APOTIAPINA 200 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. ApoTiapina PR, 200 mg, prolonged-release tablets
3. ApoTiapina PR, 300 mg, prolonged-release tablets
4. ApoTiapina PR, 400 mg, prolonged-release tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents:
5. What ApoTiapina PR is and what it is used for
6. Important information before taking ApoTiapina PR
   1. When not to take ApoTiapina PR
   2. Warnings and precautions
   3. Weight gain
   4. Children and adolescents
   5. ApoTiapina PR and other medicines
   6. ApoTiapina PR with food, drink, and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Effect on urine tests
   10. ApoTiapina PR contains lactose
7. How to take ApoTiapina PR
   1. Liver function disorders
   2. Elderly patients
   3. Use in children and adolescents
   4. Taking more ApoTiapina PR than prescribed
   5. Missing a dose of ApoTiapina PR
   6. Stopping ApoTiapina PR treatment
8. Possible side effects
   1. Very common: may affect more than 1 in 10 people
   2. Common: may affect up to 1 in 10 people
   3. Uncommon: may affect up to 1 in 100 people
   4. Rare: may affect up to 1 in 1,000 people
   5. Very rare: may affect up to 1 in 10,000 people
   6. Frequency not known (frequency cannot be estimated from available data)
   7. Additional side effects in children and adolescents
   8. Very common: may affect more than 1 in 10 people
   9. Common: may affect up to 1 in 10 people
   10. Reporting side effects
9. How to store ApoTiapina PR
10. Package contents and other information
    1. What ApoTiapina PR contains
    2. What ApoTiapina PR looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder:
    5. Manufacturer:
    6. This medicine is authorized in the Member States of the European Economic Area under the following names:
    7. Date of last revision of the package leaflet: 07/2024

Package Leaflet: Information for the User

ApoTiapina PR, 200 mg, prolonged-release tablets

ApoTiapina PR, 300 mg, prolonged-release tablets

ApoTiapina PR, 400 mg, prolonged-release tablets

Quetiapine

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

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What ApoTiapina PR is and what it is used for
• 2. Important information before taking ApoTiapina PR
• 3. How to take ApoTiapina PR
• 4. Possible side effects
• 5. How to store ApoTiapina PR
• 6. Package contents and other information

1. What ApoTiapina PR is and what it is used for

ApoTiapina PR contains the active substance quetiapine, which belongs to a group of medicines called antipsychotics. ApoTiapina PR is used to treat several diseases, such as:

• Bipolar depression and major depressive episodes in depressive disorder: when the patient feels sad. The patient may experience feelings of guilt, lack of energy, loss of appetite, or difficulty sleeping.
• Mania: when the patient may feel very excited, agitated, restless, enthusiastic, or overly active, or has impaired critical judgment, including being aggressive or exhibiting destructive behavior.
• Schizophrenia: when the patient may hear or feel things that do not exist, believe in things that are not true, or be overly suspicious, anxious, disoriented, guilty, tense, or depressed.

When ApoTiapina PR is used to treat major depressive episodes in severe depressive disorder, it will be given in combination with another medicine used to treat this disease. The doctor may continue to prescribe ApoTiapina PR even when the patient feels better.

2. Important information before taking ApoTiapina PR

When not to take ApoTiapina PR

• If the patient is allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).

(See section 6 for a list of ingredients.)

• If the patient is taking any of the following medicines:
• Certain medicines used to treat HIV.
• Medicines from the azole group (used to treat fungal infections).
• Erythromycin or clarithromycin (medicines used to treat infections).
• Nefazodone (used to treat depression).

In case of doubts before taking ApoTiapina PR, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with ApoTiapina PR, discuss the following with your doctor or pharmacist:

• If the patient or a family member has or has had any heart disease, such as arrhythmias, heart failure, or myocarditis, or if the patient is taking any medicines that may affect heart function.
• If the patient has low blood pressure.
• If the patient has had a stroke, especially if the patient is elderly.
• If the patient has liver disease.
• If the patient has ever had a seizure (epilepsy).
• If the patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may check the patient's blood sugar levels during treatment with ApoTiapina PR.
• If the patient has ever had a low white blood cell count (which may or may not have been caused by other medicines).
• If the patient is an elderly person with dementia (disorder of brain function). In such cases, ApoTiapina PR should not be taken, as medicines in the same group as ApoTiapina PR may increase the risk of stroke and, in some cases, death in elderly patients with dementia.
• If the patient is an elderly person with Parkinson's disease/parkinsonism.
• If the patient or their family members have had blood clots, as the use of medicines in this group has been associated with the formation of blood clots.
• If the patient has or has had a condition characterized by short periods of breathing cessation during normal nighttime sleep (called "sleep apnea") and is taking medicines that slow down normal brain activity (i.e., "depressant" medicines).
• If the patient has or has had a condition in which they cannot completely empty their bladder, has an enlarged prostate, intestinal obstruction, or increased eye pressure. These symptoms may be caused by medicines (called "anticholinergic" medicines) used to treat various diseases that affect nerve cell function.
• If the patient has a history of alcohol or drug abuse.
• If the patient has depression or other conditions that are treated with antidepressant medicines. The use of these medicines with ApoTiapina PR may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "ApoTiapina PR and other medicines").

Inform your doctor immediately if you experience any of the following symptoms after taking ApoTiapina PR:

• Rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, refer the patient to a cardiologist immediately.
• A combination of fever, severe muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate treatment may be necessary.
• Uncontrolled movements, mainly in the face and tongue.
• Dizziness or severe drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
• Seizures (convulsions).
• Prolonged and painful erections (priapism).

These symptoms may be caused by the use of this type of medicine. Inform your doctor immediately if you experience:

• Fever, flu-like symptoms, sore throat, or any other infection, as this may be a sign of a very low white blood cell count in the blood, which may require discontinuation of ApoTiapina PR and/or appropriate treatment.
• Constipation with persistent abdominal pain or constipation that does not respond to treatment, as this may lead to a more serious bowel obstruction.
• Suicidal thoughts or worsening depressionIf the patient has depression, they may sometimes have thoughts of self-harm or suicide. These thoughts may worsen during the initial treatment phase, as all antidepressant medicines take time to start working, usually after a few weeks, sometimes later. These thoughts may also worsen if the patient suddenly stops taking the medicine. Young adults are more likely to experience such thoughts. Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behavior in individuals under 25 years of age with depression.

If the patient experiences any thoughts of self-harm or suicidal thoughts, they should contact their doctor or go to the hospital immediately. It may be helpful to inform family members or friends about the depression and ask them to read this package leaflet. You can also ask these individuals to tell the patient if they notice any worsening of depressive symptoms or other concerning changes in behavior.

Severe cutaneous adverse reactions (SCARs)During treatment with this medicine, very rare severe skin reactions have been reported, which can be life-threatening or fatal. These reactions usually occur as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form causing widespread skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with a rash, fever, lymph node enlargement, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small blisters filled with pus.
• Erythema multiforme (EM), a skin rash with irregular, itchy, red patches.

If the patient experiences any of the above symptoms, they should stop taking ApoTiapina PR and seek medical attention immediately.

Weight gain

Patients taking ApoTiapina PR have experienced weight gain. The patient and their doctor should regularly check the patient's weight.

Children and adolescents

ApoTiapina PR should not be used in children and adolescents under 18 years of age.

ApoTiapina PR and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Do not take ApoTiapina PR if you are taking any of the following medicines:

• Certain medicines used to treat HIV.
• Medicines from the azole group (used to treat fungal infections).
• Erythromycin or clarithromycin (medicines used to treat infections).
• Nefazodone (used to treat depression).

Inform your doctor if you are taking any of the following medicines:

• Antiepileptic medicines (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (medicines used to treat sleep disorders).
• Thioridazine or lithium (other antipsychotic medicines).
• Medicines that affect heart rhythm, such as those that can disrupt electrolyte balance (decrease potassium and magnesium levels), such as diuretics (which increase urine production) or certain antibiotics.
• Medicines that can cause constipation.
• Medicines (called "anticholinergic" medicines) that affect nerve cell function, used to treat various diseases.
• Antidepressant medicines. These medicines may interact with ApoTiapina PR and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, consult a doctor.

Before stopping any medicines, consult a doctor.

ApoTiapina PR with food, drink, and alcohol

• Food may affect ApoTiapina PR, so it should be taken at least one hour before a meal or before bedtime.
• Be cautious with the amount of alcohol consumed, as the combined effect of ApoTiapina PR and alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking ApoTiapina PR, as it may affect the way the medicine works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before taking this medicine. Do not take ApoTiapina PR during pregnancy, unless discussed with your doctor. Do not take ApoTiapina PR while breastfeeding. The following symptoms, which may indicate withdrawal syndrome, may occur in newborns of mothers who took ApoTiapina PR during the last trimester (last three months) of pregnancy: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If the patient's child experiences any of these symptoms, they should contact their doctor.

