Package Insert: Information for the Patient

Quetiapina Tarbis 25 mg Film-Coated Tablets EFG

Quetiapine hemifumarate

Read this package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for 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 any adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this package insert. See Section 4.

1.What Quetiapina Tarbis is and for what it is used

2.What you need to know before takingQuetiapina Tarbis

3.How to takeQuetiapina Tarbis

4.Possible adverse effects

5.Storage ofQuetiapina Tarbis

6.Contents of the package and additional information

Quetiapina Tarbis contains a substance called quetiapine. It belongs to a group of medications called antipsychotics.Quetiapina Tarbiscan be used to treat various illnesses, such as:

• Bipolar depression: by which you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite or cannot sleep.
• Mania: by which you may feel extremely excited, euphoric, agitated, enthusiastic or hyperactive or display poor judgment which includes being aggressive or violent.
• Schizophrenia: by 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.

Your doctor may continue prescribingQuetiapina Tarbiseven when you are feeling better.

Do not takeQuetiapina Tarbis:

• If you are allergic (hypersensitive) to quetiapine or to any of the other ingredients ofQuetiapina Tarbisfilm-coated tablets(including those 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 Quetiapina Tarbis if the above applies to you.If you are unsure, consult your doctor or pharmacist before takingQuetiapina Tarbis.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeQuetiapina Tarbisif:

• You, or a family member, have or have had any heart problems, for example, irregular heart rhythm, heart muscle weakness or heart inflammation, or if you are taking any 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 had a seizure (convulsion).
• You have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while you are taking quetiapine.
• You know that you have had low white blood cell counts (which may or may not have been caused by other medicines).
• You are an elderly person with dementia (loss of brain function). If so, do not takequetiapinebecause the group of medicines to whichQuetiapina Tarbisbelongs may increase the risk of stroke or, in some cases, death in these people.
• You or a family member has a history of blood clots, as medicines like these 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 Tarbis may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Quetiapina Tarbis”).

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

• A combination of fever, intense muscle stiffness, sweating or a decrease in level of 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).
• A prolonged and painful erection (priapism).
• Fast 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 conditions 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 a very low white blood cell count and require discontinuation of quetiapine treatment 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 at the beginning of 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 behaviour 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 behaviour.

Weight gain

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

Children and adolescents

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

Use ofQuetiapina Tarbiswith other medicines

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

Do not takeQuetiapina Tarbisif 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 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).
• 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 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.

TakingQuetiapina Tarbiswith food, drinks and alcohol

• Quetiapina Tarbis can be taken with or without food.
• Be careful with the amount of alcohol you drink. This is because the combined effect ofQuetiapina Tarbisand alcohol may make you drowsy.
• Do not take grapefruit juice while takingQuetiapina Tarbis. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Do not takeQuetiapina Tarbisduring pregnancy, unless you have consulted your doctor. Do not useQuetiapina Tarbisif you are breastfeeding.

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

This medicine may make you feel drowsy. Do not drive or operate tools or machines until you know how the tablets affect you.

Quetiapina Tarbiscontains lactose

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

Effect on Drug Detection Tests in Urine

If you are having a drug detection test in urine, taking quetiapine may produce positive results for methadone or certain antidepressants called tricyclic antidepressants (TCAs) when using some methods of analysis, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your illness and needs, but will normally be between 150 mg and 800 mg.

• You will take your tablets once a day, at bedtime, or twice a day, depending on your illness.
• Swallow your tablets whole with the help of water.
• You can take the tablets with or without food.
• Do not take grapefruit juice while takingQuetiapina Tarbis. 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

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

If you take moreQuetiapina Tarbisthan you should

If you take moreQuetiapina Tarbisthan your doctor prescribed, you mayfeel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring yourQuetiapina Tarbistablets with you.

You can also call the Toxicological Information Service, Phone: 915620420, indicating the medication and the amount taken.

If you forget to takeQuetiapina Tarbis

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 dose.

If you interrupt treatment withQuetiapina Tarbis

If you stop takingQuetiapina Tarbisabruptly, you may be unable to sleep (insomnia), or you may feel nausea, or you may experience headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest reducing the dose gradually before stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may 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.

• Sensation of drowsiness (which may disappear over time as you continue to take quetiapine), (which could lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), which include insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability. It is recommended to taper off over a period of at least 1 to 2 weeks.
• 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 beating strongly, rapidly, or irregularly.

• Constipation, indigestion.
• Sensation of weakness.

• Swelling of arms or legs.

• Low blood pressure when standing. This may cause dizziness or fainting (which could lead to falls).

• Increased blood sugar levels.

• Blurred vision.

• Abnormal dreams and nightmares.
• Feeling hungrier.
• Feeling irritable.
• Speech and language disorders.
• Thoughts of suicide and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increases in liver enzymes measured in the blood.
• Increases in the amount of prolactin hormone in the blood. Prolactin increases may, in rare cases, lead to the following:
• • 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.
• Decrease in the number of red blood cells in the blood.
• Decrease in the amount of sodium 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").

• Yellowish discoloration of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).

• Prolonged and painful erection (priapism).
• Swelling of the breasts and unexpected milk production (galactorrhea).
• Menstrual disorders.
• Clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical help immediately.
• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (known as "metabolic syndrome") in which you may have 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, flu-like symptoms, 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).
• A severe condition of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Incorrect secretion of a hormone that controls urine volume.
• Rupture of muscle fibers and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

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

• Rashes on the skin with irregular red spots (erythema multiforme).
• Severe and sudden allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).
• Infants born to mothers who have used quetiapine during pregnancy may experience withdrawal symptoms.
• Drug rash with eosinophilia and systemic symptoms (DRESS), a generalized rash, high body temperature, elevated liver enzymes, abnormal blood tests (eosinophilia), swollen lymph nodes, and other affected organs. If you develop these symptoms, stop taking quetiapine and contact your doctor or seek medical attention immediately.
• Cardiomyopathy (heart muscle disorder).
• Myocarditis (inflammation of the heart muscle).
• