Fluoxetine Almus: detailed information

Package leaflet: Information for the patient

FLUOXETINE ALMUS 20 mg hard capsules

Generic medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

FLUOXETINA ALMUS contains the active substance fluoxetine hydrochloride, which belongs to a group of antidepressant 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 behavioural disorder characterised by obsessive and repetitive thoughts;
treatment of an eating disorder called bulimia nervosa, together with psychotherapy, to reduce the typical behaviours of this illness (binge eating and purging).

Children and adolescents aged 8 to 18 years:

treatment of moderate to severe major depressive disorder, if 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 FLUOXETINE ALMUS

Do not take FLUOXETINE 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 currently taking or have taken within the last 14 days other medicines used to treat depression, known as monoamine oxidase inhibitors (MAOIs), for example iproniazide;
if you are taking metoprolol for heart conditions such as heart failure (a condition in which the heart does not function properly).

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

if you develop a skin reaction or other allergic symptoms. In this case, stop taking the medicine immediately and contact your doctor right away;
if you suffer from or have previously suffered from seizures. If you have a seizure or experience an increase in seizure frequency, contact your doctor immediately; it may be necessary to discontinue this medicine;
if you suffer from or have previously suffered from mood and behavioral disorders (mania/hypomania). If you experience a manic episode, contact your doctor immediately, as it may be necessary to discontinue 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 an electrolyte imbalance due to severe and prolonged diarrhea, vomiting (feeling unwell), or as a result of taking diuretics (water tablets);
if you have diabetes, your doctor may decide to adjust your insulin or other antidiabetic treatment;
if you develop an urge to move constantly (akathisia), which may occur during the first weeks of treatment. A dosage adjustment may be needed;
if you notice the appearance of bleeding skin lesions, bruising (ecchymoses), or pinpoint red spots (purpura), or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”);
if you are taking other medicines that affect blood clotting (see section “Other medicines and FLUOXETINE ALMUS”);
if you are undergoing or are already receiving electroconvulsive therapy (ECT);
if you have increased intraocular pressure or are at risk of narrow-angle glaucoma.

Medicines such as FLUOXETINE ALMUS (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
If you are taking tamoxifen, a medicine used to treat tumors, avoid taking FLUOXETINE ALMUS.
Stop treatment with this medicine immediately and inform your doctor if you experience fever, muscle stiffness or tremor, or 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 you take MAOI medicines during treatment with fluoxetine (see section “Do not take FLUOXETINE ALMUS”).
Treatment with fluoxetine should only be started 14 days after stopping treatment with an irreversible non-selective monoamine oxidase inhibitor (irreversible MAOI), such as iproniazide. Do not start treatment with an MAOI for at least 5 weeks after stopping treatment with FLUOXETINE ALMUS.
Suicidal thoughts and worsening of depression or anxiety disorder
During the first few weeks or immediately after starting treatment, especially if you suffer from other mental health conditions (psychiatric disorders), you may experience self-harming thoughts or thoughts about harming yourself or committing suicide. For this reason, your doctor should closely monitor you, particularly at the beginning of treatment or when the dose is increased, if you have previously experienced such symptoms, or if you are young (under 25 years of age). Inform your doctor immediately if you experience these symptoms or if someone caring for you notices changes in your behavior.
It may be helpful to inform a family member or close friend that you suffer from depression or an anxiety disorder and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is worsening or if they are concerned about any changes in your behavior.
Children and adolescents
FLUOXETINE ALMUS must not be used to treat children under 8 years of age.
This medicine should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes (in combination with psychotherapy) and must not be used to treat other conditions.
Extreme caution is required when using this medicine in patients under 18 years of age, as they may have an increased risk of emotional disturbances such as suicide attempts, suicidal thoughts, and hostility (particularly aggressive, oppositional, and angry behavior); inform your doctor if you notice any of these symptoms. Additionally, only limited long-term safety data are available in this age group regarding growth, puberty, and mental, emotional, and behavioral development.
Other medicines and FLUOXETINE ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This medicine may affect how other medicines work.
Do not take FLUOXETINE ALMUS together with the following medicines:

medicines used to treat depression such as irreversible non-selective monoamine oxidase inhibitors - irreversible MAOIs (e.g., iproniazide), as serious and sometimes fatal reactions may occur (serotonin syndrome, see sections “Do not take FLUOXETINE ALMUS” and “Warnings and precautions”);
metoprolol, a medicine used to treat heart conditions (see section “Do not take FLUOXETINE ALMUS”).

FLUOXETINE ALMUS is not recommended to be taken together with the following medicines:

tamoxifen, a medicine used to treat certain tumors (see section “Warnings and precautions”);
medicines used to treat depression such as monoamine oxidase inhibitors - Type A MAOIs (such as linezolid and methylene blue chloride (methylene blue)), as serious and sometimes fatal reactions may occur (serotonin syndrome, see section “Warnings and precautions”);
mequitazine, a medicine used for allergies.

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

medicines used to treat epilepsy such as phenytoin, carbamazepine, oxcarbazepine;
Type B MAOIs (such as selegiline). These medicines may be used with FLUOXETINE ALMUS provided your doctor closely monitors you, as serious and sometimes fatal reactions (serotonin syndrome) may occur (see section “Warnings and precautions”);
medicines used to treat mental disorders and depression such as phenothiazine derivatives, pimozide, haloperidol, tricyclic antidepressants, SSRIs, butyrophenones, 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 conditions such as class IA and III antiarrhythmics;
certain antibacterials, medicines used to treat bacterial infections (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine);
medicines for malaria such as halofantrine, mefloquine, chloroquine;
certain antihistamines, medicines for allergies (astemizole, mizolastine, cyproheptadine);
non-steroidal anti-inflammatory drugs (e.g., aspirin and other NSAIDs);
warfarin or other medicines used to thin the blood;
diuretics, medicines that increase urine production;
desmopressin, a medicine used for diabetes;
medicines used for heart conditions such as flecainide, nebivolol, propafenone.

FLUOXETINE ALMUS with food, drinks, and alcohol
Do not drink alcohol during treatment with this medicine.
You may take this medicine regardless of meals.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy unless absolutely necessary, as it may cause serious problems in your baby.
When taken during pregnancy, particularly during the last three months, medicines such as FLUOXETINE ALMUS may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you have taken this medicine during late pregnancy, your baby may show signs of irritability, tremor, changes in muscle tone (hypotonia), constant crying, difficulty sleeping or feeding.
If you take FLUOXETINE ALMUS near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking FLUOXETINE ALMUS so they can advise you on what to do.
Breastfeeding
FLUOXETINE ALMUS is excreted in breast milk and may cause problems in the baby.
If treatment with FLUOXETINE ALMUS is considered necessary, discontinuation of breastfeeding should be considered; however, if breastfeeding is continued, the lowest effective dose of fluoxetine should be prescribed.
Fertility
This medicine may affect sperm quality. This effect reverses upon discontinuation of treatment (see section “Possible side effects”).
Driving and using machines
This medicine may impair your ability to drive or operate machinery, as it may reduce your judgment and reaction time in dangerous situations. Therefore, be cautious before driving or operating machinery.

3. How to take FLUOXETINE ALMUS

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the capsules with a glass of water. Do not chew the capsules. Your doctor will adjust the dose according
to your needs. Do not change the dose without first consulting your doctor (see section “If you stop taking FLUOXETINE ALMUS”).
Treatment of major depressive episodes
The recommended dose for adults and elderly patients is 20 mg daily.
If necessary, your doctor will review and adjust the dosage within 3–4 weeks after starting treatment. The dose
may be increased up to a maximum of 60 mg daily. Dose adjustments should be made carefully to ensure that
you receive the lowest effective dose.
You may not feel better immediately at the beginning of treatment for depression. This is usually because
improvement in depressive symptoms may not occur until after the first few weeks. Patients with depression
should be treated for at least 6 months.
Treatment of obsessive-compulsive disorder
The recommended dose for adults and elderly patients is 20 mg daily.
If no improvement is observed after 2 weeks, your doctor may reassess the dosage. The dose may be gradually
increased up to a maximum of 60 mg daily. Dose adjustments should be made carefully to ensure that you
receive 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 elderly patients is 60 mg daily.
Elderly patients
If you are elderly, your doctor will exercise greater caution when increasing the dose, and the daily dose
should generally not exceed 40 mg. The maximum dose is 60 mg daily.
Hepatic impairment
If you have liver problems or are taking other medicines that may interact with FLUOXETINE ALMUS, your
doctor may decide to prescribe a lower dose or dosing on alternate days.
Use in children and adolescents
Treatment in children and adolescents aged 8 to 18 years should be initiated and supervised by a specialist.
The initial dose is 10 mg daily.
After 1–2 weeks, your doctor may reassess the dose and increase it to 20 mg daily. The dose should be increased
cautiously to ensure that you receive the lowest effective dose.
Children with low body weight may require lower doses. Your doctor must evaluate the need to continue
treatment beyond 6 months. If no improvement is observed, treatment should be reassessed.
For doses not achievable with this formulation, other pharmaceutical forms and dosage strengths are available,
which your doctor may recommend.
If you take more FLUOXETINE ALMUS than you should
In case of accidental overdose of FLUOXETINE ALMUS, contact your doctor immediately or go to the nearest
hospital.
Symptoms of overdose include nausea, vomiting, seizures, heart problems (cardiovascular dysfunction ranging
from asymptomatic arrhythmia to cardiac arrest), respiratory problems (pulmonary dysfunction), and mental
disturbances ranging from agitation to coma. Death has occurred very rarely.
If you forget to take FLUOXETINE ALMUS
If you forget to take a dose, take the next dose at your usual time the following day.
Do not take a double dose to make up for the missed dose.
If you stop taking FLUOXETINE ALMUS
Do not stop treatment with FLUOXETINE ALMUS suddenly or without first discussing it with your doctor.
When stopping treatment with this medicine, the following withdrawal symptoms may occur: dizziness,
sensory disturbances such as tingling sensations in the arms and legs (paresthesia), sleep disturbances such as
inability to fall asleep (insomnia) and vivid dreams, unusual tiredness or weakness (asthenia), agitation or anxiety,
nausea and vomiting, headache (cephalalgia), tremor.
These symptoms usually appear within the first few days after stopping treatment and generally resolve within
2 weeks, although in some individuals they may persist longer (2–3 months or more).
Abrupt discontinuation should be avoided. When you stop taking FLUOXETINE ALMUS, your doctor will help
you gradually reduce the dose over a period of 1 or 2 weeks, which should help reduce the likelihood of
withdrawal symptoms.
If you experience any of these symptoms when stopping treatment, contact your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The most commonly reported side effects in patients treated with fluoxetine are headache, nausea, insomnia, fatigue and diarrhoea. These effects may decrease in intensity and frequency during treatment and generally do not lead to discontinuation of therapy.

