Apotiapina pr: detailed information

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
Quetiapinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

What ApoTiapina PR is and what it is used for
What you need to know before taking ApoTiapina PR
How to take ApoTiapina PR
Possible side effects
How to store ApoTiapina PR
Contents of the pack and other information

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

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

Bipolar affective disorder and major depressive episodes in depressive disorder: when the patient feels sadness. The patient may experience feelings of sadness, guilt, lack of energy, loss of appetite, or difficulty sleeping.
Mania: when the patient may feel extremely excited, elated, overactive, enthusiastic, or excessively active, or have impaired judgment, including aggressive behavior or destructive actions.
Schizophrenia: when the patient may hear or sense things that do not exist, believe things that are not true, or be excessively suspicious, anxious, confused, have feelings of guilt, be tense, or depressed.

When ApoTiapina PR is used to treat major depressive episodes in the course of
major depression, it will be administered in combination with another medicine used to treat this condition.
Your doctor may continue prescribing ApoTiapina PR even after your condition improves.

2. Important information before using ApoTiapina PR

When not to use ApoTiapina PR

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:
- Some medicines used in HIV infection
- Azole group medicines (used in fungal infections)
- Erythromycin or clarithromycin (medicines used in infections)
- Nefazodone (used in the treatment of depression).

If in doubt, consult your doctor or pharmacist before taking ApoTiapina PR.
Warnings and precautions
Before starting treatment with ApoTiapina PR, discuss this with your doctor or pharmacist:

if the patient or any family member has or has had any heart diseases, for example, heart rhythm disorders, weakened heart muscle, or myocarditis, or if the patient is taking any medicines that may affect heart function.
if the patient has low blood pressure.
if the patient has had a stroke, particularly if the patient is elderly.
if the patient has liver disease.
if the patient has ever had seizures (epilepsy).
if the patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may monitor blood sugar levels during treatment with ApoTiapina PR.
if the patient previously had a low white blood cell count (which may or may not have been caused by other medicines).
if the patient is an elderly person with dementia (brain function disorder). In such cases, ApoTiapina PR should not be taken, as medicines of this class have been associated with an increased risk of stroke and sometimes death in elderly patients with dementia.
if the patient is elderly and has Parkinson's disease/parkinsonism.
if the patient or their family has a history of blood clots, as use of medicines in this group has been associated with blood clot formation.
if the patient has or has had a condition involving brief periods of stopped breathing during normal nighttime sleep (called "sleep apnea") and is taking medicines that slow normal brain activity (i.e., "depressants").
if the patient has or has had a condition involving inability to fully empty the bladder (urinary retention), enlarged prostate, intestinal obstruction, or increased intraocular pressure. These symptoms may be caused by medicines (called "anticholinergics") used in treating various diseases affecting nerve cell function.
if the patient has previously abused alcohol or drugs.
if the patient has depression or other conditions treated with antidepressants. Taking these medicines together with ApoTiapina PR may lead to serotonin syndrome, a potentially life-threatening condition (see "ApoTiapina PR and other medicines").

Immediately inform the doctor if any of the following symptoms occur after taking ApoTiapina PR:

Rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, refer the patient immediately 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 required.
Uncontrolled movements, mainly of the face and tongue.
Dizziness or pronounced drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
Seizures (fits).
Prolonged and painful erection (priapism).

These symptoms may be caused by this type of medicine.
Immediately inform the doctor if the patient experiences:

Fever, flu-like symptoms, sore throat, or any other infection, as this may be due to a very low white blood cell count, which may require discontinuation of ApoTiapina PR and/or appropriate treatment.
Constipation accompanied by persistent abdominal pain or persistent constipation unresponsive to treatment, as this may lead to more serious intestinal obstruction.
Suicidal thoughts or worsening depression. If the patient has depression, they may occasionally have thoughts of self-harm or suicide. These may worsen during the initial phase of treatment, as all antidepressants take some time to become effective, 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 behaviour in individuals under 25 years of age with depression.

If the patient ever experiences thoughts of self-harm or suicidal thoughts, contact a doctor immediately or go to hospital. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet. You may also ask these people to inform the patient if they notice worsening of depressive symptoms or other worrying changes in behaviour.

Severe cutaneous adverse reactions (SCARs)
Very rarely, severe skin reactions that may be life-threatening or fatal have been reported during treatment with this medicine. These most commonly present as:

Stevens-Johnson syndrome (SJS), extensive blistering and peeling rash, particularly around the mouth, nose, eyes, and genital area.
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 cells (eosinophilia) and liver enzymes).
Acute generalized exanthematous pustulosis (AGEP), small pustules filled with pus.
Erythema multiforme (EM), skin rash with irregular, itchy, red patches.

If the patient develops any of the above symptoms, stop taking ApoTiapina PR immediately and contact a doctor or seek medical help without delay.

Weight gain
Weight gain has been observed in patients taking ApoTiapina PR. The patient and doctor should regularly monitor the patient's body weight.

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

ApoTiapina PR and other medicines
Tell your doctor about all medicines the patient is currently taking, has recently taken, or plans to take.

Do not take ApoTiapina PR if the patient is taking any of the following medicines:

Some medicines used in the treatment of HIV.
Azole group medicines (used in fungal infections).
Erythromycin or clarithromycin (used in infections).
Nefazodone (used in the treatment of depression).

Inform the 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 in sleep disorders).
Thioridazine or lithium (other antipsychotic medicines).
Medicines affecting heart rhythm, for example, medicines that may disturb electrolyte balance (reduced potassium and magnesium levels), such as diuretics (causing increased urine output) or certain antibiotics (medicines fighting infections).
Medicines that may cause constipation.
Medicines (called "anticholinergics") affecting nerve cell function, used in treating various medical conditions.
Antidepressants. These medicines may interact with ApoTiapina PR and cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, contact a doctor.

Do not stop taking any medicines without first consulting a doctor.

ApoTiapina PR with food, drink, and alcohol

Food may affect ApoTiapina PR; therefore, take it at least one hour before a meal or before bedtime.
Be cautious with alcohol consumption. The combined effect of ApoTiapina PR and alcohol may cause drowsiness.
Do not drink grapefruit juice while taking ApoTiapina PR. It may affect how the medicine works.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine. Do not use ApoTiapina PR during pregnancy unless discussed with a doctor. Do not use ApoTiapina PR during breastfeeding.

The following symptoms, which may indicate withdrawal syndrome, may occur in newborns of mothers who took ApoTiapina PR during the third trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms occur in the patient's child, contact a doctor.

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

Effect of the medicine on urine tests
In patients taking ApoTiapina PR, urine drug screening tests using certain methods may show positive results for methadone or certain antidepressants called tricyclic antidepressants (TCAs), even if the patient is not taking methadone or TCAs. In such cases, it is recommended to confirm results using alternative testing methods.

ApoTiapina PR contains lactose
ApoTiapina PR contains lactose, a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to use ApoTiapina PR

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
The initial dose will be determined by the doctor. The maintenance dose (daily dose) depends on the severity
of the illness and the individual needs of the patient, but usually ranges from 150 mg to 800 mg.

Tablets should be taken once daily.
Tablets must 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; the doctor will inform the patient when to take the dose).
Grapefruit juice must not be consumed during treatment with ApoTiapina PR. It may affect how the medicine works.
Do not stop taking the tablets even if the patient feels better, unless otherwise decided by the doctor.

Liver function disorders
If the patient has liver impairment, the doctor may adjust the dose of the medicine.
Elderly patients
If the patient is elderly, the doctor may adjust the dose of the medicine.
Use in children and adolescents
ApoTiapina PR must not be used in children and adolescents under 18 years of age.
Taking more ApoTiapina PR than prescribed
If the patient has taken more ApoTiapina PR than prescribed by the doctor, symptoms such as drowsiness, dizziness, and heart rhythm disturbances may occur. Contact a doctor immediately or go to the nearest hospital. Bring the ApoTiapina PR tablets with you.
Missed dose of ApoTiapina PR
If a dose has been missed, it should be taken as soon as the patient remembers. If the next dose is due soon, the patient should wait and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping ApoTiapina PR
If treatment with ApoTiapina PR is stopped abruptly, the patient may experience difficulty sleeping (insomnia), malaise (nausea), headache, diarrhoea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.

Very common: may affect more than 1 in 10 people

Dizziness (may lead to falls), headache, dry mouth.
Drowsiness (may diminish with continued use of quetiapine) (may lead to falls).
Withdrawal symptoms (symptoms occurring after discontinuation of quetiapine) include difficulty sleeping (insomnia), malaise (nausea), headache, diarrhoea, vomiting, dizziness, or irritability. Gradual discontinuation of the medicine over a period of at least 1–2 weeks is recommended.
Weight gain.
Abnormal muscle movements. These include difficulty initiating muscle movement, tremor, restlessness, or painless muscle stiffness.
Changes in levels of certain blood lipids (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

Fast heartbeat.
Awareness of heartbeat, rapid or irregular heartbeat.
Constipation, indigestion (dyspepsia).
Feeling weak or fatigued.
Swelling of hands or feet.
Low blood pressure upon standing. This may cause dizziness or fainting (may lead to falls).
Increased blood glucose levels.
Blurred vision.
Unusual dreams and nightmares.
Increased appetite.
Irritability.
Speech and language disturbances.
Suicidal thoughts and worsening of depression.
Shortness of breath.
Vomiting (mainly in elderly people).
Fever.
Changes in thyroid hormone levels in blood.
Decreased number of certain types of blood cells.
Increased liver enzyme activity measured in blood.
Increased blood prolactin levels. Elevated prolactin levels may, in rare cases, lead to:
- Breast enlargement in both men and women and unexpected milk production.
- Absence of menstruation or irregular menstruation in women.

Uncommon: may affect up to 1 in 100 people

Seizures.
Allergic reactions, which may include skin rash (blisters), skin swelling, and swelling around the mouth.
Unpleasant sensations in the legs (also known as restless legs syndrome).
Difficulty swallowing.
Uncontrolled movements, mainly of facial muscles or tongue.
Sexual dysfunction.
Diabetes.
Changes in electrical activity of the heart seen on ECG (prolongation of QT interval).
Slower than normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting.
Difficulty urinating.
Fainting (may lead to falls).
Nasal congestion.
Decreased number of red blood cells in blood.
Decreased sodium levels in blood.
Worsening of pre-existing diabetes.
Confusion.

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

Combination of high body temperature (fever), sweating, muscle stiffness, excessive drowsiness or fainting (a condition known as "neuroleptic malignant syndrome").
Yellowing of the skin and eyes (jaundice).
Liver dysfunction (hepatitis).
Prolonged and painful erection (priapism).
Breast enlargement and unexpected milk production (galactorrhoea).
Menstrual disorders.
Blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, the patient should contact a doctor immediately.
Walking, talking, eating, or performing other activities during sleep.
Decreased body temperature (hypothermia).
Pancreatitis.
A condition (referred to as "metabolic syndrome") involving a combination of 3 or more of the following features: increased abdominal fat, reduced "good cholesterol" (HDL-C), increased levels of certain blood lipids (triglycerides), high blood pressure, and increased blood glucose levels.
Combination of fever, flu-like symptoms, sore throat, or presence of any other infection with a very low number of white blood cells in blood, known as agranulocytosis.
Intestinal obstruction.
Increased creatine phosphokinase activity in blood (a substance originating from muscles).

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

Severe rash, blisters, or red spots on the skin.
Severe allergic reaction (called anaphylaxis), which may cause breathing difficulties or shock.
Rapid swelling of the skin, usually around the eyes, mouth, and throat (angioedema).
Severe condition involving blistering of the skin, mouth, eyes, and genital organs (Stevens-Johnson syndrome). See section 2.
Inappropriate secretion of a hormone regulating urine volume.
Muscle fibre breakdown and muscle pain (rhabdomyolysis).

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

Skin rash with irregular red patches (erythema multiforme). See section 2.
Sudden appearance of red skin areas with small pustules (small blisters filled with whitish-yellow fluid, known as "acute generalized exanthematous pustulosis" (AGEP)). See section 2.
Severe, sudden allergic reaction with symptoms such as fever, blistering of the skin, and skin peeling (toxic epidermal necrolysis). 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 (including increased white blood cells (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).
Inflammation of the heart muscle (myocarditis).
Inflammation of blood vessels (vasculitis), often with a skin rash consisting of small red or purple nodules.

Medicines of the class to which ApoTiapina PR belongs may cause disturbances in heart rhythm, which may be dangerous and, in severe cases, may lead to death.

Some adverse reactions can only be detected by blood tests. These include changes in levels of certain blood lipids (triglycerides and total cholesterol) or blood glucose, changes in thyroid hormone levels in blood, increased liver enzyme levels in blood, decreased number of certain types of blood cells, decreased number of red blood cells in blood, increased creatine phosphokinase activity in blood (a substance found in muscles), decreased sodium levels in blood, and increased blood prolactin levels. Elevated prolactin levels may, in rare cases, lead to:

Breast enlargement in both men and women and unexpected milk production.
Absence of menstruation or irregular menstruation in women.

Your doctor may recommend periodic blood tests.

Additional adverse reactions in children and adolescents

The same adverse reactions occurring in adults may also occur in children and adolescents. The following adverse reactions have been observed more frequently in children and adolescents or were not observed in adults:

Very common: may affect more than 1 in 10 people

Increased levels of a hormone called prolactin in blood. Increased prolactin levels may, in rare cases, lead to:
- Breast enlargement in both boys and girls and unexpected milk production.
- Absence of menstruation or irregular menstruation in girls.
Increased appetite.
Vomiting.
Abnormal muscle movements. These include difficulty initiating muscle movement, tremor, restlessness, or painless muscle stiffness.
Increased blood pressure.

Common: may affect up to 1 in 10 people

Feeling weak, fainting (may lead to falls).
Nasal congestion.
Irritability.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: www.smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store ApoTiapina PR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package 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: copolymer of methacrylic acid and ethyl acrylate (1:1), type A, lactose, crystalline maltose, talc, magnesium stearate.
Tablet coating: copolymer of methacrylic acid and ethyl acrylate (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, elongated, biconvex, with the number "200" engraved on one side.
The 300 mg prolonged-release tablets are white or almost white, elongated, biconvex, with the number "300" engraved on one side.
The 400 mg prolonged-release tablets are white or almost white, oval, biconvex, with the number "400" engraved on one side.

ApoTiapina PR prolonged-release tablets are available in blister packs.
Pack sizes: 10, 50, 60, and 100 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D, lok. 27
01-909 Warsaw
e-mail: [email protected]

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

This medicinal product is authorised in 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