PROZAC 20 mg Hard Capsule

Содержание инструкции

1. Prozac 20 mg hard capsules
   1. What is Prozac hard capsules and what are they for
   2. What you need to know before taking Prozac hard capsules
   3. How to take Prozac hard capsules
   4. Possible side effects
   5. How to store Prozac hard capsules
   6. Contents of the pack and other information
2. Prozac 20 mg dispersible tablets
   1. What is Prozac dispersible tablets and what it is used for
   2. Cosa deve sapere prima di prendere Prozac compresse dispersibili
   3. How to take Prozac dispersible tablets
   4. Possible side effects
   5. How to store Prozac dispersible tablets
   6. Package Contents and Other Information
3. Prozac 20 mg/5 mL oral solution
   1. What is Prozac oral solution and what is it used for
   2. Cosa deve sapere prima di prendere Prozac soluzione orale
   3. How to take Prozac oral solution
   4. Possible side effects
   5. How to store Prozac oral solution
   6. Contents of the pack and other information

Prozac 20 mg hard capsules

fluoxetine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Prozac hard capsules are and what they are used for
• 2. What you need to know before you take Prozac hard capsules
• 3. How to take Prozac hard capsules
• 4. Possible side effects
• 5. How to store Prozac hard capsules
• 6. Contents of the pack and other information

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

Prozac 20 mg hard capsules contain the active ingredient fluoxetine, which belongs to a group of medicines
called selective serotonin reuptake inhibitors (SSRIs) antidepressants.
This medicine is used to treat the following conditions:

Adults:

• Major depressive episodes
• Obsessive compulsive disorder
• Bulimia nervosa: Prozac is used together with psychotherapy to reduce binge eating and purging behaviours

Children and adolescents aged 8 years and over:

• Major depressive disorder of moderate to severe degree, if the depression does not respond to psychotherapy after 4-6 sessions. Prozac should be proposed to a child or young person with moderate to severe major depressive disorder onlyin association with psychotherapy.

How Prozac works
Each individual has, in their brain, a substance called serotonin. People who are depressed, or
have obsessive compulsive disorder, or bulimia nervosa, have lower levels of serotonin compared to
other individuals. It is not fully understood how Prozac and other SSRIs work, but they can
provide help by increasing the level of serotonin in the brain. Treatment of the aforementioned pathological conditions
is important to help you feel better. If left untreated, your pathological condition may
persist and may become even more serious and more difficult to treat.
To be sure you no longer have symptoms, treatment may need to continue for some
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 and difficulty breathing), stop taking the capsules immediately andcontact your doctor immediately.
• You are taking other medicines known as irreversible and non-selective monoamine oxidase inhibitors (MAOIs), as serious or even life-threatening reactions may occur (e.g. iproniazide used to treat depression).

Treatment with Prozac should be started at least 2 weeks after stopping treatment with an irreversible and non-selective MAOI.

Do nottake 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, the doctor needs to consider a longer time interval.

• You are taking metoprolol (for the treatment of heart failure) as there is an increased risk that your heart rate becomes too slow.

Warnings and precautions
Talk to your doctor or pharmacist before taking Prozac if any of the following applies to you:

• heart problems;
• development of fever, muscle rigidity or tremor, changes in mental status such as confusion, irritability and extreme agitation; you may be affected by the so-called “serotonin syndrome” or “neuroleptic malignant syndrome”. Although this syndrome is rare, it can lead to conditions potentially dangerous to the patient's life; contactyour doctor immediately, as it may be necessary to stop taking Prozac.
• if you have had or are currently experiencing episodes of mania; if you have a manic episode, contact your doctor immediately as it may be necessary to stop taking Prozac;
• history of bleeding disorders or bruising easily or unusual bleeding;
• ongoing treatment with medicines that improve blood fluidity (see ' Other medicines andProzac');
• 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;
• electroconvulsive therapy (ECT) treatment;
• ongoing treatment with tamoxifen (used to treat breast cancer) (see ' Othermedicines and Prozac');
• you start to feel restless and cannot sit still or remain calm (akathisia). Increasing the dose of Prozac may worsen the condition;
• diabetes (your doctor may need to adjust your insulin dosage or other antidiabetic treatment);
• 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 salt deficiency as a result of severe and prolonged diarrhea and vomiting (feeling unwell) or following the use of diuretics (water tablets);
• ongoing treatment with diuretics (water tablets), especially if you are elderly;
• glaucoma (increased pressure inside the eye);

Thoughts of suicide and worsening of depression and anxiety.
If you are depressed and/or anxious, you may sometimes have thoughts of harming yourself or killing yourself. These thoughts may increase when you first start taking antidepressants, as these medicines take time to work, usually about 2 weeks but sometimes longer.
You may be more likely to have these thoughts:

• If you have had thoughts of killing yourself or harming yourself in the past.
• If you are a young adult. Data from clinical studies have shown an increased risk of suicidal behavior 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 killing yourself, contact your doctor or go tohospital immediately. It may be helpful to tell a relative or close friendthat you are depressed or anxious, and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior. Children and adolescents aged between 8 and 18 years:

When taking this type of medicine, patients under 18 years of age have an increased risk of side effects such as suicide attempts, suicidal thoughts and hostile behavior (especially aggressive behavior, opposition and anger). Prozac should only be used in children and adolescents aged between 8 and 18 years for the treatment of moderate to severe major depressive episodes (in association with psychotherapy) and should not be used to treat other conditions.
In addition, limited information is available in this age group regarding the safety of Prozac in the long term on growth, puberty, mental, emotional and behavioral development. Despite this, and in patients under 18 years of age, the doctor may prescribe Prozac for the treatment of moderate to severe major depressive episodes in association with psychotherapy if they believe this is the best solution for them. If the doctor has prescribed Prozac to a patient under 18 years of age and you would like clarification, return to the doctor. You should inform the doctor if any of the symptoms listed above appear or worsen while taking Prozac by patients under 18 years of age.
Prozac should not be used in the treatment of 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:

• some irreversible and non-selective monoamine oxidase inhibitors (MAOIs), some used to treat depression. Irreversible and non-selective MAOIs should not be used with Prozac as serious or even life-threatening reactions (serotonin syndrome) may occur (see section “ Do not take Prozac”). Treatment with Prozac should be started strictly at least 2 weeks after stopping an irreversible and non-selective MAOI (such as tranylcypromine). Do nottake 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 and/or at high doses, the doctor may need to consider a longer time interval of more than 5 weeks.
• metoprololwhen used for heart failure; there is an increased risk that your heart rate becomes too slow.

Prozac can influence the mechanism of action of the following medicines (interaction):

• tamoxifen(used to treat breast cancer); as Prozac may change the levels of this medicine in the blood, with a possible decrease in the effect of tamoxifen, the doctor may need to consider prescribing another antidepressant treatment.
• Type A monoamine oxidase inhibitors (MAO-Type A)including moclobemide, linezolid (an antibiotic) and methylthioninium chloride (also called methylene blue and used for the symptomatic acute treatment of methemoglobinemia induced by drugs or chemicals, for the local treatment of skin infections such as plaque psoriasis, common acne and herpes labialis and as a diagnostic for renal function for the calculation of glomerular filtration rate): due to the risk of serious or even life-threatening reactions (called serotonin syndrome). Treatment with fluoxetine can be started the day after stopping treatment with a reversible MAOI but the doctor may decide to subject you to careful monitoring and use a lower dose of a Type A MAOI.
• mequitazine(used for allergic reactions); as taking this medicine with Prozac may increase the risk of changes in the electrical activity of the heart.
• phenytoin(for epilepsy); as Prozac may affect the levels of this medicine in the blood, when given with Prozac the doctor may need to administer phenytoin with greater care and perform checks.
• lithium, selegiline, St John's Wort, tramadol(a painkiller), triptans(for migraine) andtryptophan; when these medicines are taken with Prozac there is an increased risk of developing a mild serotonin syndrome. The doctor will perform checks more frequently.
• medicines that can alter the heart rhythm, e.g. Class IA and III antiarrhythmics, antipsychotics(e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antibacterialagents(e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), treatment againstmalariaand in particular halofantrine or some antihistamines(astemizole, mizolastine), because taking one or more of these medicines with Prozac may increase the risk of changes in the electrical activity of the heart.
• anticoagulants(such as warfarin), NSAIDs(non-steroidal anti-inflammatory drugs - such as ibuprofen, diclofenac), aspirinand other medicines that can improve blood fluidity(including clozapine, used to treat some mental disorders). Prozac may change the effect of these medicines on the blood. If treatment with Prozac is started or stopped while you are taking warfarin, the doctor will need to perform some tests, adjust the dosage and perform checks more frequently.
• cyproheptadine(used for allergic reactions); as it may reduce the effect of Prozac.
• medicines that lower the level of sodium in the blood(including medicines that cause an increase in urine output, desmopressin, carbamazepine and oxcarbazepine); as these medicines may increase the risk that the levels of sodium in the blood become too low when taken in association with Prozac.
• antidepressantssuch as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquineor chloroquine(used to treat malaria), tramadol(used to treat severe pain) or antipsychoticssuch as phenothiazines or butyrophenones; as Prozac may increase the risk of seizures when taken in association with these medicines.
• flecainide, propafenone, nebivololor encainide(for heart disorders), carbamazepine(for epilepsy), atomoxetineor tricyclic antidepressants(for example imipramine, desipramineand amitriptyline) or risperidone(for schizophrenia); as Prozac may in some way change the levels of these medicines in the blood, the doctor may need to lower their dosage when administered with Prozac.

Prozac with food, drinks and alcohol

• You can take Prozac with or without food, as you prefer.
• You should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Inform your doctor as soon as possible if you are or may be pregnant, or if you are planning a
pregnancy.
In newborns whose mothers have taken fluoxetine during the first months of pregnancy, there have been some studies
describing an increased risk of congenital defects affecting the heart. In the general population,
about 1 in 100 newborns is born with a heart defect. This figure has increased to about 2 in 100
newborns in mothers who have taken fluoxetine.
When taken during pregnancy, especially in the last 3 months of pregnancy, medicines like Prozac
can increase the risk of developing a serious condition in newborns, called persistent pulmonary
hypertension of the newborn (PPHN), which means that the newborn presents with accelerated breathing and a
bluish skin tone. These symptoms generally appear within the first 24 hours after birth.
If this happens to the newborn, contact the 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 can decide to gradually stop
taking Prozac before or during the period of pregnancy. However, depending on the
circumstances, the doctor may suggest that it is better for you to continue taking Prozac.
Caution is recommended when taken during pregnancy, especially during the final period of
pregnancy or immediately before delivery, as the following effects have been reported in newborns: irritability,
tremor, muscle weakness, persistent crying, difficulty sucking or sleeping.

Breastfeeding
Fluoxetine is eliminated in breast milk and can cause unwanted effects in newborns. Breastfeeding
should only be carried out if clearly necessary. If breastfeeding is continued, the
doctor may prescribe you a lower dose of fluoxetine.

Fertility
Fluoxetine, in studies on animals, 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 operating machinery
Medicines that act on mental activity like Prozac can alter your ability to judge or
coordinate. Do not drive or use tools or machinery until you are aware of how Prozac affects
you.

3. How to take Prozac hard capsules

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist. Do not take more capsules than those prescribed by your doctor.
Swallow the capsules with a sip of water. Do not chew the capsules.

Adults:
The recommended dose is:

• Depression: The recommended dose is 1 capsule (20 mg) per day. If necessary, your doctor will review and adjust the dosage within 3-4 weeks of starting treatment. If required, the dosage may be gradually increased to a maximum of 3 capsules (60 mg) per day. The dose should be increased cautiously to ensure you receive the lowest effective dose. You may not feel an immediate improvement at the beginning of treatment for depression. This is normal as an improvement in the symptoms of 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) per day.
• Obsessive compulsive disorder: The recommended dose is 1 capsule (20 mg) per day. If necessary, your doctor will review and adjust the dosage after 2 weeks of therapy. If required, the dosage may be gradually increased to a maximum of 3 capsules (60 mg) per day. If no improvements are noticed within the first 10 weeks, your doctor will re-evaluate the treatment. Use in children and adolescents aged between 8 and 18 years with depression:Treatment must be started 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 you receive the lowest effective dose. Children with low body weight may need lower doses. If a satisfactory response to treatment occurs, your doctor will re-evaluate the need to continue treatment beyond 6 months. If there has been no improvement within the first 9 weeks, your doctor will need to reconsider the treatment. Elderly:Your doctor will be more cautious when increasing the dose and the daily dosage should generally not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) per day.

Liver impairment:
If you have a liver disorder or are taking another medicine that could interfere with Prozac, your doctor
may decide to prescribe you a lower dose or provide instructions for taking Prozac on alternate days.

If you take more Prozac than you should

• If you take too many capsules, go to the Emergency Room of the nearest hospital or inform your doctor immediately.
• If possible, take the Prozac pack with you.

Symptoms of overdose include: nausea, vomiting, convulsions, heart disorders (such as an irregular
heartbeat and cardiac arrest), respiratory disorders 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 the usual time the following day. Do not take a double dose to make up for a missed dose.
• Taking the medicine every day at the same time can help you remember to take it regularly.

If you stop taking Prozac

• Do notstop taking Prozac without first asking your doctor, even when you start to feel better. It is important that you take the medicine continuously.
• Make sure you do not run out of capsules.

When you stop taking Prozac you may notice the following effects (discontinuation effects): dizziness;
tingling sensations such as pins and needles; sleep disturbances (vivid dreams, nightmares, inability
to fall asleep); feeling restless or agitated; unusual fatigue or weakness; feeling of
anxiety; nausea/vomiting; tremor; headache.
Most people report that any symptoms that occur when stopping
therapy with Prozac are mild and disappear within a few weeks. If you should observe the
appearance of symptoms when stopping treatment, contact your doctor.
When you stop taking Prozac, your doctor will help you reduce the dose gradually over one or two
weeks - this should help reduce the possibility of discontinuation effects.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

• If at any time you have thoughts of harming yourself or of suicide, contact your doctor or goimmediately to hospital(see section 2).
• If you develop a skin rash or an allergic reaction such as itching, swelling of the lips or tongue, difficulty breathing, shortness of breath, stop taking the capsules immediately and informyour doctor immediately.
• If you feel a sensation of restlessness and are unable to sit or stay still, you may have a condition called akathisia; an increase in the dose of Prozac may make you feel worse. If you experience these sensations, contact your doctor.
• Report to your doctor immediatelyif your skin begins to redden or if you develop a different skin reaction or if your skin begins to blister or peel. This is very rare.

The most common side effects (very common side effects that can affect more than
1 in 10 patients) are insomnia, headache, diarrhea, feeling of disgust (nausea) and fatigue.
Some patients have experienced:

• a collection of symptoms (known as “serotonin syndrome”) including unexplained fever with rapid breathing and heart rate, sweating, muscle rigidity or tremors, confusion, extreme agitation or drowsiness (rarely only);
• a feeling of weakness, drowsiness or confusion especially in elderly people and people (elderly) who are taking diuretics (water tablets);
• a prolonged and painful erection;
• irritability and extreme agitation;
• heart problems, such as a fast or irregular heartbeat, fainting, collapse or dizziness when standing up, which may indicate abnormal heart rate function.

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, poor concentration
• feeling tense
• reduced sexual desire and sexual problems (including difficulty achieving an erection for sexual activity)
• sleep problems, unusual dreams, tiredness or drowsiness
• dizziness
• altered taste
• uncontrolled movements
• blurred vision
• feeling of fast and 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
• excessively elevated mood
• sexual problems, including problems with orgasm, occasionally persistent after stopping treatment
• thoughts of suicide or 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 develop bruises
• unexplained bruising or bleeding
• cold sweats
• difficulty passing urine
• feeling hot 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, which increases the risk of bleeding or bruising
• decreased white blood cells
• unusual uncontrolled behavior
• 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 to the stomach
• hepatitis
• lung problems
• sensitivity to sunlight
• muscle pain
• problems with urination
• secretion of milk 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 with continued treatment.

Children and Adolescents (8-18 years)–In addition to the possible side effects listed above, Prozac can
slow down growth and possibly delay sexual maturation. Behaviors related to suicide (suicide attempt
and suicidal thoughts), hostile attitude, mania and nosebleeds have also been commonly reported
in children.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through 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 sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package (Exp). The expiry date
refers to the last day of that month.
Do not store the capsules at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. 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 Prozac hard capsules contain
The active ingredientis fluoxetine hydrochloride. Each capsule contains 20 milligrams (mg) of fluoxetine (as
fluoxetine hydrochloride).
The excipientsare: fluid corn starch and dimethicone.
The capsule shell consists of gelatin, Patent Blue V (E131), yellow iron oxide (E172), titanium
dioxide (E171) and edible black ink for printing, 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 in colour, with 'Lilly 3105' printed on them. The capsules are available in blisters of
PVC/aluminium in packs of 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)

Responsible Manufacturer for batch release:
PATHEON FRANCE, 40, boulevard de Champaret, 38300 Bourgoin-Jallieu – France

This medicinal product is authorised in the Member States of the European Economic Area 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 AIFA (Agenzia Italiana
del Farmaco) website www.aifa.gov.it

Prozac 20 mg dispersible tablets

fluoxetine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Prozac dispersible tablets are and what they are used for
• 2. What you need to know before you take Prozac dispersible tablets
• 3. How to take Prozac dispersible tablets
• 4. Possible side effects
• 5. How to store Prozac dispersible tablets
• 6. Contents of the pack and other information

1. What is Prozac dispersible tablets and what it is used for

Prozac 20 mg dispersible tablets contains the active ingredient fluoxetine which belongs to a group of
medicines called selective serotonin reuptake inhibitors (SSRIs) antidepressants.
This medicine is used to treat the following conditions:

Adults:

• Major depressive episodes
• Obsessive compulsive disorder
• Bulimia nervosa: Prozac is used together with psychotherapy to reduce binge eating and purging behaviours

Children and adolescents aged 8 years and over:

• Major depressive disorder of moderate to severe degree, if the depression does not respond to psychotherapy after 4-6 sessions. Prozac should be proposed to a child or young person with moderate to severe major depressive disorder onlyin association with psychotherapy. How Prozac works Every individual has, in their brain, a substance called serotonin. People who are depressed, or have obsessive compulsive disorder, or bulimia nervosa, have lower levels of serotonin compared to other individuals. It is not fully understood how Prozac and other SSRIs work, but they may provide help by increasing the level of serotonin in the brain. Treatment of the aforementioned pathological conditions is important to help you feel better. If left untreated, your pathological condition may persist and may become even more serious and more difficult to treat. To be sure you no longer have symptoms, treatment may need to continue for several weeks or months.

2. Cosa deve sapere prima di prendere Prozac compresse dispersibili

Non prenda Prozac se:

• È allergico alla fluoxetina o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6). Se presenta una eruzione cutanea od altre reazioni allergiche (come prurito,gonfiore alle labbra o al viso e respiro affannoso), interrompa subito l’assunzione dellecompresse e contatti immediatamente il medico.
• Sta assumendo altri medicinali noti come inibitori irreversibili e non selettivi della monoamino ossidasi (IMAO), poiché possono verificarsi reazioni gravi o anche letali (es. iproniazide usato per trattare la depressione). Il trattamento con Prozac deve essere iniziato almeno 2 settimane dopo l'interruzione del trattamento con un IMAO irreversibile e non selettivo.

Nonprenda alcun IMAO irreversibile e non selettivo per almeno 5 settimane dopo che ha cessato di
prendere Prozac. Se Prozac le è stato prescritto per un lungo periodo di tempo e/o ad alte dosi, è
necessario che il medico tenga presente un intervallo di tempo più lungo.

• Sta assumendo metoprololo (per il trattamento dell’insufficienza cardiaca) poiché c’è un aumentato rischio che il suo battito cardiaco diventi troppo lento.

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere Prozac se qualcuna delle seguenti situazioni la
riguarda:

• problemi al cuore;
• comparsa di febbre, rigidità muscolare o tremore, modificazioni dello stato mentale come stato confusionale, irritabilità ed agitazione estrema; lei può essere interessato dalla cosiddetta “sindrome serotoninergica” o “sindrome maligna da neurolettici”. Sebbene questa sindrome si manifesti raramente essa può dare luogo a condizioni potenzialmente pericolose per la vita del paziente; contattiimmediatamente il medico, poiché può essere necessario interrompere l'assunzione di Prozac.
• se ha o ha avuto in passato episodi di mania; se ha un episodio di mania, contatti immediatamente il medico perché può essere necessario interrompere l'assunzione di Prozac;
• storia di alterazioni del sanguinamento o comparsa di lividi o di un insolito sanguinamento;
• trattamento in atto con medicinali che migliorano la fluidità del sangue (vedere ' Altri medicinali eProzac');
• epilessia o crisi convulsive. Se ha una crisi convulsiva (convulsioni) o va incontro ad un aumento nella frequenza delle convulsioni, contatti immediatamente il medico; può essere necessario interrompere l'assunzione di Prozac;
• trattamento con TEC (terapia elettroconvulsiva);
• trattamento in atto con tamoxifene (usato per trattare il cancro della mammella) (vedere ' Altrimedicinali e Prozac');
• inizia a sentirsi irrequieto e non riesce a stare seduto o a stare fermo (acatisia). Aumentare la dose di Prozac può peggiorare la situazione;
• diabete (il medico può avere bisogno di aggiustarle il dosaggio di insulina o di un altro trattamento antidiabetico);
• problemi al fegato (il medico può aver bisogno di aggiustarle il dosaggio);
• bassa frequenza cardiaca a riposo e/o se lei è consapevole che può avere una carenza di sali come conseguenza di una diarrea grave e prolungata e di vomito (sensazione di malessere) o a seguito dell’impiego di diuretici (compresse per urinare);
• trattamento in atto con diuretici (compresse per urinare), specialmente se lei è anziano;
• glaucoma (aumentata pressione all’interno dell’occhio);

Pensieri di suicidio e peggioramento della depressione e del disturbo d’ansia.
Se è depresso e/o presenta stati d’ansia qualche volta può avere pensieri di farsi del male o di uccidersi.
Questi pensieri possono risultare aumentati quando per la prima volta comincia il trattamento con
antidepressivi, poiché questi medicinali richiedono un periodo di tempo per essere efficaci, solitamente circa
2 settimane ma qualche volta anche tempi più lunghi.
Può essere più probabile avere questi pensieri:

• Se ha avuto in passato pensieri di uccidersi o di farsi del male.
• Se è un giovane adulto. Dati da studi clinici hanno mostrato un aumentato rischio di comportamento suicidario negli adulti di età inferiore ai 25 anni con disturbi psichiatrici che sono stati trattati con un antidepressivo. Se in qualsiasi momento ha pensieri di farsi del male o di uccidersi, contatti il medico o si rechiimmediatamente in ospedale. Può trovare utile raccontare a un parente o ad un amico intimoche è depresso o ha un disturbo d’ansia, e chiedere loro di leggere questo foglio. Può chiedere loro di dirle se essi ritengono che la sua depressione o ansia stiano peggiorando, o se sono preoccupati per variazioni del suo comportamento.

Bambini e adolescenti di età compresa tra gli 8 e i 18 anni:
Quando assumono questo tipo di medicinali, i pazienti al di sotto dei 18 anni presentano un aumentato
rischio di effetti indesiderati come il tentativo di suicidio, pensieri suicidari ed atteggiamento ostile
(soprattutto comportamento aggressivo, oppositivo e ira). Prozac deve essere utilizzato nei bambini e negli
adolescenti di età compresa tra gli 8 e i 18 anni solo per il trattamento degli episodi di depressione maggiore
di grado da moderato a grave (in associazione con la psicoterapia) e non deve essere usato per trattare altre
situazioni.
Inoltre, in questo gruppo di età sono disponibili solo informazioni limitate per quanto concerne la sicurezza
nel lungo termine di Prozac sulla crescita, sulla pubertà, sullo sviluppo mentale, emotivo e comportamentale.
Nonostante questo, e nei pazienti al di sotto dei 18 anni, il medico può prescrivere Prozac per il trattamento
degli episodi di depressione maggiore di grado da moderato a grave in associazione con la psicoterapia, se
ritiene che questa sia per loro la soluzione migliore.
Se il medico ha prescritto Prozac a un paziente al di sotto dei 18 anni e lei desidera chiarimenti, torni dal
medico. Lei deve informare il medico se uno qualsiasi dei sintomi sopra riportati compare o peggiora durante
l’assunzione di Prozac da parte di pazienti al di sotto dei 18 anni.
Prozac non deve essere usato nel trattamento di bambini di età al di sotto degli 8 anni.

Disfunzione sessuale
Medicinali quali Prozac (i cosiddetti inibitori selettivi della ricaptazione della serotonina (SSRI)) possono
causare sintomi di disfunzione sessuale (vedere paragrafo 4). In alcuni casi, si è osservata la persistenza di
questi sintomi dopo l’interruzione del trattamento.

Altri medicinali e Prozac
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere qualsiasi
altro medicinale.

Non assuma Prozac con:

• alcuni inibitori irreversibili e non selettivi della monoamino ossidasi (IMAO), alcuni usatiper il trattamento della depressione. Gli IMAO irreversibili e non selettivi non devono essere usati con Prozac poiché possono verificarsi reazioni gravi o anche letali (sindrome serotoninergica) (vedere paragrafo “Non prenda Prozac”). Il trattamento con Prozac deve essere iniziato rigorosamente almeno 2 settimane dopo la sospensione di un IMAO irreversibile e non selettivo (come ad esempio tranilcipromina). Nonassuma alcun IMAO irreversibile e non selettivo per almeno 5 settimane dopo che ha sospeso l’assunzione di Prozac. Se Prozac è stato prescritto per un lungo periodo e/o ad alti dosaggi, può essere necessario che il medico prenda in considerazione un intervallo di tempo più lungo di 5 settimane.
• metoprololoquando usato per l’insufficienza cardiaca; c’è un aumentato rischio che il suo battito cardiaco diventi troppo lento.

Prozac può influenzare il meccanismo di azione dei seguenti medicinali (interazione):

• tamoxifene(usato per trattare il cancro della mammella); poiché Prozac può modificare i livelli di questo medicinale nel sangue, con conseguente possibilità di una diminuzione dell’effetto del tamoxifene, il medico può avere bisogno di prendere in considerazione la prescrizione di un altro trattamento antidepressivo.
• inibitori della monoamino ossidasi Tipo A (IMAO-Tipo A)inclusi moclobemide, linezolid (un antibiotico) e metiltioninio cloruro (chiamato anche blu di metilene ed usato per il trattamento sintomatico acuto della metaemoglobinemia indotta da farmaci o agenti chimici, per il trattamento locale di infezioni della cute, quali ad esempio psoriasi a placche, acne volgare ed herpes labiale e come diagnostico per la funzionalità renale per il calcolo della velocità di filtrazione glomerulare): a causa del rischio di reazioni gravi o anche letali (chiamate sindrome serotoninergica). Il trattamento con fluoxetina può essere iniziato il giorno seguente la sospensione del trattamento con un IMAO reversibile ma il medico può decidere di sottoporla ad un attento monitoraggio ed usare un dosaggio più basso di un IMAO-Tipo A.
• mequitazina(usata per le manifestazioni allergiche); poiché l’assunzione di questo medicinale con Prozac può aumentare il rischio di variazioni nell’attività elettrica del cuore.
• fenitoina(per l'epilessia); poiché Prozac può influenzare i livelli nel sangue di questo medicinale, quando viene dato con Prozac il medico può aver bisogno di somministrare fenitoina con maggiore attenzione ed effettuare dei controlli.
• litio, selegilina, Erba di S. Giovanni, tramadolo(un antidolorifico), triptani(per l'emicrania) etriptofano; quando questi medicinali vengono assunti con Prozac c'è un aumentato rischio di comparsa di una lieve sindrome serotoninergica. Il medico effettuerà controlli con maggior frequenza.
• medicinali che possono alterare il ritmo cardiaco, ad es. antiaritmici di classe IA e III, antipsicotici(ad es. derivati fenotiazinici, pimozide, aloperidolo), antidepressivi triciclici, alcuni agentiantibatterici(ad es. sparfloxacina, moxifloxacina, eritromicina IV, pentamidina), trattamento contro la malaria e in particolare alofantrina o alcuni antistaminici(astemizolo, mizolastina), perché l’assunzione di uno o più di questi medicinali con Prozac può aumentare il rischio di variazioni nell’attività elettrica del cuore.
• anticoagulanti(come warfarin), FANS(farmaci antinfiammatori non steroidei - come ibuprofene, diclofenac), aspirinaed altri medicinali che possono migliorare la fluidità del sangue(inclusa clozapina, usata per la cura di alcuni disturbi mentali). Prozac può modificare l'effetto di questi medicinali sul sangue. Se il trattamento con Prozac viene iniziato o interrotto mentre sta assumendo warfarin, il medico avrà bisogno di effettuare alcuni esami, aggiustare il dosaggio e sottoporla a controlli con maggiore frequenza.
• ciproeptadina(usata per le manifestazioni allergiche); poiché può ridurre l’effetto del Prozac.
• medicinali che abbassano il livello di sodio nel sangue(inclusi medicinali che provocano un aumento della emissione di urina, desmopressina, carbamazepina e oxcarbazepina); poiché questi medicinali possono aumentare il rischio che i livelli di sodio nel sangue diventino troppo bassi quando sono assunti in associazione con Prozac.
• antidepressivicome gli antidepressivi triciclici, altri inibitori selettivi della ricaptazione della serotonina (SSRI) o il bupropione, la meflochinao la clorochina(usati per trattare la malaria), il tramadolo(usato per trattare il dolore di forte intensità) o gli antipsicoticicome le fenotiazine o i butirrofenoni; poiché Prozac può aumentare il rischio di convulsioni quando viene assunto in associazione con questi medicinali.
• flecainide, propafenone, nebivololo o encainide(per i disturbi di cuore), carbamazepina(per l'epilessia), atomoxetinao gli antidepressivi triciclici(per esempio imipramina, desipraminaed amitriptilina) o risperidone(per la schizofrenia); poiché Prozac può in qualche modo modificare i livelli nel sangue di questi medicinali, il medico può aver bisogno di abbassare il loro dosaggio quando sono somministrati con Prozac.

