SERONIL 10 mg Tablets

Treatment with Seronil can only be started after a 2-week period after stopping the use of irreversible 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 MAOI treatment;In case of any doubts about the contraindications listed above, you should ask your doctor or pharmacist for clarification before starting treatment with Seronil.

Warnings and precautions

Before starting treatment with Seronil, you should exercise special caution and discuss it with your doctor or pharmacist in the following cases:

In elderly patients taking fluoxetine, the following have been reported: hyponatremia (low sodium levels in the blood), including cases of syndrome of inappropriate antidiuretic hormone secretion (SIADH); in case of concomitant use of medicines that may cause hyponatremia (e.g. diuretics, desmopressin, carbamazepine, and oxcarbazepine); 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 (an antimalarial medicine), chloroquine (an antimalarial medicine), 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 used concomitantly.

Seronil with food, drink, and alcohol

• Seronil can be taken with any food or on an empty stomach.
• During treatment, you should not drink alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you become pregnant, think you may be pregnant, or plan to become pregnant, you should immediately consult your doctor.
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.
You should inform your doctor and/or midwife about the use of Seronil. Taking this medicine during pregnancy, especially in the last three months, may increase the risk of a newborn developing persistent pulmonary hypertension (PPHN). This condition is characterized by rapid breathing and cyanosis and usually occurs within the first day of life. If such symptoms occur in a newborn, you should immediately contact your 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 child. You may, in agreement with your doctor, gradually stop taking Seronil when you are pregnant or planning to become pregnant. However, depending on the circumstances, your doctor may suggest continuing treatment with Seronil.
In newborns whose mothers took fluoxetine in the last 3 months of pregnancy, the following symptoms may also occur: irritability, tremors, muscle weakness, constant crying, feeding or sleeping problems. Therefore, you should exercise caution when taking Seronil, especially in late pregnancy or shortly before delivery.
Taking Seronil at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if you have a history of bleeding disorders. If you are taking Seronil, you should inform your doctor or midwife so that they can provide you with appropriate advice.
Breastfeeding
Fluoxetine is excreted in human milk and may cause side effects in the child. During treatment, breastfeeding is only recommended if absolutely necessary. In breastfeeding women, it may be recommended to use fluoxetine in a lower dose.
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. You should not drive or operate machinery without consulting your doctor or pharmacist.

Seronil contains sucrose, glycerol, and mannitol

One Seronil 10 mg coated tablet contains 0.55 mg of sucrose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
The coated tablets also contain glycerol. Since large doses of glycerol can cause headaches, gastrointestinal disturbances, and diarrhea, you should avoid overdosing on the medicine.
Mannitol (53.8 mg/tablet) contained in the tablets may have a mild laxative effect in case of high doses.

3. How to take Seronil

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is usually taken in the following doses:
Adults and the elderly:

• Depression: the recommended dose is 20 mg per day. If necessary, your 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 you are 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 gluttony): the recommended dose is 60 mg per day (6 tablets of 10 mg each).
• Obsessive-compulsive disorder: the recommended dose is 20 mg per day. If necessary, your 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 case of liver function disorders or the use of other medicines that may affect the action of fluoxetine, the doctor may recommend a lower dose or taking the medicine every other day.
The recommended dose may be increased or decreased by the doctor. In case of concomitant use of medicines that may interact with fluoxetine, the 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/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 a lower body weight may require a lower dose. The doctor should consider the need for long-term treatment (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 in a single dose or divided doses taken orally during or between meals.
The coated tablets should be swallowed with water.
After stopping the administration, 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 you feel that the effect of Seronil is too strong or too weak, you should consult your doctor.

Taking a higher dose of Seronil than recommended

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

Missing a dose of Seronil

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

Stopping treatment with Seronil:

You should not stop treatment with Seronil without consulting your doctor.

It is essential to continue taking the medicine without interruption.

