Quetiapine aurovitas: detailed information

Package leaflet: Information for the user

Quetiapine Aurovitas, 25 mg, film-coated tablets
Quetiapine Aurovitas, 100 mg, film-coated tablets
Quetiapine Aurovitas, 200 mg, film-coated tablets
Quetiapine Aurovitas, 300 mg, film-coated tablets
Quetiapinum
Please read this leaflet carefully before taking this medicine because 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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Quetiapine Aurovitas is and what it is used for

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

Depressive episodes in bipolar affective disorder: a condition in which 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 may have impaired judgment, become aggressive, or behave in an annoying manner.
Schizophrenia: when the patient may hear or sense things that are not real, believe things that are not true, become extremely suspicious, anxious, confused, experience feelings of guilt, or become tense or depressed.

Your doctor may continue prescribing Quetiapine Aurovitas even after you start feeling better.

2. Important information before using Quetiapine Aurovitas

When not to use Quetiapine Aurovitas:

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 medicines used in HIV infection
- medicines in the azole group (used in fungal infections)
- erythromycin or clarithromycin (medicines used in infections)
- nefazodone (a medicine used to treat depression).

If in doubt, consult a doctor or pharmacist before taking Quetiapine Aurovitas.
Warnings and precautions
Before starting Quetiapine Aurovitas, discuss with your doctor or pharmacist:

if the patient or a family member has or has had any heart conditions, such as 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 the patient's blood sugar levels during treatment with Quetiapine Aurovitas.
if the patient has 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 (a brain disorder). In this case, Quetiapine Aurovitas 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 family members have a history of blood clots, as use of medicines in this class 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 apnoea”) and is taking medicines that slow down normal brain activity (i.e. medicines in the “depressant” group).
if the patient has or has had a condition in which the bladder cannot be completely emptied (urinary retention), enlarged prostate, intestinal obstruction, or increased pressure inside the eye. These symptoms may be caused by medicines (called “anticholinergics”) used to treat 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 antidepressant medicines. Using these medicines together with Quetiapine Aurovitas may lead to serotonin syndrome, a potentially life-threatening condition (see “Quetiapine Aurovitas and other medicines”).

Immediately inform the doctor if any of the following symptoms occur after taking Quetiapine Aurovitas:

A combination of fever, severe muscle stiffness, sweating, or reduced level of consciousness (a disorder known as “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).
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, immediately refer the patient to a cardiologist.

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 infection, as this may be due to a very low white blood cell count, which may require discontinuation of Quetiapine Aurovitas and/or appropriate treatment.
Constipation accompanied by persistent abdominal pain or persistent constipation unresponsive to treatment, as this may lead to a more serious intestinal blockage.
Suicidal thoughts or worsening depression. If the patient has depression, they may sometimes have thoughts of self-harm or suicide. These thoughts may worsen at the beginning of treatment, as all antidepressant medicines take time to work, usually about two weeks or sometimes longer. 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, seek immediate medical advice or go to hospital. It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. You may also ask these individuals to inform the patient if they notice worsening of depressive symptoms or other concerning 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): widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals
Toxic Epidermal Necrolysis (TEN): a more severe form causing extensive skin peeling
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes)
Acute Generalised Exanthematous Pustulosis (AGEP): small pustules filled with pus
Erythema Multiforme (EM): skin rash with irregular, itchy, red patches.

If any of the above symptoms occur, stop taking Quetiapine Aurovitas immediately and contact a doctor or seek medical help without delay.

Weight gain
Weight gain has been observed in patients taking Quetiapine Aurovitas. The patient and doctor should regularly monitor the patient’s body weight.

Children and adolescents
Quetiapine Aurovitas is not intended for use in children and adolescents under 18 years of age.

Quetiapine Aurovitas and other medicines
Tell your doctor about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Quetiapine Aurovitas if the patient is taking any of the following medicines:

Certain medicines used in the treatment of HIV.
Medicines in the azole group (used in fungal infections).
Erythromycin or clarithromycin (medicines used in infections).
Nefazodone (a medicine used to treat 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 (reducing potassium and magnesium levels), such as diuretics (causing increased urine excretion) or certain antibiotics (medicines used to treat infections).
Medicines that may cause constipation.
Medicines (called “anticholinergics”) that affect nerve cell function, used in the treatment of various conditions.
Antidepressant medicines. These medicines may interact with Quetiapine Aurovitas and may cause symptoms such as involuntary, rhythmic muscle contractions, including those of the eye muscles, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, consult a doctor.

Do not stop taking any medicine without first consulting your doctor.

Quetiapine Aurovitas with food, drink, and alcohol

Quetiapine Aurovitas may be taken with or without food.
Be cautious with alcohol consumption. The combined effect of Quetiapine Aurovitas and alcohol may cause drowsiness.
Do not drink grapefruit juice while taking Quetiapine Aurovitas. It may affect how the medicine works.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine. Do not use Quetiapine Aurovitas during pregnancy unless discussed with a doctor. Do not use Quetiapine Aurovitas during breastfeeding.
The following symptoms, which may indicate withdrawal syndrome, may occur in newborns of mothers who took Quetiapine Aurovitas 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 the patient’s baby shows any of these symptoms, medical advice should be sought.

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

Quetiapine Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered “sodium-free”.

Quetiapine Aurovitas contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Effect on urine drug screening tests
In patients taking Quetiapine Aurovitas, urine drug screening tests performed by certain methods may show the presence of methadone or certain antidepressant medicines known as tricyclic antidepressants (TCAs), even if the patient is not taking methadone or TCAs. In such cases, it is recommended to use alternative testing methods to confirm the results.

3. How to take Quetiapine Aurovitas

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. Your doctor will determine the starting dose. The maintenance dose (daily dose) will depend on the severity of the illness and the individual needs of the patient, but is usually between 150 mg and 800 mg.

Take the tablets once daily before bedtime or twice daily, depending on the patient's condition.
Swallow the tablets whole with water.
The tablets may be taken with or without food.
Do not drink grapefruit juice during treatment with Quetiapine Aurovitas. Grapefruit juice may affect the way the medicine works.
Do not stop taking the tablets even if the patient feels better, unless otherwise instructed by the doctor.

Impaired liver function
If the patient has impaired liver function, 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
Quetiapine Aurovitas must not be used in children and adolescents under 18 years of age.
If you take more Quetiapine Aurovitas than prescribed
If the patient takes more Quetiapine Aurovitas than prescribed by the doctor, symptoms such as drowsiness, dizziness, and irregular heartbeat may occur. Seek immediate medical advice from a doctor or go to the nearest hospital. Bring the medicine pack with you.
If you miss a dose of Quetiapine Aurovitas
If a dose has been missed, take it as soon as the patient remembers. However, if it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Quetiapine Aurovitas
If treatment with Quetiapine Aurovitas is stopped abruptly, the patient may experience difficulty sleeping (insomnia), feeling unwell (nausea), headache, diarrhoea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before stopping treatment completely.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.

Very common: may affect more than 1 in 10 people

Dizziness (may lead to falls), headache, dry mouth.
Drowsiness (may wear off during continued treatment with Quetiapine Aurovitas) (may lead to falls).
Withdrawal symptoms (symptoms occurring after stopping Quetiapine Aurovitas) include difficulty sleeping (insomnia), malaise (nausea), headache, diarrhoea, vomiting, dizziness or irritability. Gradual discontinuation of Quetiapine Aurovitas over a period of at least 1 to 2 weeks is recommended.
Weight gain.
Movement disorders. These include difficulty initiating muscle movement, tremor, restlessness or painless muscle stiffness.
Changes in levels of certain lipids (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

Fast heartbeat.
Awareness of heartbeat, rapid heartbeat or changes in heart rhythm.
Constipation, indigestion (dyspepsia).
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.
Unusual dreams and nightmares.
Increased appetite.
Irritability.
Speech and speech disorders.
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 levels in blood.
Increased blood levels of the hormone prolactin. Increased prolactin levels may rarely 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 lumps (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 in passing urine.
Fainting (may lead to falls).
Stuffy nose.
Decreased number of red blood cells in blood.
Decreased sodium levels in blood.
Worsening of existing diabetes.
Confusion.

