Sertagen

Leaflet accompanying the packaging: information for the user

Sertagen, 50 mg, film-coated tablets

Sertagen, 100 mg, film-coated tablets

Sertraline

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sertagen and what is it used for
• 2. Important information before taking Sertagen
• 3. How to take Sertagen
• 4. Possible side effects
• 5. How to store Sertagen
• 6. Contents of the packaging and other information

1. What is Sertagen and what is it used for

Sertagen 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.

Sertagen may be 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 disease characterized by symptoms of feeling sad, having difficulty sleeping or feeling pleasure in life.
Obsessive-compulsive disorder (OCD) and panic disorder are anxiety-related diseases with symptoms of feeling constant anxiety due to persistent thoughts (obsessions), which cause repetitive rituals (compulsive actions).
Post-traumatic stress disorder (PTSD) is a condition that may occur after severe emotional shock, traumatic experience, and is characterized by symptoms similar to depression and anxiety.
Social anxiety disorder (social phobia) is characterized by a feeling of intense fear or stress in social situations (such as talking to strangers, speaking to a group of people, eating or drinking in the presence of others, or worrying about potentially embarrassing behavior).
The doctor has decided that this medicine is suitable for treating the disease in the patient.
If the patient is unsure why they are taking Sertagen, they should consult their doctor.
If the patient does not improve or feels worse after taking Sertagen, they should consult their doctor.

2. Important information before taking Sertagen

When not to take Sertagen:

• if the patient is allergic to sertraline or any of the other ingredients of this medicine (listed in section 6)
• if the patient is taking or has taken monoamine oxidase inhibitors (MAOIs, e.g., selegiline, moklobemide) or linezolid. (See "Sertagen and other medicines"). After stopping sertraline treatment, it is necessary to wait at least one week before starting MAOI treatment. After stopping MAOI treatment, it is necessary to wait at least two weeks before starting sertraline treatment
• if the patient is taking pimozide (a medicine used to treat mental disorders, such as psychoses)

Warnings and precautions

Before starting Sertagen, the patient should discuss it with their doctor or pharmacist.
Medicines do not always suit everyone. The patient should tell their doctor before taking Sertagen if they currently have or have had any of the following conditions:

• Serotonin Syndrome or Neuroleptic Malignant Syndrome (life-threatening conditions). In rare cases, these syndromes may occur in patients who have taken other medicines at the same time as sertraline (see "Sertagen and other medicines"). (Symptoms, see section 4 "Possible side effects"). The doctor should tell the patient if they have had these syndromes in the past
• Low sodium levels in the blood, as this may occur due to Sertagen treatment. The patient should also inform their doctor about taking medicines used to treat high blood pressure (hypertension), as these medicines may also change sodium levels in the blood
• Care should be taken if the patient is elderly or severely dehydrated (e.g., due to vomiting or severe diarrhea), as they may be more susceptible to decreased sodium levels in the blood (see above)
• Liver disease; the doctor may decide to reduce the dose of Sertagen
• Diabetes; Sertagen may affect changes in blood glucose levels, so it may be necessary to change the dosage of antidiabetic medicines
• History of epilepsy or seizures. If a seizure occurs, the patient should contact their doctor immediately
• Past history of manic-depressive illness (bipolar affective disorder) or schizophrenia. If a manic episode occurs, the patient should contact their doctor immediately
• Past or current thoughts of self-harm or suicide (see below "Suicidal thoughts, worsening depression or anxiety")
• Bleeding disorders or past use of blood-thinning medicines (e.g., acetylsalicylic acid (aspirin) or warfarin) or may increase the risk of bleeding or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility")
• Children or adolescents under 18 years of age. In children aged 6 to 17 years, Sertagen may be used only to treat obsessive-compulsive disorder. Patients treated for this condition should be closely monitored by their doctor (see "Children and adolescents", below)
• Electroconvulsive therapy (ECT)
• Patients with a history of glaucoma (increased eye pressure)
• Low potassium levels in the blood, family history of sudden deaths or cardiac disorders, other cardiac disorders, or taking medicines that affect heart rhythm. In such cases, the risk of cardiac arrhythmias (QT interval prolongation, torsades de pointes) increases.
• Acute or chronic pain or other conditions treated with opioid medicines. Taking these medicines with Sertagen may lead to serotonin syndrome, a life-threatening disease (see "Sertagen and other medicines").

