Seronil

Package leaflet: Information for the user

Seronil
10 mg, coated tablets
Fluoxetinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Seronil is and what it is used for
2. Important information before taking Seronil
3. How to take Seronil
4. Possible side effects
5. How to store Seronil
6. Contents of the pack and other information

1. What Seronil is and what it is used for

Seronil belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs).
Seronil contains the active substance fluoxetine, which is a selective inhibitor of serotonin reuptake, increasing serotonin concentration in the brain.
Seronil is used to treat the following conditions:
Adults:

• major depressive episodes,
• obsessive-compulsive disorder (OCD),
• bulimia (psychogenic polyphagia); Seronil is used in combination with psychotherapy to reduce compulsive binge eating and purging.

Children aged 8 years and older, and adolescents:

• moderate to severe depression, when no improvement is observed after 4–6 sessions of psychotherapy. Seronil may be prescribed to children and adolescents with moderate or severe depression only in combination with psychotherapy.

2. Important information before using Seronil

When not to use Seronil
if the patient is allergic to fluoxetine or any of the other ingredients of this medicine
(listed in section 6). Allergic reactions may include rash, itching, swelling
of the face or lips, or difficulty breathing;

• if the patient is taking other medicines known as irreversible, non-selective monoamine oxidase inhibitors (MAOIs) (e.g. iproniazid, used in the treatment of depression), as serious, even fatal, adverse reactions may occur (see section "Seronil with other medicines").

Treatment with Seronil may only be started at least 2 weeks after discontinuation
of irreversible monoamine oxidase inhibitors (MAOIs) (e.g. tranylcypromine).
Monoamine oxidase inhibitors (MAOIs) should not be used for at least 5 weeks after
stopping Seronil. If Seronil has been used for a long time and/or at a high dose,
the doctor should consider a longer washout period before starting MAOI therapy;
if the patient is taking metoprolol, used in heart failure (see section "Seronil with other medicines").
If you have any doubts regarding the contraindications listed above, please consult
your doctor or pharmacist before starting to take Seronil.

Warnings and precautions
Before starting treatment with Seronil, take special care and discuss with your
doctor or pharmacist if any of the following apply:

• if you experience suicidal thoughts or self-harming behaviour – see section "Suicidal thoughts, worsening of depression or anxiety disorders" below; in case of heart disease; if the patient has a slow heart rate at rest and/or salt deficiency due to prolonged, severe diarrhoea, vomiting, or use of diuretics (water tablets); if the patient is taking diuretics (water tablets), especially if elderly; if the patient develops: fever, muscle stiffness or tremor, altered mental status, e.g. confusion, irritability, or extreme agitation; these may be symptoms of serotonin syndrome or neuroleptic malignant syndrome. Although this syndrome is rare, it may be life-threatening; therefore, contact your doctor immediately, as discontinuation of fluoxetine may be necessary (see also section "Seronil with other medicines"); if the patient has a history of manic episodes; if a manic episode occurs, contact your doctor immediately, as discontinuation of fluoxetine may be necessary; if the patient has a history of bleeding disorders, bleeding or easy bruising, as skin haemorrhages (petechiae, purpura) may occur, rarely bleeding from the genital tract or gastrointestinal tract, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility"); if the patient is taking other medicines affecting blood clotting (see "Seronil with other medicines"); if the patient currently has or has had a history of epilepsy or seizures; if a seizure (convulsion) occurs or seizure frequency increases, contact your doctor immediately, as discontinuation of fluoxetine may be necessary; during electroconvulsive therapy (due to risk of prolonged seizures); if the patient is being treated with tamoxifen (used in breast cancer treatment) (see "Seronil with other medicines"); if the patient feels restless with an urge to move, often associated with inability to sit or stand still (akathisia). Increasing the dose may worsen these symptoms; if the patient has diabetes; a change in insulin or other antidiabetic medication dose may be necessary; in case of impaired liver or kidney function (dose adjustment, such as dose reduction or less frequent dosing, may be required); if a rash or other allergic reactions occur (e.g. itching, swelling of lips or face, difficulty breathing); stop taking the medicine immediately and contact your doctor without delay; weight loss may occur in patients taking fluoxetine, but is usually proportional to initial body weight;

in patients with glaucoma or elevated intraocular pressure or in whom there is
a risk of developing narrow-angle glaucoma;
in elderly patients, caution should be exercised when increasing the dose
of the medicine.
You must inform your doctor if any of the above conditions apply.

Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes have thoughts
about self-harm or suicide. These symptoms or behaviours may worsen
at the beginning of antidepressant treatment, as these medicines usually take
2 weeks or more to start working.
The risk of suicidal thoughts, self-harming thoughts or suicide attempts is higher if:
the patient has previously had suicidal thoughts or self-harming behaviour;
the patient is a young adult under 25 years of age with psychiatric disorders who is
being treated with antidepressant medicines.
If the patient experiences suicidal thoughts or thoughts of self-harm, contact your doctor immediately or go to hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask for help from family or friends and request them to inform you if they notice worsening of depression or anxiety or concerning changes in behaviour.
Medicines such as Seronil (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Use in children and adolescents aged 8 to 18 years
In patients under 18 years of age taking antidepressants of the same class as fluoxetine, the risk of developing suicidal behaviour (suicide attempts and suicidal thoughts) and hostility (mainly aggression, oppositional behaviour and anger) is increased. Seronil may be used in children and adolescents aged 8 to 18 years only for the treatment of moderate to severe depressive episodes (in combination with psychotherapy). The medicine should not be used for other indications in this age group.
Available data on the long-term impact of Seronil on safety in this age group, including on growth, puberty, and cognitive, emotional and general development, are limited. Nevertheless, the doctor may prescribe Seronil to patients under 18 years of age for the treatment of moderate or severe major depressive episodes, in combination with psychotherapy, if considered beneficial for their health. If the doctor has prescribed Seronil to a patient under 18 years of age, and the patient has any doubts, they should consult the prescribing doctor. If any of the symptoms listed above appear or worsen during treatment with Seronil in patients under 18 years of age, inform the doctor immediately.
Seronil should not be used in children under 8 years of age.

Seronil with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not take Seronil together with:
certain irreversible, non-selective MAO inhibitors (used in the treatment of
depression). Irreversible, non-selective MAO inhibitors must not be used
concurrently with Seronil, as this may cause severe, even fatal, adverse effects (serotonin syndrome) (see section "When not to use Seronil");
metoprolol, a medicine used in heart failure – fluoxetine may worsen metoprolol's adverse effects (e.g. slow heart rate). Do not take fluoxetine if the patient has heart failure and is being treated with metoprolol.
Concomitant use of Seronil with the following medicines is not recommended:

• tamoxifen (used in the treatment of breast cancer), because fluoxetine may reduce the effectiveness of tamoxifen;
• reversible MAO-A inhibitors, e.g. linezolid (an antibiotic), methylene blue (a medicine used in the treatment of a blood disorder called methemoglobinemia), due to severe, even fatal, adverse effects (serotonin syndrome);
• mequitazine (used in the treatment of allergies) – fluoxetine may affect blood levels of this medicine and increase the risk of adverse effects;

Exercise caution when using the following medicines concomitantly with Seronil:
phenytoin (an antiepileptic medicine); Seronil may affect blood levels of this medicine, so greater caution may be required when starting phenytoin treatment, and more frequent monitoring may be necessary when phenytoin is used together with Seronil;
lithium (used in the treatment of manic depression), tramadol (a painkiller),
buprenorphine (a strong painkiller), or triptans (migraine medicines), tryptophan (a medicine used in the treatment of conditions such as insomnia or depression), selegiline (an MAO-B inhibitor; used in depression and Parkinson's disease), St. John's wort (Hypericum perforatum); the risk of serotonin syndrome is increased when these medicines are used together with Seronil. More frequent monitoring of patients is required when fluoxetine is used with these medicines;
medicines affecting heart rhythm, e.g. class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antibacterial medicines (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarials, especially halofantrine, some antihistamines (astemizole, mizolastine);
medicines that reduce blood clotting (such as warfarin), NSAIDs (non-steroidal anti-inflammatory drugs), acetylsalicylic acid or other medicines that may thin the blood;
Seronil may affect the action of these medicines. If treatment with warfarin is ongoing and treatment with Seronil is started or stopped, the doctor may recommend specific tests;
cyproheptadine, as it may reduce the antidepressant effect of Seronil;
medicines that may cause hyponatraemia (low sodium levels in blood), e.g. diuretics,
desmopressin (used in the treatment of diabetes insipidus), carbamazepine and oxcarbazepine
(used in the treatment of epilepsy). Concurrent use may reduce sodium levels in blood;
medicines that may lower the seizure threshold, e.g. tricyclic antidepressants, other
selective serotonin reuptake inhibitors (SSRIs), phenothiazine derivatives, butyrophenone derivatives (used in the treatment of psychiatric disorders), mefloquine,
chloroquine (antimalarials), bupropion, tramadol (strong painkillers).
Concurrent use may increase the risk of seizures;
flecainide, propafenone and nebivolol (antiarrhythmics and blood pressure-lowering medicines), atomoxetine (used in attention deficit hyperactivity disorder), carbamazepine (an antiepileptic), tricyclic antidepressants, risperidone (used in the treatment of certain psychiatric disorders); since Seronil may affect blood levels of these medicines, dose reduction may be necessary when used concomitantly.

