Sertraline Krka

Package leaflet: Information for the user

Sertralina Krka 50 mg film-coated tablets, 100 mg film-coated tablets

Sertraline
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What Sertralina Krka is and what it is used for

Sertralina Krka contains the active substance sertraline. Sertraline belongs to a group of
medicines known as Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines
are used to treat depression and/or anxiety disorders.
Sertralina Krka can 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 in children and adolescents aged 6 to 17 years).

Depression is a clinical illness with symptoms such as: feeling sad, inability to sleep properly or to enjoy life as you used to.
OCD and panic disorder are anxiety-related conditions with symptoms such as persistent, intrusive thoughts (obsessions) leading to repetitive behaviours (compulsions).
PTSD is a condition that may occur following a strongly traumatic emotional experience, and some of its symptoms resemble those of depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterised by intense feelings of anxiety or stress in social situations (e.g. speaking to strangers, speaking in public, eating or drinking in front of others, or fear of behaving in an embarrassing way).
Your doctor has determined that this medicine is suitable for treating your condition.
Ask your doctor if you are unsure why Sertralina Krka has been prescribed for you.

2. What you should know before taking Sertralina Krka

Do not take Sertralina Krka

• If you are allergic to sertraline or to any of the excipients of this medicine (listed in section 6).
• If you are taking or have recently taken monoamine oxidase inhibitors (MAOIs, e.g. selegiline, moclobemide) or medicines with MAOI-like activity (such as linezolid). If you stop treatment with sertraline, you must wait one week before starting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least 2 weeks before starting treatment with sertraline.
• If you are taking another medicine called pimozide (a medicine used for mental disorders such as psychosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sertralina Krka. Medicines are not always suitable for everyone. Inform your doctor before taking Sertralina Krka if you have or have previously had any of the following conditions:

• If you have serotonin syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline (for symptoms, see section 4 Possible side effects). Your doctor will determine whether you have previously experienced this condition.
• If you have low levels of sodium in your blood, as this condition may occur as a result of treatment with Sertralina Krka. You should also inform your doctor if you are taking certain medicines for high blood pressure, as these may also affect sodium levels in the blood.
• If you are elderly, as you may be at increased risk of low sodium levels in the blood (see above).
• If you have liver problems: your doctor may decide to prescribe a lower dose of Sertralina Krka.
• If you have diabetes; glucose levels in the blood may be affected by treatment with Sertralina Krka, and it may be necessary to adjust the dose of your diabetes medicines.
• If you have epilepsy (seizures) or a history of seizures. If you experience a seizure, contact your doctor immediately.
• If you have suffered from bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
• If you have or have previously had thoughts of harming or killing yourself (see below – suicidal thoughts and worsening of depression or anxiety disorder).
• If you have experienced bleeding problems or have taken medicines that thin the blood (e.g. acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding.
• If you are a child or adolescent under 18 years of age. Sertralina Krka should only be used to treat children and adolescents aged 6 to 17 years suffering from obsessive-compulsive disorder (OCD). If the child or adolescent is being treated for this disorder, your doctor will want to monitor them closely (see below – Children and adolescents).
• If you are undergoing electroconvulsive therapy (ECT).
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If you have been told you have an abnormal heart trace on an electrocardiogram (ECG), known as QT interval prolongation.

Restlessness/Akathisia
The use of sertraline has been associated with distressing restlessness and an urge to move, often accompanied by an inability to sit or stand still (akathisia). This condition is more likely to occur during the first few weeks of treatment. Increasing the dose may be harmful; therefore, if you develop these symptoms, inform your doctor.

Withdrawal reaction
Undesirable effects related to stopping treatment (withdrawal reaction) are common, especially if treatment is stopped suddenly (see section 3 If you stop taking Sertralina Krka and section 4 Possible side effects). The risk of withdrawal reactions depends on the duration of treatment, the dose, and the extent of dose reduction. These symptoms are usually mild to moderate in intensity. However, in some patients they may be severe. They typically occur within the first few days after stopping treatment. Generally, these symptoms resolve on their own within 2 weeks. In some patients, they may last longer (2–3 months or more).
When stopping treatment with sertraline, it is recommended to gradually reduce the dose over several weeks or months, and you should always discuss the best way to discontinue treatment with your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes think about harming yourself or committing suicide. These thoughts may worsen when you first start taking antidepressants, as all these medicines take time to become effective, usually about 2 weeks but sometimes longer.

You are more likely to have such thoughts

• If you have previously thought about killing yourself or harming yourself.
• If you are a young adult. Available data from clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric conditions treated with an antidepressant. If at any time you think about harming yourself or committing suicide, contact your doctor or go immediately to the nearest hospital. It may be helpful to inform a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder is worsening, or whether they are concerned about changes in your behaviour.

Children and adolescents
Sertraline should not usually be used in children and adolescents under 18 years of age, except for patients with Obsessive-Compulsive Disorder (OCD). Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostile behaviour (mainly aggression, oppositional behaviour, and anger) when treated with this class of medicines. However, your doctor may decide to prescribe Sertralina Krka to a patient under 18 years of age if this is in the patient’s best interest. If your doctor has prescribed Sertralina Krka to you and you are under 18 years of age and wish to discuss this decision, please contact your doctor.
Furthermore, if any of the symptoms listed above develop or worsen while you are being treated with Sertralina Krka, you must inform your doctor.
Finally, the long-term safety of Sertralina Krka on growth, maturation and cognitive development, and behavioural development in this age group has not yet been established.

Other medicines and Sertralina Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect the activity of Sertralina Krka, or Sertralina Krka may reduce the effectiveness of other medicines taken at the same time.

Taking Sertralina Krka with the following medicines may cause serious adverse events:

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression) and selegiline (used to treat Parkinson’s disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methemoglobin in the blood). Do not use Sertralina Krka together with these medicines.
• Medicines used to treat mental disorders such as psychosis (pimozide). Do not use Sertralina Krka together with pimozide.

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

• Herbal remedy containing St John’s wort (Hypericum perforatum). The effects of St John’s wort may last for 1–2 weeks.
• Products containing the amino acid tryptophan.
• Medicines used to treat severe pain (e.g. tramadol).
• Medicines used in anaesthesia or for the treatment of chronic pain (fentanyl, mivacurium, and suxamethonium).
• Medicines used to treat migraine (e.g. sumatriptan).
• Medicines used to thin the blood (warfarin).
• Medicines used to treat pain/arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics (also known as “water tablets”).
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excess stomach acid, ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines used to treat mania and depression (lithium).
• Other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines used to treat schizophrenia and other mental disorders (such as 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, and 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. certain antipsychotics and antibiotics).

Sertralina Krka with food, drinks and alcohol
Sertralina Krka tablets may be taken with or without food.
Alcohol consumption should be avoided during treatment with Sertralina Krka.
Sertraline should not be taken together with grapefruit juice, as it may increase sertraline levels in your body.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline will only be administered during pregnancy if your doctor considers that the benefit to the mother outweighs any possible risk to the baby. If you are a woman of childbearing potential, you must use a reliable method of contraception (e.g. oral contraceptive pill) during treatment with sertraline.
Make sure to inform your midwife and/or doctor that you are taking Sertralina Krka. Medicines such as Sertralina Krka, if used during pregnancy, especially during the last 3 months of gestation, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension in neonates (PPHN), which causes increased breathing rate in the baby and bluish skin colouration. These symptoms usually appear within the first 24 hours after birth. If this condition affects your baby, contact your midwife and/or doctor immediately.
Your newborn may also experience other conditions, which usually manifest within the first 24 hours after birth. Symptoms include:

• Breathing difficulties.
• Bluish skin colouration or skin that is too hot or too cold,
• Bluish lips,
• Vomiting or inability to feed properly,
• Extreme tiredness, sleep disturbances, or continuous crying,
• Hypertonia or hypotonia,
• Tremors, nervousness, seizures,
• Hyperreflexia,
• Irritability,
• Low blood sugar levels.

If your baby shows any of these symptoms after birth, or if you are concerned about your baby’s health, you must contact your doctor and/or midwife immediately.

There is evidence that sertraline passes into breast milk. Sertraline should only be used during breastfeeding if your doctor considers that the benefit outweighs any possible risk to the baby.

Fertility
In animal studies, some medicines like sertraline have been shown to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.

Driving and using machines
Psychotropic medicines such as sertraline may affect your ability to drive vehicles or operate machinery. Therefore, you should not drive or operate machinery until you are certain that this medicine does not impair your ability to perform these activities.

3. How to take Sertraline Krka

Always take this medicine exactly as instructed by your doctor or pharmacist.
Consult your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults
Depression and Obsessive-Compulsive Disorder (OCD)
For depression and OCD, the usual effective dose is 50 mg/day. The daily dose may be increased in
increments of 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 (PTSD)
For panic disorder, social anxiety disorder, and PTSD, treatment should start at a dose of 25 mg/day,
which should then be increased to 50 mg/day after one week.
The daily dose may then be increased in increments of 50 mg at intervals of at least one week over
several weeks. The maximum recommended dose is 200 mg/day.
Use in children and adolescents
Sertraline Krka should only be used for the treatment of children and adolescents aged 6–17 years with
Obsessive-Compulsive Disorder (OCD).
Obsessive-Compulsive Disorder (OCD)
Children aged 6–12 years: the recommended initial dose is 25 mg/day.
After one week, your 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.
If you have problems with your liver or kidneys, inform your doctor and follow the instructions given by
your doctor.
Method of administration
Sertraline Krka tablets may be taken with or without food.
Take the medicine once daily, in the morning or in the evening.
Your doctor will tell you how long you should take this medicine. This depends on the duration of your
illness and your response to treatment. It may take several weeks before symptoms begin to improve.
Treatment for depression should generally continue for 6 months after improvement of symptoms.
If you take more Sertraline Krka than you should
If you accidentally take too much Sertraline Krka, contact your doctor immediately or go to the nearest
emergency department. Always take the medicine pack with you, whether or not it still contains any
medicine.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors,
agitation, dizziness, and in rare cases, loss of consciousness.
If you forget to take Sertraline Krka
Do not take a double dose to make up for the missed dose. Take the next dose at the usual time.
If you stop taking Sertraline Krka
Do not stop treatment with Sertraline Krka unless instructed by your doctor. Your doctor may wish to
gradually reduce the dose of Sertraline Krka over several weeks before completely stopping the
medicine. If you stop taking this medicine suddenly, you may experience unwanted effects such as
dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremors.
If you experience any of these unwanted effects, or any other side effects during treatment with
Sertraline Krka, speak to your doctor.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nausea is the most common side effect. Side effects depend on the dose and often disappear or decrease with continued treatment.
Tell your doctor immediately
If you experience any of the following symptoms after taking this medicine, these symptoms can be serious.

• If you develop a severe skin reaction causing blistering (erythema multiforme) (which may affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson syndrome or Toxic Epidermal Necrolysis (TEN). In such cases, your doctor will stop treatment.
• Allergic reactions or allergies, which may include symptoms such as an itchy rash, breathing problems, wheezing, swelling of the eyelids, face or lips.
• If you experience agitation, confusion, diarrhoea, high fever and high blood pressure, excessive sweating and rapid heartbeat. These are symptoms of Serotonin Syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline. Your doctor may decide to stop treatment.
• If you develop yellowing of the skin and eyes, which may indicate liver damage.
• If you develop depressive symptoms with thoughts of harming or killing yourself (suicidal thoughts).
• If you start to feel restless and are no longer able to sit or stand still after starting treatment with Sertralina Krka. You must inform your doctor if you start feeling restless.
• If you have a seizure.
• If you experience a manic episode (see section 2 "Warnings and precautions").

The following side effects have been observed in clinical studies conducted in adult patients.
Very common side effects (may affect more than 1 in 10 people)
Insomnia, dizziness, drowsiness, headache, diarrhoea, nausea, dry mouth, absence of ejaculation, fatigue.
Common side effects (may affect up to 1 in 10 people)

• Sore throat, anorexia, increased appetite,
• depression, feeling strange, nightmares, anxiety, agitation, nervousness, reduced sexual interest, teeth grinding,
• numbness and tingling, tremors, muscle tension, altered taste, lack of attention,
• vision disturbances, ringing in the ears,
• palpitations, hot flushes, yawning,
• abdominal pain, vomiting, constipation, stomach discomfort, gas in the stomach,
• skin rash, increased sweating, muscle pain, erectile dysfunction, chest pain,
• joint pain,
• malaise

Uncommon side effects (may affect up to 1 in 100 people)

• Cold sensation in the chest, runny nose,
• Hypersensitivity
• Low thyroid hormones
• hallucinations, feeling excessively happy, lack of personal care, altered thoughts, aggression,
• Seizures, involuntary muscle contractions, coordination disturbances, excessive movements, amnesia, reduced sensations, speech disorders, dizziness when standing up, fainting, migraine,
• Dilated pupils, ear pain, rapid heartbeat, high blood pressure, facial flushing.
• breathing difficulties, possible wheezing, shortness of breath, nosebleeds.
• Inflammation of the oesophagus, difficulty swallowing, haemorrhoids, increased salivation, tongue disorders, belching,
• eye swelling, red spots on the skin, facial oedema, hair loss, cold sweats, dry skin, urticaria, itching,
• osteoarthritis, muscle weakness, back pain, muscle cramps,
• nocturnal urination, inability to urinate, increased urine volume, increased frequency of urination, urinary problems, urinary incontinence,
• vaginal bleeding, sexual dysfunction, female sexual dysfunction, menstrual irregularities, leg swelling, chills, fever, weakness, thirst, increased liver enzyme levels, weight loss, weight gain.

