Sertranorm

Package leaflet: Information for the user

Sertranorm, 50 mg, film-coated tablets
Sertranorm, 100 mg, film-coated tablets
Sertraline
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

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

Table of contents

1. What Sertranorm is and what it is 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 Sertranorm is and what it is used for

The active substance in Sertranorm is sertraline. Sertraline belongs to a group of medicines known as antidepressants (also called selective serotonin reuptake inhibitors, SSRIs). These medicines are used to treat depressive and/or anxiety disorders.
Sertranorm is 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 6–17 years)

Depression is an illness characterised by feelings of sadness, difficulty sleeping, or reduced enjoyment of life.
OCD and panic disorder are anxiety-related conditions, associated with persistent feelings of anxiety due to intrusive thoughts (obsessions), leading to repetitive rituals (compulsions).
Post-traumatic stress disorder (PTSD) is a condition that may occur following a traumatic experience and is characterised by symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterised by intense fear or stress in social situations (such as talking to strangers, speaking in front of a group, eating or drinking in public, or worrying about potentially embarrassing behaviour).

Your doctor has decided that this medicine is suitable for treating your condition.
If you are unsure why you are taking Sertranorm, please consult your doctor.

2. Important Information Before Using Sertranorm

When not to use Sertranorm
if the patient is allergic to sertraline or 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 drugs similar to MAO inhibitors (e.g. linezolid).
After stopping treatment with sertraline, at least one week must elapse before starting treatment with an MAO inhibitor. After stopping treatment with an MAO inhibitor, at least two weeks must elapse before starting treatment with sertraline.
if the patient is taking pimozide (a medicine used to treat psychiatric disorders such as psychosis)

Warnings and Precautions
Before starting treatment with Sertranorm, discuss this with your doctor or pharmacist.
Medicines are not suitable for everyone. You should inform your doctor before taking Sertranorm if the patient currently has or has previously had any of the following conditions:
epilepsy (seizures) or a history of seizures. If a seizure occurs, contact your doctor immediately.
a previous diagnosis 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 and worsening of depressive or anxiety disorders")
serotonin syndrome or neuroleptic malignant syndrome. In rare cases, these syndromes may occur in patients taking certain medicines (other serotonergic medicines, including other serotonergic antidepressants, amphetamines, triptans, medicines affecting serotonin metabolism (including monoamine oxidase inhibitors, e.g. methylene blue), antipsychotics, other dopamine antagonists, and opioids) at the same time as sertraline (symptoms, see section 4 "Possible side effects"). If such symptoms occur, contact your doctor. The doctor should be informed whether the patient has previously suffered from these conditions.
low sodium levels in the blood, which may occur as a result of treatment with Sertranorm. You should also inform your doctor if you are 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 reduced sodium levels in the blood (see above)
liver disease; your doctor may decide to reduce the dose of Sertranorm
diabetes; Sertranorm may affect blood glucose levels, so a change in the dosage of antidiabetic medicines may be necessary
bleeding disorders (tendency to bruise) or previous use of anticoagulant medicines (e.g. acetylsalicylic acid (aspirin) or warfarin) or medicines that may increase the risk of bleeding, or if the patient is pregnant (see section 2 "Pregnancy, breastfeeding and fertility").
children or adolescents under 18 years of age. Sertranorm may only be used in the treatment of children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD). Patients being treated for this condition should be closely monitored by a doctor (see "Children and adolescents" below).
if the patient is undergoing electroconvulsive therapy
eye problems, such as certain types of glaucoma (increased eye pressure)
abnormalities on ECG, known as QT interval prolongation
heart disease, low potassium or low magnesium levels, family history of QTc prolongation, slow heart rate, and concomitant use of medicines that prolong the QTc interval

The use of sertraline may lead to false-positive results in urine tests for benzodiazepines. More specific testing can differentiate sertraline from benzodiazepines.

Psychomotor agitation/akathisia
Sertraline has been associated with the development of a condition characterized by motor restlessness and a compulsion to move—often with an inability to sit still or remain in one place (akathisia). This condition usually occurs within the first weeks of treatment. Increasing the dose of the medicine may be harmful, so if such symptoms occur, contact your doctor.

