Sertraline Medreg

Leaflet attached to the packaging: patient information

Sertraline Medreg, 50 mg, coated tablets

Sertraline Medreg, 100 mg, coated tablets

Sertraline

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

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

Table of contents of the leaflet:

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

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

Sertraline Medreg contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Sertraline Medreg can be used to treat:

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

Depression is a clinical condition characterized by symptoms such as sadness, difficulty sleeping or lack of joy in life.
OCD and panic disorder are anxiety-related conditions with accompanying persistent anxiety due to persistent thoughts (obsessions) that cause repetitive rituals (compulsions).
PTSD is a condition that can occur after a traumatic experience and is characterized by certain symptoms similar to depression and anxiety.
Social anxiety disorder (social phobia) is an anxiety-related condition. It is characterized by a feeling of intense anxiety or stress 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).
The doctor has decided that this medicine is suitable for treating the patient's condition.
The patient should consult a doctor if they are unsure why they have been prescribed Sertraline Medreg.

2. Important information before taking Sertraline Medreg

When not to take Sertraline Medreg

Warnings and precautions

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

Psychomotor agitation/Akathisia

Sertraline treatment has been associated with the occurrence of a condition characterized by psychomotor agitation and a compulsion to move, often with an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. Increasing the dose may be harmful; if such symptoms occur, the patient should discuss them with their doctor.

Withdrawal symptoms

Side effects related to discontinuation of treatment (withdrawal symptoms) are common, especially if treatment is stopped abruptly (see section 3. Discontinuation of 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 usually mild or moderate, but in some patients, they may be severe. They usually occur within the first few days after stopping treatment. They usually resolve on their own within 2 weeks, but in some patients, they may persist for 2-3 months or longer.
In the event of a decision to stop sertraline treatment, it is recommended to gradually reduce the dose over several weeks or months and always discuss the best way to stop treatment with a doctor.

Suicidal thoughts, worsening of depression or anxiety disorders

Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start to work after 2 weeks, and sometimes later.

The occurrence of suicidal thoughts, self-harm thoughts, or suicidal behavior is more likely if:

• the patient has had suicidal thoughts or self-harm in the past.
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in people under 25 years of age with mental disorders who have been treated with antidepressant medicines. If the patient has suicidal thoughts or self-harm thoughts, they should contact their doctor or go to the hospital immediately.

It may be helpful to inform relatives or friends about the patient's depression or anxiety disorder and ask them to read this leaflet. The patient may ask their relatives or friends for help and ask them to inform them if they notice that the depression or anxiety has worsened or if there are any worrying changes in behavior.

Sexual dysfunction

Medicines like Sertraline Medreg (SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after treatment was stopped.

Children and adolescents

Sertraline should not be used in children and adolescents under 18 years of age, with the exception of patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age taking medicines from this group, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggressive behavior, oppositional behavior, and anger). However, the 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 the doctor prescribes Sertraline Medreg to a patient under 18 years of age, and the patient's guardian wants to discuss it, they should contact the doctor. Moreover, if during treatment with Sertraline Medreg in a patient under 18 years of age, any of the above symptoms occur or worsen, the doctor should be informed. In a long-term observational study lasting 3 years involving over 900 children aged 6-16 years, the safety of long-term sertraline use was evaluated in terms of its effect on growth, maturation, learning (cognitive function), and behavior. In general, the study results showed that children treated with sertraline developed normally, with the exception of a slight increase in body weight in children treated with a higher dose.

Sertraline Medreg and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the way Sertraline Medreg works or Sertraline Medreg may reduce the effectiveness of other medicines taken at the same time.
Taking Sertraline Medreg with the following medicines may cause serious side effects:

• monoamine oxidase inhibitors (MAOIs, 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 methemoglobin levels in the blood). Sertraline Medreg should not be taken with MAOIs.
• medicines used to treat mental disorders, such as psychosis (pimozide). Sertraline Medreg should not be taken with pimozide.

The patient should inform their 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, e.g. tramadol, fentanyl)
• medicines used for anesthesia (e.g. fentanyl, mivacurium, and suxamethonium)
• medicines used to treat migraines (e.g. sumatriptan)
• medicines that prevent blood clotting (warfarin)
• medicines used to treat pain/inflammation of the joints (e.g. metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin))
• sedatives (diazepam)
• diuretics
• medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine)
• medicines used to treat diabetes (tolbutamide)
• medicines used to treat excessive stomach acid production, stomach ulcers, 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 mental disorders (such as perphenazine, levomepromazine, and olanzapine)
• medicines used to treat high blood pressure, chest pain, or heart rate regulation (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 (protease inhibitors, such as ritonavir, telaprevir)
• medicines used to prevent nausea and vomiting after chemotherapy (aprepitant)
• medicines that increase the risk of changes in heart electrical activity (e.g. certain antipsychotic and antibiotic medicines).

