Sertranorm

Package Leaflet: Information for the User

Sertranorm, 50 mg, coated tablets

Sertranorm, 100 mg, coated tablets

Sertraline

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Sertranorm and what is it used for

The active substance of the medicine is sertraline. Sertraline belongs to a group of antidepressant medicines (also called selective serotonin reuptake inhibitors, SSRIs); these medicines are used to treat depression and (or) anxiety disorders.

Sertranorm is used 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 feelings of sadness, difficulty sleeping or decreased joy in life.
OCD and panic disorder are anxiety-related diseases with symptoms of persistent anxiety due to persistent thoughts (obsessions) that cause repetitive rituals (compulsive actions).
Post-traumatic stress disorder (PTSD) is a condition that can occur after a traumatic experience and is characterized by certain symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related disease. It is characterized by a feeling of 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 worrying about potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for the treatment of your disease.
You should consult your doctor if you are not sure why you are taking Sertranorm.

2. Important information before taking Sertranorm

When not to take Sertranorm

if you are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6)
if you are taking or have taken monoamine oxidase inhibitors (MAOIs, e.g. selegiline, moclobemide) or medicines similar to MAOIs (e.g. linezolid).
In the event of discontinuation of sertraline treatment, you should wait at least one week before starting MAOI treatment. After discontinuation of MAOI treatment, you should wait at least two weeks before starting sertraline treatment.
if you are taking pimozide (a medicine used to treat mental disorders, such as psychoses)

Warnings and precautions

Before starting Sertranorm, discuss it with your doctor or pharmacist.
Medicines do not always suit everyone. You should tell your doctor before taking Sertranorm if you currently have or have had any of the following conditions:
seizures (epilepsy) or a history of seizures. If a seizure occurs, you should contact your doctor immediately.
a history of manic-depressive illness (bipolar) or schizophrenia. If a manic episode occurs, you should contact your doctor immediately.
a history of suicidal thoughts or self-harm (see below - "Suicidal thoughts and worsening of depressive or anxiety disorders")
serotonin syndrome or malignant neuroleptic syndrome. In rare cases, these syndromes can occur in patients taking certain medications (other serotonergic medications, including other serotonergic antidepressants, amphetamines, triptans, medications that disrupt serotonin metabolism (including monoamine oxidase inhibitors, e.g. methylene blue), antipsychotic medications, other medications in the class of dopamine antagonists, and opioids) at the same time as sertraline (symptoms, see section 4 "Possible side effects"). If such symptoms occur, you should contact your doctor. Your doctor should tell you if you have had these diseases in the past.
low sodium levels in the blood, as it may occur as a result of taking Sertranorm. You should also inform your doctor about taking certain medications used to treat high blood pressure, as they 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; your doctor may decide to reduce the dose of Sertranorm
diabetes; Sertranorm may affect changes in blood sugar levels, so it may be necessary to change the dosage of antidiabetic medications
bleeding disorders (tendency to bruise) or a history of taking medications that prevent blood clotting (e.g. acetylsalicylic acid (aspirin) or warfarin) or medications that may increase the risk of bleeding, or if you are pregnant (see section 2 "Pregnancy, breastfeeding, and fertility").
children or adolescents under 18 years of age. Sertranorm should only be used in the treatment of children and adolescents aged 6-17 years with obsessive-compulsive disorder (OCD). Patients treated for this condition should be closely monitored by a doctor (see "Children and adolescents" below).
if you are undergoing electroconvulsive therapy
eye problems, such as certain types of glaucoma (increased pressure in the eye)
ECG abnormalities, known as prolonged QT interval
heart disease, low potassium or low magnesium levels, prolonged QTc interval in the medical history, slow heart rate, and concurrent use of medications that prolong the QTc interval
Taking sertraline may lead to false-positive test results for benzodiazepines in urine. Using more specific tests can distinguish sertraline from benzodiazepines.

Psychomotor agitation/akathisia

Sertraline has been associated with the occurrence of a state characterized by psychomotor agitation 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. Increasing the dose of the medicine may be harmful, so if you experience such symptoms, you should contact your doctor.

Withdrawal symptoms

After discontinuation of treatment, side effects (withdrawal symptoms) often occur, especially if treatment is discontinued abruptly (see section 3 "Discontinuation of Sertranorm" and section 4 "Possible side effects"). The risk of withdrawal symptoms depends on the duration of treatment, dosage, 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 discontinuation of treatment. They usually resolve on their own within two weeks, but in some patients, they may persist for longer (for 2-3 months or longer). In the event of a decision to discontinue sertraline treatment, it is recommended to gradually reduce the dose over several weeks or months and consult a doctor on the best way to discontinue treatment.

Suicidal thoughts, worsening of depression or anxiety disorders

Patients with depression and (or) anxiety disorders may sometimes have suicidal thoughts or self-harm. Such symptoms or behavior may worsen at the beginning of antidepressant treatment, as these medications usually start working after about two weeks, sometimes later.

The above symptoms are more likely:

• in patients who have had suicidal thoughts or self-harm in the past
• in young adult patients. Data from clinical trials show an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressants. If you experience suicidal thoughts or self-harm, you should contact your doctor or go to the hospital immediately.

It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this package leaflet. You can ask them to inform you if they notice that your depression or anxiety has worsened or if there are worrying changes in your behavior.

Sexual dysfunction

Medicines like Sertranorm (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.

Children and adolescents

Sertranorm should not be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder (OCD). It should also be emphasized that when taking medicines of this class, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, or hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, your doctor may prescribe Sertranorm to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Sertranorm to a patient under 18 years of age and you have any doubts, please consult the doctor. If the above symptoms develop or worsen in patients taking Sertranorm, you should inform your doctor.

Sertranorm with food, drinks, and alcohol

Sertranorm tablets can be taken with or without food.
During treatment with Sertranorm, it is not recommended to consume alcohol.
While taking sertraline, you should not consume grapefruit juice, as it 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 plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The safety of sertraline in pregnant women has not been fully confirmed. The medicine can be used in pregnant women only if the doctor considers that the benefits of the medicine for the mother outweigh the potential risks to the developing child.
Taking Sertranorm at the end of pregnancy may increase the risk of severe vaginal bleeding occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If you are taking Sertranorm, you should inform your doctor or midwife so that they can provide you with appropriate advice. Taking medicines like Sertranorm during pregnancy, especially in the last three months of pregnancy, may increase the risk of the baby developing a condition called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and bluish discoloration and usually occurs within the first day of life. If such symptoms occur in the newborn, you should contact the midwife and (or) doctor immediately.
The newborn may also experience other complications, which usually occur within the first 24 hours after birth. These symptoms include:

• breathing difficulties
• bluish discoloration of the skin, too hot or cold skin
• bluish lips
• vomiting or feeding problems
• excessive tiredness, difficulty sleeping, or constant crying
• increased or decreased muscle tone
• tremors, muscle spasms, or seizures
• increased reflexes
• agitation
• low blood sugar

If the child experiences any of these symptoms or if their condition is worrying, you should contact the doctor or midwife.

Breastfeeding
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 potential risks to the child.
Fertility
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 machinery. Therefore, you should wait until you know how Sertranorm affects your ability to perform these activities.

Sertranorm contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Sertranorm

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Recommended dose

Adults

Depression and obsessive-compulsive disorder

The usual dose is 50 mg of sertraline per day. If necessary, the dose may be increased gradually by 50 mg at intervals of at least one week over several weeks. The maximum recommended daily dose is 200 mg of sertraline.

Panic disorder, social anxiety disorder, post-traumatic stress disorder

The usual daily dose is 25 mg of sertraline. After one week, the dose should be increased to 50 mg per day.
If necessary, your doctor may increase the dose gradually by 50 mg at intervals of several weeks. The maximum recommended daily dose is 200 mg.

Use in children and adolescents

Sertranorm can be used in the treatment of children and adolescents only with obsessive-compulsive disorder (OCD) aged 6-17 years.

Obsessive-compulsive disorder

Children aged 6-12 years:the recommended initial dose is 25 mg per day.
After 1 week, the doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.
Adolescents aged 13-17 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 their advice.

Method of administration

Sertranorm tablets can be taken with or without food.
The medicine should be taken once a day, in the morning or evening.
The tablet can be divided into equal doses.
Your doctor will inform you how long you should take the medicine. The treatment period depends on the type of disease and the patient's response to treatment. Improvement in condition may start only after several weeks of treatment. Treatment of depression should usually be continued for 6 months after improvement.

Taking a higher dose of Sertranorm than recommended

If you accidentally take too much Sertranorm, you should immediately contact your doctor or go to the emergency department of the nearest hospital. You should always take the medicine packaging with you, regardless of whether there is medicine left in it or not.
Overdose symptoms may include: drowsiness, nausea, and vomiting, rapid heartbeat, muscle tremors, agitation, dizziness, and, in rare cases, loss of consciousness.

Missing a dose of Sertranorm

You should not take a double dose to make up for a missed dose.
If you forget to take a tablet, you should not take the missed tablet. You should simply take the next tablet at the right time.

Discontinuation of Sertranorm

You should never stop taking Sertranorm on your own. Your doctor will gradually reduce the dose of the medicine over several weeks until you stop treatment. If you suddenly stop taking the medicine, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors. If you experience any of these side effects or any other side effects after stopping Sertranorm, you should contact your doctor.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sertranorm 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.

You should immediately contact your doctor

If you experience any of the following symptoms after taking this medicine, as they may be serious.
if you develop a severe skin rash that forms blisters (erythema multiforme; blisters may appear in the mouth and on the tongue). These may be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis. In such cases, your doctor will discontinue treatment.
allergic reaction or allergy with symptoms such as: itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips
if you experience: agitation, confusion, diarrhea, high temperature and blood pressure, excessive sweating, and rapid heartbeat. These are symptoms of serotonin syndrome or malignant neuroleptic syndrome. In rare cases, these syndromes can occur when you take certain medications at the same time as sertraline. Your doctor may discontinue treatment.
if you experience yellowing of the skin and eyes, which may indicate liver damage
if you experience symptoms of depression with suicidal thoughts or self-harm (suicidal thoughts)
if you feel restless and unable to sit or stand still after taking Sertranorm. If you feel restless, you should tell your doctor.
if you experience a seizure (epileptic fit)
if you experience manic episodes (see section 2 "Warnings and precautions")
The following side effects have been observed in clinical trials in adult patients and after the medicine was placed on the market.

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

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

Common (may affect up to 1 in 10 people)

• bronchitis, sore throat, cold
• loss of appetite, increased appetite
• anxiety, depression, agitation, decreased interest in sex, nervousness, "strange" feeling, nightmares, teeth grinding
• seizures, movement disorders (such as increased muscle activity, increased muscle tone, difficulty walking, and stiffness, cramps, and involuntary muscle movements), numbness and tingling, muscle tremors, lack of attention, taste disorders
• vision disturbances
• ringing in the ears
• palpitations
• hot flashes
• yawning
• gastrointestinal disturbances, constipation, abdominal pain, vomiting, gas
• increased sweating, rash
• back pain, joint pain, muscle pain
• irregular menstrual cycle, erectile dysfunction
• malaise, chest pain, weakness, fever
• weight gain
• injuries

Uncommon (may affect up to 1 in 100 people)

• gastrointestinal disorders, ear infection
• cancer
• hypersensitivity, seasonal allergic reactions
• low thyroid hormone levels
• suicidal thoughts, suicidal behavior, psychotic disorders, thought disorders, apathy, hallucinations, aggression, euphoria, paranoia
• memory disorders, decreased sensation, involuntary muscle spasms, fainting, increased mobility, migraine, seizures, dizziness when standing up, coordination disorders, speech disorders
• pupil dilation
• ear pain
• rapid heartbeat, heart problems
• bleeding disorders (such as gastrointestinal bleeding), high blood pressure, facial flushing, blood in urine
• shortness of breath, nosebleeds, breathing difficulties, possible snoring
• tarry stools, dental disorders, esophagitis, tongue problems, hemorrhoids, increased salivation, swallowing difficulties, belching, speech disorders
• eye swelling, hives, hair loss, itching, purpura, skin disorders with blistering, dry skin, facial swelling, cold sweats
• degenerative joint disease, muscle cramps, muscle spasms, muscle weakness
• increased urination frequency, urination problems, inability to urinate, urinary incontinence, increased urine production, nocturia
• sexual dysfunction, heavy menstrual bleeding, vaginal bleeding, sexual dysfunction in women
• leg swelling, chills, walking difficulties, increased thirst
• increased liver enzyme levels, weight loss
• suicidal thoughts or behaviors have been reported during sertraline treatment or shortly after discontinuation (see section 2)

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

• appendicitis, lymphadenopathy, decreased platelet count, decreased white blood cell count
• severe allergic reactions
• endocrine disorders
• high cholesterol, diabetes-related problems, low blood sugar, high blood sugar, low sodium levels
• 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 sign 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, vision disturbances, 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
• poor circulation in the arms and legs
• rapid breathing, progressive pulmonary fibrosis (a disease in which lung tissue becomes scarred), bronchitis, breathing difficulties, speech difficulties, slow breathing, hiccups
• a condition in which eosinophils (a type of white blood cell) appear in the lungs in increased numbers (eosinophilic pneumonia)
• mouth ulcers, pancreatitis, blood in stool, tongue pain, oral discomfort
• liver disorders, severe liver dysfunction, yellowing of the skin and eyes (jaundice)
• sun allergy, skin swelling, abnormal hair structure, abnormal skin odor, hairy skin rash
• muscle breakdown, bone disorders
• urination difficulties, decreased urination
• breast discharge, vaginal dryness, discharge, painful red penis and foreskin, breast enlargement, prolonged erection
• hernia, decreased drug tolerance
• increased cholesterol levels, abnormal laboratory test results, abnormal semen test results, bleeding disorders
• blood vessel weakness

Unknown (frequency cannot be estimated from available data)

• jaw spasms
• bedwetting
• partial loss of vision
• colitis (causing diarrhea)
• severe postpartum hemorrhage (see additional information in section 2 "Pregnancy, breastfeeding, and fertility")
• muscle weakness and severe muscle pain, which may be symptoms of a disorder similar to glutaric aciduria type II

side effects observed after the medicine was placed on the market

Additional side effects in children and adolescents

In clinical trials in 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 sudden discontinuation of treatment, side effects may occur, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3 "Discontinuation of Sertranorm").
Patients taking Sertranorm have been observed to have an increased risk of bone fractures.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should inform your doctor or pharmacist. 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: Al. Jerozolimskie 181C, 02-222 Warsaw; phone: +48 22 49 21 301; fax: +48 22 49 21 309; http://smz.ezdrowie.gov.pl.
Side effects can also be reported to the local representative of the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Sertranorm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after "Expiry date" or "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sertranorm contains

The active substance of the medicine is sertraline.
Sertranorm, 50 mg, coated tablets
Each coated tablet contains 50 mg of sertraline (as hydrochloride).
Sertranorm, 100 mg, coated tablets
Each coated tablet contains 100 mg of sertraline (as hydrochloride).
Other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone K30, sodium croscarmellose, magnesium stearate.
Coating ( Sertranorm, 50 mg): hypromellose 6, talc, propylene glycol, titanium dioxide (E 171).
Coating ( Sertranorm, 100 mg): hypromellose 6, hypromellose 15, talc, propylene glycol, titanium dioxide (E 171).

What Sertranorm looks like and contents of the pack

Sertranorm, 50 mg, coated tablets
White, oval, biconvex coated tablets, 10 mm x 5 mm in size, with a notch on one side and the inscription "L" on the other side.
Sertranorm, 100 mg, coated tablets
White, round, biconvex coated tablets, 10 mm in diameter, with a notch on one side and the inscription "C" on the other side.
Sertranorm 50 mg and 100 mg is available in the following pack sizes: blisters in a carton box of 20, 30, 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer

Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Setaloft
Poland
Sertranorm
To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
phone: +48 12 262 32 36
e-mail: krakow@pluspharma.eu
Date of last revision of the package leaflet:June 2025