Prozac: detailed information

Package leaflet: Information for the user

Prozac 20 mg hard capsules

fluoxetine
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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Prozac hard capsules are and what they are used for
What you need to know before taking Prozac hard capsules
How to take Prozac hard capsules
Possible side effects
How to store Prozac hard capsules
Contents of the pack and other information

1. What Prozac hard capsules are and what they are used for

Prozac 20 mg hard capsules contain 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: Prozac is used in combination with psychotherapy to reduce binge eating and purging behaviours

Children and adolescents aged 8 years and older :

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

How Prozac works
Each individual has in the brain a substance called serotonin. People who are depressed, or who have obsessive-compulsive disorder or bulimia nervosa, have lower levels of serotonin than others. The exact way in which Prozac 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 worse and more difficult to treat.
To ensure that symptoms do not return, treatment may need to continue for several weeks or months.

2. What you need to know before taking Prozac hard capsules

Do not take Prozac if:

You are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you develop a skin rash or other allergic reactions (such as itching, swelling of the lips or face, or shortness of breath), stop taking the capsules 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 used to treat depression).

Treatment with Prozac must be started 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 Prozac. If Prozac has been prescribed for a long period of time and/or at high doses, your doctor should consider a longer interval.

You are taking metoprolol (for the 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 Prozac if any of the following apply to you:

heart problems;
development of fever, muscle stiffness, or tremor, or changes in mental status such as confusion, irritability, or extreme agitation; you may be experiencing the so-called "serotonin syndrome" or "neuroleptic malignant syndrome". Although this syndrome is rare, it can lead to potentially life-threatening conditions; contact your doctor immediately, as it may be necessary to stop taking Prozac;
if you have or have previously had episodes of mania; if you experience an episode of mania, contact your doctor immediately, as it may be necessary to stop taking Prozac;
history of bleeding disorders or occurrence of bruising or unusual bleeding;
ongoing treatment with medicines that improve blood fluidity (see "Other medicines and Prozac");
epilepsy or seizures. If you have a seizure (convulsions) or experience an increase in the frequency of seizures, contact your doctor immediately; it may be necessary to stop taking Prozac;
undergoing electroconvulsive therapy (ECT);
ongoing treatment with tamoxifen (used to treat breast cancer) (see "Other medicines and Prozac");
you start feeling restless and unable to sit still or remain still (akathisia). Increasing the dose of Prozac may worsen this condition;
diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment);
liver problems (your doctor may need to adjust your dose);
low resting heart rate and/or if you are aware that you may have a deficiency of salts due to severe and prolonged diarrhoea and vomiting (feeling unwell) or as a result of taking diuretics (water tablets);
ongoing treatment with diuretics (water tablets), especially if you are elderly;
glaucoma (increased pressure inside the eye);

Suicidal thoughts and worsening of depression and anxiety disorders.
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide.
These thoughts may increase when you first start treatment with antidepressants, as these medicines take time to become effective, usually about 2 weeks but sometimes longer.
You may be more likely to have these thoughts:

If you have previously had thoughts of suicide or self-harm.
If you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant. If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go to hospital immediately. It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them to inform you if they believe your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Children and adolescents aged 8 to 18:

When taking this type of medicine, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostile behaviour (especially aggressive, oppositional, and angry behaviour). Prozac should be used in children and adolescents aged 8 to 18 only for the treatment of moderate to severe major depressive episodes (in combination with psychotherapy) and should not be used to treat other conditions.
Furthermore, only limited data are available regarding the long-term safety of Prozac on growth, puberty, and mental, emotional, and behavioural development in this age group. Nevertheless, and in patients under 18 years of age, your doctor may prescribe Prozac for the treatment of moderate to severe major depressive episodes in combination with psychotherapy if they consider it to be the best option for them. If your doctor has prescribed Prozac for a patient under 18 years of age and you wish to obtain clarification, consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with Prozac in patients under 18 years of age.
Prozac must not be used to treat children under 8 years of age.

Sexual dysfunction
Medicines such as Prozac (so-called selective serotonin reuptake inhibitors, SSRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after stopping treatment.

Other medicines and Prozac
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Prozac with:

certain irreversible and non-selective monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Irreversible and non-selective MAOIs must not be used with Prozac, as serious or even fatal reactions (serotonin syndrome) may occur (see section "Do not take Prozac"). Treatment with Prozac must be started strictly at least 2 weeks after stopping an irreversible and non-selective MAOI (such as tranylcypromine). Do not take any irreversible and non-selective MAOI for at least 5 weeks after stopping Prozac. If Prozac has been prescribed for a long time and/or at high doses, your doctor may need to consider a longer interval than 5 weeks.
metoprolol when used for heart failure; there is an increased risk that your heart rate may become too slow.

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

tamoxifen (used to treat breast cancer); since Prozac may alter blood levels of this medicine, potentially reducing the effectiveness of tamoxifen, your doctor may consider prescribing another antidepressant;
monoamine oxidase inhibitors Type A (MAOI-Type A) including moclobemide, linezolid (an antibiotic), and methylene blue chloride (also known as methylene blue, used for acute symptomatic treatment of drug- or chemical-induced methaemoglobinaemia, for local treatment of skin infections such as plaque psoriasis, acne vulgaris, and herpes labialis, and as a diagnostic agent for renal function and glomerular filtration rate calculation): 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 an MAOI-Type A;
mequitazine (used for allergic conditions); because taking this medicine with Prozac may increase the risk of changes in the heart's electrical activity;
phenytoin (for epilepsy); since Prozac may affect blood levels of this medicine, your doctor may need to administer phenytoin more carefully and perform monitoring tests when given with Prozac;
lithium, selegiline, St. John's Wort, tramadol (a painkiller), triptans (for migraine), and tryptophan; when these medicines are taken with Prozac, there is an increased risk of developing a mild serotonin syndrome. Your doctor will perform more frequent checks;
medicines that may alter heart rhythm, e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antibacterial agents (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine), antimalarial treatments and particularly halofantrine, or certain antihistamines (astemizole, mizolastine), because taking one or more of these medicines with Prozac 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), aspirin, and other medicines that may improve blood fluidity (including clozapine, used to treat certain mental disorders). Prozac may alter the effect of these medicines on blood. If treatment with Prozac is started or stopped while you are taking warfarin, your doctor will need to perform tests, adjust your dose, and monitor you more frequently;
cyproheptadine (used for allergic conditions); because it may reduce the effect of Prozac;
medicines that lower sodium levels in the blood (including medicines that increase urine output, desmopressin, carbamazepine, and oxcarbazepine); because these medicines may increase the risk of low blood sodium levels when taken with Prozac;
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; because Prozac may increase the risk of seizures when taken with these medicines;
flecainide, propafenone, nebivolol, or encainide (for heart conditions), carbamazepine (for epilepsy), atomoxetine, or tricyclic antidepressants (e.g. imipramine, desipramine, and amitriptyline) or risperidone (for schizophrenia); because Prozac may alter blood levels of these medicines to some extent, your doctor may need to reduce their dosage when administered with Prozac.

Prozac with food, drinks, and alcohol

You may take Prozac regardless of meals, as preferred.
You should avoid drinking alcohol while taking this medicine.

Pregnancy
Inform your doctor as soon as possible if you are or might be pregnant, or if you are planning a pregnancy.
In newborns whose mothers took fluoxetine during the first months of pregnancy, some studies have reported a slightly increased risk of congenital heart defects. In the general population, about 1 in 100 newborns is born with a heart defect. This figure increased to about 2 in 100 in mothers who took fluoxetine.
When taken during pregnancy, especially during the last 3 months, medicines such as Prozac may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe rapidly and appear bluish. These symptoms usually appear within the first 24 hours after birth.
If this occurs in the newborn, 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 Prozac before or during pregnancy. However, depending on the circumstances, your doctor may advise that it is better for you to continue taking Prozac.
Caution is recommended when taking Prozac during pregnancy, particularly during the late stages of pregnancy or shortly before delivery, as the following effects have been reported in newborns: irritability, tremor, muscle weakness, persistent crying, difficulty feeding or sleeping.

Breastfeeding
Fluoxetine is excreted in breast milk and may cause adverse effects in newborns. Breastfeeding should only be continued if clearly necessary. If breastfeeding is continued, your doctor may prescribe a lower dose of fluoxetine.

Fertility
In animal studies, fluoxetine has been shown to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.

Driving and using machines
Medicines that affect mental function, such as Prozac, may impair judgment or coordination. Do not drive or operate tools or machinery until you know how Prozac affects you.

3. How to take Prozac hard capsules

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Do not take more capsules than your doctor has prescribed.
Swallow the capsules with a glass of water. Do not chew the capsules.

Adults:
The recommended dose is:

Depression: The recommended dose is 1 capsule (20 mg) daily. If necessary, your doctor will review and adjust the dose within 3–4 weeks of 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 cautiously to ensure you receive the lowest effective dose. You may not notice an immediate improvement at the beginning of treatment for depression. This is normal, as symptom improvement in depression may only become apparent after the first few weeks of therapy. Patients with depression should be treated for at least 6 months.
Bulimia nervosa: The recommended dose is 3 capsules (60 mg) daily.
Obsessive-compulsive disorder: The recommended dose is 1 capsule (20 mg) daily. If necessary, your doctor will review and adjust the dose after 2 weeks of treatment. If required, the dose may be gradually increased up to a maximum of 3 capsules (60 mg) daily. If no improvement is observed within the first 10 weeks, your doctor will reassess the 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 daily (administered as 2.5 ml of Prozac oral solution). After 1–2 weeks, your doctor may increase the dose to 20 mg daily. The dose should be increased cautiously to ensure the lowest effective dose is given. Children with low body weight may require lower doses. If a satisfactory response to treatment is achieved, your doctor will reassess the need for continuing treatment beyond 6 months. If there is no improvement within the first 9 weeks, your doctor should reconsider the treatment.

Elderly:
Your doctor will exercise greater caution when increasing the dose, and the daily dose should generally not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) daily.

Hepatic impairment:
If you have a liver disorder or are taking another medicine that could interact with Prozac, your doctor may decide to prescribe a lower dose or instruct you to take Prozac on alternate days.

If you take more Prozac than you should

If you take too many capsules, go immediately to the nearest hospital Emergency Department or contact your doctor without delay.
If possible, bring the Prozac packaging with you.

Symptoms of overdose include: nausea, vomiting, seizures, cardiac disturbances (such as irregular heartbeat and cardiac arrest), respiratory disturbances, and changes in mental state ranging from agitation to coma.

If you forget to take Prozac

If you miss a dose, do not worry. 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.

If you stop taking Prozac

Do not stop taking Prozac without first consulting your doctor, even if you start to feel better. It is important to take the medicine continuously.
Make sure you do not run out of capsules.

When you stop taking Prozac, you may experience the following effects (withdrawal symptoms): dizziness;
pins and needles sensations (paresthesia); sleep disturbances (vivid dreams, nightmares, difficulty falling asleep);
feelings of restlessness or agitation; unusual tiredness or weakness; feelings of anxiety; nausea/vomiting;
tremor; headache.

Most people report that any symptoms that occur when stopping Prozac are mild and disappear within a few weeks. If you experience any symptoms when stopping treatment, contact your doctor.
When you stop taking Prozac, your doctor will help you gradually reduce the dose over one or two weeks—this should 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 gets them.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go to hospital immediately (see section 2).
If you develop a skin rash or an allergic reaction such as itching, swelling of the lips or tongue, difficulty breathing, or shortness of breath, stop taking the capsules immediately and inform your doctor immediately.
If you feel restless and unable to sit still or remain motionless, you may have a condition called akathisia; increasing the dose of Prozac could make you feel worse. If you experience these sensations, contact your doctor.
Contact your doctor immediately if your skin starts to become red, if you develop a different skin reaction, or if your skin begins to blister or peel. This event is very rare.