Seronil with food, drink and alcohol

• Seronil can be taken with or without food.
• Alcohol should not be consumed during treatment.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
If the patient discovers she is pregnant, suspects she may be pregnant, or is planning a pregnancy, she should consult her doctor immediately.
In children whose mothers took fluoxetine during the first few months of pregnancy, an increased risk of congenital heart defects has been observed. In the general population, 1 in 100 babies is born with a heart defect. If the mother took fluoxetine, this increases to 2 in 100 babies.
Inform your doctor and/or midwife about taking Seronil. Taking medicines such as Seronil during pregnancy, especially during the last three months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). This condition is characterised by rapid breathing and cyanosis, and usually occurs within the first day after birth. If such symptoms occur in the newborn, contact your doctor and/or midwife immediately.
It is recommended not to use this medicine during pregnancy unless the potential benefits to the mother outweigh the risks to the foetus. The patient may gradually discontinue Seronil in consultation with her doctor if she is pregnant or planning a pregnancy. However, depending on the circumstances, the doctor may advise continuing treatment with Seronil.
Newborns whose mothers took fluoxetine during the last 3 months of pregnancy may also experience symptoms such as irritability, tremor, muscle weakness, constant crying, feeding or sleeping difficulties. Therefore, caution should be exercised when using Seronil, especially in late pregnancy or immediately before delivery.
Taking Seronil towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Seronil, she should inform her doctor or midwife so they can provide appropriate advice.

Breastfeeding
Fluoxetine is excreted in breast milk and may cause adverse effects in the infant. Breastfeeding during treatment should only be considered if absolutely necessary. In breastfeeding women, a lower dose of fluoxetine may be recommended.

Fertility
Animal studies have shown that fluoxetine reduces sperm quality. This may theoretically affect fertility, although no effect on fertility in humans has been observed to date.

Driving and using machines
This medicine may affect thinking and coordination. Do not drive or operate machinery without consulting your doctor or pharmacist.

Seronil contains sucrose, glycerol and mannitol
One 10 mg Seronil coated tablet contains 0.55 mg sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking the medicine.
Coated tablets also contain glycerol. Since high doses of glycerol may cause headache, gastrointestinal disturbances and diarrhoea, overdose should be avoided.
Mannitol (53.8 mg/tablet) contained in tablets may have a mild laxative effect at high doses.

3. How to take Seronil

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual recommended doses are as follows:
Adults and elderly patients:

• Depression: The recommended dose is 20 mg once daily. If necessary, your doctor may adjust the dose 3 to 4 weeks after starting treatment. If required, the dose may be gradually increased, up to a maximum of 60 mg once daily. Dose increases should be made cautiously to ensure that the patient receives the lowest effective dose. Improvement may take some time. In depression, symptom relief usually occurs after several weeks of treatment. Patients with depression should continue taking the medicine for at least 6 months.
• Bulimia (psychogenic polyphagia): The recommended dose is 60 mg once daily (6 tablets of 10 mg).
• Obsessive-compulsive disorder: The recommended dose is 20 mg once daily. If necessary, your doctor may adjust the dose after 2 weeks of treatment. If required, the dose may be gradually increased, up to a maximum of 60 mg once daily. If there is no improvement after 10 weeks, the continued use of Seronil should be re-evaluated.

