Apiolin

Package leaflet: Information for the user

Apiolin, 50 mg, film-coated tablets
Apiolin, 100 mg, film-coated tablets
Sertralinum
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Apiolin is and what it is used for

Apiolin contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines are used in the treatment of depressive and/or anxiety disorders.

Apiolin may be used to treat:
Depression and prevention of recurrence of depression (in adults).
Social anxiety disorder (in adults).
Post-traumatic stress disorder (PTSD) (in adults).
Panic disorder (in adults).
Obsessive-compulsive disorder (OCD) (in adults and children and adolescents aged 6 to 17 years).

Depression is an illness characterized by symptoms such as sadness, sleep disturbances, and inability to feel joy in life.

Obsessive-compulsive disorder (OCD) and panic disorder are anxiety-related conditions, associated with persistent worry due to intrusive thoughts (obsessions), which lead to repetitive rituals (compulsions).

Post-traumatic stress disorder (PTSD) is a condition that may 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 illness. It is characterized by intense fear 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 fear of potentially embarrassing behavior).

Your doctor has decided that this medicine is suitable for treating your condition.
You should consult your doctor if you are unsure why you have been prescribed Apiolin.

2. Important information before using Apiolin

When not to use Apiolin
Do not use Apiolin if the patient is allergic to sertraline or to any of the other ingredients of this medicine (listed in section 6).
Do not use Apiolin if the patient is taking or has recently taken monoamine oxidase inhibitors (MAO inhibitors, e.g. selegiline, moklobemide) or medicines similar to MAO inhibitors (e.g. linezolid). At least one week must pass after stopping treatment with sertraline before starting treatment with an MAO inhibitor. After stopping treatment with an MAO inhibitor, at least two weeks must pass before starting treatment with sertraline.
Do not use Apiolin if the patient is taking a medicine called pimozide (a medicine used to treat psychiatric disorders such as psychosis).

Warnings and precautions
Medicines are not always suitable for everyone. Before starting to take Apiolin, tell your doctor or pharmacist if any of the following apply to the patient currently or in the past:

• If the patient has epilepsy (seizures) or a history of seizures. If a seizure occurs, contact a doctor immediately.
• A history of bipolar disorder (manic depression) or schizophrenia. If a manic episode occurs, contact a doctor immediately.
• Current or past suicidal thoughts (see below: Suicidal thoughts, worsening of depression or anxiety disorders).
• If the patient has serotonin syndrome, a potentially life-threatening condition. In rare cases, this syndrome may occur in patients taking other medicines at the same time as sertraline (see Apiolin and other medicines). (Symptoms are listed in section 4. Possible side effects.) The doctor should inform the patient whether they have previously experienced serotonin syndrome.
• Low sodium levels in the blood, which may occur during treatment with Apiolin. You should also inform your doctor if you are taking medicines used to treat high blood pressure, as these may also affect sodium levels in the blood.
• If the patient is elderly, they may be at increased risk of low sodium levels in the blood (see above).
• If the patient has liver disease; the doctor may decide to reduce the dose of Apiolin.
• If the patient has diabetes; Apiolin may affect blood glucose levels, so a change in the dose of antidiabetic medicines may be necessary.
• If the patient has bleeding disorders (tendency to bruise easily) or if the patient is pregnant (see: "Pregnancy, breastfeeding and effects on fertility") or has previously taken medicines that reduce blood clotting (e.g. acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding.
• If the patient is a child or adolescent under 18 years of age. Apiolin may be used in children and adolescents aged 6 to 17 years only for the treatment of obsessive-compulsive disorder (OCD). Patients being treated for this condition should be closely monitored by a doctor (see below: "Children and adolescents").
• If the patient is receiving electroconvulsive therapy (ECT).
• If the patient has eye problems such as certain types of glaucoma (increased pressure in the eye).
• If the patient has abnormalities on ECG, known as prolonged QT interval.
• If the patient has heart disease, low potassium or magnesium levels, a family history of prolonged QTc interval, slow heart rate, or is taking other medicines that cause QTc prolongation.

