QUETIAPINE SANDOZ 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Quetiapine Sandoz Pharmaceutical 100 mg film-coated tablets EFG

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

• Keep this package 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 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 package leaflet. See section 4.

Contents of the package leaflet:

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

1. What Quetiapine Sandoz Pharmaceutical is and what it is used for

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

• Bipolar depression: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or cannot sleep.
• Mania: where you may feel very excited, euphoric, agitated, enthusiastic, or hyperactive, or show 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.

Your doctor may continue to prescribe quetiapine to you even when you are feeling better.

2. What you need to know before taking Quetiapine Sandoz Pharmaceutical

Do not take Quetiapine Sandoz Pharmaceutical:

• 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 HIV medications,
• azole-type medications (for fungal infections),
• erythromycin or clarithromycin (for bacterial infections),
• nefazodone (for depression).

If you have any doubts, consult your doctor or pharmacist before taking Quetiapine Sandoz Pharmaceutical.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapine Sandoz Pharmaceutical:

Tell your doctor immediately if, after taking Quetiapine Sandoz Pharmaceutical, you experience any of the following:

• A combination of fever, severe muscle stiffness, sweating, or a decrease in the 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).

• A prolonged and painful erection (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 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 bowel blockage.
• 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 more. 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 close family member or friend that you are depressed and ask them to read this package 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 reactions (SCARs)

With the use of this medication, very rare but severe skin reactions (SCARs) have been reported, which can be life-threatening or fatal. These are commonly manifested as:

• Stevens-Johnson syndrome (SSJ), a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form that causes extensive peeling of the skin.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including an increased number of white blood cells (eosinophilia) and elevated liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red patches that itch.
• If you develop these symptoms, stop using Quetiapine Sandoz Pharmaceutical 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 Sandoz Pharmaceutical should not be used in children and adolescents under 18 years of age.

Other medications and Quetiapine Sandoz Pharmaceutical

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

Do not take Quetiapine Sandoz Pharmaceutical if you are using any of the following medications:

• Some HIV medications.
• Azole-type medications (for fungal infections).
• Erythromycin or clarithromycin (for bacterial 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 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 Sandoz Pharmaceutical with food, drinks, and alcohol

• Quetiapine Sandoz Pharmaceutical can be taken with or without food.
• Be careful with the amount of alcohol you drink. This is because the combined effect of Quetiapine Sandoz Pharmaceutical and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking Quetiapine Sandoz Pharmaceutical. 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 Quetiapine Sandoz Pharmaceutical during pregnancy, unless your doctor has advised you to do so. You should not use Quetiapine Sandoz Pharmaceutical 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

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

Quetiapine Sandoz Pharmaceutical 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 less than 1 mmol of sodium (23 mg) per film-coated tablet; this is, essentially "sodium-free".

3. How to take Quetiapine Sandoz Pharmaceutical

Follow the administration instructions for 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 is usually between 150 mg and 800 mg.

• You will take your tablets once a day, at bedtime, or twice a day, depending on your disease.
• Swallow your tablets whole with the help of water.
• You can take the tablets with or without food.
• Do not drink grapefruit juice while taking quetiapine. It may affect how the medication works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to do so.

Liver problems

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

Elderly

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

Use in children and adolescents

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

If you take more Quetiapine Sandoz Pharmaceutical than you should

If you take more quetiapine than your doctor has prescribed, you may feel drowsy, dizzy, and experience abnormal heartbeats.

If you have taken more quetiapine than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Quetiapine Sandoz Pharmaceutical

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 Sandoz Pharmaceutical

If you stop taking quetiapine 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 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 will 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), which 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 recommended.
• 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.
• Thoughts of suicide 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:
• • Both in men and women, having swollen breasts and unexpected milk production.
  • 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 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 an ECG (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 (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.
• Worsening of pre-existing diabetes.
• Confusion.

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 of 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.
• Decrease in body temperature (hypothermia).
• Pancreas inflammation.
• A condition (called "metabolic syndrome") in which you may have a combination of three 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). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

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

• Red spots on the skin with irregular red patches (erythema multiforme). See section 2.
• Rapid onset of areas of red skin with small pus-filled bumps (small blisters filled with white/yellow liquid known as 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).
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during 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 Sandoz Farmacéutica 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 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.

Additional 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 (which may lead to falls).
• Stuffy nose.
• Feeling irritated.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Sandoz Farmacéutica

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/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

6. Package Contents and Additional Information

Composition of Quetiapina Sandoz Farmacéutica

• The active ingredient is quetiapine. The tablets contain 100 mg of quetiapine (as quetiapine hemifumarate).
• The other ingredients (excipients) are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, povidone, sodium carboxymethyl starch Type A (potato starch), glycerol dibehenate, anhydrous colloidal silica, and magnesium stearate.

Coating of the tablet: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

The tablets are yellow, biconvex, round, and scored on one side. The tablet can be divided into equal doses.

They are presented in Al/Al or PVC-Aluminum blisters, in packages of 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the Last Revision of this Leaflet:July 2024

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/