Quetiapine Aurovitas 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Quetiapine Aurovitas 200 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Quetiapine Aurovitas is and what it is used for
2. What you need to know before taking Quetiapine Aurovitas
3. How to take Quetiapine Aurovitas
4. Possible side effects
5. How to store Quetiapine Aurovitas
6. 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 can be used to treat several conditions, such as:

? Bipolar depression: when you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.

? Mania: when you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or have impaired judgment, which may include being aggressive or violent.

? Schizophrenia: when you may hear or feel things that are not there, believe things that are not true, or feel abnormally suspicious, anxious, confused, guilty, tense, or depressed.

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

2. What you need to know before taking Quetiapine Aurovitas

Do not take Quetiapine Aurovitas

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

? If you are taking any of the following medicines:

• some HIV medicines
• azole-type medicines (for fungal infections)
• erythromycin or clarithromycin (for infections)
• nefazodone (for depression)

If you have any doubts, consult your doctor or pharmacist before taking quetiapine.

Warnings and precautions

Talk to your doctor or pharmacist before starting Quetiapine Aurovitas:

? If you, or a family member, have or have had any heart problems, for example, irregular heartbeat, weakened heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect your heartbeat.

? If you have low blood pressure.

? If you have had a stroke, especially if you are elderly.

? If you have liver problems.

? If you have ever had a seizure (epileptic fit).

? If you have diabetes or are at risk of diabetes. If so, your doctor may monitor your blood sugar levels while you are taking quetiapine.

? If you know you have previously had low levels of white blood cells (which may or may not have been caused by other medicines).

? If you are an elderly person with dementia (loss of brain function). In this case, you should not take quetiapine, because the group of medicines to which quetiapine belongs may increase the risk of stroke, or in some cases the risk of death, in these individuals.

• If you are an elderly person with Parkinson’s disease/parkinsonism.

? If you or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.

? If you have or have had a condition in which your breathing stops for short periods during normal sleep (called “sleep apnea”) and you are taking medicines that reduce normal brain activity (“depressants”).

? If you have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, a bowel obstruction, or increased pressure inside your eye. These conditions can sometimes be caused by medicines (called “anticholinergics”) that affect how nerve cells function, used to treat certain medical conditions.

? If you have a history of alcohol or drug abuse.

? If you have depression or other conditions treated with antidepressants. Using these medicines together with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Quetiapine Aurovitas”).

Contact your doctor immediately if, after taking quetiapine, you experience any of the following:

? A combination of fever, severe muscle stiffness, sweating, or decreased level of consciousness (a disorder known as “neuroleptic malignant syndrome”). Immediate medical treatment may be necessary.

? Uncontrollable movements, mainly of your face or tongue.

? Dizziness or feeling very drowsy. This may increase the risk of accidental injuries (falls) in elderly patients.

? Seizures (fits).

? A prolonged and painful erection (priapism).

? Rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.

These disorders may be caused by this type of medicine.

Contact your doctor as soon as possible if you experience:

? Fever, flu-like symptoms, sore throat, or any other infection, as this could be due to a very low count of white blood cells and may require stopping treatment with quetiapine and/or additional treatment.

? Constipation together with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more serious bowel blockage.

? Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This risk may increase at the beginning of treatment, as all these medicines take time to work—usually about two weeks, but sometimes longer. This risk may also increase if you stop taking the medicine abruptly. You may be more likely to have such thoughts if you are a young adult. Clinical trial data have shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression.

If at any time you think about harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may ask them to inform you if they think your depression is worsening or if they are concerned about changes in your behavior.

Severe skin adverse reactions (SCARs)

Very rarely, serious and potentially life-threatening or fatal skin reactions (SCARs) have been reported with this medicine. These commonly manifest as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blistering and peeling of the skin, particularly 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), characterized by flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red spots that itch.

If you develop any of these symptoms, stop using quetiapine and contact your doctor or seek immediate medical attention.

Weight gain

Weight gain has been observed in patients taking quetiapine. You and your doctor should monitor your weight regularly.

Children and adolescents

Quetiapine must not be used in children and adolescents under 18 years of age.

Other medicines and Quetiapine Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take quetiapine if you are using any of the following medicines:

? Some HIV medicines.
? Azole-type medicines (for fungal infections).
? Erythromycin or clarithromycin (for infections).
? Nefazodone (for depression).

Tell your doctor if you are using any of the following medicines:

? Medicines for epilepsy (such as phenytoin or carbamazepine).
? Medicines for high blood pressure.
? Barbiturates (for difficulty sleeping).
? Thioridazine or lithium (other antipsychotic medicines).
? Medicines that affect your heartbeat, for example, medicines that may cause an electrolyte imbalance (low potassium or magnesium levels), such as diuretics (“water pills”) or certain antibiotics.
? Medicines that may cause constipation.
? Medicines (called “anticholinergics”) that affect how nerve cells function, used to treat certain medical conditions.
? Antidepressants. These medicines may interact with quetiapine and you may experience symptoms such as involuntary and rhythmic muscle contractions, including of the muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor if you experience these symptoms.

Do not stop taking any of your medicines without first consulting your doctor.

Taking Quetiapine Aurovitas with food, drinks, and alcohol

? Quetiapine can be taken with or without food.

? Be cautious about the amount of alcohol you consume. This is because the combined effect of quetiapine and alcohol may make you drowsy.

? Do not drink grapefruit juice while taking quetiapine. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. You must not take quetiapine during pregnancy unless advised by your doctor. You must not use quetiapine while breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may occur in newborns of mothers who have taken quetiapine during the third trimester (last three months of pregnancy): tremor, muscle rigidity and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and using machines

These tablets may make you feel drowsy. Do not drive or operate tools or machinery until you know how these tablets affect you.

Effect on Urine Drug Screening Tests

If you are undergoing a urine drug screening test, taking quetiapine may produce positive results for methadone or certain antidepressants known as tricyclic antidepressants (TCAs) when certain testing methods are used, even if you are not taking methadone or TCAs. If this occurs, a more specific test can be performed.

Quetiapine Aurovitas contains lactose

This medicine contains lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Quetiapine Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Quetiapine Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will determine your initial dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but will usually be between 150 mg and 800 mg.

? You will take your tablets once daily at bedtime, or twice daily, depending on your condition.

? Swallow the tablets whole with water.

? You may take the tablets with or without food.

? Do not drink grapefruit juice while taking quetiapine. It may affect how the medicine works.

? Do not stop taking your tablets even if you feel better, unless your doctor tells you to.

Liver problems

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

Elderly patients

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

Use in children and adolescents

Quetiapine must not be used in children and adolescents under 18 years of age.

If you take more Quetiapine Aurovitas than you should

If you take more Quetiapine Aurovitas than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Take the Quetiapine Aurovitas tablets with you.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Quetiapine Aurovitas

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait and take the next dose at the usual time. Do not take a double dose to make up for a missed tablet.

If you stop taking Quetiapine Aurovitas

If you stop taking quetiapine abruptly, you may have difficulty sleeping (insomnia), or may feel nauseous, or may experience headache, diarrhoea, vomiting, dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common (may affect more than 1 in 10 people):

? Dizziness (which may lead to falls), headache, dry mouth.

? Drowsiness (which may disappear over time as you continue taking quetiapine) (which may lead to falls).

? Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to sleep (insomnia), feeling nauseous, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual withdrawal over a period of at least 1 to 2 weeks is recommended.

? Weight gain.

? Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, restlessness, or painless muscle stiffness.

? Changes in levels of certain fats (triglycerides and total cholesterol).

Common (may affect up to 1 in 10 people):

? Fast heartbeat.

? Feeling that your heart is pounding, beating rapidly, or having irregular beats.

? Constipation, upset stomach (indigestion).

? Feeling weak.

? Swelling of arms or legs.

? Low blood pressure when standing. This may make you feel dizzy or faint (which may lead to falls).

? Increased blood sugar levels.

? Blurred vision.

? Abnormal dreams and nightmares.

? Increased appetite.

? Feeling irritable.

? Speech and language disorder.

? Suicidal thoughts and worsening of depression.

? Shortness of breath.

? Vomiting (mainly in elderly people).

? Fever.

? Changes in levels of thyroid hormones in the blood.

? Decrease in the number of certain types of blood cells.

? Increases in liver enzyme levels measured in blood.

? Increases in blood levels of the hormone prolactin. Increases in prolactin levels may, in rare cases, lead to the following:

• In both men and women: breast enlargement and unexpected milk production.
• In women: absence of menstrual periods or irregular periods.

Uncommon (may affect up to 1 in 100 people):

? Seizures or fits.

? Allergic reactions which may include raised, itchy rashes (hives), skin swelling, and swelling around the mouth.

? Unpleasant sensations in the legs (also known as restless legs syndrome).

? Difficulty swallowing.

? Uncontrolled movements, mainly of the face or tongue.

? Sexual dysfunction.

? Diabetes.

? Changes in the heart's electrical activity seen on ECG (prolongation of the QT interval).