Prozac con cibi, bevande e alcol

• Può assumere Prozac indipendentemente dai pasti, come preferisce.
• Deve evitare di bere alcol mentre sta assumendo questo medicinale.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Inform your doctor as soon as possible if you are or may be pregnant, or if you are planning a pregnancy.
In newborns whose mothers have taken fluoxetine during the first months of pregnancy, some studies have described an increased risk of congenital defects affecting the heart. In the general population, about 1 in 100 newborns is born with a heart defect. This figure has increased to about 2 in 100 newborns in mothers who have taken fluoxetine.
When taken during pregnancy, especially in the last 3 months of pregnancy, medicines like Prozac can increase the risk of developing a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which means that the newborn has accelerated breathing and a bluish skin tone. These symptoms generally appear within the first 24 hours after birth.
If this happens to the newborn, contact the 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 can decide to gradually stop taking Prozac before or during the period of pregnancy. However, depending on the circumstances, the doctor may suggest that it is better for you to continue taking Prozac.
Caution is recommended when taken during pregnancy, especially during the terminal period of pregnancy or immediately before delivery, as the following effects have been reported in newborns: irritability, tremor, muscle weakness, persistent crying, difficulty sucking or sleeping.

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

Fertility
Fluoxetine, in studies on animals, 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 act on mental activity like Prozac can alter your ability to judge or coordinate. Do not drive or use tools or machines until you are aware of how Prozac affects you.

Prozac contains sorbitol
This medicine contains 6.71 mg of sorbitol in each tablet. If you have been told by your doctor that you have an intolerance to certain sugars, contact 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
It may have a mild laxative effect.

3. How to take Prozac dispersible tablets

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Do not take more tablets than those prescribed by your doctor.
Swallow the tablets whole with a glass of water, or dissolve them in half a glass of water
to be swallowed 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 of starting treatment. If required, the dosage may be gradually increased 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 may not experience immediate improvement at the beginning of treatment for depression. This is normal as improvement of depression symptoms 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 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 therapy. If required, the dosage may be gradually increased to a maximum of 3 tablets (60 mg) per day. If you do not notice any improvements within the first 10 weeks, your doctor will re-evaluate the treatment.

Use in children and adolescents aged between 8 and 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 you receive the lowest effective dose. Children
with low body weight may need lower doses. If a satisfactory response to
treatment is observed, your doctor will re-evaluate the need to continue treatment beyond 6 months. If there has been no
improvement within the first 9 weeks, your doctor will need to reconsider the treatment.

Elderly:
Your doctor will be more cautious when increasing the dose and the daily dosage 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 interfere with Prozac, your doctor
may decide to prescribe a lower dose or provide instructions to take Prozac on alternate days.

If you take more Prozac than you should

• If you take too many tablets, go to the Emergency Room of the nearest hospital or contact your doctor immediately.
• If possible, take the Prozac pack with you.

Symptoms of overdose include: nausea, vomiting, convulsions, heart disorders (such as irregular
heartbeat and cardiac arrest), respiratory disorders 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 the usual time the following day. Do not take a double dose to make up for a missed dose.
• Taking the medicine every day at the same time can help you remember to take it regularly.

If you stop taking Prozac

• Do notstop taking Prozac without first asking your doctor, even when you start to feel better. It is important that you take the medicine continuously.
• Make sure you do not run out of tablets.

When you stop taking Prozac, you may notice the following effects (discontinuation effects): dizziness;
tingling sensations such as pins and needles; sleep disturbances (vivid dreams, nightmares, inability
to fall asleep); feeling restless or agitated; unusual fatigue or weakness; feeling of
anxiety; nausea/vomiting; tremor; headache.
Most people report that any symptoms that occur when stopping
Prozac therapy are mild and disappear within a few weeks. If you observe the
appearance of symptoms when stopping treatment, contact your doctor.
When you stop taking Prozac, your doctor will help you reduce the dose gradually over one or two
weeks - this should help reduce the possibility of discontinuation effects.
If you have any further questions on the use of this medicine, ask 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 killing yourself, contact your doctor or goimmediately to hospital(see section 2).
• If you develop a skin rash or an allergic reaction such as itching, swelling of the lips or tongue, difficulty breathing, wheezing, stop taking the tablets immediately and tellyour doctor immediately.
• If you feel restless and unable to sit still or stay quiet, you may have a condition called akathisia; increasing the dose of Prozac may make it feel worse. If you experience these sensations, contact your doctor.
• Tell your doctor immediatelyif your skin starts to redden or if you develop a different skin reaction or if your skin begins to blister or peel. This 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, feeling sick (nausea) and fatigue.
Some patients have experienced:

• a collection of symptoms (known as “serotonin syndrome”) including unexplained fever with a fast heart rate and breathing, sweating, muscle rigidity or tremors, confusion, extreme agitation or drowsiness (very rarely);
• a feeling of weakness, drowsiness or confusion, especially in elderly people and people (elderly) who are taking diuretics (water tablets);
• a prolonged and painful erection;
• irritability and extreme agitation;
• heart problems, such as a fast or irregular heartbeat, fainting, collapse or dizziness when standing up which may indicate abnormal heart rhythm. Tell your doctor immediately if you experience any of the above side effects.

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 achieving an erection for sexual activity)
• problems sleeping, unusual dreams, tiredness or drowsiness
• dizziness
• altered taste
• uncontrollable movements
• blurred vision
• feeling of fast and irregular heartbeat
• flushing
• yawning
• indigestion, vomiting
• dry mouth
• skin rash, hives, itching
• excessive sweating
• joint pain
• urinating more frequently
• unexplained vaginal bleeding
• feeling unable to stand still or chills

Uncommon(may affect up to 1 in 100 people)

• feeling detached from yourself
• strange thoughts
• excessively high mood
• sexual problems, including problems with orgasm, occasionally persistent after stopping treatment
• thoughts of suicide or self-harm
• teeth grinding
• muscle contraction, involuntary movements or problems with balance or coordination
• memory loss
• dilated pupils
• ringing in the ears
• low blood pressure
• shortness of breath
• nosebleeds
• difficulty swallowing
• hair loss
• increased tendency to bruise
• unexplained bruising or bleeding
• cold sweats
• difficulty passing urine
• 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
• decreased platelets in the blood, which increases the risk of bleeding or bruising
• decreased white blood cells in the blood
• unusual uncontrolled behaviour
• hallucinations
• agitation
• panic attacks
• confusion
• stammering
• aggression
• convulsions
• 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 to the stomach
• hepatitis
• lung problems
• sensitivity to sunlight
• muscle pain
• problems with urination
• secretion of milk 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 with continued treatment.

