Product Information for the Patient

Quetiapina Aristo 300 mg Film-Coated Tablets

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, 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 product information. See section 4.

6. Contents of the pack and additional information

Quetiapina Aristo contains a substance called quetiapine. It belongs to a group of medications called antipsychotics. Qutiapine may be used to treat several conditions such as:

• Bipolar depression: for which you 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 display poor judgment which includes 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 prescribing quetiapine even when you are feeling better.

Do not take Quetiapina Aristo:

• If you are allergic to quetiapine or any of the other components of this medication (listed in section 6).
• If you are taking any of the following medications:

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapina Aristo 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 medication that may affect your heart rate.
• You have low blood pressure.
• You have had a stroke, especially if you are elderly.
• You have liver problems.
• You have had a seizure (convulsion).
• You have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while taking quetiapine.
• You know you have had low white blood cell counts (which may or may not have been caused by other medications).
• You are an elderly person with dementia (loss of brain function). If so, do not take quetiapine because the group of medications to which Quetiapina Aristo belongs may increase the risk of stroke or, in some cases, death in these people.
• You are an elderly person with Parkinson's disease or parkinsonism.
• You or a family member has a history of blood clots, as medications like these have been associated with blood clot formation.
• You have or have had a condition in which your breathing is interrupted by brief periods of time during normal nighttime sleep (called "sleep apnea") and are taking medications that decrease normal brain activity ("depressants").
• You have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or high pressure inside your eye. These conditions may be caused by medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.
• You have a history of alcohol or drug abuse.
• If you have depression or other conditions treated with antidepressants. The use of these medications with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Quetiapina Aristo").

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

• A combination of fever, intense muscle stiffness, sweating, or a decrease in consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• 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).
• A prolonged and painful erection (priapism).
• Rapid and irregular heartbeats, even when at rest, palpitations, respiratory problems, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

These conditions may be caused by this type of medication.

Inform your doctor as soon as possible if you have:

• Fever, symptoms similar to the flu, sore throat, or any other infection, as it could be a consequence of a very low white blood cell count 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 intestinal blockage.
• Thoughts of suicide and worsening of depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This may increase at the beginning of treatment, as all these medications take time to be effective, usually around two weeks but sometimes more. 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 with depression. If you ever think about harming yourself or committing suicide, contact your doctor or go to the 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 can 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)

With the use of this medication, very rarely reported severe skin reactions (SCARs) have been noted, which may put your life at risk or be fatal. These typically manifest as:

• Stevens-Johnson syndrome (SSJ), a generalized 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 elevated white blood cell count and liver enzymes).
• Generalized Acute Exanthematous Pustulosis (AGEP), small pus-filled blisters.
• Erythema Multiforme (EM), skin rashes with irregular red patches that itch.

If you develop these symptoms, stop using Quetiapina Aristo and contact your doctor or seek medical attention immediately.

Weight gain

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

Children and adolescents

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

Other medications and Quetiapina Aristo

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

Do not take Quetiapina Aristo if you are using any of the following medications:

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

Inform your doctor if you are using any of the following medications:

• Antiepileptic medications (such as phenytoin or carbamazepine).
• Antihypertensive medications.
• Barbiturates (for difficulty falling asleep).
• Thioridazine or lithium (other antipsychotic medications).
• Medications that affect your heart rate, for example, medications that may cause an imbalance of electrolytes (low potassium or magnesium levels) such as diuretics (urine medication), or certain antibiotics (infection medications).
• Medications that may cause constipation.
• Medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.
• Antidepressants. These medications 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, tremors, 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 medications, consult your doctor first.

Quetiapina Aristo with food, drinks, and alcohol

• Quetiapina Aristo can be taken with or without food.
• Be careful with the amount of alcohol you consume. This is because the combined effect of Quetiapina Aristo and alcohol may cause drowsiness.
• Do not take grapefruit juice while taking Quetiapina Aristo. It may affect how the medication works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take Quetiapina Aristo during pregnancy, unless you have consulted your doctor. Do not use Quetiapina Aristo if you are breastfeeding.

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

Driving and using machines

This medication may cause drowsiness. Do not drive or operate tools or machines until you know how the medication affects you.

Quetiapina Aristo contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Effects on drug detection tests in urine:

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

Follow exactly the administration instructions for this medication as indicated by your doctor. 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 illness and your needs, but it will usually be between 150 mg and 800 mg.

