Asentra

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Asentra (Sertraline Krka), 100 mg, film-coated tablets

Sertraline
Asentra and Sertraline Krka are different trade names for the same medicine.

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Asentra and what is it used for

Asentra contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs); these medicines are used to treat depressive disorders and/or anxiety disorders.
Asentra may beused 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 disease characterized by symptoms such as sadness, difficulty sleeping or lack of joy in life.
Obsessive-compulsive disorder and panic disorder are anxiety disorders with accompanying constant anxiety due to persistent thoughts (obsessions), which cause the performance of repetitive rituals (compulsive actions).
Post-traumatic stress disorder is a condition that may occur after a very traumatic experience and is characterized by symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related disease. It is characterized by intense anxiety or stress in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in the presence of others, or fear of potentially embarrassing behavior).
The doctor has decided that this medicine is suitable for the treatment of the disease in the patient.
The patient should consult a doctor if they are unsure why they are taking Asentra.

2. Important information before taking Asentra

When not to take Asentra

Warnings and precautions

Before starting Asentra, the patient should discuss it with their doctor or pharmacist.
Not every medicine can be used by every person. The patient should tell their doctor before taking Asentra if they currently or have previously experienced any of the following:

• Epilepsy or a history of seizures. If a seizure occurs, the patient should contact their doctor immediately.
• A history of manic-depressive illness (bipolar affective disorder) or schizophrenia. If a manic episode occurs, the patient should contact their doctor immediately.
• A history of thoughts of self-harm or suicide (see below - "Suicidal thoughts, worsening of depression or anxiety").
• Serotonin syndrome. In rare cases, this syndrome may occur in patients who have taken certain medicines with sertraline, including buprenorphine (symptoms, see section 4 "Possible side effects"). The doctor will inform the patient if they have had serotonin syndrome in the past.
• Low sodium levels in the blood, which may occur as a result of taking Asentra. The patient should also inform their doctor if they are taking medicines for high blood pressure, as some of them may also change sodium levels in the blood.
• Elderly patients: they may be more susceptible to decreased sodium levels in the blood (see above).
• Liver disease: the doctor may decide to reduce the dose of Asentra.
• Diabetes; Asentra may affect blood sugar levels, so it may be necessary to change the dosage of antidiabetic medicines.
• Bleeding disorders, history of taking blood-thinning medicines [e.g. acetylsalicylic acid ("aspirin") 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. In children and adolescents aged 6-17 years, Asentra may only be used to treat obsessive-compulsive disorder. Patients treated for this disease should be under close medical supervision (see below - "Children and adolescents").
• Electroconvulsive therapy (ECT).
• Eyelid problems, such as certain types of glaucoma (increased eye pressure).
• Heart rhythm disorders visible on an ECG, known as prolonged QT interval.
• Heart disease, low potassium or magnesium levels, a family history of prolonged QT interval, slow heart rate, and concurrent use of medicines that prolong the QT interval.

Psychomotor restlessness (akathisia)

Sertraline use has been associated with the occurrence of a state characterized by psychomotor restlessness and a compulsion to move - often with an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. The patient should contact their doctor if they experience increased restlessness, as this may be harmful to patients with such symptoms.

Withdrawal symptoms

After stopping treatment, side effects (withdrawal symptoms) often occur, especially if treatment is stopped abruptly (see section 4 "Possible side effects"). The risk of withdrawal symptoms depends on the duration of treatment, dose, and rate of dose reduction.
These symptoms are usually mild or moderate, but in some patients, they may be severe. They usually occur within the first few days after stopping treatment. They usually resolve on their own within 2 weeks, but in some patients, they may persist for longer (2-3 months or longer). If the decision is made to stop sertraline treatment, it is recommended to gradually reduce the dose over several weeks or months and consult a doctor on the best way to stop treatment.

Suicidal thoughts, worsening of depression or anxiety

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

Occurrence of suicidal thoughts, self-harm thoughts, 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 years of age with mental disorders who have been treated with antidepressant medicines. If the patient experiences suicidal thoughts or self-harm thoughts, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression or anxiety disorder 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 the depression or anxiety has worsened or if there are any worrying changes in behavior.

Sexual dysfunction

Medicines like Asentra (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents

As a rule, 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, an increased risk of side effects such as suicidal attempts, self-harm thoughts, or suicidal behavior (suicidal thoughts) and hostility (mainly aggressive, defiant, and angry behavior) has been observed during treatment with medicines of this group. However, the doctor may decide to prescribe Asentra to a patient under 18 years of age if it is in the patient's interest. If the doctor prescribes Asentra to a patient under 18 years of age and the child's caregiver wants to discuss this with them, they should contact the doctor. Moreover, if any of the above symptoms occur or worsen during Asentra treatment, the doctor should be informed. Additionally, there is currently a lack of data on the long-term safety of Asentra, including its impact on growth, maturation, learning (cognitive functions), and behavior.

Asentra and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the way Asentra works or Asentra may reduce the effectiveness of other medicines taken at the same time.

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

• Monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used to treat Parkinson's disease), and the antibiotic linezolid and methylene blue (a substance used to treat high methemoglobin levels in the blood). Asentra should not be taken with these medicines.
• Medicines used to treat mental disorders, such as psychoses (pimozide). Asentra should not be taken with pimozide.

The patient should inform their doctor about taking any of the following medicines:

• Medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), excessive sleepiness, and obesity).
• Herbal medicines containing St. John's Wort (Hypericum perforatum). The effect of St. John's Wort may persist for up to 2 weeks.
• Medicines containing the amino acid tryptophan.
• Medicines used to treat severe pain (e.g. tramadol).
• Buprenorphine, a medicine used to treat pain or opioid addiction.
• Medicines used during anesthesia or to treat chronic pain (fentanyl, mivacurium, and suxamethonium).
• Medicines used to treat migraines (e.g. sumatriptan).
• Blood-thinning medicines (warfarin).
• Medicines used to treat pain and/or joint inflammation [non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, acetylsalicylic 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 (e.g. perphenazine, levomepromazine, and olanzapine).
• Medicines used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (e.g. verapamil, diltiazem, flecainide, propafenone).
• Medicines used to treat bacterial infections (e.g. rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors, e.g. ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medicines that increase the risk of changes in heart electrical activity (e.g. antipsychotic medicines and antibiotics).

Taking Asentra with food, drink, and alcohol

Asentra can be taken with or without food.
The patient should not drink alcohol while taking Asentra.
The patient should not take Asentra with grapefruit juice, as this may increase the level of sertraline in the body.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline can be used in pregnant women only if the doctor considers that the benefits to the mother outweigh the potential risks to the fetus.
Taking Asentra at the end of pregnancy may increase the risk of severe bleeding from the vagina, which occurs shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Asentra, they should inform their doctor or midwife so that they can provide appropriate advice.
The patient should inform their doctor and/or midwife about taking Asentra. Medicines like Asentra, taken during pregnancy, especially during the last 3 months of pregnancy, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and blue discoloration. These symptoms usually occur within the first day after delivery. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife.
The newborn may also experience other complications, which usually occur within the first 24 hours after birth. Symptoms include:

• breathing difficulties,
• blue discoloration of the skin, too low or too high body temperature,
• blue lips,
• vomiting or difficulty feeding,
• excessive tiredness, insomnia, or very frequent crying,
• stiffness or flaccidity of the muscles,
• tremors, tremors, or seizures,
• increased reflexes,
• irritability,
• low blood sugar. If any of these symptoms occur in the child after birth or if their health is worrying, the patient should contact their doctor or midwife.

