Package leaflet: Information for the user

Seronil
20 mg, hard capsules
Fluoxetinum
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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Seronil is and what it is used for
What you need to know before you take Seronil
How to take Seronil
Possible side effects
How to store Seronil
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 serotonin reuptake inhibitor that increases the concentration of serotonin in the brain.
Seronil is used to treat the following conditions:
Adults:

episodes of major depression,
obsessive-compulsive disorder (OCD),
bulimia nervosa (bulimia); Seronil is used together with psychotherapy to reduce compulsive binge eating and purging.

Children aged 8 years and older and adolescents:

moderate to severe depression, if no improvement is seen after 4–6 sessions of psychotherapy. Seronil may be prescribed for 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 this may lead to severe, even fatal, adverse effects (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 high doses, the doctor should consider a longer waiting period before starting treatment with MAOIs;
if the patient is taking metoprolol, used in heart failure (see section "Seronil with other medicines").
If there are any doubts regarding the contraindications listed above, please consult a doctor or pharmacist before starting Seronil.

Warnings and precautions

Before starting treatment with Seronil, special caution should be taken and the following conditions should be discussed with a doctor or pharmacist:

if the patient experiences suicidal thoughts or self-harming behaviour – see section "Suicidal thoughts, worsening of depression or anxiety disorders" below;
in case of heart diseases;
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);
when the patient is taking diuretics (water tablets), especially if elderly;
if the patient develops fever, muscle stiffness, or tremor, or changes in mental state such as disorientation, irritability, or extreme agitation; these may be symptoms of serotonin syndrome or neuroleptic malignant syndrome. Although rare, these conditions may be life-threatening; therefore, immediate medical advice should be sought, as discontinuation of fluoxetine may be necessary (see also section "Seronil with other medicines");
if the patient has previously experienced manic episodes; if a manic episode occurs, immediate medical advice should be sought, as discontinuation of fluoxetine may be necessary;
if the patient has a history of bleeding disorders, bleeding, or 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 has current or previous symptoms of epilepsy or seizures; if a seizure (convulsion) occurs or seizure frequency increases, immediate medical advice should be sought, as discontinuation of fluoxetine may be necessary;
during electroconvulsive therapy (due to the risk of prolonged seizures);
if the patient is being treated with tamoxifen (used in the treatment of breast cancer) (see "Seronil with other medicines");
if the patient experiences restlessness with an urge to move, often associated with inability to sit still or remain in one place (akathisia). Increasing the dose may worsen these symptoms;
if the patient has diabetes; a change in insulin or other antidiabetic dosage may be necessary; in cases of impaired liver or kidney function (dose adjustment may be required, e.g. by reducing the dose or dosing less frequently); if a rash or other allergic reactions occur (e.g. itching, swelling of lips or face, difficulty breathing); the medicine should be stopped immediately and medical advice sought without delay; patients taking fluoxetine may experience weight loss, but this is usually proportional to initial body weight; in patients with glaucoma or elevated intraocular pressure, or those at risk of developing narrow-angle glaucoma;
in elderly patients, caution should be exercised when increasing the dose of the medicine.

It is essential to inform the 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 of self-harm or suicide. Such symptoms or behaviours may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually take at least 2 weeks, sometimes longer, to take effect.

The risk of suicidal thoughts, self-harming thoughts, or suicide attempts is higher if:

the patient has previously experienced 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, immediate medical advice should be sought or the patient should 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 the patient if they notice worsening of depression or anxiety or any concerning changes in behaviour.

Medicines such as Seronil (so-called SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of 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, there is an increased risk of suicidal behaviour (suicide attempts and suicidal thoughts) and hostility (mainly aggression, oppositional behaviour, and anger). 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, a doctor may prescribe Seronil to patients under 18 years of age for the treatment of moderate to severe major depressive episodes, in combination with psychotherapy, if considered beneficial for their health. If Seronil has been prescribed 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, the doctor should be informed immediately.

Seronil should not be used in children under 8 years of age.

Seronil with other medicines

Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans 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 taken simultaneously 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 the adverse effects of metoprolol (e.g. slow heart rate). Fluoxetine should not be taken if the patient has heart failure and is being treated with metoprolol.

