Apotiapina Pr

Leaflet attached to the packaging: 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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is ApoTiapina PR and what is it 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. Contents of the packaging and other information

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

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

• Bipolar affective depression and episodes of major depression in depressive disorder: when the patient feels sad. The patient may experience feelings of depression, 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 episodes of major depression in severe depression, 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

(listed in section 6).

• Certain medicines used to treat HIV infection.
• 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, you should consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with ApoTiapina PR, you should discuss it with your doctor or pharmacist:

You should immediately inform your doctor if, after taking ApoTiapina PR, the patient experiences any of the following symptoms:

• 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, immediately refer the patient to a cardiologist.
• 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 erection (priapism).

These symptoms may be caused by the use of this type of medicine.
You should immediately inform your doctor if the patient experiences:

• Fever, flu-like symptoms, sore throat, or any other infection, as this may be a consequence of a very low white blood cell count in the blood, which may require discontinuation of ApoTiapina PR and/or initiation of appropriate treatment.
• Constipation, along 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 phase of treatment, as all antidepressant medicines start working after some time, usually after two 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 people under 25 years of age with depression.

If the patient ever experiences thoughts of self-harm or suicidal thoughts, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet. You can also ask these people to tell the patient if they notice any worsening of depressive symptoms or other worrying changes in behavior.
Severe skin reactions (Severe Cutaneous Adverse Reactions, SCARs)
During treatment with this medicine, very rare severe skin reactions have been reported, which can be life-threatening or lead to death. They most often manifest 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 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 discontinue ApoTiapina PR and immediately consult a doctor or seek medical attention.

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

You should tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
ApoTiapina PR should not be taken 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 (used to treat infections).
• Nefazodone (used to treat depression).

You should inform your doctor if the patient is 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 medicines that can disrupt electrolyte balance (decrease potassium and magnesium levels), such as diuretics (which increase urine production) or certain antibiotics (which fight infections).
• 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 may 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, you should consult a doctor.

Before stopping any medicines, you should 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.
• You should be careful with the amount of alcohol consumed. The combined effect of ApoTiapina PR and alcohol may cause drowsiness.
• You should not drink grapefruit juice while taking ApoTiapina PR. It may affect the way the medicine works.

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 a doctor before taking this medicine. ApoTiapina PR should not be taken during pregnancy, unless discussed with a doctor. ApoTiapina PR should not be taken during breastfeeding.
The following symptoms, which may indicate withdrawal syndrome, may occur in newborns of mothers who took ApoTiapina PR during pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If the patient's child experiences any of these symptoms, they may need to consult a doctor.

Driving and using machines

This medicine may cause drowsiness. You should 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, TCAs), even if the patient is not taking methadone or TCAs. 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 the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

3. How to take ApoTiapina PR

This medicine should always be taken as directed by the doctor. In case of doubts, you should consult a doctor or pharmacist.
The initial dose will be determined by the 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.

• Tablets should be taken once a day.
• Tablets should not be divided, chewed, or crushed.
• Tablets should be swallowed whole, with water.
• Tablets should be taken on an empty stomach (at least one hour before a meal or before bedtime, as directed by the doctor).
• While taking ApoTiapina PR, you should not drink grapefruit juice. It may affect the way the medicine works.
• You should not stop taking the tablets even if the patient feels better, unless the doctor decides otherwise.

Liver function disorders

If the patient has liver disorders, the doctor may recommend a dose change.

Elderly patients

If the patient is elderly, the 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 a higher dose of ApoTiapina PR than recommended

If the patient takes a higher dose of ApoTiapina PR than prescribed by the doctor, they may experience drowsiness, dizziness, and heart rhythm disturbances. You should immediately consult a doctor or go to the nearest hospital. You should take the ApoTiapina PR tablets with you.

Missing a dose of ApoTiapina PR

If a dose is missed, it should be taken as soon as possible. If the time to the next dose is short, you should wait and take the dose at the usual time. You should not take a double dose to make up for the missed dose.

Stopping ApoTiapina PR

If ApoTiapina PR is suddenly stopped, the patient may experience difficulty sleeping (insomnia), nausea, headache, diarrhea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before stopping treatment.
In case of any further doubts about taking this medicine, you should consult a 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 anxiety, or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

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. 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 people).
• 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.
• Absence of menstruation 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 of the face or 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, excessive drowsiness, or fainting (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Liver function disorders (hepatitis).
• Prolonged and painful erection (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 difficulty breathing. If the patient notices any of these symptoms, they should immediately consult a doctor.
• Walking, talking, eating, or performing other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (known as "metabolic syndrome") in which there is a combination of three or more of the following features: 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 rash, 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).
• Severe skin condition characterized by 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 the available data)

• Skin rash with irregular, itchy, red patches (erythema multiforme). See section 2.
• Sudden onset of areas of red skin with small blisters (small blisters filled with a white-yellow fluid, known as "acute generalized exanthematous pustulosis" (AGEP)). See section 2.
• Severe, sudden allergic reaction with symptoms such as fever and blisters on the skin, and peeling skin (toxic epidermal necrolysis). See section 2.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), including flu-like symptoms with 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 may occur 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 with small red or purple spots.

Medicines from the same group as ApoTiapina PR may cause heart rhythm disturbances, which can be dangerous and, in severe cases, lead to death.
Some side effects can only be detected by blood tests in a laboratory. These include changes in the levels of certain fats (triglycerides and total cholesterol) or sugar 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.
• Absence of menstruation or irregular periods in women.

The doctor may recommend regular blood tests.

Additional side effects in children and adolescents

The same side effects that occur in adults may 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.
• Absence of menstruation or irregular periods in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle contractions. These include difficulty starting muscle movements, tremors, feelings of anxiety, 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 side effects occur, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, faks: +48 22 49 21 309, website: www.smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store ApoTiapina PR

The medicine should be stored 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.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist 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 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.
Package sizes: 10, 50, 60, 100 prolonged-release tablets.
Not all package 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 Warszawa
e-mail: medicalinformation@aurovitas.pl

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 leaflet: 07/2024