Seronil

Leaflet accompanying the packaging: information for the user

Seronil

20 mg, hard capsules

Fluoxetine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Seronil and what is it 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 packaging and other information

1. What is Seronil and what is it 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 serotonin levels in the brain.
Seronil is used to treat the following conditions:
Adults:

• episodes of major depression,
• obsessive-compulsive disorder (obsessive neurosis),
• bulimia (psychic overeating); Seronil is used in combination with psychotherapy to reduce the urge to overeat and vomit.

Children aged 8 and older and adolescents:

• moderate to severe depression, if there is no improvement after 4-6 sessions of psychotherapy. Seronil may be recommended for children and adolescents with moderate or severe depression only in combination with psychotherapy.

2. Important information before taking Seronil

When not to take Seronil

after stopping the use of non-reversible monoamine oxidase inhibitors (MAOIs, e.g. tranylcypromine).
MAOIs should not be used for at least 5 weeks after stopping Seronil.
If Seronil has been used for a long time and/or in high doses, the doctor should consider a longer interval before starting treatment with MAOIs;In case of any doubts regarding the contraindications listed above, the patient should ask their doctor or pharmacist for clarification before starting treatment with Seronil.

Warnings and precautions

Before starting treatment with Seronil, special caution should be exercised and discussed with a doctor or pharmacist in the following cases:

• if suicidal thoughts or self-harm occur - see "Suicidal thoughts, worsening of depression or anxiety disorders" below;
• in case of heart disease;
• in case of the use of diuretics (urinary medicines), especially if the patient is elderly;
• in case of a history of manic episodes; if a manic episode occurs, the doctor should be contacted immediately, as it may be necessary to discontinue fluoxetine;
• in case of a history of bleeding disorders, bleeding, and bruising, as bleeding may occur (ecchymosis, petechiae), rarely - bleeding from the genital or gastrointestinal tract, or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility");
• in case of concomitant use of medicines that affect blood clotting (see "Seronil and other medicines");
• in case of existing or previously diagnosed epilepsy or seizure disorders; if a seizure occurs or the frequency of seizures increases, the doctor should be contacted immediately, as it may be necessary to discontinue fluoxetine;
• during electroconvulsive therapy (due to the risk of prolonged seizures);
• in patients taking fluoxetine, weight loss may occur, but it is usually proportional to the initial body weight; in patients with glaucoma or increased intraocular pressure or those at risk of glaucoma with a narrow angle of vision;

It is essential to inform the doctor if any of the above conditions occur.
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 behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start working with a delay, after 2 weeks, sometimes later.
The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:
the patient has had suicidal thoughts or self-harm in the past;
the patient is a young adult under the age of 25 with mental disorders, who has been treated with antidepressant medicines.
If the patient experiences suicidal thoughts or self-harm, they should contact their doctor or go to the hospital immediately.
It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask their relatives or friends for help and ask them to inform them if they notice that depression or anxiety has worsened or if there are any worrying changes in behavior.
Medicines like 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 from 8 to 18 years

In patients under 18 years of age taking antidepressant medicines of the same class as fluoxetine, the risk of suicidal behavior (attempts and thoughts) and hostility (mainly aggression, rebellious behavior, and anger) is increased. Seronil can be used in children and adolescents from 8 to 18 years of age only for the treatment of moderate or severe episodes of depression (in combination with psychotherapy). In this age group, the medicine should not be used for other indications.
Available data on the long-term safety of Seronil in this age group, including effects on growth, maturation, and overall development, are limited. Nevertheless, the doctor may recommend the use of Seronil in patients under 18 years of age for the treatment of severe or moderate episodes of major depression, in combination with psychotherapy, if they consider it 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 their doctor. If any of the above symptoms occur or worsen during treatment with Seronil in patients under 18 years of age, the doctor should be informed.
Seronil should not be used to treat children under 8 years of age.

Seronil and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Seronil should not be taken at the same time as:
certain non-reversible, non-selective MAOIs (used to treat depression). Non-reversible, non-selective MAOIs should not be taken at the same time as Seronil, as this may cause serious, even life-threatening, side effects (serotonin syndrome) (see "When not to take Seronil");
metoprolol, a medicine used in heart failure - fluoxetine may increase the side 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.
It is not recommended to take the following medicines with Seronil:
tamoxifen (used to treat breast cancer), as fluoxetine may reduce the effect of tamoxifen;
reversible MAOIs of type A, e.g. linezolid (an antibiotic), methylene blue (a medicine used to treat a certain blood disorder, methemoglobinemia), due to serious, even life-threatening, side effects (serotonin syndrome);
mefloquine (used to treat allergies) - fluoxetine may affect the level of this medicine in the blood and increase the risk of side effects.
Care should be taken when taking the following medicines with Seronil:
phenytoin (an antiepileptic medicine); Seronil may affect the level of this medicine in the blood, and more caution may be needed when starting treatment with phenytoin, and more frequent checks may be necessary when taking phenytoin with Seronil;
lithium (a medicine used to treat manic depression), tramadol (a painkiller), buprenorphine (a strong painkiller), or triptans (migraine medicines), tryptophan (a medicine used to treat conditions such as insomnia or depression), selegiline (an MAO-B inhibitor; used to treat depression and Parkinson's disease), St. John's Wort (Hypericum perforatum); the risk of serotonin syndrome is increased when these medicines are taken with Seronil. More frequent checks may be necessary when taking these medicines with fluoxetine;
medicines that may affect heart rhythm, such as antiarrhythmic medicines of class IA and III, antipsychotic medicines (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g. sparfloxacin, moxifloxacin, erythromycin given intravenously, pentamidine), antimalarial medicines, especially halofantrine, certain antihistamines (astemizole, mizolastine);
medicines that reduce blood clotting (such as warfarin), NSAIDs, acetylsalicylic acid, or other medicines that may thin the blood;
Seronil may affect the action of these medicines. If warfarin treatment is necessary, the doctor may recommend certain tests.
cyproheptadine, as it may reduce the antidepressant effect of Seronil;
medicines that cause hyponatremia (low sodium levels in the blood), such as diuretics, desmopressin (used to treat diabetes insipidus), carbamazepine, and oxcarbazepine (used to treat epilepsy). Concomitant use may decrease sodium levels in the blood;
medicines that may lower the seizure threshold, such as tricyclic antidepressants, other SSRIs, phenothiazine derivatives, butyrophenone derivatives (a medicine used to treat mental disorders), mefloquine, chloroquine (antimalarial medicines), bupropion, tramadol (a strong painkiller). Concomitant use may increase the risk of seizures;
flecainide, propafenone, and nebivolol (antiarrhythmic and blood pressure-lowering medicines), atomoxetine (used to treat hyperactivity), carbamazepine (an antiepileptic medicine), tricyclic antidepressants, risperidone (used to treat certain mental disorders); as Seronil may affect the levels of these medicines in the blood, it may be necessary to reduce their doses when taken concomitantly.

Seronil with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
If the patient becomes pregnant, thinks they may be pregnant, or plans to become pregnant, they should consult their 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 children is born with a heart defect. If the mother took fluoxetine, this number increases to 2 in 100.
The doctor and/or midwife should be informed about the use of Seronil. Taking medicines like Seronil, especially in the last three months of pregnancy, may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and cyanosis and usually occurs in the first day after birth. If such symptoms occur in the newborn, the doctor and/or midwife should be contacted immediately.
This medicine should not be used during pregnancy unless the potential benefits to the mother outweigh the risks to the fetus. The patient may, in consultation with their doctor, gradually discontinue Seronil when pregnant or planning to become pregnant. However, depending on the circumstances, the doctor may suggest continuing treatment with Seronil.
Newborns whose mothers took fluoxetine in the last 3 months of pregnancy may also experience symptoms such as: irritability, tremors, weakness, constant crying, feeding or sleeping problems. Therefore, caution should be exercised when using Seronil, especially in late pregnancy or immediately before delivery.
Taking Seronil at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Seronil, they should inform their doctor or midwife so that they can provide appropriate advice.
Breastfeeding
Fluoxetine is excreted in breast milk and may cause side effects in the child.
Breastfeeding is possible during treatment only if absolutely necessary. In breastfeeding women, a lower dose of fluoxetine may be recommended.
Fertility
In animal studies, fluoxetine has been shown to decrease sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

The medicine may affect mental processes and coordination. The patient should not drive vehicles or operate machines without consulting their doctor or pharmacist.

