Patient Information Leaflet

Sertralina Medreg 50 mg film-coated tablets, 100 mg film-coated tablets

sertraline
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What this leaflet contains

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

1. What Sertralina Medreg is and what it is used for

Sertralina Medreg contains the active substance sertraline. Sertraline belongs to a group of
medicines known as Selective Serotonin Reuptake Inhibitors (SSRIs); these medicines
are used to treat depression and/or anxiety disorders.
Sertralina Medreg can 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 to 17 years)

Depression is a clinical illness with symptoms such as feeling sad, inability to sleep properly, or inability to enjoy life as one used to.
OCD and panic disorder are anxiety-related conditions with symptoms such as persistent, intrusive worries (obsessions) that lead to performing ritualistic actions (compulsions).
PTSD is a condition that may occur following an emotionally traumatic experience, and some symptoms of this condition are similar to those of depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense feelings of anxiety or distress in social situations (e.g. speaking to strangers, speaking in public, eating or drinking in front of others, or fear of behaving in an embarrassing way).
Your doctor has determined that this medicine is suitable for treating your condition.
Ask your doctor if you are unsure why Sertralina Medreg has been prescribed for you.

2. What you should know before taking Sertralina Medreg

Do not take Sertralina Medreg

if you are allergic to sertraline or to any of the other ingredients of this medicine (listed in section 6).
if you are taking or have recently taken medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or medicines with MAOI-like activity (such as linezolid). If you stop treatment with sertraline, you must wait at least one week before restarting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least 2 weeks before starting treatment with sertraline.
if you are taking another medicine called pimozide (a medicine for mental disorders such as psychosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sertralina Medreg.
Medicines are not always suitable for everyone. Inform your doctor before taking Sertralina Medreg if you suffer or have previously suffered from any of the following conditions:

if you have epilepsy (epileptic seizures) or a history of seizures. If you experience an epileptic seizure (convulsion), contact your doctor immediately.
if you have suffered from bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
if you are having or have ever had thoughts of harming or killing yourself (see below - Suicidal thoughts and worsening of depression or anxiety disorder).
if you suffer from serotonin syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline (for symptoms, see section 4. Possible side effects). Your doctor will determine whether you have previously experienced this condition.
if you have low levels of sodium in the blood, as this condition may occur as a result of treatment with Sertralina Medreg. You should also inform your doctor if you are taking certain medicines for high blood pressure, as these may also alter sodium levels in the blood.
if you are elderly, as you are at higher risk of low sodium levels in the blood (see above).
if you have liver disease: your doctor may decide to prescribe you a lower dose of Sertralina Medreg.
if you have diabetes: blood glucose levels may be altered due to treatment with Sertralina Medreg, and it may be necessary to adjust the dose of your diabetes medicines.
if you have a history of bleeding problems (tendency to bruise easily), or if you are pregnant (see Pregnancy, breastfeeding and fertility) or if you are taking medicines that thin the blood (e.g. acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding.
if you are a child or adolescent under 18 years of age. Sertralina Medreg should only be used to treat children and adolescents aged 6 to 17 years suffering from obsessive-compulsive disorder (OCD). If you are being treated for this disorder, your doctor will want to monitor you closely (see below Children and adolescents).
if you are undergoing electroconvulsive therapy (ECT).
if you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
if you have been diagnosed with an abnormality in your electrocardiogram (ECG) known as QT interval prolongation.
if you have heart disease, low potassium or magnesium levels, a family history of QT interval prolongation, slow heart rate, or are taking concomitant medicines that prolong the QT interval.

Restlessness/Akathisia
The use of sertraline has been associated with distressing restlessness and an urge to move, often accompanied by an inability to sit still or remain motionless (akathisia). This condition is more likely to occur during the first few weeks of treatment. Increasing the dose may be harmful for patients who develop these symptoms; therefore, discuss this with your doctor if it occurs.
Withdrawal reaction
Adverse effects related to stopping treatment (withdrawal reactions) are common, especially if treatment is stopped abruptly (see section 3 - If you stop taking Sertralina Medreg and section 4 - Possible side effects). The risk of withdrawal reactions depends on the duration of treatment, the dosage, and the extent of dose reduction. Generally, these symptoms are mild to moderate in intensity. However, in some patients, they may be severe. They usually occur within the first few days after stopping treatment. In general, these symptoms resolve on their own within 2 weeks. In some patients, they may last longer (2-3 months or more). When stopping treatment with sertraline, it is recommended to gradually reduce the dose over a period of several weeks or months. Always talk to your doctor to determine the best way to discontinue treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming or killing yourself.
These thoughts may worsen when you first start taking antidepressants, as all these medicines require time to become effective, usually about 2 weeks but sometimes longer.
You are more likely to have such thoughts if:

you have previously thought about killing yourself or harming yourself.
you are a young adult. Available data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric conditions treated with an antidepressant. If at any time you have thoughts of harming or killing yourself, contact your doctor or go immediately to the nearest hospital.

It may be helpful to inform a close family member or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them to monitor whether your depression or anxiety disorder is worsening or whether they are concerned about changes in your behaviour.
Sexual problems
Medicines such as Sertralina Medreg (so-called selective serotonin reuptake inhibitors (SSRIs)) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.
Children and adolescents
Sertraline should not routinely be used in children and adolescents under 18 years of age, except for patients with Obsessive-Compulsive Disorder (OCD). Patients under 18 years of age have a higher risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostile behaviour (mainly aggression, oppositional behaviour, and anger) when treated with this class of medicines. However, your doctor may decide to prescribe Sertralina Medreg to a patient under 18 years of age if it is in the patient's best interest. If your doctor has prescribed Sertralina Medreg to you and you are under 18 years of age and wish to discuss this decision with your doctor, please contact them. Furthermore, if any of the symptoms listed above appear or worsen while a patient under 18 years of age is being treated with Sertralina Medreg, you must inform the doctor.
The long-term safety of Sertralina Medreg on growth, maturation, learning ability (cognitive development), and behavioural development has been evaluated in a long-term study involving more than 900 children aged 6 to 16 years who were monitored for a period of 3 years. Overall, the study results showed that children treated with sertraline had normal development, except for a slight increase in weight in those treated with a higher dose.
Other medicines and Sertralina Medreg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the activity of Sertralina Medreg, or Sertralina Medreg may reduce the effectiveness of other medicines taken simultaneously.
Taking Sertralina Medreg with the following medicines may cause serious adverse events:

medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methemoglobin in the blood). Do not use Sertralina Medreg together with these medicines.
medicines for the treatment of mental disorders such as psychosis (pimozide). Do not use Sertralina Medreg together with pimozide.

Inform your doctor if you are taking any of the following medicines:

medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
herbal medicines containing St. John's wort ( Hypericum perforatum ). The effects of St. John's wort may last for 1-2 weeks.
products containing the amino acid tryptophan
medicines for the treatment of severe or chronic pain (opioids such as tramadol, fentanyl)
medicines used in anaesthesia (e.g. fentanyl, mivacurium, and suxamethonium)
medicines for the treatment of migraine (e.g. sumatriptan)
medicines to thin the blood (warfarin)
medicines for the treatment of pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin))
sedatives (diazepam)
diuretics
medicines for the treatment of epilepsy (phenytoin, phenobarbital, carbamazepine)
medicines for the treatment of diabetes (tolbutamide)
medicines for the treatment of excess stomach acid, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole)
medicines for the treatment of mania and depression (lithium)
other medicines for the treatment of depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine)
medicines for the treatment of schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine)
medicines used for the treatment of high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, and propafenone)
medicines used for the treatment of bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin)
medicines used for the treatment of fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole)
medicines used for the treatment of HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir)
medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant)
medicines known to increase the risk of changes in the heart's electrical activity (e.g. certain antipsychotics and antibiotics)

Sertralina Medreg with food, drinks and alcohol
Sertralina Medreg tablets may be taken with or without food.
Alcohol consumption should be avoided during treatment with Sertralina Medreg.
Sertraline should not be taken together with grapefruit juice, as this may increase sertraline levels in the body.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline should be administered to pregnant women only if the doctor considers that the benefit to the mother outweighs any possible risk to the developing baby.
If you take Sertralina Medreg near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders. Inform your doctor or midwife that you are taking Sertralina Medreg so they can advise you on what to do. When taken during pregnancy, particularly during the last three months, medicines such as Sertralina Medreg may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the newborn to breathe rapidly and have a bluish skin colour. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.
Your baby may also experience other conditions, which usually begin within the first 24 hours after birth. Symptoms include:

breathing difficulties
bluish skin colour or being too hot or too cold
blue lips
vomiting or feeding difficulties
being very tired, unable to sleep, or crying excessively
stiff or floppy muscles
tremors, nervousness, jerks
increased reflex responses
irritability
low blood sugar levels

If your newborn shows any of the symptoms listed above, or if you have any concerns about your baby's health, contact your doctor or midwife, who will be able to advise you.
There is evidence that sertraline is excreted in human breast milk. Sertraline should be used during breastfeeding only if the doctor considers that the benefit to the mother outweighs any possible risk to the baby.
In animal studies, some medicines like sertraline may reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.
Driving and using machines
Psychotropic medicines such as sertraline may affect your ability to drive vehicles or operate machinery. Therefore, you should not drive or operate machinery until you know whether this medicine affects your ability to perform these activities.
Sertralina Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Sertralina Medreg