Elderly patients
Dose increases in elderly patients should be made with great caution. The daily dose should not exceed 40 mg. The maximum dose is 60 mg once daily.
Hepatic impairment
In patients with impaired liver function or when taking other medicines that may interact with fluoxetine, your doctor may prescribe a lower dose or recommend taking Seronil every other day.
Your doctor may increase or decrease the recommended dose. When taking other medicines that may interact with fluoxetine, your doctor may recommend a lower dose or less frequent dosing.
Depression in children and adolescents aged 8 to 18 years:
Treatment should be initiated and supervised by a specialist. The initial dose is 10 mg once daily. Your doctor may increase the dose to 20 mg once daily after one or two weeks. Dose increases should be made cautiously, ensuring that the patient receives the lowest effective dose. Children with lower body weight may require a lower dose. Your doctor should consider whether treatment beyond 6 months is necessary. If no improvement occurs, the continued use of Seronil should be re-evaluated.
Method of administration
Fluoxetine may be administered as a single dose or divided doses taken orally during or between meals.
Film-coated tablets should be swallowed whole with water.
After discontinuation, active substances of the product remain in the body for several weeks. This should be taken into account when starting or stopping treatment.
If you feel that the effect of Seronil is too strong or too weak, consult your doctor.
Taking more Seronil than recommended

• If you take more than the prescribed amount of medicine, go immediately to the nearest hospital emergency department or contact your doctor without delay.
• If possible, bring the Seronil packaging with you.
• Symptoms of fluoxetine overdose are usually mild. The most common symptoms include nausea, vomiting, seizures, cardiovascular disturbances ranging from asymptomatic arrhythmia to cardiac arrest, respiratory disturbances, and central nervous system disturbances ranging from agitation to coma.

Missed dose of Seronil

• If you miss a dose, take the next dose as soon as possible. However, do not take a double dose to make up for the missed dose.
• Taking the medicine at the same time each day helps you remember to take it.

Stopping treatment with Seronil:
Do not stop taking Seronil without consulting your doctor.
It is important to take the medicine continuously.

• Do not stop treatment without consulting your doctor, even if you feel better.
• Ensure that you never run out of medicine during ongoing treatment.

After stopping Seronil, the following symptoms may occur:
dizziness; tingling or prickling sensations; sleep disturbances (vivid dreams, nightmares, insomnia);
psychomotor agitation or restlessness; fatigue or weakness; anxiety; nausea or vomiting;
tremor; headache.
In most people, symptoms after discontinuation of Seronil are mild and resolve spontaneously within a few weeks. If any symptoms occur after stopping treatment and are troublesome, contact your doctor.
When ending treatment with Seronil, your doctor will usually recommend gradually reducing the dose over a period of 1 to 2 weeks to minimize the risk of withdrawal symptoms.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

• If suicidal thoughts or self-harming behaviour occur, contact a doctor immediately or go to hospital.
• If a rash or allergic reaction occurs, such as itching, swelling of the lips or tongue, or wheezing or shortness of breath, stop taking the medicine immediately and contact a doctor without delay.
• If psychomotor agitation or an inability to sit still or remain still occurs (which may be symptoms of akathisia), increasing the dose of Seronil may worsen the condition. In such a case, contact a doctor. If skin redness or any other concerning skin changes occur, followed by blistering and peeling of the skin, inform a doctor immediately. This phenomenon is very rare.

In some patients the following have occurred:

• Several symptoms occurring simultaneously (so-called serotonin syndrome), including unexplained fever with increased breathing or heart rate, excessive sweating, muscle stiffness or tremor, disorientation, extreme agitation or drowsiness (rare);
• Feeling of weakness, drowsiness or disorientation – mainly in elderly individuals and in elderly individuals taking diuretics (water tablets);
• Prolonged and painful erection;
• Irritability and extreme agitation;
• Heart-related problems, such as fast or irregular heartbeat, fainting, collapse, or dizziness upon standing.

