QUETIAPINE KRKA 400 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet:Information for the Patient

Quetiapine Krka 400 mg prolonged-release tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Quetiapine Krka and what is it used for
2. What you need to know before you take Quetiapine Krka
3. How to take Quetiapine Krka
4. Possible side effects
5. Storage of Quetiapine Krka
6. Contents of the pack and other 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 medicines 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, feel 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 that is being 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 you take Quetiapine Krka

Do not take Quetiapine Krka:

• 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 in doubt, consult your doctor or pharmacist before taking this medicine.

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 problems with the heartbeat, weakening of the heart muscle, inflammation of the heart, or if you are taking any medication that may affect your heart rhythm.
• 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 medicine.
• 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 medicines to which quetiapine belongs may increase the risk of stroke, or in some cases the risk of death, in these people.
• You are an elderly person with Parkinson's disease/parkinsonism.
• You or a family member have a history of blood clots, as medicines 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 are taking medicines 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 blockage in your intestine, or high pressure inside your eye. These conditions may be caused by medicines (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 medicines together with quetiapine may cause a condition called serotonin syndrome, a potentially life-threatening condition (see "Other medicines 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 the level of consciousness (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 can increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).
• Painful and prolonged erections (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 can be caused by this type of medicine.

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 blockage of the intestine.

Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes think of harming yourself or committing suicide. This can increase when you first start treatment, as all these medicines take time to work, usually around two weeks, but sometimes longer. These thoughts can 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 of harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a relative 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 worried 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 manifested 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 blisters
• ERYthema multiforme (EM), a skin rash with irregular red patches that itch

Stop using Quetiapine Krka 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 medicines and Quetiapine Krka

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

Do not take quetiapine if 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).

Tell your doctor if you are taking any of these medicines:

• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or lithium (other antipsychotic medicines).
• Medicines that affect your heart rhythm, such as medicines that can cause an imbalance in electrolytes (low potassium or magnesium levels), such as diuretics (medicines to urinate) or certain antibiotics (medicines to treat infections).
• Medicines that can cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.
• Antidepressants. These medicines 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 tone, 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 Quetiapine Krka with food, drinks, and alcohol

• This medicine 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 medicine and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking quetiapine. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take this medicine during pregnancy unless you have discussed it with your doctor. Quetiapine should not be taken if you are 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 ability. These effects, as well as your own illness, 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 medicine.

Quetiapine Krka contains lactose and sodium

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

This medicine contains 23.46 mg of sodium (the main component of table salt) in each 400 mg prolonged-release tablet. This is equivalent to 1.17% of the maximum recommended daily intake of sodium for an adult.

Effect on urine drug screening tests

If you are having a urine drug screening test, taking quetiapine may produce positive results for methadone or certain antidepressant medicines 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 Quetiapine Krka

Follow exactly the administration instructions of this medicine given 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 medicine works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to.

Liver problems

If you have liver problems, your doctor may 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, feel 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 medicine 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 be unable to sleep (insomnia), or you may 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not 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) (which may lead to falls).
• Discontinuation symptoms (symptoms that occur when you stop taking the medicine) include being unable 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 (which 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 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 swelling of the breasts and unexpected milk production.
• Women not having their menstrual period 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 seen in the ECG in the electrical activity of the heart (prolongation of the QT interval).
• Slower heart rate than normal that can occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which may lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells.
• 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 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).
• Pancreas inflammation.
• A condition (called "metabolic syndrome") where you may experience 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.
• Increased 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 patches on the skin (erythema multiforme). See section 2.
• Rapid appearance of areas of reddish skin with small pus-filled bumps (pustular exanthematous generalized eruption (PEAG)). 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 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 appear in newborn babies of mothers who have taken Quetiapine Krka during their pregnancy.
• Stroke.
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of the blood vessels (vasculitis), often with a skin rash with small red or purple spots.

The class of medicines to which quetiapine belongs can cause heart rhythm problems that can be serious and, in severe cases, potentially 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 number of red blood cells, increased blood creatine phosphokinase (a substance found in muscles), decreased amount of sodium in the blood, and increased amount of prolactin hormone in the blood. The increases in prolactin hormone can, in rare cases, lead to the following:

• Both men and women experiencing swelling of the breasts and unexpected milk production.
• Women not having their menstrual period 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 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 can, in rare cases, lead to the following:
• Both boys and girls experiencing swelling of the breasts and unexpected milk production.
• Girls not having their menstrual period or having irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. This includes difficulty starting muscle movements, agitation, feeling tired, or muscle stiffness without pain.
• Increased blood pressure.

Common:may affect up to 1 in 10 people

• Feeling of weakness, fainting (which 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 Quetiapine 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 any unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Quetiapine Krka

• The active ingredient is quetiapine. Each prolonged-release tablet contains 400 mg of quetiapine (as quetiapine hemifumarate).
• The other ingredients are hypromellose, lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, and magnesium stearate in the coreand hypromellose, titanium dioxide (E171), and macrogol 400 in the coating. See section 2 "Quetiapine Krka contains lactose and sodium".

Appearance of the Product and Package Contents

The 400 mg prolonged-release tablets are white or almost white, capsule-shaped, biconvex, film-coated, and engraved with "400" on one side. Tablet dimensions: 18.7 - 19.5 mm in diameter and 5.5 - 7.1 mm in thickness.

Quetiapine Krka 400 mg prolonged-release tablets are available in packs 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 obtain further information on 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 Area under the following names:

Date of Last Revision of this Leaflet: April 2025

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