Apotiapina Pr

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 this leaflet carefully before taking this 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What ApoTiapina PR is and what it is used for
• 2. Before you take ApoTiapina PR
• 3. How to take ApoTiapina PR
• 4. Possible side effects
• 5. How to store ApoTiapina PR
• 6. Contents of the pack 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 bipolar disorder: when you feel sad. You may feel hopeless or worthless, or have difficulty sleeping or concentrating.
• Mania: when you feel very excited, elated, agitated, enthusiastic, or hyperactive, or have impaired judgment.
• Schizophrenia: when you hear or feel things that are not there, believe things that are not true, or feel suspicious, anxious, or confused.

When ApoTiapina PR is used to treat major depressive episodes in bipolar disorder, it is taken in combination with another medicine. Your doctor may continue to prescribe ApoTiapina PR even when you feel better.

2. Before you take ApoTiapina PR

Do not take ApoTiapina PR

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

(See section 6).

• 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 (used to treat infections).
• Nefazodone (used to treat depression).

If you are not sure, consult your doctor or pharmacist before taking ApoTiapina PR.

Warnings and precautions

Before taking ApoTiapina PR, tell your doctor or pharmacist if:

• You or someone in your family has or has had any heart problems, such as irregular heart rhythm, heart failure, or inflammation of the heart muscle, or if you are taking 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 disease.
• You have had a seizure (epilepsy).
• You have diabetes or are at risk of developing diabetes. Your doctor may check your blood sugar levels while you are taking ApoTiapina PR.
• You have had a low white blood cell count in the past (which may or may not have been caused by other medicines).
• You are an elderly person with dementia (a condition that affects brain function). In this case, you should not take ApoTiapina PR, as medicines in the same group as ApoTiapina PR may increase the risk of stroke or death in elderly people with dementia.
• You are an elderly person with Parkinson's disease.
• You or a family member have had blood clots, as medicines in this group have been associated with the formation of blood clots.
• You have a condition where you stop breathing for short periods during normal nighttime sleep (called "sleep apnea") and are taking medicines that slow down normal brain activity (such as "depressants").
• You have a condition where you cannot empty your bladder completely, have an enlarged prostate, intestinal obstruction, or increased pressure in the eye. These symptoms may be caused by medicines (called "anticholinergics") used to treat various conditions that affect nerve cell function.
• You have a history of alcohol or drug abuse.
• You have depression or other conditions that are treated with antidepressant medicines. Taking these medicines with ApoTiapina PR may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "ApoTiapina PR and other medicines").

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

• Fast 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.
• A combination of fever, stiff muscles, sweating, or decreased 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 medicines like ApoTiapina PR.
Tell 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 you have depression, you 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 2 weeks, sometimes later. These thoughts may also worsen if you suddenly stop taking the medicine. Young adults are more likely to have these thoughts. Clinical trial data indicate an increased risk of suicidal thoughts and/or behaviors in people under 25 years of age with depression.

If you ever have thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately. It may be helpful to tell your family or friends that you are depressed 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 changes in your behavior.

Severe skin reactions (SCARs)
Rarely, severe skin reactions have been reported during treatment with this medicine, which can be life-threatening or fatal. These reactions usually appear 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, swollen lymph nodes, 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 you experience any of these symptoms, stop taking ApoTiapina PR and seek medical attention immediately.

Weight gain

Weight gain has been observed in patients taking ApoTiapina PR. You and your doctor should regularly check your 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 taking now or have taken recently, and about 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 (used to treat 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 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 (which fight infections).
• Medicines that can cause constipation.
• Medicines (called "anticholinergics") that affect nerve cell function, used to treat various conditions.
• Antidepressant medicines. These medicines can 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 stiffness, and body temperature above 38°C (serotonin syndrome). If these symptoms occur, consult your doctor.

Before stopping any medicines, consult your doctor.

ApoTiapina PR with food, drink, and alcohol

• Food may affect ApoTiapina PR, so take it at least 1 hour before a meal or before bedtime.
• Be careful with the amount of alcohol you drink. 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, ask your doctor for advice before taking this medicine. Do not take ApoTiapina PR during pregnancy, unless you have discussed it with your doctor. Do not take ApoTiapina PR while breastfeeding.
The following symptoms, which may indicate withdrawal, may occur in newborns of mothers who took ApoTiapina PR during the last trimester (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, contact your doctor.

