XEREDIEN 20 mg Dispersible Tablet

Зміст інструкції

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

Xeredien 20 mg dispersible tablets

Fluoxetine

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

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

Contents of this leaflet:

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

1. What is Xeredien and what is it used for

Xeredien 20 mg dispersible tablets contain the active ingredient fluoxetine, which belongs to a group of
medicines called selective serotonin reuptake inhibitors (SSRIs) antidepressants.
This medicine is used to treat the following conditions:

Adults:

• Major depressive episodes
• Obsessive compulsive disorder
• Bulimia nervosa: Xeredien is used together with psychotherapy to reduce binge eating and purging behaviours

Children and adolescents aged 8 years and over:

• Major depressive disorder of moderate to severe degree, if the depression does not respond to psychotherapy after 4-6 sessions. Xeredien should be proposed to a child or young person with moderate to severe major depressive disorder onlyin association with psychotherapy.

How Xeredien works
Every individual has, in their brain, a substance called serotonin. People who are depressed, or
have obsessive compulsive disorder, or bulimia nervosa, have lower levels of serotonin compared to
other individuals.
It is not fully understood how Xeredien and other SSRIs work, but they may provide help
by increasing the level of serotonin in the brain. Treatment of the aforementioned pathological conditions is
important to help you feel better. If left untreated, your condition may persist and may
become even more serious and more difficult to treat.
To be sure you no longer have symptoms, treatment may need to continue for some
weeks or months.

2. What you need to know before taking Xeredien

Do not take Xeredien if:

• You are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). If you develop a skin rash or other allergic reactions (such as itching,swelling of the lips or face and difficulty breathing), stop taking thetablets immediately and contact your doctor.
• You are taking other medicines known as irreversible and non-selective monoamine oxidase inhibitors (MAOIs), as serious or even life-threatening reactions may occur (e.g. iproniazide used to treat depression). Treatment with Xeredien must be started at least 2 weeks after stopping treatment with an irreversible and non-selective MAOI. Do nottake any irreversible and non-selective MAOI for at least 5 weeks after you have stopped taking Xeredien. If Xeredien has been prescribed for a long period of time and/or at high doses, your doctor needs to consider a longer time interval.
• You are taking metoprolol (for the treatment of heart failure) as there is an increased risk that your heartbeat may become too slow.

Warnings and precautions
Talk to your doctor or pharmacist before taking Xeredien if any of the following applies to you:
 heart problems;
 development of fever, muscle stiffness or tremor, changes in mental status such as confusion, irritability and extreme agitation;
you may be affected by the so-called “serotonin syndrome” or “neuroleptic malignant syndrome”.
Although this syndrome is rare, it can lead to conditions that are potentially life-threatening; contact your doctor immediately, as it may be necessary to stop taking Xeredien.
 if you have had or have had episodes of mania in the past; if you have an episode of mania, contact your doctor immediately because it may be necessary to stop taking Xeredien;
 a history of bleeding disorders or the appearance of bruising or unusual bleeding;
 ongoing treatment with medicines that improve blood fluidity (see ' Other medicines and

Xeredien');
 epilepsy or seizures. If you have a seizure (convulsions) or experience an increase in the frequency of seizures, contact your doctor immediately; it may be necessary to stop taking Xeredien;
 electroconvulsive therapy (ECT) treatment;
 ongoing treatment with tamoxifen (used to treat breast cancer) (see ' Other medicines and

Xeredien');
 you start to feel restless and cannot sit still or remain calm (akathisia). Increasing the dose of Xeredien may worsen the condition;
 diabetes (your doctor may need to adjust your insulin or other antidiabetic treatment dosage);
 liver problems (your doctor may need to adjust your dosage);
 low resting heart rate and/or if you are aware that you may have a salt deficiency as a result of severe and prolonged diarrhea and vomiting (feeling unwell) or following the use of diuretics (water tablets);
 ongoing treatment with diuretics (water tablets), especially if you are elderly;
 glaucoma (increased pressure inside the eye).
 Medicines such as Xeredien (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) can cause symptoms of sexual dysfunction (see section 4).
 In some cases, these symptoms have been observed to persist after discontinuation of treatment.