Sertraline Medreg with food, drink, and alcohol

Sertraline Medreg tablets can be taken with or without food.
The patient should avoid drinking alcohol while taking Sertraline Medreg.
The patient should not take sertraline with grapefruit juice, as it may increase the level of sertraline in the body.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The safety of sertraline use in pregnant women has not been fully established. Sertraline may be given during pregnancy only if the doctor considers that the benefits to the patient outweigh the risks to the developing fetus.
Taking Sertraline Medreg at the end of pregnancy may increase the risk of severe vaginal bleeding occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Sertraline Medreg, they should inform their doctor or midwife so that they can provide appropriate advice. Taking medicines like Sertraline Medreg during pregnancy, especially in the last trimester, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), characterized by rapid breathing and blue skin color in the baby. These symptoms usually occur within the first 24 hours after birth. If the baby experiences any of these symptoms, the patient should contact the midwife or doctor immediately.
Other conditions may also occur in the newborn, usually within the first 24 hours after birth. The symptoms may include:

• breathing difficulties
• bluish discoloration of the skin or too hot or cold skin
• bluish lips
• vomiting or difficulty feeding
• excessive tiredness, sleeplessness, or constant crying
• increased or decreased muscle tone
• shivering, muscle spasms, or seizures
• increased reflexes
• irritability
• low blood sugar levels.

If the baby experiences any of these symptoms or if the patient is concerned about the baby's health, they should contact the doctor or midwife for advice.
Sertraline passes into breast milk. Sertraline may be used in breastfeeding women if the doctor considers that the benefits to the mother outweigh the potential risks to the baby.
In animal studies, some medicines, such as sertraline, may decrease sperm quality. This may theoretically affect fertility, but so far, no effect on fertility has been observed in humans.

Driving and using machines

Psychotropic medicines, such as sertraline, may affect the ability to drive or operate machinery. Therefore, the patient should not drive or operate machinery until they know how this medicine affects their ability to perform these activities.

Sertraline Medreg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Sertraline Medreg

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose is:

Adults

Depression and obsessive-compulsive disorder
The usual effective dose for the treatment of depression and OCD is 50 mg/day. The daily dose can be increased gradually by 50 mg at intervals of at least one week over several weeks. The maximum recommended dose is 200 mg/day.
Panic disorder, social anxiety disorder, and post-traumatic stress disorder
Treatment of panic disorder, social anxiety disorder, and post-traumatic stress disorder should be started with a dose of 25 mg/day, which can be increased to 50 mg/day after one week.
The daily dose can then be increased gradually by 50 mg at intervals of several weeks. The maximum recommended dose is 200 mg/day.

Use in children and adolescents

Sertraline Medreg can be used in children and adolescents only for the treatment of obsessive-compulsive disorder (OCD) in patients aged 6-17 years.
Obsessive-compulsive disorder
Children aged 6-12 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 13-17 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 their instructions .
Administration
Sertraline Medreg tablets can be taken with or without food.
The medicine should be taken once a day, in the morning or evening.
The doctor will inform the patient how long they should take the medicine. The duration of treatment depends on the type of disease and the patient's response to treatment. Improvement may occur only after several weeks of treatment. Treatment of depression should usually last 6 months from the time improvement is observed.

Taking a higher dose of Sertraline Medreg than recommended

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

Missing a dose of Sertraline Medreg

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

Stopping treatment with Sertraline Medreg

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

4. Possible side effects

Like all medicines, Sertraline Medreg can cause side effects, although not everybody gets them.
The most common side effect is nausea. Side effects depend on the dose and usually disappear or decrease as treatment continues.

The patient should immediately inform their doctor:

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

• If the patient develops a severe skin rash that forms 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 stop the treatment.
• An allergic reaction or allergy, with symptoms such as an itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
• If the patient experiences: agitation, disorientation, diarrhea, high temperature and blood pressure, excessive sweating, and rapid heart rate. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when the patient is taking certain medicines at the same time as sertraline. The doctor may then stop the treatment.

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

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

• insomnia
• dizziness, drowsiness, headaches
• diarrhea, nausea, dry mouth
• ejaculation disorders
• fatigue

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

• cold, sore throat, runny nose
• decreased appetite, increased appetite
• anxiety, depression, agitation, decreased sexual interest, nervousness, strange feelings, nightmares, teeth grinding
• tremors, muscle movement problems (such as increased movement, muscle tension, difficulty walking, and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of concentration, taste disturbances
• vision disturbances
• ringing in the ears
• palpitations
• hot flashes
• yawning
• stomach disturbances, constipation, abdominal pain, vomiting, gas
• increased sweating, rash
• back pain, joint pain, muscle pain
• irregular menstrual periods, erectile dysfunction
• general malaise, chest pain, weakness, fever
• weight gain
• injuries

