Prospect: Information for the user

QuetiapineAurovitas 100mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Quetiapine Aurovitas

3.How to take Quetiapine Aurovitas

4.Possible adverse effects

5.Storage of Quetiapine Aurovitas

6.Contents of the package and additional information

QuetiapinaAurovitascontains a substance called quetiapine. It belongs to a group of medications called antipsychotics.Quetiapinemay be used to treat various conditions, such as:

?Bipolar depression: for which you may feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or cannot sleep.

?Mania: for which you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or exhibit poor judgment, including being aggressive or violent.

?Schizophrenia: for which 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 prescribingquetiapineeven when you are feeling better.

Do not take Quetiapina Aurovitas

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

?If you are taking any of the following medicines:

-Some medicines for HIV

-Azole-type medicines (for fungal infections)

-Erythromycin or clarithromycin (for infections)

-Nefazodone (for depression)

If you are unsure, consult your doctor or pharmacist before taking quetiapine.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeQuetiapinaAurovitas:

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

?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 (convulsion).

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

?If you know that you have had low white blood cell counts (which may or may not have been caused by other medicines).

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

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

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

?If you have or have had a condition in which your breathing is interrupted by short periods of time during normal sleep at night (called “sleep apnea”) and are taking medicines that decrease the normal activity of the brain (“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 high pressure inside your eye. These conditions may be caused by medicines (called “anticholinergics”) that affect the way nerve cells work, to treat certain medical conditions.

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

?If you have depression or other conditions that are treated with antidepressants. The use of these medicines with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Quetiapina Aurovitas”).

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

?A combination of fever, intense muscle stiffness, sweating or a decrease in level of consciousness (a condition called “neuroleptic malignant syndrome”). You may need immediate medical treatment.

?Uncontrolled 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 (convulsions).

?Prolonged and painful erection (priapism).

?Fast and irregular heartbeats, even when at rest, palpitations, breathing problems, chest pain or unexplained fatigue. Your doctor will examine your heart and, if necessary, refer you to a cardiologist immediately.

These disorders may be caused by this type of medicine.

Inform your doctor as soon as possible if you have:

?Fever, symptoms similar to flu, sore throat, or any other infection, as it could be a consequence of very low white blood cell counts and require discontinuation of quetiapine treatment and/or additional treatment.

?Constipation with persistent abdominal pain, or constipation that has not responded to treatment, as it may lead to a more severe bowel obstruction.

?Thoughts of suicide and worsening of depression

If you are depressed, sometimes you may think about harming yourself or committing suicide. This may increase at the beginning of treatment, as all these medicines take time to work, usually around two weeks but sometimes longer. These thoughts may also increase if you stop taking your medication abruptly. You may be more likely to think this way if you are a young adult. Information obtained from clinical trials has shown an increased risk of thoughts of suicide and/or suicidal behavior in young adults under 25 years with depression.

Inform your doctor or go to the hospital immediately if you ever think about harming yourself or committing suicide. 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 tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Severe skin reactions (SCARs)

Very rarely, severe skin reactions (SCARs) have been reported with the use of this medicine, which may put your life at risk or be fatal. These usually manifest as:

•Stevens-Johnson syndrome (SSJ), a generalised rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.

•Toxic epidermal necrolysis (NET), a more severe form that causes extensive skin peeling.

•Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes).

•Generalized Acute Pustular Psoriasis (AGEP), small pus-filled blisters.

•Erythema multiforme (EM), skin rashes with irregular red patches that itch.

Stop using quetiapine and contact your doctor or seek medical attention immediately if you develop these symptoms.

Weight gain

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

Children and adolescents

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

Other medicines and Quetiapina Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Do not takequetiapineif you are using any of the following medicines:

?Some medicines for HIV.

?Azole-type medicines (for fungal infections).

?Erythromycin or clarithromycin (for infections).

?Nefazodone (for depression).

Inform 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 falling asleep).

?Thioridazine or lithium (other antipsychotic medicines).

?Medicines that affect your heart rhythm, for example, medicines that may cause an imbalance of electrolytes (low potassium or magnesium levels) such as diuretics (medicines for urination) or certain antibiotics (medicines for treating infections).

?Medicines that may cause constipation.

?Medicines (called “anticholinergics”) that affect the way nerve cells work, 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 those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor when you experience these symptoms.

Before stopping any of your medicines, consult your doctor first.

Taking Quetiapina Aurovitas with food, drinks, and alcohol

?Quetiapine can be taken with or without food.

?Be careful with the amount of alcohol you drink. This is because the combined effect ofquetiapineand alcohol may make you drowsy.

?Do not take grapefruit juice while takingquetiapine. It may affect the way the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. Do not takequetiapineduring pregnancy, unless you have consulted your doctor. Do not usequetiapineif you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may appear in newborn babies of mothers who have used quetiapine in the last trimester (last three months of their pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and operating machines

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

Effect on Drug Detection Tests in Urine

If you are having a drug detection test in urine, takingquetiapinemay produce positive results for methadone or certain antidepressants called tricyclic antidepressants (TCAs) when using certain methods of analysis, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Quetiapina Aurovitas containslactose

This medicine contains lactose, 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.

Quetiapina Aurovitas containssodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your disease and your needs, but it will normally be between 150 mg and 800 mg.

You will take your tablets once a day, at bedtime, or twice a day, depending on your disease.

Swallow the tablets whole with the help of water.

You can take the tablets with or without food.

Do not take grapefruit juice while takingquetiapine. It may affect the way the medication 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 change your dose.

Older adults

If you are an older adult, your doctor may change your dose.

Use in children and adolescents

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

Taking more Quetiapine Aurovitas than you should

If you take moreQuetiapineAurovitas than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring yourQuetiapineAurovitas tablets with you.

You can also call the Toxicological Information Service, phone91 562 04 20, indicating the medication and the amount ingested.

Missing a dose of 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 until then. Do not take a double dose to make up for the missed tablet.

Stopping treatment with Quetiapine Aurovitas

If you stop takingquetiapineabruptly, you may be unable to sleep (insomnia), or you may feel nausea, or you may experience headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest reducing the dose gradually before stopping treatment.

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

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

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

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

?Sensation of drowsiness (which may disappear over time as you continue to take quetiapine) (may lead to falls).

?Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), which include insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability. A 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, tremors, feeling restless or rigid without pain.

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

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

?Fast heart rate.

?Feeling like your heart is beating strongly, rapidly, or irregularly.

?Constipation, indigestion.

?Sensation of weakness.

?Swelling of arms or legs.

?Low blood pressure when standing. This may cause dizziness or fainting (may lead to falls).

?Increased blood sugar levels.

?Blurred vision.

?Abnormal dreams and nightmares.

?Feeling hungrier.

?Feeling irritable.

?Speech and language disorders.

?Thoughts of suicide and worsening of depression.

?Shortness of breath.

?Vomiting (mainly in elderly people).

?Fever.

?Changes in the amount of thyroid hormones in the blood.

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

?Increases in liver enzymes measured in the blood.

?Increases in prolactin hormone levels in the blood. Prolactin level increases may, in rare cases, lead to:

-Swelling of the breasts and unexpected milk production in both men and women.

-Irregular or absent menstrual periods in women.

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

?Seizures or convulsions.

?Allergic reactions that may include hives, skin swelling, and swelling around the mouth.

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

?Dysphagia.

?Involuntary movements, mainly of the face or tongue.

?Sexual dysfunction.

?Diabetes.

?Change in heart activity seen on an ECG (prolongation of the QT interval).

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

?Difficulty urinating.

?Fainting (may lead to falls).

?Stuffy nose.

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

?Decrease in the amount of sodium in the blood.