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

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through 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 which is stated on the pack (Exp). The expiry date
refers to the last day of that month.
Do not store the tablets at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 ingredientis fluoxetine hydrochloride. Each tablet contains 20 milligrams (mg) of fluoxetine
(as fluoxetine hydrochloride).
The excipientsare: microcrystalline cellulose, sodium saccharin, mannitol, sorbitol, anise flavour, peppermint flavour, anhydrous colloidal silica, pregelatinized maize starch, sodium stearylfumarate and
crospovidone.

Description of the appearance of Prozac dispersible tablets and package contents
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)

ManufacturerResponsible for batch release:
PATHEON FRANCE, 40, boulevard de Champaret, 38300, Bourgoin-Jallieu - France

This medicinal product is authorised in the Member States of the European Economic Area 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 medicine is available on the AIFA (Agenzia Italiana
del Farmaco) website www.aifa.gov.it

Prozac 20 mg/5 mL oral solution

fluoxetine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Prozac oral solution is and what it is used for
• 2. What you need to know before you take Prozac oral solution
• 3. How to take Prozac oral solution
• 4. Possible side effects
• 5. How to store Prozac oral solution
• 6. Contents of the pack and other information

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

Prozac 20 mg/5 mL oral solution contains the active ingredient fluoxetine which belongs to a group of
medicines called selective serotonin reuptake inhibitor (SSRI) antidepressants.
This medicine is used to treat the following conditions:

Adults:

• Major depressive episodes
• Obsessive compulsive disorder
• Bulimia nervosa: Prozac is used together with psychotherapy to reduce binge eating and purging behaviours

Children and adolescents of 8 years of age and over:

• Major depressive disorder of moderate to severe degree, if the depression does not respond to psychotherapy after 4-6 sessions. Prozac should be proposed to a child or young person with moderate to severe major depressive disorder onlyin association with psychotherapy.

How Prozac works
Every individual has, in their brain, a substance called serotonin. People who are depressed, or
have obsessive compulsive disorder, or bulimia nervosa, have lower levels of serotonin compared to
other individuals. It is not fully understood how Prozac and other SSRIs work, but they may
provide help by increasing the level of serotonin in the brain. Treatment of the aforementioned pathological conditions
is important to help you feel better. If left untreated, your pathological condition may
persist and may become even more serious and more difficult to treat.
To be sure you no longer have symptoms, treatment may need to continue for some
weeks or months.

2. Cosa deve sapere prima di prendere Prozac soluzione orale

Non prenda Prozac se:

• É allergico alla fluoxetina o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6). Se presenta una eruzione cutanea od altre reazioni allergiche (come prurito,gonfiore alle labbra o al viso e respiro affannoso) , interrompa subito l’assunzione della soluzioneorale e contatti immediatamente il medico.
• Sta assumendo altri medicinali noti come inibitori irreversibili e non selettivi della monoamino ossidasi (IMAO), poiché possono verificarsi reazioni gravi o anche letali (es. iproniazide usato per trattare la depressione). Il trattamento con Prozac deve essere iniziato almeno 2 settimane dopo l'interruzione del trattamento con un IMAO irreversibile e non selettivo.

Nonprenda alcun IMAO irreversibile e non selettivo per almeno 5 settimane dopo che ha cessato di
prendere Prozac. Se Prozac le è stato prescritto per un lungo periodo di tempo e/o ad alte dosi, è
necessario che il medico tenga presente un intervallo di tempo più lungo.

• Sta assumendo metoprololo (per il trattamento dell’insufficienza cardiaca) poiché c’è un aumentato rischio che il suo battito cardiaco diventi troppo lento.

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere Prozac se qualcuna delle seguenti situazioni la
riguarda:

• problemi al cuore;
• comparsa di febbre, rigidità muscolare o tremore, modificazioni dello stato mentale come stato confusionale, irritabilità ed agitazione estrema; lei può essere interessato dalla cosiddetta “sindrome serotoninergica” o “sindrome maligna da neurolettici”. Sebbene questa sindrome si manifesti raramente essa può dare luogo a condizioni potenzialmente pericolose per la vita del paziente; contattiimmediatamente il medico, poiché può essere necessario interrompere l'assunzione di Prozac.
• se ha o ha avuto in passato episodi di mania; se ha un episodio di mania, contatti immediatamente il medico perché può essere necessario interrompere l'assunzione di Prozac;
• storia di alterazioni del sanguinamento o comparsa di lividi o di un insolito sanguinamento;
• trattamento in atto con medicinali che migliorano la fluidità del sangue (vedere ' Altri medicinali eProzac');
• epilessia o crisi convulsive. Se ha una crisi convulsiva (convulsioni) o va incontro ad un aumento nella frequenza delle convulsioni, contatti immediatamente il medico; può essere necessario interrompere l'assunzione di Prozac;
• trattamento con TEC (terapia elettroconvulsiva);
• trattamento in atto con tamoxifene (usato per trattare il cancro della mammella) (vedere ' Altrimedicinali e Prozac');
• inizia a sentirsi irrequieto e non riesce a stare seduto o a stare fermo (acatisia). Aumentare la dose di Prozac può peggiorare la situazione;
• diabete (il medico può avere bisogno di aggiustarle il dosaggio di insulina o di un altro trattamento antidiabetico);
• problemi al fegato (il medico può aver bisogno di aggiustarle il dosaggio);
• bassa frequenza cardiaca a riposo e/o se lei è consapevole che può avere una carenza di sali come conseguenza di una diarrea grave e prolungata e di vomito (sensazione di malessere) o a seguito dell’impiego di diuretici (compresse per urinare);
• trattamento in atto con diuretici (compresse per urinare), specialmente se lei è anziano;
• glaucoma (aumentata pressione all’interno dell’occhio);

Pensieri di suicidio e peggioramento della depressione e del disturbo d’ansia.
Se è depresso e/o presenta stati d’ansia qualche volta può avere pensieri di farsi del male o di uccidersi.
Questi pensieri possono risultare aumentati quando per la prima volta comincia il trattamento con
antidepressivi, poiché questi medicinali richiedono un periodo di tempo per essere efficaci, solitamente circa
2 settimane ma qualche volta anche tempi più lunghi.
Può essere più probabile avere questi pensieri:

• Se ha avuto in passato pensieri di uccidersi o di farsi del male.
• Se è un giovane adulto. Dati da studi clinici hanno mostrato un aumentato rischio di comportamento suicidario negli adulti di età inferiore ai 25 anni con disturbi psichiatrici che sono stati trattati con un antidepressivo. Se in qualsiasi momento ha pensieri di farsi del male o di uccidersi, contatti il medico o si rechiimmediatamente in ospedale. Può trovare utile raccontare a un parente o ad un amico intimoche è depresso o ha un disturbo d’ansia, e chiedere loro di leggere questo foglio. Può chiedere loro di dirle se ritengono che la sua depressione o ansia stiano peggiorando, o se sono preoccupati per variazioni del suo comportamento.

