Asertin 50

Package Leaflet: Information for the User

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

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

• Keep this package 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 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 Package 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 package 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 (SSRIs); 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 compulsion 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 treating the disease in a given patient.
In case of doubts about prescribing Asertin, 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, wait at least one week before starting MAOI treatment. After stopping MAOI treatment, 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, discuss it with your doctor or pharmacist.
Medicines do not always suit every patient. Before taking Asertin, tell your doctor if any of the following apply to you:

• Serotonin syndrome. This syndrome can occur in rare cases in patients taking 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 due to Asertin use. 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. Particular caution is advised in elderly patients, as the risk of decreased sodium levels in the blood is higher in this group.
• Liver disease; the doctor may decide to reduce the dose of Asertin.
• Diabetes; Asertin may affect blood glucose levels, so a change in the dosage of antidiabetic medicines may be necessary.
• History of seizures or convulsions. If a seizure occurs, contact your doctor immediately.
• Bipolar disorder (manic-depressive) or schizophrenia. If a manic episode occurs, contact your doctor immediately.
• Suicidal thoughts (see below - Suicidal thoughts and worsening of depressive or anxiety disorders).
• Bleeding disorders or 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 condition should be closely monitored by a doctor (see: Children and adolescents, below).
• Electroconvulsive therapy.
• Medicines like Asertin (SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.

Anxiety/Akathisia

Sertraline use has been associated with the occurrence of akathisia (a distressing condition characterized by 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 often occur, 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, they can 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 antidepressant treatment, 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 antidepressants.

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 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 taking medicines from this group, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggressive, defiant, and angry behavior). 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, and behavior has not been established.

Asertin 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 how 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:

• Monoamine oxidase inhibitors (MAOIs, e.g., moclobemide, selegiline, and the antibiotic linezolid). Asertin should not be taken with MAOIs.
• Medicines used to treat mental disorders (pimozide). Asertin should not be taken with pimozide.

Tell your doctor about taking the following medicines:

• Herbal medicines containing St. John's Wort (Hypericum perforatum). The effect of St. John's Wort may last for 1-2 weeks. 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 antidepressants (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.
Do 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 baby, consult your doctor or pharmacist before taking this medicine.
Make sure your midwife and/or doctor know 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, contact the midwife and/or doctor immediately.
Taking Asertin at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If you are taking Asertin, inform your doctor or midwife so they can provide you with appropriate advice.

The safety of sertraline in pregnant women has not been fully established. Asertin should only be used in pregnant women if the doctor believes the benefits 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 if the doctor believes the benefits to the mother outweigh the potential risks to the baby.

In animal studies, some medicines similar to sertraline have been shown to decrease sperm quality. This could 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 machinery. Do 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, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, which means it is essentially "sodium-free".

3. How to take Asertin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Asertin tablets can be taken with or without food.
Take the medicine once a day, in the morning or evening.

Recommended dose:

Adults:

Depression and obsessive-compulsive disorder

The usual effective dose for treating depression and OCD is 50 mg/day. The daily dose can be increased gradually (over 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 PTSD should be started with a dose of 25 mg/day (half a 50 mg Asertin tablet), 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 50 mg Asertin tablet).
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, who will then provide guidance.
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, immediately contact a doctor or go to the nearest hospital. Take the medicine package with you, along with the label, regardless of whether it contains 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 a dose is missed, do not take the missed tablet. Take the next tablet at the right time.
Do not take a double dose to make up for a missed dose.

Stopping Asertin treatment

Do not stop taking Asertin without consulting your doctor. The doctor will gradually reduce the dose of Asertin over a period of several weeks or months 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 any of the above side effects occur or any other side effects during Asertin discontinuation, consult your doctor.
In case of further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Immediately consult a doctor:

If any of the following symptoms occur 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 advise 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 advise 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. Inform your doctor about the first signs of restlessness.

In clinical trials in adults, the following side effects were observed, occurring 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 disorder, 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 disturbances, lack of concentration, vision disturbances, ringing in the ears, palpitations, hot flashes, yawning, abdominal pain, vomiting, constipation, gastrointestinal disturbances, flatulence, rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain.

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

Cold, runny nose, hallucinations, feeling of euphoria, feeling of indifference, thinking disturbances, seizures, involuntary muscle contractions, coordination disturbances, increased restlessness, memory loss, sensation disturbances, speech disturbances, dizziness when standing up, migraine, ear pain, rapid heartbeat, high blood pressure, hot flashes, breathing difficulties, possible snoring, shallow breathing, nosebleeds, swallowing difficulties, hemorrhoids, increased salivation, tongue disturbances, oral ulcers, liver disturbances, 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, nipple discharge, hernia, scarring at the injection site, decreased drug tolerance, walking difficulties, abnormal laboratory test results, semen abnormalities, injuries, vasodilation.

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

Gastrointestinal disorders, ear infections, cancer, glandular swelling, elevated cholesterol, low blood glucose, physical symptoms caused by stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation, coma, abnormal movements, movement difficulties, increased sensitivity, sensation disturbances, glaucoma, tearing difficulties, 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 disturbances, tear secretion disturbances, heart attack, slow heartbeat, heart problems, circulation problems in the arms and legs, throat closure, rapid breathing, slow breathing, speech difficulties, hiccups, bloody stools, oral pain, tongue ulcers, dental problems, language difficulties, oral ulcers, liver disturbances, 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, nipple discharge, hernia, scarring at the injection site, decreased drug tolerance, walking difficulties, abnormal laboratory test results, semen abnormalities, injuries, vasodilation.
Frequency not known (frequency cannot be estimated from available data):partial loss of vision, colon inflammation (causing diarrhea), severe vaginal bleeding occurring shortly after delivery (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 walking difficulties), fainting, vision disturbances, 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.
Patients taking this type of medicine have been observed to have an increased risk of fractures.

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, 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 Asertin

Keep the medicine out of the sight and reach of children.
Do 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.
No special precautions for storage are necessary.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package 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.
Tablet 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 package

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 packages:
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 packages:
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