Apotiapina

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 you.

• 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 pack:

• 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 you feel very sad. You may feel hopeless, have low self-esteem, loss of interest in activities, and have difficulty sleeping.
• Mania: you may feel very excited, happy, energetic, enthusiastic, or overactive; you may also have poor judgment, aggressive or destructive behavior.
• Schizophrenia: you may hear or feel things that are not there, have delusions, or be extremely suspicious, anxious, disoriented, guilty, tense, or depressed.

Your doctor may continue to prescribe ApoTiapina even when you feel better.

2. Before you take ApoTiapina

When not to take ApoTiapina:

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

If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking ApoTiapina, discuss with your doctor or pharmacist if:

• You or someone in your family has or has had heart problems, such as irregular heartbeat, weakened heart muscle, or inflammation of the heart muscle, or if you are taking or have taken any medicines that may affect heart function.
• You have low blood pressure.
• You have had a stroke, especially if you are elderly.
• You have liver problems.
• You have had a seizure (epilepsy).
• You have diabetes or are at risk of developing diabetes. Your doctor may check your blood sugar levels during treatment with ApoTiapina.
• You have had a decreased white blood cell count (which may or may not have been caused by other medicines).
• You are elderly and have dementia (disorders of brain function). You should not take ApoTiapina, as medicines in this group may increase the risk of stroke and, in some cases, death in elderly patients with dementia.
• You are elderly and have Parkinson's disease or parkinsonism.
• You or a family member has had a blood clot, as taking medicines in this group may cause blood clots.
• You have sleep apnea (pauses in breathing during sleep) and take medicines that slow down normal brain function (depressants).
• You have a condition where you cannot empty your bladder completely, have an enlarged prostate, intestinal obstruction, or increased eye pressure. These conditions may be caused by medicines (called anticholinergic medicines) that affect the functioning of nerve cells to treat certain conditions.
• You have a history of alcohol or drug abuse.
• If you have depression or other conditions that are being treated with antidepressants. Taking these medicines with ApoTiapina may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "ApoTiapina and other medicines").

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

• Fever, severe muscle stiffness, excessive sweating, or changes in mental status (neuroleptic malignant syndrome). You may need urgent medical attention.
• Involuntary movements of the muscles, 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 or irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. Your doctor will need to examine your heart and, if necessary, refer you to a cardiologist immediately.

Such effects may occur when taking this type of medicine.
Tell your doctor immediately if you experience:

• Fever, flu-like symptoms, sore throat, or any other infection as a result of a very low white blood cell count. You may need to stop taking ApoTiapina and (or) receive appropriate treatment.
• Constipation with persistent abdominal pain or constipation that does not improve with treatment, which can lead to severe bowel obstruction.
• Suicidal thoughts and worsening depressionIf you have depression, you 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 treatment; usually after about 2 weeks, and sometimes this period may be longer. The risk of such thoughts is also higher if you suddenly stop taking the medicine. Additionally, this risk is increased if you are 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 you experience thoughts of self-harm or suicide, you should immediately contact your doctor or go to the nearest hospital. It may be helpful to inform your family or friends about your depression and ask them to read this leaflet. You can also ask them to tell you if they notice any worsening of your depression or other concerning changes in your 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), symptoms of flu-like illness with 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 you experience these symptoms, you should stop taking ApoTiapina and contact your doctor or seek medical attention immediately.

Weight gain

Weight gain has been reported in patients taking ApoTiapina. You or your doctor should regularly check your weight.

Children and adolescents

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

ApoTiapina and other medicines

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

• Certain HIV protease inhibitors.
• Azole derivatives (used to treat fungal infections).
• Erythromycin or clarithromycin (used to treat bacterial infections).
• Nefazodone (used to treat depression).

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

• Antiepileptic medicines (such as phenytoin or carbamazepine).
• Medicines used to treat high blood pressure.
• Barbiturates (used to treat insomnia).
• Thioridazine or lithium (another antipsychotic medicine).
• Medicines that affect heart rhythm, such as those that can cause electrolyte disturbances (decreased potassium or magnesium levels), such as diuretics (water pills) 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.
• Antidepressants. These medicines can interact with ApoTiapina and may cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and fever above 38°C (serotonin syndrome). If such symptoms occur, you should consult your doctor.

Before stopping any medicine, you should talk to your doctor.

ApoTiapina with food, drink, and alcohol

• ApoTiapina can be taken with or without food.
• While taking ApoTiapina, you should limit your alcohol intake, as it may cause drowsiness.
• Do not drink grapefruit juice while taking ApoTiapina, as it may affect its action.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, you should consult your doctor or pharmacist before taking ApoTiapina. You should not take ApoTiapina during pregnancy without consulting your doctor. You should not take ApoTiapina while 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 difficulties. If your baby experiences any of these symptoms, you may need to contact your doctor.

Driving and using machines

ApoTiapina may cause drowsiness. You should not drive or operate machinery until you know how your body reacts to this medicine.

Effect on urine tests for drugs

In patients taking ApoTiapina, urine tests for drugs performed by some methods may show the presence of methadone or tricyclic antidepressants, even if you are 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 you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

ApoTiapina contains sodium

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

Take this medicine always as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Your doctor will decide on the initial dose. The maintenance dose (daily dose) depends on the type of disease and individual patient needs, but it is usually between 150 mg and 800 mg.

• Take the tablets once a day before bedtime or twice a day, depending on your disease.
• Swallow the tablets whole with water.
• You can take the tablets with or without food.
• Do not drink grapefruit juice while taking ApoTiapina, as it may affect its action.
• Do not stop treatment without consulting your doctor, even if you feel better.

Patients with liver function disorders

In patients with liver problems, your doctor may adjust the dose.

Elderly patients

In elderly patients, your doctor may adjust 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 prescribed

If you take more ApoTiapina than prescribed by your doctor, you may experience: drowsiness, dizziness, and irregular heartbeat. You should immediately contact your doctor or go to the nearest hospital. Bring the ApoTiapina tablets with you.

Missing a dose of ApoTiapina

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for a missed dose.

Stopping treatment with ApoTiapina

If you suddenly stop taking ApoTiapina, you may experience: difficulty sleeping (insomnia), nausea, and headache, diarrhea, vomiting, dizziness, and irritability. Before stopping treatment, your doctor may suggest gradually reducing the dose.
If you have any further questions on the use of this medicine, ask your 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 you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Very common: may affect more than 1 in 10 people

• Dizziness (may lead to falls), headache, dry mouth.
• Feeling drowsy (may resolve 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 taking 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 (blisters), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (restless legs syndrome).
• Difficulty swallowing.
• Involuntary movements of the muscles, mainly of the face and tongue.
• Sexual dysfunction.
• 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 altered mental status (neuroleptic malignant syndrome).
• Yellowing of the skin and eyes (jaundice).
• Hepatitis.
• Prolonged and painful erection (priapism).
• Breast enlargement and unexpected milk secretion from the nipples.
• 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 break off and travel with the blood to the lungs, causing chest pain and difficulty breathing; if you notice any of these symptoms, you should immediately contact your doctor or go to the hospital.
• Sleepwalking, talking, eating, or performing other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (called "metabolic syndrome") where you have three or more of the following symptoms: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased 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 called agranulocytosis).
• Bowel 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 of difficulty breathing or shock.
• Rapidly developing swelling of the skin, usually around the eyes, mouth, and throat (angioedema).
• Severe skin reaction with blisters, peeling skin, and sores on the skin, mouth, and genitals (Stevens-Johnson syndrome), see section 2.
• Inadequate secretion of a hormone that regulates the amount of urine produced.
• 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 patches on the skin with small blisters (small pus-filled blisters, called 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.
• Rash with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with 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 newborn babies whose mothers took ApoTiapina during pregnancy.
• Stroke.
• Heart muscle disorders (cardiomyopathy).
• Heart muscle inflammation.
• Blood vessel inflammation (vasculitis), often with a skin rash with 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.

Your 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.
• Irritability.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, 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 .
You can also report side effects 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

Store in the original package.
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. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, cornstarch, sodium carboxymethylcellulose (type A), magnesium stearate, microcrystalline cellulose PH 102, talc, silicon dioxide anhydrous.
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 sizes:
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