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

• diverticulitis, lymph node inflammation
• cancer
• hypersensitivity, seasonal allergy
• decreased thyroid hormone levels
• suicidal thoughts, suicidal behavior*, psychotic disorders, thought disorders, apathy, hallucinations, aggression, euphoria, paranoia
• amnesia, decreased sensation, involuntary muscle contractions, fainting, increased movement, migraine, seizures, dizziness when standing up, coordination disturbances, speech disturbances
• pupil dilation
• ear pain
• rapid heart rate, heart problems
• bleeding problems (such as stomach bleeding)*, high blood pressure, flushing, blood in the urine
• breathing difficulties, nosebleeds, breathing difficulties, possible wheezing
• black stools, dental problems, esophagitis, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, speech disturbances
• eye swelling, hives, hair loss, itching, purpura, skin problems with blisters, dry skin, facial swelling, cold sweats
• osteoarthritis, muscle tremors, muscle spasms*, muscle weakness
• increased urination frequency, urination problems, inability to urinate, urinary incontinence, increased urination, nocturia
• sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, female sexual dysfunction
• leg swelling, chills, walking difficulties, thirst
• increased liver enzyme activity, weight loss
• * Side effects reported after marketing.

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

• diverticulitis, lymph node inflammation, decreased platelet count*, decreased white blood cell count*
• severe allergic reaction
• endocrine disorders*
• high cholesterol, diabetes control problems, low blood sugar, high blood sugar*, low sodium levels*
• physical symptoms caused by stress or emotions, terrifying nightmares*, drug dependence, sleepwalking, premature ejaculation
• coma, abnormal movements, movement difficulties, increased sensitivity, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome, RCSV)*, sensory disturbances
• floaters, glaucoma, double vision, eye pain caused by light, blood in the eye, uneven pupil size*, vision disturbances*, eye problems
• heart attack, dizziness, fainting or discomfort in the chest, which may be symptoms of changes in heart electrical activity (visible on an electrocardiogram) or abnormal heart rhythm*, slow heart rate
• poor circulation in the arms and legs
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, airway obstruction, speech difficulties, slow breathing, hiccups
• a lung condition in which eosinophils (a type of white blood cell) appear in the lungs in increased numbers (eosinophilic pneumonia)
• mouth ulcers, pancreatitis*, blood in the stool, mouth pain, tongue problems
• liver function problems, severe liver function problems*, yellowing of the skin and whites of the eyes (jaundice)*
• sunburn*, skin swelling*, abnormal hair structure, abnormal skin odor, hairy skin rash
• muscle breakdown*, bone disorders
• urination difficulties, decreased urination
• nipple discharge, vaginal dryness, genital discharge, painful erection and foreskin, breast enlargement*, prolonged erection
• hernia, decreased tolerance to the medicine
• increased blood cholesterol, abnormal laboratory test results*, abnormal sperm test results, bleeding problems*
• blood vessel weakness

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

• jaw spasms*
• nocturnal enuresis*
• partial loss of vision
• colitis (causing diarrhea)*
• excessive vaginal bleeding shortly after delivery (postpartum hemorrhage), for more information see Pregnancy, breastfeeding, and fertility in section 2*.

* Side effects reported after marketing.

Additional side effects in children and adolescents

In clinical trials involving children and adolescents, side effects were generally similar to those in adults (see above). The most common side effects in children and adolescents were headaches, insomnia, diarrhea, and nausea.

Withdrawal symptoms

After stopping treatment with Sertraline Medreg, the patient may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, and tremors (see section 3. "Discontinuation of Sertraline Medreg").
Patients taking this type of medicine have been reported to have an increased risk of fractures.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the representative of the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Sertraline Medreg

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The patient should not take this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Sertraline Medreg contains

• The active substance of the medicine is sertraline. Each coated tablet contains sertraline hydrochloride equivalent to 50 mg or 100 mg of sertraline.
• Other ingredients are: tablet core: calcium phosphate, microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose (type A), magnesium stearate coating: hypromellose, titanium dioxide (E 171), macrogol 400, polysorbate 80

What Sertraline Medreg looks like and contents of the pack

Sertraline Medreg, 50 mg:
White or almost white, biconvex, coated tablets in capsule shape, 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, coated tablets in capsule shape, approximately 13.2 x 5.3 ± 0.2 mm in size, with the imprint "100" on one side.
The coated tablets are available in non-transparent blisters of PVC/Aluminum, in a cardboard box.
Pack sizes: 10, 14, 28, 30, 84, 90, 98, or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization 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

Importer:

Pharmazet Group s.r.o.
Třtinová 260/1, Čakovice
196 00 Prague 9
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Slovakia:
Sertraline Medreg 50 mg
Sertraline Medreg 100 mg
Czech Republic: Sertraline Medreg
Poland:
Sertraline Medreg
Romania:
Sertralina Gemax Pharma 50 mg film-coated tablets
Sertralina Gemax Pharma 100 mg film-coated tablets

Date of last revision of the leaflet: 08/2024