Prospect: Information for the User

Quetiapina Kern Pharma 400 mg prolonged-release tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Quetiapina Kern Pharma

3.How to take Quetiapina Kern Pharma

4.Possible adverse effects

5.Storage of Quetiapina Kern Pharma

6.Contents of the package and additional information

Quetiapina Kern Pharma contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapina Kern Pharma may be used to treat several conditions, 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, have a loss of appetite, or cannot sleep.
• Mania: for which you may feel very excited, euphoric, agitated, enthusiastic, or hyperactive, or present poor judgment, which includes being aggressive or violent.
• Schizophrenia: for which you may hear or feel things that are not there, believe things that are not true, or feel abnormally suspicious, anxious, confused, guilty, tense, or depressed.

When using Quetiapina Kern Pharma prolonged-release tablets to treat major depressive episodes in major depressive disorder, this will be taken in addition to another medicine that is being used to treat this condition.

Your doctor may continue prescribing Quetiapina Kern Pharma even when you are feeling better.

Do not take Quetiapina Kern Pharma:

• if you are allergic (hypersensitive) to quetiapine or to any of the other ingredients of Quetiapina Kern Pharma (listed in section 6).
• if you are taking any of the following medicines:

- some HIV medicines

- azole-type medicines (for fungal infections)

- erythromycin or clarithromycin (for infections)

- nefazodone (for depression).

Do not take Quetiapina Kern Pharma if the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Quetiapina Kern Pharma.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapina Kern Pharma, if:

• You, or a family member, have or have had any heart problems, for example, irregular heart rhythm, heart muscle weakness or heart inflammation, or if you are taking any medicine 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. Your doctor may monitor your blood sugar levels while you are taking quetiapine.
• You know that you have had low white blood cell counts (which may or may not have been caused by other medicines). You are an elderly patient with dementia (loss of brain function). If so, do not take quetiapine because the group of medicines to which quetiapine belongs may increase the risk of stroke or, in some cases, death in these patients.
• You or a family member has 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 "Use of Quetiapina Kern Pharma with other medicines").

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

• A combination of fever, intense muscle stiffness, sweating, or a decrease in consciousness (a condition known as "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).
• Prolonged and painful erection (priapism).
• Rapid and irregular heartbeats, even when at rest, palpitations, respiratory problems, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

These conditions may be caused by this type of medicine.

Inform your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as it may be a consequence of very low white blood cell counts and require discontinuation of quetiapine treatment and/or additional treatment.
• Constipation with persistent abdominal pain, or constipation that has not responded to treatment, as it may lead to a more severe intestinal blockage.

Thoughts of suicide and worsening of depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This may increase at the beginning of treatment, as all these 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 thoughts of suicide and/or suicidal behavior in young adults under 25 with depression.

If you ever think about harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a close family member or friend that you are depressed, and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Weight gain

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

Children and adolescents

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

Use of Quetiapina Kern Pharma with other medicines

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

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

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

Inform 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, for example, medicines that may cause an imbalance of electrolytes (low potassium or magnesium levels) such as diuretics (medicines for urination) or certain antibiotics (medicines for treating infections).
• Medicines that may cause constipation.
• Antidepressants. These medicines may interact with quetiapine and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, 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 Quetiapina Kern Pharma with food, drinks, and alcohol

• Quetiapina Kern Pharma may be affected by food, so take your tablets at least one hour before a meal or before bedtime.
• Be careful about the amount of alcohol you drink. This is because the combined effect of Quetiapina Kern Pharma and alcohol may make you drowsy.
• Do not take grapefruit juice while taking Quetiapina Kern Pharma. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Do not take Quetiapina Kern Pharma during pregnancy, unless your doctor has advised you to. Do not use Quetiapina Kern Pharma if you are breastfeeding.

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

Driving and operating machinery

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

Quetiapina Kern Pharma contains lactose

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

Effect on drug detection tests in urine

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your illness and your needs, but it will usually be between 150 mg and 800 mg.

• You will take your tablets once a day.
• Do not break, 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 before going to bed, your doctor will tell you when).
• Do not take orange juice while taking Quetiapina Kern Pharma. 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.

Use in elderly patients

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

Use in children and adolescents

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

If you take more Quetiapina Kern Pharma than you should

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

You can also call the Toxicological Information Service, Tf: 915620420, indicating the medication and the amount taken.

If you forget to take Quetiapina 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 missed dose.

If you interrupt treatment with Quetiapina Kern Pharma

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Very common side effects(may affect more than 1 in 10 people):

• Dizziness (which may lead to falls), headache, dry mouth.
• Sensation of drowsiness (which may disappear over time as you continue to take quetiapine), (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), which include insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, feeling restless or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common side effects(may affect up to 1 in 10 people):

• Fast heart rate.
• Feeling like your heart is beating strongly, rapidly, or irregularly.
• Constipation, indigestion.
• Sensation of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing. This may cause dizziness or fainting (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased hunger.
• Feeling irritable.
• Speech and language disorders.
• Thoughts of suicide and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly patients).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increases in liver enzymes measured in the blood.
• Increases in prolactin hormone levels in the blood. Elevated prolactin levels may, in rare cases, lead to:
• Swelling of the breasts and unexpected milk production in both men and women.

Uncommon side effects(may affect up to 1 in 100 people):

• Seizures or convulsions.

• Allergic reactions that may include hives, skin swelling, and swelling around the mouth.

• Unpleasant sensations in the legs (also known as restless leg syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.

• Diabetes.
• Change in heart activity seen on an ECG (prolongation of the QT interval).
• Slower than normal heart rate that may occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which 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 side 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 condition known as "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).

• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Swelling of the breasts and unexpected milk production (galactorrhea).
• Menstrual disorders.

• Clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.

• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.

• A condition (called "metabolic syndrome") where you may experience a combination of 3 or more of the following effects: increased fat around your abdomen, decreased "good" cholesterol (HDL-C), increased levels of a type of fat in the blood called triglycerides, increased blood pressure, and increased blood sugar levels.
• A combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count, a condition known as agranulocytosis.
• Intestinal obstruction.
• Increased creatine phosphokinase levels in the blood (a substance found in muscles).

Very rare side effects(may affect up to 1 in 10,000 people):

• Severe rash, blisters, or red spots on the skin.
• Severe allergic reaction (anaphylaxis) that may cause difficulty breathing or shock.
• Quick swelling of the skin, usually around the eyes, lips, and throat (angioedema).

• Severe blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

• Incorrect secretion of a hormone that controls urine volume.
• Rhabdomyolysis (muscle fiber rupture and muscle pain).

• Worsening of pre-existing diabetes.

Side effects not known(the frequency cannot be estimated from available data):

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

• Babies born to mothers who have used quetiapine during pregnancy may experience withdrawal symptoms.

• Medication rash with eosinophilia and systemic symptoms (DRESS, for its acronym in English). Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (medication 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.
• Cardiomyopathy (heart muscle disorder).
• Myocarditis (inflammation of the heart muscle).
• Vasculitis (inflammation of blood vessels), often with a skin rash of small red or purple spots.

The class of medications to which Quetiapine Kern Pharma belongs may cause serious heart rhythm problems that can be life-threatening in severe cases.

Some side effects are only seen when a blood test is done. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in the blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased red blood cell count, increased creatine phosphokinase levels in the blood (a substance found in muscles), decreased sodium levels in the blood, and increased prolactin hormone levels in the blood. Elevated prolactin levels may, in rare cases, lead to:

• Swelling of the breasts and unexpected milk production in both men and women.
• Irregular menstrual periods in women.

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

Side effects in children and adolescents

The same side effects that may occur in adults may also occur in children and adolescents.

The following side effects have been observed more frequently in children and adolescents or have not been observed in adults:

Very common side effects(may affect more than 1 in 10 people):

• Increased levels of a hormone called prolactin in the blood. Elevated prolactin levels may, in rare cases, lead to:
• Swelling of the breasts and unexpected milk production in both boys and girls.

-Irregular menstrual periods in girls.

• Increased appetite.
• Vomiting.

• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless or muscle stiffness without pain.
• Increased blood pressure.

Common side effects(may affect up to 1 in 10 people):

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

Reporting side effects

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

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

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

Quetiapina Kern Pharma does not require special conditions for conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Quetiapina Kern Pharma

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

The other components are:

Tablet core: lactose monohydrate, hypromellose, sodium chloride, povidone K-30, talc, and magnesium stearate (E572).

Tablet coating: hypromellose 6cP (E464), titanium dioxide (E171), and macrogol (E553b).

Appearance of Quetiapina Kern Pharma and content of the packaging

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Responsible for Manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:June 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/