Fluoxetine Sandoz GmbH: detailed information

Patient Information Leaflet

Fluoxetina Sandoz Gmbh 20 mg hard capsules

Generic Medicine
Please read all of this leaflet carefully before you start 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 others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Fluoxetina Sandoz GmbH is and what it is used for

Fluoxetina Sandoz GmbH contains the active substance fluoxetine, which belongs to a group of medicines
called selective serotonin reuptake inhibitors (SSRIs).
This medicine is used to treat the following conditions:
Adults:

treatment of depression (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;
Fluoxetina Sandoz GmbH is used together with psychotherapy to reduce binge eating and purging behaviours

Children and adolescents aged 8 to 18 years:

treatment of moderate to severe major depression, if depression does not respond to psychotherapy after 4–6 sessions. The use of this medicine must always be combined with psychotherapy.

2. What you should know before taking Fluoxetina Sandoz Gmbh

Do not take Fluoxetina Sandoz Gmbh if:

you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6). If you experience a skin reaction or other allergic symptoms (such as itching, swelling of the lips or face, or shortness of breath), stop taking the medicine immediately and contact your doctor without delay;
you are currently taking other medicines used to treat depression known as monoamine oxidase inhibitors (MAOIs), as serious and sometimes fatal reactions may occur. Examples of MAOIs include medicines used to treat depression such as nialamide, iproniazide, phenelzine, tranylcypromine, isocarboxazid;
you are taking metoprolol to treat heart failure;
the person who needs to take this medicine is a child under 8 years of age (see section “Children and adolescents”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Fluoxetina Sandoz Gmbh if you are in any of the following
situations:

if you suffer or have previously suffered from seizures. If you have a seizure or notice an increase in the frequency of seizures, contact your doctor immediately; it may be necessary to discontinue this medicine;
if you suffer or have previously suffered from mood or behavioural 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 diabetes, your doctor may decide to adjust your insulin or other antidiabetic treatment dosage;
if you have liver problems, your doctor may decide to adjust your 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 deficiency due to severe and prolonged diarrhoea and vomiting (feeling unwell) or due to the use of diuretics (water tablets);
if you develop an urge to move constantly (akathisia), which may occur during the first weeks of treatment. A dosage adjustment may be required;
if you have glaucoma (increased pressure inside the eye);
if you are currently being treated with diuretics (water tablets), especially if you are elderly;
if you are undergoing or are scheduled to undergo electroconvulsive therapy (ECT);
history of bleeding disorders or occurrence of bruising or unusual bleeding;
if you are taking other medicines that improve blood fluidity or tamoxifen (used to treat breast cancer) (see “Other medicines and Fluoxetina Sandoz Gmbh”);
if you have a tendency to bleed or bruise easily […], or if you are pregnant [see section “Pregnancy” ( )].

Medicines such as Fluoxetina Sandoz (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 develop fever, muscle stiffness or tremor, changes in mental status such as confusion,
irritability and extreme agitation, you may be experiencing the so-called "serotonin syndrome" or
"neuroleptic malignant syndrome". Although this syndrome is rare, it may lead to potentially life-threatening
conditions; contact your doctor immediately, as it may be necessary to discontinue Fluoxetina Sandoz Gmbh.
Suicidal thoughts 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 conditions (psychiatric disorders), you may experience self-harming thoughts or thoughts of harming yourself or of suicide. For this reason, your doctor should monitor you closely, 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 behaviour.
It may be helpful to inform a relative 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 behaviour.
Children and adolescents
Fluoxetina Sandoz Gmbh must not be used to treat children under 8 years of age.
This medicine 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 must not be used to treat other conditions.
Extreme caution must be exercised 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 hostile behaviour (particularly aggressive, oppositional and angry behaviour); inform your doctor if you notice any of these symptoms. Furthermore, only limited data are available regarding the long-term safety of Fluoxetina Sandoz Gmbh in this age group with respect to growth, maturation, and mental, emotional and behavioural development.
Other medicines and Fluoxetina Sandoz Gmbh
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines (up to 5 weeks prior).
This medicine may affect the way other medicines work.
Do not take Fluoxetina Sandoz Gmbh together with:

irreversible non-selective monoamine oxidase inhibitors (MAOIs) (e.g. iproniazide), as serious or even fatal reactions (serotonin syndrome) may occur, including fever, muscle rigidity or tremor, changes in mental status such as confusion, irritability and extreme agitation. Treatment with Fluoxetina Sandoz Gmbh must be started strictly at least 2 weeks after discontinuation of an irreversible non-selective MAOI (e.g. tranylcypromine). Similarly, you must not take any irreversible non-selective MAOI for at least 5 weeks after stopping Fluoxetina Sandoz Gmbh. If Fluoxetina Sandoz Gmbh has been prescribed for a long period and/or at high doses, your doctor should consider a longer interval.
metoprolol (used to treat heart failure): due to the risk of increased adverse effects, including excessive reduction in heart rate (bradycardia).

