Sertagen: detailed information

Package leaflet: information for the user

Sertagen, 50 mg, film-coated tablets
Sertagen, 100 mg, film-coated tablets
Sertralinum
Please read the entire leaflet carefully before starting to take this medicine, as it contains
important information for the patient.

Keep this leaflet; you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Sertagen is and what it is used for
Important information before taking Sertagen
How to take Sertagen
Possible side effects
How to store Sertagen
Contents of the pack and other information

1. What Sertagen is and what it is used for

Sertagen contains the active substance sertraline. Sertraline belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are used in the treatment of depressive and/or anxiety disorders.
Sertagen 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 children and adolescents aged 6–17 years).

Depression is an illness characterized by symptoms such as feelings of sadness, difficulty sleeping, or inability to experience joy in life.
Obsessive-compulsive disorder (OCD) and panic disorder are anxiety-related conditions characterized by persistent feelings of anxiety due to intrusive thoughts (obsessions), which lead to repetitive rituals (compulsive behaviours).
Post-traumatic stress disorder (PTSD) is a condition that may occur after a severe emotional shock or traumatic experience and is characterized by symptoms similar to those of depression and anxiety.
Social anxiety disorder (social phobia) is characterized by intense fear or anxiety in social situations (such as talking to strangers, speaking in front of a group, eating or drinking in front of others, or worrying about potentially embarrassing behaviour).

Your doctor has decided that this medicine is appropriate for treating your condition.
If you are unsure why you are taking Sertagen, please consult your doctor.
If there is no improvement after taking Sertagen, or if you feel worse, you should contact your doctor.

2. Important information before using Sertagen

When not to use 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 currently taking or has recently taken monoamine oxidase inhibitors (MAO inhibitors, e.g. selegiline, moclobemide) or linezolid. (See section "Sertagen with other medicines"). At least one week must elapse after stopping sertraline before starting treatment with an MAO inhibitor. At least two weeks must elapse after stopping treatment with an MAO inhibitor 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 Sertagen, discuss this with your doctor or pharmacist.
Medicines are not suitable for everyone. Tell your doctor before taking Sertagen if the patient currently has or has previously had any of the following conditions:

Serotonin Syndrome or Neuroleptic Malignant Syndrome (life-threatening conditions). These syndromes may rarely occur in patients taking other medicines at the same time as sertraline (see section "Sertagen with other medicines"). (Symptoms, see section 4. "Possible side effects"). Your doctor should ask whether you have previously experienced these syndromes
Low blood sodium levels, which may occur as a result of taking Sertagen. You should also inform your doctor if you are taking medicines used to treat high blood pressure (hypertension), as these medicines may also affect blood sodium levels
Exercise caution if the patient is elderly or severely dehydrated (e.g. due to vomiting or severe diarrhoea), as they may be more susceptible to reduced blood sodium levels (see above)
Liver disease; your doctor may decide to reduce the dose of Sertagen
Diabetes; Sertagen may affect blood glucose levels, so a change in the dosage of antidiabetic medicines may be necessary
Epilepsy or history of seizures. If a seizure occurs, contact your doctor immediately
Previous history of bipolar disorder (manic-depressive illness) or schizophrenia. If a manic episode occurs, contact your doctor immediately
Current or previous thoughts of self-harm or suicide (see below: "Suicidal thoughts, worsening depression or anxiety")
Bleeding disorders or previous use of blood-thinning medicines (e.g. acetylsalicylic acid (aspirin) or warfarin), or medicines that 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 for the treatment of obsessive-compulsive disorder. Patients being treated for this condition should be closely monitored by a doctor (see: "Children and adolescents", below)
Electroconvulsive therapy (ECT) in progress
Patients with a history of glaucoma (increased pressure in the eye)
Low blood potassium levels in the patient, family history of sudden death or cardiac disorders, other cardiac disorders, or use of medicines affecting heart rhythm. In such cases, the risk of developing cardiac rhythm disturbances (prolonged QT interval, torsades de pointes ventricular tachycardia) increases.
Acute or chronic pain or other conditions treated with opioid medicines. Taking these medicines together with Sertagen may lead to serotonin syndrome, a potentially life-threatening condition (see section "Sertagen with other medicines").

Use of Sertagen may affect the result of a urine screening test.
Psychomotor agitation/Akathisia
Use of sertraline has been associated with the development of psychomotor agitation and an urge to move, often with an inability to sit still or remain motionless (akathisia). This condition usually occurs within the first few weeks of treatment.
Increasing the dose of the medicine 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 Sertagen" and section 4 "Possible side effects"). The risk of withdrawal symptoms depends on the duration of treatment, dose, and speed of dose reduction. Generally, these symptoms are mild or moderate in intensity. However, in some patients, they may be severe. They usually appear within the first few weeks after stopping treatment and typically resolve spontaneously within 2 weeks, although in some patients they may persist longer (for 2–3 months or more).
If a decision is made to discontinue treatment with Sertagen, a gradual reduction of the dose over several weeks or months is recommended, and the best way to stop treatment should always be discussed with your doctor.
Suicidal thoughts, worsening depression or anxiety
People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually take about 2 weeks, sometimes longer, to start working.
This may be more likely in:

Patients who have previously experienced thoughts of self-harm or suicide
Young adult patients. Clinical trial data show an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who were treated with antidepressant medicines

If the patient experiences thoughts of self-harm or suicide, contact a doctor immediately
or go to hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him or her if they notice worsening depression or anxiety or concerning changes in behaviour.
Medicines such as Sertagen (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.
Children and adolescents
Sertagen should not be used in children and adolescents under 18 years of age, except in 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 adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and manifestations of anger). Nevertheless, a doctor may prescribe Sertagen to patients under 18 years of age if he or she considers it to be in their best interest. If the doctor has prescribed Sertagen to a patient under 18 years of age and the patient's parents have any doubts, they should consult the prescribing doctor. If any of the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Sertagen, inform your doctor. Furthermore, there are currently no data on the long-term safety of Sertagen in this age group regarding growth, puberty, cognitive development, and behavioural development.
Sertagen with other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans 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 together with the following medicines may cause serious
side effects:

Medicines that are monoamine oxidase inhibitors (MAOIs), e.g. moclobemide (used to treat depression), selegiline (used to treat Parkinson's disease), the antibiotic linezolid, or methylene blue. Do not take Sertagen together with MAO inhibitors.
Pimozide, a medicine used to treat psychiatric disorders. Do not take Sertagen together with pimozide.
Opioid medicines used to treat acute or chronic pain (e.g. buprenorphine) and opioid receptor antagonists that block the effects of opioids (e.g. naloxone). Do not take Sertagen together with opioids or opioid receptor antagonists. These medicines may interact with Sertagen and cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C. If the patient experiences such symptoms, contact a doctor.

The patient should inform the doctor or pharmacist if taking any of 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 last for 1–2 weeks
Products containing the amino acid tryptophan
Medicines used for anaesthesia or for treating chronic, severe pain (mivacurium, suxamethonium, and opioid medicines such as fentanyl)
Medicines used to treat severe pain (tramadol)
Medicines used to treat migraine (e.g. sumatriptan)
Medicines that prevent blood clotting (warfarin, ticlopidine)
Medicines used to treat pain/joint inflammation (non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, acetylsalicylic acid (aspirin))
Metamizole, a medicine used to treat pain and fever
Diuretic medicines
Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine)
Medicines used to treat diabetes (tolbutamide)
Medicines used to treat excess stomach acid, peptic ulcer disease, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole)
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 psychiatric disorders (such as 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 infection and hepatitis C (protease inhibitors such as ritonavir, telaprevir)
Medicines used to treat fungal infections (such as 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 (rifampicin)
Medicines affecting heart rhythm (e.g. certain antipsychotics such as haloperidol or antibiotics such as levofloxacin)

Sertagen, food and alcohol
Do not consume alcohol during treatment with Sertagen. Sertagen should not be taken with grapefruit juice, as this may increase the level of sertraline in the blood.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The safety of sertraline use in pregnant women has not been fully established. The medicine may be used in pregnant women only if, in the doctor's opinion, the benefits to the mother outweigh the potential risks to the foetus. Women of childbearing potential taking sertraline should use an effective method of contraception.
Inform your midwife and (or) doctor that you are taking Sertagen. Medicines such as Sertagen taken during pregnancy, especially during the last three months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and cyanosis (bluish skin). These symptoms usually occur within 24 hours after birth. If they occur in the baby, contact your midwife and (or) doctor immediately.
Other complications may also occur in the newborn, which usually appear within the first 24 hours after birth. Symptoms include:

breathing difficulties
cold or hot skin, bluish skin
blue lips
vomiting or feeding problems
excessive tiredness, difficulty sleeping, or constant crying
muscle stiffness or floppiness
tremor, muscle twitches, or seizures
increased reflexes
irritability
low blood sugar levels

If any of these symptoms occur in the baby after birth or if the baby's condition is concerning, seek medical advice from a doctor or midwife.
Taking Sertagen towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Sertagen, she should inform her doctor or midwife so they can provide appropriate advice.
There is evidence that sertraline passes into human milk. The medicine may be used in breastfeeding women if, in the doctor's opinion, the benefits to the mother outweigh the potential risks to the infant.
Animal studies have shown that some medicines similar to sertraline may reduce semen quality. This could theoretically affect fertility, although no effect on human fertility has been observed to date.
Driving and operating machinery
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. Do not drive or operate machinery until you know how the medicine affects your ability to perform these activities.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Sertagen

This medicine should always be taken exactly as prescribed by your doctor or pharmacist.
Sertagen may be taken with meals or independently of food intake.
The tablets should be taken once daily, in the morning or in the evening. Tablets may be divided into equal doses.
Some people may notice an unusual odor and/or taste of this medicine. This is a normal phenomenon, and these sensations may be reduced by drinking a glass of water immediately after placing the tablet in the mouth.
If in doubt, consult your doctor or pharmacist.

