Setaloft 50 mg

Leaflet accompanying the packaging: patient information

Setaloft 50 mg, 50 mg, film-coated tablets

Setaloft 100 mg, 100 mg, film-coated tablets

Sertraline

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

• Keep this leaflet, you may need to read it again.
• In case of 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 Setaloft and what is it used for
• 2. Important information before taking Setaloft
• 3. How to take Setaloft
• 4. Possible side effects
• 5. How to store Setaloft
• 6. Contents of the pack and other information

1. What is Setaloft and what is it used for

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

Setaloft 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 in which the patient feels sad, has difficulty sleeping or feeling pleasure in life.
Obsessive-compulsive disorder (OCD) and panic disorder are anxiety-related diseases with accompanying symptoms of feeling constant anxiety due to persistent thoughts (obsessions), which cause repetitive rituals (compulsive actions).
Post-traumatic stress disorder (PTSD) is a condition that may occur after a severe emotional shock, traumatic experience, and is characterized by symptoms similar to depression and anxiety.
Social anxiety disorder (social phobia) is characterized by a feeling of intense anxiety or stress in social situations (such as talking to strangers, speaking to 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 treating the patient's disease.
The patient should consult a doctor if they are unsure why they are taking Setaloft.

2. Important information before taking Setaloft

When not to take Setaloft:

• If the patient is allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking or has taken monoamine oxidase inhibitors (MAOIs, e.g., selegiline, moclobemide) or medicines similar to MAOIs (e.g., linezolid). After stopping sertraline treatment, the patient must wait at least one week before starting MAOI treatment. After stopping MAOI treatment, the patient must wait at least two weeks before starting sertraline treatment.
• If the patient is taking the medicine pimozide (a medicine used to treat mental disorders, such as psychoses).

Warnings and precautions

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

• Seizures or a history of seizures. If a seizure occurs, the patient should contact their doctor immediately.
• A history of manic-depressive illness (bipolar) or schizophrenia. If a manic episode occurs, the patient should contact their doctor immediately.
• Thoughts of self-harm or suicide (see below "Suicidal thoughts and worsening of depression or anxiety disorders").
• Serotonin syndrome or malignant neuroleptic syndrome. In rare cases, these syndromes may occur in patients who have taken other medicines at the same time as sertraline (symptoms, see section 4 "Possible side effects"). The doctor should tell the patient if they have had such a condition in the past.
• Low sodium levels in the blood, as this may occur as a result of taking Setaloft. The patient should also inform their doctor if they are taking medicines used to treat high blood pressure, as they may also change sodium levels in the blood.
• If the patient is elderly, as they may be more susceptible to decreased sodium levels in the blood (see above).
• Liver disease; the doctor may decide to reduce the dose of Setaloft.
• Diabetes; Setaloft may affect blood sugar levels, so a change in the dosage of antidiabetic medicines may be necessary.
• A history of bleeding disorders (tendency to bruise) or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility"), as well as the use of blood-thinning medicines (such as acetylsalicylic acid or warfarin) or medicines that may increase the risk of bleeding.
• Children or adolescents under 18 years of age. In children aged 6 to 17 years, Setaloft may only be used to treat obsessive-compulsive disorder. Patients with this disease should be closely monitored by a doctor (see below: "Use in children and adolescents").
• Electroconvulsive therapy.
• If the patient has eye problems, such as certain types of glaucoma (increased pressure in the eyeball).
• Sertraline may lead to false-positive urine screening tests for benzodiazepines. Such an effect can be expected even a few days after stopping sertraline treatment.

after stopping sertraline treatment.

• If the patient has been diagnosed with heart rhythm disorders after an ECG (electrocardiogram), known as a prolonged QT interval.
• If the patient has heart disease, low potassium or magnesium levels, a family history of QT interval prolongation, bradycardia, and concurrent use of medicines that prolong the QT interval.

Psychomotor agitation/Akathisia

Sertraline use has been associated with the emergence of psychomotor agitation and a compulsion to perform movements, often with an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. The patient should contact their doctor if they experience an increase in dose, as this may be harmful to patients with such symptoms.

Withdrawal symptoms

After stopping treatment, side effects (withdrawal symptoms) often occur, especially if treatment is stopped abruptly (see section 3 "Stopping Setaloft" 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. 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. However, in some patients, they may persist for longer (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 consult a doctor on the best way to stop treatment.

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 working after two weeks, sometimes later.
This may be more likely in:

• Patient who have had thoughts of self-harm or suicide before.
• Young adult patients. Clinical trial data indicate an increased risk of suicidal behavior in people under 25 with mental disorders who were treated with antidepressant medicines. If the patient experiences thoughts of self-harm or suicide, they should contact their doctor or go to the hospital immediately. It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to monitor them and inform them if their depression or anxiety worsens or if they notice any worrying changes in behavior.

Sexual dysfunction

Medicines like Setaloft (SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.

Children and adolescents

Setaloft should not be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder. It should also be emphasized that patients under 18 years of age taking medicines of this class are at increased risk of side effects, such as suicidal attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Setaloft to patients under 18 years of age, considering it to be in their best interest. If the doctor prescribes Setaloft to a patient under 18 years of age, and the patient has any doubts, they should consult the doctor. Moreover, if any of the above symptoms appear or worsen while taking Setaloft, the patient should inform their doctor.
In a long-term observational study lasting three years with over 900 children aged 6 to 16, the safety of long-term sertraline use was evaluated in terms of its effect on growth, maturation, learning (cognitive functions), 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.

Setaloft and other medicines

The patient should tell their doctor or pharmacist 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 Setaloft works or Setaloft may reduce the effectiveness of other medicines taken at the same time.

Taking Setaloft with the following medicines may cause serious side effects

• Medicines that are monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (used to treat high methemoglobin levels in the blood). The patient should not take Setaloft with these medicines.
• Medicines used to treat mental disorders (pimozide). The patient should not take Setaloft with pimozide.

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

• Medicines containing amphetamines (used to treat symptoms of attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Herbal medicines containing St. John's Wort (Hypericum perforatum). The effect of St. John's Wort may persist for 1-2 weeks.
• Products containing the amino acid tryptophan.
• Medicines used to treat severe or chronic pain (opioids, such as tramadol, fentanyl).
• Medicines used for anesthesia (such as fentanyl, mivacurium, and suxamethonium).
• Medicines used to treat migraines (such as sumatriptan).
• Medicines that prevent blood clotting (warfarin).
• Medicines used to treat pain/joint inflammation (such as metamizole, non-steroidal anti-inflammatory medicines (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, stomach ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• 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 treat high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, propafenone).
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medicines used to treat HIV/AIDS and hepatitis C infections

(protease inhibitors, such as ritonavir, telaprevir).

• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medicines that prevent platelet aggregation (ticlopidine).
• Medicines that increase the risk of changes in heart electrical activity (such as antipsychotic medicines and antibiotics).

Setaloft with food, drink, and alcohol

The tablets can be taken with or without food.
The patient should not consume alcohol while taking Setaloft.
The patient should not take Setaloft 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 considers that the benefits of the medicine for the mother outweigh the potential risks to the developing child.
Taking Setaloft 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 Setaloft, they should inform their doctor or midwife so that they can provide appropriate advice. Medicines like Setaloft (SSRIs) taken by pregnant women, especially in the last trimester, may increase the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN), causing rapid breathing and blue discoloration of the baby's skin. These symptoms usually occur in the first day of life. If they occur, the patient should contact the midwife and/or doctor immediately.
Newborn babies may also have other problems, which usually start within 24 hours of birth. Symptoms include:

• breathing difficulties
• blue discoloration of the skin or skin that is too hot or too cold
• blue discoloration of the lips
• vomiting or feeding problems
• excessive tiredness, sleep problems, constant crying
• stiffness or floppiness of the muscles
• tremors, shivering, or seizures
• increased reflexes
• irritability
• low blood sugar. If the patient's baby experiences any symptoms immediately after birth or the patient is concerned about their baby's health, they should contact their doctor or midwife for advice.

There is evidence that sertraline is excreted in human milk. The medicine can be used in breastfeeding women if the doctor considers that the benefits of the medicine for the mother outweigh the potential risks to the baby.
In animal studies, it has been shown that some medicines, such as sertraline, reduce sperm quality. This effect has not been observed in humans, but it is theoretically possible.

Driving and using machines

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

Setaloft contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Setaloft

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose of Setaloft

Adults

Depression and obsessive-compulsive disorder

The usual effective dose for treating 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.

Use in children and adolescents

In children and adolescents aged 6 to 17 years, Setaloft may only be used to treat obsessive-compulsive disorder.

Obsessive-compulsive disorder

Children aged 6 to 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 to 17 years:The recommended initial dose is 50 mg per day.
The maximum dose is 200 mg per day.
Patient with liver or kidney function disorders should inform their doctor and follow their instructions.

Method of administration

The 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 treatment period depends on the type of disease and the patient's response to treatment. Symptoms may not start to improve until after several weeks of treatment. Depression treatment should usually last for six months after improvement.

Taking a higher dose of Setaloft than recommended

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

Missing a dose of Setaloft

The patient should not take a double dose to make up for a missed dose.
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.

Stopping Setaloft

The patient should not stop taking Setaloft unless their doctor advises them to do so.
The doctor should gradually reduce the dose of Setaloft over several weeks until the patient finally stops taking it. If the patient suddenly stops taking the medicine, they may experience side effects, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors. If the patient experiences any of these side effects or any other side effects after stopping Setaloft, they should contact their doctor.
In case of doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 tell their doctor immediately

If they experience any of the following symptoms after taking this medicine (as they may be serious).

• Severe skin rash, which causes blistering (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 patient's treatment.
• Allergic reaction or allergy, which may include symptoms such as: itchy skin rash, breathing problems, wheezing, swelling of the eyelids, face, or lips.
• Agitation, 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 may occur when the patient takes other medicines at the same time as sertraline (symptoms, see section 4 "Possible side effects"). The doctor may then stop the patient's treatment.
• Yellowing of the skin and eyes, which may indicate liver damage.
• Symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
• Restlessness, which does not allow the patient to sit or stand still after taking Setaloft. If the patient starts to feel restless, they should tell their doctor.
• Seizure (seizures).
• Manic episode (see section 2 "Warnings and precautions").

The following side effects have been observed in clinical trials and after the medicine was placed on the market in adult patients.

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" feeling, nightmares, teeth grinding,
• tremors, movement disorders (such as: increased muscle activity, increased muscle tone, walking problems and stiffness, tremors and involuntary muscle movements)*, numbness and tingling, muscle tension, lack of attention, taste disorders,
• vision disturbances,
• ringing in the ears,
• palpitations,
• hot flashes,
• yawning,
• gastrointestinal disturbances, constipation, abdominal pain, vomiting, gas,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstrual cycle, erectile dysfunction,
• general malaise, chest pain, weakness, fever,
• weight gain,
• injuries.

Uncommon (may affect up to 1 in 100 people)

• appendicitis, ear infection,
• tumors,
• hypersensitivity, seasonal allergy,
• hypothyroidism,
• suicidal thoughts, suicidal behavior*, psychotic disorders, abnormal thinking, apathy, hallucinations, aggression, euphoric moods, paranoia,
• amnesia, decreased sensation, involuntary muscle contractions, fainting, increased mobility, migraine, seizures, dizziness when standing up, coordination disorders, speech disorders,
• pupil dilation,
• ear pain,
• rapid heartbeat, heart disorders,
• abnormal bleeding (such as: gastrointestinal bleeding)*, high blood pressure, hot flashes, blood in the urine,
• shortness of breath, nosebleeds, breathing problems, with possible wheezing,
• black stools, dental problems, esophagitis, tongue inflammation, hemorrhoids, increased salivation, swallowing problems, belching,
• eye swelling, hives, hair loss, itching, purpura, skin disorders with blistering, dry skin, facial swelling, cold sweats,
• degenerative joint disease, muscle tremors, muscle cramps*, muscle weakness,
• increased urination frequency, urination problems, inability to urinate, urinary incontinence, excessive urination, nocturia,
• sexual dysfunction, excessive vaginal bleeding, vaginal bleeding, sexual dysfunction in women,
• leg swelling, chills, gait disturbances, thirst,
• increased liver enzyme levels, weight loss,
• suicidal thoughts and behaviors have been reported during sertraline treatment or shortly after its discontinuation (see section 2).

Rare (may affect up to 1 in 1000 people)

• appendicitis, lymph node enlargement, decreased blood clotting*, decreased white blood cell count*,
• severe allergic reactions,
• endocrine disorders*,
• high cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar, high blood sugar*, low sodium levels in the blood*,
• physical symptoms associated with stress and emotions, nightmares*, drug dependence, sleepwalking, premature ejaculation,
• coma, agitation, movement problems, increased sensitivity, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
• floaters, glaucoma, double vision, photophobia, blood in the eye, uneven pupils*, vision disturbances*, tearing,
• heart attack, feeling of emptiness in the head, dizziness 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 limbs (peripheral hypoperfusion),
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, laryngospasm, voice problems, slow breathing, hiccups,
• a lung disease 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, tongue pain, oral discomfort,
• liver function disorders, severe liver function disorders*, yellowing of the skin and whites of the eyes (jaundice)*,
• skin reactions to sunlight*, skin swelling*, abnormal hair structure, unpleasant skin odor, hairy skin rash,
• muscle tissue breakdown*, bone disorders,
• urinary system function disorders, decreased urination,
• breast discharge, vaginal dryness, genital discharge, red, painful penis and foreskin, breast enlargement*, prolonged erection,
• hernia, decreased tolerance to the medicine,
• increased cholesterol levels in the blood, abnormal laboratory test results*, abnormal semen, blood clotting problems*,
• angioplasty.

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

• jaw stiffness*,
• nocturnal enuresis*,
• partial loss of vision,
• colitis (causing diarrhea)*,
• severe vaginal bleeding occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility", section 2*.

* Side effects reported after the medicine was placed on the market.

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 suddenly stops taking the medicine, they may experience side effects, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3 "Stopping Setaloft").
There is an increased risk of bone fractures in patients taking medicines of this type.

Reporting side effects

If side effects occur, including any not listed in the leaflet, the patient 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 marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Setaloft

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 carton after EXP. The expiry date refers to the last day of the month stated.
The medicine should not be stored above 25°C.
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 need. This will help protect the environment.

6. Contents of the pack and other information

What Setaloft contains

• The active substance of the medicine is sertraline in the form of sertraline hydrochloride. Each film-coated tablet contains sertraline hydrochloride equivalent to 50 mg of sertraline. Each film-coated tablet contains sertraline hydrochloride equivalent to 100 mg of sertraline.
• The other ingredients are: Core: colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, copovidone, lactose monohydrate, magnesium stearate. Coating: hypromellose 3cP, hydroxypropyl cellulose, macrogol 400, titanium dioxide (E171), hypromellose 50cP.

What Setaloft looks like and contents of the pack

50 mg
White to almost white, film-coated, capsule-shaped tablets with a notch on one side and the inscription "50" on the other side. Size: 4.6 x 10.7 mm. The tablet can be divided into equal doses.
100 mg
White to almost white, film-coated, capsule-shaped tablets with a notch on one side and the inscription "100" on the other side. Size: 5.6 x 13.2 mm. The tablet can be divided into equal doses.
This medicine is available in blisters (PVC/Aluminum): 14, 20, 30, 100 film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Teva Pharma S.L.U.
Poligono Industrial Malpica c/C No 4, 50016 Zaragoza
Spain
This medicine is authorized in the Member States of the European Economic Area under the following names:
Sweden:
Sertralet
Slovakia:
Sertraline Actavis
Czech Republic: Sertraline Actavis
Poland
Setaloft

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of leaflet approval:September 2024.