• You should not stop treatment without consulting your doctor, even if you feel better.
• You should ensure that you never run out of medicine to continue treatment.

After stopping Seronil, the following symptoms may occur:
dizziness; feeling of tingling, pricking; sleep disturbances (vivid dreams, nightmares, insomnia);
psychomotor agitation or stimulation; fatigue or weakness; anxiety; nausea or vomiting;
tremors; headaches.
In most people, any symptoms that occur after stopping Seronil are mild and resolve on their own within a few weeks. If you experience any unbearable symptoms after stopping treatment, you should contact your doctor.
When ending therapy with Seronil, the doctor will 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, you should 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 experience suicidal thoughts or self-harm, you should immediately contact your doctor or go to the hospital.
• If you experience a rash or allergic reaction, such as itching, swelling of the lips or tongue, or wheezing, you should stop taking the medicine immediately and contact your doctor.
• If you experience 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 your condition. In this case, you should contact your doctor. If you experience skin redness or any other worrying skin changes, followed by blisters and peeling skin, you should immediately inform your doctor. This condition is very rare.

In some patients, the following have been reported:

• several of the following symptoms at the same time (serotonin syndrome), including unexplained fever with rapid heart rate or breathing, excessive sweating, muscle stiffness or tremors, disorientation, extreme agitation or drowsiness (rarely);
• feeling weak, sleepy, or disoriented - mainly in elderly patients and patients (elderly) taking diuretics (diuretics);
• prolonged and painful erection;
• irritability and extreme agitation;
• heart problems, such as rapid or irregular heart rhythm, fainting, collapse, or dizziness when standing up.

If you experience any of the above symptoms, you should immediately inform your doctor.

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 in patients taking Seronil:

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

• insomnia (including early morning awakening, difficulty falling asleep, difficulty maintaining sleep after waking up)
• 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, inner tension, decreased libido, sleep disturbances, unusual dreams (including nightmares)
• attention disorders, dizziness, taste disorders, lethargy, sleepiness (including drowsiness, 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, erectile 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 jaw closure and teeth grinding
• suicidal thoughts and behaviors, memory disorders, hyperactivity, involuntary movements, coordination disorders, balance disorders, muscle cramps, dilated pupils
• tinnitus
• hypotension
• shortness of breath, nosebleeds
• swallowing disorders, gastrointestinal bleeding
• hair loss, increased bruising, cold sweats
• muscle twitches
• urination disorders
• sexual disorders
• malaise, unusual feeling, feeling cold, feeling hot

Rare (may affect up to 1 in 1000 people):

• decreased platelet count, granulocyte count, white blood cell count
• 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 (motor agitation - a compulsion to be in constant motion), serotonin syndrome
• ventricular arrhythmias (including torsades de pointes)
• vasculitis, vasodilation
• pharyngitis
• respiratory disorders (including inflammatory and fibrotic conditions)
• esophageal pain
• hepatitis, angioedema, ecchymoses, purpura, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis (Lyell's syndrome)
• muscle pain
• urinary retention, urination disorders
• galactorrhea, hyperprolactinemia (elevated prolactin levels in the blood), painful erection
• 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 side effects listed usually resolve during treatment.
In patients taking selective serotonin reuptake inhibitors (SSRIs), such as Seronil, there is an increased risk of bone fragility.
Children and adolescents (aged 8-18 years)- the use of fluoxetine in children and adolescents may cause growth retardation or delayed pubertal development.
In children, nosebleeds are often reported.
When ending therapy, symptoms of withdrawal associated with SSRIs have been described, 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 you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Seronil

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month stated.
Store in a temperature below 25°C in the original packaging.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Seronil 10 mg coated tablets contain

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

What Seronil looks like and contents of the pack

Seronil is available in the form of white or almost white, elongated, coated tablets with a dividing line, measuring 5 x 10 mm.
Seronil, 10 mg: the pack contains 30 or 100 coated tablets.
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, you 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: