Aposerta

Package Leaflet: Information for the User

ApoSerta, 50 mg, film-coated tablets

ApoSerta, 100 mg, film-coated tablets

Sertraline

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should keep this 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 signs of illness 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 pack and other information

• 1. What ApoSerta is and what it is used for
• 2. What you need to know before you take ApoSerta
• 3. How to take ApoSerta
• 4. Possible side effects
• 5. How to store ApoSerta
• 6. Contents of the pack and other information

1. What ApoSerta is and what it is used for

ApoSerta 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.

ApoSerta is 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 condition in which you may feel sad, have trouble sleeping and/or loss of interest in activities.
Obsessive-compulsive disorder and panic disorder are anxiety disorders in which you may have persistent and recurring thoughts (obsessions) that are intrusive and/or repetitive behaviors (compulsions).
Post-traumatic stress disorder is a condition that can occur after a traumatic event and is characterized by symptoms similar to depression and anxiety. Social anxiety disorder is an anxiety disorder characterized by excessive fear or anxiety in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in front of others, or fear of potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for the treatment of your condition. You should ask your doctor if you are unsure why you have been given ApoSerta.

2. What you need to know before you take ApoSerta

Do not take ApoSerta

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 other MAOI-like drugs (e.g., linezolid). If you stop taking sertraline, you must wait at least one week before starting an MAOI. After stopping an MAOI, you must wait at least two weeks before starting sertraline;
if you are taking pimozide (a medicine used to treat certain mental disorders, such as psychosis).

Warnings and precautions

Before taking ApoSerta, you should discuss this with your doctor or pharmacist.
Medicines do not always work in the same way for everyone.
Before taking ApoSerta, you should tell your doctor if you have or have had any of the following conditions:

• If you have a history of epilepsy or seizures. If you have a seizure, you should contact your doctor immediately.
• If you have a history of manic-depressive illness (bipolar disorder) or schizophrenia. If you experience a manic episode, you should contact your doctor immediately.
• If you have a history of suicidal thoughts or behaviors (see below - Suicidal thoughts and worsening of depression or anxiety).
• If you have serotonin syndrome. This syndrome can occur in rare cases 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 serotonin syndrome in the past.
• If you are taking medicines containing buprenorphine. Taking these medicines with ApoSerta may lead to serotonin syndrome, a potentially life-threatening condition (see "ApoSerta with other medicines").
• If you have low sodium levels in your blood, as this may occur with ApoSerta use. You should also inform your doctor if you are taking medicines used to treat high blood pressure, as they may also affect sodium levels in your blood.
• If you are elderly; such individuals may be more prone to low sodium levels in the blood (see above).
• If you have liver disease; your doctor may decide to reduce the dose of ApoSerta.
• If you have diabetes; ApoSerta may affect blood sugar levels, so a change in the dosage of antidiabetic medicines may be necessary.
• If you have a history of bleeding disorders (tendency to bruise) or if you are pregnant (see "Pregnancy, breastfeeding, and fertility") or have taken medicines that prevent blood clotting (e.g., acetylsalicylic acid (aspirin) or warfarin) or may increase the risk of bleeding.
• If you are under 18 years old. ApoSerta should not be used in children and adolescents under 18 years old, except for patients with obsessive-compulsive disorder. Patients with this disorder should be closely monitored by their doctor (see below "Children and adolescents").
• If you are undergoing electroconvulsive therapy (ECT).
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If you have ECG abnormalities, known as prolonged QT interval.
• If you have heart disease, low potassium or low magnesium levels, QTc interval prolongation in family history, slow heart rate, and concomitant use of QTc-prolonging drugs.

Sexual dysfunction

Medicines like ApoSerta (SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Psychomotor restlessness/Akathisia

Sertraline use has been associated with the development of a condition characterized by restlessness and an urge to move, often accompanied by an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. Increasing the dose may be harmful; if such symptoms occur, you should discuss them with your doctor.

Withdrawal effects

Discontinuation symptoms (withdrawal effects) are common, especially if treatment is stopped abruptly (see section 3: Stopping ApoSerta and section 4: Possible side effects). The risk of withdrawal effects depends on the duration of treatment, dosage, and rate of dose reduction. These symptoms are usually mild or moderate, but in some patients, they can be severe. They usually occur within the first few days of stopping treatment. They usually resolve on their own within two weeks, but in some patients, they can persist for 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 and always discuss the best way to stop treatment with your doctor.

Suicidal thoughts, worsening of depression or anxiety

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

The risk of suicidal thoughts or behaviors may be higher if:

• you have had suicidal thoughts or self-harm in the past;
• you are a young adult; clinical trial data suggest an increased risk of suicidal behavior in patients under 25 years of age with mental disorders treated with antidepressant medicines.

If you experience suicidal thoughts or self-harm, you should contact your doctor or go to the hospital immediately.

Children and adolescents

Sertraline should not be used in children and adolescents under 18 years old, except for patients with obsessive-compulsive disorder. In children and adolescents under 18 years old treated with this type of medicine, there is an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggressive, oppositional, and angry behavior). However, your doctor may decide to prescribe ApoSerta to a patient under 18 years old if it is in the patient's best interest. If your doctor prescribes ApoSerta to a patient under 18 years old and the patient's caregiver wants to discuss this, they should contact the doctor. Furthermore, if a patient under 18 years old experiences any of the above symptoms while taking ApoSerta, the caregiver should inform the doctor. In a long-term observational study lasting 3 years with over 900 children aged 6-16 years, the safety of long-term sertraline use was evaluated in terms of its effect on growth, maturation, learning (cognitive function), and behavior. Overall, the study results showed that children treated with sertraline developed normally, except for a small increase in body weight in children treated with a higher dose.

ApoSerta with other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Some medicines may affect how ApoSerta works or ApoSerta may reduce the effectiveness of other medicines taken at the same time.

Taking ApoSerta 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), the antibiotic linezolid, and methylene blue (used to treat high levels of methemoglobin in the blood). You should not take ApoSerta with MAOIs.
• Medicines used to treat mental disorders, such as psychosis (pimozide). You should not take ApoSerta 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 effects of St. John's Wort may last for 1-2 weeks.
• Preparations containing the amino acid tryptophan.
• Medicines used to treat severe or chronic pain (opioids, e.g., tramadol, fentanyl) and opioid addiction (medicines containing buprenorphine).
• Medicines used for anesthesia (fentanyl, mivacurium, and suxamethonium).
• Medicines used to treat migraines (e.g., sumatriptan).
• Medicines that prevent blood clotting (warfarin).
• Medicines used to treat pain/inflammation of the joints (e.g., metamizole, non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, salicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics.
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excessive stomach acid production, stomach ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines used to treat mania and depression (lithium).
• Other medicines used to treat depression (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 (protease inhibitors, such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after chemotherapy (aprepitant).
• Medicines that increase the risk of changes in heart electrical activity (such as antipsychotic and antibiotic medicines).
• Metamizole, a medicine used to treat pain and fever.

Some medicines may increase the side effects of ApoSerta and sometimes may cause very serious reactions. While taking ApoSerta, you should not take any other medicines without consulting your doctor, especially:

• Medicines containing buprenorphine. These medicines may interact with ApoSerta and cause symptoms such as involuntary, rhythmic muscle contractions, including those controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle rigidity, and body temperature above 38°C. If such symptoms occur, you should contact your doctor.

ApoSerta with food, drink, and alcohol

ApoSerta film-coated tablets can be taken with or without food.
You should avoid drinking alcohol while taking ApoSerta.
You should not take ApoSerta with grapefruit juice, as it may 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 or pharmacist for advice before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline may be taken during pregnancy if your doctor considers that the benefits to you outweigh the potential risks to your unborn child.
Taking ApoSerta in the last months 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 ApoSerta, you should inform your doctor or midwife so that they can give you appropriate advice. Taking medicines like ApoSerta 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), characterized by rapid breathing and blue discoloration of the skin. These symptoms usually occur within the first day of life. If your baby experiences these symptoms, you should contact the midwife or doctor immediately.
Other disorders may also occur in newborns, usually within the first 24 hours after birth. Symptoms may include:

• breathing difficulties,
• bluish discoloration of the skin or abnormal skin temperature,
• bluish discoloration of the lips,
• vomiting or feeding difficulties,
• excessive tiredness, sleeplessness, or constant crying,
• increased or decreased muscle tone,
• tremors, muscle contractions, or convulsions,
• increased reflexes,
• agitation,
• low blood sugar.

If your baby experiences any of these symptoms or if you are concerned about your baby's health, you should contact the doctor or midwife, who will give you advice.
Sertraline passes into breast milk. The medicine can be used during breastfeeding if your doctor considers that the benefits to you outweigh the potential risks to your baby.
Some medicines, such as sertraline, may decrease sperm quality in animal studies. This may affect fertility, but no effect on fertility has been observed in humans yet.

Driving and using machines

Psychotropic medicines, such as sertraline, may affect your ability to drive or operate machinery. You should wait until you know how ApoSerta affects you before performing these activities.

ApoSerta contains sodium

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

3. How to take ApoSerta

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 ApoSerta:

Adults

Depression and obsessive-compulsive disorder

The usual effective dose for the treatment of depression and OCD is 50 mg/day. The daily dose can be increased gradually, by 50 mg, at intervals of at least one week over several weeks. The maximum recommended dose is 200 mg/day.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder

Treatment of panic disorder, social anxiety disorder, and post-traumatic stress disorder should start with a dose of 25 mg/day, which can be increased to 50 mg/day after one week. The daily dose can then be increased gradually, by 50 mg, over several weeks. The maximum recommended dose is 200 mg/day.

Children and adolescents

ApoSerta can be used in children and adolescents only for the treatment of obsessive-compulsive disorder (OCD) in patients aged 6-17 years.

Obsessive-compulsive disorder

Children aged 6-12 years:The recommended initial dose is 25 mg/day. After one week, the doctor may increase the dose to 50 mg/day. The maximum dose is 200 mg/day.
Adolescents aged 13-17 years:The recommended initial dose is 50 mg/day. The maximum dose is 200 mg/day.
Patients with liver or kidney disease should inform their doctor and follow their advice.
Administration:
ApoSerta film-coated tablets can be taken with or without food.
The medicine should be taken once a day, in the morning or evening.
Your doctor will tell you how long you should take ApoSerta. The treatment period depends on the type of disease and your response to treatment. Improvement may occur only after several weeks of treatment. Treatment of depression should usually last 6 months from the time improvement is observed.

Taking more ApoSerta than you should

If you accidentally take too much ApoSerta, you should immediately contact your doctor or go to the emergency department of the nearest hospital. You should always take the medicine packaging 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.

Forgetting to take ApoSerta

You should not take a double dose of ApoSerta to make up for a forgotten dose. If you forget to take a tablet, you should not take the missed tablet. You should simply take the next tablet at the right time.

Stopping ApoSerta treatment

You should not stop taking ApoSerta on your own. Your doctor should gradually reduce the dose of ApoSerta over several weeks until you finally stop taking it. If you suddenly stop taking ApoSerta, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors. If you experience any of these side effects or any other side effects after stopping ApoSerta, you should contact your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, ApoSerta 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.

See a doctor immediately

If you experience any of the following symptoms after taking this medicine, as they can be serious:
if you develop a severe skin rash that causes blistering (erythema multiforme; blisters may occur 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, your doctor will stop treatment.
if you experience an allergic reaction or allergy, with symptoms such as itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
if you experience: agitation, confusion, diarrhea, high temperature and blood pressure, excessive sweating, and rapid heartbeat. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when you take certain medicines at the same time as sertraline. Your doctor may then stop the treatment you are taking.
if you experience yellowing of the skin and eyes, which may indicate liver damage.
if you experience symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
if you start to feel restless and unable to sit or stand still. If you experience such restlessness, you should tell your doctor.
if you experience a seizure (convulsion).
if you experience manic episodes (see section 2 "Warnings and precautions").

The following side effects have been reported in clinical trials with adults and after marketing authorization:

• 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, runny nose,
loss of appetite, increased appetite,
anxiety, depression, agitation, nervousness, decreased sexual interest, nervousness, strange feelings, nightmares, teeth grinding,
tremors, muscle movement problems (such as increased muscle activity, increased muscle tone, difficulty walking and stiffness, convulsions (muscle contractions without affecting normal muscle movement)), feeling of numbness and tingling, concentration problems, 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, menstrual irregularities, erectile dysfunction, general malaise, chest pain, weakness, fever, weight gain, injuries.

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

appendicitis, lymph node swelling, decreased platelet count*, decreased white blood cell count*, severe allergic reaction, endocrine disorders*, high cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar, high blood sugar*, low sodium levels in the blood*, physical symptoms caused by stress or emotions, terrifying nightmares*, drug dependence, sleepwalking, premature ejaculation, coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome, RCVS)*, sensory disturbances, blurred vision*, glaucoma*, double vision*, eye pain caused by light*, blood in the eye*, uneven pupil size*, vision disturbances*, problems with tear production*, heart attack, dizziness, fainting, or discomfort in the chest, which may be symptoms of changes in heart electrical activity (visible on an electrocardiogram) or abnormal heart rhythm*, slow heartbeat, circulation problems in the arms and legs, rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, blockage of the airway, difficulty speaking, 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, mouth ulcers, mouth pain, liver function disorders, severe liver function disorders*, yellowing of the skin and eyes (jaundice)*, sunburn*, skin swelling*, abnormal hair structure, abnormal skin odor, hairy skin rash, muscle breakdown*, bone disorders, difficulty urinating, decreased urine output, nipple discharge, vaginal dryness, vaginal discharge, breast tenderness, prolonged erection of the penis, hernia, decreased drug tolerance, high cholesterol levels in the blood, abnormal laboratory test results*, abnormal sperm test results, bleeding problems*, blood vessel dilation.

Unknown frequency (frequency cannot be estimated from available data):

jaw pain*, bedwetting*, partial loss of vision*, colitis (causing diarrhea), severe postpartum bleeding (postpartum hemorrhage), see additional information in section 2 "Pregnancy, breastfeeding, and fertility".

• * Side effects reported after marketing authorization.

Additional 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 headaches, insomnia, diarrhea, and nausea.

Withdrawal symptoms

After stopping ApoSerta, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3 "Stopping ApoSerta treatment").
Patient groups treated with this type of medicine have shown an increased risk of bone fractures.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
You can also report side effects to the representative of the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ApoSerta

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 requirements for this medicine.
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 ApoSerta contains

The active substance is sertraline.
ApoSerta, 50 mg, film-coated tablets:
Each film-coated tablet contains sertraline hydrochloride, equivalent to 50 mg of sertraline.
ApoSerta, 100 mg, film-coated tablets:
Each film-coated tablet contains sertraline hydrochloride, equivalent to 100 mg of sertraline.
Other ingredients are:
Tablet core:microcrystalline cellulose (PH-101), sodium carboxymethylcellulose (type A), hydroxypropylcellulose, calcium phosphate dihydrate, magnesium stearate.
Tablet coating:Opadry White OY-S-7355 containing titanium dioxide (E 171), hypromellose 5cp (low viscosity), macrogol 400, polysorbate 80.

What ApoSerta looks like and contents of the pack

Film-coated tablets.
ApoSerta, 50 mg, film-coated tablets
White, biconvex, capsule-shaped, with "A" embossed on one side and a score line between the numbers "8" and "1" on the other. Size: 10.5 mm x 4.3 mm.
The tablet can be divided into equal doses.
ApoSerta, 100 mg, film-coated tablets
White, biconvex, capsule-shaped, with "A" embossed on one side and "82" on the other. Size: 13.3 mm x 5.3 mm.
ApoSerta film-coated tablets are available in blisters, packed in cardboard boxes.
Pack sizes: 20, 30, 60, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

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

Czech Republic:

Sertraline Aurovitas
Malta:
Sertraline Aurobindo 50 mg/100 mg film-coated tablets
Poland:
ApoSerta
Portugal:
Sertraline Aurovitas
Spain:
Sertraline Aurovitas 50 mg/100 mg film-coated tablets EFG

Date of last revision of the leaflet: 03/2024