Apiolin

Leaflet accompanying the packaging: information for the user

Apiolin, 50 mg, coated tablets

Apiolin, 100 mg, coated tablets

Sertraline

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Apiolin and what is it 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 to treat depression and/or anxiety disorders.
Apiolin can be 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 to 17 years).
Depression is a disease characterized by symptoms such as sadness, sleep problems, and inability to feel joy in life.
Obsessive-compulsive disorder (OCD) and panic disorder are anxiety-related diseases with persistent anxiety due to persistent thoughts (obsessions) that cause repetitive rituals (compulsions).
Post-traumatic stress disorder 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 fear of potentially embarrassing behavior).
The doctor has decided that this medicine is suitable for treating the patient's disease.
The patient should consult their doctor if they are unsure why they are taking Apiolin.

2. Important information before taking Apiolin

When not to take Apiolin

If the patient is allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
If the patient is taking or has taken monoamine oxidase inhibitors (MAOIs, e.g. selegiline, moclobemide) or medicines similar to MAOIs (e.g. linezolid). In the event of stopping sertraline treatment, a minimum of one week should be waited before starting MAOI treatment. After stopping MAOI treatment, a minimum of 2 weeks should be waited before starting sertraline treatment.
If the patient is taking a medicine called pimozide (a medicine used to treat mental disorders, such as psychosis).

Warnings and precautions

Medicines do not always suit everyone. Before taking Apiolin, the patient should tell their doctor or pharmacist if any of the following apply to them currently or in the past:

• If the patient has a history of epilepsy (seizures) or convulsions. In case of a seizure, the doctor should be contacted immediately.
• Past history of manic-depressive illness (bipolar) or schizophrenia. In case of a manic episode, the doctor should be contacted immediately.
• 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 who have taken other medicines at the same time as sertraline (see Apiolin and other medicines). (Symptoms, see section 4. Possible side effects). The doctor should tell the patient if they have had serotonin syndrome in the past.
• 4. Possible side effects). The doctor should tell the patient if they have had serotonin syndrome in the past.
• Decreased sodium levels in the blood, as this may occur as a result of taking Apiolin. The doctor should also be informed about taking medicines used to treat high blood pressure, as they may also change sodium levels in the blood.
• If the patient is elderly, they may be more susceptible to decreased 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 changes in blood glucose levels, so a change in the dosage of antidiabetic medicines may be necessary.
• If the patient has bleeding disorders (tendency to bruise) or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility") or if they have taken medicines that reduce blood clotting in the past (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. Patients treated for this condition should be closely monitored by a doctor (see below "Children and adolescents").
• If the patient is undergoing electroconvulsive therapy (ECT).
• If the patient has eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If the patient has ECG abnormalities, known as prolonged QT interval.
• If the patient has heart disease, low potassium or magnesium levels, QTc interval prolongation in family history, slow heart rate, and concomitant use of medicines that prolong the QTc interval.

Psychomotor agitation/akathisia

Sertraline use has been associated with the occurrence of a state characterized by restlessness and a need 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, the doctor should be consulted.

Withdrawal symptoms

Discontinuation symptoms are common, especially if treatment is stopped abruptly (see section 3. Stopping Apiolin and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dose, 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 stopping treatment. They usually resolve on their own within 2 weeks, but in some patients, they may persist for longer (2-3 months or longer). If the decision is made to stop sertraline treatment, it is recommended to gradually reduce the dose over several weeks or months and always discuss the best way to stop treatment with the doctor.

Suicidal thoughts, worsening of depression or anxiety disorders

Patients with depression and/or substance use disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start working after 2 weeks, sometimes later.

It is more likely that the patient will think this way if:

• The patient has had suicidal thoughts or self-harm in the past.
• The patient is a young adult. Data from clinical trials indicate an increased risk of suicidal behavior in patients under 25 years of age with mental disorders who were treated with antidepressant medicines.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to the hospital.
It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask relatives or friends for help and ask them to inform them if they notice that depression or anxiety has worsened or if there are worrying changes in behavior.

Sexual disorders

Medicines like Apiolin (SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after treatment was stopped.

