Setaloft 100 mg

Package Leaflet: Information for the Patient

Setaloft 50 mg, 50 mg, film-coated tablets

Setaloft 100 mg, 100 mg, film-coated tablets

Sertraline

Read the package 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.
• 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 experience any side effects, including those not listed in this leaflet, tell your 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 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 an illness in which you feel sad, have difficulty sleeping or enjoying life.
Obsessive-compulsive disorder (OCD) and panic disorder are anxiety-related disorders with symptoms of persistent anxiety due to recurring thoughts (obsessions), which cause repetitive rituals (compulsive actions).
Post-traumatic stress disorder (PTSD) is a condition that can 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 in front of a group of people, eating or drinking in the presence of others, or worrying about potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for treating your illness. You should consult your doctor if you are unsure why you have been given Setaloft.

2. Important information before taking Setaloft

When not to take Setaloft:

• 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, e.g., selegiline, moclobemide) or medicines similar to MAOIs (e.g., linezolid). After stopping sertraline treatment, you must wait at least one week before starting MAOI treatment. After stopping MAOI treatment, you must wait at least two weeks before starting sertraline treatment.
• If you are taking pimozide (a medicine used to treat mental disorders, such as psychoses).

Warnings and precautions

Before taking Setaloft, discuss this with your doctor or pharmacist.
Medicines do not always suit everyone. Tell your doctor before taking Setaloft if you have or have had any of the following conditions:

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

...

Akathisia/Psychomotor restlessness

Sertraline treatment has been associated with the occurrence of psychomotor restlessness 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. You should contact your doctor if you 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 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. In some patients, they can 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 can 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 with your 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 antidepressant treatment, 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 years of age with mental disorders who were treated with antidepressants. If you experience thoughts of self-harm or suicide, you should contact your doctor or go to the hospital immediately. It may be helpful to inform your relatives or friends about your depression or anxiety disorder and ask them to read this leaflet. You may ask them to monitor you and inform you if your depression or anxiety worsens or if you experience 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 treatment was stopped.

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, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, your doctor may prescribe Setaloft to patients under 18 years of age, considering it to be in their best interest. If your doctor has prescribed Setaloft to a patient under 18 years of age and you have any doubts, please consult the doctor. Furthermore, if any of the above symptoms appear or worsen while taking Setaloft, you should inform your doctor.
In a long-term observational study lasting three years, involving over 900 children aged 6 to 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.

Setaloft and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you 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). You must not take Setaloft with these medicines.
• Medicines used to treat mental disorders (pimozide). You must not take Setaloft with pimozide.

You should tell your doctor if you are taking any of the following medicines

• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Herbal 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/inflammation of the joints (such as metamizole, 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, stomach ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazol).
• 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

Tablets can be taken with or without food.
Do not drink alcohol while taking Setaloft.
Do not take Setaloft with grapefruit juice, as it may increase the level of sertraline in your body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The safety of sertraline use in pregnant women has not been fully established. The medicine can be used in pregnant women only if the doctor considers that the benefits to the mother outweigh the potential risks to the developing child.
Taking Setaloft at the end of pregnancy may increase the risk of severe bleeding from the uterus, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Setaloft, you should inform your doctor or midwife so that they can give you appropriate advice. Medicines like Setaloft (SSRIs) taken by pregnant women, especially in the last trimester, may increase the risk of a serious condition called persistent pulmonary hypertension in newborns (PPHN), causing rapid breathing and blue discoloration of the baby's skin. These symptoms usually occur within the first day of life. If this happens, you 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 your baby experiences any of these symptoms soon after birth or if you are concerned about your baby's health, you should contact your 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 to the mother outweigh the potential risks to the baby.
In animal studies, it has been shown that some medicines, such as sertraline, can reduce sperm quality. This effect has not been observed in humans, although it is theoretically possible.

Driving and using machines

Psychotropic medicines, such as sertraline, can affect your ability to drive or operate machines. Do not drive or operate machines until you know how the medicine affects you.

Setaloft contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Setaloft

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose of Setaloft is

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 can only be used to treat obsessive-compulsive disorder.

Obsessive-compulsive disorder

Children aged 6 to 12 years:The recommended starting 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 starting 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 advice.

Method of administration

Tablets can be taken with or without food.
Take the medicine once a day, in the morning or evening.
Your doctor will tell you how long to 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 you accidentally take too much Setaloft, contact your doctor or go to the emergency department of the nearest hospital immediately. Always take the medicine package with you, regardless of whether there is medicine left in it or not.
Overdose symptoms may include: drowsiness, nausea, and vomiting, rapid heartbeat, muscle tremors, agitation, dizziness, and, in rare cases, loss of consciousness.

Missing a dose of Setaloft

Do not take a double dose to make up for a missed dose.
If you forget to take a tablet, do not take the missed tablet. Simply take the next tablet at the right time.

Stopping Setaloft treatment

You should not stop taking Setaloft unless your doctor advises you to do so.
Your doctor should gradually reduce the dose of Setaloft over several weeks until you finally stop taking it. If you suddenly stop taking the medicine, you may experience side effects, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and muscle tremors. If you experience any of these side effects or any other side effects after stopping Setaloft treatment, you should contact your doctor.
If you have any doubts about taking the medicine, you should contact your 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.

Tell your doctor immediately

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

• Severe skin rash, which can cause blisters (erythema multiforme) (blisters may appear in the mouth and on the tongue). These can be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In such cases, your doctor will stop treatment.
• An allergic reaction or allergy, which can cause 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 neuroleptic malignant syndrome. In rare cases, these syndromes can occur when patients take other medicines at the same time as sertraline (symptoms, see section 4 "Possible side effects"). Your doctor may stop treatment in such cases.
• Yellowing of the skin and eyes, which can indicate liver damage.
• Symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
• Restlessness, which does not allow you to sit or stand still after taking Setaloft. If you experience restlessness, you should tell your doctor.
• Seizures (convulsions).
• A manic episode (see section 2 "Warnings and precautions").

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

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

Insomnia, dizziness, drowsiness, headache, diarrhea, nausea, dry mouth, ejaculation disorder, 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 disturbances,
• vision disturbances,
• ringing in the ears,
• palpitations,
• hot flushes,
• 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, hallucination, aggression, euphoric mood, 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 flushes, 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, speech disorders,
• eye swelling, hives, hair loss, itching, purple spots on the skin, 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, female sexual dysfunction,
• leg swelling, chills, gait disturbances, thirst,
• increased liver enzyme levels, weight loss,
• * Side effects reported after the medicine was marketed.

Rare (may affect up to 1 in 1,000 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 can be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome (RCVS))*, sensory disturbances,
• blind spots, glaucoma, double vision, photophobia, blood in the eye, uneven pupils*, vision disturbances*, tearing,
• heart attack, feeling of emptiness in the head, fainting or discomfort in the chest, which can 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 ischemia),
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, laryngospasm, voice problems, slow breathing, hiccups,
• a 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, 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 drug tolerance,
• increased blood cholesterol levels, abnormal laboratory test results*, abnormal semen, bleeding problems*,
• angioplasty.

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

• jaw tightness*,
• 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 marketed.

Side effects in children and adolescents

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

Symptoms that may occur after stopping treatment

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, you can help provide more information on the safety of this medicine.

5. How to store Setaloft

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 carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Setaloft contains

• The active substance 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:
Sertralin Actavis
Czech Republic Sertralin Actavis
Poland
Setaloft

To obtain more detailed information on this medicine and its names in the Member States of the European Economic Area, please 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 revision of the leaflet:September 2024.