Zotral

Leaflet accompanying the packaging: patient information

Zotral, 50 mg, coated tablets

Zotral, 100 mg, coated tablets

Sertraline

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 Zotral and what is it used for
• 2. Important information before taking Zotral
• 3. How to take Zotral
• 4. Possible side effects
• 5. How to store Zotral
• 6. Contents of the packaging and other information

1. What is Zotral and what is it used for

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

Zotral may 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 disease characterized by symptoms of sadness, increased sleep problems or loss of pleasure in life.
OCD and panic disorder are anxiety-related diseases characterized by symptoms of constant anxiety due to persistent thoughts (obsessions) that cause repetitive rituals (compulsive actions).
Post-traumatic stress disorder (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 disease. 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 worrying about potentially embarrassing behavior).
The doctor has decided that this medicine is suitable for the treatment of the disease in the patient. The patient should consult a doctor if they are unsure why they are taking Zotral.

2. Important information before taking Zotral

When not to take Zotral:

Warnings and precautions

Medicines do not always suit everyone. The patient should consult a doctor before taking Zotral if they currently have or have had any of the following conditions:

• History of epilepsy or seizures. In case of an attack (seizure), the patient should contact their doctor immediately.
• History of manic-depressive illness (bipolar) or schizophrenia. In case of a manic episode, the patient should contact their doctor immediately.
• History of suicidal thoughts (see below - suicidal thoughts and worsening of depressive or anxiety disorders).
• Serotonin syndrome. This syndrome can occur in rare cases in patients who have taken certain medicines at the same time as sertraline. (Symptoms - see section 4. Possible side effects). The doctor should tell the patient if they have had serotonin syndrome in the past.
• Malignant neuroleptic syndrome. This syndrome can occur in rare cases in patients who have taken certain medicines at the same time as sertraline. (Symptoms - see section 4. Possible side effects). The doctor should tell the patient if they have had this syndrome in the past.
• Decreased sodium levels in the blood, as this may occur as a result of taking Zotral. The patient should also inform their doctor about taking certain medicines used to treat high blood pressure, as they may also change sodium levels in the blood.
• Older age, due to increased risk of decreased sodium levels in the blood (see above).
• Liver disease; the doctor may decide to reduce the dose of Zotral.
• Diabetes; Zotral may affect changes in blood glucose levels, so it may be necessary to change the dosage of antidiabetic medicines.
• Bleeding disorders or history of taking medicines that prevent blood clotting (e.g., acetylsalicylic acid or warfarin) or that may increase the risk of bleeding or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility").
• Children or adolescents under 18 years of age. Zotral may only be used in the treatment of children and adolescents aged 6-17 years with obsessive-compulsive disorder (OCD). Patients treated for this condition should be closely monitored by a doctor (see use in children and adolescents).
• Electroconvulsive therapy (ECT).
• Eye diseases, such as a certain type of glaucoma (increased pressure inside the eye).
• While taking Zotral, screening tests for the presence of benzodiazepines in the urine may give false-positive results. Specific confirmatory tests will distinguish sertraline from benzodiazepines.
• Medicines like Zotral (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.
• Acute or chronic pain or other conditions treated with opioid medicines. Taking these medicines at the same time as Zotral may lead to serotonin syndrome, a life-threatening disease (see "Zotral and other medicines").

Psychomotor agitation/Akathisia

Sertraline use has been associated with the emergence of psychomotor agitation and compulsive movements - often with an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. Increasing the dose of the medicine may be harmful to patients who experience such symptoms, so they should inform their doctor.

Withdrawal symptoms

After stopping treatment, withdrawal symptoms often occur, especially if treatment is stopped abruptly (see section 3. Stopping Zotral treatment 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 weeks after stopping treatment. They usually resolve on their own within two weeks, but in some patients, they may persist for longer (for 2-3 months or longer).
In case of a decision to stop sertraline treatment, it is recommended to gradually reduce the dose over several weeks or months, and the patient should always discuss with their doctor the best way to stop treatment.

Suicidal thoughts, worsening of depressive or anxiety disorders

Patients with depression 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 working after two weeks, sometimes later.

Emergence of suicidal thoughts, self-harm, 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 are being treated with antidepressant medicines. If the patient has suicidal thoughts or self-harm, they should contact their doctor or go to the hospital immediately. It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask relatives or friends for help and ask them to inform them if they notice that depression or anxiety has worsened or if there are worrying changes in behavior.

Children and adolescents

Essentially, 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, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggressive, defiant, and angry behavior) when taking medicines from this group. However, the doctor may decide to prescribe Zotral to a patient under 18 years of age if it is in the patient's best interest. If the doctor prescribes Zotral to a patient under 18 years of age and the child's caregiver wants to discuss this with them, they should contact the doctor.
Furthermore, if any of the above symptoms appear or worsen while taking Zotral, the patient should inform their doctor.
The safety of long-term use of Zotral regarding its impact on growth, maturation, and cognitive and behavioral functions has not been confirmed.

Zotral 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.
Certain medicines may affect how Zotral works or Zotral may reduce the effectiveness of other medicines taken at the same time.

Taking Zotral with the following medicines may cause serious side effects

• Medicines that are monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression) and selegiline (used to treat Parkinson's disease), as well as the antibiotic linezolid. The patient should not take Zotral with these medicines.
• Medicines used to treat mental disorders, such as psychoses (pimozide). The patient should not take Zotral with pimozide.
• Opioid medicines used to treat acute or chronic pain (e.g., buprenorphine) and opioid medicines in combination with opioid antagonists for the treatment of opioid dependence (e.g., buprenorphine/naloxone). The patient should not take sertraline with opioids without consulting their doctor first. These medicines may interact with Zotral and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, excitement, hallucinations, coma, excessive sweating, tremors, increased reflexes, increased muscle tone, and body temperature above 38°C. If such symptoms occur, the patient should contact their doctor.

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

• Herbal medicines containing St. John's Wort (Hypericum perforatum). St. John's Wort may continue to work for 1-2 weeks.
• Preparations containing the amino acid tryptophan.
• Medicines used to treat severe pain (e.g., tramadol, buprenorphine, and other opioid painkillers).
• Medicines used for anesthesia or chronic pain treatment (fentanyl).
• Medicines used to treat migraines (e.g., sumatriptan).
• Medicines that prevent blood clotting (warfarin).
• Medicines used to treat pain/joint inflammation (non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, acetylsalicylic acid).
• 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 and stomach ulcers (cimetidine).
• Medicines used to treat mania and depression (lithium).
• Other medicines used to treat depression (e.g., amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines used to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines used to regulate heart rate and rhythm (such as flecainide, propafenone).
• Medicines used to treat bacterial infections (clarithromycin, telithromycin, erythromycin, rifampicin).
• Medicines used to reduce stomach acid production (e.g., omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines used to prevent vomiting and nausea after surgery or chemotherapy (e.g., aprepitant).
• Medicines used to treat and prevent fungal infections (e.g., ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Verapamil and diltiazem (medicines used to treat high blood pressure, angina pectoris).
• Medicines used to treat HIV (e.g., protease inhibitors).
• Metamizole, a medicine used to treat pain and fever.

Zotral with food, drink, and alcohol

Zotral tablets can be taken with or without food.
The patient should avoid drinking alcohol while taking Zotral.
The medicine should not be taken 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 confirmed. The medicine can be used in pregnant women only if the doctor believes that the benefits of the medicine for the mother outweigh the potential risks to the developing child. Women of childbearing age taking sertraline should use effective contraception (e.g., birth control pills).
The patient should inform their doctor and/or midwife about taking Zotral. Taking medicines like Zotral during pregnancy, especially in the last three months, may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and bluish discoloration. These symptoms usually appear within the first day of life. If such symptoms occur in the newborn, the patient should contact their doctor and/or midwife immediately.
Taking Zotral at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Zotral, they should inform their doctor or midwife so that they can provide appropriate advice.
Newborns may also experience other symptoms, which usually occur within the first 24 hours of life. These symptoms include:

• breathing difficulties,
• bluish discoloration of the skin, feeling hot or cold,
• bluish lips,
• vomiting or difficulty feeding,
• feeling tired, difficulty sleeping, or constant crying,
• stiffness or floppiness of the muscles,
• tremors, shivering, or seizures,
• increased reflexes,
• irritability,
• low blood sugar,
• low or high blood pressure.

If the newborn has any of these symptoms, or if the caregiver is concerned about the child's health, they should contact their doctor or midwife, who will provide advice.
There is evidence that sertraline passes into breast milk. The medicine can be used in breastfeeding women if the doctor believes that the benefits of the medicine for the mother outweigh the potential risks to the child.
In animal studies, some medicines similar to sertraline have been shown to decrease sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

Psychotropic medicines, such as sertraline, may affect the ability to drive or operate machinery. The patient should wait until they know how Zotral affects their ability to perform these activities.

Zotral contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Zotral contains sodium

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

3. How to take Zotral

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Zotral tablets can be taken with or without food.
The medicine should be taken once a day, in the morning or evening.

Recommended dose is

Adults:

Depression and obsessive-compulsive disorder

The usual effective dose for the treatment of depression and OCD is 50 mg per 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 per 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 per day, which can be increased to 50 mg per day after one week. The daily dose can then be increased gradually, by 50 mg, over several weeks. The maximum recommended dose is 200 mg per day.

Children and adolescents:

Zotral can only be used to treat children and adolescents with obsessive-compulsive disorder (OCD) aged 6-17 years.

Obsessive-compulsive disorder

Children aged 6-12 years:The recommended initial dose is 25 mg per day. After one week, the doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.
Adolescents aged 13-17 years:The recommended initial dose is 50 mg per day.
The maximum dose is 200 mg per day.
Patients with liver or kidney disease should inform their doctor and follow their instructions.
The doctor will inform the patient how long they should take the medicine. The treatment period depends on the type of disease and the patient's response to treatment. Improvement may begin only after several weeks of treatment. Treatment of depression should usually be continued for another six months after symptoms have resolved.
The tablet can be divided into equal doses.

Taking a higher dose of Zotral than recommended

If the patient accidentally takes too much Zotral, they should immediately contact their doctor or go to the emergency department of the nearest hospital. They should always take the medicine packaging with them, regardless of whether there is any medicine left in it or not.
Symptoms of overdose may include drowsiness, nausea, and vomiting, rapid heartbeat, muscle tremors, excitement, dizziness, and, in rare cases, loss of consciousness.

Missing a dose of Zotral

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

Stopping Zotral treatment

The patient should not stop taking Zotral on their own. The doctor will recommend gradually reducing the dose of Zotral over several weeks before the patient stops taking it.
If the patient suddenly stops taking the medicine, they may experience side effects such as dizziness, numbness, sleep disturbances, excitement or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3. Stopping Zotral treatment).
If the patient experiences any of these side effects or any other side effects after stopping Zotral treatment, they should contact their doctor.
If the patient has any further doubts about taking this medicine, they should contact their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects get worse or if the patient experiences any side effects not listed in this leaflet, they should tell their doctor or pharmacist.
The most common side effect is nausea. Side effects depend on the dose and usually disappear or decrease as treatment continues.

The patient should contact their doctor immediately

If, after taking this medicine, the patient experiences any of the following symptoms (as they can be serious):

• If the patient develops a severe skin rash that causes 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. In such cases, the doctor will stop the patient's treatment with Zotral.
• An allergic reaction or allergy, which may include symptoms such as an itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
• If the patient experiences: excitement, confusion, diarrhea, high temperature and blood pressure, excessive sweating, and rapid heartbeat. These are symptoms of serotonin syndrome or malignant neuroleptic syndrome. In rare cases, these syndromes can occur when the patient takes certain medicines at the same time as sertraline. The doctor may then stop the patient's treatment.
• If the patient's skin and eyes turn yellow, which may indicate liver damage.
• If the patient experiences symptoms of depression with thoughts of self-harm or suicide.
• If the patient feels restless and cannot sit or stand still.
• If the patient has seizures (epileptic fits).
• If the patient experiences a manic episode (see section 2. Warnings and precautions).

The following side effects have been observed in clinical trials in adult patients.

Very common (occurring in more than 1 in 10 patients):

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

Common (occurring in less than 1 in 10 patients):

• sore throat, loss of appetite, increased appetite,
• depression, "strange" feeling, nightmares, anxiety, excitement, nervousness, decreased interest in sex, teeth grinding,
• numbness and tingling, muscle tremors, increased muscle tone, taste disorders, concentration disorders,
• vision disorders, ringing in the ears,
• palpitations, hot flashes, yawning,
• abdominal pain, vomiting, constipation, gastrointestinal disorders, gas,
• rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain.

