Fluoxetine Ratiopharm: detailed information

Package leaflet: information for the patient

Fluoxetina ratiopharm 20 mg dispersible tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Fluoxetina ratiopharm is and what it is used for

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

Major depressive episodes.
Obsessive-compulsive disorder.
Bulimia nervosa: Fluoxetina ratiopharm is used in combination with psychotherapy to reduce binge eating and the associated purging of food.

Children and adolescents from 8 years of age:

Moderate to severe major depressive disorder, when depression does not respond to psychotherapy after 4–6 sessions. Fluoxetina ratiopharm should only be prescribed for a child or adolescent with moderate to severe major depressive disorder in combination with psychotherapy.

How Fluoxetina ratiopharm works
Each individual has a substance in the brain called serotonin. People who are depressed, or
have obsessive-compulsive disorder, or bulimia nervosa, have lower levels of serotonin compared to
others. The exact way in which Fluoxetina ratiopharm and other SSRIs work is not fully understood,
but they may help by increasing the level of serotonin in the brain. Treating these medical conditions is important to help you feel better. If left untreated, your condition
may persist and may become even more severe and more difficult to treat. To ensure that symptoms do not return, it may be necessary for treatment to continue for several weeks or months.

2. What you should know before taking Fluoxetina ratiopharm

Do not take Fluoxetina ratiopharm if

you are allergic to fluoxetine or to any of the other ingredients of this medicine (listed in section 6). If you develop a rash or other allergic reactions such as itching, swelling of the lips or face, or shortness of breath, stop taking the tablets immediately and contact your doctor immediately;
you are taking other medicines known as irreversible and non-selective monoamine oxidase inhibitors (MAOIs), as serious or even fatal reactions may occur (e.g. iproniazid or tranylcypromine, both used to treat depression). Treatment with Fluoxetina ratiopharm must not begin until at least 2 weeks after stopping treatment with an irreversible and non-selective MAOI. Do not take any irreversible and non-selective MAOI for at least 5 weeks after stopping Fluoxetina ratiopharm. If Fluoxetina ratiopharm has been prescribed for you for a long period of time and/or at high doses, your doctor should consider a longer interval;
you are taking metoprolol (for treatment of heart failure), as there is an increased risk that your heart rate may become too slow.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluoxetina ratiopharm if you are in any of the following
conditions:

heart problems;
if you have or have previously had manic disorder;
history of bleeding disorders, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”);
ongoing treatment with medicines that thin the blood (see “Other medicines and Fluoxetina ratiopharm”);
if you have or have had epilepsy or seizures;
undergoing electroconvulsive therapy (ECT);
undergoing treatment with tamoxifen (used to treat breast cancer) (see “Other medicines and Fluoxetina ratiopharm”);
diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment dose);
liver problems (your doctor may need to adjust your dose);
low resting heart rate and/or if you know you may lose salts due to prolonged severe diarrhoea and vomiting (nausea) or use of diuretics (water tablets);
ongoing treatment with diuretics (water tablets), especially if you are elderly;
glaucoma (increased eye pressure);
ongoing treatment with any other medicine (see “Other medicines and Fluoxetina ratiopharm”).

Contact your doctor if you experience any of the following conditions during treatment:

heart problems;
appearance of bruises or unusual bleeding;
development of fever, muscle stiffness or tremor, changes in your mental state such as confusion, irritability, and extreme agitation; these may be symptoms of so-called “serotonin syndrome” or “neuroleptic malignant syndrome”. Although this syndrome is rare, it may lead to potentially life-threatening conditions; contact your doctor immediately as it may be necessary to stop treatment with Fluoxetina ratiopharm;
if you experience an episode of mania, contact your doctor immediately, as it may be necessary to stop treatment with Fluoxetina ratiopharm;
if you have a seizure (convulsion) or notice an increased frequency of seizures, contact your doctor immediately: it may be necessary to stop treatment with Fluoxetina ratiopharm;
if you feel restless and unable to sit or stand still (akathisia). Increasing the dose of Fluoxetina ratiopharm may worsen this feeling.

Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes feel an urge to harm yourself or to commit suicide.
These thoughts may increase at the beginning of treatment with antidepressants, as these medicines
take time to work, usually two weeks but sometimes longer. You are more likely to have these thoughts if:

you have previously thought about suicide or self-harm;
you are a young adult. Data from clinical trials show that the risk of suicidal behaviour increases in young adults under 25 years of age with psychiatric disorders treated with an antidepressant. If you ever have thoughts of self-harm or suicide, contact your doctor immediately or go to hospital straight away. It may be helpful to inform a close family member or friend about your depression or anxiety disorder, and ask them to read this leaflet. You may ask them to alert you if they notice your depression or anxiety worsening, or if they are concerned about changes in your behaviour.

Children and adolescents aged 8 to 18 years
When taking this type of medicine, patients under 18 years of age have a higher risk
of adverse effects, such as suicide attempts, suicidal thoughts, and hostility (mainly aggression,
oppositional behaviour and anger). Fluoxetina ratiopharm in children and adolescents aged
8 to 18 years should only be used for the treatment of moderate to severe major depressive episodes
(in combination with psychotherapy), and should not be used to treat other conditions.
Moreover, only limited information is available regarding the long-term safety of Fluoxetina ratiopharm
with respect to growth, puberty, and mental, emotional, and behavioural development in this age group.
Despite this, if you are under 18 years of age, your doctor may prescribe Fluoxetina ratiopharm to
treat moderate to severe major depressive episodes, in combination with psychotherapy,
if they consider it the best option for you. If your doctor has prescribed Fluoxetina ratiopharm to a
patient under 18 years of age and you need clarification, speak to your doctor again. You must inform the doctor if any of the symptoms listed above appear or worsen when a patient under 18 years of age is taking Fluoxetina ratiopharm.
Fluoxetina ratiopharm must not be used in children under 8 years of age.
Sexual dysfunction
Medicines such as Fluoxetina ratiopharm (so-called selective serotonin reuptake inhibitors (SSRIs))
may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after discontinuation of treatment.
Other medicines and Fluoxetina ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Fluoxetina ratiopharm with:

certain irreversible, non-selective monoamine oxidase inhibitors (MAOIs), some used to treat depression. Irreversible and non-selective MAOIs must not be used with Fluoxetina ratiopharm as serious or even fatal reactions (serotonin syndrome) may occur (see section “Do not take Fluoxetina ratiopharm”);
metoprolol when used for heart failure; there is an increased risk that your heart rate may become too slow.

Fluoxetina ratiopharm may affect the action of the following medicines (interaction):

tamoxifen (used to treat breast cancer); since Fluoxetina ratiopharm may alter blood levels of this medicine, possibly reducing tamoxifen’s effectiveness, your doctor may consider prescribing another antidepressant;
monoamine oxidase inhibitors A (MAO-A), including moclobemide, linezolid (an antibiotic), and methylene blue chloride (also known as methylene blue, used to treat drug- or chemical-induced methemoglobinemia): due to the risk of serious or even fatal reactions (called serotonin syndrome). Treatment with fluoxetine may be started the day after stopping a reversible MAOI, but your doctor may decide to monitor you closely and use a lower dose of MAO-A;
mequitazine (used for allergic reactions); as taking this medicine with Fluoxetina ratiopharm may increase the risk of changes in the heart’s electrical activity;
phenytoin (for treatment of epilepsy); since Fluoxetina ratiopharm may affect blood levels of this medicine, your doctor may need to administer phenytoin more cautiously and perform checks if it is taken concurrently with Fluoxetina ratiopharm;
lithium, selegiline, St. John's Wort, tramadol, and buprenorphine (both for severe pain), triptans (for migraine), and tryptophan; when these medicines are taken with Fluoxetina ratiopharm, there is an increased risk of developing mild serotonin syndrome. Your doctor will perform more frequent checks;
medicines that may affect heart rhythm, e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazines, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine), antimalarial treatments, particularly halofantrine, certain antihistamines (astemizole, mizolastine), because taking one or more of these medicines with Fluoxetina ratiopharm may increase the risk of changes in the heart’s electrical activity;
anticoagulants (such as warfarin), NSAIDs (non-steroidal anti-inflammatory drugs – such as ibuprofen, diclofenac), acetylsalicylic acid, and other medicines that may increase blood fluidity (including clozapine, used to treat certain mental disorders). Fluoxetina ratiopharm may alter the effect of these medicines on blood. If treatment with Fluoxetina ratiopharm is started or stopped while you are taking warfarin, your doctor will need to perform tests, adjust the dose, and monitor you more frequently;
cyproheptadine (used for allergic reactions); as it may reduce the effect of Fluoxetina ratiopharm;
medicines that lower blood sodium levels (including those causing increased urine output, desmopressin, carbamazepine, and oxcarbazepine); as these medicines may increase the risk of low blood sodium levels when taken with Fluoxetina ratiopharm;
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 phenothiazines or butyrophenones; as Fluoxetina ratiopharm may increase the risk of seizures when taken with these medicines;
flecainide, propafenone, nebivolol, or encainide (for heart disorders), carbamazepine (for epilepsy), atomoxetine, or tricyclic antidepressants (e.g. imipramine, desipramine, and amitriptyline) or risperidone (for schizophrenia); as Fluoxetina ratiopharm may alter blood levels of these medicines, and your doctor may need to reduce their dosage when administered with Fluoxetina ratiopharm.