The most common side effects (very common side effects that 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 and increased heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation, or drowsiness (rarely only);
weakness, drowsiness, or confusion, especially in elderly people and in people (elderly) taking diuretics (water tablets);
prolonged and painful erection;
irritability and extreme agitation;
heart problems, such as increased or irregular heart rate, fainting, collapse, or dizziness when standing, which may indicate abnormal heart rhythm.

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

loss of appetite, weight loss
nervousness, anxiety
restlessness, difficulty concentrating
feeling tense
reduced sexual desire and sexual problems (including difficulty maintaining an erection during sexual activity)
sleep problems, unusual dreams, tiredness or drowsiness
dizziness
altered taste
uncontrollable movements
blurred vision
sensation of fast or irregular heartbeat
flushing
yawning
indigestion, vomiting
dry mouth
skin rash, hives, itching
excessive sweating
joint pain
increased frequency of urination
unexplained vaginal bleeding
feeling unable to stand or chills

Uncommon (may affect up to 1 in 100 people)

feeling detached from oneself
strange thoughts
abnormally elevated mood
sexual problems, including orgasm problems, occasionally persisting after stopping treatment
suicidal thoughts or thoughts of self-harm
teeth grinding
muscle contraction, involuntary movements, or problems with balance or coordination
reduced memory
dilated pupils
ringing in the ears
low blood pressure
shortness of breath
nosebleeds
difficulty swallowing
hair loss
increased tendency to bruise
appearance of unexplained bruises or bleeding
cold sweating
difficulty passing urine
sensation of heat or cold
changes in liver function tests

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

reduced levels of sodium in the blood
decreased platelets in the blood, increasing the risk of bleeding or bruising
decreased white blood cells in the blood
unusual, 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 that allows food and water to pass into the stomach
hepatitis
lung problems
sensitivity to sunlight
muscle pain
problems with urination
milk secretion from the breasts

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 if treatment is continued.
Children and Adolescents (8–18 years) – In addition to the possible side effects listed above, Prozac may
slow growth and possibly delay sexual maturation. Suicidal behaviour (suicide attempt and suicidal thoughts),
hostile behaviour, 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 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 Prozac hard capsules

Keep Prozac out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging (Exp). The expiry date refers to the last day of that month.
Do not store the capsules at temperatures above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Prozac hard capsules contain
The active substance is fluoxetine hydrochloride. Each capsule contains 20 milligrams (mg) of fluoxetine (as
fluoxetine hydrochloride).
The excipients are: fluid maize starch and dimethicone.
The capsule shell consists of gelatin, patent blue V (E131), yellow iron oxide (E172), titanium dioxide (E171), and edible black printing ink, which contains shellac, black iron oxide (E172), propylene glycol, and may contain ammonium hydroxide and potassium hydroxide.
Description of the appearance of Prozac hard capsules and contents of the pack
The capsules are yellow and green, printed with 'Lilly 3105'. The capsules are available in PVC/aluminum blisters containing 2, 7, 12, 14, 20, 28, 30, 50, 56, 70, 98, 100 and 500 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ELI LILLY ITALIA S.p.A., Via Gramsci 731/733 - Sesto Fiorentino (FI)
Manufacturer responsible for batch release:
PATHEON FRANCE, 40, boulevard de Champaret, 38300 Bourgoin-Jallieu – France
This medicinal product is authorised in the European Economic Area Member States under the following
names:
Austria: Fluctine
Belgium: Prozac, Fontex
Czech Republic: Prozac
France: Prozac
Greece: Ladose
Ireland: Prozac
Italy: Prozac
Luxembourg: Prozac, Fontex
Malta: Prozac
Portugal: Prozac
Spain: Prozac
United Kingdom: Prozac
More detailed information on this medicinal product is available on the website of AIFA (Italian Medicines Agency) www.aifa.gov.it

Package leaflet: Information for the user

Prozac 20 mg dispersible tablets

fluoxetine
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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Prozac dispersible tablets are and what they are used for
What you need to know before taking Prozac dispersible tablets
How to take Prozac dispersible tablets
Possible side effects
How to store Prozac dispersible tablets
Contents of the pack and other information

1. What Prozac dispersible tablets are and what they are used for

Prozac 20 mg dispersible tablets contain 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: Prozac is used in combination with psychotherapy to reduce binge eating and purging behaviour

Children and adolescents aged 8 years and older :

Moderate to severe major depressive disorder, when depression does not respond to psychotherapy after 4–6 sessions. Prozac should be prescribed to a child or young person with moderate to severe major depressive disorder only in combination with psychotherapy. How Prozac 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 than other individuals. The exact way in which Prozac and other SSRIs work is not fully understood, but they may help by increasing the level of serotonin in the brain. Treating the above-mentioned medical conditions is important to help you feel better. If left untreated, your condition may persist and may become worse and more difficult to treat. To ensure that your symptoms do not return, it may be necessary for treatment to continue for several weeks or months.

2. What you need to know before taking Prozac dispersible tablets

Do not take Prozac if:

You are allergic to fluoxetine or to any of the other ingredients of this medicine (listed in section 6). If you develop a skin 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 without delay.
You are currently taking other medicines known as irreversible and non-selective monoamine oxidase inhibitors (MAOIs), as serious or even fatal reactions may occur (e.g. iproniazid, used to treat depression). Treatment with Prozac 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 Prozac. If Prozac has been prescribed for a long period and/or at high doses, your doctor should consider a longer interval.

