Package Insert: Information for the User

Quetiapina Sandoz Pharmaceutical400 mg Extended-Release Tablets EFG

Read this package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others who may 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 package insert. See section 4.

Quetiapina Sandoz Pharmaceutical contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine can be used to treat several illnesses, 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 your 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 quetiapine to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medicine that is being used to treat this illness.

Your doctor may continue prescribing quetiapine, even when you are feeling better.

Do not takeQuetiapina Sandoz Pharmaceutical

• If you areallergicto quetiapine or to any of the other ingredients 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 infections),
• Nefazodone (for depression).

If you have any doubts, consult your doctor or pharmacist before taking quetiapine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapina Sandoz Pharmaceutical 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 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. 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 medications),
• You are an elderly person with dementia (loss of brain function). If so, do not take quetiapine because the group of medications to which quetiapine belongs may increase the risk of stroke or, in some cases, death in these people,
• You are an elderly person with Parkinson's disease/parkinsonism,
• You or a family member has a history of blood clots, as medications like these have been associated with blood clot formation,
• You have or have had a condition in which your breathing is interrupted by brief periods of time during normal nighttime sleep (called "sleep apnea") and are taking medications that decrease normal brain activity ("depressants"),
• You have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, an intestinal obstruction, or high pressure inside your eye. These conditions may be caused by medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions,
• You have a history of alcohol or drug abuse,
• If you have depression or other conditions that are treated with antidepressants. The use of these medications with Quetiapina Sandoz Pharmaceutical may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Quetiapina Sandoz Pharmaceutical").

Inform your doctor immediately if after taking quetiapine you experience any of the following:

• A combination of fever, intense muscle stiffness, sweating, or a decrease in consciousness (a condition called "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),
• A 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 medication.

Inform your doctor as soon as possible if you have:

• Fever, symptoms similar to the flu, sore throat, or any other infection, as it could be a consequence of a very low white blood cell count and require discontinuation of quetiapine treatment and/or additional treatment.
• Constipation along 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 medications take time to be effective, 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 thoughts of suicide and/or suicidal behavior in young adults under 25 years old with depression.

If you ever think about harming yourself or committing suicide, contact your doctor or go to the 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 may 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 rarely reported severe skin reactions (SCARs) have been noted, which may put your life at risk or be fatal. These typically manifest as:

• Stevens-Johnson syndrome (SSJ), a generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (NET), a more severe form that causes extensive skin peeling.
• 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).
• Generalized Acute 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 Quetiapina 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 regularly monitor your weight.

Children and adolescents

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

Other medicationsandQuetiapina Sandoz Pharmaceutical

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

Do not take quetiapine 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).

Inform 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 falling asleep).
• Thioridazine or Lithium (other antipsychotic medications).
• Medications that affect your heart rate, for example, medications that may cause an imbalance of electrolytes (low potassium or magnesium levels) such as diuretics (medications to urinate) or certain antibiotics (medications to treat infections).
• Medications that may cause constipation.
• Medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.
• Antidepressants. These medications 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 medications, consult your doctor first.

TakingQuetiapinaSandoz Pharmaceutical with food, drinks, and alcohol

• Quetiapine may be affected by food, so 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 and alcohol may make you drowsy.
• Do not take grapefruit juice while taking quetiapine. It may affect how the medication works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Do not take quetiapine during pregnancy, unless you have consulted your doctor. Do not use quetiapine if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may appear in newborns of mothers who have used quetiapine in the last trimester (last three months of their pregnancy): tremor, 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 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.

Effect on drug detection tests in urine

If you are undergoing a urine drug detection test, taking quetiapine may produce positive results for methadone or certain antidepressant medications called 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.

Quetiapina Sandoz Pharmaceutical 400 mg contains sodium

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

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 grapefruit juice while taking quetiapina. 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.

Older age

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

Use in children and adolescents

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

If you take moreQuetiapina Sandoz Pharmaceuticalthan you should

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

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

If you forget to takeQuetiapina 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 the missed doses.

If you interrupt treatment with Quetiapina Sandoz Pharmaceutical

If you stop taking quetiapina 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:may affect more than 1 in 10 people

• Dizziness (which could lead to falls), headache, dry mouth.
• Feeling drowsy (which may disappear over time as you continue to take quetiapine) (which could lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine) that include being unable to sleep (insomnia), feeling nauseous, headache, diarrhea, vomiting, dizziness, and irritability. It is recommended to taper off gradually over a period of at least1 to2 weeks.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremor, feeling restless 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

• Fast heart rate.
• Feeling like your heart is beating strongly, beating quickly, or having irregular heartbeats.
• Constipation, indigestion.
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This can make you feel dizzy or faint (which could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling hungrier.
• Feeling irritable.
• Speech and language disorders.
• 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. Prolactin increasesmay in rare cases lead to the following:
• • Both in men and women having breast swelling and unexpected milk production.
  • In women not having a menstrual period or having irregular periods.

Uncommon:(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 the electrical activity of the heart 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 could 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: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).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).
• Breast swelling 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 help immediately.
• Walking, talking, eating, or other activities while asleep.
• Decrease in body temperature (hypothermia).
• Inflammation of the pancreas.
• 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, symptoms similar to the flu, sore throat, or any other infection with a very low white blood cell count, a condition known as 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 (known as anaphylaxis) that may cause difficulty breathing or shock.
• Quick swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• Severe skin blistering, mouth, eyes, and genital areas (Stevens-Johnson syndrome).
• Incorrect secretion of a hormone that controls urine volume.
• Muscle fiber rupture and muscle pain (rhabdomyolysis).

Frequency not known: cannot be estimated from available data

• Rashes on the skin with irregular red spots (erythema multiforme).
• Quick appearance of areas of red skin with small white/yellow-filled blisters (Pustulosis Exanthemática Generalizada Aguda (AGEP)).See section 2.
• Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).
• Medication reaction with eosinophilia and systemic symptoms (DRESS, for its acronym in English), 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).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of blood vessels (vasculitis), often with skin rash with small red or purple spots.

The class of medicines to which quetiapine belongs can cause heart rhythm problems that can be serious and in severe cases may be fatal.

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, decreases in the number of certain types of blood cells, decreases in the number of red blood cells, increases in the amount of creatine-phosphocinase in the blood (a substance found in muscles), decreases in the amount of sodium in the blood, and increases in the amount of prolactin hormone in the blood. Prolactin increasesmay in rare cases lead to the following:

• Both in men and women having breast swelling and unexpected milk production.
• Women not having a menstrual period or having irregular periods.

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:may affect more than 1 in 10 people

• Increased amount of a hormone called prolactin in the blood. Prolactin increasesmay in rare cases lead to the following:

• Both in boys and girls having breast swelling and unexpected milk production.
• Girls not having a menstrual period or having irregular periods.

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

Common:may affect up to 1 in 10 people

• Feeling weak, fainting (which could lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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 and blister after CAD/EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Quetiapina Sandoz Pharmaceutical

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

Tablet core: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, and magnesium stearate.

Tablet coating: titanium dioxide (E-171), hypromellose, macrogol 400, and polisorbate 80.

Appearance of the product and contents of the packaging

The tablets are white, oblong, biconvex, and have “Q 400” engraved on one face and are smooth on the other face.

They are presented in: aluminum/PVC-PVDC blister, in packs of 60 tablets.

Holder of the marketing authorizationand responsible for manufacturing

Holder of the marketing authorization

Sandoz Pharmaceutical, S.A.

Corporate Park North

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle Strasse 3

D-89143 Blaubeuren-Weiler

Germany

Last review date of the leaflet: July 2024

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