Concomitant use of the following medicines with Seronil is not recommended:

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

Use caution when taking the following medicines together with Seronil:

phenytoin (an antiepileptic medicine); Seronil may affect the blood concentration of phenytoin, therefore greater caution is required when starting phenytoin treatment, and more frequent monitoring may be necessary when phenytoin is used concomitantly 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 sleep difficulties 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 taken together with Seronil. More frequent monitoring of patients is required when fluoxetine is used concomitantly with these medicines;
medicines that may affect heart rhythm, e.g. class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarials, especially halofantrine, certain 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 starting or stopping Seronil while on warfarin treatment, the doctor may recommend specific tests;
cyproheptadine, as it may reduce the antidepressant effect of Seronil;
medicines that may cause hyponatremia (low sodium levels in blood), e.g. diuretics, desmopressin (used in the treatment of diabetes insipidus), carbamazepine and oxcarbazepine (used in epilepsy treatment). Concurrent use may reduce blood sodium levels;
medicines that may lower the seizure threshold, e.g. tricyclic antidepressants, other selective serotonin reuptake inhibitors (SSRIs), phenothiazine derivatives, butyrophenone derivatives (used in 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 (antiepileptic), tricyclic antidepressants, risperidone (used in certain psychiatric disorders); since Seronil may affect blood concentrations 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 a doctor or pharmacist before using this medicine.

Pregnancy

If the patient discovers she is pregnant, suspects she may be pregnant, or is planning pregnancy, she should consult a 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 the doctor and/or midwife about the use of 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 (bluish skin), and usually occurs within the first day after birth. If such symptoms occur in the newborn, immediate medical advice should be sought from the doctor and/or midwife.

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 the doctor if she is pregnant or planning pregnancy. However, depending on the circumstances, the doctor may advise continuing treatment with Seronil.

Newborns whose mothers took fluoxetine during the last three 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 towards the end of pregnancy or immediately before delivery.

Taking Seronil towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, particularly if the patient has a history of blood clotting 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 occur 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 human fertility has been observed to date.

Driving and operating machinery

The medicine may affect mental processes and coordination. Do not drive or operate machinery without consulting a doctor or pharmacist.

3. How to use Seronil

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

For doses that cannot be achieved using 20 mg capsules, another pharmaceutical form of Seronil is available, allowing appropriate dosing (10 mg tablets).

The usual doses are as follows:

Adults and elderly:

Depression: The recommended dose is 20 mg once daily. If necessary, your doctor may adjust the dose 3 to 4 weeks after starting treatment. The dose may be gradually increased, if needed, up to a maximum of 60 mg per day. The dose should be increased cautiously to ensure the patient receives the lowest effective dose. Initial effects of treatment may take some time to appear. 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 per day (3 capsules of 20 mg).
Obsessive-compulsive disorder: The recommended dose is 20 mg per day. If necessary, your doctor may adjust the dose after 2 weeks of treatment. If needed, the dose may be gradually increased up to a maximum of 60 mg per day. If no improvement is observed within 10 weeks, the continued use of Seronil should be re-evaluated.

Elderly patients
In elderly patients, dose increases should be made with great caution. The daily dose should not exceed 40 mg. The maximum dose is 60 mg per day.

Hepatic impairment
In patients with impaired liver function or when taking other medicines that may interact with fluoxetine, your doctor may recommend a lower dose or administration of Seronil every other day.

The recommended dose may be increased or decreased by your doctor. When taking other medicines that may interact with fluoxetine, your doctor may recommend a lower dose or less frequent administration.

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/day. Your doctor may increase the dose to 20 mg/day after one or two weeks. The dose should be increased cautiously, ensuring the patient receives the lowest effective dose. Children with lower body weight may require a lower dose. The doctor should consider whether treatment beyond 6 months is necessary. If no improvement occurs, the continued use of Seronil should be reconsidered.

Method of administration
Fluoxetine may be administered as a single dose or divided doses taken orally during or between meals.

Capsules should be swallowed whole with water. Do not chew the capsules.

After discontinuation, active substances of the medicine 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.

Overdose of Seronil

In case of overdose, 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, and cardiovascular disturbances ranging from asymptomatic arrhythmias to cardiac arrest, respiratory dysfunction, and central nervous system disturbances—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 to remember to take it.

Stopping treatment with Seronil
Do not stop taking Seronil without consulting your doctor.
Continuous treatment is essential.

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

After stopping Seronil, the following symptoms may occur: dizziness; tingling or pricking sensations; sleep disturbances (vivid dreams, nightmares, insomnia); psychomotor agitation or restlessness; fatigue or weakness; anxiety; nausea or vomiting; tremor; headache.

In most patients, any symptoms occurring after discontinuation of Seronil are mild and resolve spontaneously within a few weeks. If any intolerable symptoms occur after stopping treatment, contact your doctor.

When ending treatment with Seronil, your doctor will recommend gradually reducing the dose over a period of 1 to 2 weeks, which helps reduce 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 difficulty breathing, stop taking the medicine immediately and contact a doctor without delay.
If psychomotor agitation or a feeling of inability to sit still or remain in one place occurs (possible symptoms of akathisia), increasing the dose of Seronil may worsen the condition. In such cases, 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 of the following symptoms simultaneously (so-called serotonin syndrome), including: unexplained
fever with increased respiratory or heart rate, excessive sweating, muscle stiffness or tremor,
disorientation, extreme agitation or drowsiness (rare);
feeling of weakness, drowsiness or disorientation – mainly in elderly patients and elderly patients taking diuretics (water tablets);
prolonged and painful erection;
irritability and extreme agitation;
heart-related problems such as rapid or irregular heartbeat, fainting, collapse or
dizziness upon standing.
If any of the above symptoms occur, contact a doctor immediately.
Adverse effects may become less intense and less frequent over time 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, sexual dysfunction (including decreased 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 redness of the face or other parts of the body
yawning
vomiting, dyspepsia, dry mouth
rash, urticaria, itching, excessive sweating
joint pain
frequent urination
genital bleeding, erection disorders, ejaculation disorders
feeling of unsteadiness, chills
weight loss

Uncommon (may occur in less than 1 in 100 patients):

depersonalization, 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, coordination disturbances, balance disturbances, muscle cramps, pupil dilation
tinnitus
hypotension
dyspnoea, nosebleeds
swallowing difficulties, gastrointestinal bleeding
alopecia, increased tendency to bruising, cold sweats
muscle tics
difficulty urinating
sexual disorders
malaise, unusual feelings, feeling of cold, feeling of heat

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

decreased platelet, neutrophil, or leukocyte count
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, petechiae, photosensitivity, purpura, 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 penile erection
bleeding from skin or mucous membranes
abnormal liver function test results
Frequency not known (cannot be estimated from available data):
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection “Pregnancy, breastfeeding and fertility” in section 2

Most of the adverse effects listed above usually resolve during treatment.
In patients treated with selective serotonin reuptake inhibitors (SSRIs), such as Seronil, there is an increased risk of bone fragility.
Children and adolescents (aged 8–18 years) – treatment with fluoxetine in children and adolescents may result in reduced growth velocity or delayed sexual maturation.
Nosebleeds have been frequently reported in children.
Withdrawal symptoms associated with selective serotonin reuptake inhibitors (SSRIs) have been described when stopping therapy, although available data do not suggest dependence. Common symptoms include: dizziness, paresthesia (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 a 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 authorization holder.
Reporting adverse effects helps to 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 pack following 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 you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Seronil 20 mg hard capsules contain
One Seronil 20 mg capsule contains:
Active substance: 22.4 mg fluoxetine hydrochloride, corresponding to 20 mg fluoxetine
and
Excipients: microcrystalline cellulose, maize starch, magnesium stearate;
Capsule shell components: titanium dioxide (E 171), gelatin.

What Seronil looks like and contents of the pack
Seronil is a white or almost white, opaque capsule containing a white or almost white powder.
Seronil 20 mg: pack contains 30 or 100 hard capsules.
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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]