Uncommon (occurring in less than 1 in 100 patients):

• common cold, runny nose,
• hallucinations, euphoria, apathy, thinking disorders,
• seizures, involuntary muscle contractions, coordination disorders, increased restlessness, memory loss, sensation disorders, speech disorders, dizziness when standing up, migraine,
• ear pain, rapid heartbeat, high blood pressure, hot flashes,
• breathing difficulties, possible snoring, shortness of breath, nosebleeds,
• esophagitis, difficulty swallowing, hemorrhoids, increased salivation, tongue disorders, belching,
• eye swelling, purple spots on the skin, abnormal hair structure, abnormal skin odor, bone disorders,
• decreased urination, urinary incontinence, delayed urination,
• excessive vaginal bleeding, vaginal dryness, painful red penis and foreskin, discharge, prolonged erection of the penis, nipple discharge,
• hernia, decreased drug tolerance, difficulty walking, abnormal laboratory test results, abnormal semen test results, injuries, blood vessel weakness,
• cases of suicidal thoughts and behaviors in patients taking sertraline or shortly after stopping treatment (see section 2).

Rare (occurring in less than 1 in 1000 patients):

• gastrointestinal disorders, ear infections, cancer, lymph node swelling, increased cholesterol levels, decreased glucose levels in the blood,
• physical symptoms caused by stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation,
• coma, abnormal movements, difficulty moving, increased sensitivity, sensation disorders,
• spots in front of the eyes, glaucoma, double vision, light sensitivity, blood in the eye, uneven pupil size, abnormal vision, tear disorders
• heart attack, slow heart rate, heart problems, poor circulation in the arms and legs, laryngospasm, rapid breathing, slow breathing, difficulty speaking, hiccups,
• bloody stools, painful mouth, tongue ulcers, tooth disorders, tongue inflammation, mouth ulcers, liver disorders,
• skin disorders with blistering, hairy skin rash, abnormal hair structure, abnormal skin odor, bone disorders,
• decreased urination, urinary incontinence, delayed urination,
• excessive vaginal bleeding, vaginal dryness, painful red penis and foreskin, discharge, prolonged erection of the penis, nipple discharge,
• hernia, decreased drug tolerance, difficulty walking, abnormal laboratory test results, abnormal semen test results, injuries, blood vessel weakness,

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

• decreased white blood cell count, decreased platelet count, decreased thyroid hormone levels, endocrine disorders, decreased sodium levels in the blood, difficulty controlling blood glucose levels (diabetes), increased glucose levels in the blood,
• nightmares,
• movement disorders (such as increased motor activity, increased muscle tone, and difficulty walking, as well as stiffness, muscle spasms, and involuntary movements), fainting, sudden, severe headache (which may be a sign of a serious condition called reversible cerebral vasoconstriction syndrome or Call-Fleming syndrome),
• vision disorders, uneven pupil size, partial loss of vision, bleeding disorders (including nosebleeds, gastrointestinal bleeding, or blood in the urine), pancreatitis, severe liver dysfunction, yellowing of the skin and eyes (jaundice),
• skin swelling, sun allergy, itching, joint pain, muscle spasms, breast enlargement, irregular menstruation, leg swelling, blood clotting disorders, bedwetting, severe allergic reactions, and progressive scarring of lung tissue (interstitial lung disease)
• colitis (causing diarrhea).
• Severe vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.

Side effects in children and adolescents

In clinical trials with 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.

Symptoms that may occur after stopping treatment

If the patient stops taking this medicine abruptly, they may experience side effects such as dizziness, numbness, sleep disturbances, excitement or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3. Stopping Zotral treatment).
Patient taking medicines from this group have been observed to have an increased risk of bone 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
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Zotral

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.
There are no special storage precautions.
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 Zotral contains

• The active substance of the medicine is sertraline. Zotral 50 mg coated tablets: Each coated tablet contains 50 mg of sertraline (as hydrochloride). Zotral 100 mg coated tablets: Each coated tablet contains 100 mg of sertraline (as hydrochloride).
• Other ingredients of the medicine are: tablet core: lactose monohydrate, microcrystalline cellulose (Avicel PH 102), povidone K30, sodium carboxymethylcellulose, magnesium stearate; 50 mg tablet coating: hypromellose 6, talc, propylene glycol, titanium dioxide (E 171); 100 mg tablet coating: hypromellose 6, hypromellose 15, talc, propylene glycol, titanium dioxide (E 171).

What Zotral looks like and contents of the packaging

Zotral 50 mg coated tablets:
White, oval, biconvex, with a score line on one side and the letter L embossed on the other.
The tablets can be divided into equal doses.
The packaging contains 28 tablets in a cardboard box.
Zotral 100 mg coated tablets:
White, round, biconvex, with a score line on one side and the letter C embossed on the other.
The tablets can be divided into equal doses.
The packaging contains 28 tablets in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
Actavis Ltd., BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000, Malta

Date of last revision of the leaflet: