Asentra

Patient Information Leaflet

Caution! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Asentra (Sertraline Krka), 100 mg, film-coated tablets
Sertralinum
Asentra and Sertraline Krka are different brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• 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. This medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Asentra is and what it is 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 and/or anxiety disorders.
Asentra 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 (in adults),
• obsessive-compulsive disorder (OCD) (in adults and children and adolescents aged 6–17 years).

Depression is an illness characterized by symptoms such as sadness, sleep disturbances, or loss of pleasure in life.
Obsessive-compulsive disorder and panic disorder are anxiety-related conditions, associated with persistent worry due to intrusive thoughts (obsessions), leading to repetitive rituals (compulsions).
Post-traumatic stress disorder (PTSD) is a condition that may occur after a traumatic event and is characterized by symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense fear or anxiety in social situations (such as talking to strangers, speaking in front of a group, eating or drinking in public, or fear of potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for treating your condition.
You should consult your doctor if you are unsure why you have been prescribed Asentra.

2. Important information before using the medicine Asentra

When not to use Asentra

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is currently taking or has recently taken 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 stopping treatment with sertraline before starting treatment with an MAO inhibitor. After stopping treatment with an MAO inhibitor, at least two weeks must elapse before starting treatment with sertraline;
• if the patient is taking pimozide (a medicine used to treat psychiatric disorders such as psychosis).

Warnings and precautions
Before starting treatment with Asentra, discuss this with your doctor or pharmacist.
Not every medicine can be used by everyone. You should inform your doctor before taking Asentra if any of the following apply to you currently or have applied in the past:

• Epilepsy or a history of seizures. If a seizure occurs, contact your doctor immediately.
• A history of bipolar disorder (manic-depressive illness) or schizophrenia. If a manic episode occurs, contact your doctor immediately.
• Current or past thoughts of self-harm or suicide (see below – "Suicidal thoughts, worsening of depression or anxiety disorders").
• Serotonin syndrome. In rare cases, this syndrome may occur in patients who are taking certain other medicines together with sertraline, including buprenorphine (symptoms, see section 4 "Possible side effects"). Your doctor will inform you if you have previously experienced serotonin syndrome.
• Low sodium levels in the blood, which may occur as a result of taking Asentra. You should also inform your doctor if you are taking medicines for high blood pressure, as some of these may also affect sodium levels in the blood.
• Elderly patients: they may be more susceptible to reduced sodium levels in the blood (see above).
• Liver disease: your doctor may decide to reduce the dose of Asentra.
• Diabetes; Asentra may affect blood glucose levels, so adjustment of antidiabetic medication may be necessary.
• Bleeding disorders, previous use of 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 to 17 years, Asentra may be used only for the treatment of obsessive-compulsive disorder. Patients being treated for this condition should remain under close medical supervision (see below – "Children and adolescents").
• Electroconvulsive therapy (ECT) is being administered.
• Eye problems, such as certain types of glaucoma (increased eye pressure).
• Heart function abnormalities seen on ECG, known as prolonged QT interval.
• Heart disease, low potassium or magnesium levels, prolonged QT interval in any family member, slow heart rate, and concomitant use of medicines that cause QT prolongation.

Psychomotor agitation (akathisia)
Treatment with sertraline has been associated with a condition characterised by motor restlessness and a compelling need to move, often with an inability to sit still or remain motionless (akathisia). This condition usually occurs within the first few weeks of treatment. Contact your doctor if the dose is increased, as this may be harmful in patients experiencing such symptoms.

Withdrawal symptoms
Adverse reactions (withdrawal symptoms) often occur after stopping treatment, especially if treatment is stopped abruptly (see section 4 "Possible side effects"). The risk of withdrawal symptoms depends on the duration of treatment, the dose, and the rate of dose reduction. These symptoms are generally mild or moderate in intensity, but may be severe in some patients. They usually occur within the first few days after stopping treatment. They usually resolve spontaneously within 2 weeks, but may persist longer in some patients (for 2–3 months or longer). If a decision is made to discontinue treatment with sertraline, a gradual reduction of the dose over several weeks or months is recommended, and the best way to stop treatment should be discussed with your doctor.

Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviours may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually take 2 weeks or sometimes longer to take effect.

The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely 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 behaviour in individuals under 25 years of age with psychiatric disorders who are treated with antidepressant medicines. If the patient experiences suicidal thoughts or thoughts of self-harm, they should contact their doctor immediately or go to 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 members or friends for help and ask them to inform them if they notice that depression or anxiety has worsened or if there are any concerning changes in behaviour.

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

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, there is an increased risk of adverse reactions such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostility (mainly aggressive, defiant behaviour and anger) when taking medicines from this group. However, your doctor may decide to prescribe Asentra to a patient under 18 years of age if it is in the patient's best interest. If your doctor prescribes Asentra to a patient under 18 years of age and the child's caregiver wishes to discuss this, contact the doctor. Furthermore, if any of the symptoms listed above appear or worsen during treatment with Asentra, inform the doctor. In addition, there are currently no long-term safety data available regarding the effects of Asentra on growth, maturation, learning (cognitive functions), and behaviour.

Asentra and other medicines
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 how Asentra works, or Asentra may reduce the effectiveness of other medicines taken at the same time.

Concomitant use of Asentra with the following medicines may lead to severe adverse reactions:

• Monoamine oxidase inhibitor medicines (MAO inhibitors), e.g. 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 levels of methemoglobin in the blood). Do not take Asentra together with these medicines.
• Medicines used to treat psychiatric disorders such as psychosis (pimozide). Do not take Asentra together with pimozide.

Inform your doctor if you are 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 1 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 anaesthesia or for chronic pain (fentanyl, mivacurium and suxamethonium).
• Medicines used to treat migraine (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).
• Diuretic medicines (so-called diuretics).
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excessive stomach acid secretion, peptic ulcer disease and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines used to treat mania and depression (lithium).
• Other medicines used in depression (e.g. amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines used to treat schizophrenia and other psychiatric disorders (e.g. perphenazine, levomepromazine and olanzapine).
• Medicines used to treat high blood pressure, chest pain or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, propafenone).
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors, such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medicines that increase the risk of changes in the electrical activity of the heart (e.g. antipsychotics and antibiotics).

Taking Asentra with food, drink and alcohol
Asentra can be taken with or without food.
During treatment with Asentra, alcohol should not be consumed.
Do not take Asentra together with grapefruit juice, as this may lead to increased levels of sertraline in the body.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
The safety of sertraline use in pregnant women has not been fully established. Sertraline may be used in pregnant women only if, according to the doctor's assessment, the benefits to the mother outweigh the potential risks to the developing child.
Taking Asentra towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If you are taking Asentra, inform your doctor or midwife so they can provide appropriate advice.
Inform your doctor and/or midwife that you are taking Asentra. Medicines such as Asentra, taken during pregnancy, particularly during the last three months of pregnancy, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), which is characterised by rapid breathing and cyanosis. These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact your doctor and/or midwife immediately.
Other complications may also occur in the newborn, which usually appear within the first 24 hours after birth. Symptoms include:

• difficulty breathing,
• bluish skin discoloration, abnormally low or high body temperature,
• bluish lips,
• vomiting or difficulty feeding,
• excessive tiredness, insomnia or excessive crying,
• muscle stiffness or floppiness,
• tremors, twitching or seizures,
• increased reflexes,
• irritability,
• low blood sugar levels. If any of these symptoms occur in the child after birth or if the child's health is concerning, contact your doctor or midwife.

There is evidence that sertraline passes into breast milk. The medicine may be used in women who are breastfeeding if, according to the doctor's assessment, the benefits outweigh the risks to the child.
In animal studies, some medicines similar to sertraline reduced semen quality. This may theoretically affect fertility, although no effect on fertility in humans has been observed so far.

Driving and operating machinery
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. Wait until you know how Asentra affects your ability to perform these activities before doing so.

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

3. How to use Asentra

This medicine should always be used as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
Asentra is available in 50 mg and 100 mg strengths.
Recommended dose:
Adults:
Depression and obsessive-compulsive disorder (OCD):
The usual effective dose for treating depression and OCD is 50 mg per day.
The daily dose may be gradually increased by 50 mg at intervals of at least one week over several weeks.
The maximum recommended 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 PTSD should begin with a dose of 25 mg per day,
increased after one week to 50 mg per day.
The daily dose may then be gradually increased by 50 mg at a time over several weeks.
The maximum recommended dose is 200 mg per day.
Use in children and adolescents:
Asentra may be used in children and adolescents aged 6–17 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. After one week,
the doctor may increase 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 follow the doctor's advice.
Method of administration
The tablet may be divided into equal doses.
Asentra may be taken with or without food.
The medicine should be taken once daily, in the morning or evening.
The doctor will inform the patient how long treatment should continue. The duration of treatment depends on
the type of illness and the patient's response to treatment. Improvement may take several weeks to occur.
Treatment for depression should usually continue for 6 months after improvement has occurred.
Taking more Asentra than recommended
If the patient accidentally takes too much Asentra, contact the doctor immediately or go to the emergency
department of the nearest hospital. Always bring the medicine packaging and label with you, regardless of
whether any medicine remains.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, muscle tremors,
agitation, dizziness, and in rare cases, loss of consciousness.
If a dose of Asentra is missed
If the patient forgets to take a tablet, do not take the missed dose. Simply take the next tablet at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Asentra
Do not stop taking Asentra without consulting the doctor. The doctor should gradually reduce the dose of
Asentra over several weeks until the patient stops taking it completely.
If a patient stops taking Asentra suddenly, withdrawal symptoms may occur, such as dizziness, numbness,
sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and muscle tremors. If any of these or
other adverse effects occur after stopping Asentra, consult the doctor.
If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The most common adverse reaction is nausea. Adverse reactions depend on the dose and often
diminish or weaken with continued treatment.
You should immediately inform your doctor if any of the following symptoms occur after taking this medicine, as they may be serious:

• Severe skin rash with blistering (erythema multiforme) (may involve the mouth and tongue). These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis. In such cases, the doctor will decide to discontinue treatment.
• Allergic reaction or allergy. It may manifest as itchy rash, breathing difficulties, wheezing, eyelid, facial or lip swelling.
• Agitation, confusion, diarrhoea, high body temperature and blood pressure, excessive sweating and rapid heartbeat. These are symptoms of serotonin syndrome. Serotonin syndrome rarely may occur when certain medicines are taken concomitantly with sertraline. The doctor may decide to discontinue 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).
• Motor restlessness preventing sitting or standing still after starting treatment with Asentra. If the patient begins to experience motor restlessness, the doctor should be informed.
• Seizure (epileptic fit).
• Manic episodes (see section 2 "Warnings and precautions").

In clinical trials in adult patients and after the medicine was introduced to the market, the following adverse reactions were observed:
Very common (may affect more than 1 in 10 people):

• insomnia, dizziness, drowsiness, headache, diarrhoea, nausea, dry mouth, ejaculation disorders, fatigue.

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

• bronchitis, sore throat, nasal congestion,
• decreased appetite, increased appetite,
• anxiety, depression, agitation, decreased interest in sex, nervousness, unusual feeling, nightmares, teeth grinding,
• muscle twitching, movement disorders (such as increased motor activity, increased muscle tension, difficulty walking and stiffness, muscle spasms and involuntary movements)*, numbness and tingling sensations, increased muscle tension, lack of concentration, taste disturbances,
• visual disturbances,
• tinnitus,
• palpitations,
• hot flushes,
• yawning,
• gastrointestinal discomfort, constipation, abdominal pain, vomiting, flatulence,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstruation, erectile dysfunction,
• malaise, chest pain, asthenia, fever,
• weight gain,
• injuries.

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

• gastritis and enteritis, ear infection,
• tumour,
• hypersensitivity, seasonal allergy,
• decreased thyroid hormone levels,
• suicidal thoughts, suicidal behaviour*, psychotic disorders, thought disorders, emotional blunting, hallucinations, aggression, feeling of euphoria, paranoia,
• memory loss, reduced sensation, involuntary muscle contractions, loss of consciousness, increased motor activity, migraine, seizures, dizziness upon standing, coordination disorders, speech disorders,
• pupil dilation,
• ear pain,
• increased heart rate, heart problems,
• haemorrhagic disorders (including gastrointestinal bleeding)*, high blood pressure, sudden skin reddening, blood in urine,
• shortness of breath, nosebleeds, breathing difficulties, wheezing,
• tarry stools, dental disorders, oesophagitis, tongue problems, haemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• eye swelling, urticaria, hair loss, itching, purpuric skin spots, blistering skin disorders, dry skin, facial swelling, cold sweats,
• osteoarthritis, muscle tics, painful muscle cramps*, decreased muscle strength,
• increased frequency of urination, urinary problems, inability to urinate, urinary incontinence, increased urine volume, nocturia,
• sexual disorders, excessive vaginal bleeding, vaginal haemorrhage, sexual disorders in women,
• leg swelling, chills, difficulty walking, excessive thirst,
• increased liver enzyme activity, weight loss,
• Cases of suicidal thoughts and behaviours have been reported during treatment with sertraline or shortly after discontinuation (see section 2).

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

• diverticulitis, lymph node swelling, decreased platelet count*, decreased white blood cell count*,

• severe allergic reactions,

• endocrine disorders*,

• high cholesterol levels, problems maintaining normal blood sugar levels (diabetes), low blood sugar, high blood sugar*, low blood sodium levels*,

• physical symptoms caused by stress or emotions, nightmares*, drug dependence, sleepwalking, premature ejaculation,

• coma, abnormal movements, difficulty moving, increased sensitivity to touch, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome)*, sensory disturbances,

• spots before the eyes, glaucoma, double vision, photophobia, blood in the eye, unequal pupil size*, visual disturbances*, tear secretion disorders,

• myocardial infarction, sensation of "emptiness" in the head, fainting or chest discomfort which may be symptoms of changes in the heart's electrical activity (visible on electrocardiogram) or irregular heartbeat*, bradycardia,

• worsening of blood circulation in upper and lower limbs,

• rapid breathing, progressive lung tissue fibrosis (interstitial lung disease)*, throat closure (laryngospasm), difficulty speaking, slowed breathing, hiccups,

• oral ulceration, pancreatitis*, blood in stool, tongue ulceration, oral pain,

• liver function disorders, severe liver function disorders*, yellowing of the skin and eyes (jaundice)*,

• skin reaction to sunlight*, skin swelling*, abnormal hair structure, abnormal skin odour, rash of hairy skin,

• rhabdomyolysis*, bone disorders,

• difficulty initiating urination, reduced urine output,

• nipple discharge, vaginal dryness, genital discharge, redness and pain of penis and foreskin, breast enlargement*, prolonged penile erection,

• hernia, decreased drug tolerance,

• increased blood cholesterol, abnormal laboratory test results*, abnormal semen analysis, blood clotting problems*,

• vasodilation.

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

• partial loss of vision,
• colitis (causing diarrhoea),
• severe postpartum vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2,
• bruxism*,
• nocturnal enuresis*.

*Adverse reaction reported after the medicine was introduced to the market.
Additional adverse reactions in children and adolescents
In clinical trials involving children and adolescents, adverse reactions were generally similar
to those occurring in adults (see above). The most commonly occurring adverse reactions in children and adolescents were: headache, insomnia, diarrhoea and nausea.
Symptoms occurring after discontinuation
After abrupt discontinuation of the medicine, adverse reactions such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and muscle tremors may occur (see section 3 "Discontinuing treatment with Asentra").
In patients taking this type of medicine, an increased risk of bone fractures has been observed.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Asentra

Keep this medicine out of the sight and reach of children.
No special storage conditions apply.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Asentra contains

• The active substance is sertraline hydrochloride. Each coated tablet contains 111.90 mg of sertraline hydrochloride, equivalent to 100 mg of sertraline.
• Other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethyl starch (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 contents of the pack
White, round tablets with a score line on one side.
The tablet can be divided into equal doses.
Pack:
28 or 84 coated tablets in blisters, packed in a cardboard carton.
For more detailed information, contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Ireland, 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Irish Marketing Authorisation number, country of export: PA1347/019/002
Parallel Import Licence number: 214/22