Fluoxetina ratiopharm with food, drinks and alcohol
You may take Fluoxetina ratiopharm with or without food, as preferred.
You should avoid drinking alcohol while taking this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
In infants whose mothers took fluoxetine during the first months of pregnancy, some studies have reported an increased risk of congenital heart defects. In the general population, about 1 in 100 babies is born with a heart defect. This estimate increases to about 2 in 100 in babies whose mothers took fluoxetine. Medicines such as fluoxetine, if taken during pregnancy, particularly during the last 3 months of gestation, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually appear within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
It is preferable not to use this treatment during pregnancy unless the potential benefit outweighs the potential risk. Therefore, together with your doctor, you may decide to gradually discontinue Fluoxetina ratiopharm before or during pregnancy. However, depending on the circumstances, your doctor may advise continuing treatment with Fluoxetina ratiopharm.
Caution is required when using this product during pregnancy, especially during the late stages of gestation or shortly before delivery, as the following effects have been reported in newborns: irritability, tremor, muscle weakness, persistent crying, and difficulty sucking or sleeping.
If you take Fluoxetina ratiopharm close to the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking Fluoxetina ratiopharm so they can advise you accordingly.
Breastfeeding
Fluoxetine is excreted in breast milk and may cause adverse effects in infants. Breastfeeding should therefore only be undertaken if clearly necessary. If breastfeeding is continued, your doctor may prescribe a lower dose of fluoxetine.
Fertility
Fluoxetine has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed to date.
Driving and using machines
Psychotropic medicines such as Fluoxetina ratiopharm may impair your judgement and coordination. Do not drive or operate machinery until you know how Fluoxetina ratiopharm affects you.
Fluoxetina ratiopharm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Fluoxetina ratiopharm

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Do not take more tablets than your doctor has prescribed.

Adults
The recommended dose is:

Depression: The recommended dose is 20 mg daily. If necessary, your doctor will review and adjust your dose within 3 to 4 weeks after starting treatment. If needed, the dose may be gradually increased up to a maximum of 60 mg daily. The dose should be increased cautiously to ensure you receive the lowest effective dose. You may not feel better immediately at the beginning of treatment with this medicine for depression. This is normal, as improvement in depressive symptoms may only become evident after several weeks of therapy. Patients with depression should be treated for at least 6 months.
Bulimia nervosa: The recommended dose is 60 mg daily.
Obsessive-compulsive disorder: The recommended dose is 20 mg daily. If necessary, your doctor will review and adjust your dose after 2 weeks of treatment. If needed, the dose may be gradually increased up to a maximum of 60 mg daily. If no improvement is observed within 10 weeks, your doctor will reconsider your treatment.

Use in children and adolescents aged 8 to 18 years with depression
Treatment must be initiated and supervised by a specialist. The initial dose is 10 mg/day. After 1 or 2 weeks, your doctor may increase the dose to 20 mg/day. The dose should be increased cautiously to ensure you receive the lowest effective dose. Children with low body weight may require lower doses. If the response to treatment is satisfactory, your doctor will evaluate whether continued treatment beyond 6 months is necessary. If no improvement is observed within 9 weeks, your doctor will reassess your treatment.

Elderly patients
If you are elderly, your doctor will increase the dose more cautiously, and the daily dose should generally not exceed 40 mg. The maximum dose is 60 mg daily.

Impaired hepatic function
If you have liver problems or are taking another medicine that may interact with Fluoxetina ratiopharm, your doctor may decide to prescribe a lower dose or instruct you to take Fluoxetina ratiopharm on alternate days.

Method of administration
It is recommended to take one or half a dispersible tablet, swallowed whole with some water or dissolved in ½ to 1 glass of water. The resulting suspension should be drunk immediately and completely.

If you take more Fluoxetina ratiopharm than you should
If you have taken too many dispersible tablets, go immediately to the nearest hospital emergency department or contact your doctor without delay.
If possible, bring a pack of Fluoxetina ratiopharm with you.
Symptoms of overdose include: nausea, vomiting, seizures, heart problems (such as irregular heartbeat and cardiac arrest), respiratory disorders, and variable mental status changes ranging from agitation to coma.

If you forget to take Fluoxetina ratiopharm
If you miss a dose, do not worry. Take the next dose the following day at your usual time. Do not take a double dose to make up for the missed dose.
Taking the medicine every day at the same time may help you remember to take it regularly.

If you stop taking Fluoxetina ratiopharm
Do not stop taking Fluoxetina ratiopharm without first consulting your doctor, even if you start to feel better. It is important that you continue taking the medicine.
Make sure you do not run out of medicine.
You may experience the following effects (withdrawal symptoms) when stopping Fluoxetina ratiopharm: dizziness, tingling sensations like pins and needles, sleep disturbances (vivid dreams, nightmares, difficulty falling asleep), feelings of restlessness or agitation, unusual tiredness or weakness, feelings of anxiety, nausea/vomiting (feeling unwell), tremor (motor instability), headache. For most people, withdrawal symptoms after stopping Fluoxetina ratiopharm are mild and disappear within a few weeks. If you experience symptoms when stopping treatment, contact your doctor. When discontinuing treatment with Fluoxetina ratiopharm, your doctor will help you gradually reduce the dose over one or two weeks: this will help reduce the likelihood of withdrawal effects.

If you have any 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 at any time you experience thoughts of self-harm or suicide, contact your doctor immediately or go to hospital straight away (see section 2).
If you develop a skin rash or an allergic reaction such as itching, swelling of the lips/tongue, or shortness of breath/wheezing, stop taking the tablets immediately and contact your doctor immediately.
If you feel restless and unable to sit or stand still, this may be akathisia: increasing the dose of Fluoxetina ratiopharm may worsen this feeling. If you experience these sensations, contact your doctor.
Inform your doctor immediately if your skin becomes red or if you develop a skin reaction, or if your skin starts blistering or peeling. This occurrence is rare.

The most common side effects (very common side effects which may affect more than 1 in 10 patients) 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 rapid heartbeat, sweating, muscle stiffness or tremor, confusion, extreme agitation or drowsiness (rarely only);
feeling weak, numb or confused, especially in elderly people and patients (elderly) being treated with diuretics (tablets for urination);
prolonged and painful erection;
irritability and extreme restlessness;
heart problems such as fast or irregular heartbeat, fainting, collapse or dizziness, which may indicate abnormal heart function.

If you experience any of the above side effects, inform your doctor immediately.
The following side effects have also been reported in patients treated with fluoxetine:
Common (may affect up to 1 in 10 people)

loss of appetite, weight loss;
nervousness, anxiety;
restlessness, poor concentration;
feeling tense;
decreased sexual desire or sexual problems (including difficulty maintaining an erection during sexual activity);
sleep disturbances, abnormal dreams, tiredness or drowsiness;
dizziness;
altered taste;
uncontrollable trembling movements;
blurred vision;
sensation of rapid or irregular heartbeat;
hot flushes;
yawning;
indigestion, vomiting;
dry mouth;
rash, hives, itching;
excessive sweating;
joint pain;
need to urinate more frequently;
unexplained vaginal bleeding;
sensation of trembling or chills.

Uncommon (may affect up to 1 in 100 people)

feeling detached from oneself;
unusual thoughts;
abnormally elevated mood;
sexual problems, including orgasm problems, occasionally persisting after stopping treatment;
suicidal thoughts or thoughts of 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;
gastrointestinal bleeding;
cold sweat;
difficulty urinating;
general feeling of being unwell;
unusual feeling of discomfort;
sensation of feeling hot or cold;
changes in liver function tests.

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

low levels of sodium in the blood;
reduced platelet count, increasing the risk of bleeding and bruising;
reduced white blood cells in the blood;
unusually uncontrolled behaviour;
hallucinations;
agitation;
panic attacks;
confusion;
stuttering;
aggression;
seizures;
vasculitis (inflammation of a blood vessel);
rapid swelling of tissues around the neck, face, mouth and/or throat;
pain in the tube connecting the throat to the stomach (oesophagus);
sore throat;
hepatitis;
lung problems;
sensitivity to sunlight;
bleeding of the skin;
muscle pain;
problems urinating;
milk production from the breasts;
bleeding from mucous membranes.

Not known (frequency cannot be estimated from the available data)

heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section “Pregnancy, breastfeeding and fertility” in section 2 for further information.

Bone fractures – an increased risk of bone fractures has been observed in patients taking this type of medicine.
Most of these side effects are likely to disappear with continued treatment.

In children and adolescents (aged 8–18 years)
In addition to the possible side effects listed above, fluoxetine may slow growth or possibly delay sexual maturation. Suicidal-related behaviours (suicide attempt and suicidal thoughts), hostility, mania and nosebleeds have also been commonly reported in children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluoxetina ratiopharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fluoxetina ratiopharm contains

The active substance is fluoxetine.

Each dispersible tablet contains 20 mg of fluoxetine (as hydrochloride).

The other ingredients are: microcrystalline cellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica.

What Fluoxetina ratiopharm looks like and contents of the pack
White, round tablets with a score line.
The tablet can be divided into two equal doses.
Pack sizes: 10, 10x1, 12, 14, 20, 28, 30, 30x1, 50, 100 and 100x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: ratiopharm GmbH, Graf-Arco Strasse 3, Ulm (Germany)
Responsible manufacturer for batch release:
Merckle GmbH – Ludwig-Merckle Strasse 3 – 89143 Blaubeuren (Germany)
This patient information leaflet was last approved on