SERTRALINA 50 mg Film-Coated Tablets

Зміст інструкції

1. Sertralina Medreg 50 mg film-coated tablets, 100 mg film-coated tablets
   1. What is Sertralina Medreg and what is it used for
   2. What you need to know before taking Sertralina Medreg
   3. How to take Sertralina Medreg
   4. Possible side effects
   5. How to store Sertralina Medreg
   6. Package contents and other information

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

sertralina

Generic medicine

Read this leaflet carefully before taking this medicine because 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Sertralina Medreg is and what it is used for
• 2. What you need to know before you take Sertralina Medreg
• 3. How to take Sertralina Medreg
• 4. Possible side effects
• 5. How to store Sertralina Medreg
• 6. Contents of the pack and other information

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

Sertralina Medreg contains the active ingredient 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.
Sertralina Medreg can be used to treat:

• depression and prevention of depressive relapses (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 between 6 and 17 years)

Depression is a clinical illness with symptoms such as feeling sad, inability to sleep properly or to enjoy life as you used to.
OCD and panic disorder are anxiety-related illnesses with symptoms such as being
constantly worried about persistent thoughts (obsessions) that make them perform ritual actions
(compulsions).
PTSD is a condition that can occur after an emotionally strong traumatic experience and
some symptoms of this condition are similar to depression and anxiety. Social anxiety disorder
(social phobia) is an anxiety-related illness. It is characterised by feelings of intense anxiety or
distress in social situations (e.g. talking to strangers, speaking in public, eating or drinking in
the presence of other people or the worry of behaving embarrassingly).
Your doctor has decided that this medicine is suitable for treating your condition.
Ask your doctor if you are not sure why Sertralina Medreg has been prescribed to you.

2. What you need to know before taking Sertralina Medreg

Do not take Sertralina Medreg

• if you are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
• if you are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or medicines with a similar action to MAOIs (such as linezolid). If you stop taking sertraline, you must wait at least one week before starting treatment with an MAOI again. 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. Tell your doctor before taking Sertralina Medreg, if
you suffer from or have previously suffered from any of the following conditions:

• if you suffer from epilepsy (seizures) or a history of convulsions. If you experience a seizure (convulsion), contact your doctor immediately.
• if you have suffered from manic-depressive disorder (bipolar disorder) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
• if you think you have or have ever thought about harming yourself or committing suicide (see below - Suicidal thoughts and worsening of depression or anxiety).
• if you suffer from serotonin syndrome. In rare cases, this syndrome can occur when taking certain medicines together with sertraline (for symptoms, see section 4. Possible side effects). Your doctor will tell you if you have suffered from this condition in the past.
• if you have low levels of sodium in your blood, because this condition can occur as a result of treatment with Sertralina Medreg. You should also tell your doctor if you are taking certain medicines for high blood pressure, as these medicines can also alter sodium levels in the blood.
• if you are elderly because you are at greater risk of low levels of sodium in the blood (see above).
• if you suffer from liver disease: your doctor may decide to prescribe you a lower dose of Sertralina Medreg.
• if you suffer from 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 develop bruises), or if you are pregnant (see Pregnancy, breastfeeding and fertility) or if you have taken medicines that make your blood thinner (e.g. acetylsalicylic acid (aspirin) or warfarin) or that can increase the risk of bleeding.
• if you are a child or adolescent under the age of 18. Sertralina Medreg should only be used to treat children and adolescents aged between 6 and 17 years who suffer from obsessive-compulsive disorder (OCD). If you are being treated for this disorder, your doctor will want to monitor you carefully (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 found to have an abnormality in your heart tracing following an electrocardiogram (ECG) known as prolongation of the QT interval.
• if you have heart disease, low levels of potassium or magnesium, a family history of prolongation of the QT interval, slow heart rate and are taking medicines that prolong the QT interval at the same time.

Restlessness/Akathisia
The use of sertraline has been associated with distressing restlessness and a need to move, often
associated with the inability to sit or stay still (akathisia). This condition is more likely to occur in the
early weeks of treatment. An increase in dose may be harmful to patients who develop these symptoms
therefore, in this case, talk to your doctor.

Drug discontinuation reaction
Adverse effects related to stopping treatment (discontinuation 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 discontinuation reactions depends on the duration of
treatment, the dosage and the extent of the dose reduction. Generally, these symptoms are mild-to-
moderate in intensity. However, in some patients they can be severe. They usually occur in the first few
days after stopping treatment. In general, these symptoms resolve on their own within 2 weeks. In some
patients they may have a longer duration (2-3 months or more). When stopping treatment with
sertraline, it is recommended to reduce the dose gradually over a period of several weeks or months,
always talk to your doctor to determine the best way to stop treatment.

Suicidal thoughts and worsening of depression or anxiety
If you are depressed and/or have anxiety disorders, you may sometimes think about harming yourself or
committing suicide. These thoughts may worsen when you take antidepressants for the first time, because
all these medicines take time to become effective, usually about 2 weeks but sometimes even longer.

You are more likely to have thoughts of this kind if:

• you have thought about killing yourself or harming yourself in the past.
• if you are a young adult. The available information from clinical studies has shown an increased risk of suicidal behavior in adults under the age of 25 with psychiatric conditions treated with an antidepressant. If at any time you think about harming yourself or committing suicide, contact your doctor or go to the nearest hospital immediately.

It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and
that they are worsening, or if they are concerned about changes in your behavior.

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, persistence of these
symptoms has been observed after discontinuation of treatment.

Children and adolescents
Sertraline should not usually be used in children and adolescents under the age of
18, except for patients with Obsessive Compulsive Disorder (OCD). Patients under the age of
18 have an increased risk of side effects, such as attempting suicide, thinking about harming
themselves or committing suicide (suicidal thoughts) and hostile behavior (mainly aggression,
oppositional behavior and anger) when treated with this class of medicines. However, it is possible
that the doctor may decide to prescribe Sertralina Medreg to a patient under the age of 18 if this is in
the patient's best interest. If your doctor has prescribed Sertralina Medreg and you are under 18 and
want to talk to the doctor about this decision, please contact him/her. Also, if any of the above
symptoms occur or worsen when a patient under the age of 18 is being treated with Sertralina
Medreg, you should tell your doctor. The long-term safety of Sertralina Medreg on growth,
maturation, learning ability (cognitive development) and behavioral development has been assessed
in a long-term study conducted on more than 900 children aged between 6 and 16 who have been
monitored for a period of 3 years. Overall, the study results showed that children treated with
sertraline had normal development, except for a slight weight gain in those who were treated with a
higher dose.

Other medicines and Sertralina Medreg
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Some medicines can affect the activity of Sertralina Medreg or Sertralina Medreg can
reduce the effectiveness of other medicines you are taking at the same time.
Taking Sertralina Medreg with the following medicines can cause serious adverse events:

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

Tell 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 medicine containing St. John's Wort ( Hypericum perforatum). The effects of St. John's Wort can last for 1-2 weeks.
• products containing the amino acid tryptophan
• medicines for the treatment of severe or chronic pain (opioids e.g. tramadol, fentanyl)
• medicines used in anesthesia (e.g. fentanyl, mivacurium and suxamethonium)
• medicines for the treatment of migraine (e.g. sumatriptan)
• medicines for thinning 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 to treat high blood pressure, chest pain or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide and propafenone)
• medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin)
• medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole)
• medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir)
• medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant)
• medicines known to increase the risk of changes in the electrical activity of the heart (e.g. some antipsychotics and antibiotics)

Sertralina Medreg with food, drinks and alcohol
Sertralina Medreg tablets can be taken with or without food.
Alcohol consumption should be avoided during treatment with Sertralina Medreg.
Sertraline should not be taken in combination with grapefruit juice, as this may
increase the levels of sertraline in the body

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The safety of sertraline has not been fully established in pregnant women. Sertraline
should only be administered to pregnant women if the doctor believes that the benefit
to the mother outweighs any possible risk to the development of the child.
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 suffer from
bleeding disorders. Inform your treating doctor or midwife/obstetrician that you are taking Sertralina
Medreg, so they can advise you on what to do. When taken during pregnancy, especially
during the last three months, medicines like Sertralina Medreg can increase the risk of a
serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN)
which causes rapid breathing and a bluish skin color in the newborn. These symptoms usually begin
within the first 24 hours after delivery. If this happens to your baby, contact
your midwife and/or doctor immediately.
Your baby may also experience other conditions, which generally begin within the first 24 hours
after delivery. Symptoms include:

• difficulty breathing
• bluish skin color or being too warm or too cold
• blue lips
• vomiting or difficulty feeding
• being very tired, unable to sleep or crying a lot
• stiff or floppy muscles
• tremors, nervousness, jerks
• increased reflex reactions
• irritability
• low blood sugar levels

If your baby presents any of the above symptoms at birth, or if you have any doubts
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 believes that the benefit to the mother outweighs any
possible risk to the baby.
In animal studies, some drugs like sertraline may reduce sperm quality. In theory
this may affect fertility, but the impact on human fertility has not yet been observed.

Driving and using machines
Psychotropic medicines like sertraline can affect the ability to drive vehicles and
use machines. Therefore, you should not drive vehicles or use machines until you
have ascertained whether this medicine alters 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 following exactly the instructions of 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 and 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 and post-traumatic stress disorder, treatment
should begin at a dose of 25 mg/day, 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 suffering
from Obsessive-Compulsive Disorder (OCD) aged between 6 and 17 years.
Obsessive-Compulsive Disorder

Children aged 6-12 years:the recommended starting 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 13-17 years: The recommended starting dose is 50 mg/day. The maximum dose is
200 mg/day.
If you have liver or kidney problems, tell your doctor and follow the instructions given to you by your doctor.
Method of administration
Sertralina Medreg tablets can be taken with or without food.
Take the medicine once a day, in the morning or evening.
Your doctor will tell you how long you will need to take this medicine. This will depend on the duration of the
illness and the response to treatment. Several weeks may be necessary before the
symptoms begin to improve. Treatment for depression should usually continue for 6 months
from when 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 it contains or
does not contain the 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 a missed dose. If you forget to take a
dose, do not take the missed dose. Take the next dose at the right time.

If you stop taking Sertralina Medreg
Do not stop treatment with Sertralina Medreg unless your doctor has told you to do so. The
doctor may want to gradually reduce the dose of Sertralina Medreg over several weeks,
before completely stopping the use of this medicine. If you suddenly stop
using this medicine, side effects such as dizziness, numbness,
sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremors may occur. If you experience any
of these side effects, or other side effects during treatment with Sertralina
Medreg, talk to your doctor
If you have any doubts about the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

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

Tell your doctor immediately:
If you experience any of the following symptoms after taking this medicine, these
symptoms may be serious.

• If you develop a severe skin rash that causes blistering (erythema multiforme) (may affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). In these cases, your doctor will stop treatment.
• Allergic reactions or allergies, which may include symptoms such as an itchy rash, breathing problems, wheezing, swelling of eyelids, face or lips.
• If you experience agitation, confusion, diarrhea, high fever and high blood pressure, excessive sweating and a fast heartbeat. These are the symptoms of Serotonin Syndrome. In rare cases, this syndrome may occur when taking certain medicines together with sertraline. Your doctor may want to stop treatment.
• If you develop a yellowing of the skin and eyes, which may be indicative of liver damage.
• If you develop depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
• If you start to feel restless and can no longer sit still or remain calm after starting treatment with Sertralina Medreg. You should tell your doctor if you start to feel restless.
• If you have seizures (convulsions).
• If you experience a manic episode (see section 2 “Warnings and precautions”).

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

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

• insomnia
• dizziness, drowsiness, headache
• diarrhea, feeling unwell, dry mouth
• lack of ejaculation
• fatigue.

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

• bronchitis, sore throat, runny nose
• decreased appetite, increased appetite
• anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding
• tremors, movement problems (such as frequent movements, tense muscles, difficulty walking and rigidity, spasms and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of attention, altered taste
• vision disturbances
• ringing in the ears
• palpitations
• hot flashes
• yawning
• stomach discomfort, constipation, abdominal pain, vomiting, gas in the stomach
• increased sweating, rash
• back pain, joint pain, muscle pain
• irregular periods, erectile dysfunction
• feeling unwell, chest pain, weakness, fever
• weight gain
• wounds

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

• intestinal problems, ear infections
• tumor
• hypersensitivity, seasonal allergy
• low levels of thyroid hormones
• suicidal thoughts, suicidal behavior*, abnormal thoughts, lack of self-care, hallucinations, aggression, euphoric mood, paranoia
• amnesia, reduced sensations, involuntary muscle contractions, fainting, excessive movements, migraine, dizziness when standing up, impaired coordination, speech disorders
• pupil dilation
• ear pain
• fast heartbeat, heart problems
• bleeding problems (such as stomach bleeding)*, high blood pressure, hot flashes, blood in urine
• shortness of breath, nosebleeds, difficulty breathing, possible wheezing
• tarry stools, dental problems, inflammation of the esophagus, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders
• swollen eyes, hives, hair loss, itching, formation of purple spots on the skin, skin problems with blister formation, dry skin, facial edema, cold sweats
• osteoarthritis, muscle contractions, muscle cramps*, muscle weakness
• increased frequency of urination, problems with urination, inability to urinate, urinary incontinence, increased urine volume, nighttime urination
• sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction
• leg swelling, chills, difficulty walking, thirst
• increased levels of liver enzymes, weight loss
• cases of suicidal ideation and suicidal behavior 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 blood cells responsible for coagulation*, reduced number of white blood cells*
• severe allergic reaction
• endocrine problems*
• high levels of cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar levels, increased blood sugar levels*, low blood salt levels*
• physical symptoms due to stress or emotions, terrifying altered dreams*, drug dependence, sleepwalking, premature ejaculation
• coma, abnormal movements, difficulty moving, increased sensations, sudden severe headaches (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS))*, altered state of consciousness
• formation of spots in front of the eyes, glaucoma, double vision, sensitivity to light, blood in the eye, unequal pupils*, altered vision*, problems with tearing
• heart attack, feeling dizzy, fainting or chest pain, which may be signs of changes in heart electrical activity (as evidenced by an electrocardiogram) or irregular heartbeat*, slowed heartbeat
• poor blood circulation in the arms and legs
• rapid breathing, progressive scarring of lung tissue (Interstitial Lung Disease)*, throat closure, difficulty speaking, slowed breathing, hiccups
• a type of lung disease in which eosinophils (a type of white blood cells) appear in the lung in increased numbers (eosinophilic pneumonia)
• mouth ulceration, pancreatitis*, blood in stools, tongue ulceration, mouth pain
• liver dysfunction problems, severe liver dysfunction*, yellowing of the skin and eyes (jaundice)*
• skin reaction to sunlight*, skin edema*, altered hair structure, altered body odor, inflammation of hair follicles
• muscle tissue rupture*, bone disorders
• initial difficulty urinating, reduced urination
• nipple discharge, vaginal dryness, genital discharge, red and painful penis and prepuce, enlarged breasts*, prolonged erection
• hernia, reduced tolerance to the medicine
• increased cholesterol in the blood, altered laboratory results*, altered semen, coagulation problems*
• procedure for relaxing blood vessels

Not known(frequency cannot be estimated based on available data):

• jaw locking*
• bedwetting*
• partial loss of vision
• inflammation of the colon (causing diarrhea)*
• heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see Pregnancy, breastfeeding and fertility in section 2, for more information*

* Side effect reported after marketing authorization.
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, diarrhea and nausea.

Symptoms that may occur when treatment is stopped
If you suddenly stop taking this medicine, side effects such as dizziness, tingling, sleep
disturbances, agitation or anxiety, headache, nausea,
vomiting and tremor may occur (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 get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
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 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 package and blister after
“Scad” or “EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 ingredient 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), macrogol 400, polysorbate 80

Description of the appearance of Sertralina Medreg and package contents

Sertralina Medreg 50 mg:
Film-coated tablets, biconvex from white to almost white, capsule-shaped, approximately 10.4 x
4.2 ± 0.2 mm, with a score line on one side and imprinted with “50” on the scored side.
The tablet can be divided into equal doses.

Sertralina Medreg 100 mg:
Film-coated tablets, biconvex from white to almost white, capsule-shaped, approximately
13.2 x 5.3 ± 0.2 mm, and imprinted with “100” on one side.
The film-coated tablets are supplied in opaque PVC/Al blisters 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 and Manufacturer
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
Italy Sertralina Medreg
Poland: Sertraline Medreg
Czech Republic: Sertraline Medreg
Romania: Sertralină Gemax Pharma 50 mg film-coated tablets
Sertralină Gemax Pharma 100 mg film-coated tablets
Slovakia: Sertraline Medreg 50 mg
Sertraline Medreg 100 mg