Package leaflet: Information for the patient

Sertraline Medreg, 50 mg, coated tablets
Sertraline Medreg, 100 mg, coated tablets
Sertralinum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

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

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

Sertraline Medreg contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin re-uptake inhibitors (SSRIs). These medicines are used in the treatment of depressive and/or anxiety disorders.
Sertraline Medreg may be used to treat:

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

Depression is a clinical illness characterized by symptoms such as sadness, sleep disturbances, or loss of pleasure in life.
OCD and panic disorder are anxiety-related conditions involving persistent worry due to intrusive thoughts (obsessions), leading to repetitive rituals (compulsions).
PTSD is a condition that may occur following a traumatic experience and is characterized by certain symptoms similar to depression and anxiety.
Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense fear or anxiety in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in the presence of others, or fear of potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for treating your condition.
You should consult your doctor if you are unsure why you are taking Sertraline Medreg.

2. Important information before using Sertraline Medreg

When not to use Sertraline Medreg

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 medicines similar to MAO inhibitors (e.g. linezolid). After stopping treatment with sertraline, at least one week must elapse before starting treatment with an MAO inhibitor. After stopping treatment with an MAO inhibitor, at least two weeks must elapse before starting treatment with sertraline.
if the patient is taking pimozide (a medicine used to treat psychiatric disorders such as psychosis).

Warnings and precautions
Before starting treatment with Sertraline Medreg, discuss this with your doctor or pharmacist.
Medicines are not always suitable for everyone. Before starting treatment with Sertraline Medreg, consult your doctor or pharmacist if the patient currently has or has previously had any of the following conditions:

if the patient has epilepsy or a history of seizures. If a seizure occurs, contact a doctor immediately.
if the patient has had bipolar disorder (manic-depressive illness) or schizophrenia. If a manic episode occurs, contact a doctor immediately.
if the patient currently has or has previously had suicidal thoughts (see below – suicidal thoughts and worsening of depression or anxiety).
if the patient has serotonin syndrome. In rare cases, this syndrome may occur in patients taking other medicines concomitantly with sertraline. (Symptoms, see section 4. Possible side effects). The doctor should inform the patient whether they have previously experienced serotonin syndrome.
if the patient has low sodium levels in the blood, which may occur as a result of treatment with Sertraline Medreg. Inform the doctor about taking medicines used to treat high blood pressure, as these may also affect sodium levels in the blood.
if the patient is elderly; such patients may be more susceptible to low sodium levels in the blood (see above).
if the patient has liver disease; the doctor may decide to reduce the dose of Sertraline Medreg.
if the patient has diabetes; Sertraline Medreg may affect blood glucose levels, so a change in the dosage of antidiabetic medicines may be necessary.
if the patient has previously had bleeding disorders (tendency to bruise) or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility") or has previously taken medicines that prevent blood clotting (e.g. acetylsalicylic acid (aspirin) or warfarin) or medicines that may increase the risk of bleeding.
if the patient is a child or adolescent under 18 years of age. Sertraline Medreg may be used in children and adolescents aged 6 to 17 years only for the treatment of obsessive-compulsive disorder. Patients being treated for this condition should be closely monitored by a doctor (see below "Children and adolescents").
if the patient is undergoing electroconvulsive therapy (ECT).
if the patient has eye problems, such as certain types of glaucoma (increased eye pressure).
if the patient has been diagnosed with abnormalities in the heart's electrical activity on electrocardiogram (ECG), known as prolonged QT interval.
if the patient has heart disease, low potassium or low magnesium levels, a family history of prolonged QT interval, slow heart rate, and is taking medicines that prolong the QT interval.

Psychomotor agitation/Akathisia
Treatment with sertraline has been associated with the development of a condition characterised by motor restlessness 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 may be harmful; therefore, if such symptoms occur, consult your doctor.
Abnormalities in urine screening tests
Sertraline may affect the results of urine tests for benzodiazepines. Inform your doctor if the patient is to undergo such a test.
Withdrawal symptoms
Adverse reactions related to discontinuation of treatment (withdrawal symptoms) are common, especially if treatment is stopped abruptly (see section 3. Discontinuing Sertraline Medreg and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dosage, and rate of dose reduction. These symptoms are generally mild or moderate in intensity, but in some patients they may be severe. They usually occur within the first few days after stopping treatment. They usually resolve spontaneously within 2 weeks, but in some patients they may persist longer (for 2-3 months or more).
If a decision is made to discontinue treatment with sertraline, it is recommended to gradually reduce the dose over several weeks or months, and the best way to discontinue treatment should always be discussed with a doctor.
Suicidal thoughts, worsening of depression or anxiety disorders
People who have depression and (or) anxiety disorders may sometimes have thoughts about self-harm or suicide. Such symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take at least 2 weeks to start working, and sometimes longer.
The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

the patient has previously had suicidal thoughts or self-harm tendencies.
the patient is a young adult; clinical trial data indicate an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders who are treated with antidepressants. If the patient experiences suicidal thoughts or thoughts of self-harm, contact a doctor immediately or go to 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 family members or friends for help and ask them to inform him or her if they notice that the depression or anxiety has worsened or if there are disturbing changes in behaviour.
Sexual dysfunction
Medicines such as Sertraline Medreg (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Children and adolescents
Sertraline should generally not be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age, an increased risk of adverse reactions such as suicide attempts, thoughts of killing oneself (suicidal thoughts) and hostility (mainly aggressive behaviour, oppositional behaviour and anger) has been observed during treatment with medicines from this group. However, a doctor may decide to prescribe Sertraline Medreg to a patient under 18 years of age if it is in the patient's best interest. If a doctor prescribes Sertraline Medreg to a patient under 18 years of age and the child's caregiver wishes to discuss this, contact the doctor. Furthermore, if any of the symptoms listed above appear or worsen during treatment with Sertraline Medreg in a patient under 18 years of age, inform the doctor. In a long-term observational study lasting 3 years involving over 900 children aged 6 to 16 years, the long-term safety of sertraline was evaluated with regard to its effects on growth, maturation, learning (cognitive functions) and behaviour. Overall, the study results showed that children treated with sertraline developed normally, except for a slightly reduced weight gain in children treated with higher doses.
Sertraline Medreg and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect how Sertraline Medreg works, or Sertraline Medreg may reduce the effectiveness of other medicines taken at the same time.
Taking Sertraline Medreg together with the following medicines may cause serious adverse effects:

monoamine oxidase inhibitors (MAO inhibitors), e.g. moclobemide (used to treat depression) and 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 take Sertraline Medreg together with MAO inhibitors.
medicines used to treat psychiatric disorders such as psychosis (pimozide). Do not take Sertraline Medreg together with pimozide.

The patient should inform the doctor if they are taking any of the following medicines:

medicines containing amphetamine (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 to treat severe or chronic pain (opioids such as tramadol, fentanyl, buprenorphine)
medicines used in anaesthesia (e.g. fentanyl, mivacurium and suxamethonium)
medicines used to treat migraine (e.g. sumatriptan)
medicines that prevent blood clotting (warfarin)
medicines used to treat joint pain/inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin))
metamizole, a medicine used to treat pain and fever
sedatives (diazepam)
diuretics (so-called water tablets)
medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine)
medicines used to treat diabetes (tolbutamide)
medicines used to treat excessive stomach acid secretion, peptic ulcer disease and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole)
medicines used to treat mania and depression (lithium)
other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine)
medicines used to treat schizophrenia and other psychiatric disorders (such as perphenazine, levomepromazine and olanzapine)
medicines used to treat high blood pressure, chest pain or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, propafenone)
medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin)
medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole)
medicines used to treat HIV/AIDS and hepatitis C virus infection (protease inhibitors such as ritonavir, telaprevir)
medicines used to prevent nausea and vomiting after chemotherapy (aprepitant)
medicines that increase the risk of changes in the heart's electrical activity (e.g. some antipsychotics and antibiotics).

Sertraline Medreg with food, drink and alcohol
Sertraline Medreg tablets can be taken with or without food.
During treatment with Sertraline Medreg, alcohol consumption should be avoided.
Do not take sertraline together with grapefruit juice, as this may lead to increased levels of sertraline in the body.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
The safety of sertraline use in pregnant women has not been fully established. Sertraline may be administered during pregnancy only if the doctor considers that the benefits to the patient outweigh the risks to the developing baby.
Taking Sertraline Medreg towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after childbirth, especially if the patient has a history of bleeding disorders. If the patient is taking Sertraline Medreg, she should inform her doctor or midwife so that appropriate advice can be provided.
The use of medicines such as Sertraline Medreg during pregnancy, particularly in the third trimester, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), characterised by rapid breathing and bluish skin colour in the baby. These symptoms usually occur within the first 24 hours after birth. If the baby develops any of these symptoms, contact the midwife or doctor immediately.
Other conditions may also occur in the newborn, which usually appear within the first 24 hours after birth. Symptoms may include:

difficulty breathing
bluish skin or skin that is too hot or too cold
blue lips
vomiting or difficulty feeding
extreme tiredness, insomnia or constant crying
increased or decreased muscle tension
tremors, muscle twitches or seizures
increased reflex responses
irritability
low blood sugar levels.

If the baby develops any of these symptoms after birth or if there is any concern about the baby's health, contact the doctor or midwife for advice.
There is evidence that sertraline passes into breast milk. Sertraline should be used in breastfeeding women only if, according to the doctor's assessment, the benefits to the mother outweigh the potential risks to the baby.
In animal studies, some medicines such as sertraline have been shown to reduce semen quality. This may theoretically affect fertility, but no effect on fertility has been observed in humans so far.
Driving and operating machinery
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. Therefore, do not drive or operate machinery until you know how this medicine affects your ability to perform these tasks.
Sertraline Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Sertraline Medreg

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Recommended dose:
Adults
Depression and obsessive-compulsive disorder
The usual effective dose in the treatment of depression and OCD is 50 mg/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/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
initiated at a dose of 25 mg/day, increasing to 50 mg/day after one week.
The daily dose may then be gradually increased by 50 mg at a time over several weeks. The maximum
recommended dose is 200 mg/day.
Use in children and adolescents
Sertraline Medreg may be used in the treatment of children and adolescents aged 6–17 years
exclusively for obsessive-compulsive disorder (OCD).
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 disease should inform their doctor and follow the doctor's advice.
Method of administration
Sertraline Medreg tablets may be taken with or without food.
The medicine should be taken once daily, either in the morning or in the evening.
Your doctor will inform you how long you should continue treatment. The duration of treatment
depends on the type of illness and your response to therapy. Improvement may take several weeks.
Treatment of depression should usually continue for 6 months after improvement is observed.
Taking more Sertraline Medreg than recommended
If you accidentally take too much Sertraline Medreg, contact your doctor immediately or go to the
nearest hospital emergency department.
Always take the medicine package and label with you, regardless of whether any medicine remains.
Symptoms of overdose may include drowsiness, nausea and vomiting, increased heart rate, tremor,
agitation, dizziness, and in rare cases, loss of consciousness.
Missed dose of Sertraline Medreg
Do not take a double dose to make up for a missed dose. If you forget to take a tablet, do not take the
missed tablet. Take the next dose at the usual time.
Stopping Sertraline Medreg
Do not stop taking Sertraline Medreg unless your doctor tells you to. Your doctor should gradually
reduce the dose of Sertraline Medreg over several weeks until you finally stop taking it. If you stop
taking this medicine suddenly, you may experience adverse effects such as dizziness, numbness,
sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremor. If you experience any
of these or any other adverse effects after stopping Sertraline Medreg, consult your doctor.
If you have any further 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.
The most commonly occurring side effect is nausea. Side effects depend on the
dose and often diminish or weaken as treatment continues.
You should inform your doctor immediately:
If any of the following symptoms occur in the patient after taking this medicine, as
they may be serious.

If the patient develops a severe skin rash causing 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 (TEN). In such cases, the doctor will discontinue treatment.
Allergic reaction or allergy, with symptoms such as itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
If the patient experiences: agitation, disorientation, diarrhoea, high temperature and blood pressure, excessive sweating and increased heart rate. These are symptoms of serotonin syndrome. In rare cases, this syndrome may occur when the patient is taking certain medicines at the same time as sertraline. The doctor may then discontinue the patient's treatment.
If the patient develops yellowing of the skin and whites of the eyes, which may indicate liver damage.
If the patient experiences symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
If, after starting treatment with Sertraline Medreg, the patient begins to feel restless and unable to sit or stand still. If the patient feels restless, they should inform their doctor.
If the patient has a seizure.
If the patient experiences a manic episode (see section 2. "Warnings and precautions").

The following side effects have been observed in clinical trials in adults and after
marketing:

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

insomnia
dizziness, drowsiness, headache
diarrhoea, nausea, dry mouth
ejaculation disorders
fatigue

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

cold symptoms, sore throat, runny nose
decreased appetite, increased appetite
anxiety, depression, agitation, decreased interest in sex, restlessness, strange feelings, nightmares, teeth grinding
tremor, movement problems (such as increased mobility, muscle tension, difficulty walking, and stiffness, spasms and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of concentration, taste disturbances
visual disturbances
tinnitus
palpitations
hot flushes
yawning
stomach discomfort, constipation, abdominal pain, vomiting, flatulence
increased sweating, rash
back pain, joint pain, muscle pain
irregular menstruation, erectile dysfunction
malaise, chest pain, weakness, fever
weight gain
injuries

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

gastrointestinal inflammation causing vomiting and diarrhoea (gastroenteritis), ear infection
tumour
hypersensitivity, seasonal allergy
decreased concentration of thyroid hormones
suicidal thoughts, suicidal behaviour*, psychotic disorders, thought disorders, emotional blunting, hallucinations, aggression, feeling of euphoria, paranoia
memory loss, reduced sensation, involuntary muscle contractions, fainting, increased mobility, migraine, convulsions, dizziness upon standing, coordination disturbances, speech disorders
dilated pupils
ear pain
rapid heartbeat, heart problems
bleeding problems (such as gastrointestinal bleeding)*, high blood pressure, sudden reddening of the skin, blood in urine
shortness of breath, nosebleeds, breathing difficulties, possible wheezing
tarry stools, dental problems, oesophagitis, tongue problems, haemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders
eye swelling, urticaria, hair loss, itching, purpuric skin spots, skin problems with blisters, dry skin, facial swelling, cold sweats
degenerative joint disease, muscle twitching, muscle spasms*, muscle weakness
increased frequency of urination, urination problems, inability to urinate, urinary incontinence, increased urination, nocturnal urination
sexual disorders, excessive vaginal bleeding, vaginal bleeding, sexual disorders in women
leg swelling, chills, difficulty walking, thirst
increased liver enzyme activity, weight loss
During treatment with sertraline or shortly after its discontinuation, cases of suicidal thoughts and behaviours have been reported (see section 2).

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

diverticulitis, lymph node swelling, decreased platelet count*, decreased white blood cell count*
severe allergic reaction
endocrine disorders*
high cholesterol levels, problems controlling blood sugar levels (diabetes), low blood sugar, high blood sugar*, low blood sodium levels*
physical symptoms caused by stress or emotions, frightening nightmares*, drug dependence, sleepwalking, premature ejaculation
stupor, abnormal movements, difficulty moving, increased sensitivity to touch, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome, RCVS)*, sensory disturbances
visual spots, glaucoma, double vision, light-sensitive eye pain, blood in the eye, unequal pupil size*, visual disturbances*, tearing problems
heart attack, dizziness, fainting or discomfort in the chest, which may be symptoms of changes in the heart's electrical activity (visible on electrocardiogram) or irregular heartbeat*, slow heart rate
poor circulation in arms and legs
rapid breathing, progressive lung tissue fibrosis (interstitial lung disease)*, throat obstruction, speech difficulties, slowed breathing, hiccups
a form of lung disease in which eosinophils (a type of white blood cell) appear in increased numbers in the lungs (eosinophilic pneumonia)
oral ulceration, pancreatitis*, blood in stool, tongue ulceration, mouth pain
liver function problems, severe liver function problems*, yellowing of the skin and whites of the eyes (jaundice)*
skin reaction to sunlight*, skin swelling*, abnormal hair structure, abnormal skin odour, rash of hairy skin
muscle tissue breakdown*, bone disorders
difficulty urinating, decreased urine output
nipple discharge, vaginal dryness, genital discharge, painful redness of the penis and foreskin, breast enlargement*, prolonged erection
hernia, decreased drug tolerance
increased blood cholesterol levels, abnormal laboratory test results*, abnormal semen analysis, blood clotting problems*
vasodilation

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

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

* Adverse reactions reported after marketing authorization.
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). The most commonly occurring adverse
reactions in children and adolescents were headache, insomnia, diarrhoea and nausea.
Symptoms occurring after discontinuation
After abrupt discontinuation of the medicine, adverse reactions such as dizziness,
numbness, sleep disturbances, agitation or anxiety, headache, nausea and tremor may occur (see section 3.
"Discontinuing treatment with Sertraline Medreg").
In patients taking this type of medicine, an increased risk of bone fractures has been observed.
Reporting of adverse reactions
If any adverse reactions occur, including any 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the representative of the responsible entity.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Sertraline Medreg

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Sertraline Medreg contains

The active substance is sertraline. Each coated tablet contains sertraline hydrochloride equivalent to 50 mg or 100 mg of sertraline.
Other ingredients are:
Tablet core: calcium hydrogen phosphate anhydrous (E341), microcrystalline cellulose (E460), hydroxypropylcellulose (E463), sodium carboxymethyl starch (type A), magnesium stearate (E572).
Tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521), polysorbate 80 (E433).

What Sertraline Medreg looks like and contents of the pack
Sertraline Medreg, 50 mg:
White or almost white, biconvex, film-coated capsules-shaped tablets, approximately 10.4 x 4.2 ± 0.2 mm in size, with a score line on one side and the imprint "50" on one side of the score line.
The tablet can be divided into equal doses.
Sertraline Medreg, 100 mg:
White or almost white, biconvex, film-coated capsules-shaped tablets, approximately 13.2 x 5.3 ± 0.2 mm in size, with the imprint "100" on one side.
Film-coated tablets are available in opaque PVC/aluminum blisters, packed in a cardboard box.
Pack sizes: 10, 14, 28, 30, 84, 90, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Manufacturer/Importer:
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

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

Sertraline medreg