Stimuloton

Package Leaflet: Information for the User

Stimuloton, 50 mg, Film-Coated Tablets

Sertraline

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

• You should 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Leaflet

• 1. What is Stimuloton and What is it Used For
• 2. Before You Take Stimuloton
• 3. How to Take Stimuloton
• 4. Possible Side Effects
• 5. How to Store Stimuloton
• 6. Contents of the Pack and Other Information

1. What is Stimuloton and What is it 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 depression and/or anxiety disorders.

Stimuloton is Used to Treat:

• depression and prevention of depression relapse (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 children and adolescents aged 6-17 years).

Depression is a condition where you feel sad, have difficulty sleeping or enjoying life.
Obsessive-compulsive disorder and panic disorder are anxiety-related conditions, with persistent worry due to recurring thoughts (obsessions), which cause repetitive behaviors (compulsive acts).
Post-traumatic stress disorder (PTSD) is a condition that can occur after a traumatic experience and has some symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related condition. It is characterized by an intense fear or anxiety in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in front of others, or worrying about potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for treating your condition. You should ask your doctor if you are unsure why you have been given Stimuloton.

2. Before You Take Stimuloton

When Not to Take Stimuloton

• If you are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have taken monoamine oxidase inhibitors (MAOIs) such as moclobemide, selegiline or other MAOI-like drugs (e.g., linezolid) or other medicines used to treat depression. After stopping treatment with sertraline, you must wait at least one week before starting treatment with a MAOI. After stopping treatment with a MAOI, you must wait at least 2 weeks before starting treatment with sertraline.
• If you are taking pimozide (a medicine used to treat certain psychiatric conditions, such as psychosis).

Warnings and Precautions

Before taking Stimuloton, discuss this with your doctor.
Not all medicines are suitable for everyone. Before taking Stimuloton, tell your doctor if you have or have had any of the following conditions:

• Seizures or a history of seizures. If you have a seizure, contact your doctor immediately.
• A history of mania or bipolar disorder. If you experience a manic episode, contact your doctor immediately.
• Suicidal thoughts - current or past (see below - suicidal thoughts and worsening of depression or anxiety).
• Serotonin syndrome or neuroleptic malignant syndrome. These syndromes may occur in rare cases in patients taking other medicines, such as certain antidepressants, amphetamine derivatives, triptans, methylene blue, antipsychotics, and opioid analgesics (e.g., buprenorphine (or its combination with naloxone)), see "Stimuloton and Other Medicines"). Your doctor should check if you have had any of these conditions in the past.
• Low sodium levels in the blood, as this may occur with the use of Stimuloton. You should also inform your doctor if you are taking medicines for high blood pressure, as they may also affect sodium levels in the blood. Elderly people should be cautious, as they may be more prone to decreased sodium levels in the blood (see above).
• Liver disease; your doctor may decide to reduce the dose of Stimuloton.
• Diabetes; Stimuloton may affect blood sugar levels, so a change in the dosage of antidiabetic medicines may be necessary.
• Bleeding disorders (tendency to bruise) or if you are pregnant (see "Pregnancy, Breastfeeding, and Fertility"), as well as past use of anticoagulant medicines (e.g., acetylsalicylic acid (aspirin) or warfarin) or medicines that may increase the risk of bleeding.
• You are under 18 years old: Stimuloton should not be used in children and adolescents under 18 years old, except for patients with obsessive-compulsive disorder (OCD). Patients with this condition should be closely monitored by their doctor (see "Use in Children and Adolescents" below).
• You are receiving electroconvulsive therapy (ECT).
• Eyelid problems, such as certain types of glaucoma (increased eye pressure).
• Abnormal heart rhythms observed in an electrocardiogram (ECG), known as QT interval prolongation.
• Heart disease, low potassium or magnesium levels, prolonged QT interval in a family member, slow heart rate, and concomitant use of medicines that cause QT interval prolongation.

Psychomotor Restlessness, Akathisia:

The use of Stimuloton has been associated with the occurrence of akathisia (a condition characterized by 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. You should contact your doctor if you experience an increase in dose, as this may be harmful to patients with these symptoms.

Withdrawal Symptoms:

After stopping treatment, withdrawal symptoms often occur, 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 rate of dose reduction. These symptoms are usually mild or moderate, but in some patients, they can be severe. They usually occur within the first few days after stopping treatment.
They usually resolve on their own within 2 weeks, but in some patients, they can persist for 2-3 months or longer. If you decide to stop taking Stimuloton, it is recommended to gradually reduce the dose over several weeks or months. You should always discuss with your doctor the best way to stop taking Stimuloton.

Suicidal Thoughts, Worsening of Depression or Anxiety:

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 start to work usually after 2 weeks, sometimes later.

Occurrence of Suicidal Thoughts is More Likely if:

• you have had suicidal thoughts or self-harm in the past
• you are a young adult; clinical trial data suggest an increased risk of suicidal behavior in people under 25 years old with mental disorders who are treated with antidepressants. If you experience suicidal thoughts or self-harm, you should contact your doctor or go to the hospital immediately.

It may be helpful to inform your family or friends about your depression or anxiety disorder and ask them to read this leaflet.
You can ask your family or friends to tell you if they notice that your depression or anxiety has worsened or if you have any disturbing changes in behavior.

Sexual Dysfunction

Medicines like Stimuloton (selective serotonin reuptake inhibitors, SSRIs) may cause sexual dysfunction (see section 4).
In some cases, these symptoms have persisted after stopping treatment.

Children and Adolescents

Stimuloton should not be used in children and adolescents under 18 years old, except for patients with obsessive-compulsive disorder (OCD).
In children and adolescents under 18 years old, there is a greater risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggressive, defiant, and angry behavior), if they take medicines of this type.
However, your doctor may prescribe Stimuloton to a patient under 18 years old if it is in the patient's best interest. If your doctor prescribes Stimuloton to a patient under 18 years old, and the patient wants to discuss this, they should contact their doctor. You should inform your doctor if any of the above symptoms occur or worsen in a person under 18 years old taking Stimuloton.
In a long-term observational study lasting 3 years with over 900 children aged 6-16 years, the safety of long-term use of sertraline was evaluated in terms of its effect on growth, maturation, learning (cognitive function), and behavior. In general, the study results showed that children treated with sertraline developed normally, except for a small increase in body weight in children treated with a higher dose.

Stimuloton and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Some medicines may affect the way Stimuloton works or Stimuloton may reduce the effectiveness of other medicines taken at the same time.

Taking Stimuloton with the Following Medicines May Cause Serious Side Effects:

• monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression) and selegiline (used to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (used to treat high methemoglobin levels in the blood). Do not take Stimuloton with these medicines.
• medicines used to treat mental disorders (pimozide). Do not take Stimuloton with pimozide.

Tell Your Doctor if You are Taking the Following Medicines:

• medicines containing amphetamine derivatives (used to treat 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, such as tramadol, fentanyl).
• medicines containing buprenorphine (used to treat opioid dependence or severe pain) or buprenorphine in combination with naloxone (used to treat opioid dependence).
• 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, arthritis (non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, aspirin).
• metamizole, a medicine used to treat pain and fever.
• sedatives (diazepam).
• diuretics (also known as water pills).
• medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• medicines used to treat diabetes (tolbutamide).
• medicines used to treat excessive stomach acid production and stomach ulcers (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 mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• medicines used to treat high blood pressure, chest pain, or heart rhythm regulation (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 drink alcohol while taking Stimuloton.
Food does not affect the absorption of Stimuloton. Stimuloton can be taken with or without food.
Do not drink grapefruit juice while taking Stimuloton, as it may increase the levels of sertraline in your body.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The safety of sertraline in pregnant women has not been fully established. Stimuloton should only be used during pregnancy if your doctor considers it essential.
Taking Stimuloton at the end of pregnancy may increase the risk of severe bleeding from the vagina, which can occur shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Stimuloton, you should inform your doctor or midwife so that they can give you appropriate advice.
Make sure your midwife and/or doctor know you are taking Stimuloton. Medicines like Stimuloton, taken especially in the last 3 months of pregnancy, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), in which the baby has rapid breathing and turns blue. These symptoms usually occur within 24 hours of birth. If this happens, you should contact your midwife and/or doctor immediately.
The baby may also experience other conditions, usually appearing in the first day of life. These symptoms include:

• breathing difficulties,
• blue skin, too cold or hot, as in a fever,
• blue lips,
• vomiting or feeding problems,
• excessive tiredness, sleep problems, constant crying,
• too tense or too floppy muscles,
• tremors or seizures,
• increased reflexes,
• agitation
• low blood sugar levels.

If your baby experiences any of these symptoms or if you are concerned about their health, you should contact your doctor or midwife for advice.
Breastfeeding
Sertraline passes into breast milk. Stimuloton can be used during breastfeeding if your doctor considers it essential for you.
Fertility
In animal studies, it has been shown that some medicines, such as Stimuloton, may decrease sperm quality. This may theoretically affect fertility, but so far, no such effect has been observed in humans.

Driving and Using Machines

Psychotropic medicines, such as sertraline, may affect your ability to drive or operate machinery.
You should wait until you know how Stimuloton affects you before performing these activities.

Stimuloton Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to Take Stimuloton

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
The recommended dose is:

Adults

• -depression and obsessive-compulsive disorder (OCD) The usual effective dose for treating depression and OCD is 50 mg per day. The daily dose can be increased gradually, 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 PTSD should start with a dose of 25 mg per day, which can be increased to 50 mg per day after one week. The daily dose can then be increased gradually, by 50 mg, over several weeks. The maximum recommended dose is 200 mg per day.

Use in Children and Adolescents

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

• The recommended initial dose for children aged 6-12 years with OCD is 25 mg per day. After one week, the doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.
• The recommended initial dose for children aged 13-17 years with OCD is 50 mg per day. The maximum dose is 200 mg per day.

Patients with liver or kidney disease should inform their doctor and follow their advice.
Administration
Stimuloton can be taken with or without food.
Take the medicine once a day, in the morning or evening.
The tablet can be divided into equal doses.
Your doctor will tell you how long you should take Stimuloton. The treatment period depends on the type of disease and your response to treatment. Improvement may start after several weeks of treatment. Treatment of depression should usually last for 6 months after improvement.

Overdose

If you accidentally take too much Stimuloton, you should immediately contact your doctor or go to the emergency department of the nearest hospital. Always take the medicine package with you, whether it contains medicine or not.
Overdose symptoms may include drowsiness, nausea, and vomiting, rapid heart rate, muscle tremors, agitation, dizziness, and in rare cases, loss of consciousness.

Missed Dose

If you forget 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 the missed dose.

Stopping Stimuloton

Do not stop taking Stimuloton without consulting your doctor.
Your doctor should gradually reduce the dose of Stimuloton over several weeks, until you finally stop taking it.
If you suddenly stop taking Stimuloton, you may experience side effects, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors. If you experience any of these side effects or other side effects after stopping Stimuloton, you should contact your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Stimuloton can cause side effects, although not everybody gets them.
The most common side effect is nausea. Side effects depend on the dose and usually disappear or decrease as treatment continues.

See a Doctor Immediately if You Experience:

any of the following symptoms, as they can be serious:

• severe skin rash, which can cause blisters (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. Your doctor will stop treatment with Stimuloton.
• allergic reaction or allergy, with symptoms such as: itchy skin rash, difficulty breathing, wheezing, swelling of the eyelids, face, or lips.
• agitation, confusion, hallucinations, diarrhea, nausea, vomiting, high body temperature above 38 °C, and high blood pressure, excessive sweating, increased muscle tone, tremors, and rapid heart rate. These are symptoms of serotonin syndrome or neuroleptic malignant syndrome. In rare cases, these syndromes can occur in patients taking other medicines, such as certain antidepressants, amphetamine derivatives, triptans, methylene blue, antipsychotics, and opioid analgesics (e.g., buprenorphine (or its combination with naloxone)), see "Stimuloton and Other Medicines"). Your doctor may stop treatment with Stimuloton.
• yellowing of the skin and eyes, which may indicate liver damage.
• symptoms of depression with suicidal thoughts.
• restlessness and inability to sit or stand still after starting Stimuloton. If you experience restlessness, you should tell your doctor.
• seizures.
• manic episodes (see section 2. Warnings and Precautions).

The following side effects have been reported in clinical trials with adults:

Very Common (May Affect More Than 1 in 10 People):

• insomnia, dizziness, drowsiness, headaches,
• diarrhea, nausea, dry mouth,
• ejaculation disorder,
• fatigue.

Common (May Affect Up to 1 in 10 People):

• bronchitis, sore throat, cold,
• loss of appetite, increased appetite,
• anxiety, depression, agitation, decreased sexual interest, nervousness, abnormal sensation, nightmares, teeth grinding,
• tremors, muscle movement disorders (such as increased muscle activity, increased muscle tone, difficulty walking, and stiffness), numbness and tingling, increased muscle tone, lack of concentration, taste disturbances,
• vision disturbances,
• ringing in the ears,
• palpitations,
• hot flushes,
• yawning,
• gastrointestinal disturbances, constipation, abdominal pain, vomiting, flatulence,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstrual periods, erectile dysfunction,
• general malaise, chest pain, weakness, fever,
• weight gain,
• injuries.