If during treatment you are thinking about harming yourself or have thoughts of suicide, contact your doctor immediately or go immediately to hospital.

The following side effects may occur:

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

headache (cephalalgia)
insomnia
diarrhoea, 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
tremor
dizziness
reduced 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
urinary problems
joint pain (arthralgia)
agitation, chills
vaginal bleeding (gynaecological haemorrhage)

Uncommon (may affect up to 1 in 100 people)

feeling detached from oneself (depersonalization)
mood changes (elevated mood, euphoria), abnormal thoughts
sexual disorders (e.g. abnormal orgasm)
teeth grinding (bruxism)
suicidal behaviour and thoughts
movement disorders (psychomotor hyperactivity, dyskinesia, myoclonus, balance disorder, ataxia)
memory problems
vision problems (mydriasis)
perception of ringing or other sounds in the ear (tinnitus)
reduced blood pressure (hypotension)
breathing problems
increased tendency to bruise
nosebleeds or bleeding from the stomach or intestine
difficulty swallowing (dysphagia)
excessive hair loss (alopecia)
cold sweats
muscle contractions
urinary problems (dysuria)
malaise, feeling unwell, sensation of heat 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 difficulties)
problems caused by inappropriate production of antidiuretic hormone (ADH), which regulates urine production (SIADH)
reduced sodium levels in the blood
manic reactions (hypomania, mania)
hallucinations
agitation
panic attacks
confusion
speech disorders (dysphemia)
aggression
lung problems, inflammation of the pharynx (pharyngitis)
oesophageal pain
heart problems (ventricular arrhythmia including torsade de pointes and QT prolongation on ECG)
inflammation of blood vessels (vasculitis), vasodilation
serotonin syndrome, which presents with symptoms such as: fever, muscle rigidity or tremor, changes in mental status such as confusion, irritability and extreme agitation
movement disorders of the tongue and mouth
liver inflammation (idiopathic hepatitis)
skin reactions caused by exposure to sunlight (photosensitivity reaction), severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome, purpura
seizures
restlessness and inability to sit or stand still
muscle pain (myalgia)
urinary problems (urinary retention, micturition disorder)
prolonged and painful erection (priapism)
increased prolactin levels in women (hyperprolactinaemia)
sudden milk secretion from the breast (galactorrhoea)
bleeding, gastrointestinal bleeding and other bleeding affecting the skin or mucous membranes
changes in liver function (increased transaminases, increased gamma-glutamyl transferase)
sudden appearance of bruises (ecchymoses)

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

increased blood pressure (hypertension)
heart problems (angina pectoris, arrhythmias, first-degree atrioventricular block)
reduced potassium levels in the blood (hypokalaemia)
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); 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 of age)

In addition to the possible side effects listed above, FLUOXETINE ALMUS may slow growth and possibly delay sexual maturation. Suicidal-related behaviours (suicide attempt and suicidal thoughts), hostile behaviour, mania, nosebleeds and changes in alkaline phosphatase enzyme levels have been reported.

Reporting of side effects

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

5. How to store FLUOXETINE 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FLUOXETINA ALMUS contains

The active substance is fluoxetine hydrochloride. Each capsule contains 22.36 mg of fluoxetine hydrochloride, equivalent to 20 mg of fluoxetine.
The other components are: maize 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 pack sizes
Box containing 12 or 28 hard capsules of 20 mg.
Not all pack sizes may be marketed.

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

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