QUENTIAX 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Quentiax 200 mg film-coated tablets EFG

quetiapine

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• • If you have any questions, consult your doctor or pharmacist.
  • This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Quentiax is and what it is used for
2. What you need to know before taking Quentiax
3. How to take Quentiax
4. Possible side effects
5. Storage of Quentiax
6. Package contents and additional information

1. What Quentiax is and what it is used for

Quentiax contains a substance called quetiapine. It belongs to a group of medications called antipsychotics. Quentiax can be used to treat several diseases, such as:

• Bipolar depression: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or cannot sleep.
• Mania: where you may feel very excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including being aggressive or violent.
• Schizophrenia: where you may see, 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 to prescribe Quentiax to you even when you are feeling better.

2. What you need to know before taking Quentiax

Do not takeQuentiax

• 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:
• certain medications for the treatment of HIV.
• azole-type antifungal agents (for fungal infections).
• erythromycin or clarithromycin (for infections).
• nefazodone (for depression).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quentiax if:

• You, or a family member, have or have had any heart problems, such as heart rhythm problems, 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 an elderly person.
• You have liver problems.
• You have ever had a seizure (convulsion).
• You have diabetes or are at risk of developing diabetes. If so, your doctor may monitor your blood sugar levels while you are taking Quentiax.
• You know that you have had low white blood cell counts in the past (which may or may not have been caused by other medications).
• You are an elderly person with dementia (loss of brain function). If so, you should not take Quentiax because the group of medications that Quentiax belongs to may increase the risk of stroke, or in some cases the risk of death, in these individuals.
• You are an elderly person with Parkinson's disease/parkinsonism.
• You or a family member have a history of blood clots, as medications like this have been associated with the formation of blood clots.
• You have or have had a condition in which your breathing is interrupted for short periods during normal nighttime sleep (called "sleep apnea") and you 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, a bowel obstruction, or increased pressure inside your eye. These conditions may be caused by medications (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.
• You have a history of alcohol or drug abuse.
• If you suffer from depression or other conditions that are treated with antidepressants. The use of these medications with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Quentiax").

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

• A combination of fever, severe muscle stiffness, sweating, or a decrease in consciousness level (a disorder 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).
• A prolonged and painful erection (priapism).
• Fast and irregular heartbeats, even when you are at rest, palpitations, breathing problems, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

These disorders may be caused by this type of medication.

Inform your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as this could be the result of a low white blood cell count, which may require that treatment with quetiapine be interrupted and/or treatment be given.
• Constipation along with persistent abdominal pain, or constipation that has not responded to treatment, as it could lead to a more severe bowel obstruction.

Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This may increase when you first start treatment, as all these medications take time to work, 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 from clinical trials has 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 be helpful to tell a family member or close friend that you are depressed and ask them to read this package 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 reaction (SSR)

Severe skin reactions (SSRs) have been reported, which can be life-threatening or fatal, very rarely with quetiapine treatment. These have often been characterized by:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals
• Toxic epidermal necrolysis (TEN), a more severe condition causing widespread skin peeling
• Drug reaction with eosinophilia and systemic symptoms (DRESS) consists of flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including an increase in white blood cells (eosinophilia) and liver enzymes)
• Acute generalized exanthematous pustulosis (AGEP), small pus-filled blisters
• Erythema multiforme (EM), a skin rash with irregular red patches that itch

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

Weight gain

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

Children and adolescents

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

Other medications and Quentiax

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

Do not take Quentiax if you are taking any of the following medications:

• Certain medications for HIV.

• Azole-type antifungal agents (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

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

• Medications for epilepsy (such as phenytoin or carbamazepine).
• Medications for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or lithium (another antipsychotic medication).
• Medications that affect your heart rate, such as medications that can cause an imbalance in electrolytes (low potassium or magnesium levels), such as diuretics (medications to urinate) or certain antibiotics (medications to treat infections).
• Medications that can cause constipation.
• Medications (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.
• Antidepressants. These medications can interact with quetiapine, and you may experience symptoms such as involuntary muscle contractions and rhythmic movements of the muscles, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tone, 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.

Taking Quentiax with food, drinks, and alcohol

• Quentiax can be taken with or without food.
• Be careful with the amount of alcohol you drink. This is because the combined effect of Quentiax and alcohol may sedate you.
• Do not drink grapefruit juice while taking Quentiax. It may affect how the medication 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 medication.

You should not take Quentiax during pregnancy, unless you have discussed it with your doctor.

You should not use Quentiax if you are breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may occur 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, breathing problems, and difficulty feeding. If your baby experiences any of these symptoms, it is possible that you need to contact your doctor.

Driving and using machines

Quentiax may cause symptoms such as drowsiness, dizziness, or changes in vision, and may reduce your reaction ability. These effects, as well as the disease itself, may make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Quentiax contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

Effect on urine drug detection tests

If you are undergoing a urine drug detection test, taking Quentiax may produce positive results for methadone or certain antidepressant medications called tricyclic antidepressants (TCAs) when some analysis methods are used, even if you are not taking methadone or TCAs. If this happens, a more specific test can be performed.

3. How to take Quentiax

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your disease and needs but 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 disease.
• Swallow your tablets whole with the help of water.
• You can take the tablets with or without food.
• Do not drink grapefruit juice while taking Quentiax. 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.

Elderly people

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

Use in children and adolescents

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

If you take more Quentiax than you should

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

You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Quentiax

If you forget to take Quentiax, take your corresponding dose 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 forgotten doses.

If you stop taking Quentiax

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Very Common:may affect more than 1 in 10 people

• Dizziness (which may lead to falls), headache, dry mouth.
• Feeling of drowsiness (which may disappear over time, as you continue taking Quentiax) (may lead to falls).
• Discontinuation symptoms (symptoms that occur when you stop taking Quentiax) include inability to sleep (insomnia), feeling nauseous, headache, diarrhea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is advised.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common:may affect up to 1 in 10 people

• Fast heartbeat.
• Feeling like your heart is beating strongly, beating fast, or has skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing up. This can make you feel dizzy or faint (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Disorder of speech and language.
• Suicidal thoughts 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 the amount of liver enzymes measured in the blood.
• Increases in the amount of prolactin hormone in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:

• Both in men and women, having swollen breasts and unexpected milk production.
• In women, not having menstrual periods or having irregular periods.

Uncommon:may affect up to 1 in 100 people

• Seizures or convulsions.
• Allergic reactions that can include hives, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual 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 can 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.
• 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 disorder called "neuroleptic malignant syndrome").
• Yellowish color of the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Swollen breasts and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs) that can travel to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• Decreased body temperature (hypothermia).
• Pancreas inflammation.
• A condition (called "metabolic syndrome") in which you may have a combination of three or more of the following effects: increased fat around your abdomen, decreased "good" cholesterol (HDL-C), increased 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 called 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 (called anaphylaxis) that can cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A severe blistering condition of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

Frequency Not Known:frequency cannot be estimated from the available data

• Red, irregular skin patches (erythema multiforme). See section 2.
• Rapid onset of reddish skin areas with small blisters (small, fluid-filled bumps called acute generalized exanthematous pustulosis (AGEP)). See section 2.

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

• Pharmacological reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with rash, fever, enlarged lymph nodes, and altered 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 have used Quentiax during pregnancy.
• Stroke.
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of blood vessels (vasculitis), often with a skin rash with small red or purple spots.

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

Some adverse effects are only observed when a blood test is performed. 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 your blood, increased liver enzymes, decreased number of certain types of blood cells, decreased red blood cell count, increased creatine phosphokinase in the blood (a substance found in muscles), decreased sodium in the blood, and increased prolactin hormone in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:

• Both in men and women, having swollen breasts and unexpected milk production.
• In women, not having menstrual periods or having irregular periods.

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

Other Adverse Effects in Children and Adolescents

The same side effects that can occur in adults can 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

• Increased amount of a hormone called prolactin in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:

• Both in boys and girls, having swollen breasts and unexpected milk production.
• In girls, not having menstrual periods or having irregular periods.

• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Increased blood pressure.

Common:may affect up to 1 in 10 people

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Quentiax

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

Do not use this medicine after the expiration date stated on the carton, container, and blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Quentiax

The active ingredient is quetiapine. Each film-coated tablet contains 200 mg of quetiapine (as quetiapine hemifumarate).

The other ingredients are:

Core of the tablet: lactose monohydrate (lactose), calcium phosphate dihydrate, microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A) potato starch, magnesium stearate.

Coating of the tablet: hypromellose, titanium dioxide (E171), macrogol 4000. See section 2 "Quentiax contains lactose and sodium".

Appearance and Package Contents

The 200 mg film-coated tablets are round and white.

They are available in aluminum/PVC blisters of 60 tablets per box.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

or

KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Date of Last Revision of this Leaflet: April 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/