Asertin 50

Package leaflet: Information for the user

Asertin 50, 50 mg, film-coated tablets
Asertin 100, 100 mg, film-coated tablets
Sertralinum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Asertin is and what it is 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 pack and other information

1. What Asertin is and what it is 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 may be used to treat:

• depression and prevention of recurrence of depression (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 in children and adolescents aged 6 to 17 years).

Depression is an illness characterized by symptoms such as sadness, sleep disturbances, and loss of enjoyment in life.
Obsessive-compulsive disorder and panic disorder are anxiety-related conditions. They involve persistent feelings of anxiety due to intrusive thoughts (obsessions), which lead to an inner compulsion to perform certain repetitive rituals (compulsive behaviors).
Post-traumatic stress disorder (PTSD) is a condition that may occur after an exceptionally traumatic experience and is characterized by certain symptoms similar to those of depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense fear or stress in social situations (such as talking to strangers, public speaking, eating or drinking in front of others, or fear of behaving in a way that may lead to embarrassment).
Your doctor decides whether this medicine is suitable for treating the condition affecting the individual patient.
If you have any doubts regarding the prescription of Asertin, consult your doctor.

2. Important information before using Asertin

When not to use 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 currently taking or has recently taken medicines from the group of monoamine oxidase inhibitors (MAO inhibitors, e.g. selegiline, moclobemide) or medicines similar to MAO inhibitors (e.g. linezolid). At least one week must elapse after discontinuing sertraline before starting treatment with an MAO inhibitor. After stopping treatment with an MAO inhibitor, at least two weeks must pass before starting treatment with sertraline,
• if the patient is taking pimozide (a medicine used to treat psychiatric disorders, e.g. psychosis).

Warnings and precautions
Before starting to take Asertin, discuss this with your doctor or pharmacist.
Medicines are not always suitable for every patient. Before taking Asertin, inform your doctor if any of the following apply to the patient:

• Serotonin syndrome. In rare cases, this syndrome may occur in patients who have taken certain medicines at the same time as sertraline. (Symptoms, see section 4.: Possible side effects). Your doctor will inform you if you have previously experienced serotonin syndrome.
• Low sodium blood levels, as this may occur as a result of taking Asertin. You should also inform your doctor if you are taking certain medicines used to treat high blood pressure, as they may also affect blood sodium levels. Particular caution is advised in elderly patients, as they have a higher risk of reduced blood sodium levels.
• Liver disease; your 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.
• Epilepsy or history of seizures. If a seizure occurs, contact your doctor immediately.
• Bipolar disorder (manic-depressive illness) or schizophrenia. If a manic episode occurs, contact your doctor immediately.
• Suicidal thoughts (see below: Suicidal thoughts and worsening of depression or anxiety disorders).
• Bleeding disorders or previous use of medicines that prevent blood clotting (e.g. acetylsalicylic acid or warfarin), or medicines that 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 may be used in children and adolescents aged 6 to 17 years only for the treatment of obsessive-compulsive disorder. Patients being treated for this condition should be closely monitored by a doctor (see: Children and adolescents, below).
• Electroconvulsive therapy (ECT) is being used.
• Medicines such as Asertin (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Anxiety/akathisia
Use of sertraline has been associated with akathisia (a distressing condition characterized by motor restlessness and a compulsion to move—often an inability to sit still or stand in one place). The likelihood of such symptoms is highest during the first few weeks of treatment. In patients experiencing such symptoms, increasing the dose of the medicine may be harmful.

Withdrawal symptoms
Withdrawal symptoms are common, especially after abrupt discontinuation of the medicine (see section 4. "Possible side effects"). The risk of withdrawal symptoms depends on the duration of treatment, dosage, and speed of dose reduction. These symptoms are usually mild to moderate in severity, but in some patients they may be severe. They typically occur within the first few days after stopping treatment. Such symptoms usually resolve spontaneously within 2 weeks. However, in some patients they may persist longer (for 2–3 months or more). Therefore, before completely discontinuing Asertin, gradual dose reduction over several weeks or months is recommended, depending on the individual patient's needs.

Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes have thoughts about self-harm or suicide. Such symptoms or behaviors may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, or sometimes longer, to start working.

The risk of suicidal thoughts, thoughts of self-harm, or suicide attempts is higher if:

• the patient has previously experienced suicidal thoughts or self-harm,
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders who were treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, contact a doctor immediately or go to a hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask family or friends for support and ask them to inform him or her if they notice worsening depression or anxiety, or concerning changes in behavior.

Children and adolescents
Sertraline should generally not be used in children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder. In patients under 18 years of age, treatment with medicines from this group has been associated with an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggressive behaviors, defiance, and anger). However, a doctor may decide to prescribe Asertin to a patient under 18 years of age if it is in the patient's best interest. If a doctor prescribes Asertin to a patient under 18 years of age and the caregiver wishes to discuss this, contact the doctor.
Additionally, if any of the symptoms listed above appear or worsen in a patient under 18 years of age taking Asertin, inform the doctor.
Furthermore, the long-term safety of Asertin with regard to its effects on growth, maturation, cognitive development, and behavioral development has not been established.

Asertin and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans 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 together with the following medicines may cause serious side effects:

• Medicines from the group of monoamine oxidase inhibitors (MAO inhibitors), e.g. moclobemide (used to treat depression), selegiline (used to treat Parkinson's disease), and the antibiotic linezolid. Asertin must not be taken together with MAO inhibitors.
• Medicines used to treat psychiatric disorders (pimozide). Asertin must not be taken together with pimozide.

Inform your doctor if you are taking any of the following medicines:

• Herbal remedies containing St. John's wort (Hypericum perforatum). The effect of St. John's wort may persist 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 migraine (e.g. sumatriptan).
• Medicines that prevent blood clotting (warfarin).
• Medicines used to treat joint pain/inflammation (non-steroidal anti-inflammatory drugs - NSAIDs), e.g. ibuprofen, salicylic acid.
• Sedatives (e.g. diazepam).
• Diuretics.
• Medicines used to treat epilepsy (phenytoin).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excessive stomach acid secretion and peptic ulcer disease (cimetidine).
• Medicines used to treat mania and depression (lithium).
• Other antidepressants (amitriptyline, nortriptyline).
• Medicines used to treat schizophrenia and other psychiatric disorders (e.g. perphenazine, levomepromazine, olanzapine).

Taking Asertin with food, drink and alcohol
Asertin can be taken with or without food.
Alcohol must not be consumed during treatment with Asertin.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Ensure that the midwife and/or doctor knows that the patient is taking Asertin. Using medicines such as Asertin during pregnancy, particularly during the last three months, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and bluish skin coloration in the newborn.
These symptoms usually occur within the first 24 hours after birth. If any of these symptoms occur in the newborn, contact the midwife and/or doctor immediately.
Taking Asertin late in pregnancy may increase the risk of serious vaginal bleeding shortly after childbirth, especially if the patient has a history of blood clotting disorders. If the patient is taking Asertin, she should inform her doctor or midwife so they can provide appropriate advice.
The safety of sertraline use in pregnant women has not been fully confirmed. Asertin may be used in pregnant women only if, in the doctor's assessment, the benefits outweigh the potential risks to the fetus. Women of childbearing potential treated with sertraline should use an effective method of contraception.
There is evidence that sertraline passes into breast milk. Sertraline may be used in breastfeeding women only if, in the doctor's assessment, the benefits to the mother outweigh the potential risks to the infant.
Animal studies have shown that some medicines similar to sertraline may reduce semen quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans to date.

Driving and operating machinery
Psychotropic medicines, including sertraline, may affect the ability to drive or operate machinery. Do not drive or operate machinery until you know how this medicine affects your ability to perform these activities.

Asertin contains lactose. If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Asertin contains less than 1 mmol (23 mg) of sodium per maximum daily dose, meaning that the medicine is considered "sodium-free".

3. How to use Asertin

This medicine should always be taken exactly as your doctor has told you. If you are unsure,
you should consult your doctor or pharmacist.
Asertin tablets may be taken with or without food.
The medicine should be taken once daily, in the morning or evening.
Recommended dosage:
Adults:
Depression and obsessive-compulsive disorder (OCD)
The usual effective dose for treating depression and OCD is 50 mg/day. The daily dose may be
gradually increased (over several weeks) by 50 mg, at intervals of at least one week. The maximum
recommended daily dose is 200 mg per 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 initiated at a dose of 25 mg/day (half a tablet of Asertin 50), increasing to 50 mg/day
after one week. The daily dose may then be gradually increased by 50 mg over several weeks.
The maximum recommended daily dose is 200 mg per day.
Use in children and adolescents
Asertin may be used in children and adolescents aged 6 to 17 years only for the treatment of
obsessive-compulsive disorder (OCD).
Obsessive-compulsive disorder (OCD)
Children aged 6 to 12 years: The recommended initial dose is 25 mg per day (half a tablet of
Asertin 50).
After one week, the doctor may recommend increasing the dose to 50 mg per day. The maximum
dose is 200 mg per day.
Adolescents aged 13 to 17 years: The recommended initial dose is 50 mg per day.
The maximum dose is 200 mg per day.
Patients with liver or kidney disease should inform their doctor and then follow the doctor’s
advice.
Your doctor will inform you how long you should continue taking this medicine. The duration of
treatment depends on the type of illness and the individual response to treatment. Improvement in
symptoms may not occur until after several weeks of treatment.
Taking more Asertin than recommended
If you accidentally take too much Asertin, contact your doctor immediately or go to the nearest
hospital. Take the medicine package and its label with you, regardless of whether any medicine
remains in the container.
Symptoms of overdose in adults may include: drowsiness, nausea, vomiting, rapid heartbeat, tremor,
agitation, dizziness, and in rare cases, loss of consciousness.
If you miss a dose of Asertin
If you forget to take a dose, do not take the missed tablet. Take the next tablet at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Asertin
Do not stop taking Asertin without first consulting your doctor. Your doctor will gradually reduce
the dose of Asertin over a period of several weeks before stopping treatment completely.
Suddenly stopping the medicine may cause unwanted effects such as dizziness, numbness, sleep
disturbances, agitation or anxiety, headache, nausea, vomiting, and muscle tremors.
If any of these unwanted effects, or any other unwanted effects, occur during discontinuation of
Asertin, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet,
you should consult your doctor or pharmacist.
The most commonly reported adverse reaction is nausea. Adverse reactions depend on the dose taken and often subside as treatment continues.
You should contact your doctor immediately 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, your doctor will advise discontinuation of treatment; allergic reactions or allergies which may cause symptoms such as itchy rash, difficulty breathing, wheezing, swelling of the eyelids, face or lips;
• Agitation, confusion, diarrhoea, high fever and elevated blood pressure, excessive sweating and rapid heartbeat. These are symptoms of serotonin syndrome. In rare cases, this syndrome may occur in patients taking certain medicines at the same time as sertraline. Your doctor may then advise stopping treatment;
• Yellowing of the skin and eyes, which may indicate liver damage;
• Symptoms of depression accompanied by suicidal thoughts;
• Motor restlessness and inability to sit still or remain motionless after taking Asertin. You should inform your doctor at the first signs of motor restlessness.

In clinical trials in adult patients, the following adverse reactions were observed, occurring at the frequencies described below:
Very common adverse reactions (occur in more than 1 in 10 patients):
Insomnia, dizziness, somnolence, headache, diarrhoea, nausea, dry mouth, ejaculation disorders, fatigue.
Common adverse reactions (occur in 1 to 10 in 100 patients):
Sore throat, loss of appetite, increased appetite, depression, strange feelings, nightmares, anxiety, agitation, nervousness, decreased libido, teeth grinding, numbness and tingling, muscle tremors, increased muscle tension, taste disturbances, lack of concentration, visual disturbances, tinnitus, palpitations, hot flushes, yawning, abdominal pain, vomiting, constipation, gastric discomfort, flatulence, rash, excessive sweating, muscle pain, sexual dysfunction, erectile disorders, chest pain.
Uncommon adverse reactions (occur in 1 to 10 in 1,000 patients):
Common cold, nasal congestion, hallucinations, feeling of euphoria, feeling of indifference, thinking disturbances, seizures, involuntary muscle contractions, coordination disturbances, increased mobility, memory loss, reduced sensation, speech disturbances, dizziness upon standing, migraine, ear pain, increased heart rate, high blood pressure, hot flushes, breathing difficulties, possible gasping, shallow breathing, nosebleeds, oesophageal problems, swallowing difficulties, haemorrhoids, increased salivation, tongue disorders, belching, eye swelling, purpuric skin spots, hair loss, cold sweats, dry skin, urticaria, osteoarthritis, muscle weakness, back pain, muscle tics, nocturnal urination, inability to urinate, increased urine output, increased frequency of urination, urinary problems, vaginal bleeding, sexual dysfunction in women, malaise, chills, fever, weakness, increased thirst, weight loss, weight gain.
Rare adverse reactions (occur in 1 to 10 in 10,000 patients):
Intestinal disorders, ear infections, neoplastic disease, glandular swelling, elevated cholesterol levels, low blood glucose levels, physical symptoms caused by stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation, stupor, abnormal movements, difficulty moving, increased sensitivity to touch, sensory disturbances, glaucoma, tearing problems, visual spots, double vision, feeling of harmful light effects on the eye, bloodshot eyes, pupil dilation, spots before the eyes, glaucoma, double vision, photophobia, blood in the eye, unequal pupil size, abnormal vision, tear secretion disorders, myocardial infarction, slowed heart rate, heart-related problems, impaired blood circulation in the upper and lower limbs, throat closure, rapid breathing, slowed breathing, speech difficulties, hiccups, bloody stools, oral pain, tongue ulceration, dental problems, tongue problems, oral ulcers, liver disorders, skin disorders with blister formation, scalp rash, abnormal hair structure, abnormal skin odour, bone disorders, reduced urine output, urinary incontinence, delayed urination, excessive vaginal bleeding, vaginal dryness, painful red penis and foreskin, discharge, prolonged penile erection, nipple discharge, hernia, injection site fibrosis, reduced drug tolerance, walking difficulties, abnormal laboratory test results, semen abnormalities, injuries, vascular collapse.
Frequency not known (frequency cannot be estimated from available data): partial loss of vision, colitis (causing diarrhoea), severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in section 2 under Pregnancy, breastfeeding and fertility. Muscle weakness and severe muscle pain, which may be symptoms of a disorder resembling glutaric aciduria type II.
The following adverse reactions have been reported since sertraline has been marketed:
Decreased white blood cell count, decreased platelet count, reduced thyroid hormone levels, endocrine disorders, low blood sodium levels, nightmares, suicidal behaviour, movement disorders (e.g. increased motor activity, increased muscle tension and difficulty walking), fainting, visual disturbances, haemorrhagic disorders (including nosebleeds, gastrointestinal bleeding or haematuria), pancreatitis, severe liver dysfunction, jaundice, skin swelling, photosensitivity reaction, itching, joint pain, muscle cramps, breast enlargement, irregular menstruation, swelling of the lower limbs, blood clotting problems and severe allergic reactions.
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Additional adverse reactions in children and adolescents
In clinical trials involving children and adolescents, adverse reactions were generally similar to those observed in adults (see above). The most commonly occurring adverse reactions in children and adolescents were: headache, insomnia, diarrhoea and nausea.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland,
Tel: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Asertin

Keep this medicine out of 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 stated month.
No special precautions for storage are required.
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 packaging and other information

What Asertin contains
The active substance is sertraline.
Asertin 50, 50 mg, film-coated tablets
Each film-coated tablet contains 50 mg of sertraline (as hydrochloride).
Asertin 100, 100 mg, film-coated tablets
Each film-coated tablet contains 100 mg of sertraline (as hydrochloride).
The other ingredients are:
Tablet core: monohydrate lactose, 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 pack
Asertin 50, 50 mg, film-coated tablets
White, film-coated, oval, biconvex tablets, 10 x 5 mm, with a score line on one side.
The tablet can be divided into equal doses.
Pack sizes available:
Cardboard box containing 10, 28, 30 or 60 film-coated tablets.
Blister packs made of PVC/PVDC/Aluminium.

Asertin 100, 100 mg, film-coated tablets
White, film-coated, round, biconvex tablets, 10 mm, with a groove on one side and the letter C embossed on the other.
The tablet can be divided into equal doses.
Pack sizes available:
Cardboard box containing 28, 30 or 60 film-coated tablets.
Blister packs made of PVC/PVDC/Aluminium.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland

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