Fluoxetine Doc Generici: detailed information

Package leaflet: Information for the user

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

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

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

Children and adolescents aged 8 years and older:

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

2. What you should know before taking FLUOXETINA DOC Generici

Do not take FLUOXETINA DOC Generici:

If you are allergic to fluoxetine or to 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 (called MAOIs, also used to treat depression), as serious and sometimes fatal reactions may occur. Examples of MAOI medicines include nialamide, iproniazide, selegiline, moclobemide, phenelzine, tranylcypromine, isocarboxazid, and toloxatone.

Treatment with fluoxetine should only be started at least 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 stopping treatment with FLUOXETINA DOC Generici.
If FLUOXETINA DOC Generici has been prescribed for you for a long period of time and/or at high doses, your doctor should consider a longer 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, facial or lip swelling, or shortness of breath); stop taking FLUOXETINA DOC Generici immediately and contact your doctor without delay.
If you have epilepsy or have previously had a seizure; if you experience a seizure (convulsion) or an increase in seizure frequency, contact your doctor immediately, as it may be necessary to discontinue FLUOXETINA DOC Generici.
If you have previously experienced a manic disorder; if you develop 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 insulin dose or other antidiabetic treatment.
If you have liver problems (your doctor may need to adjust the dose).
If you have heart rhythm disorders known as QT interval prolongation (delayed electrical conduction, visible on an ECG, an electrical recording of heart activity), or a family history of such conditions.
If you are taking diuretics ("water tablets"), especially if you are elderly.
If you are receiving treatment with ECT (electroconvulsive therapy).
If you are taking tamoxifen (see "Other medicines and FLUOXETINA DOC Generici").
If you begin to feel restless and unable to sit still or remain motionless (akathisia). In such cases, increasing the dose of FLUOXETINA DOC Generici may be harmful.
If you have any condition that makes you more susceptible to heart rhythm disturbances (e.g. low potassium or magnesium levels, slow heart rate, acute myocardial infarction, uncompensated heart failure).
If you have an eye condition called glaucoma (increased pressure inside the eye).
If you have a history of bleeding disorders, or if you develop bruising or unusual bleeding, or if you are pregnant (see section "Pregnancy").
If you are experiencing weight loss.
If you are taking medicines affecting blood clotting (see "Other medicines and FLUOXETINA DOC Generici").
If you are taking medicines containing buprenorphine (with or without naloxone). Using these medicines together with fluoxetine may lead to serotonin syndrome (see "Other medicines and FLUOXETINA DOC Generici").
- If you develop fever, muscle stiffness, or tremor, or changes in your mental state such as confusion, irritability, or extreme agitation, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Although rare, this syndrome can lead to potentially life-threatening conditions; contact your doctor immediately, as it may be necessary to stop taking FLUOXETINA DOC Generici.
If you have suicidal thoughts or worsening depression and anxiety: if you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or suicide. These thoughts may increase when starting antidepressant treatment, as these medicines require time to become effective, usually about 2 weeks but sometimes longer. You may be more likely to have such thoughts:
if you have previously had thoughts of suicide or self-harm;
if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you have thoughts of harming yourself or suicide, contact your doctor or go immediately to hospital.
You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.

Medicines such as FLUOXETINA DOC Generici (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.

Children and adolescents aged 8 to 18 years
Patients under 18 years of age taking this type of medicine have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger). FLUOXETINA DOC Generici should be used in children and adolescents aged 8 to 18 years only for the treatment of moderate to severe major depressive episodes (in combination with psychotherapy) and should not be used for other indications.
Furthermore, only limited data are available regarding the long-term safety of FLUOXETINA DOC Generici on growth, puberty, and mental, emotional, and behavioural development in this age group.
Nevertheless, your doctor may prescribe FLUOXETINA DOC Generici to patients under 18 years of age for the treatment of moderate to severe major depressive episodes in combination with psychotherapy if they consider it the best option. If FLUOXETINA DOC Generici has been prescribed for a patient under 18 years of age and you wish to discuss it further, please consult your doctor.
You must inform your doctor if any of the above symptoms appear or worsen during treatment with FLUOXETINA DOC Generici in patients under 18 years of age.
FLUOXETINA DOC Generici must not be used to treat children under 8 years of age.