Bambini e adolescenti di età compresa tra gli 8 e i 18 anni:
Quando assumono questo tipo di medicinali, i pazienti al di sotto dei 18 anni presentano un aumentato
rischio di effetti indesiderati come il tentativo di suicidio, pensieri suicidari ed atteggiamento ostile
(soprattutto comportamento aggressivo, oppositivo e ira). Prozac deve essere utilizzato nei bambini e negli
adolescenti di età compresa tra gli 8 e i 18 anni solo per il trattamento degli episodi di depressione maggiore
di grado da moderato a grave (in associazione con la psicoterapia) e non deve essere usato per trattare altre
situazioni.
Inoltre, in questo gruppo di età sono disponibili solo informazioni limitate per quanto concerne la sicurezza
nel lungo termine di Prozac sulla crescita, sulla pubertà, sullo sviluppo mentale, emotivo e
comportamentale. Nonostante questo, e nei pazienti al di sotto dei 18 anni, il medico può prescrivere Prozac
per il trattamento degli episodi di depressione maggiore di grado da moderato a grave in associazione con la
psicoterapia, se ritiene che questa sia per loro la soluzione migliore. Se il medico ha prescritto Prozac a un
paziente al di sotto dei 18 anni e lei desidera chiarimenti, torni dal medico. Lei deve informare il medico se
uno qualsiasi dei sintomi sopra riportati compare o peggiora durante l’assunzione di Prozac da parte di
pazienti al di sotto di 18 anni.
Prozac non deve essere usato nel trattamento di bambini di età al di sotto degli 8 anni.

Disfunzione sessuale
Medicinali quali Prozac (i cosiddetti inibitori selettivi della ricaptazione della serotonina (SSRI)) possono
causare sintomi di disfunzione sessuale (vedere paragrafo 4). In alcuni casi, si è osservata la persistenza di
questi sintomi dopo l’interruzione del trattamento.

Altri medicinali e Prozac
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere qualsiasi
altro medicinale.

Non assuma Prozac con:

• alcuni inibitori irreversibili e non selettivi della monoamino ossidasi (IMAO), alcuni usati per il trattamento della depressione. Gli IMAO irreversibili e non selettivi non devono essere usati con Prozac poiché possono verificarsi reazioni gravi o anche letali (sindrome serotoninergica) (vedere paragrafo “ Non prenda Prozac”). Il trattamento con Prozac deve essere iniziato rigorosamente almeno 2 settimane dopo la sospensione di un IMAO irreversibile e non selettivo (come ad esempio tranilcipromina). Nonassuma alcun IMAO irreversibile e non selettivo per almeno 5 settimane dopo che ha sospeso l’assunzione di Prozac. Se Prozac è stato prescritto per un lungo periodo e/o ad alti dosaggi, può essere necessario che il medico prenda in considerazione un intervallo di tempo più lungo di 5 settimane.
• metoprololoquando usato per l’insufficienza cardiaca; c’è un aumentato rischio che il suo battito cardiaco diventi troppo lento.

Prozac può influenzare il meccanismo di azione dei seguenti medicinali (interazione):

• tamoxifene(usato per trattare il cancro della mammella);poiché Prozac può modificare i livelli di questo medicinale nel sangue,con conseguente possibilità di una diminuzione dell’effetto del tamoxifene, il medico può avere bisogno di prendere in considerazione la prescrizione di un altro trattamento antidepressivo.
• inibitori della monoamino ossidasi Tipo A (IMAO-Tipo A)inclusi moclobemide, linezolid (un antibiotico) e metiltioninio cloruro (chiamato anche blu di metilene ed usato per il trattamento sintomatico acuto della metaemoglobinemia indotta da farmaci o agenti chimici, per il trattamento locale di infezioni della cute, quali ad esempio psoriasi a placche, acne volgare ed herpes labiale e come diagnostico per la funzionalità renale per il calcolo della velocità di filtrazione glomerulare); a causa del rischio di reazioni gravi o anche letali (chiamate sindrome serotoninergica). Il trattamento con fluoxetina può essere iniziato il giorno seguente la sospensione del trattamento con un IMAO reversibile ma il medico può decidere di sottoporla ad un attento monitoraggio ed usare un dosaggio più basso di un IMAO-Tipo A.
• mequitazina(usata per le manifestazioni allergiche); poiché l’assunzione di questo medicinale con Prozac può aumentare il rischio di variazioni nell’attività elettrica del cuore.
• fenitoina(per l'epilessia); poiché Prozac può influenzare i livelli nel sangue di questo medicinale, quando viene dato con Prozac il medico può aver bisogno di somministrare fenitoina con maggiore attenzione ed effettuare dei controlli.
• litio, selegilina, Erba di S. Giovanni, tramadolo(un antidolorifico), triptani(per l'emicrania) etriptofano; quando questi medicinali vengono assunti con Prozac c'è un aumentato rischio di comparsa di una lieve sindrome serotoninergica. Il medico effettuerà controlli con maggior frequenza.
• medicinali che possono alterare il ritmo cardiaco, ad es. antiaritmici di classe IA e III, antipsicotici(ad es. derivati fenotiazinici, pimozide, aloperidolo), antidepressivi triciclici, alcuni agentiantibatterici(ad es. sparfloxacina, moxifloxacina, eritromicina IV, pentamidina), trattamento contro la malaria e in particolare alofantrina o alcuni antistaminici(astemizolo, mizolastina), perché l’assunzione di uno o più di questi medicinali con Prozac può aumentare il rischio di variazioni nell’attività elettrica del cuore.
• anticoagulanti(come warfarin), FANS(farmaci antinfiammatori non steroidei - come ibuprofene, diclofenac), aspirinaed altri medicinali che possono migliorare la fluidità del sangue(inclusa clozapina, usata per la cura di alcuni disturbi mentali). Prozac può modificare l'effetto di questi medicinali sul sangue. Se il trattamento con Prozac viene iniziato o interrotto mentre sta assumendo warfarin, il medico avrà bisogno di effettuare alcuni esami, aggiustare il dosaggio e sottoporla a controlli con maggiore frequenza.
• ciproeptadina(usata per le manifestazioni allergiche); poiché può ridurre l’effetto del Prozac.
• medicinali che abbassano il livello di sodio nel sangue(inclusi medicinali che provocano un aumento della emissione di urina, desmopressina, carbamazepina e oxcarbazepina); poiché questi medicinali possono aumentare il rischio che i livelli di sodio nel sangue diventino troppo bassi quando sono assunti in associazione con Prozac.
• antidepressivicome gli antidepressivi triciclici, altri inibitori selettivi della ricaptazione della serotonina (SSRI) o il bupropione, la meflochinao la clorochina(usati per trattare la malaria), il tramadolo(usato per trattare il dolore di forte intensità) o gli antipsicoticicome le fenotiazine o i butirrofenoni; poiché Prozac può aumentare il rischio di convulsioni quando viene assunto in associazione con questi medicinali.
• flecainide, propafenone, nebivololoo encainide(per i disturbi di cuore), carbamazepina(per l'epilessia), atomoxetinao gli antidepressivi triciclici (per esempio imipramina, desipramina edamitriptilina) o risperidone(per la schizofrenia); poiché Prozac può in qualche modo modificare i livelli nel sangue di questi medicinali, il medico può aver bisogno di abbassare il loro dosaggio quando sono somministrati con Prozac.

