QUETIAPINE TEVA-RATIO 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Quetiapine Teva-ratio 50 mg Film-Coated Tablets

quetiapine

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 and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See Section 4.

Contents of the Package Leaflet:

1. What Quetiapine Teva-ratio is and what it is used for
2. What you need to know before taking Quetiapine Teva-ratio
3. How to take Quetiapine Teva-ratio
4. Possible side effects
5. Storage of Quetiapine Teva-ratio
6. Package Contents and Additional Information

1. What Quetiapine Teva-ratio is and what it is used for

Quetiapine Teva-ratio contains a substance called quetiapine. It belongs to a group of medications called antipsychotics. Quetiapine Teva-ratio 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 Teva-ratio even when you are feeling better.

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

Do not takeQuetiapine Teva-ratio

• if you are allergic to quetiapine or any of the other ingredients of this medication (listed in Section 6).

• if you are taking any of the following medications:
• • Some medications for HIV.
  • Medications of the azole type (for fungal infections).
  • Erythromycin or clarithromycin (for infections).
  • Nefazodone (for depression).

If you are unsure, 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 a family member, have or have had any heart problems, such as heart rhythm problems, heart muscle weakness, or heart inflammation, or if you are taking any medication that may affect your heart rate.
• 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 with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Quetiapine Teva-ratio").
• 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 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 individuals.
• 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 bowel obstruction, or increased 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, you experience any of the following:

• A combination of fever, severe muscle stiffness, sweating, and decreased level of consciousness (a disorder called "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• Fast 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.
• 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 prolonged 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 bowel obstruction.
• 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 medications take time to work, usually around two weeks but sometimes longer. 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 from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression.

If at any time you think about harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may be helpful to tell a family member or close friend that you are depressed and ask them to read this 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 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 Medications and Quetiapine Teva-ratio

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

Do not take quetiapine if you are using any of the following medications:

• Some medications for HIV.
• Medications 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 those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tension, and body temperature above 38 °C (serotonin syndrome). Contact your doctor if you experience these symptoms.
• Medications that affect your heart rate, such as those 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-ratio with Food, Drinks, and Alcohol

• Quetiapine Teva-ratio can be taken with or without food.
• 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 medication works.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. 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.

Quetiapine Teva-ratio Contains Lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Quetiapine Teva-ratio Contains Sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

Effect on Drug Detection Tests in Urine

If you are undergoing a drug detection test in urine, 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 occurs, a more specific test can be performed.

3. How to Take Quetiapine Teva-ratio

Follow your doctor's instructions for taking this medication exactly. If you are unsure, 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 People

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 Teva-ratio Than You Should

If you take more quetiapine than your doctor has prescribed, you may feel drowsy, 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, Telephone: 915620420, indicating the medication and the amount taken.

If You Forget to Take Quetiapine 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 missed tablet.

If You Stop Taking Quetiapine Teva-ratio

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 suffer from them.

Very Frequent: may affect more than 1 in 10 people

• Decrease in hemoglobin levels (a protein in red blood cells that carries oxygen)
• Dizziness (may lead to falls), headache, dry mouth.

• Feeling of drowsiness (which may disappear over time, as you continue taking quetiapine) (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), which include being unable to sleep (insomnia), feeling nauseous, headache, diarrhea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is advised.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Frequent: may affect up to 1 in 10 people

• Rapid heartbeat.
• Feeling like your heart is beating strongly, beating fast, 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 (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 swelling of the breasts and unexpected production of milk.
  • In women, not having menstrual periods or having irregular periods.

Infrequent: 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 your face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart seen on the ECG (prolongation of the QT interval).
• Slower heart rate than normal, which can occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (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: may affect up to 1 in 1,000 people

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or dizzy (a disorder called "neuroleptic malignant syndrome").

• Yellowish color in the skin and eyes (jaundice).
• Liver inflammation (hepatitis).

• Prolonged and painful erection (priapism).
• Swelling of the breasts and unexpected production of milk (galactorrhea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• Walking, talking, eating, or other activities while you are asleep.
• Decrease in body temperature (hypothermia).
• Pancreas inflammation.
• A state (called "metabolic syndrome") in which you may have 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 blistering condition of 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).

Unknown: 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.
• 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).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of the blood vessels (vasculitis), often with a skin rash with small red or purple spots.

The class of medicines to which Quetiapina Teva-ratio belongs may cause heart rhythm problems that can be serious and, in severe cases, life-threatening.

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 number of red blood cells, increased creatine phosphokinase in the blood (a substance found in muscles), decreased amount of sodium in the blood, and increased amount of prolactin hormone in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:

• Both in men and women having swelling of the breasts and unexpected production of milk.
• In women, not having menstrual periods or having irregular periods.

Your doctor may ask you to have blood tests from time to time.

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 Frequent: may affect more than 1 in 10 people

• Increased amount of a hormone called prolactin in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:
• • Both in boys and girls having swelling of the breasts and unexpected production of milk.
  • In girls, not having menstrual periods or having irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Increased blood pressure.

Frequent: may affect up to 1 in 10 people

• Feeling of weakness, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritated.

Reporting of 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 does not appear 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 Teva-ratio

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

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Quetiapina Teva-ratio

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

The other ingredients are:

Core of the tablet: Hypromellose, calcium hydrogen phosphate dihydrate, lactose monohydrate, corn starch, sodium carboxymethyl starch Type A potato, magnesium stearate, microcrystalline cellulose, talc, and anhydrous colloidal silica

Coating of the tablet: Opadry white 20A28735 consisting of: hydroxypropylcellulose, hypromellose, titanium dioxide (E171), and talc

Appearance of Quetiapina Teva-ratio film-coated tablets and package contents

The tablets are white, round, biconvex, film-coated, with a score line on one side and a diameter of 7.8 mm.

They are presented in PVC opaque/Aluminum blister packs in packages of 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer

Genepharm S.A.

18th km Marathonos Ave,

Pallini Attikis, 15351

Greece

or

PharmaPath S.A.

1, 28th Oktovriou St.,

Agia Varvara, 123 51

Greece

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Date of the last revision of this leaflet: June 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/