Quetiapine Aurovitas

Leaflet accompanying 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

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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.
• 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 medicines (used to treat fungal infections)
o erythromycin or clarithromycin (medicines used to treat infections)
o nefazodone (a medicine used to treat depression).
In case of doubts before taking Quetiapine Aurovitas, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Quetiapine Aurovitas, discuss it with your doctor or pharmacist:

Tell your doctor immediately if, after taking Quetiapine Aurovitas, the patient experiences any of the following symptoms:

• A combination of fever, severe muscle stiffness, sweating, or decreased level of consciousness (a disorder 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).
• 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.
Tell your doctor immediately if the patient experiences:

• Fever, flu-like symptoms, sore throat, or any other infection, as this may be a consequence of a very low white blood cell count in the blood, which may require discontinuation of Quetiapine Aurovitas and/or appropriate treatment.
• Constipation along 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 phase of treatment, as all antidepressant medicines start to work after some time, 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 has ever had thoughts of self-harm or suicidal thoughts, they should contact their doctor or go to the hospital immediately. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet. You can also ask these people to tell the patient 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 lead to death. They 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, 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

Patients taking Quetiapine Aurovitas have experienced weight gain. 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

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

• Certain HIV medicines.
• Azole medicines (used to treat fungal infections).
• Erythromycin or clarithromycin (medicines used to treat infections).
• Nefazodone (a medicine used to treat depression).

Tell your 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 to treat sleep disorders).
• Thioridazine or lithium (other antipsychotic medicines).
• Medicines that affect heart rhythm, such as medicines that may disrupt electrolyte balance (reduced potassium and magnesium levels), such as diuretics (which increase urine production) or certain antibiotics (medicines that fight infections).
• Medicines that may 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 may cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, consult a doctor.

Before stopping any medicines, consult a doctor.

Quetiapine Aurovitas with food, drink, and alcohol

• Quetiapine Aurovitas can be taken with or without food.
• Be careful with the amount of alcohol consumed. The combined effect of Quetiapine Aurovitas and alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Quetiapine Aurovitas. 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 a doctor before taking this medicine. Do not take Quetiapine Aurovitas during pregnancy, unless discussed with a doctor. Do not take Quetiapine Aurovitas while 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): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If the patient's child experiences any of these symptoms, they should contact a doctor.

Driving and using machines

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

Quetiapine Aurovitas contains sodium

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

Quetiapine Aurovitas contains lactose

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

Effect on urine tests for drug detection

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

3. How to take Quetiapine Aurovitas

Take this medicine always as directed by your doctor. In case of doubts, consult a 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 individual patient's needs, but is usually between 150 mg and 800 mg.

• Take the tablets once a day before bedtime or twice a day, depending on the patient's disease.
• Swallow the tablets whole with water.
• The tablets can be taken with or without food.
• Do not drink grapefruit juice while taking Quetiapine Aurovitas. It may affect the way the medicine works.
• Do not stop taking the tablets even if the patient feels better, unless the doctor decides otherwise.

Liver function disorders

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

Elderly patients

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

Use in children and adolescents

Quetiapine Aurovitas should not be used in 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. Contact a doctor or go to the nearest hospital immediately. Take the Quetiapine Aurovitas tablets with you.

Missing a dose of Quetiapine Aurovitas

If a dose is missed, take it as soon as possible. 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 Quetiapine Aurovitas treatment

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.
In case of any further doubts about taking this medicine, consult a 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

• Rapid 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.
• Unusual 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:

o Breast swelling in both men and women and unexpected milk production.

Uncommon: may affect up to 1 in 100 people

• Seizures (convulsions).
• Allergic reactions, which may include hives (blisters), 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 disorder called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Hepatitis.
• Prolonged and painful erection (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 contact a doctor immediately.
• Walking, talking, eating, or performing other activities while sleeping.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (called "metabolic syndrome") in which there is 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 condition associated with the formation of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Abnormal secretion of a hormone that regulates the amount of urine produced.
• 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 (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 group as Quetiapine Aurovitas may cause heart rhythm disturbances, which can be dangerous and, in severe cases, lead to death.
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.
• Loss of menstrual periods or irregular menstrual periods 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 effect has been observed more frequently in children and adolescents or has 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.
• -Loss of menstrual periods or irregular menstrual periods 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 side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Quetiapine Aurovitas

Keep the 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 month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. 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" embossed 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" embossed 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" embossed 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" embossed on one side and smooth on the other side.
Quetiapine Aurovitas, coated tablets are 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 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 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 film-coated tablets / coated tablets / film tablets
Germany:
Quetiapin PUREN 50 mg/200 mg/300 mg/400 mg film-coated tablets
Poland:
Quetiapine Aurovitas
Portugal:
Quetiapina Ritisca
Spain:
Quetiapina Aurovitas 50 mg coated tablets

Date of last revision of the leaflet: 07/2024