Driving and using machines

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

Effects on urine tests

In patients taking ApoTiapina PR, urine tests for certain medicines may show positive results for methadone or tricyclic antidepressants (TCAs), even if the patient is not taking these medicines. 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 an intolerance to some sugars, contact 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, ask your doctor or pharmacist.
Your doctor will determine the starting dose. The maintenance dose (daily dose) will depend on the severity of your disease and your individual needs, but it is usually between 150 mg and 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 1 hour before a meal or before bedtime, as directed 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 problems

If you have liver problems, your doctor may adjust your dose.

Elderly people

If you are elderly, your doctor may adjust your dose.

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 feel drowsy, dizzy, or have 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), feeling unwell (nausea), headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.
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 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 lead to falls) (may resolve during continued treatment with quetiapine).
• Withdrawal symptoms (symptoms that occur when quetiapine is stopped) include difficulty sleeping (insomnia), feeling unwell (nausea), headache, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop taking the medicine over a period of at least 1-2 weeks.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling anxious or stiff muscles 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

• Fast 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 people).
• Fever.
• Changes in thyroid hormone levels in the blood.
• Decreased levels of certain types of blood cells.
• Increased levels of liver enzymes in the blood.
• Increased levels of the hormone prolactin in the blood. Increased prolactin levels may rarely lead to:
• Breast swelling in both men and women and unexpected milk production.
• Missed or irregular periods in women.

Uncommon: may affect up to 1 in 100 people

• Seizures (convulsions).
• Allergic reactions, which may include hives, skin swelling, and swelling around the mouth.
• Unpleasant feelings in the legs (also known as "restless legs syndrome").
• Difficulty swallowing.
• Uncontrolled movements, mainly of 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, or decreased consciousness (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Liver problems (hepatitis).
• Prolonged and painful erection (priapism).
• Breast swelling and unexpected milk production (galactorrhoea).
• Menstrual disorders.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can move through the bloodstream to the lungs, causing chest pain and difficulty breathing. 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 (called "metabolic syndrome") in which you have a combination of 3 or more of the following: increased waist circumference, 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 called agranulocytosis.
• Bowel obstruction.
• Increased levels of the enzyme creatine phosphokinase in the blood (a substance from muscles).

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

• Severe skin reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
• Anaphylaxis, a severe allergic reaction that can cause difficulty breathing or shock.
• Angioedema, a severe allergic reaction that can cause swelling of the skin, usually around the eyes and mouth, and throat.
• A condition called "serotonin syndrome" (see section 2).
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Frequency not known: cannot be estimated from the available data

• Erythema multiforme (EM), a skin rash with irregular, itchy, red patches (see section 2).
• Acute generalized exanthematous pustulosis (AGEP), small blisters filled with pus (see section 2).
• Toxic epidermal necrolysis (TEN), a severe skin reaction with widespread skin peeling (see section 2).
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (see section 2).
• Withdrawal symptoms in newborns whose mothers took ApoTiapina PR during pregnancy.
• Stroke.
• Heart muscle disorders (cardiomyopathy).
• Heart muscle inflammation (myocarditis).
• Blood vessel inflammation (vasculitis), 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, life-threatening.
Some side effects can only be detected by blood tests. 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 levels in the blood, decreased levels of certain types of blood cells, decreased red blood cell count in the blood, increased creatine phosphokinase levels in the blood (a substance from 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 or irregular periods in women.

Your doctor may perform periodic 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 levels of the hormone prolactin in the blood. Increased prolactin levels may rarely lead to:
• Breast swelling in both boys and girls and unexpected milk production.
• Missed or irregular periods in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling anxious or stiff muscles 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, tell your doctor, pharmacist, or nurse. You can also report side effects 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, fax: +48 22 49 21 309, website: www.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 PR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What 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 - ethyl acrylate copolymer (1:1) type A, lactose, maltose, talc, magnesium stearate.
Tablet coating: methacrylic acid - 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 "200" embossed on one side.
The 300 mg prolonged-release tablets are white or almost white, oblong, biconvex, with "300" embossed on one side.
The 400 mg prolonged-release tablets are white or almost white, oval, biconvex, with "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 Warszawa
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 leaflet: 07/2024