? Slower than normal heart rate, which may occur at the start of treatment and may be associated with low blood pressure and fainting.

? Difficulty urinating.

? Fainting (which may lead to falls).

? Stuffy nose.

? Decrease in the number of red blood cells in blood.

? Decrease in blood sodium levels.

? Worsening of pre-existing diabetes.

? Confusion.

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

? A combination of high temperature (fever), sweating, muscle stiffness, and feeling very drowsy or dizzy (a disorder known as “neuroleptic malignant syndrome”).

? Yellowing of the skin and eyes (jaundice).

? Inflammation of the liver (hepatitis).

? Prolonged, painful erection (priapism).

? Breast enlargement and unexpected milk production (galactorrhoea).

? Menstrual disorder.

? Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through the bloodstream to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical help immediately.

? Walking, talking, eating, or other activities while asleep.

? Decrease in body temperature (hypothermia).

? Inflammation of the pancreas.

? A condition (called “metabolic syndrome”) in which you may have a combination of 3 or more of the following: increased fat around the abdomen, decreased “good cholesterol” (HDL-C), increased levels of a type of fat in the blood called triglycerides, increased blood pressure, and increased blood sugar.

? A combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count, a condition known as agranulocytosis.

? Intestinal obstruction.

? Increased creatine phosphokinase in blood (a substance 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 difficulty breathing or shock.

? Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).

? A serious blistering disease affecting the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

? Inappropriate secretion of a hormone that controls urine volume.

? Breakdown of muscle fibres and muscle pain (rhabdomyolysis).

Not known (frequency cannot be estimated from available data):

? Skin rashes with irregular red patches (erythema multiforme). See section 2.

? Rapid appearance of areas of red skin with small pustules (small blisters filled with white/yellow fluid known as Acute Generalized Exanthematous Pustulosis (AGEP). See section 2.

? Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS). If you develop these symptoms, stop using quetiapine and contact your doctor or seek immediate medical attention.

? Sudden, severe allergic reaction with symptoms such as fever, blisters on the skin, and skin peeling (toxic epidermal necrolysis). See section 2.

? Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.

? Stroke.

? Heart muscle disorder (cardiomyopathy).

? Inflammation of the heart muscle (myocarditis).

? Inflammation of blood vessels (vasculitis), often with a skin rash showing small red or purple spots.

The class of medicines to which quetiapine belongs can cause problems with heart rhythm that may be serious and, in severe cases, could be fatal.

Some adverse effects are only detected by blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in levels of thyroid hormones in the blood, increases in liver enzymes, decreases in the number of certain types of blood cells, decrease in red blood cells, increase in creatine phosphokinase in blood (a substance found in muscles), decrease in blood sodium levels, and increases in blood levels of the hormone prolactin. Increases in prolactin levels may, in rare cases, lead to the following:

? In both men and women: breast enlargement and unexpected milk production.

? In women: absence of menstrual periods or irregular periods.

Your doctor may ask you to have blood tests from time to time.

Additional adverse effects in children and adolescents

The same adverse effects that may occur in adults may also occur in children and adolescents.

The following adverse 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):

? Increase in levels of a hormone called prolactin in the blood. Increases in prolactin levels may, in rare cases, lead to the following:

• In both boys and girls: breast enlargement and unexpected milk production.
• In girls: absence of menstrual periods or irregular periods.

? Increased appetite.

? Vomiting.

? Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, restlessness, or painless muscle stiffness.

? Increased blood pressure.

Common (may affect up to 1 in 10 people):

? Feeling weak, fainting (which may lead to falls).

? Stuffy nose.

? Feeling irritable.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be returned to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Quetiapine Aurovitas

• The active substance is quetiapine. Each film-coated tablet contains 200 mg of quetiapine (as quetiapine fumarate).
• The other components are:

Tablet core: calcium hydrogen phosphate dihydrate, lactose monohydrate, microcrystalline cellulose, sodium carboxymethylstarch (Type A) (potato starch), povidone (K30), magnesium stearate, colloidal anhydrous silica, talc.

Tablet coating: hypromellose (6 cps), macrogol 400, titanium dioxide (E171), black printing ink containing shellac and black iron oxide.

Appearance of the product and package contents

Film-coated tablets, white in colour, round, biconvex, with the imprint “E55” on one side and smooth on the other.

Quetiapine Aurovitas film-coated tablets are available in blister packs.

Pack sizes: 6, 10, 20, 50, 60 and 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain:	Quetiapine Aurovitas 200 mg film-coated tablets EFG
Portugal:	Quetiapine Aurovitas

Date of the most recent review of this leaflet: October 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).