Prozac con cibi, bevande e alcol

• Può assumere Prozac indipendentemente dai pasti, come preferisce.
• Deve evitare di bere alcol mentre sta assumendo questo medicinale.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Inform your doctor as soon as possible if you are or may be pregnant, or if you are planning a pregnancy.
In newborns whose mothers have taken fluoxetine during the first months of pregnancy, some studies have described an increased risk of congenital defects affecting the heart. In the general population, about 1 in 100 newborns is born with a heart defect. This figure has increased to about 2 in 100 newborns in mothers who have taken fluoxetine.
When taken during pregnancy, especially in the last 3 months of pregnancy, medicines like Prozac can increase the risk of developing a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which means that the newborn has accelerated breathing and a bluish skin tone. These symptoms generally appear within the first 24 hours after birth.
If this happens to the newborn, contact the 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 can decide to gradually stop taking Prozac before or during pregnancy. However, depending on the circumstances, your doctor may suggest that it is better for you to continue taking Prozac.
Caution is recommended when taken during pregnancy, especially during the late pregnancy or just before delivery, as the following effects have been reported in newborns: irritability, tremor, muscle weakness, persistent crying, difficulty sucking or sleeping.

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

Fertility
Fluoxetine, in studies on animals, has been shown to reduce sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not yet been observed.

Driving and operating machinery
Medicines that act on mental activity like Prozac can alter judgment or coordination skills. Do not drive or use tools or machinery until you are aware of how Prozac affects you.

Prozac contains sucrose
Prozac oral solution contains 3 g of sucrose per 5 mL of dose. To be taken into consideration in people affected by diabetes mellitus. It may be harmful to teeth. If you have been told by your doctor 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 of dose.

3. How to take Prozac oral solution

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
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) per day. If necessary, your doctor will review and adjust the dosage within 3-4 weeks of starting treatment. If required, the dosage may be gradually increased to a maximum of 15 mL of oral solution (60 mg) per day. The dose should be increased cautiously to ensure you receive the lowest effective dose. You may not feel an immediate improvement at the beginning of treatment for depression. This is normal as an improvement in the symptoms of depression may only appear after the first few weeks of therapy. Patients suffering from depression should be treated for at least 6 months.
• Bulimia nervosa: The recommended dose is 15 mL of oral solution (60 mg) per day.
• Obsessive compulsive disorder: The recommended dose is 5 mL of oral solution (20 mg) per day. If necessary, your doctor will review and adjust the dosage after 2 weeks of therapy. If required, the dosage may be gradually increased to a maximum of 15 mL of oral solution (60 mg) per day. If no improvements are noticed within the first 10 weeks, your doctor will re-evaluate the treatment. Use in children and adolescents aged between 8 and 18 years suffering from depression: Treatment must be started 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 you receive the lowest effective dose. Children with low body weight may need lower doses. If a satisfactory response to treatment occurs, your doctor will re-evaluate the need to continue treatment beyond 6 months. If there has been no improvement within the first 9 weeks, your doctor should reconsider the treatment.

Elderly:
Your doctor will be more cautious when increasing the dose and the daily dosage should generally not exceed
10 mL of oral solution (40 mg). The maximum dose is 15 mL of oral solution (60 mg) per day.

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

If you take more Prozac than you should

• If you take too much, go to the Emergency Room of the nearest hospital or tell your doctor immediately.
• If possible, take the Prozac bottle with you.

The symptoms of overdose include: nausea, vomiting, convulsions, heart disorders (such as an irregular
heartbeat and cardiac arrest), breathing difficulties 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 the usual time the following day. Do not take a double dose to make up for a missed dose.
• Taking the medicine every day at the same time can help you remember to take it regularly.

If you stop taking Prozac

• Do notstop taking Prozac without first asking your doctor, even when you start to feel better. It is important that you take the medicine continuously.
• Make sure you do not run out of medicine.

When you stop taking Prozac you may notice the following effects (withdrawal effects): dizziness;
tingling sensations like pinpricks and needles; sleep disturbances (vivid dreams, nightmares, inability
to fall asleep); feeling restless or agitated; unusual fatigue or weakness; feeling of
anxiety; nausea/vomiting; tremor; headache.
Most people report that any symptoms that occur when stopping
Prozac therapy are mild and disappear within a few weeks. If you should observe the occurrence of symptoms when stopping treatment, contact your doctor.
When you stop taking Prozac, your doctor will help you reduce the dose gradually over one or two
weeks - this should help reduce the possibility of withdrawal effects.
If you have any doubts about the use of this medicine, ask 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 goimmediately to hospital(see section 2).
• If you develop a skin rash or an allergic reaction such as itching, swelling of the lips or tongue, difficulty breathing, wheezing, stop taking the medicine immediately and informyour doctor immediately.
• If you feel a sensation of restlessness and are unable to sit or stay still, you may have a condition called akathisia; an increase in the dose of Prozac may make you feel worse. If you experience these sensations, contact your doctor.
• Report to your doctor immediatelyif the skin begins to redden or if you develop a different skin reaction or if the skin begins to blister or peel. This is very rare.

The most common side effects (very common side effects that can affect more than 1
patient in 10) are insomnia, headache, diarrhea, feeling of disgust (nausea) and fatigue.
Some patients have experienced:

• a collection of symptoms (known as “serotonin syndrome”) including unexplained fever with rapid breathing and accelerated heart rate, sweating, muscle rigidity or tremors, confusion, extreme agitation or drowsiness (rarely);
• a feeling of weakness, drowsiness or confusion especially in elderly people and people (elderly) who are taking diuretics (water tablets);
• prolonged and painful erection;
• irritability and extreme agitation;
• heart problems, such as a fast or irregular heartbeat, fainting, collapse or dizziness when standing up 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 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 achieving an erection for sexual activity)
• sleep problems, unusual dreams, tiredness or drowsiness
• dizziness
• altered taste
• uncontrolled movements
• blurred vision
• feeling of fast and 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
• excessively elevated mood
• sexual problems, including problems with orgasm, occasionally persistent after stopping treatment
• thoughts of suicide or 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 develop bruises
• unexplained bruising or bleeding
• cold sweats
• difficulty passing urine
• 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
• decreased platelets in the blood, which increases the risk of bleeding or bruising
• decreased white blood cells in the blood
• unusual uncontrolled behavior
• 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 to the stomach
• hepatitis
• lung problems
• sensitivity to sunlight
• muscle pain
• problems with urination
• secretion of milk 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 with continued treatment.

Children and adolescents (8-18 years)–In addition to the possible side effects listed above, Prozac can
slow down growth and possibly delay sexual maturation. Behaviors related to suicide (suicide attempt
and suicidal thoughts), hostile attitude, mania and nosebleeds have also been commonly reported
in children.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date that is reported on the package (Exp). The expiry date
refers to the last day of that month.
Do not store the medicine at a temperature above 30°C.
Store in the original container to protect from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Prozac oral solution contains
The active substanceis fluoxetine hydrochloride. Each 5 mL of oral solution contains 20 milligrams (mg) of
fluoxetine (as fluoxetine hydrochloride).
The excipientsare: benzoic acid, sucrose, glycerol, peppermint 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 solution with a peppermint taste.
The medicine is contained in amber glass bottles of 60 mL, 70 mL or 140 mL of oral solution. The
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)

Responsible Manufacturer for batch release:
PATHEON FRANCE, 40, boulevard de Champaret, 38300 Bourgoin-Jallieu - France

This medicinal product is authorised in the Member States of the European Economic Area 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 medicine is available on the AIFA (Agenzia Italiana
del Farmaco) website www.aifa.gov.it