FLUOXETINA 20 mg Диспергируемые Таблетки

Содержание инструкции

1. Fluoxetina Generics 20 mg dispersible tablets
   1. What is Fluoxetina Generics and what it is used for
   2. What you need to know before taking Fluoxetina Generics
   3. How to take Fluoxetina Generics
   4. Possible side effects
   5. HOW TO STORE FLUOXETINA GENERICS
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Fluoxetina Generics 20 mg dispersible tablets

Fluoxetina

Generic medicine
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Fluoxetina Generics and what it is used for

Fluoxetina Generics is an antidepressant that affects the central nervous system.
Fluoxetina Generics is used for:

Adults

• Depression
• Obsessive thoughts and actions
• Bulimia (compulsive eating disorder).

Children and adolescents aged 8 years and over(only under the supervision of a specialist):

• Major depressive disorder from moderate to severe, if the depression does not respond to psychotherapy after 4-6 sessions. Fluoxetina must be administered to a child or young person with moderate to severe major depressive disorder only in combination with psychological therapy.

Caution: your doctor may have prescribed this medicine for a different disorder and/or at dosages
provided on the package label.

2. What you need to know before taking Fluoxetina Generics

Do not take Fluoxetina Generics

• if you are allergic to fluoxetine or to any of the other ingredients of this medicine (listed in section 6).
• if you are already taking any of the medicines specifically known as Non-selective irreversible Monoamine Oxidase Inhibitors (MAOIs). An example of such medicines is iproniazide, used to treat depression
• if you are already taking the medicine metoprolol used to treat heart failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluoxetina Generics:

• if you have diabetes, because Fluoxetina Generics may increase or decrease blood sugar. You may need to adjust the dose of insulin or the oral antidiabetic medicine you are taking.
• if you have had convulsions, have epilepsy, reduced liver, kidney or heart function or if you have recently had a heart attack you must inform your doctor, because you may need to be prescribed a lower dose of medicine.
• if you have heart rhythm disorders called prolongation of the 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 suffer from any condition that makes you more exposed to having irregular heartbeats (e.g. low levels of potassium or magnesium, slow heartbeat).
• if you start to feel restless and cannot sit or stand still (akathisia). Increasing the dose of Fluoxetina Generics may worsen the situation.
• if you have or have had manic episodes.
• if you have a tendency to bleed.
• if you are taking tamoxifen (used to treat breast cancer) (see section 2 “Fluoxetina Generics and other medicines”).
• if you are taking other medicines or herbal remedies that contain St. John's Wort (Hypericum, Hypericum perforatum) (See section 2 “Fluoxetina Generics and other medicines”).
• if you are undergoing electroconvulsive therapy (ECT)
• if you have increased pressure in the eye (glaucoma)

Suicidal thoughts and worsening of depression
If you are depressed you may sometimes have thoughts of self-harm or suicide. These may increase when
you take an antidepressant for the first time, as these medicines all need time to work:
usually about two weeks, but sometimes longer.

It is possible that you may have such thoughts:

• If you have previously had suicidal thoughts or thoughts of self-harm.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults under 25 years of age with psychiatric disorders treated with an antidepressant. If at any time you have thoughts of self-harm or suicide,contact your doctor or go tohospital immediately.It may be helpful to tell a relative or close friendthat you are depressed and ask them to read

getting worse, or if they are concerned about changes in your behavior.
If you develop an allergic reaction such as itching, hives or swelling of the face, lips, tongue and/or throat
(sometimes with shortness of breath or difficulty swallowing) treatment with Fluoxetina Generics must be stopped.
Contact your doctor if you develop symptoms such as high fever, muscle contractions, confusion and anxiety (‘serotonin
syndrome’ or “neuroleptic malignant syndrome”). You may need to stop treatment with
Fluoxetina Generics.
During treatment with Fluoxetina Generics you may experience weight loss.

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
adverse effects such as suicide attempts, suicidal thoughts and hostility (essentially aggression,
oppositional behavior and anger). Fluoxetine should be used in children and adolescents aged
between 8 and 18 years only for the treatment of major depressive episodes of moderate to severe
degree (in association with psychotherapy) and should not be used to treat other conditions.
Only limited information is available in this age group regarding the long-term safety of fluoxetine on
growth, puberty and mental, emotional and behavioral development.
Despite this, the doctor may prescribe fluoxetine to patients under 18 years of age for the treatment
of major depressive episodes of moderate to severe degree in association with psychotherapy, if
he/she believes that this is the best solution for them. If the doctor has prescribed fluoxetine to a patient
under 18 years of age and you would like clarification, return to the doctor. You must inform the doctor if any
of the above symptoms appear or worsen, when patients under 18 years of age are taking
fluoxetine.

Fluoxetine must not be used in the treatment of children under 8 years of age.
Fluoxetina Generics and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Some medicines can affect Fluoxetina Generics or be affected by it. Contact your doctor if
you are taking any of the medicines listed below.:

• some irreversible and non-selective monoamine oxidase inhibitors (MAOIs),some used to treat depression. Irreversible and non-selective MAOIs must not be used with fluoxetine as serious or even life-threatening reactions (serotonin syndrome) may occur (see section “Do not take Fluoxetina Generics”). Treatment with Fluoxetina Generics must be started strictly at least 2 weeks after stopping an irreversible and non-selective MAOI (such as tranilcipromine). Do not take any irreversible and non-selective MAOI for at least 5 weeks after you have stopped taking fluoxetine. If fluoxetine has been prescribed for a long period and/or at high doses, the doctor may need to consider a longer time interval than 5 weeks.
• metoprolol when used for heart failure (see also “Do not take Fluoxetina Generics”).

Fluoxetine can affect the mechanism of action of the following medicines (interaction), in particular
the following:
some medicines known as monoamine oxidase inhibitors (MAOIs, including moclobemide, linezolid
(an antibiotic) and methylthioninium chloride (also called methylene blue and used to treat a
blood disease known as methemoglobinemia): due to the risk of serious or even
life-threatening reactions (called serotonin syndrome). Treatment with fluoxetine may be started the day
following the discontinuation of treatment with a reversible MAOI but the doctor may decide to
subject you to careful monitoring and use a lower dose of an MAOI-Type A. • lithium (used
to treat bipolar disorder), tryptophan (used to treat some mental illnesses), selegiline (used for
Parkinson's disease), the herbal remedy St. John's Wort (used to treat depression), tramadol (a
painkiller) or medicines known as “triptans” (e.g. sumatriptan, zolmitriptan) used to treat migraine);
there is an increased risk of serotonin syndrome when these medicines are taken with fluoxetine

• medicines to thin the blood (e.g. warfarin)
• medicines for epilepsy (e.g. phenytoin or carbamazepine)
• painkillers and anti-inflammatory medicines such as acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin, ibuprofen)
• some antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin i.v., pentamidine)
• anti-malarial treatments, in particular halofantrine
• astemizole, mequitazine, cyproheptadine or mizolastine (antihistamines, used to treat allergic reactions)
• medicines used to treat heart problems (e.g. flecainide, propafenone, nebivolol)
• diuretics, medicines used to treat high blood pressure
• medicines that affect the heart rhythm, e.g. Class IA and III antiarrhythmics
• tricyclic antidepressants
• antipsychotic drugs (e.g. pimozide, haloperidol, risperidone)
• tamoxifen (used to treat breast cancer), as fluoxetine may change the levels of this medicine in the blood, with a possible decrease in the effect of tamoxifen, the doctor may need to consider prescribing another antidepressant treatment.
• atomoxetine (used to treat Attention Deficit Hyperactivity Disorder, ADHD)
• desmopressin, used to treat some types of hormonal problems that affect urination
• medicines that can increase the possibility of convulsions, such as other SSRI antidepressants (e.g. sertraline, citalopram, paroxetine), medicines used for mental illnesses (e.g. perphenazine, chlorpromazine), some medicines for mental illnesses called butyrophenones (e.g. benperidol, haloperidol), mefloquine or chloroquine (for malaria) or bupropion (for depression or nicotine addiction).

Fluoxetina Generics with alcohol
The combination of Fluoxetina Generics and alcohol is not recommended.

Pregnancy, breastfeeding and fertility
If you are pregnant if you think you may be pregnant or if you are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine

Pregnancy:
Regarding babies whose mothers have taken fluoxetine during the first months of pregnancy, some studies
indicate an increased risk of birth defects, in particular concerning the
heart. In the general population, babies born with heart defects are about 1 in 100. This
ratio increases to about 2 babies in 100, in mothers who have taken fluoxetine.
When taken during pregnancy, especially in the last 3 months of pregnancy, medicines such as Fluoxetina
Generics, can increase the risk of a serious disorder in babies, called persistent pulmonary hypertension of the
newborn (PPHN), which involves rapid breathing in the newborn and the appearance of bluish skin.
Usually, these symptoms appear during the first 24 hours after the baby is born. Immediately inform
the midwife and/or doctor if your baby should present these symptoms.
It is preferable not to use fluoxetine during pregnancy unless the potential
benefit outweighs the potential risk. Therefore, together with your doctor you can decide to gradually stop
taking fluoxetine before or during the period of pregnancy. However, depending on the circumstances, the
doctor may suggest that it is better for you to continue taking
fluoxetine.
Care must be taken when fluoxetine is used during pregnancy, especially during
the last stage of pregnancy or shortly before delivery as the following symptoms have been reported in
newborn babies: irritability, tremor, muscle weakness, persistent crying, difficulty sucking or
sleeping.