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

• Intestinal problems, ear infections, cancer, swollen glands, elevated cholesterol levels, low blood sugar levels,
• physical symptoms due to stress or emotions, drug dependence, psychotic disorders, paranoia, suicidal thoughts, sleepwalking, premature ejaculation,
• severe allergic reaction,
• coma, abnormal movements, difficulty moving, increased sensations, sensory disturbances,
• glaucoma, tear problems, formation of spots on the eye, double vision, light sensitivity, presence of blood in the eye, problems controlling blood sugar levels (diabetes),
• heart attack, slowed heartbeat, heart problems, poor blood circulation to arms and legs, throat closure, rapid breathing, slowed breathing, difficulty speaking, hiccups,
• blood in the stools, sore throat, tongue ulceration, dental problems, tongue problems, mouth ulceration, liver function problems,
• skin problems with blister formation, inflammation of hair follicles, changes in hair structure, altered skin odour, bone disorders, reduced urination, urinary hesitation, blood in the urine,
• excessive vaginal bleeding, dryness of the vaginal area, red and painful penis and foreskin, genital discharge, prolonged erection, breast secretion,
• hernia, scar tissue formation at injection site, reduced drug tolerance, difficulty walking, altered seminal fluid, increased blood cholesterol levels, wounds, blood vessel relaxation.
• Cases of suicidal ideation and suicidal behaviour have been reported during treatment with sertraline or immediately after discontinuation of treatment (see section 2).

During the post-marketing phase of sertraline, the following adverse reactions have been reported:

• Decreased white blood cell count, decreased number of blood clotting cells, endocrine problems, low levels of salt in the blood, increased blood sugar levels.
• Altered, frightening dreams, suicidal behaviour
• Movement disorders (such as frequent movements, tense muscles, difficulty walking, and muscle rigidity, spasms and involuntary movements), sudden and severe headaches (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS)).
• Altered vision, unequal pupil size, bleeding problems (such as stomach bleeding), progressive scarring of lung tissue (interstitial lung disease), pancreatitis, severe liver function problems, yellowing of the skin and eyes (jaundice),
• Skin oedema, skin reaction to sunlight, muscle cramps, breast enlargement, coagulation problems,
• Abnormal laboratory tests, bed-wetting. Dizziness, fainting, or chest pain which could be signs of changes in electrical activity (detected on electrocardiogram) or abnormal heart rhythm.

Side effects in children and adolescents
In clinical studies in children and adolescents, side effects were generally similar to those observed in adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhoea and nausea.
Symptoms that may occur when stopping treatment
If treatment is stopped abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremor (see section 3 “If you stop taking Sertralina Krka”).
An increased risk of bone fractures has been observed in patients treated with this type of medicine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sertralina Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after Exp.. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sertralina Krka contains:

• The active substance is sertraline. Each film-coated tablet contains 50 mg or 100 mg of sertraline (as sertraline hydrochloride).
• The other ingredients are dibasic calcium phosphate dihydrate (E341), microcrystalline cellulose (E460), sodium carboxymethylstarch (Type A), hydroxypropylcellulose (E463), talc (E553b), magnesium stearate (E572) in the tablet core, and hypromellose (E464), titanium dioxide (E171), talc (E553b), propylene glycol in the coating.

Description of the appearance of Sertralina Krka tablets and pack contents
50 mg: white, slightly biconvex, oval film-coated tablet, with a break line on one side and the imprint “S3” on the other. The tablet can be divided into two equal doses.
100 mg: white, round, slightly biconvex film-coated tablet with bevelled edges and a break line on one side. The tablet can be divided into two equal doses.

Available pack sizes: 10, 14, 15, 20, 28, 30, 50, 60, 98, 100 x 1 (unit dose) and 100 film-coated tablets in blisters (PVC/Al).
Plastic HDPE (high-density polyethylene) bottles containing 100, 250 and 500 film-coated tablets are also available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible manufacturer for batch release
KRKA d.d., Novo Mesto – Šmarješka cesta 6 – 8501 Novo Mesto (Slovenia)

This medicinal product is authorised in the European Economic Area Member States under the following names:

This patient information leaflet was last updated on