Quetiapine Aurovitas

Leaflet attached to the packaging: information for the user

Quetiapine Aurovitas, 25 mg, coated tablets

Quetiapine Aurovitas, 100 mg, coated tablets

Quetiapine Aurovitas, 200 mg, coated tablets

Quetiapine Aurovitas, 300 mg, coated tablets

Quetiapine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Quetiapine Aurovitas and what is it used for
• 2. Important information before taking Quetiapine Aurovitas
• 3. How to take Quetiapine Aurovitas
• 4. Possible side effects
• 5. How to store Quetiapine Aurovitas
• 6. Contents of the packaging and other information

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

Quetiapine Aurovitas contains the active substance quetiapine. It belongs to a group of antipsychotic medicines. Quetiapine Aurovitas is used to treat several diseases, such as:

• Depression in bipolar disorder: a condition where the patient feels sad. The patient may experience feelings of guilt, lack of energy, loss of appetite, or difficulty sleeping.
• Mania: when the patient may feel very excited, agitated, restless, enthusiastic, or overly active, or has impaired critical judgment, is aggressive, or troublesome.
• Schizophrenia: when the patient may hear or feel things that do not exist, believe in things that are not true, or become extremely suspicious, anxious, disoriented, guilty, tense, or depressed.

The doctor may continue to prescribe Quetiapine Aurovitas even when the patient feels better.

2. Important information before taking Quetiapine Aurovitas

When not to take Quetiapine Aurovitas:

o certain HIV medicines
o azole antifungals (used to treat fungal infections)
o erythromycin or clarithromycin (antibiotics)
o nefazodone (an antidepressant).
In case of doubt before taking Quetiapine Aurovitas, the patient should consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Quetiapine Aurovitas, the patient should discuss the following with their doctor or pharmacist:

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

• A combination of fever, severe muscle stiffness, sweating, or decreased level of 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 erections (priapism).
• Rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, refer the patient to a cardiologist immediately.

These symptoms may be caused by the use of this type of medicine.
The patient should immediately inform their doctor if they experience:

• Fever, flu-like symptoms, sore throat, or any other infection, as this may be a sign of a very low white blood cell count in the blood, which may require discontinuation of Quetiapine Aurovitas 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 the patient has depression, they 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 two weeks, sometimes later. These thoughts may also worsen if the patient suddenly stops taking the medicine. Young adults are more likely to have such thoughts. Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behavior in people under 25 years of age with depression.

If the patient ever has thoughts of self-harm or suicidal thoughts, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet. The patient can also ask these people to tell them if they notice any worsening of depressive symptoms or other worrying changes in behavior.
Severe skin reactions (SCARs)
Very rarely, severe skin reactions have been reported during treatment with this medicine, which can be life-threatening or fatal. These reactions usually occur 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 peeling of the skin
• -Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, lymph node enlargement, 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 the patient experiences any of these symptoms, they should stop taking Quetiapine Aurovitas and seek medical attention immediately.

Weight gain

Weight gain has been observed in patients taking Quetiapine Aurovitas. The patient and their doctor should regularly check the patient's 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

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should not take Quetiapine Aurovitas if they are taking any of the following medicines:

• Certain HIV medicines.
• Azole antifungals (used to treat fungal infections).
• Erythromycin or clarithromycin (antibiotics).
• Nefazodone (an antidepressant).

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

• Antiepileptic medicines (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (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.
• Medicines that can cause constipation.
• Medicines (called "anticholinergic" medicines) that affect nerve cell function, used to treat various diseases.
• Antidepressant medicines. These medicines may interact with Quetiapine Aurovitas and cause symptoms such as involuntary, rhythmic muscle contractions, including those that affect eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, the patient should consult their doctor.

The patient should not stop taking any medicines without consulting their doctor.

Quetiapine Aurovitas with food, drink, and alcohol

• Quetiapine Aurovitas can be taken with or without food.
• The patient should be careful with the amount of alcohol they consume. The combined effect of Quetiapine Aurovitas and alcohol may cause drowsiness.
• The patient should not drink grapefruit juice while taking Quetiapine Aurovitas, as it may affect the way the medicine works.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Quetiapine Aurovitas should not be taken during pregnancy, unless discussed with the doctor. Quetiapine Aurovitas should not be taken during breastfeeding.
The following symptoms, which may indicate withdrawal syndrome, may occur in newborns of mothers who took Quetiapine Aurovitas during pregnancy (last three months of pregnancy): trembling, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If the patient's child experiences any of these symptoms, they should consult their doctor.

Driving and using machines

This medicine may cause drowsiness. The patient should not drive or operate machinery until they know how the medicine affects them.

Quetiapine Aurovitas contains sodium

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

Quetiapine Aurovitas contains lactose

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking this medicine.

Effect on urine tests for drugs

In patients taking Quetiapine Aurovitas, urine tests for drugs performed with certain methods may show the presence of methadone or certain antidepressant medicines (called tricyclic antidepressants), even if the patient is not taking methadone or tricyclic antidepressants. In such cases, it is recommended to perform tests with other methods to confirm the results.

3. How to take Quetiapine Aurovitas

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The initial dose will be determined by the doctor. The maintenance dose (daily dose) will depend on the severity of the disease and the patient's needs, but is usually between 150 mg and 800 mg.