Breastfeeding
Fluoxetine is excreted in breast milk and may cause side effects in babies. You should only
breastfeed when it is clearly necessary. If breastfeeding is continued, your doctor may prescribe
a lower dose of fluoxetine.

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

Driving and using machines
Fluoxetina Generics may impair your ability to judge, think and motor skills. This must be
taken into account in situations that require greater mental attention, e.g. when driving or
using dangerous machinery.

3. How to take Fluoxetina Generics

Always take this medicine exactly as your doctor or pharmacist has told you. If you have doubts, you should
consult your doctor or pharmacist.
Fluoxetina Generics dispersible tablets can be dissolved in a glass of water or swallowed whole with or
without food. The score line is not for breaking the tablet.

Adults

Depression, obsessive thoughts and actions (OCD, Obsessive-Compulsive Disorder):
The recommended dose is 20 mg - 60 mg/day.
Your doctor will review and adjust your dosage, if necessary, within 3 or 4 weeks of starting treatment. The
dose should be increased carefully to ensure that you receive the minimum effective dose.

Bulimia nervosa:
The recommended dose is 60 mg/day.

Use in children and adolescents aged 8 years and over with moderate to severe depression
Treatment must be started and supervised by a specialist.
The initial dose is 10 mg per day (administered as 2.5 ml of Fluoxetina oral solution).
After one to two weeks, the dose may be increased to 20 mg per day. The dose should be increased with
caution to ensure that you receive the minimum effective dose. Children with low body weight may
need lower doses. If there is a satisfactory response to treatment, the doctor should assess the need to
continue treatment after 6 months. If no improvements are noticed within 9 weeks, the doctor will re-evaluate the
treatment.

Patients with liver problems
If you suffer from impaired liver function, your doctor may reduce your dosage.

If you take more Fluoxetina Generics than you should
If you have taken too much of this medicine, you should contact your doctor or a hospital.
Signs of overdose: nausea, vomiting, convulsions, anxiety, restlessness, excessive euphoria, impaired
cardiac function (e.g. arrhythmia and cardiac arrest) and difficulty breathing.

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

If you stop taking Fluoxetina Generics
Do not stop treatment without consulting your doctor, even if you start to feel better.
If you stop treatment with Fluoxetina Generics, withdrawal symptoms may occur, e.g. sleep disturbances (vivid
dreams, nightmares, inability to sleep), feeling restless or agitated, unusual fatigue or weakness, nausea, vomiting, unsteady
balance, dizziness, headache, anxiety and skin sensation abnormalities such as numbness, tingling, prickling or burning (paresthesia). These disturbances are mild and temporary.
When the doctor decides that you should stop taking Fluoxetina Generics, they may choose to reduce
the dose gradually over several weeks. If undesirable effects occur during dose reduction, the doctor may decide to reduce it more slowly.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following side effects, stop taking the tablets and tell your doctor
immediately or go to the nearest hospital emergency room:
Uncommon(may affect up to 1 in 100 people):

• thoughts of harming yourself or suicide (see paragraph 2 “Suicidal thoughts and worsening of depression”).

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

• an allergic reaction. These reactions may manifest as anaphylaxis (a severe form of allergic reaction) with symptoms such as:
• skin rash
• swelling of the face, tongue and/or throat, difficulty swallowing, hives and difficulty breathing (angioedema)
• sudden wheezing, fainting or difficulty swallowing
• fever, rapid swelling of tissues around the neck, face, mouth and/or throat, skin rash, enlarged lymph nodes (serum sickness)
• convulsions
• heart rhythm disturbances called prolongation of the QT interval (delayed conduction of electrical signals which can be seen on an electrocardiogram (ECG), an electrical recording of the heart's activity). In some people this can develop into a potentially life-threatening condition known as “Torsade de Pointes”. This can lead to a very fast heartbeat causing sudden loss of consciousness
• if you feel restless and cannot sit or stand still, you may have akathisia; increasing the dose of Fluoxetine Generics may make you feel worse
• high fever, muscle contractions, confusion and anxiety. These symptoms may be a sign of the so-called “serotonin syndrome ”.
• skin rash, which may lead to blisters, which appear as small target lesions (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), widespread rash with blisters and peeling of the skin, especially on the body surface, around the mouth, nose, eyes and genitals (toxic epidermal necrolysis, Stevens Johnson syndrome).
• prolonged and painful erection.