Driving and using machines

This medicine may cause drowsiness. Do not drive or operate machinery until you know how the medicine affects you.

Effect on urine tests

In patients taking ApoTiapina PR, urine tests for the presence of certain medicines may show the presence of methadone or certain antidepressant medicines (tricyclic antidepressants), even if the patient is not taking methadone or tricyclic antidepressants. In such cases, it is recommended to perform tests using other methods to confirm the results.

ApoTiapina PR contains lactose

ApoTiapina PR contains lactose, a type of sugar. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take ApoTiapina PR

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist. The initial dose will be determined by your doctor. The maintenance dose (daily dose) will depend on the severity of the disease and the individual patient's needs, but it usually ranges from 150 mg to 800 mg.

• Take the tablets once a day.
• Do not divide, chew, or crush the tablets.
• Swallow the tablets whole with water.
• Take the tablets on an empty stomach (at least one hour before a meal or before bedtime, as advised by your doctor).
• Do not drink grapefruit juice while taking ApoTiapina PR, as it may affect the way the medicine works.
• Do not stop taking the tablets even if you feel better, unless your doctor decides otherwise.

Liver function disorders

If you have liver problems, your doctor may recommend a dose change.

Elderly patients

If you are an elderly patient, your doctor may recommend a dose change.

Use in children and adolescents

ApoTiapina PR should not be used in children and adolescents under 18 years of age.

Taking more ApoTiapina PR than prescribed

If you take more ApoTiapina PR than prescribed, you may experience drowsiness, dizziness, and heart rhythm disturbances. Contact your doctor or go to the nearest hospital immediately. Bring the ApoTiapina PR tablets with you.

Missing a dose of ApoTiapina PR

If you miss a dose, take it as soon as you remember. If the time to the next dose is short, wait and take the dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping ApoTiapina PR treatment

If you suddenly stop taking ApoTiapina PR, you may experience difficulty sleeping (insomnia), nausea, headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, ApoTiapina PR can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 people

• Dizziness (may lead to falls), headache, dry mouth.
• Feeling drowsy (may resolve during continued treatment with quetiapine) (may lead to falls).
• Withdrawal symptoms (symptoms that occur after stopping quetiapine) include difficulty sleeping (insomnia), nausea, headache, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop the medicine over a period of at least 1-2 weeks.
• Weight gain.
• Abnormal muscle contractions. These include difficulty starting muscle movements, tremors, feelings of restlessness, or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol) in the blood.

Common: may affect up to 1 in 10 people

• Rapid heartbeat.
• Feeling of heartbeat, rapid heartbeat, or changes in heart rhythm.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of hands or feet.
• Low blood pressure when standing up. This may cause dizziness or fainting (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling hungry.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and worsening depression.
• Shortness of breath.
• Vomiting (mainly in elderly patients).
• Fever.
• Changes in thyroid hormone levels in the blood.
• Decreased levels of certain types of blood cells.
• Increased liver enzyme activity in the blood.
• Increased prolactin levels in the blood. Increased prolactin levels may rarely lead to:
• Breast swelling in both men and women and unexpected milk production.
• Missed periods or irregular periods in women.

Uncommon: may affect up to 1 in 100 people

• Seizures.
• Allergic reactions, which may include hives, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly in the face and tongue.
• Sexual function disorders.
• Diabetes.
• Changes in the electrical activity of the heart visible on an ECG (prolonged QT interval).
• Slower than normal heart rate, which may occur when starting treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Feeling of a blocked nose.
• Decreased red blood cell count in the blood.
• Decreased sodium levels in the blood.
• Worsening of existing diabetes.
• Confusion.

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

• A combination of high body temperature (fever), sweating, muscle stiffness, and decreased consciousness or fainting (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Liver function disorders (hepatitis).
• Prolonged and painful erections (priapism).
• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorders.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, contact your doctor immediately.
• Walking, talking, eating, or performing other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (known as "metabolic syndrome") in which three or more of the following features occur: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides, high blood pressure, and increased blood sugar levels.
• A combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count in the blood, a condition known as agranulocytosis.
• Bowel obstruction.
• Increased creatine phosphokinase activity in the blood (a substance found in muscles).

Very rare: may affect up to 1 in 10,000 people

• Severe skin reactions, blisters, or red patches on the skin.
• Severe allergic reaction (anaphylaxis), which can cause difficulty breathing or shock.
• Rapidly developing swelling of the skin, usually around the eyes and mouth, as well as the throat (angioedema).
• A severe condition associated with the formation of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Abnormal secretion of a hormone that regulates urine production.
• Muscle breakdown and muscle pain (rhabdomyolysis).

Frequency not known (frequency cannot be estimated from available data)

• A skin rash with irregular, itchy, red patches (erythema multiforme). See section 2.
• Sudden onset of areas of red skin with small blisters (acute generalized exanthematous pustulosis (AGEP)). See section 2.
• A severe, sudden allergic reaction with symptoms such as fever and blisters on the skin, as well as peeling skin (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with a rash, fever, lymph node enlargement, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes). See section 2.
• Withdrawal symptoms in newborns of mothers who took ApoTiapina PR during pregnancy.
• Stroke.
• Heart muscle disorders (cardiomyopathy).
• Myocarditis.
• Vasculitis (inflammation of blood vessels), often with a skin rash and small red or purple spots.

Medicines in the same group as ApoTiapina PR may cause heart rhythm disturbances, which can be dangerous and, in severe cases, fatal. Some side effects can only be detected by blood tests, including changes in fat (triglycerides and total cholesterol) and sugar levels in the blood, changes in thyroid hormone levels in the blood, increased liver enzyme activity in the blood, decreased levels of certain types of blood cells, decreased red blood cell count in the blood, increased creatine phosphokinase activity in the blood (a substance found in muscles), decreased sodium levels in the blood, and increased prolactin levels in the blood. Increased prolactin levels may rarely lead to:

• Breast swelling in both men and women and unexpected milk production.
• Missed periods or irregular periods in women.

Your doctor may recommend regular blood tests.

Additional side effects in children and adolescents

The same side effects that occur in adults can also occur in children and adolescents. The following side effects have been observed more frequently in children and adolescents or have not been observed in adults:

Very common: may affect more than 1 in 10 people

• Increased prolactin levels in the blood. Increased prolactin levels may rarely lead to:
• Breast swelling in both boys and girls and unexpected milk production.
• Missed periods or irregular periods in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle contractions. These include difficulty starting muscle movements, tremors, feelings of restlessness, or muscle stiffness without pain.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

• Feeling weak, fainting (may lead to falls).
• Feeling of a blocked nose.
• Feeling irritable.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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: www.smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ApoTiapina PR

Keep this medicine out of the 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. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What ApoTiapina PR contains

The active substance is quetiapine. Each prolonged-release tablet contains 200 mg of quetiapine (as quetiapine fumarate). Each prolonged-release tablet contains 300 mg of quetiapine (as quetiapine fumarate). Each prolonged-release tablet contains 400 mg of quetiapine (as quetiapine fumarate). The other ingredients are: Tablet core: methacrylic acid and ethyl acrylate copolymer (1:1), type A, lactose, crystalline maltose, talc, magnesium stearate. Tablet coating: methacrylic acid and ethyl acrylate copolymer (1:1), type A, triethyl citrate.

What ApoTiapina PR looks like and contents of the pack

Prolonged-release tablet. The 200 mg prolonged-release tablets are white or almost white, oblong, biconvex, with the number "200" embossed on one side. The 300 mg prolonged-release tablets are white or almost white, oblong, biconvex, with the number "300" embossed on one side. The 400 mg prolonged-release tablets are white or almost white, oval, biconvex, with the number "400" embossed on one side. ApoTiapina PR is available in blisters. Pack sizes: 10, 50, 60, 100 prolonged-release tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: [email protected]

Manufacturer:

Pharmathen International S.A. Industrial Park Sapes, Rodopi Prefecture, Block No 5 69300 Rodopi Greece Pharmathen S.A. Dervenakion 6 15351 Pallini Attiki Greece

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

Belgium: Quetiapine AB 50mg/150mg/200mg/300mg/400mg tabletten met verlengde afgifte / comprimés à libération prolongée / Retardtabletten Germany: Quetiapin Aurobindo 50 mg/150 mg/200 mg/300 mg/400 mg Retardtabletten Netherlands: Quetiapine Aurobindo 50 mg/150 mg/ 200 mg/ 300 mg/ 400 mg, tabletten met verlengde afgifte Poland: ApoTiapina PR Portugal: Quetiapina Aurobindo

Date of last revision of the package leaflet: 07/2024