Withdrawal symptoms
After stopping treatment, adverse effects (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 the speed of dose reduction. These symptoms are generally mild or moderate in intensity, but in some patients they may be severe. They usually appear within the first few days after stopping treatment. They usually resolve spontaneously within 2 weeks, but in some patients they may persist longer (for 2–3 months or more). If a decision is made to discontinue treatment with sertraline, gradual dose reduction over several weeks or months is recommended, and the best way to stop treatment should be discussed with your doctor.

Suicidal thoughts, worsening depression or anxiety disorders
Patients with depression and (or) anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviors may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start to work only after about 2 weeks, sometimes later.

The above symptoms are more likely:

• in patients who have previously had thoughts of self-harm or suicide
• in young adult patients. Clinical trial data show an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders who were treated with antidepressant medicines. If the patient develops thoughts of self-harm or suicide, contact a doctor immediately or go to hospital.

It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him/her if they notice that depression or anxiety has worsened or if there are worrying changes in behavior.

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

Children and adolescents
Sertranorm should not be used in children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder (OCD). It should also be emphasized that patients under 18 years of age taking medicines of this class are at increased risk of side effects such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostility (particularly aggression, oppositional behavior, and anger). Nevertheless, a doctor may prescribe Sertranorm to patients under 18 years of age if he/she considers 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 prescribing doctor. If any of the above symptoms develop or worsen in patients taking Sertranorm, inform your doctor.

In a long-term observational study lasting 3 years involving over 900 children aged 6 to 16 years, the long-term safety of sertraline was evaluated with regard to its effects on growth, maturation, learning (cognitive functions), and behavior. Overall, study results showed that children treated with sertraline developed normally, except for a slightly reduced weight gain in children treated with higher doses.

Sertranorm and other medicines
You should inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Some medicines may affect treatment with Sertranorm or Sertranorm may reduce the effectiveness of other medicines taken at the same time.

Taking Sertranorm together with the following medicines may cause severe adverse effects

• MAO inhibitors, e.g. 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). Sertranorm should not be used together with these medicines.
• medicines used to treat psychiatric disorders such as psychosis (pimozide). Sertranorm should not be used together with pimozide.

The patient should inform the doctor if taking 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). The effect of St. John's wort may persist for 1–2 weeks.
medicines containing the amino acid tryptophan
medicines used to treat severe or chronic pain (opioids, e.g. tramadol, fentanyl)
medicines used in anesthesia (e.g. fentanyl, mivacurium, and suxamethonium)
medicines used to treat migraines (e.g. sumatriptan)
medicines preventing blood clot formation (warfarin)
painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, salicylic acid (aspirin))
sedatives (diazepam)
diuretics (so-called water pills)
medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine)
medicines used to treat diabetes (tolbutamide)
medicines used to treat excessive stomach acid secretion, peptic ulcer disease, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole)
medicines used to treat mania and depression (lithium)
other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine)
medicines used to treat schizophrenia and other psychiatric 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, 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 increasing the risk of changes in the heart's electrical activity (such as certain antipsychotics and antibiotics)
metamizole, a medicine used to treat pain and fever

Sertranorm with food, drink, and alcohol
Sertranorm tablets may be taken with or without food. During treatment with Sertranorm, alcohol consumption is not recommended.
While taking sertraline, grapefruit juice should not be consumed, as it may lead to increased levels of sertraline in the body.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The safety of using sertraline in pregnant women has not been fully confirmed. The medicine may be used in pregnant women only if, according to the doctor's assessment, the benefits of treatment for the mother outweigh the potential risks to the developing child.
Taking Sertranorm towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Sertranorm, she should inform her doctor or midwife so they can provide appropriate advice. Taking medicines such as Sertranorm during pregnancy, especially 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). This condition is characterized by rapid breathing and cyanosis and usually occurs within the first day after birth. If such symptoms occur in the newborn, contact the midwife and (or) doctor immediately.
Other complications may also occur in the newborn, which usually appear within the first 24 hours after birth. These symptoms include:

• difficulty breathing
• bluish or too hot or too cold skin
• blue lips
• vomiting or feeding problems
• excessive tiredness, difficulty sleeping, or constant crying
• increased or decreased muscle tone
• tremors, muscle twitches, 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 the doctor or midwife.

Breastfeeding
There is evidence that sertraline passes into breast milk. The medicine may be used in women during breastfeeding if, according to the doctor's assessment, the benefits of treatment outweigh the potential risks to the child.

Effect on fertility
In animal studies, some medicines similar to sertraline reduced semen quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans to date.

Driving and operating machinery
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. Therefore, you should wait before performing the above activities until you know how Sertranorm affects your ability to perform them.

Sertranorm contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Sertranorm

This medicine should always be taken exactly as directed by the doctor or pharmacist. If in doubt,
consult the 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 gradually increased
by 50 mg at intervals of at least one week over a period of 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, the doctor may gradually increase the dose by 50 mg at a time, over several weeks.
The maximum recommended daily dose is 200 mg.
Use in children and adolescents
Sertranorm may be used in children and adolescents aged 6–17 years only for the treatment of
obsessive-compulsive disorder (OCD).
Obsessive-compulsive disorder
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 his or her instructions.
Method of administration
Sertranorm tablets may be taken with food or independently of meals.
The medicine should be taken once daily, in the morning or evening.
The tablet may be divided into equal doses.
The doctor will inform the patient how long the medicine should be taken. The duration of treatment
depends on the type of illness and the patient's response to treatment. Improvement in health may
only begin after several weeks of treatment. Treatment for depression should usually continue for
6 months after improvement is achieved.
Taking more Sertranorm than recommended
If the patient accidentally takes too much Sertranorm, contact a doctor immediately or go to the
emergency department of the nearest hospital. Always bring the medicine package, including the label,
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.
Missing a dose of Sertranorm
Do not take a double dose to make up for a missed dose.
If the patient forgets to take a tablet, do not take the missed tablet. Simply take the next tablet at the
correct time.
Stopping Sertranorm
The patient must not stop taking Sertranorm without consulting the doctor. The doctor will gradually
reduce the dose over several weeks until treatment is discontinued. In patients who abruptly stop taking
the medicine, adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety,
headache, nausea, vomiting, and muscle tremors may occur. If any of these or other adverse effects occur
after stopping Sertranorm, consult the doctor.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The most commonly occurring adverse reaction is nausea. Adverse reactions are dose-dependent and often diminish or resolve with continued treatment.
You should inform your doctor immediately
if any of the following symptoms occur in the patient after taking this medicine, as they may be serious:

• if the patient develops a severe skin rash causing blistering (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, the 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 the patient experiences: agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating, and increased heart rate. These are symptoms of serotonin syndrome or neuroleptic malignant syndrome. In rare cases, these syndromes may occur when the patient is taking certain medicines simultaneously with sertraline. The doctor may then discontinue the patient's treatment.
• if the patient develops yellowing of the skin and eyes, which may indicate liver damage
• if the patient experiences symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts)
• if the patient begins to feel inner restlessness and an inability to sit or stand still after taking Sertranorm. If the patient experiences such restlessness, they should inform their doctor.
• if the patient has a seizure (epileptic fit)
• if the patient experiences manic episodes (see section 2 "Warnings and precautions")

The following adverse reactions have been observed in clinical trials in adult patients and after the medicine has been marketed.

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

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

Common (may affect up to 1 in 10 patients)

• bronchitis, sore throat, nasal congestion
• loss of appetite, increased appetite
• anxiety, depression, agitation, reduced interest in sex, nervousness, "strange" feelings, nightmares, teeth grinding
• convulsions, movement disorders (such as increased motor activity, increased muscle tension, difficulty walking, and muscle stiffness, spasms, and involuntary movements), numbness and tingling sensations, muscle tremors, lack of attention, taste disturbances
• visual disturbances
• tinnitus (ringing in the ears)
• palpitations
• hot flushes
• yawning
• gastrointestinal discomfort, constipation, abdominal pain, vomiting, flatulence
• increased sweating, rash
• back pain, joint pain, muscle pain
• irregular menstruation, erectile dysfunction
• malaise, chest pain, weakness, fever
• weight gain
• injuries

Uncommon (may affect up to 1 in 100 patients)

• gastrointestinal disorders, ear infection
• neoplastic disease
• hypersensitivity, seasonal allergic reactions
• low thyroid hormone levels
• suicidal thoughts, suicidal behaviour, psychotic disorders, thought disturbances, emotional blunting, hallucinations, aggression, feelings of euphoria, paranoia
• memory impairment, reduced sensation, involuntary muscle contractions, fainting, increased motor activity, migraine, convulsions, dizziness upon standing, coordination disturbances, speech disorders
• pupil dilation
• ear pain
• increased heart rate, heart problems
• haemorrhagic disorders (such as gastrointestinal bleeding), high blood pressure, facial flushing, presence of blood in urine
• shortness of breath, nosebleeds, breathing difficulties, possible wheezing
• tarry stools, dental disorders, oesophagitis, tongue problems, haemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders
• eye swelling, urticaria, hair loss, itching, purpuric skin spots, skin disorders with blister formation, dry skin, facial swelling, cold sweats
• degenerative joint disease, muscle cramps, muscle tics, muscle weakness
• increased frequency of urination, difficulty urinating, inability to urinate, urinary incontinence, increased urine output, nocturnal urination
• sexual disorders, excessive vaginal bleeding, vaginal haemorrhage, sexual dysfunction in women
• leg swelling, chills, difficulty walking, increased thirst
• increased liver enzyme levels, weight loss
• during treatment with sertraline or shortly after discontinuation, cases of suicidal thoughts or behaviours have been reported (see section 2)

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

• diverticulitis, lymph node swelling, decreased platelet count, decreased white blood cell count
• severe allergic reactions
• endocrine disorders
• high cholesterol levels, problems maintaining normal blood sugar levels (diabetes), low blood sugar, high blood sugar, low blood sodium levels
• physical symptoms caused by stress or emotions, nightmares, drug dependence, sleepwalking, premature ejaculation
• stupor, abnormal movements, difficulty moving, increased sensitivity to touch, sudden severe headache (which may be a sign of a serious condition called reversible cerebral vasoconstriction syndrome), sensory disturbances
• spots before the eyes, glaucoma, double vision, photophobia, blood in the eye, unequal pupil size, abnormal vision, disturbances in tear secretion
• myocardial infarction, feeling of emptiness in the head, fainting or discomfort in the chest, which may be symptoms of changes in the heart's electrical activity (visible on electrocardiogram) or irregular heartbeat, slowed heart rate
• poor blood circulation in the upper and lower limbs
• rapid breathing, progressive pulmonary fibrosis (interstitial lung disease), throat closure, speech difficulties, slowed breathing, hiccups
• a form of lung disease in which eosinophils (a type of white blood cell) appear in increased numbers in the lungs (eosinophilic pneumonia)
• oral ulceration, pancreatitis, blood in stool, tongue ulceration, oral pain
• liver disorders, severe liver function impairment, yellowing of the skin and eyes (jaundice)
• skin reaction to sunlight, skin swelling, abnormal hair structure, abnormal skin odour, rash on hairy skin
• muscle tissue breakdown, bone disorders
• difficulty urinating, reduced urine output
• nipple discharge, vaginal dryness, vaginal discharge, painful red penis and foreskin, breast enlargement, prolonged penile erection
• hernia, decreased drug tolerance
• increased blood cholesterol levels, abnormal laboratory test results, abnormal semen analysis, blood clotting problems
• vasodilation

Unknown frequency (cannot be estimated from the available data)

• bruxism (teeth grinding)
• nocturnal enuresis (bedwetting)
• partial loss of vision
• colitis (causing diarrhoea)
• severe postpartum vaginal bleeding (postpartum haemorrhage); see additional information in section 2 "Pregnancy, breastfeeding and effects on fertility"
• muscle weakness and severe muscle pain, which may be symptoms of a disorder resembling glutaric aciduria type II

Adverse reactions observed after marketing authorization

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

Symptoms occurring after discontinuation
After abrupt discontinuation of the medicine, adverse reactions such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and muscle tremors may occur (see section 3 "Discontinuing treatment with Sertranorm").

In patients taking Sertranorm, an increased risk of bone fractures has been observed.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions 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; http://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the local representative of the responsible entity.

By reporting adverse reactions, more information on the safety of this medicine can be collected.

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 cardboard box after "Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents 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).
The other ingredients are: monohydrate lactose, 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 an imprint "L" 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 an imprint "C" on the other side.
Sertranorm 50 mg and 100 mg are available in the following pack sizes: blisters in cardboard boxes containing 20, 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria

Manufacturer
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

This medicinal product is authorised in the following names in the European Economic Area:
Czech Republic: Setaloft
Poland: Sertranorm

For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel.: +48 12 262 32 36
e-mail: [email protected]