SERTRALINE 25 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Sertraline Zentiva, 25 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the Package Leaflet:
3. What Sertraline Zentiva is and what it is used for
4. Important information before taking Sertraline Zentiva
   1. When not to take Sertraline Zentiva:
   2. Warnings and precautions:
   3. Akathisia/psychomotor restlessness
   4. Withdrawal symptoms
   5. Suicidal thoughts and worsening of depression or anxiety
   6. Suicidal thoughts or self-harm are more likely to occur if:
   7. Sexual dysfunction
   8. Children and adolescents
   9. Interactions with other medicines
   10. Concomitant use of Sertraline Zentiva with other medicines can lead to serious side effects:
   11. Tell your doctor if you are taking any of the following medicines:
   12. Sertraline Zentiva with food, drink, and alcohol
   13. Pregnancy, breastfeeding, and fertility
   14. Driving and using machines
   15. Sertraline Zentiva contains lactose and sodium
5. How to take Sertraline Zentiva
   1. Recommended dose of Sertraline Zentiva:
   2. Adults
   3. Depression and obsessive-compulsive disorder
   4. Panic disorder, social anxiety disorder, and post-traumatic stress disorder
   5. Use in children and adolescents
   6. Overdose
   7. Missed dose
   8. Stopping Sertraline Zentiva
6. Possible side effects
   1. Very common (may affect more than 1 in 10 people):
   2. Common (may affect up to 1 in 10 people):
   3. Uncommon (may affect up to 1 in 100 people):
   4. Rare (may affect up to 1 in 1,000 people):
   5. Frequency not known (cannot be estimated from the available data):
   6. Additional side effects in children and adolescents
   7. Withdrawal symptoms
   8. Reporting side effects
7. How to store Sertraline Zentiva
8. Contents of the pack and other information
   1. What Sertraline Zentiva contains
   2. What Sertraline Zentiva looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. For further information on this medicine, please contact:
   7. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

Sertraline Zentiva, 25 mg, Film-Coated Tablets

Sertraline

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

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

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

Sertraline Zentiva 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 Zentiva 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 mental illness that affects your thoughts, feelings, and physical health to the point where it interferes with your daily life. Symptoms of depression include feelings of sadness, changes in sleep and appetite, and loss of interest in activities you used to enjoy.

Obsessive-compulsive disorder (OCD) and panic disorder are anxiety disorders. OCD is characterized by persistent ideas (obsessions) and repetitive actions (compulsions). Panic disorder is characterized by panic attacks, which are intense episodes of fear or discomfort.

Post-traumatic stress disorder (PTSD) is a condition that can occur after a person experiences a traumatic event, and it can cause symptoms similar to depression and anxiety.

Social anxiety disorder (social phobia) is an anxiety disorder characterized by an intense fear of social situations, such as talking to strangers, speaking in front of a group, eating or drinking in public, or fear of embarrassing oneself.

Your doctor will decide if Sertraline Zentiva is suitable for your condition. If you have any questions about why you have been prescribed Sertraline Zentiva, you should discuss them with your doctor.

2. Important information before taking Sertraline Zentiva

When not to take Sertraline Zentiva:

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 monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other MAOI-like drugs (such as linezolid, methylene blue) within the last 14 days. If you stop taking sertraline, you should wait at least 7 days before taking an MAOI.

if you are taking pimozide (a medicine used to treat mental disorders such as psychosis).

Warnings and precautions:

Medicines like Sertraline Zentiva (SSRIs) may not be suitable for everyone. Before taking Sertraline Zentiva, you should tell your doctor if:

• you have epilepsy or have had seizures in the past. If you have a seizure, you should contact your doctor immediately.
• you have a history of bipolar disorder or schizophrenia. If you experience a manic episode, you should contact your doctor immediately.
• you have a history of suicidal thoughts or self-harm.
• you have serotonin syndrome, a potentially life-threatening condition. In rare cases, this syndrome can occur in patients taking sertraline, especially when taken with other medicines (see "Sertraline Zentiva and other medicines"). Your doctor should tell you if you have had serotonin syndrome in the past.
• you have low sodium levels in your blood, as this can occur when taking Sertraline Zentiva. You should also tell your doctor if you are taking medicines for high blood pressure, as they can also affect sodium levels in your blood.
• you are elderly, as you may be more prone to low sodium levels in your blood.
• you have liver disease; your doctor may decide to reduce the dose of Sertraline Zentiva.
• you have diabetes; Sertraline Zentiva may affect blood sugar levels, so your diabetes medication may need to be adjusted.
• you have bleeding disorders or are pregnant (see "Pregnancy") or have taken medicines that affect blood clotting (such as aspirin or warfarin).
• you are under 18 years old. Sertraline Zentiva should only be used in children and adolescents aged 6-17 years with obsessive-compulsive disorder (OCD). Patients under 18 years old should be closely monitored by their doctor (see "Children and adolescents").
• you are undergoing electroconvulsive therapy (ECT).
• you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• you have heart problems, low potassium or magnesium levels, or a family history of QT prolongation.

Akathisia/psychomotor restlessness

Sertraline has been associated with the development of akathisia, characterized by a subjective feeling of restlessness and an urge to move, often accompanied by an inability to sit or stand still. This usually occurs within the first few weeks of treatment. If you experience any of these symptoms, you should contact your doctor.

Withdrawal symptoms

When stopping treatment with Sertraline Zentiva, withdrawal symptoms are common, especially if treatment is stopped abruptly (see section 3, "Stopping Sertraline Zentiva" and section 4, "Possible side effects"). The risk of withdrawal symptoms depends on the duration of treatment, dose, and rate of dose reduction. Symptoms are usually mild to moderate and usually resolve within 2 weeks, but in some patients, they can be severe and last longer (2-3 months or longer). If your doctor decides to stop your treatment with sertraline, it is recommended to gradually reduce the dose over several weeks or months.

Suicidal thoughts and worsening of depression or anxiety

Patients with depression or anxiety disorders may sometimes experience thoughts of self-harm or suicide. These thoughts can worsen when first taking antidepressants, as these medicines can take 2 weeks or longer to start working.

Suicidal thoughts or self-harm are more likely to occur if:

• you have had suicidal thoughts or self-harm in the past;
• you are a young adult; clinical trials have shown an increased risk of suicidal behavior in young adults (under 25 years) with mental health conditions who were treated with antidepressants.

Sexual dysfunction

Medicines like Sertraline Zentiva (SSRIs) can cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents

Sertraline should not be used in children and adolescents under 18 years old, except for those with obsessive-compulsive disorder (OCD). In patients under 18 years old, treatment with this type of medicine has been associated with an increased risk of side effects such as suicidal thoughts, self-harm, and hostility (mainly aggressive, oppositional, and angry behavior). However, your doctor may decide to prescribe Sertraline Zentiva if it is in your best interest. If your doctor prescribes Sertraline Zentiva and you are under 18 years old, and you or your caregiver want to discuss this, you should contact your doctor. Additionally, if you are under 18 years old and taking Sertraline Zentiva, and you experience any of the above symptoms, you should tell your doctor. Furthermore, the long-term safety of Sertraline Zentiva in terms of its effects on growth, puberty, cognitive, and behavioral development in this age group has not been established.

Interactions with other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take. Some medicines can affect the way Sertraline Zentiva works or increase the risk of side effects.

Concomitant use of Sertraline Zentiva with other medicines can lead to serious side effects:

• monoamine oxidase inhibitors (MAOIs, such as moclobemide, selegiline) and other MAOI-like drugs (such as linezolid, methylene blue);
• medicines used to treat mental disorders (such as pimozide);
• medicines used to treat opioid addiction (such as buprenorphine);

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

• medicines containing amphetamine (used to treat ADHD, narcolepsy, and obesity);
• herbal medicines containing St. John's Wort (Hypericum perforatum);
• tryptophan supplements;
• metamizole (a medicine used to treat pain and fever);
• medicines used to treat severe pain (such as tramadol);
• medicines used for anesthesia or to treat chronic pain (such as fentanyl, mivacurium, and suxamethonium);
• medicines used to treat migraines (such as sumatriptan);
• anticoagulant medicines (such as warfarin);
• non-steroidal anti-inflammatory medicines (NSAIDs, such as ibuprofen or aspirin);
• sedatives (such as diazepam);
• diuretics;
• medicines used to treat epilepsy (such as phenytoin, phenobarbital, carbamazepine);
• medicines used to treat diabetes (such as tolbutamide);
• medicines used to treat excessive stomach acid, stomach ulcers, and gastroesophageal reflux disease (such as cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole);
• medicines used to treat mania and depression (such as 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 to regulate heart rate (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 (such as protease inhibitors, such as ritonavir, telaprevir);
• medicines used to prevent nausea and vomiting after chemotherapy (such as aprepitant);
• medicines that can increase the risk of changes in heart rhythm (such as antipsychotics and antibiotics).

Sertraline Zentiva with food, drink, and alcohol

Sertraline Zentiva can be taken with or without food.

Do not drink alcohol while taking Sertraline Zentiva.

Do not take Sertraline Zentiva with grapefruit juice, as it can increase the levels of sertraline in your body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

The safety of sertraline in pregnant women has not been fully established. Sertraline Zentiva should only be used during pregnancy if your doctor considers it essential.

Women who are pregnant or may become pregnant should use a reliable method of contraception (such as the pill) while taking sertraline.

Taking Sertraline Zentiva near the end of pregnancy may increase the risk of severe bleeding after delivery, especially if you have a history of bleeding disorders. If you are taking Sertraline Zentiva, you should tell your doctor or midwife so they can give you appropriate advice.

Tell your midwife or doctor that you are taking Sertraline Zentiva. Taking medicines like Sertraline Zentiva during pregnancy, especially in the last trimester, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), where the baby breathes faster and turns blue. These symptoms usually appear in the first day of life. If your baby experiences these symptoms, you should contact your midwife or doctor immediately.

Newborn babies may also experience other complications, which usually appear within the first 24 hours after birth. Symptoms may include:

• difficulty breathing;
• bluish skin or too hot or cold skin;
• bluish lips;
• vomiting or difficulty feeding;
• excessive sleepiness, sleeplessness, or constant crying;
• increased or decreased muscle tone;
• tremors, muscle spasms, or seizures;
• increased reflexes;
• restlessness;
• low blood sugar.

If your baby experiences any of these symptoms after birth, or if you have concerns about your baby's health, you should contact your doctor or midwife immediately.

Sertraline passes into breast milk. Sertraline Zentiva can be used during breastfeeding if your doctor considers it essential for you.

Some medicines, such as sertraline, may affect sperm quality in animal studies. This could theoretically affect fertility, but it has not been shown to affect fertility in humans.

Driving and using machines

Psychotropic medicines like sertraline can affect your ability to drive or operate machinery. You should wait until you know how Sertraline Zentiva affects you before driving or operating machinery.

Sertraline Zentiva contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

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

3. How to take Sertraline Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Recommended dose of Sertraline Zentiva:

Adults

Depression and obsessive-compulsive disorder

The usual effective dose is 50 mg per day. The 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 should start with a dose of 25 mg per day, which can be increased to 50 mg per day after one week.

The dose can then be increased gradually, by 50 mg, over several weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents

Sertraline Zentiva can be used in children and adolescents aged 6-17 years with obsessive-compulsive disorder (OCD).

Obsessive-compulsive disorder

Children aged 6-12 years:the recommended starting dose is 25 mg per day. After one week, your 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 starting dose is 50 mg per day. The maximum dose is 200 mg per day.

Patient with liver or kidney disease should inform their doctor and follow their advice.

Take the medicine once daily, in the morning or evening. Sertraline Zentiva film-coated tablets can be taken with or without food.

Your doctor will tell you how long you should take Sertraline Zentiva. The length of treatment will depend on the type of disease and your response to treatment. Improvement can take several weeks. Treatment of depression should usually continue for 6 months after improvement.

Overdose

If you have taken more Sertraline Zentiva than you should, contact your doctor or go to the nearest hospital immediately. Take the medicine pack with you.

Symptoms of overdose may include drowsiness, nausea, vomiting, rapid heartbeat, tremors, agitation, dizziness, and rarely, loss of consciousness.

Missed dose

Do not take a double dose to make up for a forgotten dose.

If you forget to take a dose, do not take the missed dose. Take the next dose at the usual time.

Stopping Sertraline Zentiva

Do not stop taking Sertraline Zentiva without talking to your doctor first. Your doctor will gradually reduce your dose over several weeks or months.

Suddenly stopping Sertraline Zentiva can cause side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors (see section 2, "Withdrawal symptoms"). If you experience any of these symptoms or any other side effects when stopping Sertraline Zentiva, you should contact your doctor.

4. Possible side effects

Like all medicines, Sertraline Zentiva can cause side effects, although not everybody gets them.

The most common side effect is nausea. Side effects are usually dose-dependent and often disappear after continued treatment.

Tell your doctor immediatelyif you experience any of the following symptoms, as they can be serious:

• severe skin rash, which can cause blisters (erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis);
• allergic reactions or allergies, with symptoms such as itching, difficulty breathing, wheezing, swelling of the face, lips, tongue, or throat;
• agitation, confusion, diarrhea, high blood pressure, increased heart rate, sweating, and tremors. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when taking certain medicines with sertraline. Your doctor may stop your treatment;
• yellowing of the skin and eyes, which can indicate liver damage;
• suicidal thoughts or self-harm;
• restlessness and inability to sit or stand still;
• seizures;
• manic episodes (see section 2, "Warnings and precautions");

After marketing, the following side effects have been reported in clinical trials with sertraline in adults:

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

• insomnia, dizziness, somnolence, headache, diarrhea, nausea, dry mouth, ejaculation disorder, fatigue.

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

cold, sore throat, cough;

loss of appetite, increased appetite;

anxiety, depression, agitation, libido decreased, nervousness, feeling abnormal, nightmare, bruxism;

tremor, movement disorders (such as increased muscle tone, muscle contractions, or restlessness), hypertonia, seizure *, hypoaesthesia, concentration impaired, taste disturbance;

vision disturbance;

tinnitus;

palpitations;

flushing;

yawning;

gastrointestinal disorders, constipation, abdominal pain, vomiting, flatulence, dyspepsia, increased salivation, dysphagia;

back pain, arthralgia, myalgia;

menstrual disorder, erectile dysfunction;

generalized edema, chest pain, fatigue, pyrexia;

weight increased, injury;

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

gastrointestinal infection, ear infection;

tumor;

hypersensitivity, seasonal allergy;

hypothyroidism;

suicidal ideation, suicidal behavior *, psychotic disorder, thinking abnormal, apathy, hallucination, aggression, elation, euphoria, paranoia;

amnesia, emotional lability, hyperkinesia, hypertonia, syncope, dystonia, movement disorder, dysarthria;

mydriasis;

ear pain;

tachycardia, cardiac disorders, palpitations, thrombophlebitis;

hypertension, flushing, hot flush;

dyspnea, epistaxis, dysphonia;

gastrointestinal hemorrhage *, hematemesis, gastrointestinal disorder, gastroesophageal reflux disease, stomatitis, tongue disorder, tooth disorder, gingivitis;

pruritus, urticaria, alopecia, eczema, dermatitis, skin discoloration, purpura, rash, seborrhoea;

arthrosis, muscle spasms *, muscle weakness, neck pain, trismus;

pollakiuria, urinary incontinence, urinary retention, dysuria, nocturia, menstrual disorder, erectile dysfunction, ejaculation disorder;

peripheral edema, pyrexia, chills, thirst;

increased hepatic enzymes, blood glucose increased *, blood glucose decreased, hyponatremia *;

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

appendicitis, lymphadenopathy, hypothyroidism;

severe allergic reactions;

endocrine disorders *;

hypercholesterolemia, glucose tolerance impaired, diabetes mellitus, hypoglycemia, hyperglycemia *;

psychomotor restlessness, bruxism *, sleep talking;

coma, dyskinesia, dystonia, extrapyramidal disorder, movement disorder, choreoathetosis, akathisia, parkinsonism, amnesia, seizure *, serotonin syndrome, suicidal ideation, aggression;

mydriasis, blindness *, glaucoma *, cataract, photophobia *, eye pain *, conjunctivitis, periorbital edema;

cardiac disorders, myocardial infarction, bradycardia, ventricular arrhythmia, torsade de pointes;

hypertension, hypotension, thrombophlebitis;

dyspnea, bronchospasm, pulmonary embolism, pulmonary hypertension;

gastrointestinal hemorrhage, pancreatitis *, gastrointestinal disorder, glossitis, gingivitis, esophagitis, stomatitis, tooth disorder, tongue disorder, enteritis;

angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, eczema, dermatitis, pruritus, urticaria, rash, exfoliative dermatitis, hyperhidrosis, photosensitivity reaction;

rhabdomyolysis *, osteoporosis, trismus, muscle spasms *;

nocturia, urinary incontinence, urinary retention, pollakiuria, hematuria;

erectile dysfunction, priapism, ejaculatory disorder, gynaecomastia, galactorrhoea, breast pain, menstrual disorder;

hernia, abdominal pain, thirst;

increased hepatic enzymes, blood glucose increased, hyponatremia *;

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

bruxism *;

nocturnal enuresis *;

partial loss of vision *;

colitis, postpartum hemorrhage (see "Pregnancy");

Additional side effects in children and adolescents

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

Withdrawal symptoms

When stopping treatment with Sertraline Zentiva, withdrawal symptoms can occur, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors (see section 3, "Stopping Sertraline Zentiva").

Patients taking this type of medicine have reported an increased risk of bone fractures.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in the "Contact details" section below.

5. How to store Sertraline Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.

There are no special storage conditions for this medicine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Sertraline Zentiva contains

• The active substance is sertraline. Each film-coated tablet contains sertraline hydrochloride equivalent to 25 mg sertraline.
• The other ingredients are: tablet core:lactose monohydrate, microcrystalline cellulose (PH-102), povidone K-30, croscarmellose sodium, and magnesium stearate. tablet coating:hypromellose 2910/5, macrogol 400, titanium dioxide (E171), and talc.

What Sertraline Zentiva looks like and contents of the pack

Sertraline Zentiva 25 mg film-coated tablets are white or almost white, round, biconvex film-coated tablets with a diameter of 6.0 mm ± 0.5 mm.

The tablets are packed in transparent PVC/PVDC/Aluminum blisters in a cardboard box.

Available pack sizes: 28, 30, 98, 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

S.C. Zentiva S.A., B-dul Theodor Pallady nr. 50, sector 3, Bucharest, 032266, Romania

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

Denmark, Czech Republic, Sweden: Sertralin Zentiva

Poland, Slovakia: Sertraline Zentiva

Romania: Sertralină Zentiva

For further information on this medicine, please contact:

Zentiva Polska Sp. z o.o.

ul. Bonifraterska 17

00-203 Warsaw

Tel. +48 (22) 375 92 00

Date of last revision of the package leaflet: