APOTIAPINA 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet:
2. What ApoTiapina is and what it is used for
3. Before you take ApoTiapina
   1. When not to take ApoTiapina:
   2. Warnings and precautions
   3. Severe skin reactions (SCAR)
   4. Weight gain
   5. Children and adolescents
   6. ApoTiapina and other medicines
   7. ApoTiapina with food, drink, and alcohol
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Effect on urine tests for drug use
   11. Excipients:
   12. ApoTiapina contains lactose monohydrate
   13. ApoTiapina contains sodium
   14. Orange yellow S
4. How to take ApoTiapina
   1. Patients with liver function disorders
   2. Elderly patients
   3. Use in children and adolescents under 18 years of age
   4. Taking a higher dose of ApoTiapina than recommended
   5. Missing a dose of ApoTiapina
   6. Stopping treatment with ApoTiapina
5. 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: cannot be estimated from the 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
6. How to store ApoTiapina
7. Contents of the pack and other information
   1. What ApoTiapina contains
   2. What ApoTiapina looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Aurovitas Pharma Polska Sp. z o.o.
   6. Manufacturer
   7. Date of last revision of the leaflet: 06.2024

Package Leaflet: Information for the Patient

ApoTiapina, 25 mg, coated tablet
ApoTiapina, 100 mg, coated tablet
ApoTiapina, 200 mg, coated tablet
Quetiapine

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

• 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

• 1. What ApoTiapina is and what it is used for
• 2. Before you take ApoTiapina
• 3. How to take ApoTiapina
• 4. Possible side effects
• 5. How to store ApoTiapina
• 6. Contents of the pack and other information

1. What ApoTiapina is and what it is used for

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

• Depression in bipolar disorder: when the patient feels deep sadness. They may feel depressed, guilty, lack energy and appetite, or have difficulty sleeping.
• Mania: the patient may be very excited, happy, agitated, enthusiastic, or overly active; they may also have an inappropriate assessment of the situation, including aggressive or destructive behavior.
• Schizophrenia: the patient may hear or feel things that do not exist in reality, have beliefs that contradict reality, or be extremely suspicious, frightened, disoriented, guilty, tense, or depressed.

The doctor may prescribe continued use of ApoTiapina even when the patient feels better.

2. Before you take ApoTiapina

When not to take ApoTiapina:

• If the patient is allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking any of the following medicines: certain HIV medicines, azole derivatives (used for fungal infections), erythromycin or clarithromycin (used for bacterial infections), or nefazodone (used for depression).

If the patient is not sure, they should consult their doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting to take ApoTiapina, the patient should discuss with their doctor or pharmacist if:

• the patient or someone in their family has or has had any heart problems, such as arrhythmias, heart failure, or myocarditis, or if the patient is taking or has taken any medicines that may affect heart function.
• the patient has low blood pressure.
• the patient has had a stroke, especially if the patient is elderly.
• the patient has liver problems.
• the patient has ever had a seizure (epilepsy).
• the patient has diabetes or is at risk of developing diabetes. In these cases, the doctor may check the patient's blood sugar levels during treatment with ApoTiapina.
• the patient has had a decreased white blood cell count in the past (which may or may not have been caused by other medicines).
• the patient is elderly and has dementia (brain function disorders). In these patients, ApoTiapina should not be used, as medicines in the same group may increase the risk of stroke and sometimes death.
• the patient is elderly and has Parkinson's disease or parkinsonism.
• the patient or someone in their family has had a blood clotting disorder, as ApoTiapina may cause blood clots.
• the patient has sleep apnea (temporary cessation of breathing during normal nighttime sleep) and is taking medicines that slow down normal brain function (depressants).
• the patient has a condition where they cannot completely empty their bladder (urinary retention), has an enlarged prostate, intestinal obstruction, or increased intraocular pressure. These conditions are sometimes caused by medicines (called anticholinergic medicines) that affect the functioning of nerve cells to treat certain conditions.
• the patient has abused alcohol or drugs.
• If the patient has depression or other conditions that are being treated with antidepressant medicines. Taking these medicines with ApoTiapina may lead to the development of serotonin syndrome, a life-threatening condition (see "ApoTiapina and other medicines").