There is evidence that sertraline passes into breast milk. The medicine can be used in breastfeeding women if the doctor considers that the benefits of the medicine outweigh the risks to the child.
In animal studies, some medicines similar to sertraline have been shown to decrease 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, such as sertraline, may affect the ability to drive or operate machines. The patient should wait until it is known how Asentra affects their ability to perform these activities.

Asentra contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Asentra

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Asentra is available in 50 mg and 100 mg doses.

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 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 be started 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.

Use in children and adolescents:

Asentra can be used in children and adolescents aged 6-17 years only to treat obsessive-compulsive disorder (OCD).

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.
Method of administration
The tablet can be divided into equal doses.
Asentra can be taken with or without food.
The medicine should be taken once a day, in the morning or evening.
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 may start only after several weeks of treatment. Treatment of depression should usually last for 6 months from the time of improvement.

Taking a higher dose of Asentra than recommended

If the patient accidentally takes too much Asentra, they should immediately contact their doctor or go to the emergency department of the nearest hospital. The patient should take the medicine packaging with the label with them, regardless of whether there is any medicine left in it or not.
Symptoms of overdose may include drowsiness, nausea, and vomiting, rapid heart rate, muscle tremors, agitation, dizziness, and in rare cases, loss of consciousness.

Missing a dose of Asentra

If the patient forgets to take a tablet, they should not take the missed tablet. They should simply take the next tablet at the right time.
The patient should not take a double dose to make up for the missed dose.

Stopping Asentra treatment

The patient should not stop taking Asentra without consulting their doctor. The doctor should gradually reduce the dose of Asentra over several weeks, until the patient finally stops taking it.
If the patient suddenly stops taking Asentra, they may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors. If the patient experiences any of these side effects or any other side effects after stopping Asentra, they should contact their doctor.
If the patient has any further doubts about taking this medicine, they should contact their doctor or pharmacist.

4. Possible side effects

Like all medicines, Asentra 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.
The patient should immediately inform their doctorif they experience any of the following symptoms after taking this medicine, as they may be serious:

• Severe skin rash with blistering (erythema multiforme) (may affect the mouth and tongue). These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis. In this case, the doctor will decide to stop treatment.
• Allergic reaction or allergy. May cause itching skin rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
• Agitation, confusion, diarrhea, high blood pressure, excessive sweating, rapid heart rate, tremors. These are symptoms of serotonin syndrome. Rarely, serotonin syndrome may occur during treatment with certain medicines concurrently with sertraline. The doctor may decide to stop treatment.
• Yellowing of the skin and whites of the eyes, which may indicate liver damage.
• Symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
• Psychomotor restlessness that prevents sitting or standing still after starting Asentra treatment. If the patient starts to feel psychomotor restlessness, they should inform their doctor.
• Seizure (epileptic).
• Manic episodes (see section 2 "Warnings and precautions").

In clinical trials in adults and after the medicine was marketed, the following side effects were observed:

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

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

Common (may affect up to 1 in 10 people):

• bronchitis, sore throat, cold,
• decreased appetite, increased appetite,
• anxiety, depression, agitation, decreased sexual interest, nervousness, abnormal sensations, nightmares, teeth grinding,
• muscle tremors, movement disorders (such as increased muscle activity, increased muscle tone, difficulty walking and stiffness, spasms, and involuntary muscle movements)*, numbness and tingling, increased muscle tone, lack of concentration, taste disorders,
• vision disorders,
• ringing in the ears,
• palpitations,
• hot flashes,
• yawning,
• gastrointestinal disorders, constipation, abdominal pain, vomiting, gas,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstrual periods, erectile dysfunction,
• malaise, chest pain, weakness, fever,
• weight gain,
• injuries.

