FLUOXETINA 20 mg Hard Capsule

Зміст інструкції

1. FLUOXETINA ALMUS 20 mg hard capsules
   1. What is FLUOXETINA ALMUS and what is it used for
   2. What you need to know before taking FLUOXETINA ALMUS
   3. How to take FLUOXETINA ALMUS
   4. Possible side effects
   5. How to store FLUOXETINA ALMUS
   6. Contents of the pack and other information

FLUOXETINA ALMUS 20 mg hard capsules

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

1. What is FLUOXETINA ALMUS and what is it used for

FLUOXETINA ALMUS contains the active ingredient fluoxetine hydrochloride, which belongs to a group of
medicines called selective serotonin reuptake inhibitors (SSRIs).
This medicine is used for the following conditions:

Adults:

• treatment of major depressive episodes;
• treatment of obsessive-compulsive disorder, a behavioral disorder characterized by obsessive and repetitive thoughts;
• treatment of an eating disorder called bulimia nervosa, together with psychotherapy, to reduce the behaviors typical of this disease (binge eating and purging behaviors).

Children and adolescents aged between 8 and 18 years:

• treatment of moderate or severe major depressive disorder, if the depression does not respond to psychotherapy after 4-6 sessions. The use of this medicine must always be associated with psychotherapy.

2. What you need to know before taking FLUOXETINA ALMUS

Do not take FLUOXETINA ALMUS

• if you are allergic to fluoxetine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking or have taken in the last 14 days other medicines used to treat depression, known as monoamine oxidase inhibitors (MAOIs), such as iproniazide;
• if you are taking metoprolol for heart problems such as heart failure (a condition in which the heart does not work as it should).

Warnings and precautions
Talk to your doctor or pharmacist before taking FLUOXETINA ALMUS if you are in any of these
conditions:

• if you experience a skin reaction or other manifestations of an allergic nature. In this case, stop taking the medicine immediately and contact your doctor immediately;
• if you suffer from or have suffered from convulsions. If you have a convulsion or experience an increase in the frequency of convulsions, contact your doctor immediately; it may be necessary to stop taking this medicine;
• if you suffer from or have suffered in the past from mood and behavioral disorders (mania/hypomania). If you have a manic episode, contact your doctor immediately because it may be necessary to stop taking this medicine;
• if you have liver problems, your doctor may decide to adjust the dosage;
• if you have heart problems;
• if you have a 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);
• if you have diabetes, your doctor may decide to adjust the dose of insulin or other antidiabetic treatment;
• if you develop a need to move constantly (akathisia), this disorder may appear during the first weeks of treatment. A dosage adjustment may be indicated;
• if you notice the appearance of bleeding skin lesions, bruises (ecchymoses) and pinpoint red spots (purpura) or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”);
• if you are taking other medicines that improve blood fluidity (see section “Other medicines and FLUOXETINA ALMUS”);
• if you are to undergo or are already undergoing electroconvulsive therapy (ECT);
• if you have increased pressure inside the eye or are at risk of narrow-angle glaucoma.

Medicines such as FLUOXETINA ALMUS (so-called selective serotonin reuptake inhibitors
(SSRIs) and serotonin-noradrenaline (SNRIs)) can cause symptoms of sexual dysfunction (see
section 4). In some cases, persistence of these symptoms has been observed after discontinuation of treatment.
If you are taking tamoxifen, a medicine used to treat cancer, avoid taking
FLUOXETINA ALMUS.
Immediately stop treatment with this medicine and inform your doctor if you experience fever,
muscle rigidity or tremor, changes in your mental state such as confusion, irritability and
extreme agitation. These may be symptoms of a condition called serotonin syndrome, which
although rare, can lead to potentially life-threatening conditions. These
symptoms may also occur if, during treatment with fluoxetine, you take medicines called
MAOIs (see section “Do not take FLUOXETINA ALMUS”).
Treatment with fluoxetine should only be started 14 days after stopping treatment with a
non-selective irreversible monoamine oxidase inhibitor called irreversible MAOI (such as
iproniazide). Do not start therapy with an MAOI for at least 5 weeks after stopping treatment
with FLUOXETINA ALMUS.

Thoughts of suicide and worsening of your depression or anxiety disorder
During the first few weeks or immediately after starting treatment, especially
if you suffer from other mental health problems (psychiatric disorders), you may have self-harming thoughts and think about
hurting yourself or committing suicide. For this reason, the doctor must monitor you closely, especially
at the beginning of treatment or when the dose is increased, if you have already experienced these disorders in the past and
if you are young (under 25 years of age). Immediately inform your doctor if you experience these disorders or if
someone who cares for you notices changes in your behavior.
It may be helpful to inform a family member or close friend that you are suffering from depression or an anxiety disorder or that they are worried about any changes in your
behavior.

Children and adolescents
FLUOXETINA ALMUS must notbe used in the treatment of children under 8 years of age.
This medicine should only be used in children and adolescents between the ages of 8 and 18 years
for the treatment of moderate or severe major depressive episodes (in association with
psychotherapy) and should not be used to treat other conditions.
Much care should be taken when using this medicine in patients under 18 years of age, because
they may have an increased risk of emotional disorders such as suicide attempts, suicidal thoughts
and hostile behavior (especially aggressive, oppositional and angry behavior); inform your doctor if you notice
any of these symptoms. In addition, only limited information is available in this age group
regarding long-term safety on growth, puberty, mental, emotional and behavioral development.

Other medicines and FLUOXETINA ALMUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
This medicine can affect the mechanism of action of other medicines.
Do not take FLUOXETINA ALMUS together with the following medicines:

• medicines used to treat depression such as non-selective irreversible monoamine oxidase inhibitors - irreversible MAOIs(for example iproniazide) because serious and sometimes fatal reactions (serotonin syndrome, see sections “Do not take FLUOXETINA ALMUS” and “Warnings and precautions”) may occur;
• metoprolol, a medicine for the treatment of heart problems (see section “Do not take FLUOXETINA ALMUS”).

FLUOXETINA ALMUS is not recommended together with the following medicines:

• tamoxifen, a medicine for the treatment of some cancers (see section “Warnings and precautions”);
• medicines used to treat depression such as monoamine oxidase inhibitors - MAOIs ofType A(such as linezolid and methylthioninium chloride (methylene blue)) because serious and sometimes fatal reactions (serotonin syndrome, see section “Warnings and precautions”) may occur;
• mequitazine, a medicine for allergies.

Take this medicine with cautionand inform your doctor if you are taking:

• medicines used to treat epilepsy such as phenytoin, carbamazepine, oxcarbazepine;
• MAOIs of Type B(such as selegiline). These medicines can be used with FLUOXETINA ALMUS as long as your doctor keeps you under close monitoring, because serious and sometimes fatal reactions (serotonin syndrome, see section “Warnings and precautions”) may occur;
• medicines used to treat mental disorders and to treat depression such as phenothiazinederivatives, pimozide, haloperidol, tricyclicantidepressants, SSRIs, butyrophenone, bupropion,atomoxetine, risperidone, medicines containing lithium);
• medicines used for chronic headaches (triptans);
• tramadol, a medicine used to treat pain;
• herbal products containing St. John's Wort (Hypericum perforatum);
• medicines used for heart problems such as Class IA and III antiarrhythmics;
• some antibacterials, medicines used to treat infections caused by bacteria (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine);
• medicines for malaria such as alofantrine, mefloquine, chloroquine;
• some antihistamines, medicines for allergies (astemizole, mizolastine, cyproheptadine);
• non-steroidal anti-inflammatory drugs (e.g. aspirinand other NSAIDs);
• warfarinor other medicines used to thin the blood;
• diuretics, medicines that increase urine production;
• desmopressin, a medicine used for diabetes;
• medicines used for heart problems such as flecainide, nebivolol, propafenone.

FLUOXETINA ALMUS with food, drinks and alcohol
Do not drink alcohol during treatment with this medicine.
You can take this medicine with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine if you are pregnant, unless absolutely necessary, because it can
cause serious problems for your baby.
When taken during pregnancy, especially in the last 3 months of pregnancy, medicines such as
FLUOXETINA ALMUS can increase the risk of a serious condition in babies, called
persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and makes them
appear bluish. If this happens to your baby, you should contact your midwife and/or doctor immediately.
If you have taken this medicine during the late stages of pregnancy, your baby may experience
irritability, tremor, altered muscle tone (hypotonia), continuous crying, difficulty sleeping or
sucking.
If you take FLUOXETINA ALMUS near the end of pregnancy there may be an increased
risk of heavy vaginal bleeding shortly after delivery, especially if you suffer from bleeding disorders
(easy bleeding). Inform your treating doctor or midwife/obstetrician that you are taking
FLUOXETINA ALMUS, so they can advise you on what to do.
Breastfeeding
FLUOXETINA ALMUS is excreted in breast milk and this can cause problems for the baby.
If treatment with FLUOXETINA ALMUS is considered necessary, the
suspension of breastfeeding should be considered; however, if breastfeeding is continued, the
lowest effective dose of fluoxetine should be prescribed.
Fertility
This medicine can affect the quality of sperm. The effect disappears when the
treatment is stopped (see section “Possible side effects”).

