PATIENT INFORMATION LEAFLET

QuetiapinaTarbis 400 mg prolonged-release tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

This medication contains a substance called quetiapina. It belongs to a group of medications called antipsicotics. Quetiapina may be used to treat various diseases, such as:

• Bipolar depression and major depressive episodes in major depressive disorder: for which you may 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 this medication to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medication that is being used to treat this disease.

Your doctor may continue prescribing this medication even when you are feeling better.

Do not take QuetiapinaTarbis

• if you are allergic (hypersensitive) to quetiapina or to 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)

Do not take this medicine if the above applies to you. If you are unsure, consult your doctor or pharmacist before takingthismedicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to takethismedicine if:

• You, or a family member, have or have had any heart problems, for example, irregular heart rhythm, weakening of the heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect your heart rhythm.
• You have low blood pressure.
• You have had a stroke, especially if you are elderly.
• You have liver problems.
• You have ever had a seizure (convulsion).
• You have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while you are taking this medicine.
• You know that you have had low white blood cell counts (which may or may not have been caused by other medicines).
• You are an elderly person with dementia (loss of brain function). If so, do not takequetiapinabecause the group of medicines to which it belongs may increase the risk of stroke or, in some cases, death in these people.
• You or a family member have a history of blood clots, as medicines like this have been associated with the formation of blood clots.
• You have depression or other conditions that are treated with antidepressants. The use of these medicines with quetiapina may cause serotonin syndrome, a potentially fatal condition (see "Other medicines and Quetiapina Tarbis").

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

• A combination of fever, intense muscle stiffness, sweating, or a decrease in consciousness (a condition known as "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).
• Prolonged and painful erection (priapism).
• Rapid and irregular heartbeats, even when at rest, palpitations, breathing problems, chest pain, or unexplained fatigue. Your doctor will examine your heart and, if necessary, refer you to a cardiologist immediately.

These disorders may be caused by this type of medicine.

Inform your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as it may be a consequence of very low white blood cell counts and require discontinuation of this medicine and/or additional treatment.
• Constipation 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 when you first start treatment, as all these medicines take time to work, 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 from clinical trials has shown an increased risk of thoughts of suicide and/or suicidal behavior in young adults under 25 with depression.

If you ever think about harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a close family member or friend that you are depressed, and ask them to read this leaflet. You may ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Weight gain

Weight gain has been observed in patients taking quetiapina. You and your doctor should monitor your weight regularly.

Children and adolescents

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

Taking Quetiapina Tarbis with other medicines

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

Do not takequetiapinaif 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).

Inform your doctor if you are taking any of the following medicines:

• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or lithium (other antipsychotic medicines).
• Medicines that affect your heart rhythm, for example, medicines that may cause an imbalance of electrolytes (low potassium or magnesium) such as diuretics (medicines for urination) or certain antibiotics (medicines for treating infections).
• Medicines that may cause constipation.
• Antidepressants. These medicines may interact with Quetiapina Tarbis 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 a body temperature above 38 °C (serotonin syndrome). Contact your doctor when you experience these symptoms.

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

Taking Quetiapina Tarbis with food, drinks, and alcohol

• This medicine may be affected by food and you should take your tablets at least one hour before a meal or before going to bed.
• Be careful about the amount of alcohol you drink. This is because the combined effect of this medicine and alcohol may make you drowsy.
• Do not take grapefruit juice while taking quetiapina. It may affect how the medicine works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Do not take this medicine during pregnancy unless your doctor has advised you to. Do not use this medicine if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may appear in newborn babies of mothers who have used quetiapina in the last trimester (last three months of pregnancy): shivering, 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 operating machinery

This medicine may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying illness, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Effect on Drug Detection Tests in Urine

If you are undergoing a urine drug detection test, taking this medicine may produce positive results for methadone or certain antidepressants known as tricyclic antidepressants (TCAs) when using certain analysis methods, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Follow exactly the administration instructions of 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 normally 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 this medication. 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 adults

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

Use in children and adolescents

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

If you take more Quetiapina Tarbis than you should

If you take more medication than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring your Quetiapina tablets with you. You can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Quetiapina Tarbis

If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for the missed tablet.

If you interrupt the treatment with Quetiapina Tarbis

If you stop taking this medication 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 medications,quetiapinemay cause side effects, although not everyone will experience them.

Very common side 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 to take this medication) (which could lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine) include insomnia, nausea, 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, tremor, feeling restless or stiff without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common side effects(may affect up to 1 in 10 people):

• Fast heart rate.
• Feeling like your heart is pounding, beating too quickly, or having irregular heartbeats.
• Constipation, indigestion.
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This may cause you to feel dizzy or faint (which could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased hunger.
• Feeling irritable.
• Speech and language disorders.
• Thoughts of suicide and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in older people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decreased number of certain types of blood cells.
• Increased levels of liver enzymes measured in the blood.
• Increased levels of prolactin hormone in the blood. Elevated levels of prolactin hormone may, in rare cases, lead to:
• • Both men and women having breast swelling and unexpected milk production.
  • Women not having a menstrual period or having irregular periods.

Uncommon side effects(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 heart activity 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.
• Decreased number of red blood cells in the blood.
• Decreased sodium levels in the blood.

Rare side effects(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 you are asleep.
• Decreased body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (known as "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 side effects(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 condition (Stevens-Johnson syndrome).
• Incorrect secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

Not known(the frequency cannot be estimated from the available data):

• Rashes on the skin with irregular red spots (erythema multiforme).
• Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).
• Symptoms of withdrawal in newborn babies of mothers who have taken quetiapine during pregnancy.
• Drug rash with eosinophilia and systemic symptoms (DRESS, for its acronym in English). Generalized rash, high 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 taking quetiapine and contact your doctor or seek medical attention immediately.
• Heart muscle disorder (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Inflammation of blood vessels (vasculitis), often with a skin rash with small red or purple spots.

The class of medications to whichQuetiapinebelongs may cause heart rhythm problems that can be serious and, in severe cases, 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, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase in the blood (a substance found in muscles), decreased sodium levels in the blood, and increased levels of prolactin hormone in the blood. Elevated levels of prolactin hormone may, in rare cases, lead to:

• Both 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 side effects (may affect more than 1 in 10 people):Increased levels of a hormone called prolactin in the blood. Elevated levels of prolactin hormone may, in rare cases, lead to:

• • Both 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 stiff without pain.
• Increased blood pressure.

Common side effects(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 or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (website: www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Thismedicationdoes not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointat 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 Tarbis

• The active ingredient is quetiapine. Each prolonged-release tablet contains 400 mg of quetiapine (as fumarate).
• The other components (excipients) are: hypromellose, cellulose, microcrystalline, anhydrous sodium citrate, magnesium stearate, titanium dioxide (E-171), macrogol 400, polysorbate 80.

Appearance of the product and contents of the packaging

The tablets of this medication are white in color and have "Q 400" engraved on one side.

The available packaging are:

• Aluminum/PVC/Aclar blister packaging containing 60 tablets.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for Manufacturing

Merckle GmbH

Ludwig-Merckle Strasse 3

D-89143 Blaubeuren-Weiler

Germany

or

Teva UK

Brampton Road, HampdenPark, Eastbourne, East Sussex, BN22 9AG

United Kingdom

Last review date of the leaflet:July 2024

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