Children and adolescents

As a rule, sertraline should not be used in children and adolescents under 18 years of age, with the exception of patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age, during treatment with medicines of this group, an increased risk of side effects such as suicidal attempts, self-harm, or suicidal thoughts and hostility (mainly aggressive, defiant, and angry behavior) has been observed. 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 wants to discuss this, they should contact the doctor. Moreover, if any of the above symptoms occur or worsen during Apiolin treatment in a patient under 18 years of age, the doctor should be informed.
In a long-term observational study lasting 3 years with over 900 children aged 6 to 16 years, the safety of long-term sertraline use was evaluated in terms of its impact on growth, maturation, learning (cognitive function), and behavior. In general, the study results showed that children treated with sertraline developed normally, with the exception of a slight increase in body weight in children treated with a higher dose.

Apiolin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Some medicines may affect the way Apiolin works or Apiolin may reduce the effectiveness of other medicines taken at the same time.
Taking Apiolin with the following medicines may cause serious side effects:

• Medicines that are monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression) and selegiline (used to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methemoglobin in the blood). Apiolin should not be taken with MAOIs.
• Medicines used to treat mental disorders, such as psychosis (pimozide). Apiolin should not be taken with pimozide.
• Medicines used for substitution therapy for opioid dependence (such as buprenorphine). Medicines containing buprenorphine may interact with Apiolin and may lead to the occurrence of serotonin syndrome, a potentially life-threatening condition. The patient may experience symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C. If such symptoms occur, the doctor should be contacted.

The patient should inform their 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 for anesthesia (e.g. fentanyl, mivacurium, and suxamethonium).
• Medicines used to treat migraines (e.g. sumatriptan).
• Medicines that prevent blood clotting (warfarin).
• Medicines used to treat pain/inflammation of the joints (non-steroidal anti-inflammatory medicines (NSAIDs), e.g. ibuprofen, salicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics.
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excessive stomach acid production, 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 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 chemotherapy (aprepitant).
• Medicines that increase the risk of changes in heart electrical activity (e.g. antipsychotic medicines and antibiotics).

Apiolin with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.
The safety of sertraline use in pregnant women has not been fully established. Sertraline may be given during pregnancy only if the doctor considers that the benefits to the mother outweigh the potential risks to the fetus.
If Apiolin is taken at the end of pregnancy, there may be an increased risk of severe bleeding from the uterus, occurring shortly after delivery, especially if the patient has a history of bleeding disorders. The doctor or midwife should be informed that the patient is taking Apiolin so that they can provide appropriate advice.
Taking medicines like Apiolin during pregnancy, especially in the last trimester, may increase the risk of a serious disease in the baby called persistent pulmonary hypertension in newborns (PPHN), in which the baby breathes faster and turns blue. These symptoms usually appear within the first 24 hours after birth. If the baby experiences these symptoms, the midwife and/or doctor should be contacted immediately.
The baby may also experience other disorders, which usually appear within the first 24 hours after birth. Symptoms include:

• breathing difficulties,
• bluish skin, too hot or cold skin,
• bluish lips,
• vomiting or inability to feed properly,
• excessive tiredness, insomnia, or constant crying,
• increased or decreased muscle tone,
• tremors, muscle contractions, or convulsions,
• increased reflexes,
• agitation,
• low blood sugar.

If the baby experiences these symptoms after birth, or if the mother has any doubts about the baby's health, they should immediately contact the doctor or midwife, who will be able to provide appropriate information.
There is evidence that sertraline passes into breast milk. Sertraline can be used in breastfeeding women if the doctor considers that the benefits to the mother outweigh the potential risks to the baby.
In animal studies, it has been shown that some medicines, such as sertraline, may reduce sperm quality. This may theoretically affect fertility, but no effect on fertility has been demonstrated in humans.

Driving and using machines

Psychotropic medicines, such as sertraline, may affect the ability to drive or operate machinery. Therefore, the patient should not drive or operate machinery until it is known how this medicine affects their ability to perform these activities.

