FLUOXETINA 20 mg Kapsułki Twarde

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1. FLUOXETINA DOC Generici 20 mg hard capsules, mg/5 ml oral solution
   1. What is FLUOXETINA DOC Generici and what it is used for
   2. What you need to know before taking FLUOXETINA DOC Generici
   3. How to take FLUOXETINA DOC Generici
   4. Possible side effects
   5. How to store FLUOXETINA DOC Generici
   6. Package Contents and Other Information

FLUOXETINA DOC Generici 20 mg hard capsules, mg/5 ml oral solution

Generic medicine

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

1. What is FLUOXETINA DOC Generici and what it is used for

FLUOXETINA DOC Generici belongs to a group of antidepressant medications called
selective serotonin reuptake inhibitors (SSRIs).
This medicine is used for the treatment of the following conditions:
Adults:

• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia nervosa: FLUOXETINA DOC Generici is used together with psychotherapy to reduce binge eating and purging behaviors.

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. FLUOXETINA DOC Generici should only be proposed to a child or young person with moderate to severe major depressive disorder in association with psychotherapy.

2. What you need to know before taking FLUOXETINA DOC Generici

Do not take FLUOXETINA DOC Generici:

• If you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6).
• If you are taking metoprolol for the treatment of heart failure (a heart condition).
• If you are taking medicines known as non-selective, irreversible monoamine oxidase inhibitors (also called MAOIs and also used for the treatment of depression), as serious and sometimes fatal reactions may occur. Examples of MAOI medicines include nialamide, iproniazide, selegiline, moclobemide, phenelzine, tranylcypromine, isocarboxazide and toloxatone.

Treatment with fluoxetine should only be started 2 weeks after stopping treatment with an irreversible non-selective MAOI (such as tranylcypromine).
Do not take any MAOI for at least 5 weeks after you have stopped taking FLUOXETINA DOC Generici. If FLUOXETINA DOC Generici has been prescribed for a long
period of time and/or at high doses, the doctor needs to consider a longer time interval.

Warnings and precautions
Talk to your doctor or pharmacist before taking FLUOXETINA DOC Generici:

• If you develop a skin reaction or other allergic symptoms (such as itching, swelling of the face or lips and difficulty breathing); stop taking FLUOXETINA DOC Generici immediately and contact your doctor immediately.
• If you have epilepsy or have had a seizure in the past; if you have a seizure (convulsion) or an increase in the frequency of seizures, contact your doctor immediately as it may be necessary to stop taking FLUOXETINA DOC Generici.
• If you have previously suffered from mania; if you have a manic episode, contact your doctor immediately, as it may be necessary to stop taking FLUOXETINA DOC Generici.
• If you have diabetes, your doctor may need to adjust your dose of insulin or other antidiabetic treatment.
• If you have liver problems (your doctor may need to change the dose).
• If you have heart rhythm problems called prolonged QT interval (delayed conduction of electrical signals that can be seen on an ECG, an electrical recording of the heart's activity), or a family history of such conditions.
• If you are taking diuretics (water tablets), especially if you are elderly.
• If you are receiving electroconvulsive therapy (ECT).
• If you are taking tamoxifen (see “Other medicines and FLUOXETINA DOC Generici”).
• If you start to feel restless and unable to sit still (akathisia). In these cases, increasing the dose of FLUOXETINA DOC Generici may be harmful.
• If you suffer from any condition that makes you more prone to having heart rhythm disturbances (for example, low levels of potassium or magnesium, slow heartbeat, acute myocardial infarction, uncompensated heart failure).
• If you have an eye disease called glaucoma (increased pressure inside the eye).
• If you have a history of bleeding disorders or start to develop bruises or unusual bleeding, or if you are pregnant (see section “Pregnancy”).
• If you are losing body weight.
• If you are taking medicines that affect blood clotting (see “Other medicines and FLUOXETINA DOC Generici”).
• If you are taking medicines containing buprenorphine (with or without naloxone). The use of these medicines together with fluoxetine can lead to serotonin syndrome (see “Other medicines and FLUOXETINA DOC Generici”).
• If you start to experience fever, muscle stiffness or tremors, changes in your 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 that are potentially life-threatening , contact your doctor immediately, as it may be necessary to stop taking FLUOXETINA DOC Generici.
• If you have thoughts of suicide and worsening of depression and anxiety: if you are depressed and/or have anxiety, 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 be effective, 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 have been treated with an antidepressant.

If at any time you have thoughts of harming yourself or killing yourself, contact your doctor or go
to hospital immediately.

It may be helpful to tell a relative or close friendthat you are depressed, and ask
them to monitor you for worsening depression or anxiety, or if they are concerned about changes in your
behavior.
Medicines such as FLUOXETINA DOC Generici (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline (SNRIs) can cause symptoms of
sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after stopping treatment.

Children and adolescents aged between 8 and 18 years
When taking this type of medicine, patients under the age of 18 years have an
increased risk of undesirable effects such as suicide attempts, suicidal ideation and hostility
(essentially aggression, oppositional behavior and anger). FLUOXETINA DOC
Generici should be used in children and adolescents aged between 8 and 18 years
only for the treatment of moderate to severe major depressive episodes (in
combination with psychotherapy) and should not be used in other indications.
In addition, only limited information is available in this age group regarding the
long-term safety of FLUOXETINA DOC Generici on growth, puberty, mental, emotional and behavioral development.
Despite this, the doctor may prescribe FLUOXETINA DOC Generici to patients under
the age of 18 years for the treatment of moderate to severe major depressive episodes in
combination with psychotherapy if he/she believes that this is the best solution for them. If
the doctor has prescribed FLUOXETINA DOC Generici to a patient under the age of 18 years and you
would like clarification, return to the doctor.
You should inform the doctor if any of the symptoms listed above appear or worsen
during the taking of FLUOXETINA DOC Generici by patients under the age of 18 years.
FLUOXETINA DOC Generici should not be used in the treatment of children under the age of
8 years.

Other medicines and FLUOXETINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine (even within 5 weeks).
These medicines must not be taken while you are being treated with FLUOXETINA DOC
Generici:

• Non-selective, irreversible Monoamine Oxidase Inhibitors (for example iproniazide), used for the treatment of depression, as serious or even fatal reactions (serotonin syndrome) may occur. See section Do not take FLUOXETINA DOC Generici;
• Metoprolol, used for the treatment of heart failure.

Take this medicine with caution and tell your doctor if you are taking any of the following
medicines:

• Tamoxifen (used for the treatment of breast cancer). Because FLUOXETINA DOC Generici may change the levels of this medicine in the blood and a decrease in the effect of tamoxifen cannot be ruled out.
• Monoamine Oxidase Inhibitors IMAO-A (for example linezolid and methylene blue) as an increased risk of serotonin syndrome may occur .
• Mequitazine (an antihistamine used for the treatment of allergic reactions).
• Phenytoin (used for the treatment of epilepsy). Because FLUOXETINA DOC Generici may affect the levels of this medicine in the blood, your doctor may need to administer phenytoin with greater care and perform checks when it is used with FLUOXETINA DOC Generici.
• Lithium, tramadol, buprenorphine (with or without naloxone), triptans, tryptophan, selegiline, herbal preparations containing St. John's Wort ( Hypericum perforatum): when these drugs are administered in combination with FLUOXETINA DOC Generici there is an increased risk of serotonin syndrome. When FLUOXETINA DOC Generici is used in combination with these medicines, the doctor will perform checks more frequently.
• Medicines known for their effects on the heartbeat. These include medicines used for the treatment of heart rhythm disorders (antiarrhythmics of class IA and III, such as quinidine, procainamide, amiodarone, dofetilide and sotalol), depression (so-called tricyclic antidepressants), mental disorders (antipsychotics such as phenothiazine derivatives, pimozide and haloperidol), bacterial infections (antibiotics such as sparfloxacin, moxifloxacin, erythromycin IV and pentamidine), malaria (especially halofantrine) and some antihistamines (astemizole, mizolastine).
• Oral anticoagulants (such as warfarin) ,non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents (such as acetylsalicylic acid) and other medicines that affect blood clotting such as clozapine, phenothiazines, most tricyclic antidepressants (used to treat some mental disorders), aspirin. If treatment with FLUOXETINA DOC Generici is started or stopped while you are taking an oral anticoagulant, the doctor will need to perform some checks and adjust the dose during and/or after stopping treatment.
• Cyproheptadine (an antihistamine used for the treatment of allergic reactions and itchy skin).
• Medicines that reduce sodium levels in the blood, such as diuretics , desmopressin (used for the treatment of diabetes insipidus), carbamazepine and oxcarbazepine (used for the treatment of epilepsy).
• Medicines that can increase the risk of seizures. These include medicines used for the treatment of depression (bupropion and other antidepressants), mental disorders (phenothiazine derivatives, butyrophenones), malaria (mefloquine, chloroquine) and pain (tramadol).
• Flecainide, encainide, propafenone and nebivolol (used for the treatment of heart disorders), carbamazepine (used for the treatment of epilepsy), tricyclic antidepressants (for example imipramine, desipramine and amitriptyline), atomoxetine used for the treatment of attention deficit hyperactivity disorder (ADHD) and risperidone (used for the treatment of mental disorders). Because FLUOXETINA DOC GENERICI may in some way change the levels of these medicines in the blood, the doctor may need to reduce the dose when they are administered with FLUOXETINA DOC GENERICI.

FLUOXETINA DOC Generici with food, drinks and alcohol
You can take FLUOXETINA DOC Generici regardless of meals, as you prefer.
You should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Regarding newborns whose mothers have taken fluoxetine during the first months of pregnancy, data are
available indicating an increased risk of birth defects, particularly
regarding the heart. In the general population, children born with heart defects are about 1 in 100. This ratio increases to about 2 children in 100, in mothers who
have taken fluoxetine.
Together with your doctor, you can decide whether it is more appropriate to gradually reduce the intake of
FLUOXETINA DOC Generici during pregnancy. However, depending on the circumstances, the
doctor may suggest continuing, or not, the intake of FLUOXETINA DOC Generici.
Make sure your midwife and/or your doctor are aware of the fact that you are taking
FLUOXETINA DOC Generici.
Medicines such as FLUOXETINA DOC Generici, if taken during pregnancy, especially in the last 3
months of pregnancy, can increase the risk of developing a serious condition in newborns,
called persistent pulmonary hypertension (PPHN) which manifests with increased respiratory rate and bluish skin color. These symptoms generally appear within the first
24 hours after birth. Immediately inform your midwife and/or your doctor if your baby
should present these symptoms.
Although studies in animals have not shown any teratogenic or embryotoxic effects
selective, the safety of fluoxetine in pregnant women has not been established; therefore the
product should not be used during pregnancy unless the potential
benefit outweighs the possible risk and in any case under the direct control of the doctor.
If you take FLUOXETINA DOC Generici near the end of pregnancy there may be a
increased risk of heavy vaginal bleeding shortly after delivery, especially if you suffer
from bleeding disorders (tendency to bleed). Inform your treating doctor or midwife/obstetrician of
the fact that you are taking FLUOXETINA DOC Generici, so that they can advise you what to do.
Breastfeeding
Fluoxetine is excreted in breast milk and can cause undesirable effects in infants.
Breastfeeding should only be carried out if clearly necessary. If breastfeeding is
continued, your doctor may prescribe a lower dose of fluoxetine.
Since the drug is present in breast milk, patients must immediately notify
their doctor of any breastfeeding.
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
This medicine can alter the ability to drive vehicles or use machines because it can
reduce the ability to judge and react in dangerous situations. Do not drive or do not use tools
or machinery if you are not sure of your condition.

FLUOXETINADOCGenerici hard capsules contains lactose and sodium

• If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

FLUOXETINADOCGenerici oral solution contains sorbitol (E 420) and benzoic acid (E
210)

• This medicine contains 9450 mg of sorbitol per 60 mg dose. Sorbitol is a source of fructose. If your doctor has told you that you (or the child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot transform fructose, talk to your doctor before you (or the child) take this medicine. It may cause gastrointestinal problems and have a mild laxative effect.
• This medicine contains 2.5 mg per 20 mg dose and 7.5 mg of benzoic acid per 60 mg dose. Benzoic acid can increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age (see Pregnancy, breastfeeding and fertility).

3. How to take FLUOXETINA DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is:

Major depressive episodes: The recommended dose is 20 mg per day. If necessary, the
doctor will review and adjust the dose within 3–4 weeks of starting treatment. If appropriate,
the dose may be gradually increased to a maximum of 60 mg. The dose should be
increased cautiously to ensure that you receive the lowest effective dose. It is possible that
at the beginning of treatment with the medicine for depression you may not feel an immediate
improvement. This is normal as an improvement in the symptoms of depression may only
manifest 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 60 mg per day.