Psychomotor agitation/akathisia
Treatment with sertraline has been associated with a condition characterised by motor restlessness and an urge to move, often with an inability to sit or stand still (akathisia). This condition usually occurs within the first few weeks of treatment. Increasing the dose may be harmful, so if such symptoms occur, talk to your doctor.

Withdrawal symptoms
Adverse reactions related to stopping treatment (withdrawal symptoms) are common, especially if treatment is stopped abruptly (see section 3. Discontinuing treatment with Apiolin and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dose and speed of dose reduction. These symptoms are usually mild or moderate in intensity, but may be severe in some patients. They usually begin within the first few days after stopping treatment and typically resolve spontaneously within 2 weeks, although in some patients they may persist longer (for 2–3 months or more). When deciding to discontinue treatment with sertraline, it is recommended to gradually reduce the dose over several weeks or months, and the best way to stop treatment should always be discussed with a doctor.

Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks to start working, sometimes longer.

The patient is more likely to have such thoughts if:

• The patient has previously had suicidal thoughts or self-harm tendencies.
• The patient is a young adult. Clinical trial data indicate an increased risk of suicidal behaviour in patients under 25 years of age with psychiatric disorders who are being treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, contact a doctor immediately or go to hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask family or friends for help and ask them to inform them if they notice that depression or anxiety has worsened or if there are disturbing changes in behaviour.

Sexual dysfunction
Medicines such as Apiolin (known as SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Children and adolescents
Sertraline should not generally be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age, treatment with medicines from this group has been associated with an increased risk of adverse reactions such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostility (mainly aggressive, defiant and angry behaviours).
However, the doctor may decide to prescribe Apiolin to a patient under 18 years of age if it is in the patient's best interest. If the doctor prescribes Apiolin and the patient is under 18 years of age, and the child's caregiver wishes to discuss this, contact the doctor. Furthermore, if any of the symptoms listed above appear or worsen during treatment with Apiolin in a patient under 18 years of age, inform the 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 behaviour. Overall, study results showed that children treated with sertraline developed normally, except for a small reduction in weight gain in children treated with higher doses.

Apiolin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Some medicines may affect how Apiolin works, or Apiolin may reduce the effectiveness of other medicines taken at the same time.
Taking Apiolin together with the following medicines may cause serious adverse effects:

• Monoamine oxidase inhibitors (MAO inhibitors), e.g. moclobemide (used to treat depression), selegiline (used to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methaemoglobin in the blood). Do not take Apiolin together with MAO inhibitors.
• Medicines used to treat psychiatric disorders such as psychosis (pimozide). Do not take Apiolin together with pimozide.
• Medicines used in opioid addiction substitution therapy (such as buprenorphine). Medicines containing buprenorphine may interact with Apiolin and may lead to serotonin syndrome, a potentially life-threatening condition. The patient may experience symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle rigidity, body temperature above 38°C. If such symptoms occur, contact a doctor.

The patient should inform the doctor if they are taking any of the following medicines:

• Medicines containing amphetamine (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.
• Products containing the amino acid tryptophan.
• Metamizole, a medicine used to treat pain and fever.
• Medicines used to treat severe or chronic pain (opioids, tramadol, fentanyl).
• Medicines used in anaesthesia (e.g. fentanyl, mivacurium and suxamethonium).
• Medicines used to treat migraine (e.g. sumatriptan).
• Medicines that prevent blood clotting (warfarin).
• Medicines used to treat joint pain/inflammation (non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, salicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics (so-called water tablets).
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excess stomach acid, peptic ulcer disease and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines used to treat mania and depression (lithium).
• Other medicines used to treat depression (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 infection and hepatitis C (protease inhibitors, such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after chemotherapy (aprepitant).
• Medicines that increase the risk of changes in the electrical activity of the heart (e.g. antipsychotics and antibiotics).