If any of the above symptoms occur, inform a doctor immediately.
Adverse effects may become less intense and less frequent over time with continued treatment, and usually do not lead to discontinuation of treatment.
The following adverse effects have also been reported during treatment with Seronil:
Very common (may occur in more than 1 in 10 patients):

• Insomnia (including early morning awakening, difficulty falling asleep, difficulty maintaining sleep after waking)
• Headache
• Diarrhoea, nausea
• Fatigue (including feeling of chronic exhaustion)

Common (may occur in less than 1 in 10 patients):

• Decreased appetite (including anorexia)
• Anxiety, nervousness, psychomotor agitation, inner tension, disturbances in sexual drive (including reduced libido), sleep disturbances, unusual dreams (including nightmares)
• Attention disturbances, dizziness, taste disturbances, lethargy, drowsiness (including somnolence, sedation), tremor
• Blurred vision
• Palpitations, QT interval prolongation on ECG
• Sudden reddening of the face or other parts of the body
• Yawning
• Vomiting, indigestion, dry mouth
• Rash, urticaria, itching, excessive sweating
• Joint pain
• Frequent urination
• Genital bleeding, erectile dysfunction, ejaculation disorders
• Feeling of unsteadiness, chills
• Weight loss

Uncommon (may occur in less than 1 in 100 patients):
Depersonalisation, elevated mood, euphoria, thought disturbances, orgasm disorders (including anorgasmia)

• Involuntary jaw clenching and teeth grinding
• Suicidal thoughts and behaviour, memory disturbances, psychomotor hyperactivity, involuntary movements, movement coordination disturbances, balance disturbances, muscle cramps, pupil dilation
• Tinnitus
• Hypotension
• Shortness of breath, nosebleeds
• Swallowing difficulties, gastrointestinal bleeding
• Hair loss, increased tendency to bruising, cold sweat
• Muscle tics
• Difficulty urinating
• Sexual disturbances
• Malaise, unusual feelings, feeling of cold, feeling of heat

Rare (may occur in less than 1 in 1000 patients):

• Decreased platelet, neutrophil, and leukocyte counts
• Anaphylactic reactions, serum sickness
• Inappropriate antidiuretic hormone secretion
• Decreased sodium concentration
• Manic reactions (hypomania, mania), hallucinations, agitation, panic attacks, confusion, stuttering, dysthymia (neurotic depression), aggression
• Seizures, akathisia (motor restlessness – compulsion to keep moving), orofacial dyskinesia, serotonin syndrome
• Ventricular cardiac arrhythmias (including torsade de pointes)
• Vasculitis, blood vessel dilation
• Sore throat
• Lung disorders (including inflammatory conditions, pulmonary fibrosis)
• Oesophageal pain
• Hepatitis, angioedema, purpura, photosensitivity, petechiae, erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome)
• Muscle pain
• Urinary retention, urinary disorders
• Galactorrhoea, hyperprolactinaemia (increased prolactin levels in blood), painful erection
• Bleeding from skin or mucous membranes
• Abnormal liver function tests

Frequency not known (cannot be estimated from available data):

• Severe vaginal bleeding shortly after childbirth (postpartum haemorrhage), see additional information in section “Pregnancy, breastfeeding and fertility” in section 2

Most of the adverse effects listed above usually resolve during treatment.
Patients taking selective serotonin reuptake inhibitors (SSRIs), such as Seronil, have an increased risk of bone fragility.
Children and adolescents (aged 8–18 years) – treatment with fluoxetine in children and adolescents may result in slowed growth rate or delayed sexual maturation.
Nosebleeds have been frequently reported in children.
Withdrawal symptoms associated with selective serotonin reuptake inhibitors (SSRIs) have been described upon discontinuation of therapy, although available data do not suggest dependence. Common symptoms include dizziness, paraesthesia (tingling, burning sensations), headache, anxiety, and nausea. Most of these are mild and self-limiting. Such symptoms have rarely been associated with fluoxetine treatment.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Seronil

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister marked EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Seronil 10 mg film-coated tablets contain
One Seronil 10 mg film-coated tablet contains:
active substance: 11.2 mg fluoxetine hydrochloride, equivalent to 10 mg fluoxetine
and
excipients: mannitol (E 421), corn starch, povidone, microcrystalline cellulose, magnesium stearate;
components of the coating: hypromellose 6 cPs, sucrose, polysorbate 80, 85% glycerol, magnesium stearate, titanium dioxide (E 171).

What Seronil looks like and contents of the pack
Seronil is available as white or almost white, elongated film-coated tablets with a division line, measuring 5 x 10 mm.
Seronil 10 mg: packs containing 30 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]