3. How to take Seronil

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
For doses that cannot be achieved with 20 mg capsules, another pharmaceutical form of Seronil is available, allowing for appropriate dosing (10 mg tablets).
The medicine is usually taken in the following doses:
Adults and the elderly:

• Depression: the recommended dose is 20 mg per day. If necessary, the doctor may change the dose of the medicine within 3 to 4 weeks after starting treatment. If necessary, the dose can be gradually increased to a maximum of 60 mg per day. The dose should be increased with caution to ensure that the patient is taking the smallest effective dose. The first effects of treatment may not be noticeable for some time. In the case of depression, improvement usually occurs after a few weeks of treatment. Patients with depression should take the medicine for at least 6 months.
• Bulimia (psychic overeating): the recommended dose is 60 mg per day (3 capsules of 20 mg each).
• Obsessive-compulsive disorder: the recommended dose is 20 mg per day. If necessary, the doctor may change the dose of the medicine after 2 weeks of treatment. If necessary, the dose can be gradually increased to a maximum of 60 mg per day. If there is no improvement in the patient's condition within 10 weeks, the doctor should reconsider the use of Seronil.

Elderly patients
In elderly patients, the dose can be increased with caution. The daily dose should not exceed 40 mg. The maximum dose is 60 mg per day.
Liver dysfunction
In cases of liver dysfunction or the use of other medicines that may affect the action of fluoxetine, the doctor may recommend a lower dose or less frequent administration of Seronil.
The recommended dose may be increased or decreased by the doctor. In cases where medicines that may interact with fluoxetine are taken concomitantly, the doctor may recommend a lower dose or less frequent administration.
Depression in children and adolescents from 8 to 18 years:

Treatment should be initiated and supervised by a specialist. The initial dose is 10 mg/day. The doctor may increase the dose to 20 mg/day after one or two weeks.
The dose should be increased with caution to ensure that the patient is taking the smallest effective dose. Children with lower body weight may require a lower dose. The doctor should consider the need for long-term treatment, i.e., more than 6 months. If there is no improvement in the patient's condition, the doctor should reconsider the use of Seronil.

Method of administration

Fluoxetine can be administered as a single dose or divided doses taken orally during or between meals.
The capsules should be swallowed with water. The capsules should not be chewed.
After discontinuation, the active substances of the product remain in the body for several weeks. This should be taken into account when starting or stopping treatment.
If the patient feels that the effect of Seronil is too strong or too weak, they should consult their doctor.

Use of a higher than recommended dose of Seronil

• In case of overdose, the patient should go to the emergency room or the nearest hospital or immediately contact their doctor.
• If possible, the patient should take the packaging of Seronil with them.
• Symptoms of fluoxetine overdose are usually mild. The most common symptoms are nausea, vomiting, seizures, and cardiovascular disorders, from asymptomatic arrhythmia to cardiac arrest, respiratory disorders, and central nervous system disorders - from agitation to coma.

Seronil should not be used after the expiry date stated on the packaging.

Missed dose of Seronil

• In case of a missed dose, the patient should take the next dose as soon as possible. However, a double dose should not be taken to make up for the missed dose.
• Taking the medicine at the same time every day helps to remember to take it.

Discontinuation of Seronil

Seronil should not be discontinued without consulting a doctor.

It is essential to continue taking the medicine without interruption.

• Seronil should not be discontinued without consulting a doctor, even if the patient feels better.
• The patient should ensure that they never run out of medicine to continue treatment.

After discontinuing Seronil, the following symptoms may occur: dizziness; a feeling of tingling or prickling; sleep disturbances (vivid dreams, nightmares, insomnia); psychomotor agitation or excitement; fatigue or weakness; anxiety; nausea or vomiting; tremors; headaches.
In most patients, any symptoms that occur after discontinuation of Seronil are mild and resolve on their own within a few weeks. If any symptoms occur after discontinuation of treatment that are not tolerated by the patient, they should contact their doctor.
When stopping treatment with Seronil, the doctor will recommend a gradual reduction in dose over a period of 1 to 2 weeks to minimize the risk of withdrawal symptoms.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Seronil can cause side effects, although not everybody gets them.

• If suicidal thoughts or self-harm occur, the patient should contact their doctor or go to the hospital immediately.
• In case of a rash or allergic reaction, such as itching, swelling of the lips or tongue, or wheezing, the patient should stop taking the medicine immediately and contact their doctor.
• If the patient experiences psychomotor agitation and a feeling of being unable to sit or stand still (which may be symptoms of akathisia), increasing the dose of Seronil may worsen the condition. In this case, the patient should contact their doctor.
• If the patient experiences skin redness or any other worrying skin changes, followed by blisters and peeling skin, they should inform their doctor immediately. This condition is very rare.

In some patients, the following symptoms have occurred:
several of the following symptoms at the same time (so-called serotonin syndrome), including: unexplained fever with rapid heart rate or breathing, excessive sweating, stiffness or tremors, disorientation, extreme agitation or drowsiness (rarely);
weakness, drowsiness, or disorientation - mainly in elderly patients and those (elderly) taking diuretics (urinary medicines);
prolonged and painful erections;
irritability and extreme agitation;
heart problems, such as rapid or irregular heart rhythm, fainting, collapse, or dizziness when standing up.

If any of the above symptoms occur, the doctor should be informed immediately.

Side effects may become less intense and less frequent over time and usually do not lead to discontinuation of treatment.
The following side effects have also been reported during treatment with Seronil:

Very common (may affect more than 1 in 10 people):

• insomnia (including early morning awakening, difficulty falling asleep, difficulty maintaining sleep)
• headache
• diarrhea, nausea
• fatigue (including a feeling of chronic fatigue)

Common (may affect up to 1 in 10 people):

• decreased appetite (including anorexia)
• anxiety, nervousness, restlessness, tension, sexual dysfunction (including decreased libido), sleep disturbances (including unusual dreams),
• attention disorders, dizziness, taste disorders, lethargy, drowsiness (including somnolence, sedation), tremors
• blurred vision
• palpitations, QT interval prolongation on the ECG
• sudden flushing of the skin of the face or other parts of the body
• yawning
• vomiting, indigestion, dry mouth
• rash, urticaria, itching, excessive sweating
• joint pain
• frequent urination
• bleeding from the genital tract, sexual dysfunction, ejaculation disorders
• feeling unsteady, chills
• weight loss

Uncommon (may affect up to 1 in 100 people):

• depersonalization, elevated mood, euphoria, thought disorders, orgasm disorders (including anorgasmia)
• involuntary clenching of the jaws and grinding of the teeth
• suicidal thoughts and behaviors, memory disorders
• psychomotor agitation, involuntary movements, coordination disorders, balance disorders, muscle spasms, pupil dilation
• tinnitus
• hypotension
• shortness of breath, nosebleeds
• swallowing disorders, gastrointestinal bleeding
• hair loss, increased bruising, cold sweats
• muscle twitches
• urination disorders
• sexual dysfunction
• malaise, abnormal sensations, feeling cold, feeling hot

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

• decreased platelet count, granulocytopenia, leukopenia
• anaphylactic reactions, serum sickness
• inappropriate antidiuretic hormone secretion
• hyponatremia
• manic reactions (hypomania, mania), hallucinations, agitation, panic attacks, confusion, stuttering, dysthymia (neurotic depression), aggression
• seizures, akathisia (psychomotor agitation - a compulsion to be in constant motion), buccoglossal syndrome, serotonin syndrome
• ventricular arrhythmias (including torsade de pointes)
• vasculitis, vasodilation
• pharyngitis
• pulmonary disorders (including inflammatory and fibrotic conditions)
• esophageal pain
• hepatitis
• angioedema, ecchymosis, petechiae, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis (Lyell's syndrome)
• muscle pain
• urination disorders
• galactorrhea, hyperprolactinemia (elevated prolactin levels in the blood), painful erections
• bleeding from the skin or mucous membranes
• abnormal liver function tests

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

• severe postpartum hemorrhage, see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2

Most of the above side effects usually resolve during treatment.
Patients taking selective serotonin reuptake inhibitors (SSRIs), such as Seronil, are at increased risk of bone fragility.
Children and adolescents (8-18 years old)- the use of fluoxetine in children and adolescents may cause growth retardation or delayed pubertal development.
In children, nosebleeds are often reported.
During the discontinuation of treatment, withdrawal symptoms related to SSRIs have been reported, although available data do not suggest addiction. Common symptoms include dizziness, paresthesia (tingling, burning), headaches, anxiety, and nausea. Most of them are mild and self-limiting. The use of fluoxetine has rarely been associated with such symptoms.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Seronil

The medicine should be stored out of sight and reach of children.
Seronil should not be used after the expiry date stated on the packaging.
The medicine should be stored at a temperature below 25°C in the original packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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:
the active substance: 22.4 mg fluoxetine hydrochloride, equivalent to 20 mg fluoxetine, and
the excipients: microcrystalline cellulose, maize starch, magnesium stearate;
the capsule shell ingredients: titanium dioxide (E 171), gelatin.

What Seronil looks like and contents of the pack

Seronil is available in the form of white or almost white, opaque capsules containing a white or almost white powder.
Seronil 20 mg: the pack contains 30 or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

Date of last revision of the leaflet: