QUETIAPINE QUALIGEN FARMA 200 mg PROLONGED-RELEASE TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Quetiapine Qualigen Farma 200 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 questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given 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 Quetiapine Qualigen Farma is and what it is used for
2. What you need to know before taking Quetiapine Qualigen Farma
3. How to take Quetiapine Qualigen Farma
4. Possible side effects
5. Storage of Quetiapine Qualigen Farma
6. Package contents and additional information

1. What Quetiapine Qualigen Farma is and what it is used for

Quetiapine Qualigen Farma contains a substance called quetiapine. It belongs to a group of medications called antipsychotics. Quetiapine Qualigen Farma 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 exhibit 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 using Quetiapine Qualigen Farma prolonged-release tablets to treat major depressive episodes in major depressive disorder, this will be taken in addition to another medication used to treat this disease.

Your doctor may continue to prescribe Quetiapine Qualigen Farma even when you are feeling better.

2. What you need to know before taking Quetiapine Qualigen Farma

Do not take Quetiapine Qualigen Farma:

• If you are allergic (hypersensitive) to quetiapine or any of the other components of Quetiapine Qualigen Farma (listed in section 6).
• If you are taking any of the following medications:
  • some HIV medications
  • azole-type medications (for fungal infections)
  • erythromycin or clarithromycin (for infections)
  • nefazodone (for depression)

Do not take Quetiapine Qualigen Farma if the above applies to you. If you have any doubts, consult your doctor or pharmacist before taking Quetiapine Qualigen Farma.

Warnings and precautions

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

• You, or a family member, have or have had any heart problems, such as heart rhythm problems, heart muscle weakness, or heart inflammation, or if you are taking any medication that may affect your heart rate.
• You have low blood pressure.
• You have had a stroke, especially if you are elderly.
• 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 medications).
• You are an elderly person with dementia (loss of brain function). If so, you should not take quetiapine, as the group of medications to which Quetiapine Qualigen Farma belongs may increase the risk of stroke, or in some cases, the risk of death, in these individuals.

If you are an elderly person with Parkinson's disease/parkinsonism.

• You, or a family member, have a history of blood clots, as medications like this have been associated with the formation of blood clots.

If you have or have had a disorder in which you stop breathing for short periods during normal nighttime sleep (called "sleep apnea") and are taking medications that slow down normal brain activity ("depressants").

• You have or have had a disorder in which you cannot completely empty your bladder (urinary retention), prostate enlargement, intestinal obstruction, or increased eye pressure. These disorders are sometimes caused by medications (called "anticholinergics") that affect the functioning of nerve cells and are used to treat certain diseases.
• You have a history of alcoholism or drug abuse.
• If you suffer from depression or other conditions that are treated with antidepressants.

The use of these medications with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see Other medications and Quetiapine Qualigen Farma).

Tell your doctor immediately if, after taking Quetiapine Qualigen Farma, 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 injuries (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
  • Rapid 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 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 severe intestinal blockage.

Suicidal thoughts 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 obtained 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.

Weight gain

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

Children and adolescents

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

Other medications and Quetiapine Qualigen Farma

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

Do not take Quetiapine Qualigen Farma if you are using any of the following medications:

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

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

• Medications for epilepsy (such as phenytoin or carbamazepine).
• Medications for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or lithium (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 the functioning of nerve cells and are used to treat certain diseases.

Antidepressants. These medications may interact with quetiapine, and you may experience symptoms such as involuntary muscle contractions, agitation, hallucinations, coma, excessive sweating, tremors, 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 Qualigen Farma with food, drinks, and alcohol

• Quetiapine Qualigen Farma 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 consume. This is because the combined effect of Quetiapine Qualigen Farma and alcohol may make you drowsy.
• Do not take grapefruit juice while taking Quetiapine Qualigen Farma. 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 before using this medication.

Do not take Quetiapine Qualigen Farma during pregnancy, unless your doctor has advised you to do so. Do not use Quetiapine Qualigen Farma 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, respiratory problems, and feeding difficulties. 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 operate tools or machines until you know how the tablets affect you.

Effect on urine drug tests

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

Quetiapine Qualigen Farma contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking the medication.

3. How to take Quetiapine Qualigen Farma

Follow the administration instructions of this medication exactly as indicated by your doctor. If in 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.

• Take the 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, as your doctor indicates).
• Do not take grapefruit juice while taking Quetiapine Qualigen Farma. It may affect how the medication works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to.

Patients with liver problems

If you have liver problems, your doctor may change your dose.

Elderly patients

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

Use in children and adolescents

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

If you take more Quetiapine Qualigen Farma than you should

If you take more Quetiapine Qualigen Farma than your doctor prescribed, you may feel drowsy, dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring the Quetiapine Qualigen Farma tablets with you. You can also call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount taken.

If you forget to take Quetiapine Qualigen Farma

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 tablet.

If you stop taking Quetiapine Qualigen Farma

If you stop taking Quetiapine Qualigen Farma abruptly, you may experience insomnia, nausea, or headaches, or feel dizzy or irritable. Your doctor may suggest gradually reducing the dose before stopping treatment.

If you have any further 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 Adverse Effects (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 quetiapine), (which 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, beating quickly, 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 elderly people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increases in the amount of liver enzymes measured in the blood.
• Increases in the amount of prolactin hormone in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:

o Both in men and women having swelling of the breasts and unexpected production of milk.

o In women not having menstrual periods or having irregular periods.

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 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 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).
• Swelling of the breasts and unexpected production of milk (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.
• 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 very low white blood cell count, a condition called agranulocytosis.
• Intestinal obstruction.
• Increase in 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.
• Rupture of muscle fibers and muscle pain (rhabdomyolysis).

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

• Red spots on the skin with irregular edges (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.

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 Quetiapina Qualigen 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, increase in liver enzymes, decrease in the number of certain types of blood cells, decrease in the number of red blood cells, increase in creatine phosphokinase in the blood (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 in men and women having swelling of the breasts and unexpected production of milk.
• 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 swelling of the breasts and unexpected production of milk.
  • 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 (which 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: 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 Qualigen Farma

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

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

This medicine does not require special storage conditions. Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE Point at the pharmacy. If in doubt, 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

The active ingredient is quetiapine. The tablets contain 50 mg of quetiapine (as quetiapine fumarate).

The other ingredients are:

Core of the tablet: lactose, methacrylic acid - ethyl acrylate copolymer (1:1), crystalline maltose type A, magnesium stearate, and talc.

Coating of the tablet: Methacrylic acid - ethyl acrylate copolymer (1:1), type A, triethyl citrate.

Appearance of Quetiapina Qualigen Farma and Package Contents

The 50 mg prolonged-release tablets are white or almost white, round, biconvex, with "50" engraved on one face, 7.1 mm in diameter, and 3.2 mm in thickness.

They are presented in aluminum/PVC/PCTFE blisters in a cardboard box.

The package sizes are: 10, 30, 50, 60, 100, and 180 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Manufacturer

Pharmathen International, S.A.

Industrial Park Sapes Rodopi Prefecture Block Nº 5

Rodopi 69300

Greece

or

Pharmathen, S.A.

Dervenakion 6

Pallini Attiki, 15351

Greece

or

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Date of 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/