?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, feeling very drowsy or dizzy (a condition known as "neuroleptic malignant syndrome").

?Yellowish discoloration of the skin and eyes (jaundice).

?Inflammation of the liver (hepatitis).

?Prolonged and painful erection (priapism).

?Swelling of the breasts and unexpected milk production (galactorrhea).

?Menstrual disorders.

?Clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.

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

?Decreased body temperature (hypothermia).

?Inflammation of the pancreas.

?A condition (known as "metabolic syndrome") in which you may have a combination of 3 or more of the following effects: increased fat around your 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 levels.

?A combination of fever, symptoms similar to the flu, 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 the blood (a substance found in muscles).

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

?Severe rash, blisters, or red spots on the skin.

?Severe allergic reaction (known as anaphylaxis) that may cause difficulty breathing or shock.

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

?A severe skin condition, known as Stevens-Johnson syndrome, which affects the skin, mouth, eyes, and genitals.

?Inadequate secretion of a hormone that controls urine volume.

?Rhabdomyolysis, a condition in which muscle fibers break down and cause muscle pain.

Unknown (frequency cannot be estimated from available data):

?Rash with irregular red spots (erythema multiforme). See Section 2.

?Quick appearance of skin areas with red spots and small white or yellowish pustules (Pustulosis Exanthemática Generalizada Aguda (AGEP)). See Section 2.

?Drug rash with eosinophilia and systemic symptoms (DRESS), a generalized rash, high body temperature, elevated liver enzymes, abnormal blood counts (eosinophilia), swollen lymph nodes, and involvement of other organs. If you develop these symptoms, stop taking quetiapine and contact your doctor or seek medical attention immediately.

?Severe allergic reaction with symptoms such as fever and skin blisters, and skin peeling (toxic epidermal necrolysis). See Section 2.

?Birth defects in babies born to mothers who took quetiapine during pregnancy.

?Stroke.

?Cardiomyopathy, a disorder of the heart muscle.

?Myocarditis, inflammation of the heart muscle.

?Vasculitis, inflammation of the blood vessels, often with a rash of small red or purple spots.

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

Some side effects are only seen when a blood test is done. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in the blood, increases in liver enzymes, decreases in the number of certain types of blood cells, decreases in the number of red blood cells, increases in creatine phosphokinase in the blood (a substance found in muscles), decreases in the amount of sodium in the blood, and increases in the amount of prolactin hormone in the blood. Prolactin level increases may, in rare cases, lead to:

?Swelling of the breasts and unexpected milk production in both men and women.

?Irregular or absent menstrual periods in women.

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

Additional side effects in children and adolescents

The same side effects that can 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 a hormone called prolactin in the blood. Prolactin level increases may, in rare cases, lead to:

-Swelling of the breasts and unexpected milk production in both boys and girls.

-Irregular or absent menstrual periods in girls.

?Increased appetite.

?Vomiting.

?Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless or rigid without pain.

?Increased blood pressure.

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

?Sensation of weakness, fainting (may lead to falls).

?Stuffy nose.

?Feeling irritable.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medicationdoes not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Quetiapina Aurovitas

-The active ingredient is quetiapine. Each film-coated tablet contains 100 mg of quetiapine (as quetiapine fumarate).

-The other components are:

Core tablet:calcium dihydrogen phosphate, lactose monohydrate, microcrystalline cellulose, sodium carboxymethylstarch (Type A) (potato starch), povidone (K30), magnesium stearate, anhydrous colloidal silica, talc.

Film coating:hypromellose (6cps), macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), black printing ink containing shellac and black iron oxide.

Appearance of the product and contents of the package

Film-coated tablets of yellow color, round, biconvex, with the imprint “E53” on one face and smooth on the other.

QuetiapinaAurovitas film-coated tabletsare available in blister packs.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

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 with the following names:

Last review date of this leaflet: October 2024

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