Apiolin with food, drink and alcohol
Apiolin can be taken with or without food.
During treatment with Apiolin, alcohol should be avoided.
Sertraline should not be taken together with grapefruit juice, as this may lead to increased sertraline levels in the body.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
The safety of sertraline use in pregnant women has not been fully established. Sertraline may be administered during pregnancy only if the doctor considers that the benefits to the patient outweigh the potential risks to the developing baby.
If Apiolin is taken towards the end of pregnancy, there may be an increased risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. The doctor or midwife should be aware that the patient is taking Apiolin so they can provide appropriate advice.
Taking medicines such as Apiolin during pregnancy, particularly in the third trimester, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes faster and turns blue. Symptoms usually appear within the first 24 hours after birth. If the baby shows any of these symptoms, contact the midwife and/or doctor immediately.
Other conditions may also occur in the newborn, usually within the first 24 hours after birth. Symptoms include:

• Breathing difficulties,
• Skin that is too hot or too cold,
• Blue lips,
• Vomiting or inability to suckle properly,
• Extreme tiredness, insomnia or constant crying,
• Increased or decreased muscle tone,
• Tremors, muscle twitches or seizures,
• Increased reflexes,
• Irritability,
• Low blood sugar.

If the baby shows any of the above symptoms after birth, or if the mother has any doubts about the baby's health, contact a doctor or midwife immediately for appropriate advice.
There is evidence that sertraline passes into breast milk. Sertraline may be used in women who are breastfeeding if, in the doctor's opinion, the benefits to the mother outweigh the potential risks to the baby.
Animal studies have shown that some medicines such as sertraline may reduce semen quality. This could theoretically affect fertility, but no effect on human fertility has been demonstrated to date.

Driving and operating machinery
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. Therefore, do not drive or operate machinery until you know how this medicine affects your ability to perform these activities.

Apiolin contains lactose and sodium
If the patient has been told by a doctor that they have an intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Apiolin

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Recommended dosage:
Adults

• Depression and obsessive-compulsive disorder (OCD)
  The usual effective dose for treating depression and OCD is 50 mg per day. The daily dose may be gradually increased by 50 mg at intervals of at least one week over several weeks. The maximum recommended dose is 200 mg per day.

• Panic disorder, social anxiety disorder, and post-traumatic stress disorder (PTSD)
  Treatment of panic disorder, social anxiety disorder, and PTSD should be initiated at a dose of 25 mg/day, increasing after one week to 50 mg per day. The daily dose may then be gradually increased by 50 mg every few weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents
Apiolin may be used in the treatment of children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD) only.
Obsessive-compulsive disorder (OCD)
Children aged 6 to 12 years: the recommended starting dose is 25 mg per day. After one week, the doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.
Adolescents aged 13 to 17 years: the recommended starting dose is 50 mg per day. The maximum dose is 200 mg per day.
Patients with liver or kidney disease should inform their doctor and follow medical advice.

Method of administration
Take the medicine once daily, in the morning or evening. Apiolin tablets may be taken with or without food.
Apiolin 50 mg: The tablet may be divided into equal doses.
Apiolin 100 mg: The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not indicate division into equal doses.

Your doctor will inform you how long you should continue taking this medicine. The duration of treatment depends on the type of illness and your response to therapy. Improvement may take several weeks. Treatment for depression should usually continue for 6 months after improvement is observed.

Overdose of Apiolin
If you accidentally take more Apiolin than recommended, contact your doctor immediately or go to the nearest hospital. Take the medicine packaging with you, regardless of whether any medicine remains.
Symptoms of overdose may include drowsiness, nausea and vomiting, increased heart rate, tremor, agitation, dizziness, and in rare cases, loss of consciousness.

Missed dose of Apiolin
Do not take a double dose to make up for a missed dose. If you miss a dose, do not take the missed tablet. Take the next dose at the scheduled time.

Stopping Apiolin
Do not stop taking Apiolin unless your doctor advises you to do so. Your doctor should gradually reduce the dose of Apiolin over several weeks before stopping treatment completely. Abruptly stopping this medicine may cause adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremor. If you experience any of these or other adverse effects while discontinuing Apiolin, speak with your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most commonly occurring side effect is nausea. Side effects are dose-dependent and often
subside as treatment continues.
You should immediately inform your doctor 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 blisters (erythema multiforme) (which may
affect the mouth and tongue). These may be symptoms of a condition called Stevens-Johnson
syndrome or toxic epidermal necrolysis (TEN). In such cases, the doctor will discontinue
treatment.
If the patient experiences an allergic reaction or allergy, with symptoms such as itchy rash,
difficulty breathing, wheezing, swelling of the eyelids, face or lips.
If the patient experiences agitation, confusion, diarrhoea, high body temperature, high blood
pressure, excessive sweating and rapid heart rate. These are symptoms of serotonin syndrome.
In rare cases, this syndrome may occur when the patient is taking certain medicines at the
same time as 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, after starting treatment with Apiolin, the patient begins to feel inner restlessness and is
unable to sit or stand still. If the patient begins to feel restless, they should inform the doctor.
If the patient experiences a seizure.
If the patient experiences a manic episode (see section 2. "Warnings and precautions").

The following side effects have been observed in clinical trials in adult patients and after
sertraline was introduced to the market:

Very common (may occur in more than 1 in 10 patients):

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

Common (may occur in 1 in 10 patients):
cold symptoms, sore throat, runny nose;
loss of appetite, increased appetite;
anxiety, depression, nervous agitation, decreased interest in sex, nervousness, unusual sense of
well-being, nightmares, teeth grinding;
tremor, movement disorders (such as increased mobility, increased muscle tension,
difficulty walking and stiffness, twitching (muscle contractions without affecting normal
movement), involuntary muscle movements)*, tingling and numbness sensations, difficulty
concentrating, taste disturbances;
vision disturbances;
ringing in the ears;
palpitations;
hot flushes;
yawning;
gastrointestinal disturbances, constipation, abdominal pain, vomiting, flatulence,
excessive sweating, skin rash;
back pain, joint pain, muscle pain;
irregular menstruation, erection disorders;
general malaise, chest pain, weakness, fever;
weight gain;
injuries.

Uncommon (may occur in 1 in 100 patients):
intestinal disorders, ear infection;
tumour;
hypersensitivity, seasonal allergy;
decreased concentration of thyroid hormones in blood;
suicidal thoughts, suicidal behaviour*, psychotic disorders, thought disturbances,
unwarranted worrying, hallucinations, aggression, euphoria, paranoia;
memory loss, emotional blunting, involuntary muscle contractions, fainting, increased
mobility, migraine, seizures, dizziness upon standing, coordination disorders, speech
disturbances;
dilated pupils;
ear pain;
rapid heartbeat, heart problems;
bleeding (such as gastrointestinal bleeding)*, high blood pressure, hot flushes, blood in urine;
shortness of breath, nosebleeds, breathing difficulties, possible wheezing;
blood in stool, dental disorders, oesophagitis, tongue problems, haemorrhoids, increased
saliva production, difficulty swallowing, belching, tongue disorders;
eyelid swelling, urticaria, hair loss, itching, purpuric skin spots, skin disorders with blister
formation, dry skin, facial swelling, cold sweats;
osteoarthritis, muscle tremor, muscle cramps*, muscle weakness;
increased frequency of urination, urinary disorders, inability to urinate, urinary incontinence,
increased urine output, nocturnal urination;
sexual disorders, increased menstrual bleeding, vaginal bleeding, sexual dysfunction in
women;
leg swelling, chills, difficulty walking, thirst;
increased liver enzyme activity, weight loss;

Cases of suicidal thoughts and behaviours have been reported during treatment with
sertraline or shortly after its discontinuation (see section 2).

Rare (may occur in 1 in 1000 patients):
diverticulitis, lymph node swelling, decreased platelet count*, decreased white blood cell
count*;
severe allergic reaction;
endocrine disorders*;
high cholesterol levels, difficulty controlling blood glucose levels (diabetes), decreased
glucose levels, increased blood glucose levels*, decreased blood sodium levels*;
physical symptoms caused by stress or emotions, frightening nightmares*, drug dependence,
sleepwalking, premature ejaculation;
coma, abnormal movements, difficulty moving, increased sensitivity to touch, sudden severe
headache (which may be a symptom of a serious condition known as Reversible Cerebral
Vasoconstriction Syndrome, RCVS)*, sensory disturbances;
visual scotoma*, glaucoma*, double vision*, photophobia*, blood in the eye*, unequal pupil
size*, vision disturbances*, lacrimation problems*;
myocardial infarction, dizziness, fainting or chest discomfort which may be symptoms of
changes in electrical activity of the heart (visible on electrocardiogram) or abnormal heart
rhythm*, bradycardia;
circulatory disorders in arms and legs;
rapid breathing, progressive lung tissue fibrosis (interstitial lung disease)*, throat obstruction,
difficulty speaking, 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 function disorders, severe liver dysfunction*, yellowing of the skin and whites of the eyes
(jaundice)*;
photosensitivity skin reaction*, skin swelling*, abnormal hair structure, abnormal skin odour,
rash on hairy skin;
rhabdomyolysis*, bone disorders;
inability to continuously pass urine, reduced urine output;
nipple discharge, vaginal dryness, vaginal discharge, penile and foreskin pain and redness,
breast enlargement*, prolonged penile erection;
hernia, decreased drug tolerance;
increased blood cholesterol levels, abnormal laboratory test results*;
abnormal semen analysis, blood clotting problems*;
vasodilation.

Frequency not known (cannot be estimated from available data):
bruxism*;
nocturnal enuresis*;
partial loss of vision;
colitis (causing diarrhoea)*;
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see
additional information in section 2: "Pregnancy, breastfeeding and fertility".

* Adverse reactions reported after market authorization.

Additional side effects in children and adolescents
In clinical trials involving children and adolescents, adverse reactions were generally similar
to those occurring 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 Apiolin").

In patients taking this type of medicine, an increased risk of bone fractures has been observed.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your
doctor or pharmacist. Adverse reactions can be reported directly to the Department of
Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its
representative in Poland.
By reporting adverse reactions, additional information on the safety of the medicine can be
collected.

5. How to store the medicine Apiolin

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after the word "EXP". The expiry date refers to the last day of the specified month.
Store below 30 °C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Apiolin tablets contain

• The active substance is sertraline. Apiolin 50 mg, coated tablets: Each coated tablet contains sertraline hydrochloride equivalent to 50 mg of sertraline. Apiolin 100 mg, coated tablets: Each coated tablet contains sertraline hydrochloride equivalent to 100 mg of sertraline.
• Other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose (PH-102) (E 460i), povidone K-30, sodium croscarmellose (E 468) and magnesium stearate (E 572).
  Tablet coating: hypromellose (E 464), titanium dioxide (E 171), talc (E 553b) and propylene glycol (E 1520).

What Apiolin looks like and contents of the pack
Apiolin 50 mg are white or almost white, round, biconvex coated tablets, 10 x 5 mm in size, with a score line on one side and engraved letter "L" on the other. The tablet can be divided into equal doses.
Apiolin 100 mg are white or almost white, round, biconvex coated tablets with a diameter of 10 mm, with a score line on one side and engraved letter "C" on the other.
The division line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not guarantee equal dosing.
Clear PVC/PVDC/Aluminium blisters in a cardboard carton.
Pack sizes: 10, 20, 28, 30, 50, 60, 84 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Zentiva S.A.
B-dul Theodor Pallady nr. 50
Sector 3, 032266 Bucharest
Romania

For further information, contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Aflizan
Poland: Apiolin
Austria, Denmark, Sweden, Germany, Norway: Sertralin Zentiva
Portugal: Sertralina ZenPrime