Uncommon (May Affect Up to 1 in 100 People):

• gastrointestinal disorders, ear infection,
• tumor,
• hypersensitivity, seasonal allergy,
• decreased thyroid hormone levels,
• suicidal thoughts, suicidal behavior, psychotic disorders, thought disorders, apathy, hallucinations, aggression, euphoria, delusions,
• amnesia, decreased sensation, involuntary muscle contractions, loss of consciousness, increased muscle activity, migraine, seizures, dizziness when standing up, coordination disturbances, speech disturbances,
• pupil dilation,
• ear pain,
• rapid heart rate, heart problems,
• bleeding disorders (including gastrointestinal bleeding), high blood pressure, flushing, blood in urine,
• shortness of breath, nosebleeds, breathing difficulties, wheezing,
• tarry stools, dental disorders, esophagitis, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• eye swelling, hives, hair loss, itching, purpura, skin disorders with blistering, dry skin, facial swelling, cold sweats,
• degenerative joint disease, muscle twitches, painful muscle spasms, muscle weakness,
• increased urination frequency, urination problems, inability to urinate, urinary incontinence, increased urine production, nocturia,

urination

• sexual dysfunction, excessive menstrual bleeding, menstrual disorders, sexual dysfunction in women,
• swelling of the legs, chills, walking difficulties, increased thirst,
• increased liver enzyme activity, weight loss.
• During treatment with sertraline or shortly after stopping treatment, there have been reports of suicidal thoughts and behaviors (see section 2).

Rare (May Affect Up to 1 in 1000 People):

• diverticulitis, lymphadenopathy, decreased platelet count, decreased white blood cell count,
• severe allergic reactions,
• endocrine disorders,
• high cholesterol levels, diabetes-related problems (diabetes), low blood sugar levels, high blood sugar levels, low sodium levels in the blood,
• physical symptoms caused by stress or emotions, nightmares, drug dependence, sleepwalking, premature ejaculation,
• coma, abnormal movements, difficulty walking, increased sensitivity, sudden severe headache (which may be a sign of a serious condition called reversible cerebral vasoconstriction syndrome), sensory disturbances,
• blind spots, glaucoma, double vision, photophobia, blood in the eye, uneven pupils, vision disturbances, tear disturbances,
• spots in front of the eyes, glaucoma, double vision, photophobia, blood in the eye, uneven pupils, vision disturbances, tear disturbances
• heart attack, feeling of impending fainting or fainting, chest discomfort, which may be symptoms of changes in heart electrical activity (visible on an electrocardiogram) or abnormal heart rhythm,
• worsening of blood circulation in the arms and legs,
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease), narrowing of the airways, difficulty speaking, slow breathing, hiccups,
• a condition in which eosinophils (a type of white blood cell) appear in the lungs in increased numbers (eosinophilic pneumonia),

Frequency Not Known (Frequency Cannot be Estimated from the Available Data):

• jaw stiffness
• bedwetting
• partial loss of vision
• inflammation of the colon (causing diarrhea)
• severe postpartum bleeding (postpartum hemorrhage), see additional information in section 2. Pregnancy, Breastfeeding, and Fertility, side effects reported after marketing authorization

Additional Side Effects in Children and Adolescents:

In clinical trials with children and adolescents, side effects were generally similar to those in adults (see above). The most common side effects in children and adolescents were headaches, insomnia, diarrhea, and nausea.

Withdrawal Symptoms:

After stopping treatment with Stimuloton, side effects may occur, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3. Stopping Stimuloton).
Patients taking this type of medicine have been observed to have an increased risk of bone fractures.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects 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 Stimuloton

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

6. Contents of the Pack and Other Information

What Stimuloton Contains

The active substance is sertraline: each film-coated tablet contains 50 mg of sertraline in the form of hydrochloride.
Other ingredients are: magnesium stearate, hydroxypropyl cellulose, sodium carboxymethyl cellulose, 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 film-coated tablets with the inscription 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 blisters. Each carton contains 30 tablets.

Marketing Authorization Holder

PROTERAPIA Sp. z o.o.
Komitetu Obrony Robotników 45 D
02-146 Warsaw

Manufacturer

EGIS Pharmaceuticals PLC
Mátyás király u. 65
9900 Körmend
Hungary
To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:
Name: EGIS Polska Sp. z o.o.
Komitetu Obrony Robotników 45 D
02-146 Warsaw
Phone: (22) 417 92 00

Date of Last Revision of the Leaflet: