Package leaflet: Information for the user

Stimuloton, 50 mg, film-coated tablets
Sertralinum
Please read this leaflet carefully before taking this medicine, as it contains important information
for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

What Stimuloton is and what it is used for
What you need to know before taking Stimuloton
How to take Stimuloton
Possible side effects
How to store Stimuloton
Contents of the pack and other information

1. What Stimuloton is and what it is used for

Stimuloton contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines are used to treat depressive disorders and (or) anxiety disorders.
Stimuloton may be used to treat:

depression and prevention of recurrence of depression (in adults)
social anxiety disorder (in adults)
post-traumatic stress disorder (PTSD) (in adults)
panic disorder (in adults)
obsessive-compulsive disorder (OCD) (in adults and in children and adolescents aged 6–17 years).

Depression is an illness in which the patient feels sadness, has difficulty sleeping, or is unable to experience joy in life.
Obsessive-compulsive disorder and panic disorder are anxiety-related conditions, associated with persistent worry due to intrusive thoughts (obsessions), leading to repetitive rituals (compulsive acts).
Post-traumatic stress disorder (PTSD) is a condition that may occur after a traumatic experience and is characterized by certain symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense fear or stress in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in the presence of others, or worrying about potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for treating your condition.
You should consult your doctor if you are unsure why you have been prescribed Stimuloton.

2. Important information before using Stimuloton

When not to use Stimuloton

If the patient is allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
If the patient is currently taking or has recently taken medicines known as monoamine oxidase inhibitors (MAO inhibitors such as moclobemide, selegiline) or medicines similar to monoamine oxidase inhibitors (MAO) (e.g. linezolid). At least one week must elapse after stopping sertraline before starting treatment with a monoamine oxidase inhibitor (MAO). At least two weeks must elapse after stopping treatment with a monoamine oxidase inhibitor (MAO) before starting sertraline treatment.
If the patient is taking pimozide (a medicine used to treat psychiatric disorders such as psychosis).

Warnings and precautions
Before starting treatment with Stimuloton, discuss this with your doctor.
Not every medicine is suitable for everyone. Before starting treatment with Stimuloton, discuss with your doctor if the patient currently has or has previously had any of the following conditions:

Epilepsy or a history of seizures. If a seizure occurs, contact your doctor immediately.
Previous bipolar disorder (manic-depressive illness) or schizophrenia. If a manic episode occurs, contact your doctor immediately.
Suicidal thoughts – currently present or in the past (see below – suicidal thoughts and worsening of depression or anxiety disorders).
Serotonin syndrome or neuroleptic malignant syndrome. These syndromes may rarely occur in patients taking other medicines (such as certain antidepressants, amphetamine derivatives, triptans, methylene blue, antipsychotics and other dopamine antagonists, and opioid medicines such as buprenorphine (or its combination with naloxone), see section “Stimuloton and other medicines”) at the same time as sertraline (symptoms, see section 4. Possible side effects). Discuss with your doctor whether the patient has previously experienced any of these conditions.
Low sodium levels in the blood, which may occur as a result of taking Stimuloton. Inform your doctor if you are taking medicines for high blood pressure, as these may also affect sodium levels in the blood. Particular caution is required in elderly patients, who may be more susceptible to reduced sodium levels in the blood (see above).
Liver disease; your doctor may decide to reduce the dose of Stimuloton.
Diabetes; Stimuloton may affect blood glucose levels, so a change in dosage of antidiabetic medicines may be necessary.
Bleeding disorders (tendency to bruise) or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”), and also if the patient has previously taken medicines that prevent blood clotting (e.g. acetylsalicylic acid (aspirin) or warfarin) or medicines that may increase the risk of bleeding.
The patient is under 18 years of age: in children and adolescents aged 6 to 17 years, Stimuloton may be used only for the treatment of obsessive-compulsive disorder (OCD). Patients being treated for this condition should be closely monitored by a doctor (see use in children and adolescents, below).
The patient is receiving electroconvulsive therapy (ECT).
Eye problems, e.g. certain types of glaucoma (increased eye pressure).
Abnormalities in heart function observed on ECG, known as QT interval prolongation.
Heart disease, low potassium or magnesium levels, a family history of prolonged QT interval, slow heart rate, and concomitant use of medicines causing QT interval prolongation.

Psychomotor agitation, akathisia:
Treatment with Stimuloton has been associated with the occurrence of akathisia (a condition characterized by motor restlessness and a compulsion to move – often with an inability to sit or stand still). This condition usually occurs within the first few weeks of treatment. Contact your doctor if the dose is increased, as this may be harmful in patients experiencing such symptoms.
Withdrawal symptoms:
Withdrawal symptoms often occur after stopping treatment, especially if treatment is stopped abruptly (see section 3: Stopping Stimuloton and section 4: Possible side effects).
The risk of withdrawal symptoms depends on the duration of treatment, dose, and speed of dose reduction. These symptoms are usually mild or moderate in intensity, but may be severe in some patients. They usually occur within the first few days after stopping treatment. They usually resolve spontaneously within 2 weeks, but may persist longer (2-3 months or more) in some patients. If deciding to discontinue treatment with Stimuloton, gradual dose reduction over several weeks or months is recommended. Always discuss the best way to stop treatment with your doctor.
Suicidal thoughts, worsening of depression or anxiety disorders:
People with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviors may worsen at the beginning of treatment with antidepressants, as these medicines usually take 2 weeks or more to start working.
The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

the patient has previously experienced suicidal thoughts or self-harm
the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders who are treated with antidepressants. If the patient experiences suicidal thoughts or thoughts of self-harm, contact a doctor immediately or go to a hospital.

Informing family members or friends about the depression or anxiety disorder and asking them to read this leaflet may be helpful. The patient may ask for help from family or friends and request them to inform the patient if they notice worsening depression or anxiety, or concerning changes in behavior.
Sexual dysfunction
Medicines such as Stimuloton (so-called selective serotonin reuptake inhibitors, SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.
Children and adolescents
Stimuloton is generally not recommended for use in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age, there is an increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (mainly aggressive, defiant behaviors, and anger) when taking medicines from this group. However, a doctor may prescribe Stimuloton to a patient under 18 years of age if it is in the patient's best interest. If a doctor prescribes Stimuloton to a patient under 18 years of age and the patient wishes to discuss this, contact the doctor. Inform the doctor if any of the above-mentioned symptoms appear or worsen in a person under 18 years of age taking Stimuloton. In a long-term observational study lasting 3 years involving over 900 children aged 6 to 16 years, the long-term safety of sertraline use was evaluated regarding its impact on growth, maturation, learning (cognitive functions), and behavior. Overall, study results showed that children treated with sertraline developed normally, except for a small increase in body weight in children treated with higher doses.
Stimuloton and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Some medicines may affect how Stimuloton works, or Stimuloton may reduce the effectiveness of other medicines taken at the same time.
Concomitant use of Stimuloton with the following medicines may cause severe adverse effects:

Medicines that are monoamine oxidase inhibitors (MAO inhibitors), e.g. moclobemide (used to treat depression), selegiline (used in Parkinson's disease), the antibiotic linezolid, and methylene blue (used to treat high methemoglobin levels in the blood). Do not use Stimuloton with these medicines.
Medicines used to treat psychiatric disorders (pimozide). Do not use Stimuloton together with pimozide.

Inform your doctor if the patient is taking the following medicines:

Medicines containing amphetamine derivatives (used in attention deficit hyperactivity disorder (ADHD), excessive sleepiness, and obesity).
Herbal medicines containing St. John's wort (Hypericum perforatum). The effect of St. John's wort may persist for 1-2 weeks.
Products containing the amino acid tryptophan.
Medicines used to treat severe or chronic pain (opioids, e.g. tramadol, fentanyl).
Medicines containing buprenorphine (used to treat opioid addiction or severe pain) or buprenorphine in combination with naloxone (used to treat opioid addiction).
Medicines used for anesthesia (fentanyl, mivacurium, suxamethonium).
Medicines used to treat migraines (e.g. sumatriptan).
Medicines that prevent blood clotting (warfarin).
Medicines used to treat pain and joint inflammation (non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, salicylic acid (aspirin)).
Metamizole, a medicine used to treat pain and fever.
Sedatives (diazepam).
Diuretics (also known as water tablets).
Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines used to treat diabetes (tolbutamide).
Medicines used to treat excessive stomach acid secretion and peptic ulcer disease (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines used to treat mania and depression (lithium).
Other medicines used to treat depression (e.g. amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines used to treat schizophrenia and other psychiatric disorders (such as perphenazine, levomepromazine, and olanzapine).
Medicines used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, propafenone).
Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
Medicines used to prevent nausea and vomiting after surgery or chemotherapy (e.g. aprepitant).
Medicines known to increase the risk of changes in heart electrical activity (e.g. certain antipsychotics and antibiotics).

Stimuloton with food, drink and alcohol
Do not consume alcoholic beverages during treatment with Stimuloton.
Taking food does not affect the absorption of the medicine. The tablet form of the medicine can be taken with or without food.
Do not consume grapefruit juice while taking Stimuloton, as it may increase sertraline levels in the patient's body.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
The safety of sertraline use in pregnant women has not been fully established. Stimuloton may be used in pregnant women only if, in the doctor's judgment, the benefits to the mother outweigh the potential risks to the fetus.
Taking Stimuloton late in pregnancy may increase the risk of serious vaginal bleeding shortly after childbirth, especially if the patient has a history of bleeding disorders. If the patient is taking Stimuloton, she should inform her doctor or midwife so they can provide appropriate advice.
Ensure that the midwife and/or doctor know that the patient is taking Stimuloton. Medicines such as Stimuloton, especially when taken during the last three months of pregnancy, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually occur within 24 hours after birth. If this happens, inform the midwife and/or doctor immediately.
Other conditions may also occur in the newborn, usually appearing within the first day of life. Symptoms include:

breathing difficulties,
blue skin, skin too cold or too hot, as in fever,
blue lips,
vomiting or feeding problems,
extreme tiredness, difficulty sleeping, constant crying,
muscles too tense or too floppy,
tremors or seizures,
increased reflexes,
irritability,
low blood glucose (sugar) levels.

If any of these symptoms are observed in the patient's newborn after birth or if the patient is concerned about the baby's health, seek advice from a doctor or midwife.
Breastfeeding
Sertraline passes into breast milk. Stimuloton may be used in women during breastfeeding if, in the doctor's judgment, the benefits to the mother outweigh the potential risks to the infant.
Fertility
Animal studies have shown that certain medicines such as Stimuloton may reduce semen quality. This could theoretically affect fertility, but such an effect has not been observed in humans to date.
Driving and operating machinery
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. Wait until you know how Stimuloton affects your ability before performing the above activities.
Stimuloton contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Stimuloton

This medicine should always be used as directed by the physician.
If in doubt, consult a doctor or pharmacist.
Recommended dosage:
Adults

Depression and obsessive-compulsive disorder (OCD) The usual effective dose in the treatment of depression and obsessive-compulsive disorder (OCD) is 50 mg once daily. The daily dose may be gradually increased by 50 mg at intervals of at least one week over several weeks. The maximum recommended dose is 200 mg per day.
Panic disorder, social anxiety disorder, and post-traumatic stress disorder (PTSD) Treatment of panic disorder, social anxiety disorder, and post-traumatic stress disorder (PTSD) should be initiated at a dose of 25 mg once daily. After one week, the dose may be increased to 50 mg once daily. The daily dose may then be gradually increased by 50 mg at a time over several weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents
Stimuloton may be used in the treatment of children and adolescents aged 6–17 years only for obsessive-compulsive disorder (OCD).

Recommended initial dose for children aged 6 to 12 years with obsessive-compulsive disorder (OCD) is 25 mg once daily. After one week, the physician may increase the dose to 50 mg once daily. The maximum dose is 200 mg per day.
Recommended initial dose for adolescents aged 13 to 17 years with obsessive-compulsive disorder (OCD) is 50 mg once daily. The maximum dose is 200 mg per day.

Patients with liver or kidney disease should inform their doctor and follow the doctor's advice.
Method of administration
Stimuloton may be taken with or without food.
The medicine should be taken once daily, either in the morning or in the evening.
The tablet may be divided into equal doses.
The doctor will inform the patient how long the treatment should last. The duration of treatment depends on the type of illness and the patient's response to therapy. Improvement may not occur until after several weeks of treatment. Treatment of depression should usually continue for 6 months after improvement has occurred.
Taking more Stimuloton than recommended
If a patient accidentally takes too much Stimuloton, seek medical advice immediately or go to the nearest hospital emergency department. Always bring the medicine package, including the label, regardless of whether any medicine remains.
Symptoms of overdose may include drowsiness, nausea and vomiting, increased heart rate, muscle tremors, agitation, dizziness, and in rare cases, loss of consciousness.
Missed dose of Stimuloton
If a patient forgets to take a dose of Stimuloton, do not take the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping the use of Stimuloton
Do not stop taking Stimuloton without consulting a doctor.
The doctor should gradually reduce the dose of Stimuloton over several weeks until the patient finally stops taking it. In patients who abruptly discontinue the medicine, adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and muscle tremors may occur. If any of these or other adverse effects occur after stopping Stimuloton, consult a doctor.
If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects:

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most commonly occurring adverse effect is nausea. Adverse effects depend on the dose
and often diminish or weaken with continued treatment.
You should inform your doctor immediately if any of the following symptoms occur after taking this medicine, as they may be serious:

Severe skin rash causing blistering (erythema multiforme; blisters may appear in the mouth and on the tongue). These may be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis. In such cases, the doctor will discontinue treatment.
Allergic reaction or allergy, with symptoms such as itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
Agitation, confusion, hallucinations, diarrhoea, nausea, vomiting, body temperature above 38 °C and high blood pressure, excessive sweating, increased muscle tension, tremor and rapid heartbeat. These are symptoms of serotonin syndrome or neuroleptic malignant syndrome. In rare cases, these syndromes may occur when the patient is taking certain other medicines at the same time as sertraline. The doctor may then discontinue the patient's treatment.
Yellowing of the skin and eyes, which may indicate liver damage.
Symptoms of depression with suicidal thoughts.
Motor restlessness and inability to sit still or remain in one place after starting treatment with Stimuloton. If the patient begins to experience motor restlessness, they should inform their doctor.
Seizure.
Manic episodes (see section 2. Warnings and precautions).

The following adverse effects have been observed in clinical trials in adult patients.
Very common (may affect more than 1 in 10 people):

insomnia, dizziness, drowsiness, headache,
diarrhoea, nausea, dry mouth,
ejaculation disorders,
fatigue. Common (may affect up to 1 in 10 people):
bronchitis, sore throat, cold,
loss of appetite, increased appetite,
anxiety, depression, agitation, decreased interest in sex, nervousness, unusual feelings, nightmares, teeth grinding,
muscle tremors, movement disorders (such as increased motor activity, increased muscle tension, difficulty walking, muscle stiffness, cramps and involuntary muscle movements), numbness and tingling sensations, increased muscle tension, lack of concentration, taste disturbances,
visual disturbances,
tinnitus,
palpitations,
hot flushes,
yawning,
stomach discomfort, constipation, abdominal pain, vomiting, flatulence,
increased sweating, rash,
back pain, joint pain, muscle pain,
irregular menstruation, erectile dysfunction,
malaise, chest pain, weakness, fever,
weight gain,
injuries.

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

intestinal disorders, ear infection,
tumour,
hypersensitivity, seasonal allergy,
decreased thyroid hormone levels,
suicidal thoughts, suicidal behaviour, psychotic disorders, thought disorders, emotional blunting, hallucinations, aggression, feelings of euphoria, delusions,
amnesia, sensory impairment, involuntary muscle contractions, loss of consciousness, increased motor activity, migraine, seizures, dizziness upon standing, coordination disorders, speech disorders,
pupil dilation,
ear pain,
increased heart rate, heart problems,
haemorrhagic disorders (including gastrointestinal bleeding), high blood pressure, sudden skin redness, blood in urine,
shortness of breath, nosebleeds, breathing difficulties, wheezing,
tarry stools, dental disorders, oesophagitis, tongue problems, haemorrhoids, increased salivation, swallowing difficulties, belching, tongue diseases,
eye swelling, urticaria, hair loss, itching, purpuric skin spots, blistering skin disorders, dry skin, facial swelling, cold sweats,
degenerative joint disease, muscle tics, painful muscle cramps, decreased muscle strength,
increased frequency of urination, urinary problems, inability to urinate, urinary incontinence, increased volume of urine excreted, nocturnal urination,
sexual disorders, excessive bleeding from the genital tract, genital tract haemorrhage, sexual disorders in women,
leg swelling, chills, difficulty walking, excessive thirst,
increased liver enzyme activity, weight loss.
Cases of suicidal thoughts and behaviours have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