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults
Depression and Obsessive-Compulsive Disorder
For depression and OCD, the usual effective dose is 50 mg/day. The daily dose may be
increased 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
For panic disorder, social anxiety disorder and post-traumatic stress disorder, treatment
should start at a dose of 25 mg/day, which should then be increased to 50 mg/day after one week.
The daily dose may then be increased by 50 mg over several weeks. The maximum recommended dose is 200 mg/day.
Use in children and adolescents
Sertralina Medreg should only be used for the treatment of children and adolescents aged
6 to 17 years with Obsessive-Compulsive Disorder (OCD).
Obsessive-Compulsive Disorder
Children aged 6-12 years: the recommended initial dose is 25 mg/day.
After one week, your doctor may increase the dose to 50 mg/day. The maximum dose is 200 mg/day.
Adolescents aged 13-17 years: the recommended initial dose is 50 mg/day. The maximum dose is
200 mg/day.
If you have problems with your liver or kidneys, inform your doctor and follow the instructions given by your doctor.
Method of administration
Sertralina Medreg tablets may be taken with or without food.
Take the medicine once daily, in the morning or in the evening.
Your doctor will tell you how long you should take this medicine. This depends on the duration of the
illness and your response to treatment. It may take several weeks before symptoms begin to improve.
Treatment for depression should usually continue for 6 months after improvement is observed.
If you take more Sertralina Medreg than you should
If you accidentally take an excessive dose of Sertralina Medreg, contact your doctor immediately or go
to the nearest emergency room. Always carry a package of the medicine with you, whether or not it still contains any medicine.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and in rare cases loss of consciousness.
If you forget to take Sertralina Medreg
Do not take a double dose to make up for the forgotten dose. If you forget to take a dose, do not take the missed dose. Take the next dose at the correct time.
If you stop taking Sertralina Medreg
Do not stop treatment with Sertralina Medreg unless your doctor tells you to. Your
doctor may wish to gradually reduce the dose of Sertralina Medreg over several weeks
before stopping the medicine completely. If you stop taking this medicine suddenly, you may experience unwanted effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremors. If you experience any of these unwanted effects, or any other unwanted effects during treatment with Sertralina
Medreg, talk to your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Nausea is the most common side effect. Side effects depend on the dose and often disappear or decrease with continued treatment.

Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious:

If you develop a severe skin rash causing blistering (erythema multiforme) (which may affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In such cases, your doctor will discontinue treatment.
Allergic reactions or allergies, which may include symptoms such as an itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
If you experience agitation, confusion, diarrhoea, high fever and high blood pressure, excessive sweating and rapid heartbeat. These are symptoms of Serotonin Syndrome. Rarely, this syndrome may occur when certain medicines are taken together with sertraline. Your doctor may decide to discontinue treatment.
If you develop yellowing of the skin and eyes, which may indicate liver damage.
If you develop depressive symptoms with thoughts of harming yourself or suicide (suicidal thoughts).
If you begin to feel restless and can no longer sit still or remain motionless after starting treatment with Sertralina Medreg. You must inform your doctor if you start feeling restless.
If you have seizures (epileptic fits).
If a manic episode occurs (see section 2 “Warnings and precautions”).

The following side effects have been observed in clinical studies conducted in adult patients and after marketing authorisation:

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

insomnia
dizziness, drowsiness, headache
diarrhoea, feeling unwell, dry mouth
absence of ejaculation
fatigue

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

bronchitis, sore throat, runny nose
decreased appetite, increased appetite
anxiety, depression, agitation, reduced sexual desire, nervousness, feeling strange, nightmares, teeth grinding
tremor, movement disorders (such as frequent movements, tense muscles, difficulty walking and stiffness, spasms and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of attention, altered taste
vision disturbances
ringing in the ears
palpitations
hot flushes
yawning
stomach discomfort, constipation, abdominal pain, vomiting, gas in the stomach
increased sweating, rash
back pain, joint pain, muscle pain
menstrual irregularities, erectile dysfunction
malaise, chest pain, weakness, fever
weight gain
injuries

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

intestinal problems, ear infections
tumour
hypersensitivity, seasonal allergy
low levels of thyroid hormones
suicidal thoughts, suicidal behaviour*, psychotic disorders, abnormal thoughts, lack of self-care, hallucinations, aggression, euphoric mood, paranoia
amnesia, reduced sensations, involuntary muscle contractions, fainting, excessive movements, migraine, seizures, dizziness upon standing, coordination disturbances, speech disorders
dilated pupils
ear pain
rapid heartbeat, heart problems
bleeding problems (such as stomach bleeding)*, high blood pressure, hot flushes, blood in urine
shortness of breath, nosebleeds, difficulty breathing, possible wheezing
tarry stools, dental problems, oesophagitis, tongue disorders, haemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders
eye swelling, urticaria, hair loss, itching, development of purplish spots on the skin, skin disorders with blistering, dry skin, facial oedema, cold sweats
osteoarthritis, muscle contractions, muscle cramps*, muscle weakness
increased frequency of urination, difficulty urinating, inability to urinate, urinary incontinence, increased urine volume, nocturnal urination
sexual dysfunction, excessive vaginal bleeding, vaginal haemorrhage, female sexual dysfunction
leg swelling, chills, difficulty walking, thirst
increased liver enzyme levels, weight loss
cases of suicidal ideation and suicidal behaviour have been reported in patients treated with sertraline or immediately after discontinuation of treatment (see section 2)

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

diverticulitis, swollen glands, reduced number of platelets (cells responsible for blood clotting)*, reduced number of white blood cells*
severe allergic reaction
endocrine disorders*
elevated cholesterol levels, problems controlling blood sugar levels (diabetes), low blood sugar levels, increased blood sugar levels*, low blood sodium levels*
physical symptoms due to stress or emotions, disturbing nightmares*, drug dependence, sleepwalking, premature ejaculation
coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headaches (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS))*, disturbance of consciousness
appearance of spots in front of the eyes, glaucoma, double vision, light sensitivity, presence of blood in the eye, unequal pupil size*, altered vision*, tear production problems
heart attack, dizziness, fainting or chest pain, which could be signs of changes in the heart's electrical activity (as seen on electrocardiogram) or abnormal heart rhythm*, slow heartbeat
poor blood circulation to arms and legs
rapid breathing, progressive scarring of lung tissue (Interstitial Lung Disease)*, throat closure, difficulty speaking, slow breathing, hiccups
a type of lung disease in which eosinophils (a type of white blood cells) appear in increased numbers in the lungs (eosinophilic pneumonia)
mouth ulceration, pancreatitis*, blood in stools, tongue ulceration, mouth pain
liver function problems, severe liver function problems*, yellowing of the skin and eyes (jaundice)*
skin reaction to sunlight*, skin oedema*, changes in hair structure, altered skin odour, inflammation of hair follicles
muscle tissue rupture*, bone disorders
initial difficulty urinating, reduced urination
breast secretion, dryness of the vaginal area, genital discharge, red and painful penis and foreskin, breast enlargement*, prolonged erection
hernia, reduced tolerance to the medicine
increased cholesterol in blood, changes in laboratory test results*, changes in seminal fluid, coagulation problems*
procedure for relaxing blood vessels

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

jaw locking*
enuresis*
partial loss of vision
inflammation of the colon (causing diarrhoea)*
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see Pregnancy, breastfeeding and fertility in section 2 for further information*

* Side effect reported after marketing authorisation.

Side effects in children and adolescents
In clinical studies in children and adolescents, side effects were generally similar to those observed in adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhoea and nausea.

Symptoms that may occur when treatment is stopped
If you stop treatment with this medicine suddenly, you may experience side effects such as dizziness, tingling, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremor (see section 3 “If you stop taking Sertralina Medreg”).

An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sertralina Medreg

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after
"Exp" or "EXP". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sertralina Medreg contains

The active substance is sertraline. Each film-coated tablet contains sertraline hydrochloride equivalent to 50 mg or 100 mg of sertraline.
The other excipients are:
Tablet core: anhydrous calcium hydrogen phosphate, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (type A), magnesium stearate
Film coating: hypromellose, titanium dioxide (E171), polyethylene glycol 400, polysorbate 80

Description of the appearance of Sertralina Medreg and the contents of the pack
Sertralina Medreg 50 mg:
Film-coated tablets, biconvex, white to almost white, capsule-shaped, approximately 10.4 x 4.2 ± 0.2 mm, with a score line on one side and the imprint “50” on the scored side.
The tablet can be divided into equal doses.
Sertralina Medreg 100 mg:
Film-coated tablets, biconvex, white to almost white, capsule-shaped, approximately 13.2 x 5.3 ± 0.2 mm, with the imprint “100” on one side.
The film-coated tablets are supplied in opaque PVC/Al blisters packed in cardboard cartons.
Pack sizes: 10, 14, 28, 30, 84, 90, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Manufacturer:
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Sertralina Medreg
Poland: Sertraline Medreg
Czech Republic: Sertraline Medreg
Romania: Sertralină Gemax Pharma 50 mg comprimate filmate
Sertralină Gemax Pharma 100 mg comprimate filmate
Slovakia: Sertraline Medreg 50 mg
Sertraline Medreg 100 mg