Uncommon (may affect up to 1 in 100 people):

• gastritis, ear infection,
• tumor,
• allergy, seasonal allergy,
• decreased thyroid hormone levels,
• suicidal thoughts, suicidal behavior*, psychotic disorders, thought disorders, apathy, hallucinations, aggression, euphoria, paranoia,
• amnesia, decreased sensation, involuntary muscle contractions, loss of consciousness, increased muscle activity, migraine, dizziness when standing up, coordination disorders, speech disorders,
• pupil dilation,
• ear pain,
• rapid heart rate, heart problems,
• bleeding disorders (including gastrointestinal bleeding)*, high blood pressure, flushing, blood in the urine,
• shortness of breath, nosebleeds, breathing difficulties, wheezing,
• black stools, dental disorders, esophagitis, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• eye swelling, hives, hair loss, itching, purpura, skin disorders with blistering, dry skin, facial swelling, cold sweats,
• osteoarthritis, muscle twitches, painful muscle spasms*, muscle weakness,
• increased urination frequency, urination problems, inability to urinate, incontinence, increased urine production, nocturia,
• sexual dysfunction, excessive menstrual bleeding, menstrual bleeding, sexual dysfunction in women,
• swelling of the legs, chills, walking difficulties, increased thirst,
• increased liver enzyme activity, weight loss,
• During sertraline treatment or shortly after stopping it, cases of suicidal thoughts and behaviors have been reported (see section 2).

Rare (may affect up to 1 in 1000 people):

• diverticulitis, lymphadenopathy, decreased platelet count*, decreased white blood cell count*,
• severe allergic reactions,
• endocrine disorders*,
• high cholesterol, diabetes-related problems (diabetes), low blood sugar, high blood sugar*, low sodium levels in the blood*,
• physical symptoms caused by stress or emotions, 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)*, sensory disturbances,
• eye spots, glaucoma, double vision, light sensitivity, blood in the eye, uneven pupil size*, abnormal vision*, tear disorders,
• heart attack, feeling of "emptiness" in the head, 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 heart rate,

circulatory problems in the arms and legs,

• rapid breathing, progressive pulmonary fibrosis (interstitial lung disease)*, laryngospasm, difficulty speaking, slow breathing, hiccups,
• mouth ulcers, pancreatitis*, blood in the stool, tongue pain, oral discomfort,
• liver function disorders, severe liver function disorders*, yellowing of the skin and eyes (jaundice)*,
• sun allergy*, skin swelling*, abnormal hair structure, abnormal skin odor, hair loss on the skin,
• muscle breakdown*, bone disorders,
• difficulty starting urination, decreased urination,
• nipple discharge, vaginal dryness, genital discharge, penis and foreskin redness and pain, breast enlargement*, prolonged erection of the penis,
• hernia, decreased drug tolerance,
• increased blood cholesterol, abnormal laboratory test results*, abnormal sperm test results, bleeding disorders*,
• vascular collapse.

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

• partial loss of vision,
• colitis (causing diarrhea),
• severe bleeding from the vagina, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2,
• jaw spasms*,
• nocturnal enuresis*.

*Side effect reported after the medicine was marketed.

Additional side effects in children and adolescents

In clinical trials with children and adolescents, side effects 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 treatment, side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors may occur (see section 3 "Stopping Asentra treatment").
Patients taking this type of medicine have been observed to have an increased risk of fractures.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: 22 49-21-301
fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Asentra

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Asentra contains

• The active substance of Asentra is sertraline hydrochloride. Each film-coated tablet contains 111.90 mg of sertraline hydrochloride, which corresponds to 100 mg of sertraline.
• Other ingredients are: calcium phosphate dihydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), hydroxypropylcellulose, talc, magnesium stearate, and in the tablet coating: hypromellose, titanium dioxide (E 171), talc, propylene glycol. See section 2 "Asentra contains sodium".

What Asentra looks like and what the packaging contains

White, round, with a dividing line on one side.
The tablet can be divided into equal doses.

Packaging

28 or 84 film-coated tablets in blisters, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Ireland, the country of export:

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer:

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Ireland export license number: PA1347/019/002

Parallel import license number: 214/22 Date of leaflet approval: 18.05.2022

[Information about the trademark]