You are taking metoprolol (for the 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 Prozac if any of the following apply to you:

heart problems;
development of fever, muscle stiffness or tremor, or changes in mental state such as confusion, irritability, or extreme agitation; you may be experiencing so-called "serotonin syndrome" or "neuroleptic malignant syndrome". Although rare, these syndromes can lead to potentially life-threatening conditions; contact your doctor immediately, as it may be necessary to stop taking Prozac;
you have or have previously had episodes of mania; if you experience a manic episode, contact your doctor immediately, as it may be necessary to stop taking Prozac;
history of bleeding disorders, or occurrence of bruising or unusual bleeding;
concurrent treatment with medicines that affect blood fluidity (see "Other medicines and Prozac");
epilepsy or seizures. If you have a seizure (convulsion) or experience an increase in seizure frequency, contact your doctor immediately; it may be necessary to stop taking Prozac;
undergoing electroconvulsive therapy (ECT);
concurrent treatment with tamoxifen (used to treat breast cancer) (see "Other medicines and Prozac");
you start feeling restless and unable to sit still or remain motionless (akathisia). Increasing the dose of Prozac may worsen this condition;
diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment);
liver problems (your doctor may need to adjust your dose);
low resting heart rate and/or if you are aware that you may have a deficiency of salts due to severe and prolonged diarrhoea and vomiting (feeling unwell), or as a result of taking diuretics (water tablets);
concurrent treatment with diuretics (water tablets), especially if you are elderly;
glaucoma (increased pressure inside the eye);

Suicidal thoughts and worsening of depression and anxiety disorders
If you are depressed and/or have anxiety disorders, you may occasionally have thoughts of harming yourself or committing suicide. These thoughts may increase when you first start treatment with antidepressants, as these medicines usually take about 2 weeks to become effective, and sometimes longer.
You may be more likely to have such thoughts:

If you have previously had thoughts of suicide or self-harm.
If you are a young adult. Data from clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant. If at any time you have thoughts of harming yourself or committing suicide, contact your doctor or go to hospital immediately. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them to inform you if they believe your depression or anxiety is 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 an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostile behaviour (particularly aggressive, oppositional, and irritable behaviour). Prozac should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes (in combination with psychotherapy), and should not be used to treat other conditions.
Furthermore, only limited data are available on the long-term safety of Prozac in this age group regarding growth, puberty, and mental, emotional, and behavioural development.
Despite this, and in patients under 18 years of age, your doctor may prescribe Prozac for the treatment of moderate to severe major depressive episodes in combination with psychotherapy if they consider it to be the best option for you.
If Prozac has been prescribed for a patient under 18 years of age and you wish to obtain clarification, consult your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen during Prozac treatment in patients under 18 years of age.
Prozac must not be used to treat children under 8 years of age.

Other medicines and Prozac
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Prozac with:

certain irreversible and non-selective monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Irreversible and non-selective MAOIs must not be used with Prozac, as serious or even fatal reactions (serotonin syndrome) may occur (see section "Do not take Prozac"). Treatment with Prozac must begin at least 2 weeks after stopping an irreversible and non-selective MAOI (e.g. tranylcypromine). Do not take any irreversible and non-selective MAOI for at least 5 weeks after stopping Prozac. If Prozac has been prescribed for a long period and/or at high doses, your doctor may need to consider a longer interval than 5 weeks.
metoprolol when used for heart failure; there is an increased risk that your heart rate may become too slow.

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

tamoxifen (used to treat breast cancer); since Prozac may alter blood levels of this medicine, potentially reducing tamoxifen's effectiveness, your doctor may consider prescribing a different antidepressant.
monoamine oxidase inhibitors Type A (MAO-A inhibitors) including moclobemide, linezolid (an antibiotic), and methylene blue (used for the acute symptomatic treatment of drug- or chemical-induced methemoglobinemia, for local treatment of skin infections such as plaque psoriasis, acne vulgaris, and herpes labialis, and as a diagnostic agent for renal function and glomerular filtration rate calculation): due to the risk of serious or even fatal reactions (called serotonin syndrome). Fluoxetine treatment 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 the MAO-A inhibitor.
mequitazine (used for allergic conditions); as co-administration with Prozac may increase the risk of changes in heart electrical activity.
phenytoin (for epilepsy); since Prozac may affect blood levels of this medicine, your doctor may need to monitor phenytoin more closely and perform additional checks when it is given with Prozac.
lithium, selegiline, St. John's wort, tramadol (a painkiller), triptans (for migraine), and tryptophan; when taken with Prozac, there is an increased risk of developing mild serotonin syndrome. Your doctor will monitor you more frequently.
medicines that may alter heart rhythm, e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine), antimalarial treatments, particularly halofantrine, or certain antihistamines (astemizole, mizolastine), as co-administration with Prozac may increase the risk of changes in heart electrical activity.
anticoagulants (such as warfarin), NSAIDs (non-steroidal anti-inflammatory drugs – such as ibuprofen, diclofenac), aspirin, and other medicines that may increase blood fluidity (including clozapine, used to treat certain mental disorders). Prozac may alter the effect of these medicines on blood. If Prozac treatment is started or stopped while you are taking warfarin, your doctor will need to perform blood tests, adjust your dose, and monitor you more frequently.
cyproheptadine (used for allergic conditions); as it may reduce the effect of Prozac.
medicines that lower sodium levels in the blood (including diuretics, desmopressin, carbamazepine, and oxcarbazepine); as these medicines may increase the risk of low blood sodium levels when taken with Prozac.
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 Prozac may increase the risk of seizures when taken with these medicines.
flecainide, propafenone, nebivolol, or encainide (for heart conditions), carbamazepine (for epilepsy), atomoxetine, or tricyclic antidepressants (e.g. imipramine, desipramine, and amitriptyline), or risperidone (for schizophrenia); as Prozac may alter blood levels of these medicines, and your doctor may need to reduce their dosage when administered with Prozac.

Prozac with food, drinks, and alcohol

You may take Prozac with or without food, as preferred.
You should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor as soon as possible if you are or might be pregnant, or if you are planning a pregnancy.
Some studies in newborns whose mothers took fluoxetine during the first months of pregnancy have reported an increased risk of congenital heart defects. In the general population, about 1 in 100 newborns is born with a heart defect. This increases to about 2 in 100 among mothers who took fluoxetine.
Medicines such as Prozac, when taken during pregnancy, especially during the last 3 months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe rapidly and appear bluish. These symptoms usually occur within the first 24 hours after birth.
If this occurs in the newborn, 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 Prozac before or during pregnancy. However, depending on the circumstances, your doctor may advise that it is better for you to continue taking Prozac.
Caution is recommended when taking Prozac during pregnancy, particularly during the late stages or just before delivery, as the following effects have been reported in newborns: irritability, tremor, muscle weakness, persistent crying, difficulty feeding or sleeping.