Other medicines and FLUOXETINA DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (up to 5 weeks before).
The following medicines must not be taken while you are being treated with FLUOXETINA DOC Generici:

Non-selective, irreversible monoamine oxidase inhibitors (e.g. iproniazide), used to treat depression, as serious or even fatal reactions (serotonin syndrome) may occur. See section Do not take FLUOXETINA DOC Generici;
Metoprolol, used to treat heart failure.

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

Tamoxifen (used to treat breast cancer). Since FLUOXETINA DOC Generici may alter blood levels of this medicine, a reduced effect of tamoxifen cannot be ruled out.
Monoamine oxidase inhibitors MAO-A (e.g. linezolid and methylene blue), as there is an increased risk of serotonin syndrome.
Mequitazine (an antihistamine used to treat allergic reactions).
Phenytoin (used to treat epilepsy). Since FLUOXETINA DOC Generici may affect blood levels of this medicine, your doctor may need to monitor phenytoin more closely 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 medicines are taken together with FLUOXETINA DOC Generici, there is an increased risk of serotonin syndrome. When FLUOXETINA DOC Generici is used with these medicines, your doctor will perform more frequent monitoring.
Medicines known to affect heart rhythm. These include medicines used to treat heart rhythm disorders (class IA and III antiarrhythmics such as quinidine, procainamide, amiodarone, dofetilide, and sotalol), depression (tricyclic antidepressants), mental disorders (antipsychotics such as phenothiazine derivatives, pimozide, and haloperidol), bacterial infections (antibiotics such as sparfloxacin, moxifloxacin, intravenous erythromycin, and pentamidine), malaria (particularly halofantrine), and some antihistamines (astemizole, mizolastine).
Oral anticoagulants (such as warfarin), non-steroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents (such as acetylsalicylic acid), and other medicines affecting blood clotting such as clozapine, phenothiazines, most tricyclic antidepressants (used to treat certain mental disorders), and aspirin. If treatment with FLUOXETINA DOC Generici is started or stopped while taking an oral anticoagulant, your doctor will need to perform checks and may adjust the dose during and/or after discontinuation of treatment.
Cyproheptadine (an antihistamine used to treat allergic reactions and pruritic dermatoses).
Medicines that reduce sodium levels in the blood, such as diuretics, desmopressin (used to treat diabetes insipidus), carbamazepine, and oxcarbazepine (used to treat epilepsy).
Medicines that may increase the risk of seizures. These include medicines used to treat depression (bupropion and other antidepressants), mental disorders (phenothiazine derivatives, butyrophenones), malaria (mefloquine, chloroquine), and pain (tramadol).
Flecainide, encainide, propafenone, and nebivolol (used to treat heart conditions), carbamazepine (used to treat epilepsy), tricyclic antidepressants (e.g. imipramine, desipramine, amitriptyline), atomoxetine (used to treat attention deficit hyperactivity disorder (ADHD)), and risperidone (used to treat mental disorders). Since FLUOXETINA DOC Generici may alter blood levels of these medicines, your doctor may need to reduce the dose when they are taken together with FLUOXETINA DOC Generici.

FLUOXETINA DOC Generici with food, drinks, and alcohol
You may take FLUOXETINA DOC Generici with or without food, as preferred.
You should avoid drinking alcohol while taking this medicine.

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

Pregnancy
Data on newborns whose mothers took fluoxetine during the first months of pregnancy indicate an increased risk of birth defects, particularly heart defects. In the general population, about 1 in 100 babies are born with heart defects. This risk increases to about 2 in 100 babies when mothers took fluoxetine during pregnancy.
Together with your doctor, you may decide whether to gradually reduce your intake of FLUOXETINA DOC Generici during pregnancy. However, depending on the circumstances, your doctor may advise continuing or discontinuing treatment.
Ensure that your midwife and/or doctor are aware that you are taking FLUOXETINA DOC Generici.
Medicines such as FLUOXETINA DOC Generici, if taken during pregnancy, particularly during the last 3 months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension (PPHN), which manifests as increased breathing rate and bluish skin colour. These symptoms usually appear within the first 24 hours after birth. Inform your midwife and/or doctor immediately if your baby shows these symptoms.
Although animal studies have not shown any selective teratogenic or embryotoxic effects, 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 only under direct medical supervision.
If you take FLUOXETINA DOC Generici 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 FLUOXETINA DOC Generici so they can advise you accordingly.

Breastfeeding
Fluoxetine is excreted in breast milk and may cause adverse effects in infants.
Breastfeeding should only be continued 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 inform their doctor immediately if they are breastfeeding.

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

Driving and using machines
This medicine may impair your ability to drive or operate machinery, as it may reduce your judgment and reactivity in dangerous situations. Do not drive or operate tools or machinery unless you are confident in your ability to do so safely.

FLUOXETINA DOC Generici hard capsules contain lactose and sodium

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

FLUOXETINA DOC Generici 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) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, talk to your doctor before you (or the child) take this medicine. It may cause gastrointestinal problems and has a mild laxative effect.
This medicine contains 2.5 mg of benzoic acid per 20 mg dose and 7.5 mg per 60 mg dose. Benzoic acid may 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 exactly as directed by 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 daily. If necessary, your doctor will review and adjust the dose within 3–4 weeks after starting treatment. If appropriate, the dose may be gradually increased up to a maximum of 60 mg. The dose should be increased cautiously to ensure you receive the lowest effective dose. It is possible that you will not experience immediate improvement at the beginning of treatment for depression. This is normal, as symptom improvement in depression may only occur after the first few weeks of therapy. Patients with depression should be treated for at least 6 months.
Bulimia nervosa: The recommended dose is 60 mg daily.
Obsessive-compulsive disorder: The recommended dose is 20 mg daily. If necessary, your doctor will review and adjust the dose after 2 weeks of treatment. If appropriate, the dose may be gradually increased up to a maximum of 60 mg. If no improvement is observed within the first 10 weeks, treatment with FLUOXETINA DOC Generici should be reconsidered.

Use in children and adolescents aged 8 to 18 years with depression
Treatment must be initiated and supervised by a specialist. The initial dose is 10 mg daily (administered as 2.5 ml of FLUOXETINA DOC Generici oral solution). After one or two weeks, your doctor may increase the dose to 20 mg daily. The dose should be increased cautiously to ensure you receive the lowest effective dose. Children with low body weight may require lower doses. Your doctor must evaluate the need for continuing treatment beyond 6 months. If no improvement is observed, treatment should be reassessed.

Elderly
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 another medicine that could interact with fluoxetine, your doctor may decide to prescribe a lower dose or advise you to take FLUOXETINA DOC Generici on alternate days.

Instructions for administration:
Hard capsules: Swallow the capsules with a glass of water. Do not chew the capsules.
Oral solution: Measure the correct amount of medicine using the provided measuring device, syringe, or dosing spoon, then swallow it.

If you take more FLUOXETINA DOC Generici than you should

If you take too many capsules or too much oral solution, go immediately to the nearest hospital emergency department or contact your doctor without delay.
If possible, bring the FLUOXETINA DOC Generici packaging with you.

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

If you forget to take FLUOXETINA DOC Generici

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

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

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

When you stop taking FLUOXETINA DOC Generici, you may experience the following symptoms: dizziness; tingling sensations like pins and needles; sleep disturbances (vivid dreams, nightmares, difficulty falling asleep); feelings of restlessness or agitation; unusual tiredness or weakness; anxiety; nausea/vomiting (feeling unwell); tremor; headache; confusion; sweating; diarrhea; palpitations; emotional instability; irritability; and visual disturbances.
Most people report that any symptoms occurring when stopping FLUOXETINA DOC Generici are mild and resolve on their own within a few weeks. If you experience symptoms when stopping treatment, contact your doctor.
When you stop taking FLUOXETINA DOC Generici, your doctor will help you gradually reduce the dose over one or two weeks—this should help reduce the likelihood of withdrawal symptoms.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

Some patients have experienced:

a group of symptoms (known as serotonin syndrome), including unexplained fever with rapid breathing and rapid heartbeat, sweating, muscle stiffness or tremors, confusion, extreme agitation, or drowsiness (rarely only);
a feeling of weakness, drowsiness, or confusion, especially in elderly people and in people (elderly) being treated with diuretics (water tablets);
prolonged and painful erection;
irritability and extreme agitation.

If you experience any of the above-mentioned side effects, inform your doctor immediately.
If you experience any of the following symptoms and they cause you discomfort or last for a prolonged period of time, inform 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 appetite and loss of appetite, weight loss
anxiety, nervousness, agitation, feeling tense
decreased or loss of sexual desire and sexual problems (including difficulty maintaining an erection for sexual activity and ejaculation problems)
sleep disturbances, unusual dreams (including nightmares), deep sleep (lethargy) or drowsiness
poor concentration
dizziness
altered taste
tremor
blurred vision
sensation of rapid or irregular heartbeat
flushing, hot flushes
yawning
indigestion, vomiting
dry mouth
skin rash, hives, itching
excessive sweating
joint pain
increased need to urinate
vaginal bleeding
feeling nervous
chills

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

feeling detached from oneself
excessively elevated mood
unusual thoughts
orgasm problems
teeth grinding
suicidal thoughts and thoughts of self-harm
hyperactivity, muscle contractions, involuntary movements, or problems with balance or coordination
memory problems
dilated pupils
ringing in the ears
low blood pressure
laboured breathing
nosebleeds
difficulty swallowing
gastrointestinal bleeding
hair loss
increased tendency to bruise
cold sweats
difficulty passing urine
sexual disturbances
sensation of feeling hot 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 with the secretion of a hormone called antidiuretic hormone
reduced levels of sodium in the blood
unusual, uncontrolled behaviour
hallucinations
agitation
panic attacks
confusion
speech problems
aggression
seizures
restlessness and inability to sit or stand still
changes in tongue and mouth movements
serotonin syndrome (high fever, tremors, muscle contractions, and anxiety)
heart rhythm disorders (prolongation of the QT interval, torsades de pointes, atrioventricular arrhythmia)
inflammation of blood vessels (vasculitis)
dilation of blood vessels
sore throat
lung problems
oesophageal pain
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 blistering and itching
severe skin reactions with blistering and skin detachment (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis)
muscle pain (myalgia)
problems and difficulty in urinating
sudden production of milk from the breast
increased level of prolactin (a hormone) in the blood
prolonged and painful erection
bleeding from mucous membranes
abnormal liver function test results

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

Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); 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 growth and possibly delay sexual maturation. Nosebleeds and changes in levels of the enzyme alkaline phosphatase have also been reported.

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

5. How to store FLUOXETINE 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 carton, blister pack, and bottle 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 DOC Generici contains
FLUOXETINA DOC Generici 20 mg hard capsules
The active substance is: fluoxetine hydrochloride.
Each hard capsule contains 22.36 mg of fluoxetine hydrochloride, equivalent to 20 mg of fluoxetine.
The other components are: capsule contents: maize 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 substance is fluoxetine hydrochloride.
5 ml of solution contain 22.36 mg of fluoxetine hydrochloride, equivalent to 20 mg of fluoxetine.
The other components are: benzoic acid (E 210), sorbitol (E 420) 70% solution, glycerin, peppermint flavor, purified water.

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

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

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