Apiolin

Package Leaflet: Information for the User

Apiolin, 50 mg, Film-Coated Tablets

Apiolin, 100 mg, Film-Coated Tablets

Sertraline

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

• You should 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 get 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 and Other Information

• 1. What Apiolin is and what it is used for
• 2. Before you take 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 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 6-17 years).

Depression is a mental illness that can affect your thoughts, feelings, and physical health. It can make you feel sad, anxious, and hopeless, and can affect your sleep, appetite, and energy levels.

Obsessive-compulsive disorder (OCD) and panic disorder are anxiety disorders that can cause you to feel anxious, fearful, or uneasy, and can affect your daily life.

Post-traumatic stress disorder (PTSD) is a condition that can develop after a traumatic event, and can cause symptoms such as flashbacks, nightmares, and avoidance of reminders of the event.

Social anxiety disorder (social phobia) is a condition that can cause you to feel anxious or fearful in social situations, such as when meeting new people, speaking in public, or eating in front of others.

Your doctor has decided that this medicine is suitable for your condition. If you are not sure why you have been prescribed Apiolin, you should ask your doctor.

2. Before You Take Apiolin

Do Not Take Apiolin

If you are allergic to sertraline or any of the other ingredients of this medicine.

If you are taking or have taken monoamine oxidase inhibitors (MAOIs) or other medicines that are similar to MAOIs (such as linezolid or methylene blue). If you stop taking sertraline, you must wait at least one week before taking an MAOI. If you stop taking an MAOI, you must wait at least two weeks before taking sertraline.

If you are taking pimozide (a medicine used to treat mental disorders such as psychosis).

Warnings and Precautions

Medicines do not always work in the same way for everyone. Before taking Apiolin, you should tell your doctor or pharmacist if any of the following apply to you:

• If you have a history of epilepsy or seizures. If you have a seizure, you should contact your doctor immediately.
• If you have a history of bipolar disorder or schizophrenia. If you experience a manic episode, you should contact your doctor immediately.
• If you have a history of suicidal thoughts or self-harm.
• If you have a condition called serotonin syndrome, a potentially life-threatening condition that can occur when taking certain medicines, including sertraline. Your doctor should tell you if you have had serotonin syndrome in the past.
• If you have low sodium levels in your blood, as this can occur when taking sertraline. You should also tell your doctor if you are taking medicines to treat high blood pressure, as these can also affect sodium levels in your blood.
• If you are elderly, as you may be more likely to experience low sodium levels in your blood.
• If you have liver disease, as your doctor may need to reduce your dose of Apiolin.
• If you have diabetes, as sertraline can affect blood sugar levels, and you may need to adjust your diabetes medication.
• If you have a history of bleeding disorders or if you are pregnant or breastfeeding, or if you have taken medicines that affect blood clotting (such as aspirin or warfarin).
• If you are under 18 years old. Apiolin should only be used in children and adolescents aged 6-17 years with obsessive-compulsive disorder (OCD). Patients under 18 years old should be closely monitored by their doctor when taking this medicine.
• If you are having electroconvulsive therapy (ECT).
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If you have heart problems, such as abnormal heart rhythms or low potassium or magnesium levels.

Akathisia/Psychomotor Restlessness

Sertraline has been associated with the development of akathisia, a condition characterized by restlessness, agitation, and an inability to sit or stand still. This usually occurs within the first few weeks of treatment. If you experience these symptoms, you should talk to your doctor.

Withdrawal Symptoms

Withdrawal symptoms, such as dizziness, numbness, sleep disturbances, agitation, or anxiety, are common when stopping treatment with sertraline, especially when stopping abruptly. The risk of withdrawal symptoms depends on the duration of treatment, dose, and rate of dose reduction. These symptoms are usually mild to moderate and resolve on their own within two weeks, but in some patients, they can be severe and last longer (up to 3 months or more). If you are considering stopping treatment with sertraline, you should talk to your doctor about the best way to do so.

Suicidal Thoughts, Worsening of Depression or Anxiety

Patients with depression and/or anxiety disorders may sometimes experience thoughts of self-harm or suicide. These thoughts can worsen when first starting treatment with antidepressants, as these medicines can take up to two weeks to start working.

Increased Risk of Suicidal Thoughts

• If you have had suicidal thoughts or self-harm in the past.
• If you are a young adult. Clinical trials have shown an increased risk of suicidal behavior in young adults (under 25 years old) with mental health conditions who were treated with antidepressants.

If you experience suicidal thoughts or self-harm, you should contact your doctor or go to the hospital immediately. It may be helpful to tell a friend or relative that you are taking this medicine and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety has got worse, or if they are worried about changes in your behavior.

Sexual Dysfunction

Medicines like Apiolin (SSRIs) can cause sexual dysfunction (see section 4). In some cases, these effects have continued after stopping treatment.

Children and Adolescents

Sertraline should not be used in children and adolescents under 18 years old, except for those with obsessive-compulsive disorder (OCD). In clinical trials, an increased risk of suicidal thoughts and self-harm has been observed in children and adolescents under 18 years old who were treated with medicines like sertraline. If your doctor has prescribed Apiolin for a child or adolescent under 18 years old, you should talk to your doctor if you have any concerns.

Apiolin with Other Medicines

You should tell your doctor or pharmacist about all medicines you are taking, including those you have bought without a prescription. Some medicines can interact with Apiolin and affect its efficacy or increase the risk of side effects.

• Medicines called monoamine oxidase inhibitors (MAOIs), such as selegiline (used to treat Parkinson's disease) and moklobemide (used to treat depression). You should not take Apiolin with MAOIs.
• Medicines used to treat mental disorders, such as pimozide. You should not take Apiolin with pimozide.
• Medicines used to treat opioid addiction, such as buprenorphine. These medicines can interact with Apiolin and increase the risk of serotonin syndrome, a potentially life-threatening condition.

You should also tell your doctor or pharmacist if you 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).
• Medicines 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 anesthesia (such as fentanyl, mivacurium, and suxamethonium).
• Medicines used to treat migraines (such as sumatriptan).
• Medicines that affect blood clotting (such as warfarin).
• Medicines used to treat pain/inflammation of the joints (non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or aspirin).
• Sedatives (such as diazepam).
• Diuretics (water tablets).
• Medicines used to treat epilepsy (such as phenytoin, phenobarbital, or carbamazepine).
• Medicines used to treat diabetes (such as tolbutamide).
• Medicines used to treat excessive stomach acid, stomach ulcers, and heartburn (such as cimetidine, omeprazole, lansoprazole, pantoprazole, or rabeprazole).
• Medicines used to treat mania and depression (such as lithium).
• Other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, or fluvoxamine).
• Medicines used to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine, or olanzapine).
• Medicines used to treat high blood pressure, chest pain, or to regulate heart rate (such as verapamil, diltiazem, flecainide, or propafenone).
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, or erythromycin).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole).
• Medicines used to treat HIV/AIDS or hepatitis C (such as protease inhibitors, such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after chemotherapy (such as aprepitant).
• Medicines that can affect the heart's electrical activity (such as antipsychotics and antibiotics).

Apiolin with Food, Drink, and Alcohol

Apiolin can be taken with or without food.

You should avoid drinking alcohol while taking Apiolin.

Sertraline should not be taken with grapefruit juice, as it can increase the levels of sertraline in your body.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

The safety of sertraline in pregnancy has not been fully established. Sertraline should only be used in pregnancy if your doctor considers it essential.

If you are taking Apiolin near the end of your pregnancy, there may be an increased risk of heavy bleeding after giving birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Apiolin so that they can give you appropriate advice.

Taking medicines like Apiolin during pregnancy, especially in the last trimester, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), where the baby breathes faster and turns blue. These symptoms usually appear within the first 24 hours after birth. If your baby experiences these symptoms, you should contact your midwife and/or doctor immediately.

Newborn babies may also experience other conditions, usually within the first 24 hours after birth, including:

• Difficulty breathing
• Blue-tinged skin
• Too hot or cold
• Vomiting or difficulty feeding
• Excessive sleepiness, sleeplessness, or constant crying
• Increased or decreased muscle tone
• Shakiness, muscle twitching, or seizures
• Increased reflexes
• Restlessness
• Low blood sugar

If your baby experiences any of these symptoms, you should contact your doctor or midwife immediately.

Sertraline passes into breast milk, and your doctor will decide if the benefits of taking this medicine outweigh the risks to your baby.

Animal studies have shown that some medicines, such as sertraline, can affect sperm quality. This could theoretically affect fertility, but it has not been shown to affect fertility in humans.

Driving and Using Machines

Medicines like sertraline can affect your ability to drive or operate machinery. You should not drive or operate machinery until you know how this medicine affects you.