Apiolin contains lactose and sodium

If the patient has been informed by their doctor that they have an intolerance to some sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Apiolin

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The recommended dose is:

Adults

• Depression and obsessive-compulsive disorder: The usual effective dose for the treatment of depression and OCD is 50 mg per day. The daily dose can be increased gradually 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: Treatment of panic disorder, social anxiety disorder, and post-traumatic stress disorder should be started with a dose of 25 mg/day, which can be increased to 50 mg/day after one week. The daily dose can then be increased gradually by 50 mg at intervals of several weeks. The maximum recommended dose is 200 mg per day.

Use in children and adolescents

Apiolin can be used in children and adolescents only for the treatment of obsessive-compulsive disorder (OCD) in patients aged 6 to 17 years.
Obsessive-compulsive disorder
Children aged 6 to 12 years:The recommended initial 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 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

The medicine should be taken once a day, in the morning or evening. Apiolin coated tablets can be taken with or without food.
Apiolin 50 mg: The tablet can be divided into equal doses.
Apiolin 100 mg: The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
The doctor will inform the patient how long they should take this medicine. The treatment period depends on the type of disease and the patient's response to treatment. Improvement may occur only after several weeks of treatment. Treatment of depression should usually last 6 months from the time improvement is observed.

Taking a higher dose of Apiolin than recommended

In case of accidental ingestion of too much Apiolin, the doctor or the nearest hospital should be contacted immediately. The medicine packaging should be taken along, regardless of whether it contains medicine or not.
Overdose symptoms may include drowsiness, nausea, and vomiting, rapid heart rate, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

Missing a dose of Apiolin

A double dose should not be taken to make up for a missed dose. If a dose is missed, the missed tablet should not be taken. The next dose should be taken at the right time.

Stopping Apiolin treatment

Apiolin treatment should not be stopped unless the doctor advises it. The doctor should gradually reduce the dose of Apiolin over several weeks until it is finally stopped. If the treatment is stopped abruptly, side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors may occur. If any of these side effects or any other side effects occur when stopping Apiolin, the doctor should be consulted.
In case of further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine 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 as treatment continues.
The doctor should be informed immediatelyif the patient experiences any of the following symptoms, as they may be serious:
If the patient develops a severe skin rash that causes blistering (erythema multiforme) (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 stop the treatment.
If the patient experiences an allergic reaction or allergy, with symptoms such as an itchy skin rash, breathing difficulties, wheezing, swelling of the eyelids, face, or lips.
If the patient experiences agitation, confusion, diarrhea, high body temperature, and high blood pressure, sweating, and rapid heart rate. These are symptoms of serotonin syndrome. In rare cases, this syndrome may occur when the patient takes certain medicines at the same time as sertraline. The doctor may then stop the treatment.
If the patient experiences 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 experiences restlessness and is unable to sit or stand still. If the patient experiences restlessness, they should tell their 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 the marketing of sertraline:
Very common(may affect more than 1 in 10 people):

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

Common(may affect up to 1 in 10 people):
cold, sore throat, runny nose;
loss of appetite, increased appetite;
anxiety, depression, agitation, decreased interest in sex, nervousness, abnormal feelings, nightmares, teeth grinding;
tremors, muscle movement problems (such as increased movement, increased muscle tone, difficulty walking, and stiffness), convulsions (muscle contraction without affecting normal muscle movement), involuntary muscle movements*;
visual disturbances;
ringing in the ears;
palpitations;
hot flashes;
yawning;
gastrointestinal disorders, constipation, abdominal pain, vomiting, gas, increased sweating, rash;
back pain, joint pain, muscle pain;
irregular menstrual cycle, erectile dysfunction;
general malaise, chest pain, weakness, fever;
weight gain;
injuries.
Uncommon(may affect up to 1 in 100 people):
gastrointestinal disorders, ear infection;
cancer;
allergic reactions, seasonal allergy;
decreased thyroid hormone levels in the blood;
suicidal thoughts, suicidal behavior*, psychotic disorders, thought disorders, unwarranted worries, hallucinations, aggression, euphoria, paranoia;
memory loss, emotional flattening, involuntary muscle contractions, fainting, increased movement, migraine, convulsions, dizziness when standing up, coordination disorders, speech disorders;
dilated pupils;
ear pain;
rapid heart rate, heart problems;
bleeding (such as stomach bleeding)*, high blood pressure, hot flashes, blood in the urine;
shortness of breath, nosebleeds, breathing difficulties, possible wheezing;
blood in the stool, tooth disorders, esophagitis, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, speech disorders;
swelling of the eyelids, hives, hair loss, itching, skin disorders with blistering, dry skin, facial swelling, cold sweats;
joint disease, muscle tremors, muscle contractions*, muscle weakness;
increased urination frequency, urination disorders, inability to urinate, urinary incontinence, increased urine production, nocturia;
sexual disorders, increased menstrual bleeding, vaginal bleeding, sexual function disorders in women;
swelling of the legs, chills, difficulty walking, thirst;
increased liver enzyme activity, weight loss;
During sertraline treatment or shortly after its discontinuation, cases of suicidal thoughts and behaviors have been reported (see section 2).
Rare(may affect up to 1 in 1,000 people):
appendicitis, lymph node swelling, decreased platelet count*;
severe allergic reaction;
endocrine disorders*;
high cholesterol, difficulty controlling blood glucose levels (diabetes), low blood glucose, high blood glucose*;
physical symptoms caused by stress or emotions, terrifying nightmares*, drug dependence, sleepwalking, premature ejaculation;
coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome, RCVS)*, sensory disturbances;
visual disturbances*, glaucoma*, double vision*, eye pain caused by light*, blood in the eye*, uneven pupil size*, visual disturbances*, problems with tearing*;
heart attack, dizziness, fainting, or chest discomfort, which may be symptoms of changes in heart electrical activity (visible on an electrocardiogram) or abnormal heart rhythm*, slow heart rate;
circulatory disorders in the arms and legs;
rapid breathing, progressive scarring of lung tissue (interstitial lung disease)*, throat obstruction, difficulty speaking, slow breathing, hiccups;
a form of lung disease 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 ulcers, mouth pain;
liver function disorders, severe liver function disorders*, yellowing of the skin and the whites of the eyes (jaundice)*;
sun-related skin reaction*, skin swelling*, abnormal hair structure, abnormal skin odor, skin rash;
muscle tissue breakdown*, bone disorders;
inability to urinate continuously, decreased urine output;
breast discharge, vaginal dryness, vaginal discharge, breast engorgement*, penile pain and swelling;
hernia, decreased drug tolerance;
increased cholesterol levels in the blood, abnormal laboratory test results*;
abnormal sperm test results, bleeding disorders*;
blood vessel dilation.
Frequency not known(cannot be estimated from the available data):
jaw tension*;
nocturnal enuresis*;
partial loss of vision;
inflammation of the colon (causing diarrhea)*;
severe postpartum hemorrhage (postpartum hemorrhage), see additional information in section 2: "Pregnancy, breastfeeding, and fertility".
* Side effects reported after the medicine was marketed.

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 the medicine, side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, nausea, vomiting, and tremors may occur (see section 3. "Stopping Apiolin treatment").
Patients taking this type of medicine have reported an increased risk of bone fractures.

Reporting side effects

If side effects occur, including any not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Apiolin

Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month.
Store at a temperature below 30°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Apiolin contains

• The active substance of the medicine 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: lactose monohydrate, 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 the letter "L" engraved on the other side. The tablet can be divided into equal doses.
Apiolin, 100 mg, are white or almost white, round, biconvex, coated tablets, 10 mm in diameter, with a score line on one side and the letter "C" engraved on the other side.
The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
Transparent PVC/PVDC/Aluminum blisters in a cardboard box.
Pack sizes: 10, 20, 28, 30, 50, 60, 84, or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization 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, please contact the local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00

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

Czech Republic: Aflizan
Poland: Apiolin
Austria, Denmark, Sweden, Germany, Norway: Sertralin Zentiva
Portugal: Sertralina ZenPrime
Date of last revision of the leaflet:January 2025