Driving and using machines
This medicine can alter your ability to drive vehicles or use machines because it can reduce
your ability to judge and react in dangerous situations. Therefore, be careful before driving or using machines.

3. How to take FLUOXETINA ALMUS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Swallow the capsules with a glass of water. Do not chew the capsules. The doctor will adjust the dose based
on your needs. Do not change the dose without consulting your doctor (see paragraph “If you stop the
treatment with FLUOXETINA ALMUS”).

Treatment of major depressive episodes
The recommended dose, for adults and the elderly, is 20 mg per day.
If necessary, the doctor will review and adjust the dosage within 3-4 weeks of starting therapy. The dose
may be increased up to a maximum of 60 mg per day. Dosage changes must be
made carefully, to ensure that you take the lowest effective dose.
You may not feel well immediately at the beginning of treatment for depression. This is usually due to the
fact that an improvement in depressive symptoms may not occur until after the first few weeks. Patients with depression must be treated for at least 6 months.

Treatment of obsessive compulsive disorder
The recommended dose, for adults and the elderly, is 20 mg per day.
If necessary, the doctor will re-evaluate the dosage if no improvements are noticed after 2 weeks. The dosage
may be gradually increased up to a maximum of 60 mg per day. Dosage changes must be
made carefully, to ensure that you take the lowest effective dose.
If no improvement is observed within 10 weeks, your doctor will reconsider your treatment.

Treatment of bulimia nervosa
The recommended dose, for adults and the elderly, is 60 mg per day.

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.

Hepatic impairment
If you have a liver problem or if you are taking other medicines that may interact with FLUOXETINA
ALMUS, your doctor may decide to prescribe you a lower dose or take it on alternate days.

Use in children and adolescents
In children and adolescents between the ages of 8 and 18, treatment must be initiated and
supervised by a specialist. The initial dose is 10 mg per day.
After 1-2 weeks, the doctor may re-evaluate the dose and increase it to 20 mg per day. The dose must
be increased cautiously to ensure that you receive the lowest effective dose.
Children with low body weight may need lower doses. The doctor must assess the
need to continue treatment beyond 6 months. If no improvements are noticed, the treatment must
be re-evaluated.
For doses not possible with this dosage, other pharmaceutical forms and other dosages are available that your
doctor can advise.

If you take more FLUOXETINA ALMUS than you should
In case of accidental ingestion/intake of an excessive dose of FLUOXETINA ALMUS, immediately inform
your doctor or go to the nearest hospital.
Symptoms of overdose are nausea, vomiting, convulsions, heart problems (cardiovascular dysfunction
ranging from asymptomatic arrhythmia to cardiac arrest), breathing problems (pulmonary
dysfunction) and mental disorders ranging from agitation to coma. Very rarely, cases of
death have been reported.

If you forget to take FLUOXETINA ALMUS
If you forget to take a dose, take the next dose at the usual time the following day.
Do not take a double dose to make up for the missed tablet.

If you stop taking FLUOXETINA ALMUS
Do notstopthe treatment with FLUOXETINA ALMUS suddenly or without first having
agreed with your doctor.
The following withdrawal symptomsmay occur when stopping treatment with this medicine: dizziness, sensory disturbances such as tingling in the arms and legs
(paresthesia), sleep disturbances such as inability to fall asleep (insomnia) and dreams that seem real
(vivid dreams), unusual fatigue or weakness (asthenia), agitation or anxiety, nausea and vomiting, headache
(cephalalgia), tremor.
These symptoms appear within the first few days after stopping treatment and usually
resolve within 2 weeks, although in some subjects they may be prolonged (2-3 months or more).
Abrupt discontinuation should be avoided. When you stop taking FLUOXETINA ALMUS, the doctor
will help you gradually reduce the dose over 1 or 2 weeks, which should help reduce the
likelihood of withdrawal effects.
If you experience these symptoms when stopping treatment, contact your
doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most commonly reported side effects in patients treated with fluoxetine were headache,
nausea, insomnia, fatigue and diarrhea. These effects may decrease in intensity and frequency during
treatment and generally do not lead to discontinuation of therapy.
If you think of harming yourself or have suicidal thoughts during treatment, seek medical attention
immediately or go to hospital immediately.
The following side effects may occur:

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

• headache
• insomnia
• diarrhea, nausea
• fatigue

Common (may affect up to 1 in 10 people)