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

other medicines used to treat depression such as monoamine oxidase inhibitors - MAO-A (such as linezolid and methylene blue); when these medicines are taken with Fluoxetina Sandoz Gmbh, there is an increased risk of serotonin syndrome. If the combination cannot be avoided, your doctor may need to reduce their dosage when administered with Fluoxetina Sandoz Gmbh and will perform more frequent monitoring. MAO-B inhibitors (such as selegiline) may be used with Fluoxetina Sandoz Gmbh provided your doctor keeps you under close supervision, as serious and sometimes fatal reactions (serotonin syndrome) may occur (see section “Warnings and precautions”);
medicines containing lithium, used to treat mental disorders;
tramadol, a medicine used to treat pain;
medicines used for chronic migraine headaches (triptans);
tryptophan-containing supplements;
herbal products containing St. John's Wort (Hypericum perforatum);
medicines used to treat epilepsy such as phenytoin, carbamazepine;
medicines that may alter heart rhythm, e.g. class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antibacterial agents (e.g. sparfloxacin, moxifloxacin, IV erythromycin, pentamidine), medicines used to treat malaria and in particular halofantrine, some antihistamines (astemizole, mizolastine, cyproheptadine);
medicines used for heart problems such as flecainide, encainide and propafenone;
other medicines used to treat depression such as imipramine, desipramine and amitriptyline;
mequitazine, a medicine used to treat allergies;
nebivolol, used to treat high blood pressure (hypertension);
atomoxetine, used for attention deficit in childhood;
medicines used to treat mental disorders (risperidone, phenothiazines, butyrophenones);
mefloquine, chloroquine, used to treat malaria;
other medicines used to treat depression such as tricyclic antidepressants and bupropion;
medicines that may cause a reduction in blood sodium levels (hyponatraemia) such as diuretics used to promote urine elimination, desmopressin used to treat diabetes insipidus;
tamoxifen (used to treat breast cancer); your doctor may need to consider alternative antidepressant treatments;
certain medicines used to treat allergies (antihistamines such as astemizole, mizolastine, cyproheptadine);
medicines that affect bleeding time (haemostasis) such as oral anticoagulants, antiplatelet agents including aspirin and NSAIDs (non-steroidal anti-inflammatory drugs).

Fluoxetina Sandoz Gmbh and alcohol
Do not drink alcohol during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant or are planning a pregnancy, or if you are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless your doctor considers it necessary,
as it may cause serious problems in your baby.
When taken during pregnancy, particularly during the last 3 months, medicines such as
Fluoxetina Sandoz Gmbh 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. These symptoms usually appear within the first 24 hours after birth. 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), continuous crying, difficulty sleeping or feeding.
Fluoxetina Sandoz Gmbh is excreted in breast milk and this may cause problems in the baby.
If treatment with Fluoxetina Sandoz Gmbh is considered necessary, discontinuation of breastfeeding should be considered; however, if breastfeeding is continued, the lowest effective dose of fluoxetine should be prescribed.
This medicine may affect sperm quality.
Pregnancy
If you take Fluoxetina Sandoz Gmbh 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). Inform your doctor or midwife that you are taking Fluoxetina Sandoz
Gmbh, so they can advise you on what to do.
Driving and using machines
This medicine may affect your ability to drive or use machinery, as it may impair your judgment and reaction time in dangerous situations. Therefore, exercise caution before driving or operating machinery.
Fluoxetina Sandoz Gmbh contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Fluoxetina Sandoz Gmbh

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Fluoxetina Sandoz Gmbh may be administered as a single dose or in divided doses, taken during or away from meals.
Swallow the capsules with a glass of water. Do not chew the capsules.
Your doctor will adjust the dose according to your individual needs. Do not change the dose without first consulting your doctor.

Treatment of major depressive episodes
The recommended dose for adults and elderly patients is 1 capsule (20 mg) daily.
If necessary, your doctor may 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 1 capsule (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 3 capsules (60 mg) daily.

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 for continuing 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 and may be recommended by your doctor.

Use in patients with liver problems
If you have liver disease or are taking another medicine that may interact with Fluoxetina Sandoz Gmbh, your doctor may decide to prescribe a lower dose or advise you to take Fluoxetina Sandoz Gmbh every other day.

If you take more Fluoxetina Sandoz Gmbh than you should
In case of accidental overdose or ingestion of an excessive amount of Fluoxetina Sandoz Gmbh, 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 rarely.

If you forget to take Fluoxetina Sandoz Gmbh
Do not take a double dose to make up for the missed dose.

If you stop taking Fluoxetina Sandoz Gmbh
Do not stop treatment with Fluoxetina Sandoz Gmbh 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 arms and legs (paresthesias), sleep disturbances such as difficulty falling 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. Abrupt discontinuation should be avoided; make sure you do not run out of capsules.
When you stop taking Fluoxetina Sandoz Gmbh, 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 effects.
If you experience any of these symptoms when stopping treatment, contact your doctor.

If you have any questions about the use of Fluoxetina Sandoz Gmbh, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fluoxetina Sandoz Gmbh can cause side effects, although not everybody gets them.

If you have thoughts of harming yourself or of suicide at any time, contact your doctor or go to hospital immediately (see section Warnings and precautions).
If you develop a rash or an allergic reaction such as itching, swelling of the lips or tongue, difficulty breathing, or shortness of breath, stop taking the capsules immediately and inform your doctor immediately.
If you feel restless and are unable to sit still or remain motionless, you may have a condition called akathisia; increasing the dose of Fluoxetina Sandoz Gmbh might make you feel worse. If you experience these sensations, contact your doctor.
Contact your doctor immediately if your skin starts to redden, if you develop another skin reaction, or if your skin begins to blister or peel. This occurrence is rare.

Some patients have experienced:

a group of symptoms (known as "serotonin syndrome") including unexplained fever with rapid breathing and increased heart rate, sweating, muscle stiffness or tremors, confusion, extreme agitation, or drowsiness (only rarely);
feeling weak, drowsy, or confused, especially in elderly people and in people (elderly) who are taking diuretics (tablets for passing urine);
prolonged and painful erection;
irritability and extreme agitation;
heart problems, such as a fast or irregular heartbeat, fainting, collapse, or dizziness when standing, which may indicate abnormal heart rhythm;
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, Pregnancy (2), for further information. (Frequency not known).

If you experience any of the side effects listed above, inform your doctor immediately.
The following side effects have also been reported in patients taking Fluoxetina Sandoz Gmbh:
Very common (may occur in more than 1 in 10 patients)

insomnia;
headache (cephalalgia);
diarrhoea, nausea;
fatigue including excessive tiredness accompanied by lack of energy (asthenia).

Common (may occur in 1 to 10 patients out of 100)

loss of appetite, weight loss;
nervousness, anxiety;
restlessness, poor concentration, tension;
reduced or loss of sexual desire (libido) and sexual problems (including difficulty maintaining an erection for sexual activity);
sleep problems, unusual dreams, tiredness or drowsiness;
dizziness;
altered taste;
tremor;
blurred vision;
increased awareness of heartbeat (palpitations);
changes in the electrical activity of the heart (prolonged QT interval);
flushing;
yawning;
indigestion, vomiting;
dry mouth;
skin rash, hives, itching;
excessive sweating;
joint pain (arthralgia);
need to urinate frequently;
unexplained vaginal bleeding;
feeling unable to stand or chills.

Uncommon (may occur in 1 to 10 patients out of 1,000)

feeling detached from oneself (depersonalization);
suicidal behaviour and thoughts (these symptoms may be due to an underlying disease);
excessively elevated or euphoric mood;
orgasm problems and sexual dysfunction;
teeth grinding (bruxism);
hyperactivity, muscle contraction, involuntary movements, or problems with balance or coordination;
dilation of the pupil (mydriasis);
low blood pressure;
laboured breathing;
difficulty swallowing (dysphagia);
gastrointestinal bleeding;
excessive hair loss (alopecia);
increased tendency to develop bruises (ecchymosis);
cold sweating;
problems urinating;
sensation of feeling hot or cold;
nosebleeds;
perception of ringing or other sounds in the ear (tinnitus);
memory impairment;
malaise.

Rare (may occur in 1 to 10 patients out of 10,000)

reduced levels of sodium in the blood;
unusual, uncontrolled behaviour;
hallucinations;
agitation;
panic attacks;
euphoria, seizures, restlessness and need to keep moving (akathisia) (see section “Warnings and precautions”);
vasculitis (inflammation of a blood vessel), dilation of blood vessels;
rapid swelling of tissues;
pain in the tube allowing passage of food and water to the stomach, inflammation of the pharynx (pharyngitis);
sensitivity to sunlight (photosensitivity);
increased blood levels of certain liver enzymes (transaminases and gamma-glutamyltransferase);
prolonged and painful erection (priapism), sudden production of milk from the breast (galactorrhoea) in men;
problems urinating;
muscle pain;
lung problems;
hepatitis;
confusion;
stuttering;
aggression;
decrease in platelets in the blood, increasing the risk of bleeding or bruising;
decrease in white blood cells in the blood;
severe skin and/or mucosal membrane reactions which may include painful blisters with detachment of large areas of skin;
anaphylactic reaction;
problems with the secretion of a hormone called antidiuretic hormone;
changes in heart rhythm;
bleeding from mucous membranes.

Bone fractures – 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 while continuing treatment.

Additional side effects in children and adolescents

hostile behaviour, manic reactions, including mania and hypomania;
delayed sexual maturation or sexual dysfunction;
changes in blood phosphate levels (alkaline phosphatase).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluoxetina Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging label. 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 no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Fluoxetina Sandoz GmbH contains

The active substance is fluoxetine (as fluoxetine hydrochloride). Each capsule contains fluoxetine hydrochloride equivalent to 20 milligrams (mg) of fluoxetine.
The other components are: dimethicone 350, pregelatinized maize starch. The capsule shell is composed of gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), patent blue V (E 131).

Description of the appearance of Fluoxetina Sandoz GmbH hard capsules and pack sizes
Fluoxetina Sandoz GmbH is a hard capsule.
The capsules are light green in colour.
Capsules are available in PP/aluminum blisters containing 12, 28 or 50 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH, Biochemiestrasse 10 – 6250 Kundl, Austria

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee, 1 –
39179 Barleben (Germany)