QUETIAPINE TEVA-RATIO 50 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Quetiapine Teva-ratio

Do not takeQuetiapine Teva-ratio:

• 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
• Medicines of the azole type (for fungal infections)
• Erythromycin or clarithromycin (for infections)
• Nefazodone (for depression).

If you are in doubt, consult your doctor or pharmacist before taking Quetiapine Teva-ratio.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapine Teva-ratio:

• if you, or someone in your family, 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.
• if you have low blood pressure.
• if you have had a stroke, especially if you are elderly.
• if you have liver problems.
• if you have ever had a seizure (convulsion).
• if you suffer from depression or other conditions that are treated with antidepressants. The use of these medications along with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Use of Quetiapine Teva-ratio with other medications").
• if 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.
• if 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).
• if you are an elderly person with dementia (loss of brain function). If so, you should not take quetiapine, because the group of medications to which Quetiapine Teva-ratio belongs may increase the risk of stroke, or in some cases the risk of death, in these people with dementia.
• if you are an elderly person with Parkinson's disease/parkinsonism.
• if 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 condition in which your breathing stops for short periods during normal nighttime sleep (called "sleep apnea") and are taking medications that decrease normal brain activity ("depressants").
• if 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 medications (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.
• if you have a history of alcohol or drug abuse.

Tell your doctor immediately if after taking Quetiapine Teva-ratio 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.
• 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.

• 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-lasting and painful erection (priapism).

These disorders can 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 can increase when you start treatment, as all these medications take time to work, usually around two weeks but sometimes more. These thoughts can 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 in 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.

Severe skin reactions (SCARs)

With the use of this medication, 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 rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (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 Teva-ratio 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 Teva-ratio should not be used in children and adolescents under 18 years of age.

Use of Quetiapine Teva-ratiowith other medications

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

Do not take Quetiapine Teva-ratio if you are using any of the following medications:

• Some medications for HIV.
• Medicines of the azole type (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).
• Antidepressants. These medications can interact with Quetiapine Teva-ratio and you may experience symptoms such as involuntary contractions and rhythmic muscle contractions, 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.
• 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 how nerve cells work, to treat certain medical conditions.

Before stopping any of your medications, consult your doctor first.

Taking Quetiapine Teva-ratiowith food, drinks, and alcohol

• Quetiapine Teva-ratio may be affected by food and should be taken 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 Teva-ratio and alcohol can make you drowsy.
• Do not drink grapefruit juice while taking Quetiapine Teva-ratio. It may affect how the medication works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not take Quetiapine Teva-ratio during pregnancy, unless your doctor has told you to. You should not use Quetiapine Teva-ratio 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 their 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 use tools or machines 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 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 Teva-ratio contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Quetiapine Teva-ratio

Follow the instructions for administration 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.

• 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 Teva-ratio. 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.

Elderly patients

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

Use in children and adolescents

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

If you take moreQuetiapine Teva-ratiothan you should

If you take more Quetiapine Teva-ratio than your doctor has prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring the Quetiapine Teva-ratio tablets with you.

You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to takeQuetiapine Teva-ratio

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 forgotten tablet.

If you stop takingQuetiapine Teva-ratio

If you stop taking Quetiapine Teva-ratio 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 reducing the dose gradually before stopping treatment.

If you have any further questions on 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.

If you experience any of the following serious adverse effects, stop taking Quetiapina Teva-ratioand go to your doctor or nearest hospital immediately:

Frequent Adverse Effects(may affect up to 1 in 10 people)

• Suicidal thoughtsand worsening of your depression.

Uncommon Adverse Effects(may affect up to 1 in 100 people)

• Sudden fever, especially with sore throatand flu-like symptoms. These may be signs of a very low white blood cell count.
• Signs of skin reactionssuch as skin rash, hives, itching, redness, possibly with swelling of the face, eyelids, and lips. This could also cause difficulty breathing, dizziness, or shock.
• Seizuresor convulsions.
• Uncontrolled movements, mainly of your face or tongue (tardive dyskinesia).
• Feeling that your heart is beating very strongly or very fastalong with dizziness or fainting. This may be a sign of serious heart rhythm problems and in severe cases can be fatal.

