Sertranorm

Package Leaflet: Information for the User

Sertranorm, 50 mg, coated tablets

Sertranorm, 100 mg, coated tablets

Sertraline

Read this carefully before taking your medicine.

• Keep this 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. 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Sertranorm is and what it is used for
• 2. Before you take 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 Sertranorm is and what it is used for

The active substance of Sertranorm is sertraline. Sertraline belongs to a group of medicines called antidepressants (also known as 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 condition where you may feel sad, have sleep problems, or lose interest in activities you once enjoyed.
OCD and panic disorder are anxiety-related conditions where you may experience persistent thoughts (obsessions) that compel you to perform repetitive rituals (compulsive acts).
PTSD is a condition that can occur after a traumatic experience and is characterized by symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related condition where you may feel intense fear or anxiety in social situations (such as talking to strangers, speaking in front of a group, eating or drinking in public, or worrying about your potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for treating your condition. If you are not sure why you have been prescribed Sertranorm, you should ask your doctor.

2. Before you take Sertranorm

Do not 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 other MAOI-like medicines (e.g., linezolid). If you stop taking sertraline, you must wait at least one week before starting an MAOI. After stopping an MAOI, you must wait at least two weeks before starting sertraline.
if you are taking pimozide (a medicine used to treat certain mental disorders, such as psychoses)

Warnings and precautions

Before taking Sertranorm, discuss this with your doctor or pharmacist.
Medicines do not always suit everyone. Tell your doctor before taking Sertranorm if you have or have had any of the following conditions:
seizures or a history of seizures. If you experience a seizure, contact your doctor immediately.
a history of manic-depressive illness (bipolar disorder) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
a history of suicidal thoughts or self-harm (see below – "Suicidal thoughts and worsening of depression or anxiety")
serotonin syndrome or neuroleptic malignant syndrome. These syndromes can occur in rare cases in patients taking certain medicines, including other serotonergic antidepressants, amphetamines, triptans, medicines that affect serotonin metabolism (including MAOIs, e.g., methylene blue), antipsychotics, and opioids, at the same time as sertraline (symptoms, see section 4 "Possible side effects"). If you experience such symptoms, contact your doctor. Your doctor should tell you if you have a history of these conditions.
low sodium levels in the blood, as this may occur with the use of Sertranorm. You should also inform your doctor about taking certain medicines used to treat high blood pressure, as they may also affect sodium levels in the blood.
elderly patients; they may be more susceptible to low sodium levels in the blood (see above)
liver disease; your doctor may decide to reduce the dose of Sertranorm
diabetes; Sertranorm may affect blood sugar levels, so a change in the dosage of antidiabetic medicines may be necessary
bleeding disorders (tendency to bruise) or previous use of medicines that prevent blood clotting (e.g., acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding, or if you are pregnant (see section 2 "Pregnancy, breastfeeding, and fertility").
children and adolescents under 18 years of age. Sertranorm should only be used in children and adolescents aged 6-17 years with obsessive-compulsive disorder (OCD). Patients treated for this condition should be closely monitored by their doctor (see "Children and adolescents" below).
if you are undergoing electroconvulsive therapy (ECT)
eye problems, such as certain types of glaucoma (increased pressure in the eye)
ECG changes, 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 medicines that prolong the QTc interval
Sertraline may cause false-positive results in urine tests for benzodiazepines. More specific tests can distinguish sertraline from benzodiazepines.

Akathisia/psychomotor restlessness

Sertraline has been associated with the development of a condition characterized by restlessness and a compulsion to move, often accompanied by an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. Increasing the dose may be harmful, so if you experience such symptoms, contact your doctor.

Withdrawal symptoms

After stopping treatment, withdrawal symptoms often occur, especially if treatment is stopped abruptly (see section 3 "Stopping 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 can be severe in some patients. They usually occur within the first few days after stopping treatment and typically resolve on their own within two weeks, although some patients may experience symptoms for 2-3 months or longer. If your doctor decides to stop your treatment with sertraline, it is recommended to gradually reduce the dose over several weeks or months and consult your doctor on the best way to stop treatment.

Suicidal thoughts, worsening of depression or anxiety

Patients with depression and (or) anxiety disorders may sometimes have suicidal thoughts or behaviors. Such symptoms or behaviors may worsen at the beginning of treatment with antidepressants, as these medicines may take about two weeks to start working, sometimes longer.

These symptoms are more likely:

• in patients who have had suicidal thoughts or behaviors in the past
• in young adult patients. Clinical trial data have shown an increased risk of suicidal behavior in patients under 25 years of age with mental disorders who were treated with antidepressants. If you experience suicidal thoughts or behaviors, contact your doctor or go to the hospital immediately.