Breastfeeding
Fluoxetine is excreted in breast milk and may cause adverse effects in the newborn. Breastfeeding should only be continued if clearly necessary. If breastfeeding is continued, your doctor may prescribe a lower dose of fluoxetine.

Fertility
In animal studies, fluoxetine has been shown to reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed to date.

Prozac contains sorbitol
This medicine contains 6.71 mg of sorbitol per tablet. If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.

Prozac contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

Prozac contains mannitol
May have a mild laxative effect.

3. How to take Prozac dispersible tablets

Take this medicine exactly as instructed 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.
Swallow the tablets whole with a glass of water, or dissolve them in half a glass of water and drink the solution immediately and completely. Do not chew the tablets.

Adults:
The recommended dose is:

Depression: The recommended dose is 1 tablet (20 mg) per day. If necessary, your doctor will review and adjust the dosage within 3–4 weeks after starting treatment. If required, the dose may be gradually increased up to a maximum of 3 tablets (60 mg) per day. The dose should be increased cautiously to ensure you receive the lowest effective dose. It is possible that you will not notice immediate improvement at the beginning of treatment for depression. This is normal, as symptom improvement in depression may only become evident after the first few weeks of therapy. Patients with depression should be treated for at least 6 months.
Bulimia nervosa: The recommended dose is 3 tablets (60 mg) per day.
Obsessive-compulsive disorder: The recommended dose is 1 tablet (20 mg) per day. If necessary, your doctor will review and adjust the dosage after 2 weeks of treatment. If required, the dose may be gradually increased up to a maximum of 3 tablets (60 mg) per day. If no improvement is observed within the first 10 weeks, your doctor will reassess the 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 per day
(administered as 2.5 ml of Prozac oral solution). After 1–2 weeks, your doctor may increase the dose
to 20 mg per day.
The dose should be increased cautiously to ensure the lowest effective dose is administered. Children
with low body weight may require lower doses. If a satisfactory response to treatment is achieved, your doctor will reassess the need to continue treatment beyond 6 months. If no improvement is seen within the first 9 weeks, your doctor will reconsider the treatment.

Elderly:
Your doctor will exercise greater caution when increasing the dose, and the daily dose should generally not exceed 2 tablets (40 mg). The maximum dose is 3 tablets (60 mg) per day.

Hepatic impairment:
If you have a liver disorder or are taking another medicine that could interact with Prozac, your doctor
may decide to prescribe a lower dose or advise you to take Prozac on alternate days.

If you take more Prozac than you should

If you take too many tablets, go immediately to the nearest hospital emergency department or contact your doctor right away.
If possible, bring the Prozac packaging with you.

Symptoms of overdose may include: nausea, vomiting, seizures, cardiac disturbances (such as irregular heartbeat and cardiac arrest), respiratory problems, and changes in mental status ranging from agitation to coma.

If you forget to take Prozac

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

If you stop taking Prozac

Do not stop taking Prozac without first consulting your doctor, even if you start to feel better. It is important to take the medicine continuously.
Make sure you do not run out of tablets.

When you stop taking Prozac, you may experience the following effects (withdrawal symptoms): dizziness;
tingling sensations like pins and needles; sleep disturbances (vivid dreams, nightmares, difficulty falling asleep); restlessness or agitation; unusual tiredness or weakness; feelings of anxiety; nausea/vomiting; tremor; headache.
Most people report that any symptoms occurring when stopping Prozac are mild and disappear within a few weeks. If you notice any symptoms when stopping treatment, contact your doctor.
When you stop taking Prozac, your doctor will help you gradually reduce the dose over one or two weeks—this should 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 gets them.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go to hospital immediately (see section 2).
If you develop a skin rash or an allergic reaction such as itching, swelling of the lips or tongue, difficulty breathing, or shortness of breath, stop taking the tablets immediately and inform your doctor immediately.
If you feel restless and unable to sit still or remain still, you may have a condition called akathisia; increasing the dose of Prozac could make you feel worse. If you experience these sensations, contact your doctor.
Contact your doctor immediately if your skin starts to become red, if you develop a different skin reaction, or if your skin begins to blister or peel. This event is very rare.

The most common side effects (very common side effects that 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 and rapid heartbeat, sweating, muscle stiffness or tremors, confusion, extreme agitation, or drowsiness (rarely only);
weakness, drowsiness, or confusion, particularly in elderly people and in people (elderly) taking diuretics (water tablets);
prolonged and painful erection;
irritability and extreme agitation;
heart problems, such as rapid or irregular heartbeat, fainting, collapse, or dizziness when standing, which may indicate abnormal heart rhythm. If you experience any of the side effects listed above, inform your doctor immediately.

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

loss of appetite, weight loss
nervousness, anxiety
restlessness, poor concentration
feeling tense
reduced sexual desire and sexual problems (including difficulty maintaining an erection for sexual activity)
sleep problems, unusual dreams, tiredness or drowsiness
dizziness
altered taste
uncontrollable movements
blurred vision
sensation of rapid or irregular heartbeat
flushing
yawning
indigestion, vomiting
dry mouth
rash, hives, itching
excessive sweating
joint pain
increased frequency of urination
unexplained vaginal bleeding
feeling unable to stand or chills

Uncommon (may affect up to 1 in 100 people)

feeling detached from oneself
strange thoughts
excessively elevated mood
sexual problems, including orgasm problems, occasionally persisting after stopping treatment
suicidal thoughts or thoughts of self-harm
teeth grinding
muscle contraction, involuntary movements, or problems with balance or coordination
reduced memory
dilated pupils
ringing in the ears
low blood pressure
shortness of breath
nosebleeds
difficulty swallowing
hair loss
increased tendency to bruise
appearance of unexplained bruises or bleeding
cold sweats
difficulty passing urine
sensation of feeling hot or cold
changes in liver function tests

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

reduced sodium levels in the blood
decreased platelets in the blood, increasing the risk of bleeding or bruising
decreased white blood cells in the blood
unusual, 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 allowing food and water to pass into the stomach (oesophagus)
hepatitis
lung problems
sensitivity to sunlight
muscle pain
problems with urination
milk secretion from the breast

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 if treatment is continued.