• The tablets should be taken once a day before bedtime or twice a day, depending on the patient's disease.
• The tablets should be swallowed whole, with a glass of water.
• The tablets can be taken with or without food.
• The patient should not drink grapefruit juice while taking Quetiapine Aurovitas, as it may affect the way the medicine works.
• The patient should not stop taking the tablets even if they feel better, unless the doctor decides otherwise.

Liver function disorders

If the patient has liver function disorders, the doctor may recommend a dose adjustment.

Elderly patients

If the patient is elderly, the doctor may recommend a dose adjustment.

Use in children and adolescents

Quetiapine Aurovitas should not be taken by children and adolescents under 18 years of age.

Taking a higher dose of Quetiapine Aurovitas than prescribed

If the patient takes a higher dose of Quetiapine Aurovitas than prescribed by the doctor, they may experience drowsiness, dizziness, and heart rhythm disturbances. The patient should immediately consult their doctor or go to the nearest hospital. The patient should take the Quetiapine Aurovitas tablets with them.

Missing a dose of Quetiapine Aurovitas

If the patient misses a dose, they should take it as soon as they remember. If the time to the next dose is short, the patient should wait and take the dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Quetiapine Aurovitas

If the patient suddenly stops taking Quetiapine Aurovitas, they may experience difficulty sleeping (insomnia), nausea, headache, diarrhea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before stopping treatment.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Quetiapine Aurovitas 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 resolve during continued treatment with Quetiapine Aurovitas) (may lead to falls).
• Withdrawal symptoms (symptoms that occur after stopping Quetiapine Aurovitas) include difficulty sleeping (insomnia), nausea, headache, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop taking the medicine over a period of at least 1 to 2 weeks.
• Weight gain.
• Abnormal muscle contractions. These include difficulty starting muscle movements, tremors, feelings of restlessness, or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

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.
• 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 patients).
• 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:

o Breast swelling in both men and women and unexpected milk production.
o Absence of menstruation or irregular menstruation 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 sensations in the legs (also called "restless legs syndrome").
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or 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.
• 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 drowsiness (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Hepatitis.
• Prolonged and painful erections (priapism).
• Breast swelling and unexpected milk production.
• Menstrual disorders.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If the patient notices any of these symptoms, they should immediately consult their doctor.
• Walking, talking, eating, or performing other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (called "metabolic syndrome") where the patient has a combination of three or more of the following features: increased abdominal fat, 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 creatine phosphokinase in the blood (a substance found in muscles).

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

• Severe skin rash, blisters, or red patches on the skin.
• Severe allergic reaction (called anaphylaxis), which may cause difficulty breathing or shock.
• Rapidly developing swelling of the skin, usually around the eyes and mouth, as well as the throat (angioedema).
• Severe skin condition related to the formation of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Abnormal secretion of a hormone that regulates urine production.
• Muscle breakdown and muscle pain (rhabdomyolysis).

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

• Skin rash with irregular red patches (erythema multiforme). See section 2.
• Sudden onset of areas of red skin with small blisters (small blisters filled with a white-yellowish fluid, 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.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, lymph node enlargement, 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).
• Myocarditis.
• Vasculitis (inflammation of blood vessels), often with a skin rash with small red or purple spots.

Medicines in the same class as Quetiapine Aurovitas may cause heart rhythm disturbances, which can be dangerous and, in severe cases, fatal.
Some side effects can only be detected by blood tests in the 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 levels in the blood, decreased levels of certain types of blood cells, decreased red blood cell count, increased creatine phosphokinase levels in the blood (a substance found in 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.
• Absence of menstruation or irregular menstruation in women.

The doctor may recommend regular blood tests.

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.
• -Absence of menstruation or irregular menstruation in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle contractions. These include difficulty starting muscle movements, tremors, feelings of 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).
• Feeling of a blocked nose.
• Feeling irritable.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Quetiapine Aurovitas

The medicine should be stored out of 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 month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Quetiapine Aurovitas contains

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

What Quetiapine Aurovitas looks like and contents of the pack

Coated tablet.
Quetiapine Aurovitas, 25 mg, coated tablets:[Size: approximately 5.6 mm]
Round, biconvex, peach-colored coated tablets with "E 52" engraved on one side and smooth on the other side.
Quetiapine Aurovitas, 100 mg, coated tablets:[Size: approximately 8.6 mm]
Round, biconvex, yellow coated tablets with "E 53" engraved on one side and smooth on the other side.
Quetiapine Aurovitas, 200 mg, coated tablets:[Size: approximately 11.1 mm]
Round, biconvex, white coated tablets with "E 55" engraved on one side and smooth on the other side.
Quetiapine Aurovitas, 300 mg, coated tablets:[Size: approximately 19.1 x 7.7 mm]
Round, biconvex, white coated tablets with "E 56" engraved on one side and smooth on the other side.
Quetiapine Aurovitas is available in blisters and HDPE bottles in a cardboard box.
Pack sizes:
Blister: 6, 10, 20, 30, 50, 60, 90, 100, 120, 180, 240 coated tablets.
HDPE bottle: 60, 100, 250, 500, 1000 coated 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: medicalinformation@aurovitas.pl

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 authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: 07/2024