Fluoxetina Aurovitas 20 mg cápsulas duras EFG