QUETIAPINE RATIOPHARM 50 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Quetiapine ratiopharm 50 mg prolonged-release tablets EFG

quetiapine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 and other information

1. What is Quetiapine ratiopharm and what is it used for
2. What you need to know before you take Quetiapine ratiopharm
3. How to take Quetiapine ratiopharm
4. Possible side effects
5. Storage of Quetiapine ratiopharm
6. Contents of the pack and other information

1. What is Quetiapine ratiopharm and what is it used for

Quetiapine ratiopharm contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine ratiopharm 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 ratiopharm prolonged-release tablets are used to treat major depressive episodes in major depressive disorder, they will be taken in addition to another medication that is being used to treat this disease.

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

2. What you need to know before you take Quetiapine ratiopharm

Do not takeQuetiapineratiopharmif:

• you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).
• 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 ratiopharm.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapine ratiopharm:

• if you, or someone in your family, have or have had any heart problems, such as problems with the heartbeat, weakening of the heart muscle or inflammation of the heart, or if you are taking any medication that may affect your heartbeat.
• 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 "Use of Quetiapine ratiopharm with other medicines").
• 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 medicines to which Quetiapine ratiopharm 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 medicines like this one have been associated with the formation of blood clots.
• if you have or have had a condition in which your breathing is interrupted for short periods of time during normal nighttime sleep (called "sleep apnea") and are taking medications that reduce 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 ratiopharm 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 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 serious 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 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 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 be helpful to tell a relative 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 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 (NET), 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 increase in the 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 ratiopharm 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 ratiopharm should not be used in children and adolescents under 18 years of age.

Use of Quetiapine ratiopharm with other medicines

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

Do not take Quetiapine ratiopharm if you are using 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).

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).
• Antidepressants. These medications can interact with Quetiapine ratiopharm and you may experience symptoms such as involuntary 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.
• Medicines that affect your heartbeat, 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.

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

Taking Quetiapine ratiopharm with food, drinks, and alcohol

• Quetiapine ratiopharm 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 ratiopharm and alcohol can make you drowsy.
• Do not drink grapefruit juice while taking Quetiapine ratiopharm. 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 ratiopharm during pregnancy, unless your doctor has told you to. You should not use Quetiapine ratiopharm 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 drug detection tests in urine

If you are having 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 ratiopharm contains sodium

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

3. How to take Quetiapine ratiopharm

Follow the instructions for administration of this medicine exactly 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 disease and needs but will usually 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 ratiopharm. 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 patients

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

Use in children and adolescents

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

If you take more Quetiapine ratiopharm than you should

If you take more Quetiapine ratiopharm 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 ratiopharm tablets with you.

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

If you forget to take Quetiapine ratiopharm

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 taking Quetiapine ratiopharm

If you stop taking Quetiapine ratiopharm 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 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.

If you experience any of the following serious adverse effects, stop taking Quetiapina ratiopharmand 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.

Infrequent 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 hard 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 the veins.
• Severe upper stomach pain, often radiating to the 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 intestinal blockage.
• Yellowing of the skin and eyes(jaundice), dark urine, especially along with unusual fatigue or fever (signs of hepatitis).
• A prolonged and painful erection.
• A combination of fever, sweating, stiff muscles, feeling of drowsiness 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 blistering condition of 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.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) which consists of flu-like symptoms with skin rash, fever, lymph node inflammation, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes). See section 2.
• Heart muscle disorder (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Stroke

Other Possible Adverse Effects

Do not worry if you see a tablet in your stoolafter taking Quetiapina ratiopharm. As the tablet passes 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 (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 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.
• 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)

• 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 (may 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. Increased prolactin levels could, in rare cases, lead to:

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

Infrequent 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 (may lead to falls).
• Stuffy nose.
• Decrease in red blood cell count.
• Decrease in sodium levels in the blood.
• Worsening of pre-existing diabetes.
• Confusion

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

• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Walking, talking, eating, or other activities while you are asleep.
• 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, 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 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 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. Increased prolactin levels could, in rare cases, lead to:

• 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. Increased prolactin levels could, in rare cases, lead to:

• 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 of restlessness or muscle stiffness without pain.
  • Increased blood pressure.

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

• Feeling of weakness, fainting (may 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 leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Quetiapina ratiopharm

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

Do not use this medicine after the expiration date stated 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 ratiopharm does not require any special storage temperature.

Only for bottles

After the first opening of the package, the product must be used within 60 days.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at 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 Quetiapina ratiopharm

The active ingredient is quetiapine. Quetiapina ratiopharm 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 ratiopharm 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, 20, 30, 50, 50x1 (single-dose blister pack) (hospital packaging), 56 (calendar pack), 60, 90, or 100 tablets.

Not all pack 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

PHARMACHEMIE B.V. Swensweg, 5. P.O. Box 552 (Haarlem) - NL-2003 RN - Netherlands

MERCKLE GMBH Ludwig-Merckle-Strasse, 3 (Blaubeuren) - D-89143 - Germany

TEVA UK LIMITED Brampton Road, Hampden Park (Eastbourne, East Sussex) - BN22 9AG - United Kingdom

TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY

Pallagi ut 13 (Debrecen) - H-4042 - Hungary

TEVA CZECH INDUSTRIES S.R.O.

Ostravska 29, c.p. 305, Building No 80 Small OSD and building No 881 NOSD

(Opava-Komarov) - 747 70 - Czech Republic

TEVA PHARMA, S.L.U. C/ C, n 4 Polígono Industrial Malpica (Zaragoza) - 50016 - Spain

TEVA OPERATIONS POLAND SP.Z.O.O. Ul. Mogilska 80 (Krakow) - 31-546 - Poland

Date of Last Revision of this Leaflet: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/"