QUETIAPINE SANDOZ 400 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Quetiapine Sandoz Pharmaceutical400 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, as 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 Sandoz Pharmaceutical and what is it used for
2. What you need to know before you take Quetiapine Sandoz Pharmaceutical
3. How to take Quetiapine Sandoz Pharmaceutical
4. Possible side effects
5. Storage of Quetiapine Sandoz Pharmaceutical
6. Pack contents and further information

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

Quetiapine Sandoz Pharmaceutical contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine 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 your appetite, or cannot sleep.
• 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 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 for you even when you feel better.

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

Do not takeQuetiapine Sandoz Pharmaceutical

• 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 quetiapine.

Warnings and precautions

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

• you, or a family member, have or have had any heart problems, such as problems with your heart rhythm, weakening of your heart muscle, or inflammation of your 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 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 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 this one 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 Sandoz Pharmaceutical may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Quetiapine Sandoz Pharmaceutical").

Tell your doctor immediately if, after taking quetiapine, 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 can increase the risk of accidental injuries (falls) in elderly patients,
• seizures (convulsions),
• a long 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 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 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.

• Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes think about 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 more. These thoughts can also increase if you stop taking your medication abruptly. You are 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 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 worried about changes in your behavior.

Severe skin reactions (SCARs)

With the use of this medicine, very rare 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 should not be used in children and adolescents under 18 years of age.

Other medicinesandQuetiapine Sandoz Pharmaceutical

Tell your doctor 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 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.
• 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 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.

TakingQuetiapineSandoz Pharmaceutical with food, drinks, and alcohol

• Quetiapine 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 quetiapine and alcohol can 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 plan to become pregnant, consult your doctor before using this medicine. You should not take quetiapine during pregnancy, unless your doctor has advised you to do so. You should not use quetiapine 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 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.

Quetiapine Sandoz Pharmaceutical 400 mg contains sodium

This medicine contains 25.6 mg of sodium (the main component of table salt) in each prolonged-release tablet. This is equivalent to 1.275% of the maximum recommended daily intake of sodium for an adult.

3. How to take Quetiapine Sandoz Pharmaceutical

Follow the instructions for administration of this medicine 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 it is usually 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. 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

If you are an elderly person, 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 moreQuetiapine Sandoz Pharmaceuticalthan you should

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

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

If you forget to takeQuetiapine Sandoz Pharmaceutical

If you forget to take a dose, take it as soon as you remember. If it is close to the 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 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 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 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: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 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: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 heart's electrical activity 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 (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.
• 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 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.
• 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, 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.
• Increased creatine phosphokinase in the blood (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).
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

Frequency Not Known: cannot be estimated from the available data

• Red spots on the skin with irregular red patches (erythema multiforme).
• Rapid appearance of red skin areas 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 quetiapine belongs may 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: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: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 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 help provide more information on the safety of this medicine.

5. Storage of Quetiapine Sandoz Pharmaceutical

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 and blister after CAD/EXP. The expiration date is the last day of the month indicated.

Store in the original package to protect it from moisture.

This medicine does not require any special storage temperature.

Medicines should not be disposed of through 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 Quetiapine Sandoz Pharmaceutical

• The active ingredient is quetiapine. Each tablet contains 400 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:

Core of the tablet: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, and magnesium stearate.

Coating of the tablet: titanium dioxide (E-171), hypromellose, macrogol 400, and polysorbate 80.

Appearance of the Product and Package Contents

The tablets are white, oblong, biconvex, and have "Q 400" engraved on one side and are smooth on the other side.

They come in: aluminum/PVC-PVDC blister packs, in packages of 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle Strasse 3

D-89143 Blaubeuren-Weiler

Germany

Date of the Last Revision of the 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/