The patient should immediately inform their doctor if they experience any of the following symptoms after taking ApoTiapina:

• fever, severe muscle stiffness, excessive sweating, or changes in consciousness (so-called "malignant neuroleptic syndrome"). Immediate medical attention may be necessary.
• involuntary muscle movements, mainly of the face and tongue.
• dizziness or excessive drowsiness; these changes in elderly patients may increase the risk of accidental injury (falls).
• seizures (epilepsy).
• prolonged and painful erection (priapism).
• 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.

Such actions may occur when taking this type of medicine. The patient should immediately inform their doctor if they experience:

• fever, flu-like symptoms, sore throat, or any other infection as a result of a very low white blood cell count. It may be necessary to discontinue ApoTiapina and/or use appropriate treatment.
• constipation with persistent abdominal pain or constipation that does not improve with treatment, which can lead to severe intestinal obstruction.
• Suicidal thoughts and worsening depressionIf the patient has depression, they may sometimes experience thoughts of self-harm or suicide. These thoughts may be particularly severe at the beginning of treatment with ApoTiapina, as all medicines in this group start working only after a certain period of use; usually after about 2 weeks, and sometimes this period may be longer. The risk of such thoughts in the patient is also higher if they suddenly stop taking the medicine. Additionally, this risk is increased if the patient is a young adult. Clinical trial data have shown an increased risk of suicidal thoughts and/or behaviors in young adults under 25 years of age with depression.

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

Severe skin reactions (SCAR)

During treatment with this medicine, very rare severe skin reactions (SCAR) have been reported, which can be life-threatening or lead to death. The symptoms of these reactions usually include:

• 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 of rash causing widespread skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), flu-like symptoms with a rash, fever, swelling of lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and increased liver enzyme activity).
• Acute generalized exanthematous pustulosis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), a skin rash with irregular, itchy, red patches.

If the patient experiences these symptoms, they should discontinue ApoTiapina and immediately contact their doctor or seek medical attention.

Weight gain

Weight gain has been reported in patients taking ApoTiapina. The patient or their doctor should regularly monitor their weight.

Children and adolescents

Children and adolescents under 18 years of age should not take ApoTiapina.

ApoTiapina 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. The patient should not take ApoTiapina if they are taking any of the following medicines:

• Certain HIV medicines.
• Azole derivatives (used for fungal infections).
• Erythromycin or clarithromycin (used for bacterial infections).
• Nefazodone (used for depression).

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

• Antiepileptic medicines (such as phenytoin or carbamazepine).
• Medicines used for high blood pressure.
• Barbiturates (used for insomnia).
• Thioridazine or lithium (another antipsychotic medicine).
• Medicines that affect heart rhythm, such as medicines that can cause electrolyte disturbances (decreased potassium or magnesium levels), such as diuretics (which increase urine production) or certain antibiotics (used to treat infections).
• Medicines that can cause constipation.
• Medicines (called anticholinergic medicines) that affect the functioning of nerve cells, used to treat certain conditions.
• Antidepressant medicines. These medicines may interact with ApoTiapina and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, the patient should consult their doctor.

Before stopping any medicine, the patient should talk to their doctor.

ApoTiapina with food, drink, and alcohol

• ApoTiapina can be taken with or without food.
• During treatment with ApoTiapina, the patient should limit their alcohol intake, as it may cause drowsiness.
• The patient should not drink grapefruit juice while taking ApoTiapina, as it may affect the medicine's action.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking ApoTiapina. ApoTiapina should not be used during pregnancy without consulting the doctor. ApoTiapina should not be taken during breastfeeding. The following symptoms may occur in newborn babies whose mothers took quetiapine during the last trimester of pregnancy (last three months of pregnancy): trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If the patient's baby experiences any of these symptoms, they may need to contact their doctor.

Driving and using machines

ApoTiapina may cause drowsiness. The patient should not drive or operate machinery until they know how their body reacts to this medicine.

Effect on urine tests for drug use

In patients taking ApoTiapina, urine tests for drug use performed by some methods may show the presence of methadone or tricyclic antidepressants, even if the patient is not taking them. In such cases, it is recommended to perform other, more accurate tests.

Excipients:

ApoTiapina contains lactose monohydrate

This medicine contains lactose monohydrate, a type of sugar. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

ApoTiapina contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

Orange yellow S

One of the ingredients of ApoTiapina 25 mg is orange yellow S (E110), which may cause allergic reactions.

3. How to take ApoTiapina

This medicine should always be taken as directed by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist. The doctor will decide on the initial dose. The maintenance dose (daily dose) depends on the type of disease and the individual needs of the patient, but it is usually between 150 mg and 800 mg.