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

diverticulitis, lymph node swelling, thrombocytopenia, leukopenia,
severe allergic reactions,
endocrine disorders,
high cholesterol levels, problems maintaining normal blood sugar levels (diabetes), low blood sugar, increased blood sugar, low blood sodium levels,
physical symptoms caused by stress or emotions, nightmares, drug dependence, sleepwalking, premature ejaculation,
coma, abnormal movements, difficulty moving, increased sensory sensitivity, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome), sensory disturbances,
visual spots, glaucoma, double vision, photophobia, blood in the eye, unequal pupils, visual disturbances, tear secretion disorders,
spots before the eyes, glaucoma, double vision, light sensitivity, blood in the eye, unequal pupils, abnormal vision, tear secretion disorders,
myocardial infarction, feeling of impending fainting, fainting or chest discomfort, which may be symptoms of changes in the heart's electrical activity (visible on electrocardiogram) or irregular heartbeat, slowed heart rate,
worsening of blood circulation in the upper and lower limbs,
rapid breathing, progressive lung tissue fibrosis (interstitial lung disease), laryngospasm, difficulty speaking, slowed breathing, hiccups,
a form of lung disease in which eosinophils (a type of white blood cell) appear in increased numbers in the lungs (eosinophilic pneumonia),
oral ulceration, pancreatitis, presence of blood in stool, tongue ulceration, oral pain,
liver function disorders, severe liver function disorders, yellowing of the skin and eyes (jaundice),
skin reaction to sunlight, skin swelling, abnormal hair structure, abnormal skin odour, rash of hairy skin,
rhabdomyolysis, bone disorders,
difficulty initiating urination, reduced urine output,
nipple discharge, vaginal dryness, genital discharge, painful red penis and foreskin, breast enlargement, prolonged penile erection,
hernia, decreased drug tolerance,
increased blood cholesterol, abnormal laboratory test results, abnormal semen analysis, blood clotting problems,
vasodilatation.

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

bruxism
nocturnal enuresis
partial loss of vision
colitis (causing diarrhoea)
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage); see additional information in subsection Pregnancy, breastfeeding and fertility in section 2.
muscle weakness and severe muscle pain, which may be symptoms of a disorder resembling glutaric aciduria type II*.

Adverse effects reported after marketing of the medicine
Additional adverse effects in children and adolescents:
In clinical trials involving children and adolescents, adverse effects were generally similar to those occurring in adults (see above). The most commonly occurring adverse effects in children and adolescents were: headache, insomnia, diarrhoea and nausea.
Symptoms occurring after discontinuation:
After abrupt discontinuation of the medicine, adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and muscle tremors may occur (see section 3. Discontinuing treatment with Stimuloton).
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 Stimuloton

This medicine does not require any special storage conditions.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date (month and year) stated on the cardboard
pack after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help
protect the environment.

6. Contents of the pack and other information

What Stimuloton contains
The active substance is sertraline: each coated tablet contains 50 mg of sertraline as sertraline hydrochloride.
The other ingredients are: magnesium stearate, hydroxypropylcellulose, sodium carboxymethyl starch, calcium hydrogen phosphate dihydrate, microcrystalline cellulose.
Coating:
hypromellose, macrogol 6000, titanium dioxide (E 171).

What Stimuloton looks like and contents of the pack
White or almost white, oval, biconvex coated tablets with the code E 271 on one side and a score line on the other side. The tablet can be divided into equal doses.
Stimuloton is available in blister packs. Each carton contains 30 tablets.

Marketing Authorisation Holder
PROTERAPIA Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Poland

Manufacturer
EGIS Pharmaceuticals PLC
Mátyás király u. 65
9900 Körmend
Hungary

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Name: EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
Phone: (22) 417 92 00
04.07.2025