Bchildren and adolescents (8–18 years) – In addition to the possible side effects listed above, Prozac may slow growth and possibly delay sexual maturation. Suicidal behaviour (suicide attempt and suicidal thoughts), hostile behaviour, 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 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 Prozac dispersible tablets

Keep Prozac out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (Exp). The expiry date refers to the last day of that month.
Do not store the tablets above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Prozac dispersible tablets contain
The active substance is fluoxetine hydrochloride. Each tablet contains 20 milligrams (mg) of fluoxetine
(as fluoxetine hydrochloride).
The excipients are: microcrystalline cellulose, sodium saccharin, mannitol, sorbitol, anise flavour,
peppermint flavour, anhydrous colloidal silica, pregelatinized corn starch, sodium stearyl fumarate and
crospovidone.
Description of the appearance of Prozac dispersible tablets and contents of the pack
The tablets are white, elongated in shape, uncoated and pre-scored. The tablets can be divided into two equal parts. The tablets are available in blisters of 14, 20, 28, 30, 50, 56, 70 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ELI LILLY ITALIA S.p.A., Via Gramsci 731/733 - 50019 Sesto Fiorentino (FI)
Manufacturer/Responsible person for batch release:
PATHEON FRANCE, 40, boulevard de Champaret, 38300, Bourgoin-Jallieu - France
This medicinal product is authorised in the European Economic Area countries under the following
names:
Belgium: Prozac
Denmark: Fontex
France: Prozac
Greece: Ladose
Iceland: Fontex
Italy: Prozac
Luxembourg: Prozac
Netherlands: Prozac
Norway: Fontex
Romania: Prozac
Spain: Prozac
Sweden: Fontex
More detailed information on this medicinal product is available on the website of AIFA (Agenzia Italiana del Farmaco) www.aifa.gov.it

Package leaflet: information for the user

Prozac 20 mg/5 mL oral solution

fluoxetine
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, consult 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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Prozac oral solution is and what it is used for

Prozac 20 mg/5 mL oral solution 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: Prozac is used in combination with psychotherapy to reduce binge eating and purging behaviours

Children and adolescents aged 8 years and older :

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

How Prozac works
Each individual has a substance in the brain called serotonin. People who are depressed, or who have obsessive-compulsive disorder or bulimia nervosa, have lower levels of serotonin than others. The exact way in which Prozac 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 worse and more difficult to treat.
To ensure that symptoms do not return, treatment may need to continue for several weeks or months.

2. What you should know before taking Prozac oral solution

Do not take Prozac if:

You are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you develop a skin rash or other allergic reactions (such as itching, swelling of the lips or face, or shortness of breath), stop taking the oral solution 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 used to treat depression). Treatment with Prozac must be started 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 you have stopped taking Prozac. If Prozac has been prescribed for a long period of time and/or at high doses, your doctor should consider a longer interval.
You are taking metoprolol (for the 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 Prozac if any of the following apply to you:

heart problems;
development of fever, muscle stiffness, or tremor, or changes in mental state such as confusion, irritability, or extreme agitation; you may be experiencing the so-called "serotonin syndrome" or "neuroleptic malignant syndrome". Although this syndrome is rare, it can lead to potentially life-threatening conditions; contact your doctor immediately, as it may be necessary to stop taking Prozac;
if you have or have previously had episodes of mania; if you experience a manic episode, contact your doctor immediately, as it may be necessary to stop taking Prozac;
history of bleeding disorders or occurrence of bruising or unusual bleeding;
currently being treated with medicines that improve blood fluidity (see "Other medicines and Prozac");
epilepsy or seizures. If you have a seizure (convulsions) or experience an increase in the frequency of seizures, contact your doctor immediately; it may be necessary to stop taking Prozac;
undergoing electroconvulsive therapy (ECT);
currently being treated with tamoxifen (used to treat breast cancer) (see "Other medicines and Prozac");
you start feeling restless and unable to sit still or remain motionless (akathisia). Increasing the dose of Prozac may worsen this condition;
diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment dosage);
liver problems (your doctor may need to adjust your dosage);
low resting heart rate and/or if you are aware that you may have a deficiency of salts due to severe and prolonged diarrhea and vomiting (feeling unwell) or due to the use of diuretics (water tablets);
currently being treated with diuretics (water tablets), especially if you are elderly;
glaucoma (increased pressure inside the eye);

Suicidal thoughts and worsening of depression and anxiety disorders.
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide.
These thoughts may increase when you first start treatment with antidepressants, as these medicines require a period of time to become effective, usually about 2 weeks but sometimes longer.
You may be more likely to have these thoughts:

If you have previously had thoughts of suicide or self-harm.
If you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant. If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go immediately to hospital. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them to inform you if they believe your depression or anxiety is 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 an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostile behaviour (especially aggressive, oppositional, and angry behaviour). Prozac should be used in children and adolescents aged 8 to 18 years only for the treatment of moderate to severe major depressive episodes (in combination with psychotherapy) and should not be used to treat other conditions.
Furthermore, in this age group, there is only limited information available on the long-term safety of Prozac regarding growth, puberty, and mental, emotional, and behavioural development. Nevertheless, and in patients under 18 years of age, your doctor may prescribe Prozac for the treatment of moderate to severe major depressive episodes in combination with psychotherapy if they consider this to be the best option for you. If your doctor has prescribed Prozac to a patient under 18 years of age and you wish to clarify anything, consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen during treatment with Prozac in patients under 18 years of age.
Prozac must not be used to treat children under 8 years of age.
Sexual dysfunction
Medicines such as Prozac (so-called selective serotonin reuptake inhibitors (SSRIs)) can 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 Prozac
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Prozac with :

certain irreversible and non-selective monoamine oxidase inhibitors (MAOIs), some of which are used to treat depression. Irreversible and non-selective MAOIs must not be used with Prozac, as serious or even fatal reactions (serotonin syndrome) may occur (see section "Do not take Prozac"). Treatment with Prozac must be started strictly at least 2 weeks after discontinuation of an irreversible and non-selective MAOI (such as tranylcypromine). Do not take any irreversible and non-selective MAOI for at least 5 weeks after stopping Prozac. If Prozac has been prescribed for a long period and/or at high doses, your doctor may need to consider a longer interval than 5 weeks.
metoprolol when used for heart failure; there is an increased risk that your heart rate may become too slow.

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

tamoxifen (used to treat breast cancer); since Prozac may alter blood levels of this medicine, possibly reducing the effectiveness of tamoxifen, your doctor may need to consider prescribing another antidepressant treatment;
monoamine oxidase inhibitors Type A (MAOI-Type A), including moclobemide, linezolid (an antibiotic), and methylene blue chloride (also known as methylene blue, used for acute symptomatic treatment of drug- or chemical-induced methemoglobinemia, for local treatment of skin infections such as psoriasis, acne vulgaris, and cold sores, and as a diagnostic agent for renal function to calculate glomerular filtration rate); due to the risk of serious or even fatal reactions (called serotonin syndrome). Treatment with fluoxetine may be started the day after discontinuation of a reversible MAOI, but your doctor may decide to monitor you closely and use a lower dose of an MAOI-Type A;
mequitazine (used for allergic conditions); as taking this medicine with Prozac may increase the risk of changes in heart electrical activity;
phenytoin (for epilepsy); since Prozac may affect blood levels of this medicine, your doctor may need to administer phenytoin more carefully and perform monitoring tests when given with Prozac;
lithium, selegiline, St. John's wort, tramadol (a painkiller), triptans (for migraine), and tryptophan; when these medicines are taken with Prozac, there is an increased risk of developing a mild serotonin syndrome. Your doctor will perform more frequent checks;
medicines that may alter heart rhythm, e.g. class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antibacterial agents (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine), antimalarial treatments, particularly halofantrine, or certain antihistamines (astemizole, mizolastine), because taking one or more of these medicines with Prozac may increase the risk of changes in heart electrical activity;
anticoagulants (such as warfarin), NSAIDs (non-steroidal anti-inflammatory drugs - such as ibuprofen, diclofenac), aspirin, and other medicines that may improve blood fluidity (including clozapine, used to treat certain mental disorders). Prozac may alter the effect of these medicines on blood. If treatment with Prozac is started or stopped while you are taking warfarin, your doctor will need to perform some tests, adjust your dosage, and monitor you more frequently;
cyproheptadine (used for allergic conditions); as it may reduce the effect of Prozac;
medicines that lower sodium levels in the blood (including medicines that increase urine output, desmopressin, carbamazepine, and oxcarbazepine); as these medicines may increase the risk of low blood sodium levels when taken with Prozac;
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 Prozac may increase the risk of seizures when taken in combination with these medicines;
flecainide, propafenone, nebivolol, or encainide (for heart conditions), carbamazepine (for epilepsy), atomoxetine, or tricyclic antidepressants (e.g. imipramine, desipramine, and amitriptyline) or risperidone (for schizophrenia); as Prozac may in some way alter blood levels of these medicines, your doctor may need to reduce their dosage when administered with Prozac.

Prozac with food, drinks, and alcohol

You may take Prozac regardless of meals, as preferred.
You should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor as soon as possible if you are or might be pregnant, or if you are planning a pregnancy.
In newborns 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 newborns is born with a heart defect. This figure increases to about 2 in 100 in mothers who took fluoxetine.
When taken during pregnancy, especially during the last 3 months, medicines such as Prozac may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the newborn to breathe rapidly and appear bluish. These symptoms usually occur within the first 24 hours after birth. If this happens to the newborn, 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 Prozac before or during pregnancy. However, depending on the circumstances, your doctor may advise that it is better for you to continue taking Prozac.
Caution is recommended when taking Prozac during pregnancy, especially during the late stages of pregnancy or just before delivery, as the following effects have been reported in newborns: irritability, tremor, muscle weakness, persistent crying, difficulty feeding or sleeping.
Breastfeeding
Fluoxetine is excreted in breast milk and may cause adverse effects in newborns. Breastfeeding should only be continued 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 so far.
Driving and using machines
Medicines that act on mental function, such as Prozac, may alter your judgment or coordination abilities. Do not drive or operate tools or machinery until you know how Prozac affects you.
Prozac contains sucrose
Prozac oral solution contains 3 g of sucrose per 5 mL dose. This should be taken into account in people with diabetes mellitus. It may be harmful to teeth. If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
Prozac contains ethanol
The flavouring of this medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose (see section 6).
Prozac contains benzoic acid
This medicine contains 2.5 mg of benzoic acid per 5 mL dose.

3. How to take Prozac oral solution

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Do not take more medicine than
your doctor has prescribed.
Measure the correct amount of medicine using the measuring device, syringe, or a dosing spoon, then
drink it.

Adults:
The recommended dose is:

Depression: The recommended dose is 5 mL of oral solution (20 mg) daily. If necessary, your doctor will review and adjust the dose within 3–4 weeks of starting treatment. If required, the dose may be gradually increased up to a maximum of 15 mL of oral solution (60 mg) daily. The dose should be increased cautiously to ensure you receive the lowest effective dose. You may not notice immediate improvement at the beginning of treatment for depression. This is normal, as symptom improvement in depression may only become evident after the first few weeks of therapy. Patients with depression should be treated for at least 6 months.
Bulimia nervosa: The recommended dose is 15 mL of oral solution (60 mg) daily.
Obsessive-compulsive disorder (OCD): The recommended dose is 5 mL of oral solution (20 mg) daily. If necessary, your doctor will review and adjust the dose after 2 weeks of treatment. If required, the dose may be gradually increased up to a maximum of 15 mL of oral solution (60 mg) daily. If no improvement is observed within the first 10 weeks, your doctor will reassess the 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 daily (administered as 2.5 mL of Prozac oral solution). After 1–2 weeks, your doctor may increase the dose to 20 mg daily. The dose should be increased cautiously to ensure you receive the lowest effective dose. Children with low body weight may require lower doses. If a satisfactory response to treatment is achieved, your doctor will reassess the need for continuing treatment beyond 6 months. If no improvement is seen within the first 9 weeks, your doctor should reconsider the treatment.

Elderly:
Your doctor will exercise greater caution when increasing the dose, and the daily dose should generally not exceed 10 mL of oral solution (40 mg). The maximum dose is 15 mL of oral solution (60 mg) daily.

Hepatic impairment:
If you have a liver disorder or are taking another medicine that may interact with Prozac, your doctor may decide to prescribe a lower dose or advise you to take Prozac on alternate days.

If you take more Prozac than you should

If you take too much, go immediately to the nearest hospital emergency department or contact your doctor without delay.
If possible, bring the Prozac bottle with you.

Symptoms of overdose may include: nausea, vomiting, seizures, cardiac disturbances (such as irregular heartbeat and cardiac arrest), respiratory disturbances, and changes in mental status ranging from agitation to coma.

If you forget to take Prozac

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

If you stop taking Prozac

Do not stop taking Prozac 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 do not run out of medicine.

When you stop taking Prozac, you may experience the following effects (withdrawal symptoms): 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; tremor; headache.
Most people report that any symptoms occurring when stopping Prozac are mild and resolve within a few weeks. If you experience symptoms when stopping treatment, contact your doctor.
When you stop taking Prozac, your doctor will help you gradually reduce the dose over one or two weeks—this should 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 everyone will experience them.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go immediately to hospital (see section 2).
If you develop a rash or an allergic reaction such as itching, swelling of the lips or tongue, difficulty breathing, or shortness of breath, stop taking the medicine immediately and inform your doctor immediately.
If you feel restless and unable to sit still or remain motionless, you may have a condition called akathisia; increasing the dose of Prozac could make you feel worse. If you experience these sensations, contact your doctor.
Inform your doctor immediately if your skin starts to redden, if you develop a different skin reaction, or if your skin begins to blister or peel. This occurrence is very rare.

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

a group of symptoms (known as “serotonin syndrome”) including unexplained fever with rapid breathing and rapid heartbeat, sweating, muscle stiffness or tremors, confusion, extreme agitation, or drowsiness (rarely);
weakness, drowsiness, or confusion, particularly in elderly people and in people (elderly) taking diuretics (water tablets);
prolonged and painful erection;
irritability and extreme agitation;
heart problems, such as rapid or irregular heartbeat, fainting, collapse, or dizziness when standing, which may indicate abnormal heart rhythm. If you experience any of the side effects listed above, inform your doctor immediately.

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

loss of appetite, weight loss
nervousness, anxiety
restlessness, poor concentration
feeling tense
reduced sexual desire and sexual problems (including difficulty maintaining an erection during sexual activity)
sleep problems, unusual dreams, tiredness or drowsiness
dizziness
altered taste
involuntary movements
blurred vision
sensation of fast or irregular heartbeat
flushing
yawning
indigestion, vomiting
dry mouth
rash, hives, itching
excessive sweating
joint pain
increased frequency of urination
unexplained vaginal bleeding
feeling unable to stand or chills

Uncommon (may affect up to 1 in 100 patients)

feeling detached from oneself
strange thoughts
excessively elevated mood
sexual problems, including orgasm problems, occasionally persisting after stopping treatment
suicidal thoughts or thoughts of self-harm
teeth grinding
muscle contraction, involuntary movements, or problems with balance or coordination
reduced memory
dilated pupils
ringing in the ears
low blood pressure
shortness of breath
nosebleeds
difficulty swallowing
hair loss
increased tendency to bruise
appearance of bruises or unexplained bleeding
cold sweating
difficulty passing urine
sensation of feeling hot or cold
changes in liver function tests

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

reduced levels of sodium in the blood
decreased platelets in the blood, increasing the risk of bleeding or bruising
decreased white blood cells in the blood
unusual, 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 that carries food and water to the stomach
hepatitis
lung problems
sensitivity to sunlight
muscle pain
problems urinating
milk secretion from the breast

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 if treatment is continued.
Children and adolescents (8–18 years) – In addition to the possible side effects listed above, Prozac may
slow growth and possibly delay sexual maturation. Suicidal behaviour (suicide attempt and suicidal thoughts),
hostile behaviour, 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 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 Prozac oral solution

Keep Prozac out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (Exp). The expiry date refers to the
last day of that month.
Do not store the medicine above 30°C.
Store in the original bottle to protect from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Prozac oral solution contains
The active substance is fluoxetine hydrochloride. Each 5 mL of oral solution contains 20 milligrams (mg) of
fluoxetine (as fluoxetine hydrochloride).
The excipients are: benzoic acid, sucrose, glycerin, mint flavour [containing 0.23% ethanol (alcohol)], and purified water.
Description of the appearance of Prozac oral solution and contents of the pack
Prozac 20 mg oral solution is a clear, colourless, mint-flavoured solution.
The medicine is contained in amber glass bottles of 60 mL, 70 mL or 140 mL of oral solution. Packs may also include a measuring cup, a syringe or a spoon. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ELI LILLY ITALIA S.p.A., Via Gramsci 731/733 - Sesto Fiorentino (FI)
Manufacturer responsible for batch release:
PATHEON FRANCE, 40, boulevard de Champaret, 38300 Bourgoin-Jallieu - France
This medicinal product is authorised in the European Economic Area countries under the following
names:
France: Prozac
Greece: Ladose
Hungary: Prozac
Ireland: Prozac
Italy: Prozac
Portugal: Prozac
Spain: Prozac
Sweden: Fontex
United Kingdom: Prozac
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA) www.aifa.gov.it