Asertin 100

Leaflet accompanying the packaging: information for the user

Asertin 50,50 mg, coated tablets
Asertin 100,100 mg, coated tablets
Sertraline

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Asertin and what is it used for

Asertin contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRI); these are medicines used to treat depression and/or anxiety disorders.
Asertin 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 with or without agoraphobia,
• obsessive-compulsive disorder (OCD) (in adults and children and adolescents from 6 to 17 years of age).

Depression is a disease characterized by symptoms such as sadness, sleep problems, and loss of joy in life.
Obsessive-compulsive disorder and panic disorder are anxiety-related diseases. They are accompanied by feelings of constant anxiety due to persistent thoughts (obsessions) that cause an internal urge to perform certain repetitive rituals (compulsive actions).
Post-traumatic stress disorder (PTSD) is a condition that can occur after an extremely traumatic experience and is characterized by certain symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related disease. It is characterized by a feeling of intense anxiety or stress in social situations (such as talking to strangers, public appearances, eating or drinking in the presence of others, or fears related to embarrassing behavior).
The doctor decides whether this medicine is suitable for the treatment of the disease in a given patient. If there are any doubts about prescribing Asertin, you should consult a doctor.

2. Important information before taking Asertin

When not to take Asertin

• 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, you should wait at least one week before starting MAOI treatment. After stopping MAOI treatment, you should wait at least two weeks before starting sertraline treatment,
• if the patient is taking pimozide (a medicine used to treat mental disorders, e.g., psychosis).

Warnings and precautions

Before starting Asertin, you should discuss it with your doctor or pharmacist.
Medicines do not always suit everyone. Before taking Asertin, you should tell your doctor if any of the following apply to you:

• Serotonin syndrome. This syndrome can occur in rare cases in patients who have taken certain medicines at the same time as sertraline. (Symptoms, see section 4: Possible side effects). The doctor will inform you if you have had serotonin syndrome in the past.
• Low sodium levels in the blood, as it may occur as a result of taking Asertin. You should also inform your doctor about taking certain medicines used to treat high blood pressure, as they may also change sodium levels in the blood. You should be particularly careful in elderly patients, as the risk of decreased sodium levels in the blood is higher in them.
• Liver disease; the doctor may decide to reduce the dose of Asertin.
• Diabetes; Asertin may affect blood sugar levels, so it may be necessary to change the dosage of antidiabetic medicines.
• Seizures or a history of seizures. If a seizure occurs, you should contact your doctor immediately.
• Bipolar disorder (manic-depressive) or schizophrenia. If a manic episode occurs, you should contact your doctor immediately.
• Suicidal thoughts (see below - Suicidal thoughts and worsening of depressive or anxiety disorders).
• Bleeding disorders or a history of taking medicines that prevent blood clotting (e.g., acetylsalicylic acid or warfarin) or may increase the risk of bleeding or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility").
• Children or adolescents under 18 years of age. Asertin should only be used in children and adolescents from 6 to 17 years of age for the treatment of obsessive-compulsive disorder. Patients treated for this disease should be closely monitored by a doctor (see: Children and adolescents, below).
• Electroconvulsive therapy.
• Medicines like Asertin (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.

Anxiety/akathisia

Sertraline use has been associated with the occurrence of akathisia (a distressing condition characterized by motor restlessness and a compulsion to move - often with an inability to sit or stand still). The greatest likelihood of such symptoms occurs within the first few weeks of treatment. In patients who experience such symptoms, increasing the dose of the medicine may be harmful.

Withdrawal symptoms

Withdrawal symptoms occur frequently, especially after sudden discontinuation of the medicine (see section 4. "Possible side effects"). The risk of withdrawal symptoms depends on the duration of treatment, dosage, and rate of dose reduction. Usually, the mentioned symptoms are mild to moderate, but in some patients, their course may be severe. They usually occur within the first few days after stopping the treatment. Such symptoms usually resolve on their own within two weeks. However, in some patients, they may persist for longer (for 2-3 months or longer). Therefore, before completely stopping Asertin, it is recommended to gradually reduce the dose over a period of several weeks or months - depending on the needs of the individual patient.

Suicidal thoughts, worsening of depression or anxiety disorders

Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start working after two weeks, and sometimes later.

The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

• the patient has had suicidal thoughts or self-harm in the past,
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in people under 25 with mental disorders who were treated with antidepressant medicines.

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

Children and adolescents

Essentially, sertraline should not be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder. In patients under 18 years of age, during the use of medicines from this group, an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggressive, defiant, and angry behavior) has been observed. However, the doctor may decide to prescribe Asertin to a patient under 18 years of age if it is in the patient's interest. If the doctor prescribes Asertin to a patient under 18 years of age, and the child's caregiver wants to discuss it, they should contact the doctor.
Additionally, if any of the above symptoms occur or worsen in a patient under 18 years of age taking Asertin, the doctor should be informed.
Furthermore, the long-term safety of Asertin in terms of its effect on growth, maturation, cognitive function development, and behavior has not been established.

Asertin and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the way Asertin works or Asertin may reduce the effectiveness of other medicines taken at the same time.

Taking Asertin with the following medicines may cause serious side effects:

• Medicines from the group of monoamine oxidase inhibitors (MAOIs, e.g., moclobemide, used to treat depression), selegiline (used to treat Parkinson's disease), and the antibiotic linezolid. Asertin should not be taken at the same time as MAOIs.
• Medicines used to treat mental disorders (pimozide). Asertin should not be taken at the same time as pimozide.

You should inform your doctor about taking the following medicines:

• Herbal medicines containing St. John's Wort (Hypericum perforatum). The effect of St. John's Wort may persist for 1-2 weeks. You should contact your doctor.
• Preparations containing the amino acid tryptophan.
• Medicines used to treat severe pain (e.g., tramadol).
• Medicines used to treat migraines (e.g., sumatriptan).
• Medicines that prevent blood clotting (warfarin).
• Medicines used to treat pain/inflammation of the joints (non-steroidal anti-inflammatory drugs - NSAIDs), e.g., ibuprofen, salicylic acid.
• Sedatives (diazepam).
• Diuretics.
• Medicines used to treat epilepsy (phenytoin).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excessive stomach acid production and stomach ulcers (cimetidine).
• Medicines used to treat mania and depression (lithium).
• Other antidepressant medicines (amitriptyline, nortriptyline).
• Medicines used to treat schizophrenia and other mental disorders (e.g., perphenazine, levomepromazine, and olanzapine).

Taking Asertin with food, drink, and alcohol

Asertin can be taken with or without food.
You should not drink alcohol while taking Asertin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
You should make sure that your midwife and/or doctor know that you are taking Asertin. The use of medicines like Asertin during pregnancy, especially in the last three months, may increase the risk of a serious condition in the baby, called persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and blue discoloration of the newborn's skin. These symptoms usually occur within the first 24 hours after birth. If a newborn experiences any of these symptoms, you should immediately inform the midwife and/or doctor.
Taking Asertin 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 you are taking Asertin, you should inform your doctor or midwife so that they can give you appropriate advice.

The safety of sertraline in pregnant women has not been fully confirmed. Asertin can be used in pregnant women only when, in the doctor's judgment, the benefits of its use outweigh the potential risks to the fetus. Women of childbearing age treated with sertraline should use effective contraception.

There is evidence that sertraline passes into breast milk. Sertraline can be used in breastfeeding women only when, in the doctor's judgment, the benefits to the mother outweigh the potential risks to the baby.

In animal studies, some medicines similar to sertraline have reduced sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

Psychotropic medicines, including sertraline, may affect the ability to drive or operate machines. You should not drive or operate machinery until you know how the medicine affects you.
Asertin contains lactose. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg)of sodium per maximum daily dose, which means that the medicine is considered "sodium-free".

3. How to take Asertin

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Asertin tablets can be taken with or without food.
The medicine should be taken once a day, in the morning or evening.

Recommended dose:

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 (over a period of several weeks) by 50 mg, at intervals of at least one week. The maximum recommended daily dose is 200 mg/day.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder (PTSD)

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

Use in children and adolescents

Asertin can be used in children and adolescents from 6 to 17 years of age only for the treatment of obsessive-compulsive disorder.

Obsessive-compulsive disorder

Children from 6 to 12 years of age:The recommended initial dose is 25 mg/day (half a tablet of Asertin 50).
After one week, the doctor may recommend increasing the dose to 50 mg/day.
The maximum dose is 200 mg/day.
Adolescents from 13 to 17 years of age: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 then follow their recommendations.
The doctor will inform the patient how long they should take the medicine. The treatment period depends on the type of disease and the patient's response to treatment. Improvement of symptoms may start only after several weeks of treatment.

Taking a higher dose of Asertin than recommended

In case of accidental ingestion of too much Asertin, you should immediately inform your doctor or go to the nearest hospital. You should take the packaging of the medicine with you, along with the label, regardless of whether it contains the medicine or not.
Symptoms of overdose in adults include: drowsiness, nausea, vomiting, rapid heartbeat, tremors, agitation, dizziness, and in rare cases - loss of consciousness.

Missing a dose of Asertin

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

Stopping Asertin treatment

You should not stop taking Asertin without consulting your doctor first. The doctor will gradually reduce the dose of Asertin over a period of several weeks, until the treatment is completely stopped. Stopping the medicine abruptly may cause side effects, such as dizziness, numbness, sleep disturbances, agitation, or anxiety, headaches, nausea, vomiting, and muscle tremors.
If you experience any of the above side effects or any other side effects during the discontinuation of Asertin, you should consult your doctor.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects, including those not listed in this leaflet, you should consult your doctor or pharmacist.
The most commonly reported side effect is nausea. Side effects depend on the dose taken and often disappear as treatment continues.

You should immediately inform your doctor:

If you experience any of the following symptoms while taking Asertin (these symptoms may be serious):

• severe skin rash, causing blisters (erythema multiforme); blisters may appear in the mouth and on the tongue. These may be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In such cases, the doctor will recommend stopping the treatment; allergic reactions or allergies that may cause symptoms such as: itchy skin rash, difficulty breathing, wheezing, swelling of the eyelids, face, or lips;
• agitation, confusion, diarrhea, high fever, and high blood pressure, excessive sweating, and rapid heartbeat. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur in patients taking certain medicines at the same time as sertraline. The doctor may then recommend stopping the treatment;
• yellowing of the skin and eyes, which may indicate liver damage;
• symptoms of depression with suicidal thoughts;
• restlessness and inability to sit or stand still after taking Asertin. You should inform your doctor about the first signs of restlessness.

In clinical trials in adults, the following side effects were observed, which occurred at the following frequencies:

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

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

Common side effects (occurring in 1 to 10 in 100 patients):

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

Uncommon side effects (occurring in 1 to 10 in 1000 patients):

Cold, runny nose, hallucinations, feeling of euphoria, feeling of indifference, thinking disorders, seizures, involuntary muscle contractions, coordination disorders, increased restlessness, memory loss, sensation disorders, speech disorders, dizziness when standing up, migraine, ear pain, rapid heartbeat, high blood pressure, hot flashes, breathing difficulties, possible snoring, shallow breathing, nosebleeds, problems with swallowing, difficulty speaking, hiccups, bloody stools, oral pain, tongue ulcers, dental problems, language problems, oral ulcers, liver disorders, skin disorders with blistering, hairy skin rash, abnormal hair structure, abnormal skin odor, bone disorders, decreased urination, urinary incontinence, delayed urination, excessive vaginal bleeding, vaginal dryness, painful red penis and foreskin, discharge, prolonged erection of the penis, nipple discharge, hernia, scarring at the injection site, decreased drug tolerance, walking difficulties, abnormal laboratory test results, semen abnormalities, injuries, vascular rupture.

Rare side effects (occurring in 1 to 10 in 10,000 patients):

Gastrointestinal disorders, ear infections, cancer, glandular swelling, elevated cholesterol levels, low blood sugar levels, physical symptoms caused by stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation, coma, abnormal movements, difficulty moving, increased sensitivity, sensation disorders, glaucoma, eye problems, blurred vision, double vision, sensitivity to light, eye bleeding, pupil dilation, spots before the eyes, glaucoma, double vision, light sensitivity, eye bleeding, uneven pupil size, vision disorders, tear secretion disorders, heart attack, slow heartbeat, heart problems, worsening of blood circulation in the arms and legs, throat closure, rapid breathing, slow breathing, speech difficulties, hiccups, bloody stools, oral pain, tongue ulcers, dental problems, language problems, oral ulcers, liver disorders, skin disorders with blistering, hairy skin rash, abnormal hair structure, abnormal skin odor, bone disorders, decreased urination, urinary incontinence, delayed urination, excessive vaginal bleeding, vaginal dryness, painful red penis and foreskin, discharge, prolonged erection of the penis, nipple discharge, hernia, scarring at the injection site, decreased drug tolerance, walking difficulties, abnormal laboratory test results, semen abnormalities, injuries, vascular rupture.
Frequency not known (frequency cannot be estimated from available data):partial loss of vision, colitis (causing diarrhea), severe postpartum hemorrhage, see additional information in the subsection Pregnancy, breastfeeding, and fertility in section 2.

After the introduction of sertraline to the market, the following side effects have been reported:

Decreased white blood cell count, decreased platelet count, decreased thyroid hormone levels, endocrine disorders, decreased sodium levels, nightmares, suicidal behavior, movement disorders (e.g., increased motor activity, increased muscle tone, and difficulty walking), fainting, vision disorders, bleeding disorders (including nosebleeds, gastrointestinal bleeding, or hematuria), pancreatitis, severe liver function disorders, jaundice, skin swelling, sun-related skin reaction, itching, joint pain, muscle spasms, breast enlargement, irregular menstruation, swelling of the legs, problems with blood clotting, and severe allergic reactions.
In patients taking this type of medicine, an increased risk of fractures has been observed.

Additional side effects in children and adolescents

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Asertin

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Asertin contains

The active substance of Asertin is sertraline.
Asertin 50, 50 mg, coated tablets
Each coated tablet contains 50 mg of sertraline (as hydrochloride).
Asertin 100, 100 mg, coated tablets
Each coated tablet contains 100 mg of sertraline (as hydrochloride).
Other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, povidone K30, sodium croscarmellose, magnesium stearate.
Coating: hypromellose 6 (Asertin 50), hypromellose 6 and hypromellose 15 (Asertin 100), talc, propylene glycol, titanium dioxide (E 171).

What Asertin looks like and contents of the pack

Asertin 50, 50 mg, coated tablets
White, coated, oval, biconvex, 10 x 5 mm tablets, with a dividing line on one side.
The tablet can be divided into equal doses.
Available packs:
Carton box containing 10, 28, 30, and 60 coated tablets.
Blisters of PVC/PVDC/Aluminum.
Asertin 100, 100 mg, coated tablets
White, coated, round, biconvex, 10 mm tablets, with a notch on one side and the letter C embossed on the other.
The tablet can be divided into equal doses.
Available packs:
Carton box containing 28, 30, and 60 coated tablets.
Blisters of PVC/PVDC/Aluminum.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań

Date of last revision of the leaflet: 03.11.2023

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
www.urpl.gov.pl