It may be helpful to inform your relatives or friends about your depression or anxiety disorder and ask them to read this leaflet. You may want to ask them to tell you if they notice any worsening of your depression or anxiety or any worrying changes in your behavior.

Sexual dysfunction

Medicines like Sertranorm (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping 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 noted 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, rebelliousness, and anger). Nevertheless, your doctor may prescribe Sertranorm to patients under 18 years of age if they believe it is in their best interest. If your doctor prescribes Sertranorm to a patient under 18 years of age and you have any concerns, please consult your doctor. If any of the above symptoms develop or worsen in patients taking Sertranorm, you should inform your doctor.

Interactions with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Some medicines may affect the treatment with Sertranorm or Sertranorm may reduce the effectiveness of other medicines taken at the same time.

Taking Sertranorm with the following medicines may cause serious side effects

• 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 take Sertranorm with these medicines.
• medicines used to treat mental disorders, such as psychoses (pimozide). Do not take Sertranorm with pimozide.

Tell your doctor if you are taking any of the following medicines

medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
herbal medicines containing St. John's Wort (Hypericum perforatum)
medicines containing the amino acid tryptophan
medicines used to treat severe or chronic pain (opioids, e.g., tramadol, fentanyl)
medicines used for anesthesia (e.g., fentanyl, mivacurium, and suxamethonium)
medicines used to treat migraines (e.g., sumatriptan)
medicines used to prevent blood clots (warfarin)
medicines used to treat pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, acetylsalicylic acid (aspirin))
medicines used to treat anxiety (diazepam)
diuretics (water pills)
medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine)
medicines used to treat diabetes (tolbutamide)
medicines used to treat excessive stomach acid, stomach 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 irregular heartbeat (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)
antiplatelet medicines (ticlopidine)
medicines that may increase the risk of changes in heart rhythm (such as certain antipsychotics and antibiotics)
metamizole, a medicine used to treat pain and fever

Sertranorm with food, drink, and alcohol

Sertranorm tablets can be taken with or without food.
Do not drink alcohol while taking Sertranorm.
Do not drink grapefruit juice while taking sertraline, as it may increase the level of sertraline in your body.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The safety of sertraline in pregnant women has not been fully established. This medicine should only be used during pregnancy if your doctor considers it essential.
Taking Sertranorm at the end of pregnancy may increase the risk of severe bleeding from the vagina, which can occur shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Sertranorm, inform your doctor or midwife so they can provide you with appropriate advice. Taking medicines like Sertranorm, especially in the last three months of pregnancy, may increase the risk of a condition called persistent pulmonary hypertension in newborns (PPHN). This condition is characterized by rapid breathing and bluish discoloration and usually occurs within the first day after birth. If such symptoms occur in your newborn, contact your midwife and (or) doctor immediately.
Your 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
• shivering, muscle contractions, or seizures
• increased reflexes
• restlessness
• low blood sugar

If your child experiences any of these symptoms or if their condition is worrying, contact your doctor or midwife.
Breastfeeding
Sertraline passes into breast milk. This medicine can be used during breastfeeding if your doctor considers it essential for you and the benefits outweigh the risks for your baby.
Fertility
Some medicines similar to sertraline have been shown to decrease sperm quality in animal studies. This may theoretically affect fertility, although no effect on fertility has been observed in humans.

Driving and using machines

Psychotropic medicines, such as sertraline, may affect your ability to drive or operate machinery. Therefore, wait until you know how Sertranorm affects you before performing these activities.

Sertranorm contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Sertranorm

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, 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 dose is 25 mg of sertraline per day. 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 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 one week, the dose may be increased 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 tablets should be taken once daily, in the morning or evening.
The tablet can be divided into equal doses.
Your doctor will tell you how long you should take Sertranorm. The treatment period depends on the type of disease and your response to treatment. Improvement in your condition may only be noticeable after several weeks of treatment. Treatment of depression should usually be continued for 6 months after improvement.

Overdose

If you accidentally take too much Sertranorm, contact your doctor or go to the emergency department of your nearest hospital immediately. Take the medicine package with you, even if it is empty.
Overdose symptoms may include: drowsiness, nausea, and vomiting, rapid heartbeat, muscle tremors, agitation, dizziness, and in rare cases, loss of consciousness.

Missed dose

Do not take a double dose to make up for a forgotten dose.
If you forget to take a tablet, do not take the missed tablet. Just take the next tablet at the right time.

Stopping Sertranorm

You must not stop taking Sertranorm on your own. Your doctor will gradually reduce the dose of Sertranorm over several weeks before you stop treatment. If you stop taking Sertranorm abruptly, 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, contact your doctor.
If you have any further questions on the use of this product, 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 in severity as treatment continues.

See your doctor immediately

If you experience any of the following symptoms after taking this medicine, as they can be serious:
if you develop a severe skin rash that causes blistering (this can be a sign of a condition known as Stevens-Johnson syndrome or toxic epidermal necrolysis). Your doctor will stop your treatment with Sertranorm.
allergic reactions or allergies with symptoms such as itchy skin rash, difficulty breathing, wheezing, swelling of the eyelids, face, or lips
if you experience: agitation, confusion, diarrhea, high blood pressure, and rapid heartbeat. These are symptoms of serotonin syndrome or neuroleptic malignant syndrome. In rare cases, these syndromes can occur when you take certain medicines, including other serotonergic antidepressants, at the same time as sertraline. Your doctor may stop your treatment with Sertranorm.
if you develop yellowing of the skin and eyes, which can be a sign of liver damage
if you experience symptoms of depression with suicidal thoughts or behaviors (suicidal thoughts)
if you feel restless and unable to sit or stand still after taking Sertranorm. If you experience restlessness, tell your doctor.
if you experience a seizure (convulsion)
if you experience manic episodes (see section 2 "Warnings and precautions")

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 libido, nervousness, "feeling strange", 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, tremors, lack of attention, taste disturbances
• vision disturbances
• ringing in the ears
• rapid heartbeat
• hot flushes
• yawning
• gastrointestinal disturbances, constipation, abdominal pain, vomiting, gas
• increased sweating, rash
• back pain, joint pain, muscle pain
• irregular menstrual periods, erectile dysfunction
• feeling unwell, chest pain, weakness, fever
• weight gain
• injuries

Uncommon (may affect up to 1 in 100 people)

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

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

• appendicitis, lymph node swelling, decreased platelet count, decreased white blood cell count
• severe allergic reactions
• endocrine disorders
• high cholesterol levels, 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 can be a sign of a serious condition called reversible cerebral vasoconstriction syndrome), sensory disturbances
• floaters, glaucoma, double vision, light sensitivity, blood in the eye, uneven pupil size, vision disturbances, tear disturbances
• heart attack, feeling of emptiness in the head, fainting or discomfort in the chest, which can be symptoms of changes in heart rhythm (visible on an electrocardiogram) or irregular heartbeat, slow heartbeat
• poor circulation in the arms and legs
• rapid breathing, progressive scarring of lung tissue (interstitial lung disease), blockage of the airways, difficulty speaking, 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 the stool, tongue pain, oral discomfort
• liver disorders, severe liver dysfunction, yellowing of the skin and eyes (jaundice)
• sunburn, skin swelling, abnormal hair structure, abnormal skin odor, skin rash on hairy areas
• muscle breakdown, bone disorders
• urination problems, decreased urination
• breast discharge, vaginal dryness, vaginal discharge, painful penis and foreskin, breast enlargement, prolonged erection
• hernia, decreased drug tolerance
• increased cholesterol levels, abnormal laboratory test results, abnormal semen analysis, bleeding disorders
• blood vessel disorders

Unknown (frequency cannot be estimated from the available data)

• jaw locking
• bedwetting
• partial loss of vision
• colitis (causing diarrhea)
• severe bleeding from the vagina shortly after delivery (postpartum hemorrhage), see additional information in section 2 "Pregnancy, breastfeeding, and fertility"
• muscle weakness and severe muscle pain, which can be symptoms of a condition similar to glutaric aciduria type II

side effects reported after marketing

Additional side effects in children and adolescents

In clinical trials with children and adolescents, side effects were generally similar to those in adults (see above). The most common side effects in children and adolescents were headaches, insomnia, diarrhea, and nausea.

Withdrawal symptoms

After stopping treatment, withdrawal symptoms may occur, such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and muscle tremors (see section 3 "Stopping Sertranorm").
Patients taking Sertranorm have an increased risk of bone fractures.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide 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 which is stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Sertranorm contains

The active substance 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 score line on one side and "L" engraved on the other side.
Sertranorm, 100 mg, coated tablets
White, round, biconvex coated tablets, 10 mm in diameter, with a score line on one side and "C" engraved 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
For more information on this medicine, contact your local representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel.: +48 12 262 32 36
e-mail: [email protected]
Date of last revision of the leaflet:June 2025