Other possible side effects
Very common(may affect more than 1 in 10 people)

• difficulty sleeping (insomnia)
• headache
• diarrhea
• feeling unwell (nausea)
• fatigue (tiredness), feeling abnormally tired

Common(may affect up to 1 in 10 people)

• loss of appetite, weight loss
• nervousness, anxiety
• restlessness
• difficulty concentrating
• feeling of tension
• decreased sexual desire or sexual problems (including difficulty maintaining an erection for sexual intercourse)
• sleep disturbances, unusual dreams (including nightmares)
• tiredness or drowsiness
• dizziness
• altered taste
• involuntary trembling movements
• blurred vision
• feeling of a fast and irregular heartbeat, another change in the heart's electrical activity called QT prolongation, which can be observed with an ECG, an electrical recording of the heart's activity
• hot flushes
• yawning
• indigestion, vomiting
• dry mouth
• skin rash, hives, itching
• excessive sweating
• joint pain
• more frequent urination
• unexplained vaginal bleeding feeling shaken or having chills Uncommon(may affect up to 1 in 100 people)
• feeling detached from yourself
• memory problems
• strange thoughts
• abnormally elevated mood
• ringing in the ears
• nosebleeds
• problems with orgasm
• teeth grinding
• muscle contractions, involuntary movements or problems with balance or coordination
• dilated pupils
• low blood pressure
• shortness of breath
• difficulty swallowing
• gastrointestinal bleeding
• hair loss
• increased tendency to bruise
• cold sweat
• painful urination
• feeling of hot or cold
• general feeling of discomfort/abnormal
• increased liver enzymes observed in laboratory tests.

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

• low levels of sodium in the blood, which can cause weakness and confusion, with muscle pain. This may be due to inappropriate secretion of vasopressin (ADH) a hormone that causes fluid retention in the body and dilution of the blood, reducing the amount of sodium
• frequent infections with fever, chills, sore throat or mouth ulcers (reduced number of white blood cells)
• lung problems, scarring and thickening of the lungs, with difficulty breathing
• liver disorder with the following signs: feeling unwell or sick, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, pale stools, dark urine
• low levels of salts in the blood
• wild atypical behavior
• seeing, perceiving or hearing things that do not exist (hallucinations)
• agitation
• panic attacks
• aggression
• confusion
• stuttering
• inflammation of blood vessels (vasculitis)
• dilation of blood vessels
• pain in the esophagus (the tube that carries food or water to the stomach)
• sensitivity to sunlight
• production of milk from the breasts
• increased level of prolactin (a hormone) in the blood
• sore throat and difficulty swallowing
• muscle pain
• bruising
• ecchymosis or unexplained bleeding
• difficulty urinating
• bleeding from mucous membranes in areas such as the mouth and nose.

Not known(the frequency cannotbe defined on the basisof the available data)

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

Side effects in children and adolescents(8-18 years)
In addition to the side effects listed above, fluoxetine may slow growth or possibly delay
sexual maturity. Behaviors related to suicide (suicide attempt and suicidal thoughts), hostility, mania and
nosebleeds have been commonly reported in children.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. Side effects can also be reported directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili . Reporting of side
effects helps to provide more information on the safety of this medicine.

5. HOW TO STORE FLUOXETINA GENERICS

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, blister or label of the
bottle, after the wording “EXP”.
The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Fluoxetina Generics contains:

The active substance isfluoxetine hydrochloride, equivalent to 20 mg of fluoxetine.

The other ingredients aremicrocrystalline cellulose, anhydrous colloidal silica, corn starch, crospovidone,
sodium saccharin, magnesium stearate and peppermint powder.

Description of the appearance of Fluoxetina Generics and package contents
The medicine is available as dispersible tablets. These are white, oval shaped and marked “FL|20” on one
side and “G” on the other.
The medicine is available in plastic bottles with a screw cap, containing 30, 100, 250 and 500 tablets or in blisters
containing 7, 12, 14, 28 and 30 tablets, as well as blisters containing 30x1 and 100x1 unit dose tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

MYLAN S.P.A
VIA VITTOR PISANI, 20
20124 MILANO

Batch Release
Generics (UK) Ltd.
Station Close, Potters Bar, Hertfordshire, EN6 1TL – United Kingdom
McDermott Laboratories Ltd (t/a Gerard Laboratories Ltd)
35-36 Baldoyle Industrial Estate, Grange Road, Dublin 13 - Ireland
Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1
Hungary