• loss of appetite, weight loss
• restlessness, anxiety, nervousness, difficulty concentrating, feeling tense
• sleep problems, abnormal dreams, tiredness or drowsiness
• tremors
• dizziness
• decreased sexual desire and sexual dysfunction in men (erectile dysfunction, failure to ejaculate)
• altered taste
• vision problems (blurred vision)
• heart problems (palpitations)
• flushing
• yawning
• digestive problems (dyspepsia), vomiting
• dry mouth
• allergic and anaphylactic reactions such as hives, rash, itching
• sweating
• problems with urination
• joint pain (arthralgia)
• shivering, agitated state
• vaginal bleeding (gynecological hemorrhage)

Uncommon (may affect up to 1 in 100 people)

• feeling detached from oneself (depersonalization)
• mood changes (elevated mood, euphoria), abnormal thoughts
• sexual dysfunction (e.g. abnormal orgasm)
• teeth grinding (bruxism)
• suicidal behavior and thoughts
• movement problems (psychomotor hyperactivity, dyskinesia, myoclonus, balance disorder, ataxia)
• memory problems
• vision problems (mydriasis)
• perception of sounds in the ear (tinnitus)
• low blood pressure (hypotension)
• breathing problems
• increased tendency to develop bruises
• bleeding from the nose or stomach and intestines
• difficulty swallowing (dysphagia)
• excessive hair loss (alopecia)
• cold sweats
• muscle contractions
• problems with urination (dysuria)
• feeling unwell, sensation of abnormality, feeling of warmth or cold

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

• reduced number of platelets in the blood (thrombocytopenia)
• decreased white blood cells (neutropenia, leucopenia)
• anaphylactic reaction, serum sickness, angioedema (swelling of the face, lips, mouth, tongue or throat due to fluid accumulation and breathing problems)
• problems caused by inappropriate production of the antidiuretic hormone (ADH) which regulates urine production (SIADH)
• reduced levels of sodium in the blood
• manic reactions (hypomania, mania)
• hallucinations
• agitation
• panic attacks
• confused state
• speech disorders (dysphemia)
• aggression
• lung problems, inflammation of the pharynx (pharyngitis)
• esophageal pain
• heart problems (ventricular arrhythmias including torsade de pointes and prolonged QT interval on ECG)
• inflammation of blood vessels (vasculitis), vasodilation
• serotonin syndrome, which manifests with symptoms such as: fever, muscle rigidity or tremor, changes in your mental state such as confusion, irritability and extreme agitation
• altered movement of the tongue and mouth, liver inflammation (idiosyncratic hepatitis)
• skin reactions caused by exposure to sunlight (photosensitivity reaction), severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome, purpura
• convulsions
• restlessness and inability to sit or stand still, muscle pain (myalgia)
• problems with urination (urinary retention, difficulty urinating)
• prolonged and painful erection (priapism)
• increased levels of prolactin in women (hyperprolactinemia)
• sudden secretion of milk from the breasts (galactorrhea)
• blood loss, bleeding from the gastrointestinal tract and other bleeding at the skin or mucous membranes
• altered liver function (increased transaminases, increased gamma-glutamyl transferase)
• sudden appearance of bruises (ecchymosis)

Not known (frequency cannot be estimated from available data)

• increased blood pressure (hypertension)
• heart problems (angina pectoris, arrhythmias, first-degree atrioventricular block)
• reduced levels of potassium in the blood (hypokalaemia)
• heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see section 2 “Pregnancy, breastfeeding and fertility”, for further information.

An increased risk of bone fractures has been observed in patients taking this type of
medicine.

Children and adolescents (8-18 years)
In addition to the possible side effects listed above, FLUOXETINA ALMUS may slow growth
and possibly delay sexual maturation. Suicidal behaviors (suicide attempt and suicidal thoughts), hostile attitude, nosebleeds and changes in alkaline phosphatase enzyme levels have been reported.

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

5. How to store FLUOXETINA ALMUS

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 packaging after “Exp.”.
The expiry date refers to the last day of that month.
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 FLUOXETINA ALMUS contains

• The active ingredient is fluoxetine hydrochloride. Each capsule contains 22.36 mg of fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.
• The other ingredients are: corn starch, dimethicone, gelatin, titanium dioxide (E-171), yellow iron oxide (E-172), Patent Blue V (E-131).

Description of the appearance of FLUOXETINA ALMUS and contents of the pack
Pack of 12 or 28 hard capsules containing 20 mg.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genoa
E-mail: [email protected]

Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A.- Via Grignano, 43 - 24041 Brembate (BG)