Obsessive compulsive disorder:The recommended dose is 20 mg per day. If necessary, the doctor
will review and adjust the dose after 2 weeks of therapy. If appropriate, the dose may be
gradually increased to a maximum of 60 mg. If no improvements are noticed within the
first 10 weeks, treatment with FLUOXETINA DOC Generici should be reconsidered.

Use in children and adolescents aged between 8 and 18 years with depression
Treatment should be initiated and supervised by a specialist. The initial dose is 10 mg per
day (administered as 2.5 ml of FLUOXETINA DOC Generici oral solution). After one or
two weeks, the doctor may increase the dose to 20 mg per day. The dose should be increased
cautiously to ensure that you receive the lowest effective dose. Children with low body
weight may need lower doses. The doctor should assess the need to continue
treatment beyond 6 months. If no improvements are noticed, the treatment should be reevaluated.

Elderly
If you are an elderly person, the doctor will be more cautious in increasing the dose and the daily
dose should generally not exceed 40 mg. The maximum dose is 60 mg per day.

Liver problems
If you have liver problems or are taking another medicine that could interfere with
fluoxetine, the doctor may decide to prescribe you a lower dose or give you instructions to
take FLUOXETINA DOC Generici on alternate days.

Method of administration:
Hard capsules: Swallow the capsules with a sip of water. Do not chew the capsules.
Oral solution: Measure the correct amount of medicine using the measuring device, syringe or a
dosing spoon, then drink it.

If you take more FLUOXETINA DOC Generici than you should

• If you take too many capsules or too much oral solution, go to the Emergency Room of the nearest hospital or inform your doctor immediately.
• If possible, bring the package of FLUOXETINA DOC Generici with you.

The symptoms of overdose include: nausea, vomiting, convulsions, heart problems (such as
an irregular heartbeat and cardiac arrest), respiratory problems and changes in mental status
ranging from agitation to coma.

If you forget to take FLUOXETINA DOC Generici

• 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 the missed dose.
• Taking the medicine every day at the same time can help you remember to take it regularly.

If you stop taking FLUOXETINA DOC Generici
Do not stop taking FLUOXETINA DOC Generici until your doctor tells you to
do so.
It is important that you take the medicine continuously.

• Do not stop taking the medicine without first asking your doctor, even when you start to feel better.
• Make sure you do not run out of the medicine.

When you stop taking FLUOXETINA DOC Generici, you may notice the following 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 anxious; nausea/vomiting (feeling sick or unwell);
tremor (unsteadiness); headache; confusion; sweating; diarrhea; palpitations; emotional instability;
irritability and visual disturbances.
Most people report that any symptoms that occur when stopping therapy with FLUOXETINA DOC Generici are mild and disappear
on their own within a few weeks. If you should observe the onset of symptoms when
stopping treatment, contact your doctor.
When you stop taking FLUOXETINA DOC Generici, the doctor will help you reduce the dose
gradually over one or two weeks – this should help reduce the likelihood of
the occurrence 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 everyone will experience 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 experience a skin reaction or an allergic reaction such as itching, swelling of the lips or tongue, difficulty breathing, shortness of breath, stop taking the medicine immediately and inform your doctor immediately.
• If you feel a sensation of restlessness and are unable to sit or remain still, you may have a condition called akathisia; an increase in the dose of FLUOXETINA DOC Generici may make you feel worse. If you experience these sensations, contact your doctor.
• Report to your doctor immediatelyif your skin begins to redden and then blister or peel. This is very rare.

Some patients have experienced:

• a collection of symptoms (known as serotonin syndrome) including unexplained fever with a rapid 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 in elderly people treated with diuretics (water tablets);
• a prolonged and painful erection;
• irritability and extreme agitation.

If you experience any of the side effects listed above, inform your doctor immediately.
If you experience any of the following symptoms and they cause you discomfort, or last for a certain period of time, report them to your doctor or pharmacist.