Apiolin Contains Lactose and Sodium

If you have been told by your doctor that you have an intolerance to some sugars, you should 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 Apiolin

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.

Adults

• Depression and obsessive-compulsive disorder: The usual effective dose is 50 mg per day. The dose can be increased gradually to a maximum of 200 mg per day.
• Panic disorder, social anxiety disorder, and post-traumatic stress disorder: Treatment should start with a dose of 25 mg per day, which can be increased to 50 mg per day after one week. The dose can then be increased gradually to a maximum of 200 mg per day.

Children and Adolescents

Apiolin can be used to treat obsessive-compulsive disorder (OCD) in children and adolescents aged 6-17 years.

Obsessive-compulsive disorder:

Children aged 6-12 years:The recommended starting dose is 25 mg per day. After one week, your doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.

Adolescents aged 13-17 years:The recommended starting dose is 50 mg per day. The maximum dose is 200 mg per day.

Patients with liver or kidney disease should tell their doctor, who will give them guidance on taking this medicine.

Method of Administration

Take one dose per day, in the morning or evening. Apiolin film-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 help you break the tablet to make it easier to swallow, and not to divide it into equal doses.

Your doctor will tell you how long you should take this medicine. The duration of treatment will depend on the type of illness and how you respond to treatment. Improvement may not occur until after several weeks of treatment. Treatment of depression should usually continue for at least 6 months after the symptoms have improved.

If You Take More Apiolin Than You Should

If you accidentally take too much Apiolin, you should contact your doctor or go to the hospital immediately. You should take the medicine pack with you, even if it is empty.

Symptoms of overdose may include sleepiness, nausea, and vomiting, rapid heartbeat, tremors, restlessness, and dizziness.

If You Forget to Take Apiolin

Do not take a double dose to make up for a forgotten dose. If you forget a dose, you should take the next dose at the usual time.

Stopping Treatment with Apiolin

Do not stop taking Apiolin unless your doctor tells you to. Your doctor will gradually reduce your dose over several weeks before stopping treatment completely. If you stop taking this medicine abruptly, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation, or anxiety, headaches, nausea, and tremors. If you experience any of these side effects, you should talk to your doctor.

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 are usually dose-dependent and often disappear after continued treatment.

You should contact your doctor immediatelyif you experience any of the following side effects, as they can be serious:

• A severe skin rash that causes blisters (Stevens-Johnson syndrome or toxic epidermal necrolysis). These conditions can be life-threatening.
• An allergic reaction or allergy, with symptoms such as itching, difficulty breathing, wheezing, swelling of the face, lips, tongue, or throat.
• A condition called serotonin syndrome, which can cause symptoms such as agitation, confusion, diarrhea, high blood pressure, changes in mental status, and a fast or irregular heartbeat.
• Jaundice (yellowing of the skin and eyes), which can be a sign of liver damage.
• Suicidal thoughts or self-harm.
• Akathisia (restlessness and an inability to sit or stand still).
• Seizures (fits).
• Manic episodes (see section 2).

The following side effects have been reported in clinical trials or after marketing:

Very Common(may affect more than 1 in 10 people):

• Insomnia
• Dizziness, drowsiness, headache
• Diarrhea, nausea, dry mouth
• Ejaculation disorder
• Fatigue

Common(may affect up to 1 in 10 people):

• Cold, sore throat, cough
• Loss of appetite, increased appetite
• Anxiety, depression, restlessness, decreased libido, nervousness, abnormal dreams, teeth grinding
• Tremors, muscle weakness, movement disorders (such as increased muscle tone, muscle spasms, or involuntary movements)
• Visual disturbances
• Ringing in the ears
• Palpitations
• Flushing
• Yawning
• Gastrointestinal disorders, constipation, abdominal pain, vomiting, gas, increased sweating, rash
• Back pain, joint pain, muscle pain
• Menstrual disorders, erectile dysfunction
• General feeling of being unwell, chest pain, weakness, fever
• Weight gain
• Injuries

Uncommon(may affect up to 1 in 100 people):

• Gastrointestinal disorders, ear infection
• Cancer
• Hypersensitivity, seasonal allergy
• Decreased thyroid hormone levels
• Suicidal thoughts, suicidal behavior, psychotic disorders, abnormal thinking, anxiety, euphoria, paranoia
• Memory loss, emotional flattening, involuntary muscle contractions, fainting, increased muscle tone, migraines, seizures, dizziness when standing up, coordination disorders, speech disorders
• Dilated pupils
• Ear pain
• Fast heartbeat, heart problems
• Bleeding (such as gastrointestinal bleeding), high blood pressure, flushing, nosebleeds, difficulty breathing, wheezing
• Blood in stool, tooth disorders, esophagitis, tongue problems, gum bleeding, increased salivation, difficulty swallowing, hiccup
• Eye swelling, hives, hair loss, itching, purpura, skin disorders with blisters, dry skin, facial swelling, cold sweats
• Arthrosis, muscle twitching, muscle weakness, muscle spasms
• Increased urination, urinary disorders, urinary incontinence, increased urine production, nocturia
• Sexual disorders, increased menstrual bleeding, vaginal bleeding, sexual dysfunction in women
• Leg swelling, chills, difficulty walking, thirst
• Increased liver enzyme levels, weight loss

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

• Diverticulitis, lymphadenopathy, decreased platelet count
• Severe allergic reaction
• Endocrine disorders
• High cholesterol, difficulty controlling blood sugar levels (diabetes), low blood sugar, high blood sugar
• Physical symptoms caused by stress or emotions, terrifying nightmares, drug dependence, sleepwalking, premature ejaculation
• Coma, abnormal movements, difficulty moving, increased sensitivity, severe headache (which can be a sign of a condition called reversible cerebral vasoconstriction syndrome (RCVS))
• Blurred vision, eye pain, glaucoma, double vision, eye bleeding, unequal pupil size, visual disturbances, eye problems
• Heart attack, dizziness, fainting, or chest discomfort, which can be signs of changes in heart rhythm or abnormal heart rhythm
• Circulatory disorders in the arms and legs
• Rapid breathing, progressive scarring of lung tissue (interstitial lung disease), obstruction of the airways, difficulty speaking, slow breathing, hiccups
• A condition in which eosinophils (a type of white blood cell) accumulate in the lungs (eosinophilic pneumonia)
• Mouth ulcers, pancreatitis, rectal bleeding, tongue ulcers, mouth pain
• Liver disorders, severe liver dysfunction, jaundice
• Skin reactions to sunlight, skin swelling, abnormal hair texture, abnormal skin odor, rash on hairy skin
• Muscle breakdown, bone disorders
• Urinary incontinence, decreased urine production
• Galactorrhea, vaginal discharge, breast swelling, prolonged erection
• Hernia, decreased drug tolerance
• High cholesterol, abnormal laboratory test results
• Abnormal sperm quality, bleeding disorders
• Vasodilation

Frequency Not Known(cannot be estimated from the available data):

• Jaw tightness
• Nocturnal enuresis
• Partial loss of vision
• Colitis (which can cause diarrhea)
• Postpartum hemorrhage (severe bleeding after childbirth), see additional information in section 2: Pregnancy, breastfeeding, and fertility

* Side effects reported after marketing.

Additional Side Effects in Children and Adolescents

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

Withdrawal Symptoms

When stopping treatment with sertraline, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation, or anxiety, headaches, nausea, and tremors (see section 3: Stopping treatment with Apiolin).

Patients taking this type of medicine have reported an increased risk of bone fractures.

Reporting Side Effects

If you experience any side effects, you should tell your doctor or pharmacist. You can also report side effects directly to the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Apiolin

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.

Store in a cool, dry place, below 30°C. Store in the original package to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Apiolin Contains

• The active substance is sertraline. Apiolin 50 mg film-coated tablets: Each film-coated tablet contains sertraline hydrochloride equivalent to 50 mg sertraline. Apiolin 100 mg film-coated tablets: Each film-coated tablet contains sertraline hydrochloride equivalent to 100 mg sertraline.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose (PH-102), povidone K-30, sodium croscarmellose, and magnesium stearate. Tablet coating: hypromellose, titanium dioxide, talc, and propylene glycol.

What Apiolin Looks Like and Contents of the Pack

Apiolin 50 mg is a white or almost white, round, biconvex film-coated tablet, 10 x 5 mm in size, with a score line on one side and engraved with the letter "L" on the other side. The tablet can be divided into equal doses.

Apiolin 100 mg is a white or almost white, round, biconvex film-coated tablet, 10 mm in diameter, with a score line on one side and engraved with the letter "C" on the other side. The score line is only to help break 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 film-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

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, Poland. 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