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

Combination of high body temperature (fever), sweating, muscle stiffness, drowsiness or near-fainting (a condition called "neuroleptic malignant syndrome").
Yellowing of the skin and eyes (jaundice).
Inflammation of the liver.
Prolonged and painful erection (priapism).
Breast enlargement and unexpected milk production (galactorrhea).
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 difficulty breathing. If a patient notices any of these symptoms, they should contact their doctor immediately.
Walking, talking, eating or performing other activities during sleep.
Decreased body temperature (hypothermia).
Inflammation of the pancreas.
A condition (referred to as "metabolic syndrome") in which three or more of the following features occur together: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of certain blood lipids (triglycerides), high blood pressure, and increased blood sugar 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, a condition known as agranulocytosis.
Intestinal obstruction.
Increased levels of creatine kinase 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 hypersensitivity reaction (called anaphylaxis), which may cause difficulty breathing 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.
Breakdown of muscle fibres 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 cell count (eosinophilia) and liver enzymes). See section 2.
Withdrawal symptoms may occur in newborns of mothers who took Quetiapine Aurovitas during pregnancy.
Stroke.
Heart muscle disorders (cardiomyopathy).
Inflammation of the heart muscle.
Inflammation of blood vessels (vasculitis), often with a skin rash consisting of small red or purple lumps.

Medicines in the same group as Quetiapine Aurovitas may cause heart rhythm disturbances, which
can be dangerous and, in severe cases, may lead to death.
Some adverse reactions can only be detected by laboratory blood tests. These include changes in
levels of certain lipids (triglycerides and total cholesterol) or blood sugar, 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 levels of creatine kinase in blood
(a substance found in muscles), decreased sodium levels in blood, and increased blood levels of the
hormone prolactin. Increased prolactin levels may rarely 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.

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 blood levels of a hormone called prolactin. Increased prolactin levels may rarely lead to:
- Breast enlargement in both boys and girls and unexpected milk production.
- Absence of menstruation or irregular menstruation in girls.
Increased appetite.
Vomiting.
Movement disorders. 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).
Stuffy nose.
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 provide more information on the safety of this medicine.

5. How to store Quetiapine Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and bottle
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 the wastewater system 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 pack and other information

What Quetiapine Aurovitas contains

The active substance is quetiapine.
Other ingredients are:
Tablet core: calcium hydrogen phosphate dihydrate, monohydrate lactose, microcrystalline cellulose (PH-101 and 102), sodium carboxymethyl starch (type A), povidone (K-30), colloidal anhydrous silica, talc, magnesium stearate.
Tablet coating: hypromellose (6 cP), macrogol 400, titanium dioxide, iron oxide yellow (E 172) (for 25 mg and 100 mg tablets), iron oxide red (E 172) (only for 25 mg tablets). Black printing ink containing shellac and iron oxide black (for 100 mg, 200 mg, and 300 mg tablets).

What Quetiapine Aurovitas looks like and contents of the pack
Film-coated tablet.
Quetiapine Aurovitas 25 mg film-coated tablets: [Size: approximately 5.6 mm]
Round, biconvex film-coated tablets peach-colored with the imprint “E 52” on one side and smooth on the other side.
Quetiapine Aurovitas 100 mg film-coated tablets: [Size: approximately 8.6 mm]
Round, biconvex film-coated tablets yellow with the imprint “E 53” on one side and smooth on the other side.
Quetiapine Aurovitas 200 mg film-coated tablets: [Size: approximately 11.1 mm]
Round, biconvex film-coated tablets white with the imprint “E 55” on one side and smooth on the other side.
Quetiapine Aurovitas 300 mg film-coated tablets: [Size: approximately 19.1 x 7.7 mm]
Round, biconvex film-coated tablets white with the imprint “E 56” on one side and smooth on the other side.
Quetiapine Aurovitas film-coated tablets are available in blisters and HDPE bottles, packed in cardboard boxes.
Pack sizes:
Blisters: 6, 10, 20, 30, 50, 60, 90, 100, 120, 180, 240 film-coated tablets.
HDPE bottles: 60, 100, 250, 500, 1000 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicine is authorised for marketing in the European Economic Area countries under the following names:
Belgium: Quetiapine AB 25 mg / 100 mg / 200 mg / 300 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten
Germany: Quetiapin PUREN 50 mg/200 mg/300 mg/400 mg Filmtabletten
Poland: Quetiapine Aurovitas
Portugal: Quetiapina Ritisca
Spain: Quetiapina Aurovitas 50 mg comprimidos recubiertos con pelicula