Thoughts of suicide and worsening of depression and anxiety.
If you are depressed and/or anxious, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may increase when you first start taking antidepressants, as these medicines take time to be effective, usually about 2 weeks but sometimes longer.
You may be more likely to have these thoughts:

Children and adolescents aged between 8 and 18 years:
When taking this type of medicine, patients under 18 years of age have an increased risk of undesirable effects such as suicide attempts, suicidal thoughts and hostile behavior (especially aggressive behavior, opposition and anger). Xeredien 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.
In addition, limited information is available in this age group regarding the safety of Xeredien in the long term on growth, puberty, mental, emotional and behavioral development.
Despite this, and in patients under 18 years of age, the doctor may prescribe Xeredien for the treatment of major depressive episodes of moderate to severe degree in association with psychotherapy, if they believe that this is the best solution for them.
If the doctor has prescribed Xeredien to a patient under 18 years of age and you would like clarification, return to the doctor. You should inform the doctor if any of the symptoms listed above appear or worsen during the taking of Xeredien by patients under 18 years of age.
Xeredien should not be used in the treatment of children under 8 years of age.

Other medicines and Xeredien
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Xeredien with:
 some irreversible and non-selective monoamine oxidase inhibitors (MAOIs), some used for the treatment of depression. Irreversible and non-selective MAOIs should not be used with Xeredien as serious or even life-threatening reactions (serotonin syndrome) may occur (see ‘Do not take Xeredien’). Treatment with Xeredien must be started strictly at least 2 weeks after stopping an irreversible and non-selective MAOI (such as, for example, tranylcypromine). Do nottake any irreversible and non-selective MAOI for at least 5 weeks after you have stopped taking Xeredien.
If Xeredien has been prescribed for a long period and/or at high dosages, your doctor may need to consider a longer time interval of 5 weeks.
 metoprololwhen used for heart failure; there is an increased risk that your heartbeat may become too slow.
Xeredien can affect the mechanism of action of the following medicines (interaction):
 tamoxifen(used to treat breast cancer); as Xeredien may change the levels of this medicine in the blood, with a possible decrease in the effect of tamoxifen, your doctor may need to consider prescribing another antidepressant.
 monoamine oxidase inhibitors Type A (MAO-Type A)including moclobemide, linezolid (an antibiotic) and methylthioninium chloride (also called methylene blue and used for the symptomatic acute treatment of methemoglobinemia induced by drugs or chemicals, for the local treatment of skin infections such as plaque psoriasis, common acne and herpes labialis and as a diagnostic for renal function for the calculation of glomerular filtration rate): due to the risk of serious or even life-threatening reactions (called serotonin syndrome). Treatment with fluoxetine can be started the day after stopping treatment with a reversible MAOI but the doctor may decide to subject you to careful monitoring and use a lower dosage of a MAO-Type A.
 mequitazine(used for allergic manifestations); as taking this medicine with Xeredien may increase the risk of changes in the electrical activity of the heart.
 phenytoin(for epilepsy); as Xeredien may affect the levels of this medicine in the blood, when given with Xeredien the doctor may need to administer phenytoin with greater care and perform checks.
 lithium, selegiline, St John's Wort, tramadol(a painkiller), triptans(for migraine) and tryptophan; when these medicines are taken with Xeredien there is an increased risk of developing a mild serotonin syndrome. The doctor will perform checks more frequently.
 medicines that can alter the heart rhythm, e.g. antiarrhythmics class IA and III, antipsychotics(e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antibacterial agents(e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), treatment against malaria and in particular halofantrine or some antihistamines(astemizole, mizolastine), because taking one or more of these medicines with Xeredien may increase the risk of changes in the electrical activity of the heart.
 anticoagulants(such as warfarin), NSAIDs(non-steroidal anti-inflammatory drugs - such as ibuprofen, diclofenac), aspirinand other medicines that can improve blood fluidity(including clozapine, used for the treatment of some mental disorders). Xeredien may change the effect of these medicines on the blood. If treatment with Xeredien is started or stopped while you are taking warfarin, the doctor will need to perform some tests, adjust the dosage and subject you to more frequent checks.
 cyproheptadine(used for allergic manifestations); as it may reduce the effect of Xeredien.
 medicines that lower the level of sodium in the blood(including medicines that cause an increase in urine output, desmopressin, carbamazepine and oxcarbazepine); as these medicines may increase the risk that the levels of sodium in the blood become too low when taken in association with Xeredien.
 antidepressantssuch as tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquineor chloroquine(used to treat malaria), tramadol(used to treat severe pain) or antipsychoticssuch as phenothiazines or butyrophenones; as Xeredien may increase the risk of seizures when taken in association with these medicines.
 flecainide, propafenone, nebivolol or encainide(for heart disorders), carbamazepine(for epilepsy),

atomoxetineor tricyclic antidepressants(for example imipramine, desipramineand amitriptyline) or risperidone(for schizophrenia), haloperidol, clozapine, alprazolam; as Xeredien may in some way change the levels of these medicines in the blood, the doctor may need to lower their dosage when they are administered with Xeredien.
 diazepam(for the treatment of anxiety states); as Xeredien may cause a prolongation of the effects of this medicine.

Xeredien with food, drinks and alcohol
 You can take Xeredien independently of meals, as you prefer.
 You should avoid drinking alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Inform your doctor as soon as possible if you are or may be pregnant, or if you are planning a
pregnancy.
In newborns whose mothers have taken fluoxetine during the first few months of pregnancy, some studies
have described an increased risk of congenital defects affecting the heart. In the general population,
about 1 in 100 newborns are born with a heart defect. This figure increased to about 2 in 100
newborns in mothers who took fluoxetine.
When taken during pregnancy, especially in the last 3 months of pregnancy, medicines like Xeredien
can increase the risk of developing a serious condition in newborns, called persistent pulmonary
hypertension of the newborn (PPHN), which means that the newborn has accelerated breathing and a
bluish skin tone. These symptoms usually appear within the first 24 hours after birth.
If this happens to the newborn, contact your midwife and/or doctor immediately.
It is preferable not to use this treatment during pregnancy unless the potential benefit
outweighs the potential risk. Therefore, together with your doctor you can decide to gradually stop
taking Xeredien before or during the period of pregnancy. However, depending on the circumstances,
your doctor may suggest that it is better for you to continue taking Xeredien.
Caution is recommended when taken during pregnancy, especially during the terminal period of
pregnancy or just before delivery, as the following effects have been reported in newborns: irritability,
tremor, muscle weakness, persistent crying, difficulty sucking or sleeping.

Breastfeeding
Fluoxetine is excreted in breast milk and can cause undesirable effects in newborns. Breastfeeding
should only be carried out if clearly necessary. If breastfeeding is continued, your doctor
may prescribe a lower dose of fluoxetine.

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

Driving and operating machinery
Medicines that affect mental activity like Xeredien can alter judgment or
coordination skills. Do not drive or use tools or machinery until you are aware of how Xeredien affects
you.

Xeredien contains sorbitol and sodium
The dispersible tablets contain sorbitol: each tablet provides 6.7 mg of sorbitol,
equivalent to a maximum of 0.28 mg/kg/day in adults weighing 70 kg and to 0.24 mg/kg/day in
children (see section 3 How to take Xeredien). The presence of sorbitol in the dispersible tablets
may cause gastric disturbances and diarrhoea. If you have been told by your doctor that you have an
intolerance to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic
disease in which patients are unable to metabolize fructose, talk to your doctor before taking this
medicine
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
sodium-free

3. How to take Xeredien

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Do not take more tablets than those prescribed by your doctor.
Swallow the tablets whole with a sip of water, or dissolved in half a glass of water
to be swallowed immediately and completely. Do not chew the tablets.

Adults:
The recommended dose is:
 Depression: The recommended dose is 1 tablet (20 mg) per day. If necessary, your doctor will review and
adjust the dosage within 3–4 weeks of starting treatment. If required, the dosage may be
gradually increased up to a maximum of 3 tablets (60 mg) per day. The dose should be
increased with caution to ensure you receive the lowest effective dose.
You may not feel an immediate
improvement at the beginning of treatment for depression. This is normal as an improvement in the symptoms of depression may only
manifest after the first few weeks of therapy. Patients suffering from depression should be treated for at least 6 months.
 Bulimia nervosa: The recommended dose is 3 tablets (60 mg) per day.
 Obsessive compulsive disorder: The recommended dose is 1 tablet (20 mg) per day. If necessary, your
doctor will review and adjust the dosage after 2 weeks of therapy. If required, the dosage may be
gradually increased up to a maximum of 3 tablets (60 mg) per day. If no
improvements are noticed within the first 10 weeks, your doctor will re-evaluate the treatment.

Use in children and adolescents aged between 8 and 18 years suffering from depression:
Treatment must be started and supervised by a specialist.
The initial dose is 10 mg per day.
After 1-2 weeks, your doctor may increase the dose to 20 mg per day.
The dose should be increased with caution to ensure you receive the lowest effective dose. Children
with low body weight may need lower doses. If a satisfactory response to
treatment is observed, your doctor will re-evaluate the need to continue treatment beyond 6 months. If no
improvement is observed within the first 9 weeks, your doctor should reconsider the treatment.

Use in the elderly:
Your doctor will be more cautious when increasing the dose and the daily dosage should generally not exceed
2 tablets (40 mg). The maximum dose is 3 tablets (60 mg) per day.

Use in people with liver problems:
If you have a liver disorder or are taking another medicine that could interfere with Xeredien, your doctor
may decide to prescribe you a lower dose or provide you with instructions to take Xeredien on alternate days.

If you take more Xeredien than you should
 If you take too many tablets, go to the Emergency Room of the nearest hospital or inform your doctor immediately.
 If possible, bring the Xeredien package with you.
Symptoms of overdose include: nausea, vomiting, convulsions, heart disorders (such as an irregular
heartbeat and cardiac arrest), respiratory disorders and changes in mental status ranging
from agitation to coma.

If you forget to take Xeredien
 If you forget to take a dose, do not worry. Take the next dose at the usual time of day
following. Do not take a double dose to compensate for the missed dose.
 Taking the medicine every day at the same time can help you remember to take it regularly.

If you stop taking Xeredien
 Do notstop taking Xeredien without first asking your doctor, even when you start to feel
better. It is important that you take the medicine continuously.
 Make sure you do not run out of tablets.
When you stop taking Xeredien, you may notice the following effects (withdrawal effects): dizziness;
tingling sensations such as pin and needle sensations; sleep disturbances (vivid dreams, nightmares, inability
to fall asleep); feeling restless or agitated; unusual fatigue or weakness; feeling of
anxiety; nausea/vomiting; tremor; headache.
Most people report that any symptoms that occur when stopping
therapy with Xeredien are mild and disappear within a few weeks. If you should observe the
appearance of symptoms when stopping treatment, contact your doctor.
When you stop taking Xeredien, your doctor will help you reduce the dose gradually over one or two
weeks - this should help reduce the possibility of withdrawal effects occurring.
If you have any doubts about 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.
 If you have thoughts of harming yourself or ending your life, contact your doctor or go to hospital
immediately(see section 2).
If you develop a skin rash or an allergic reaction such as itching, swelling of the lips or tongue,
difficulty breathing, wheezing, stop taking the tablets immediately and tell your doctor
immediately.
 If you feel restless and cannot sit or stay still, you may have a condition called akathisia; increasing the dose of Xeredien may make it feel worse. If you experience these sensations, contact your doctor.
 Tell your doctor immediatelyif your skin starts to redden or if you develop a different skin reaction
or if your skin begins to blister or peel. This is very rare.
The most common side effects (very common side effects that can affect more than 1 in 10 people) are insomnia, headache, diarrhoea, feeling sick (nausea) and fatigue.
Some patients have experienced:
 a collection of symptoms (known as “serotonin syndrome”) including unexplained fever
with a fast heart rate and breathing, sweating, muscle stiffness or tremors, confusion, extreme agitation or drowsiness (rarely);
 a feeling of restlessness and inability to sit or stay still, which may be a condition called akathisia;
 prolonged and painful erection;
 irritability and extreme agitation;
 heart problems, such as a fast or irregular heartbeat, fainting, collapse or dizziness when standing up, which may indicate abnormal heart rhythm.

If you experience any of the side effects listed above, tell your doctor immediately.
The following side effects have also been reported in patients taking Xeredien:

Common(may affect up to 1 in 10 people)
 loss of appetite, weight loss
 nervousness, anxiety
 restlessness, poor concentration
 feeling tense
 reduced sexual drive and sexual problems (including difficulty getting or maintaining an erection for sexual activity)
 sleep problems, unusual dreams, tiredness or drowsiness
 dizziness
 altered taste
 uncontrolled movements
 blurred vision
 feeling of fast and irregular heartbeat
 flushing
 yawning
 digestive problems, vomiting
 dry mouth
 skin rash, hives, itching
 excessive sweating
 joint pain
 more frequent urination
 unexplained vaginal bleeding
 feeling unable to stand or chills

Uncommon(may affect up to 1 in 100 people)
 feeling detached from yourself
 strange thoughts
 excessively high mood
 problems with orgasm
 thoughts of suicide or self-harm
 teeth grinding
 muscle contractions, involuntary movements or problems with balance or coordination
 reduced memory
 dilated pupils
 ringing in the ears
 low blood pressure
 shortness of breath
 nosebleeds
 difficulty swallowing
 hair loss
 increased tendency to bruise
 unexplained bruising or bleeding
 cold sweats
 difficulty passing urine
 feeling hot or cold
 changes in liver function tests
 gastrointestinal bleeding
 sexual dysfunction
 feeling unwell

Rare(may affect up to 1 in 1,000 people)
 reduced levels of sodium in the blood
 decreased platelets in the blood, which increases the risk of bleeding or bruising
 decreased white blood cells in the blood
 allergic reactions (anaphylactic reactions and serum sickness)
 altered production of the antidiuretic hormone
 uncontrolled, unusual behaviour
 hallucinations
 agitation
 panic attacks
 confusion
 stuttering
 aggression
 seizures, inability to sit still, problems with the muscles of the mouth and tongue, serotonin syndrome
 heart problems (ventricular arrhythmia including torsade de pointes)
 vasculitis (inflammation of a blood vessel), dilation of blood vessels
 rapid swelling of tissues around the neck, face, mouth and/or throat
 pain in the tube that allows food and water to pass to the stomach
 inflammation of the liver (hepatitis)
 severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)
 lung problems
 sensitivity to sunlight
 muscle pain
 problems with urination
 secretion of milk from the breasts, increased production of prolactin
 prolonged and painful erection (priapism)
 bleeding from mucous membranes
 changes in the levels of certain enzymes in the blood (transaminases, gamma-glutamyl transferase)

Not Known
Other side effects occur in a very small number of people but their exact frequency is not known
 low potassium levels in the blood
 low blood sugar
 chest pain (angina)
 increased blood pressure

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 with continued treatment.

Additional side effects in children and adolescents (8-18 years)
In addition to the possible side effects listed above, Xeredien may slow growth and possibly delay
sexual maturation. Suicidal-related behaviours (suicide attempt and suicidal thoughts), hostile behaviour, mania and nosebleeds have also been reported commonly in children.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Xeredien

Keep Xeredien out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack (Exp). The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Xeredien contains
The active substanceis fluoxetine hydrochloride.
Each tablet contains 20 milligrams (mg) of fluoxetine (as fluoxetine hydrochloride).
The excipientsare: microcrystalline cellulose, sodium saccharin, mannitol, sorbitol, anise flavour, mint flavour, colloidal silica, corn starch, sodium stearylfumarate and povidone.

Description of the appearance of Xeredien and contents of the pack
The tablets are white in colour.
The tablets are available in blisters of 12 and 28 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milan

Responsible Manufacturer releasing the batches:
Special Product’s Line SPA – Via Fratta Rotonda Vado Largo 1 - 03012 Anagni (FR)

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy: Xeredien