Recommended dosage:
Adults:
Depression and obsessive-compulsive disorder (OCD):
The recommended effective dose for treatment of depression and OCD is 50 mg per day. 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 PTSD should begin with a dose of 25 mg per day, increasing after one week to 50 mg per day.
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:
Sertagen may be used in children and adolescents aged 6 to 17 years only for the treatment of obsessive-compulsive disorder (OCD).

Obsessive-compulsive disorder (OCD):
Children aged 6 to 12 years: The recommended initial dose 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.
Adolescents aged 13 to 17 years: The recommended initial dose is 50 mg per day. The maximum dose is 200 mg per day.

Patients with impaired liver or kidney function should inform their doctor and follow medical advice.
Your doctor will inform you how long you should continue taking this medicine. The duration of treatment depends on the type of illness and your individual response to therapy. Improvement in symptoms may not begin until several weeks after starting treatment.

Taking more Sertagen than recommended
If you accidentally take too much Sertagen, contact your doctor immediately or go to the nearest hospital emergency department. Always bring the medicine packaging and label with you, 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.

If you miss a dose of Sertagen
If you forget to take a tablet, do not take the missed dose. Simply take the next tablet at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Sertagen
Do not stop taking Sertagen unless your doctor advises you to do so. Your doctor should gradually reduce the dose of Sertagen over several weeks before you stop taking it completely.
If you stop taking Sertagen suddenly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and muscle tremors.
If you experience any of these or other adverse effects after stopping Sertagen, consult your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
You should inform your doctor immediately if:
Any of the following symptoms occur in the patient after taking this medicine (because
they may be serious).
Uncommon (may affect 1 in 100 people):

seizures
depressive symptoms with suicidal thoughts and behaviours. These symptoms have been reported during treatment with sertraline or shortly after discontinuation of treatment (see section 2)
blood in stool, tarry stools
unexpected and atypical (e.g. very strong) vaginal bleeding
bleeding disorders (e.g. bleeding from the stomach – which may look like coffee grounds)
inability to pass urine

Rare (may affect 1 in 1000 people):

allergic reaction or allergy, which may include symptoms such as itchy, raised skin rash (urticaria), difficulty breathing, wheezing or sudden swelling of the eyelids, face or lips
heart attack
loss of consciousness (coma)
severe stomach and abdominal pain, bloating and high fever. This may indicate diverticulitis, an inflammation or infection of pouches in the intestinal lining. Presence of fresh blood in stool (hematochezia)
disturbances in blood sugar control (diabetes)
glaucoma (increased pressure in the eyeball), which may cause severe eye pain, redness of the eye, or "halo" or "blurred" vision
very slow breathing
severe muscle pain, weakness or swelling (due to muscle breakdown – rhabdomyolysis)
severe skin rash causing blistering (blisters may appear in the mouth, on the tongue or in the genital area). These may be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In such cases, the doctor will discontinue treatment
agitation, confusion, diarrhoea, high temperature and blood pressure, excessive muscle stiffness, sweating and increased 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 discontinue 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 sputum or worsening shortness of breath
yellowing of the skin and eyes, which may indicate liver damage
pancreatitis with severe pain in the upper abdomen, often accompanied by nausea or vomiting
if the patient develops motor restlessness and cannot sit or stand still after taking Sertagen. If the patient experiences motor restlessness, they should inform their doctor
occurrence of a manic episode (see section 2 "Warnings and precautions")
lower than normal sodium levels in the blood, which may cause weakness, confusion or muscle pain. This may be due to inappropriate secretion of a hormone (ADH), which causes water retention and dilution of the blood, reducing sodium levels
decreased number of white blood cells, which help fight infections (infections may occur more frequently, e.g. sore throat, mouth ulcers and fever)
changes in heart rhythm, which may be visible on ECG (indicating serious changes such as QT interval prolongation or ventricular tachycardia of the torsade de pointes type)

The following other adverse reactions have been observed in clinical trials and after marketing in adult patients.
Very common (may affect more than 1 in 10 patients):

insomnia (sleep problems), dizziness, drowsiness, headache, diarrhoea, nausea, dry mouth, ejaculation disorders, fatigue