Rare Adverse Effects(may affect up to 1 in 1,000 people)

• Painand/or swellingand redness in one of your legs; severe chest painthat may radiate to your left arm or difficulty breathingsuddenly. These may be signs of blood clots in your veins.
• Severe upper stomach pain, often radiating to your back, sometimes with nausea and vomiting. This may be a sign of pancreatitis.
• Constipationalong with persistent abdominal painor constipation that has not responded to treatment, as this can lead to a more serious bowel obstruction.
• Yellowing of the skin and eyes(jaundice), dark urine, especially along with unusual tiredness or fever (signs of hepatitis).
• A prolonged and painful erection.
• A combination of fever, sweating, stiff muscles, feeling drowsy or fainting (a disorder called "neuroleptic malignant syndrome").

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 skin condition with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

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

• Skin rash with irregular red spots (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). See section 2.
• Heart muscle disorder (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Stroke

Drug reaction with eosinophilia and systemic symptoms (DRESS, for its acronym in English). 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 immediate medical attention.

Other Possible Adverse Effects

Do not worry if you see a tablet in your stoolafter taking Quetiapina Teva-ratio. As the tablet travels through your gastrointestinal tract, quetiapine is slowly released. The tablet shape remains undissolved and is eliminated in the stool. Therefore, although you may see a tablet in your stool, your dose of quetiapine has been absorbed.

Very Frequent Adverse Effects(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 taking quetiapine), (could 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. 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 restless or muscle stiffness without pain.
• Decrease in hemoglobin levels (proteins in red blood cells that carry oxygen).
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Frequent Adverse Effects(may affect up to 1 in 10 people)

• Fast heartbeat.
• Feeling like your heart is beating strongly, beating fast, or has skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing up. This can make you feel dizzy or faint (could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritable.
• Disorder of speech and language.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Changes 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. Increases in prolactin hormone may, in rare cases, lead to the following:

• Both in men and women having breast swelling 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)

• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Sexual dysfunction.
• Diabetes.
• Slower than normal heart rate, which may occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (could lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells in the blood.
• Decrease in sodium levels in the blood.
• Confusion

Rare Adverse Effects(may affect up to 1 in 1,000 people)

• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Decreased body temperature (hypothermia).
• 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, decreased "good" cholesterol (HDL-C), increased triglycerides in the blood, increased blood pressure, and increased blood sugar.
• Intestinal obstruction.
• Increased creatine phosphokinase in the blood (a substance found in muscles).

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Inappropriate secretion of a hormone that controls urine volume.

Unknown(frequency cannot be estimated from available data)

• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.
• Inflammation of blood vessels (vasculitis), often with a skin rash with small red or purple spots.

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 your blood, increased liver enzymes, decreased number of certain types of blood cells, decreased red blood cell count, increased creatine phosphokinase in the blood (a substance found in muscles), decreased sodium levels in the blood, and increased prolactin hormone levels in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:

• Both in men and women having breast swelling 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 Frequent Adverse Effects(may affect more than 1 in 10 people)

• Increased levels of a hormone called prolactin in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:

• Both in boys and girls having breast swelling 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 restless or muscle stiffness without pain.
  • Increased blood pressure.

Frequent Adverse Effects(may affect up to 1 in 10 people)

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

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 prospectus. 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 Teva-ratio

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 on the blister after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Quetiapina Teva-ratio does not require any special storage temperature.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Quetiapina Teva-ratio

The active ingredient is quetiapine. Quetiapina Teva-ratio tablets contain 50 mg of quetiapine (as quetiapine fumarate).

The other ingredients are:

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

Coating of the tablet: titanium dioxide (E171), hypromellose, macrogol/PEG 400, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172).

Appearance of Quetiapina Teva-ratio and Package Contents

The tablets are brown, biconvex, oblong, coated, and engraved with "Q 50" on one side.

They are available in packages of 10, 10x1 (perforated unit-dose blister), 20, 30, 30x1 (perforated unit-dose blister), 50, 50x1 (perforated unit-dose blister) (hospital package), 56 (calendar package), 60, 60x1 (perforated unit-dose blister), 90, 100, or 100x1 (perforated unit-dose blister) tablets

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11. Edificio Albatros B, 1ª planta.

28108 Alcobendas. Madrid

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770 Opava-Komarov

Czech Republic

PLIVA Krakow Zaklady Farmaceutyczne S.A.

ul. Mogilska 80. 31-546, Krakow

Poland

Teva Pharma, S.L.U.

C/C, n. 4, Polígono Industrial Malpica, 50016 Zaragoza

Spain

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

Adamed Pharma S.A

Pienków, ul. Mariana Adamkiewicza 6A

05-152 Czosnów

Poland

Date of the Last Revision of this Prospectus: July 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/ "

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75279/P_75279.html