• Tablets are taken once a day before bedtime or twice a day, depending on the patient's disease.
• Tablets should be swallowed whole with water.
• Tablets can be taken with or without food.
• During treatment with this medicine, the patient should not drink grapefruit juice, as it may interfere with the medicine's action.
• The patient should not stop treatment without consulting their doctor, even if they feel better.

Patients with liver function disorders

In patients with liver problems, the doctor may change the dose.

Elderly patients

In elderly patients, the doctor may change the dose.

Use in children and adolescents under 18 years of age

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

Taking a higher dose of ApoTiapina than recommended

If the patient takes a higher dose than recommended by their doctor, they may experience drowsiness, dizziness, and abnormal heartbeat. The patient should immediately contact their doctor or go to the nearest hospital. They should take the ApoTiapina tablets with them.

Missing a dose of ApoTiapina

If the patient forgets to take a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they should not take the missed dose. The patient should not take a double dose of the medicine to make up for the missed dose.

Stopping treatment with ApoTiapina

If the patient suddenly stops taking ApoTiapina, they may experience difficulty sleeping (insomnia), nausea, as well as headache, diarrhea, vomiting, dizziness, and irritability. Before stopping treatment, the doctor may suggest gradually reducing the dose of the medicine. If the patient has any further questions about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, ApoTiapina can cause side effects, although not everybody gets them. If any of the side effects get serious or if the patient notices any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Very common: may affect more than 1 in 10 people

• Dizziness (may lead to falls), headache, dry mouth.
• Feeling drowsy (may improve during treatment with ApoTiapina) (may lead to falls).
• Withdrawal symptoms (symptoms that occur after stopping ApoTiapina) include: difficulty sleeping (insomnia), nausea, headache, diarrhea, vomiting, dizziness, and irritability. It is recommended to gradually stop the medicine over at least 1 to 2 weeks.
• Weight gain.
• Abnormal muscle contractions. These are difficulties in initiating movement, tremors, restlessness, or muscle stiffness without pain.
• Changes in the levels of certain fats in the blood: increased triglycerides, total cholesterol (mainly LDL cholesterol), decreased HDL cholesterol.
• Decreased hemoglobin levels in the blood.

Common: may affect up to 1 in 10 people

• Increased heart rate.
• Strong heartbeat, palpitations, irregular heartbeat.
• Constipation, stomach upset (indigestion).
• Weakness.
• Swelling of hands or feet.
• Decreased blood pressure when standing up, which may cause dizziness or fainting (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Sleep disturbances and nightmares.
• Increased appetite.
• Irritability.
• 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 white blood cell count in the blood.
• Increased liver enzyme activity in the blood (ALT, gamma-GT).
• Increased levels of the hormone prolactin in the blood. This may lead to:
• breast enlargement in both men and women and unexpected milk secretion from the nipples.
• absence or irregular menstrual periods in women.

Uncommon: may affect up to 1 in 100 people

• Seizures or convulsions.
• Allergic reactions, including hives, skin swelling, and swelling around the mouth.
• Unpleasant leg symptoms (restless legs syndrome).
• Difficulty swallowing.
• Involuntary muscle movements, mainly of the face and tongue.
• Sexual disorders.
• Diabetes.
• Changes in the electrical activity of the heart visible on an ECG (prolonged QT interval).
• Slower than normal heartbeat, which may occur when starting treatment and may be associated with decreased blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Stuffy nose.
• Decreased red blood cell count, platelet count, or certain types of white blood cells.
• Decreased thyroid hormone levels in the blood, hypothyroidism.
• Increased liver enzyme activity in the blood (AST).
• Decreased sodium levels in the blood.
• Worsening of existing diabetes.
• Disorientation.

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

• Simultaneous occurrence of high body temperature (fever), sweating, muscle stiffness, and/or decreased consciousness (a condition known as "malignant neuroleptic syndrome").
• Yellowing of the skin and eyes (jaundice).
• Hepatitis.
• Prolonged and painful erection (priapism).
• Breast enlargement and unexpected milk secretion (galactorrhea).
• Menstrual disorders.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs); a fragment of the clot can move with the blood flow to the lungs, causing chest pain and difficulty breathing; if the patient notices any of these symptoms, they should immediately go to the doctor or hospital.
• Sleepwalking, 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 symptoms occur simultaneously: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased levels of certain fats in the blood (triglycerides), high blood pressure, and increased blood sugar levels.
• Simultaneous occurrence of fever, flu-like symptoms, sore throat, or any other infection as a result of a very low white blood cell count (a condition known as agranulocytosis).
• Intestinal obstruction.
• Increased creatine kinase levels in the blood (a substance derived from muscles).