Very common(may affect more than 1 in 10 people):

• insomnia
• headache
• diarrhoea, nausea
• fatigue

Common(may affect up to 1 in 10 people):

• decreased and loss of appetite, weight loss
• anxiety, nervousness, agitation, feeling of tension
• decreased and loss of sexual desire and sexual problems (including difficulty maintaining an erection for sexual activity and problems with ejaculation)
• sleep disturbances, unusual dreams (including nightmares), deep sleep (lethargy) or drowsiness
• poor concentration
• dizziness
• altered taste
• tremor
• blurred vision
• feeling of a fast and irregular heartbeat
• flushing, hot flushes
• yawning
• indigestion, vomiting
• dry mouth
• skin rash, hives, itching
• excessive sweating
• joint pain
• more frequent need to urinate
• vaginal bleeding
• feeling nervous
• chills

Uncommon(may affect up to 1 in 100 people):

• feeling detached from oneself
• excessively elevated mood
• abnormal thoughts
• problems with orgasm
• teeth grinding
• thoughts of suicide and self-harm
• hyperactivity, muscle contractions, involuntary movements or problems with balance or coordination
• memory problems
• dilated pupils
• ringing in the ears
• low blood pressure
• shortness of breath
• nosebleeds
• difficulty swallowing
• gastrointestinal bleeding
• hair loss
• increased tendency to develop bruises
• cold sweat
• difficulty in passing urine
• sexual dysfunction
• feeling of heat or cold
• feeling generally unwell

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

• reduced number of platelets in the blood
• reduced number of certain white blood cells (leukocytes and granulocytes)
• anaphylactic reaction, serum sickness
• problems in the secretion of a hormone called antidiuretic hormone
• reduced levels of sodium in the blood
• unusual, uncontrolled behaviour
• hallucinations
• agitation
• panic attacks
• confusion
• problems with speech
• aggression
• convulsions
• restlessness and inability to sit or stand still
• alterations in the movement of the tongue and mouth
• serotonin syndrome (high fever, tremors, muscle contractions and anxiety)
• heart rhythm disturbances (prolongation of the QT interval, torsades de pointes, atrioventricular arrhythmia)
• inflammation of blood vessels (vasculitis)
• dilation of blood vessels
• sore throat
• lung problems
• pain in the esophagus
• inflammation of the liver (hepatitis)
• rapid swelling of tissues around the neck, face, mouth and/or throat
• bruising
• skin reactions caused by exposure to sunlight (photosensitivity reaction)
• formation of red spots on the skin and bleeding (purpura)
• skin reaction with blister formation and itching
• severe skin reactions with blister formation and detachment of the skin (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis)
• muscle pain (myalgia)
• problems and difficulty in urination
• sudden production of milk from the breast
• increased level of prolactin (a hormone) in the blood
• prolonged and painful erection
• bleeding from the mucous membranes
• abnormal results of liver function tests

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

• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see section 2, Pregnancy, for further information

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.

Additional side effects in children and adolescents (8-18 years)
In addition to the possible side effects listed above, FLUOXETINA DOC Generici may
slow down growth and possibly delay sexual maturation. Nosebleeds and changes in alkaline phosphatase levels have also been reported.

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 FLUOXETINA DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, on the blister and on the
bottle after “Exp.”. The expiry date refers to the last day of that month.
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 FLUOXETINA DOC Generici contains
FLUOXETINA DOC Generici 20 mg hard capsules
The active ingredient is: fluoxetine hydrochloride.
Each hard capsule contains 22.36 mg of fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.
The other ingredients are: capsule content: corn starch, lactose, magnesium stearate, sodium
lauryl sulfate; capsule components: yellow iron oxide (E172), titanium dioxide (E171),
gelatin.

FLUOXETINA DOC Generici 20 mg/5 ml oral solution
The active ingredient is fluoxetine hydrochloride.
5 ml of solution contains 22.36 mg of fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.
The other ingredients are: benzoic acid (E 210), sorbitol (E 420) 70% solution, glycerin,
mint flavor, purified water.

Description of the appearance of FLUOXETINA DOC Generici and package contents
20 mg hard capsules in blisters, packs of 12 and 28 capsules.
20 mg/5 ml oral solution in 60 ml bottle.

Marketing Authorization Holder and Manufacturer
DOC Generici S.r.l. - Via Turati, 40 – 20121 Milano.

Manufacturers
CAPSULES: Laboratorio Farmaceutico C.T. S.r.l. - Via Dante Alighieri, 71 - Sanremo (IM) -
Italy
Laboratorio Chimico Farmaceutico Salentino - LACHIFARMA S.r.l. - s.s. 16 zona
industriale - 73010 Zollino (LE) - Italy
Vamfarma S.r.l. - Via Kennedy 5 - 26833 Comazzo (Lodi) - Italy
SOLUTION: Laboratorio Chimico Farmaceutico Salentino - LACHIFARMA S.r.l. - s.s. 16 zona
industriale - 73010 Zollino (LE) - Italy