QUETIAPINE KRKA 150 mg PROLONGED-RELEASE TABLETS

Introduction

Leaflet:Information for the patient

Quetiapine Krka 150 mg prolonged-release tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 leaflet. See section 4.

Contents of the leaflet

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

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

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

• Bipolar depression and major depressive episodes in major depressive disorder: for which you feel sad. You may find that you feel depressed, guilty, lack energy, lose appetite, or have difficulty sleeping.
• Mania: for which you may feel very excited, euphoric, agitated, enthusiastic, or hyperactive, or show 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.

When Quetiapine Krka is used to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medication used to treat this disease.

Your doctor may continue to prescribe Quetiapine Krka even if you feel better.

2. What you need to know before taking Quetiapine Krka

Do not take Quetiapine Krka:

• 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 medications for HIV
• 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 this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapine Krka if:

• You, or a family member, have or have had any heart problems, such as heart rhythm problems, heart muscle weakness, 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 patient.
• 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 this medication.
• 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 quetiapine because the group of medications to which quetiapine belongs 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 these have been associated with the formation of blood clots.
• You have or have had a condition in which your breathing stops for short periods during normal nighttime sleep (called "sleep apnea") and you are taking medications that reduce normal brain activity ("depressants").
• You have or have had a condition in which you cannot empty your bladder completely (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 along with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Quetiapine Krka").

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

• A combination of fever, severe muscle stiffness, sweating, or a decrease in level of consciousness (a disorder 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).
• Painful and prolonged erections (priapism).
• Fast and irregular heartbeats, even when 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.

Tell 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 discontinued and/or additional treatment be given.
• Constipation with persistent abdominal pain, or constipation that has not responded to treatment, as this can lead to a more serious 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 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 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 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), which can be life-threatening or fatal, have been reported very rarely with quetiapine treatment. These have often been characterized by:

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

Stop using quetiapine if you develop these symptoms 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

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

Other medications and Quetiapine Krka

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

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

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

Tell your doctor if you are taking 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 (other antipsychotic medications).
• 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, exaggerated reflexes, increased muscle tension, and body temperature above 38 °C (serotonin syndrome). Contact your doctor if you experience these symptoms.

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

Taking Quetiapine Krka with food, drinks, and alcohol

• This medication may be affected by food, and therefore, you should take your tablets at least one hour before a meal or before bedtime.
• Be careful with the amount of alcohol you drink. This is because the combined effect of this medication and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking quetiapine. 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 this medication during pregnancy unless you have discussed it with your doctor. Quetiapine should not be taken during breastfeeding.

The following symptoms, which may represent a 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, breathing problems, and difficulty feeding. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and using machines

Quetiapine may cause symptoms such as drowsiness, dizziness, or changes in vision, and may reduce your reaction time. These effects, as well as the disease itself, may impair your ability 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.

Quetiapine Krka 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 14.53 mg of sodium (the main component of table salt/cooking salt) in each 150 mg prolonged-release tablet. This is equivalent to 0.73% of the maximum recommended daily sodium intake for an adult.

Effect on urine drug detection tests

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 some analysis methods are used, even if you are not taking methadone or TCAs. If this occurs, a more specific test can be performed.

3. How to take Quetiapine Krka

Follow exactly the administration instructions of this medication 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 needs but will normally be between 150 mg and 800 mg.

• You will take your tablets once a day.
• Do not split, chew, or crush the tablets.
• Swallow your tablets whole with the help of water.
• Take the tablets without food (at least one hour before a meal or at bedtime, your doctor will indicate when).
• Do not drink grapefruit juice while taking Quetiapine Krka. 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 an elderly person, your doctor may change your dose.

Use in children and adolescents

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

If you take more Quetiapine Krka than you should

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

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 forgotten doses.

If you stop taking Quetiapine Krka

If you stop taking Quetiapine Krka abruptly, you may experience insomnia, nausea, or headaches, or you may feel dizzy or irritable. 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 this medicine) (may lead to falls).
• Discontinuation symptoms (symptoms that occur when you stop taking the medicine) 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

• Rapid heartbeat.
• Feeling like your heart is beating strongly, rapidly, 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.
• Thoughts of suicide and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in the elderly).
• 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 measurable in blood.
• Increases in the amount of prolactin hormone in blood. The increases in prolactin hormone can, in rare cases, lead to the following:
• Men and women experiencing breast swelling and unexpected milk production.
• Women not having their menstrual period or having it irregularly.

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 seen in the ECG in the electrical activity of the heart (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.
• 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 disorder called "neuroleptic malignant syndrome").
• Yellowish color of the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Swelling of the breasts and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the bloodstream 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.
• Decrease in body temperature (hypothermia).
• Pancreas inflammation.
• A condition (called "metabolic syndrome") where you may suffer from a combination of 3 or more of the following effects: increased 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.
• A combination of fever, flu-like symptoms, sore throat, or any other infection with a low white blood cell count, a condition called agranulocytosis.
• Intestinal obstruction.
• Increase in blood creatine phosphokinase (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 condition of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Rupture of muscle fibers and muscle pain (rhabdomyolysis).

Frequency Not Known: cannot be estimated from the available data

• Red, irregular spots on the skin (erythema multiforme). See section 2.
• Rapid appearance of areas of reddish skin with small pus-filled bumps (small blisters filled with white/yellow liquid 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.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) consisting of symptoms similar to the flu 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 appear in newborn babies of mothers who have taken Quetiapina Krka during their pregnancy.
• Stroke.
• Heart muscle disorder (cardiomyopathy).
• Heart muscle inflammation (myocarditis).
• Blood vessel inflammation (vasculitis), often with a skin rash with small red or purple spots.

The class of medicines to which Quetiapina Krka 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 the blood, increase in liver enzymes, decrease in the number of certain types of blood cells, decrease in the number of red blood cells, increase in blood creatine phosphokinase (a substance found in muscles), decrease in the amount of sodium in the blood, and increases in the amount of prolactin hormone in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:

• Both men and women experiencing breast swelling and unexpected milk production.
• Women not having their menstrual period or having it irregularly.

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

Other Adverse Effectsin Children and Adolescents

The same adverse 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 seen 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 boys and girls experiencing breast swelling and unexpected milk production.
• Girls not having their menstrual period or having it irregularly.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. This includes difficulty starting muscle movements, restlessness, feeling tired, 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 does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Quetiapina Krka

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

Do not use this medicine after the expiration date that appears on the blister pack and the outer packaging after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Quetiapina Krka

• The active ingredient is quetiapine. Each prolonged-release tablet contains 150 mg of quetiapine (as quetiapine hemifumarate).
• The other ingredients are hypromellose, lactose monohydrate, microcrystalline cellulose, disodium phosphate dihydrate, and magnesium stearate in the coreand polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc, red iron oxide (E172), and yellow iron oxide (E172) in the coating. See section 2 "Quetiapina Krka contains lactose and sodium".

Appearance of the Product and Package Contents

The 150 mg prolonged-release tablets are orange-pink, round, biconvex, film-coated, with beveled edges. Tablet dimensions: 10 mm in diameter and 4.6 - 6.0 mm in thickness.

Quetiapina Krka 150 mg prolonged-release tablets are available in packages containing 10, 30, 50, 60, 90, and 100 prolonged-release tablets in OPA/Al/PVC-Al blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

TAD Pharma GmbH, Heinz-Lohmann Str. 5, 27472 Cuxhaven, Germany

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 andin the Member States of the European Economic Area 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/