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

• Severe skin rash, blisters, or red patches on the skin.
• Severe allergic reactions (anaphylactic reactions) with symptoms such as difficulty breathing or shock.
• Rapidly spreading skin swelling, usually around the eyes, mouth, and throat (angioedema).
• Severe skin reaction with blisters, peeling skin, and mucous membrane lesions (Stevens-Johnson syndrome), see section 2.
• Inadequate secretion of a hormone that regulates urine production.
• Muscle breakdown and muscle pain (rhabdomyolysis).

Frequency not known: cannot be estimated from the available data

• Skin rash with irregular red patches (erythema multiforme), see section 2.
• Sudden appearance of red, blistering skin lesions (acute generalized exanthematous pustulosis (AGEP)), see section 2.
• Severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling (toxic epidermal necrolysis), see section 2.
• Rash with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with a rash, fever, swelling of lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and increased liver enzyme activity), see section 2.
• Withdrawal symptoms in newborns whose mothers took ApoTiapina during pregnancy.
• Stroke.
• Heart muscle disorders (cardiomyopathy).
• Myocarditis.
• Blood vessel inflammation (vasculitis), often with a skin rash and small red or purple spots.

Medicines in the same group as ApoTiapina may cause heart rhythm disorders, 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 white blood cell count, decreased red blood cell count, increased creatine kinase levels in the blood (a substance derived from muscles), decreased sodium levels in the blood, and increased prolactin levels in the blood. Increased prolactin levels may lead to:

• breast enlargement in both men and women and unexpected milk secretion from the nipples.
• absence or irregular menstrual periods in women.

The doctor may recommend regular check-ups.

Additional side effects in children and adolescents

In children and adolescents, the same side effects may occur as in adults. The following side effect has been observed more frequently or exclusively in children and adolescents:

Very common: may affect more than 1 in 10 people

• Increased levels of the hormone prolactin in the blood. Increased prolactin levels may rarely cause: in boys and girls - breast enlargement and milk secretion from the nipples; in girls - absence or irregular menstrual periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle contractions, including difficulties in initiating movement, tremors, 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).
• Stuffy nose.
• Feeling irritable.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store ApoTiapina

Store in the original package. The medicine should be stored in a place that is out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What ApoTiapina contains

The active substance of ApoTiapina is quetiapine. Each 25 mg coated tablet contains 25 mg of quetiapine (as quetiapine fumarate). Each 100 mg coated tablet contains 100 mg of quetiapine (as quetiapine fumarate). Each 200 mg coated tablet contains 200 mg of quetiapine (as quetiapine fumarate). The other ingredients are: tablet core: hypromellose 2910 (E464), calcium hydrogen phosphate dihydrate, lactose monohydrate, maize starch, sodium carboxymethylcellulose (type A), magnesium stearate, microcrystalline cellulose PH 102, talc, silicon dioxide. coating: 25 mg: iron oxide red and yellow (E172), hypromellose 2910 (E464), titanium dioxide (E171), macrogol 400, orange yellow S (E110). 100 mg: iron oxide yellow (E172), hypromellose 2910, titanium dioxide (E171), macrogol 400. 200 mg: hydroxypropylcellulose (E463), hypromellose 2910 (E464), talc, titanium dioxide (E171).

What ApoTiapina looks like and contents of the pack

25 mg: round, biconvex, peach-colored coated tablets with a diameter of about 5.7 mm. 100 mg: round, biconvex, yellow coated tablets with a score line on one side, with a diameter of about 9.1 mm. 200 mg: round, biconvex, white coated tablets with a score line on one side, with a diameter of about 12.1 mm. The 100 mg and 200 mg coated tablets can be divided into equal doses. Pack size: the pack contains: 25 mg: 30 coated tablets (in blisters of 10 tablets). 100 mg, 200 mg: 30 or 60 coated tablets (in blisters of 10 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 lok. 27
01-909 Warsaw
Poland

Manufacturer

Genepharm S.A.
18th km Marathonos Avenue
15351 Pallini Attikis,
Greece

Date of last revision of the leaflet: 06.2024