Taking Sertagen may affect the result of a urine screening test.

Psychomotor restlessness/Akathisia

Sertraline use has been associated with the occurrence of psychomotor restlessness and a compulsion to move, often with an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment.
Increasing the dose of Sertagen may be harmful to patients who experience such symptoms.

Withdrawal symptoms

After stopping treatment, withdrawal symptoms often occur, especially if treatment is stopped abruptly (see section 3 "Stopping Sertagen" and section 4 "Possible side effects"). The risk of withdrawal symptoms depends on the duration of treatment, dosage, and rate of dose reduction. Usually, these symptoms are mild or moderate. In some patients, they may be severe. They usually occur within the first few weeks after stopping treatment. They usually resolve on their own within two weeks, but in some patients, they may persist for longer (2-3 months or longer).
If the decision is made to stop Sertagen treatment, it is recommended to gradually reduce the dose over several weeks or months and always discuss the best way to stop treatment with the doctor.

Suicidal thoughts, worsening depression or anxiety

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 antidepressant treatment, as these medicines usually start working after two weeks, sometimes later.

This may be more likely in:

• Patients who have had thoughts of self-harm or suicide in the past
• Young adult patients. Clinical trial data show an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressants

If the patient experiences thoughts of self-harm or suicide, they should contact their doctor or go to the hospital immediately.
It may be helpful to inform relatives or friendsabout depression or anxiety disorders and ask them to read this leaflet. The patient may ask to be informed if they notice that their depression or anxiety has worsened or if there are worrying changes in their behavior.
Medicines like Sertagen (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.

Children and adolescents

Sertagen should not be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder. It should also be emphasized that patients under 18 years of age taking medicines of this class are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Sertagen to patients under 18 years of age, considering that it is in their best interest. If the doctor prescribes Sertagen to a patient under 18 years of age, and the patient's parents have any doubts, they should consult the doctor. If the patient under 18 years of age taking Sertagen develops or worsens the above symptoms, they should inform their doctor. Additionally, as of now, there is a lack of data on the long-term safety of Sertagen in this age group regarding growth, maturation, and cognitive and behavioral development.

Sertagen 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.
Some medicines may affect how Sertagen works or Sertagen may reduce the effectiveness of other medicines taken at the same time.

Taking Sertagen with the following medicines may cause serious side effects:

• Monoamine oxidase inhibitors (MAOIs), e.g., moklobemide (used to treat depression), selegiline (used to treat Parkinson's disease), the antibiotic linezolid, or methylene blue. Sertagen should not be taken with MAOIs.
• Pimozide, a medicine used to treat mental disorders. Sertagen should not be taken with pimozide.
• Opioid medicines used to treat acute or chronic pain (e.g., buprenorphine) and opioid receptor antagonists that block the action of opioids (e.g., naloxone). Sertagen should not be taken with opioids or opioid receptor antagonists. These medicines may interact with Sertagen and cause symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tone, and a body temperature above 38°C. If such symptoms occur, the patient should contact their doctor.

The patient should inform their doctor or pharmacist if they are taking the following medicines:

• Medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, 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 for anesthesia or used to treat chronic, severe pain (e.g., mivacurium, suxamethonium, and opioid medicines such as fentanyl)
• Medicines used to treat pain (e.g., tramadol)
• Medicines used to treat migraines (e.g., sumatriptan)
• Medicines that prevent blood clotting (e.g., warfarin, ticlopidine)
• Medicines used to treat pain/inflammation of the joints (non-steroidal anti-inflammatory medicines (NSAIDs), e.g., ibuprofen, acetylsalicylic acid (aspirin))
• Metamizole, a medicine used to treat pain and fever
• Diuretics
• Medicines used to treat epilepsy (e.g., phenytoin, phenobarbital, carbamazepine)
• Medicines used to treat diabetes (e.g., tolbutamide)
• Medicines used to treat excessive stomach acid production, stomach ulcers, and heartburn (e.g., cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazol)
• Lithium, a medicine used to treat mania and depression
• Other medicines used to treat depression (e.g., amitriptyline, nortriptyline, desipramine, nefazodone, fluoxetine, fluvoxamine)
• Medicines used to treat schizophrenia and other mental disorders (e.g., perphenazine, levomepromazine, and olanzapine)
• Medicines used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (e.g., flecainide, propafenone, verapamil, and diltiazem)
• Medicines used to treat HIV/AIDS and hepatitis C (e.g., protease inhibitors such as ritonavir, telaprevir)
• Medicines used to treat fungal infections (e.g., fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole)
• Antibiotics (e.g., erythromycin, clarithromycin, telithromycin)
• Aprepitant, a medicine used to treat nausea and vomiting
• Medicines used to treat tuberculosis (e.g., rifampicin)
• Medicines that affect heart rhythm (e.g., certain antipsychotic medicines such as haloperidol or antibiotics such as levofloxacin)

Sertagen with food and alcohol

During Sertagen treatment, the patient should not consume alcohol. Sertagen should not be taken with grapefruit juice, as it may increase the level of sertraline in the blood.

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.
The safety of sertraline in pregnant women has not been fully established. The medicine can be used in pregnant women only if the doctor considers that the benefits to the mother outweigh the potential risks to the fetus. Women of childbearing age taking sertraline should use effective contraception.
The patient should inform their midwife and/or doctor that they are taking Sertagen. Medicines like Sertagen taken during pregnancy, especially in the last three months, may increase the risk of a serious disease in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and cyanosis. These symptoms usually occur within 24 hours of birth. If they occur in the baby, the patient should immediately inform their midwife and/or doctor. Newborns may also experience other complications, which usually appear within the first 24 hours after birth. Symptoms include:

• breathing difficulties
• bluish skin, too hot or cold skin
• bluish lips
• vomiting or problems with sucking
• excessive tiredness, difficulty sleeping, or constant crying
• stiffness or flaccidity of muscles
• tremors, muscle spasms, or seizures
• increased reflexes
• agitation
• low blood sugar

If the baby experiences any of these symptoms or if their condition is worrying, the patient should consult their doctor or midwife.
Taking Sertagen at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Sertagen, they should inform their doctor or midwife so they can provide appropriate advice.
There is evidence that sertraline passes into breast milk. The medicine can be used in breastfeeding women if the doctor considers that the benefits to the mother outweigh the potential risks to the baby.
In animal studies, some medicines similar to sertraline have 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

Psychotropic medicines, such as sertraline, may affect the ability to drive or operate machines. The patient should not drive or operate machines until they know how the medicine affects their ability to perform these activities.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free”.

3. How to take Sertagen

This medicine should always be taken exactly as prescribed by the doctor or pharmacist.
Sertagen can be taken with or without food.
The medicine should be taken once a day, in the morning or evening. The tablets can be divided into equal doses.
For some patients, Sertagen may have an unusual odor and/or taste. This is a normal phenomenon, and these sensations can be reduced by drinking a glass of water immediately after putting the medicine in the mouth.
If the patient has any doubts, they should consult their doctor or pharmacist.

Recommended dose:

Adults:

Depression and obsessive-compulsive disorder:

The recommended effective dose for treating depression and OCD is 50 mg/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/day.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder:

Treatment of panic disorder, social anxiety disorder, and post-traumatic stress disorder should be started with a dose of 25 mg/day, which can be increased to 50 mg/day after one week.
The daily dose can then be increased gradually by 50 mg at intervals of several weeks. The maximum recommended dose is 200 mg/day.

Use in children and adolescents:

In children and adolescents aged 6 to 17 years, Sertagen may be used only to treat obsessive-compulsive disorder.

Obsessive-compulsive disorder:

Children aged 6 to 12 years:The recommended initial dose is 25 mg/day. After one week, the doctor may increase the dose to 50 mg/day. The maximum dose is 200 mg/day.
Adolescents aged 13 to 17 years:The recommended initial dose is 50 mg/day. The maximum dose is 200 mg/day.
Patients with liver or kidney function disorders should inform their doctor and follow their recommendations.
The doctor will inform the patient how long they should take the medicine. The treatment period depends on the type of disease and the patient's response to treatment. Improvement of symptoms may start only after several weeks of treatment.

