QUETIAPINE KERN PHARMA 400 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Quetiapine Kern Pharma 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 and other information

1. What Quetiapine Kern Pharma is and what it is used for
2. What you need to know before you take Quetiapine Kern Pharma
3. How to take Quetiapine Kern Pharma
4. Possible side effects
5. Storage of Quetiapine Kern Pharma
6. Contents of the pack and other information

1. What Quetiapine Kern Pharma is and what it is used for

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

• Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite or have difficulty sleeping.
• Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or violent.
• Schizophrenia: where 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 Kern Pharma prolonged-release tablets are used to treat major depressive episodes in major depressive disorder, they will be taken in addition to another medicine being used to treat this disease.

Your doctor may continue to prescribe Quetiapine Kern Pharma even when you are feeling better.

2. What you need to know before you take Quetiapine Kern Pharma

Do not take Quetiapine Kern Pharma:

• if you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Quetiapine Kern Pharma (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).

Do not take Quetiapine Kern Pharma if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking Quetiapine Kern Pharma.

Warnings and precautions

Consult your doctor or pharmacist before starting Quetiapine Kern Pharma if:

• You, or a family member, have or have had heart problems, such as problems with your heart rhythm, weakening of the heart muscle or inflammation of the heart, or if you are taking any medicine that may affect your heart beat.
• 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 quetiapine.
• You know you have had low white blood cell counts in the past (which may or may not have been caused by other medicines). You are an elderly patient with dementia (loss of brain function). If so, you should not take quetiapine because the group of medicines to which Quetiapine Kern Pharma belongs may increase the risk of stroke, or in some cases the risk of death, in these patients.
• 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 depression or other conditions that are treated with antidepressants. The use of these medicines with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Using Quetiapine Kern Pharma with other medicines").

Tell your doctor immediately if, after taking Quetiapine Kern Pharma, 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"). 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 injury (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Rapid and irregular heartbeats, even when at rest, palpitations, breathing difficulties, 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 medicine.

Tell your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as it could be a consequence of a very low white blood cell count and may require interruption of treatment with quetiapine and/or additional treatment.
• Constipation along with persistent abdominal pain, or constipation that has not responded to treatment, as it could lead to a more serious bowel obstruction.

Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes think of harming or killing yourself. This may increase at the beginning of treatment, as all these medicines take time to work, usually around two weeks but sometimes longer. These thoughts may also increase if you stop taking your medication abruptly. You may be more likely to think this way if you are a young adult. Information 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 or killing yourself, 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.

Weight gain

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

Children and adolescents

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

Using Quetiapine Kern Pharma with other medicines

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

Do not take Quetiapine Kern Pharma if you are using any of the following medicines:

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

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

• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty 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.
• 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 tension and body temperature above 38 °C (serotonin syndrome). Contact your doctor when you experience these symptoms.

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

Taking Quetiapine Kern Pharma with food, drinks and alcohol

• Quetiapine Kern Pharma may be affected by food and should be taken 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 Quetiapine Kern Pharma and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking Quetiapine Kern Pharma. It may affect how the medicine works.

Pregnancy and breast-feeding

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

Do not take Quetiapine Kern Pharma during pregnancy, unless your doctor has advised you to do so. You should not use Quetiapine Kern Pharma if you are breast-feeding.

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

Driving and using machines

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

Quetiapine Kern Pharma contains lactose

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

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 test 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 Kern Pharma

Follow exactly the administration instructions of this medicine given 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 disease and needs but will usually 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 water.
• Take the tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when).
• Do not drink grapefruit juice while taking Quetiapine Kern Pharma. 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.

Use in elderly patients

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

Use in children and adolescents

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

If you take more Quetiapine Kern Pharma than you should

If you take more Quetiapine Kern Pharma 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 Kern Pharma tablets with you.

You can also call the Toxicology Information Service, Tel: 915620420, indicating the medicine and the amount taken.

If you forget to take Quetiapine Kern Pharma

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 forgotten tablet.

If you stop taking Quetiapine Kern Pharma

If you stop taking Quetiapine Kern Pharma 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 Adverse Effects(may affect more than 1 in 10 people):

• Dizziness (may lead to falls), headache, dry mouth.
• Feeling of drowsiness (which may disappear over time, as you continue taking quetiapine), (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including 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 Adverse Effects(may affect up to 1 in 10 people):

• Fast heartbeat.
• Feeling like your heart is beating strongly, rapidly, or skipping 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 patients).
• 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.

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

• Seizures or convulsions.

• Allergic reactions that can include swollen 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 the ECG (prolongation of the QT interval).
• Slower heart rate than normal, which 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.

Rare Adverse Effects(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 in 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 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 suffer from a combination of 3 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 Adverse Effects(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).

• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

• Worsening of pre-existing diabetes.

Unknown Frequency Adverse Effects(frequency cannot be estimated from available data):

• Skin rash with irregular red spots (erythema multiforme).
• Sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).

• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.

• Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs involved (drug rash 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.
• Cardiac 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 Quetiapina Kern Pharma 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 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 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.

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 observed in adults:

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

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

Reporting Adverse Effects

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

5. Storage of Quetiapina Kern Pharma

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

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

Quetiapina Kern Pharma does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, 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 Kern Pharma

The active ingredient is quetiapine. The tablets contain 400 mg of quetiapine (as quetiapine hemifumarate).

The other ingredients are:

Core of the tablet: lactose monohydrate, hypromellose, sodium chloride, povidone K-30, talc, and magnesium stearate (E572).

Coating of the tablet: hypromellose 6cP (E464), titanium dioxide (E171), and macrogol (E553b).

Appearance of Quetiapina Kern Pharma and Package Contents

The tablets are white, round, biconvex, film-coated, and engraved with the inscription "I4" on one side and smooth on the other. They are presented in PVC/PVDC/Aluminum blisters, in packages of 60 tablets.

Only certain package sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Leaflet:June 2024

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