Common (may affect 1 in 10 patients):

cold, runny nose
sore throat, decreased or increased appetite
depression, "strange" feelings, malaise (general feeling of being unwell), nightmares, anxiety, agitation, nervousness, reduced interest in sex, teeth grinding
numbness and tingling, muscle twitching, increased muscle tension, taste disturbances, lack of attention
vision disturbances, ringing in the ears
palpitations, hot flushes, yawning
abdominal pain, vomiting, constipation, stomach disturbances such as indigestion or heartburn, passing gas
rash, increased sweating, muscle or joint pain, erection problems, chest pain
back pain, muscle twitching, abnormal contraction of neck, upper limbs or trunk muscles
irregular menstruation, sexual disturbances
fever, weakness
weight gain
injuries

Uncommon (may affect 1 in 100 patients):

intestinal problems
tumour
seasonal allergy
hallucinations (seeing, hearing and feeling things that do not exist), feeling of euphoria, emotional blunting, thought disturbances, aggression, psychotic disorders, paranoia (a mental disorder characterised by extreme suspicion)
involuntary muscle contractions, coordination disturbances, increased activity, memory loss (amnesia), reduced sensation, speech disturbances, dizziness upon standing, fainting, migraine
ear pain, increased heart rate, high blood pressure, hot flushes, swelling of arms and legs
shortness of breath, nosebleeds, breathing difficulties, wheezing, swallowing problems, difficulty swallowing, haemorrhoids, increased salivation, tongue disorders, dental diseases, belching
dilated pupils, purple spots on the skin, facial and periorbital swelling, hair loss, cold sweats, dry skin, itchy skin, urticaria, skin inflammation
degenerative joint disease, muscle weakness, muscle cramps, abnormal movements, difficulty moving
nocturnal urination, increased urine output, increased frequency of urination, difficulty urinating, urinary incontinence
heavy and prolonged menstruation (excessive menstrual bleeding)
chills, increased thirst, increased liver enzyme levels, weight loss
decreased thyroid hormone levels

Rare (may affect 1 in 1000 patients):

gland swelling, high cholesterol levels, low blood glucose levels
decreased number of platelets (may result in increased tendency to bleed or bruise)
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, light sensitivity, blood in the eye, unequal pupil size, abnormal vision, tear secretion disorders
slow heart rate, other heart problems, worsening of blood circulation in the upper and lower limbs, rapid or loud breathing, very slow breathing, difficulty speaking, 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 pain, tongue ulceration, mouth ulceration, liver disorders
skin disorders with blister formation, rash around hair follicles, abnormal hair structure, abnormal skin odour, bone disorders, skin reaction to sunlight
in patients taking this type of medicine, an increased risk of bone fractures has been observed
presence of blood in urine, reduced urine output, delayed urination
endocrine disorders, low blood salt (sodium) levels, increased blood sugar levels (hyperglycaemia), abnormal laboratory test results
vaginal dryness, painful red penis and foreskin, vaginal discharge, prolonged penile erection, nipple discharge, breast enlargement
hernia, decreased drug tolerance, abnormal semen analysis results, vasodilation

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

partial loss of vision
trismus (partial or complete inability to open the mouth)
colitis (causing diarrhoea)
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and effects on fertility" in section 2
muscle weakness and severe muscle pain, which may be symptoms of a disorder resembling glutaric aciduria type II

Additional adverse reactions in children and adolescents:
In clinical trials involving children and adolescents, adverse reactions were generally similar
to those occurring in adults (see above). After sertraline was introduced to the market,
bedwetting has also been reported. The most commonly occurring adverse reactions in children and adolescents
were: headache, insomnia, diarrhoea and nausea.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions 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.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Sertagen

Keep this medicine 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, following "EXP".
The expiry date refers to the last day of the specified month.
Medicines must 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 Sertagen contains

The active substance is sertraline hydrochloride. Each tablet contains 50 mg or 100 mg of sertraline.
Other ingredients are: microcrystalline cellulose (Avicel PH 101), calcium hydrogen phosphate, microcrystalline cellulose (Avicel PH 102), sodium carboxymethyl starch (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 coated tablets:
White or almost white, capsule-shaped coated tablets, marked with "ST/50" on one side and "G" on the other side.
Sertagen 100 mg coated tablets:
White or almost white, capsule-shaped coated tablets, marked with "ST/100" on one side and "G" on the other side.
Sertagen 50 mg and 100 mg tablets are available in blister packs containing 28 coated tablets.

Marketing Authorisation Holder:
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer:
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1.
Hungary

For further information about this medicinal product and its names in the European Economic Area countries, please contact the representative of the marketing authorisation holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00