• You will take your tablets once a day at bedtime, or twice a day, depending on your illness.
• Swallow your tablets whole with the help of water.
• You can take the tablets with or without food.
• Do not take grapefruit juice while taking Quetiapina Aristo. It may affect how 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

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

If you take more Quetiapina Aristo than you should

If you take more quetiapina than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring your Quetiapina Aristo tablets with you. You can also call the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Quetiapina Aristo

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 dose.

If you interrupt treatment with Quetiapina Aristo

If you stop taking quetiapina abruptly, 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 medicine can cause side effects, although not everyone will experience them.

Very common:can affect more than 1 in 10 people

• Dizziness (may lead to falls), headache, dry mouth.
• Sensation of drowsiness that may disappear over time as you continue to take quetiapine (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine) that 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, tremor, feeling of restlessness or muscle rigidity without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common:can 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 you to feel dizzy or faint (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased hunger.
• 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.
• Decreased number of certain types of blood cells.
• Increased amount of liver enzymes measured in the blood.
• Increased amount of prolactin hormone in the blood. The increase in prolactin hormone could, in rare cases, lead to the following:
• • Both men and women having breast swelling and unexpected milk production.
  • Women not having a menstrual period or having irregular periods.

Uncommon:can 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).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart 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.
• Decreased number of red blood cells in the blood.
• Decreased amount of sodium in the blood.
• Worsening of pre-existing diabetes
• Confusion

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

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or dizzy (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).
• Breast swelling 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 may 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 asleep.
• Decreased 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 effects:increase in fat around your abdomen, decrease in "good" cholesterol (HDL-C), increase in a type of fat in the blood called triglycerides, increase in blood pressure, and increase in 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 that is called agranulocytosis.
• Intestinal obstruction.
• Increased creatine phosphokinase in the blood (a substance found in muscles).

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

• Severe rash, blisters, or red spots on the skin.
• Severe allergic reaction (called anaphylaxis) that may cause difficulty breathing or shock.
• Quick swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A severe condition of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Incorrect secretion of a hormone that controls urine volume.
• Rhabdomyolysis (muscle fiber rupture and muscle pain).

Unknown:the frequency cannot be estimated from available data

• Rashes on the skin with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance of areas of skin with red spots and small pustules (small blisters filled with white/yellow liquid known as Pustulosis Exantemática Generalizada Aguda (AGEP). See section 2.
• Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis). See section 2.
• Medication reaction with eosinophilia and systemic symptoms (DRESS, for its acronym in English). Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs involved (medication reaction with eosinophilia and systemic symptoms, also known as DRESS). If you develop these symptoms, stop using quetiapine and contact your doctor or seek medical attention immediately.
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.
• Stroke
• Heart muscle disorders (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Inflammation of blood vessels (vasculitis), often with a rash of small red or purple spots.

The class of medicines to which Quetiapina Aristo belongs can cause serious heart rhythm problems that may be life-threatening.

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, increased liver enzymes, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase in the blood (a substance found in muscles), decreased amount of sodium in the blood, and increased amount of prolactin hormone in the blood. The increase in prolactin hormone could, in rare cases, lead to the following:

• Both men and women having breast swelling and unexpected milk production.
• Women not having a menstrual period or having irregular periods.

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

Side effects in children and adolescents

The same side effects that may occur in adults may 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:can affect more than 1 in 10 people

• Increased amount of a hormone called prolactin in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:
• • Both boys and girls having breast swelling and unexpected milk production.
  • Girls not having a menstrual period or having irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling of restlessness or muscle rigidity without pain.
• Increased blood pressure.

Common:can affect up to 1 in 10 people

• Sensation of weakness, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Pharmacovigilance of Medicines for Human Use: https//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 packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required..

Medications should not be disposed of through drains or 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 Aristo

• The active ingredient is quetiapine. The tablets contain 300 mg of quetiapine (as quetiapine fumarate).

• The other components are:

Tablet core:povidone, calcium dihydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethylcellulose type A (potato starch), lactose monohydrate (lactose), magnesium stearate, anhydrous colloidal silica, and talc.

• Tablet coating:hypromellose, macrogol 400, and titanium dioxide (E171).

Appearance of the product and contents of the package

White film-coated tablets, capsule-shaped, biconvex, marked with “E 56” on one side and smooth on the other.

HDPE bottles and PVC/aluminum blisters.

Bottles:

100, 250, 500, or 1,000 tablets.

Blister packs:

1, 10, 20, 30, 50, 60, 90, 100, 120, 180, or 240 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last review date of this prospectus:August 2024

For more detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/