Package leaflet: Information for the patient

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

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Asentra is and what it is used for
Important information before taking Asentra
How to take Asentra
Possible side effects
How to store Asentra
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 disorders, associated with persistent anxiety due to intrusive thoughts (obsessions), leading to repetitive rituals (compulsive acts, compulsions).
Post-traumatic stress disorder is a condition that may occur after a highly traumatic experience and is characterized by symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by marked fear or anxiety 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).
Your doctor has decided that this medicine is suitable for treating the condition you have.
You should consult your doctor if you are unsure why you are receiving Asentra.

2. Important information before using 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 pass after stopping treatment with 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 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 tell your doctor before taking Asentra if any of the following apply to the patient 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").
Serotonin syndrome. In rare cases, this syndrome may occur in patients taking sertraline together with certain medicines, 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 blood sodium levels.
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 dosage adjustments of antidiabetic medicines 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. Asentra 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 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, a family history of prolonged QT interval, 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 an urge to move, often with an inability to sit still or remain in one place (akathisia). This condition usually occurs during 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 effects (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 appear 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, it is recommended to gradually reduce the dose over several weeks or months and to consult your doctor about the best way to stop treatment.

Suicidal thoughts, worsening of depression or anxiety
People 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 had suicidal thoughts or self-harm tendencies;
the patient is a young adult; clinical trial data indicate an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders treated with antidepressant medicines. If the patient experiences suicidal thoughts or thoughts of self-harm, contact a 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 or friends for help and ask them to inform him or her if they notice worsening depression or anxiety or 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 stopping 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 effects such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostility (mainly aggressive, defiant and angry behaviours) 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 your doctor. In addition, there are currently no data on the long-term safety of Asentra regarding its effects on growth, maturation, learning (cognitive functions), and behaviour.

Asentra with 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.

Taking Asentra together with the following medicines may cause serious adverse effects:

Medicines that are monoamine oxidase inhibitors (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.

Tell 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 last 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 dependence.
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).
Diuretics (so-called water tablets).
Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines used to treat diabetes (tolbutamide).
Medicines used to treat excessive stomach acid, peptic ulcer disease 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 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 heart's electrical activity (e.g. antipsychotics and antibiotics).

Taking Asentra with food, drink and alcohol
Asentra can be taken with or without food.
Do not consume alcohol while taking Asentra.
Do not take Asentra 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 manifests as rapid breathing and cyanosis (bluish skin). These symptoms usually appear within the first 24 hours 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:

breathing difficulties,
bluish skin, abnormally low or high body temperature,
bluish lips,
vomiting or difficulty feeding,
excessive tiredness, insomnia or excessive crying,
muscle stiffness or floppiness,
trembling, tremors or seizures,
increased reflexes,
irritability,
low blood sugar. If any of these symptoms occur in the newborn or if the baby'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.
Animal studies have shown that some medicines similar to sertraline reduce semen quality. This may theoretically affect fertility, although no effects on fertility have been observed in humans to date.

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 before performing these activities.

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

3. How to take Asentra

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Asentra is available in 50 mg and 100 mg strengths.
Recommended dosage:
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 weekly intervals 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 be initiated at 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 weekly intervals 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 starting 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 starting 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 instructions.
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.
Your doctor will inform you how long you should continue treatment. The duration of treatment depends on the type of illness and your response to therapy. Improvement may not occur until after several weeks of treatment. Treatment for depression should usually continue for 6 months after improvement occurs.
Taking more Asentra than prescribed
If you accidentally take too much Asentra, contact your doctor immediately or go to the nearest hospital emergency department.
You must take 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.
Missed dose of Asentra
If you forget 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 your doctor. Your doctor should gradually reduce the dose of Asentra over several weeks until you finally stop taking it.
If you stop taking Asentra suddenly, you may experience adverse effects such as dizziness, numbness or tingling, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and muscle tremors. If you experience any of these or other adverse effects after stopping Asentra, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most common adverse effect is nausea. Adverse effects are dose-dependent 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 a case, the doctor will decide to discontinue treatment.
Allergic reaction or allergy. It may manifest as itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
Agitation, confusion, diarrhea, high temperature and blood pressure, excessive sweating, and rapid heart rate. These are symptoms of serotonin syndrome. Serotonin syndrome rarely may occur when taking certain medicines 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").

The following adverse effects have been observed in clinical studies in adult patients and after the medicine was placed on the market:

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

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

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

bronchitis, sore throat, runny nose,
decreased appetite, increased appetite,
anxiety, depression, agitation, decreased interest in sex, nervousness, unusual sense of well-being, nightmares, teeth grinding,
muscle tremors, movement disorders (such as increased motor activity, increased muscle tension, difficulty walking and stiffness, muscle spasms and involuntary muscle movements)*, numbness and tingling sensations, increased muscle tension, difficulty concentrating, taste disturbances,
visual disturbances,
ringing in the ears,
palpitations,
hot flushes,
yawning,
stomach discomfort, constipation, abdominal pain, vomiting, flatulence,
increased sweating, rash,
back pain, joint pain, muscle pain,
irregular menstruation, erectile dysfunction,
malaise, chest pain, weakness, fever,
weight gain,
injuries.

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

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

Rare (may affect up to 1 in 1000 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, increased blood sugar*, low blood sodium levels*,
physical symptoms caused by stress or emotions, nightmares*, drug dependence, sleepwalking, premature ejaculation,
stupor, 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, light sensitivity, blood in the eye, unequal pupil size*, abnormal vision*, tear secretion disorders,
heart attack, sensation of "emptiness" in the head, fainting or discomfort in the chest which may be symptoms of changes in the electrical activity of the heart (visible on electrocardiogram) or abnormal heart rhythm*, slowed heart rate,
worsening of blood circulation in the upper and lower limbs,
rapid breathing, progressive lung tissue fibrosis (interstitial lung disease)*, closure of the throat (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 odor, rash on hairy skin,
muscle tissue breakdown*, bone disorders,
difficulty initiating urination, reduced urine output,
nipple discharge, vaginal dryness, genital discharge, redness and pain in the penis and foreskin, breast enlargement*, prolonged penile erection,
hernia, decreased drug tolerance,
increased blood cholesterol, abnormal laboratory test results*, abnormal semen analysis results, blood clotting problems*,
vasodilation.

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

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

*Adverse effect reported after the medicine was placed on the market.

Additional adverse effects in children and adolescents
In clinical studies involving children and adolescents, adverse effects were generally similar
to those occurring in adults (see above). The most commonly occurring adverse effects in children and adolescents were: headache, insomnia, diarrhea, and nausea.

Symptoms occurring after discontinuation
After abrupt discontinuation of the medicine, adverse effects 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 effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

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 packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Asentra contains

The active substance is sertraline. Each coated tablet contains 100 mg of sertraline in the form of sertraline hydrochloride.
The other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), hydroxypropylcellulose, talc, magnesium stearate and for 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.
Packaging
28 or 84 coated tablets in blisters, packed in a cardboard box.
For more detailed information, please contact the responsible party or 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Ireland, country of export: PA1347/019/002
Parallel Import Licence Number: 81/23