Taking a higher dose of Sertagen than recommended

If the patient accidentally takes too much Sertagen, they should immediately inform their doctor or go to the emergency department of the nearest hospital. The patient should always take the medicine packaging with the label, regardless of whether there is still medicine in it or not.
Symptoms of overdose may include drowsiness, nausea, and vomiting, rapid heart rate, muscle tremors, agitation, dizziness, and in rare cases, loss of consciousness.

Missing a dose of Sertagen

If the patient forgets to take a tablet, they should not take the missed tablet. They should simply take the next tablet at the right time. The patient should not take a double dose to make up for the missed dose.

Stopping Sertagen treatment

The patient should not stop Sertagen treatment unless their doctor advises them to do so.
The doctor should gradually reduce the dose of Sertagen over several weeks until the patient finally stops taking it. If the patient suddenly stops taking Sertagen, they may experience side effects such as dizziness, numbness, sleep disturbances, agitation, or anxiety, headaches, nausea, vomiting, and muscle tremors. If the patient experiences any of these side effects or any other side effects after stopping Sertagen treatment, they should consult their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately inform their doctor:

If they experience any of the following symptoms after taking this medicine (as they can be serious).

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

• seizures
• depressive symptoms with suicidal thoughts and behaviors. These symptoms have been reported during sertraline treatment or shortly after stopping treatment (see section 2)
• blood in stool, black stools
• unexpected and unusual (e.g., very heavy) vaginal bleeding
• bleeding disorders (e.g., stomach bleeding - which may look like coffee grounds)
• inability to urinate

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

• allergic reaction or allergy, which may cause symptoms such as itching, hives, difficulty breathing, wheezing, or sudden swelling of the eyelids, face, or lips
• heart attack
• loss of consciousness (coma)
• severe abdominal pain and bloating, high fever. This may indicate inflammation of the intestines, in which there is swelling or infection of the intestinal mucosa. Presence of fresh blood in stool (hematochezia)
• disorders of blood sugar control (diabetes)
• glaucoma (increased eye pressure), which may cause severe eye pain, redness of the eye, or "halo" or "blurred" vision
• very slow breathing
• severe muscle pain, weakness, or stiffness (due to muscle breakdown - rhabdomyolysis)
• severe skin rash, which causes blistering. These may be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In such cases, the doctor will stop the patient's treatment
• agitation, confusion, diarrhea, high fever, and high blood pressure, excessive muscle stiffness, sweating, and rapid heart rate. These are symptoms of Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS). In rare cases, these syndromes may occur when the patient is taking other medicines at the same time as sertraline. The doctor may then stop the patient's treatment
• sudden severe headaches (which may indicate serious conditions known as reversible cerebral vasoconstriction syndrome or Call-Fleming syndrome)
• severe lung problems. Persistent cough without expectoration or worsening shortness of breath
• jaundice (yellowing of the skin and eyes), which may indicate liver damage
• pancreatitis with severe abdominal pain, which is often accompanied by nausea or vomiting
• if the patient experiences restlessness and cannot sit or stand still after taking Sertagen. If the patient experiences restlessness, they should tell their doctor
• occurrence of a manic episode (see section 2 "Warnings and precautions")
• low sodium levels in the blood, which may cause feelings of weakness and confusion or muscle pain. This may be due to inappropriate secretion of the antidiuretic hormone (ADH), which causes water retention and blood dilution, reducing sodium levels
• decreased white blood cell count, which may cause increased susceptibility to infections (e.g., sore throat, mouth ulcers, and fever)
• changes in heart rhythm, which may be visible on an ECG (indicating serious changes, such as QT interval prolongation or torsades de pointes)

The following other side effects have been observed in clinical trials and after the medicine was marketed in adults.

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

• insomnia (sleep problems), dizziness, drowsiness, headaches, diarrhea, nausea, dry mouth, ejaculation disorders, fatigue

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

• common cold, runny nose
• sore throat, decreased or increased appetite
• depression, "strange" feeling, feeling unwell (general malaise), nightmares, anxiety, agitation, nervousness, decreased interest in sex, teeth grinding
• numbness and tingling, muscle tremors, increased muscle tone, taste disorders, lack of attention
• vision disturbances, ringing in the ears
• palpitations, hot flashes, yawning
• abdominal pain, vomiting, constipation, gastrointestinal disorders, such as indigestion or heartburn, gas
• rash, increased sweating, muscle pain or joint pain, sexual dysfunction, chest pain
• back pain, muscle spasms, abnormal neck muscle contractions, involuntary movements
• nocturia, increased urination, frequent urination, problems with urination, urinary incontinence
• severe and prolonged menstrual bleeding (menorrhagia)
• chills, increased thirst, increased liver enzyme levels, weight loss
• decreased thyroid hormone levels

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

• gastrointestinal problems
• tumors
• hay fever
• hallucinations (seeing, hearing, and feeling things that do not exist), feelings of euphoria, apathy, thinking disorders, aggression, psychotic disorders, paranoia (a mental disorder characterized by extreme suspiciousness)
• involuntary muscle contractions, coordination disorders, increased sensitivity, sensory disturbances
• spots before the eyes, glaucoma, double vision, increased sensitivity to light, blood in the eye, unequal pupil size, vision disturbances, tear secretion disorders
• slow heart rate, other heart problems, worsening circulation in the arms and legs, rapid breathing or loud breathing, very slow breathing, speech difficulties, hiccups
• a form of lung disease in which eosinophils (a type of white blood cell) appear in the lungs in increased numbers (eosinophilic pneumonia)
• mouth pain, tongue ulcers, mouth ulcers, liver disorders
• skin disorders with blistering, rash in the hair follicle area, abnormal hair structure, abnormal skin odor, bone disorders, sun-related skin reaction
• in patients taking this type of medicine, an increased risk of bone fractures has been observed
• blood in urine, decreased urination, delayed urination
• endocrine disorders, low sodium levels in the blood, high blood sugar levels (hyperglycemia), abnormal laboratory test results
• vaginal dryness, painful red penis and foreskin, discharge, prolonged erection of the penis, nipple discharge, breast enlargement
• hernia, decreased drug tolerance, abnormal sperm test results, blood vessel weakness

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

• gland swelling, high cholesterol levels, low blood glucose levels
• decreased platelet count (may cause increased bleeding or bruising)
• physical symptoms caused by stress or emotions, drug dependence, sleepwalking, premature ejaculation
• nightmares
• abnormal movements, difficulty moving, increased sensitivity, sensory disturbances
• spots before the eyes, glaucoma, double vision, increased sensitivity to light, blood in the eye, unequal pupil size, vision disturbances, tear secretion disorders
• slow heart rate, other heart problems, worsening circulation in the arms and legs, rapid breathing or loud breathing, very slow breathing, speech difficulties, hiccups

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

• partial loss of vision
• jaw tightness (partial or complete inability to open the mouth)
• inflammation of the colon (causing diarrhea)
• severe vaginal bleeding shortly after delivery (postpartum hemorrhage), 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 similar to glutaric aciduria type II

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). After sertraline was marketed, nocturnal enuresis was also reported. The most common side effects in children and adolescents were headaches, insomnia, diarrhea, and nausea.

Reporting side effects

If side effects occur, including any not listed in the leaflet, the patient should tell their 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, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Sertagen

The medicine should be stored out of sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging, after "EXP".
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Sertagen contains

• The active substance of Sertagen is sertraline hydrochloride. Each tablet contains 50 mg or 100 mg of sertraline.
• The other ingredients of the medicine are: microcrystalline cellulose (Avicel PH 101), calcium hydrogen phosphate, microcrystalline cellulose (Avicel PH 102), sodium carboxymethyl cellulose (type A), magnesium stearate, hypromellose, titanium dioxide (E171), polydextrose, triacetin, and macrogol 8000.

What Sertagen looks like and contents of the pack

Sertagen 50 mg film-coated tablets:
White or almost white film-coated tablets in the shape of a capsule with the inscription "ST/50" on one side and "G" on the other side.
Sertagen 100 mg film-coated tablets:
White or almost white film-coated tablets in the shape of a capsule with the inscription "ST/100" on one side and "G" on the other side.
Sertagen 50 mg and 100 mg is available in blisters containing 28 film-coated tablets.

Marketing authorization holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer:

McDermott Laboratories trading as Gerard Laboratories
35-36 Baldoyle Industrial Estate, Grange Road
Dublin 13
Irlandia
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1.
Węgry
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 546 64 00
Date of last revision of the leaflet:July 2025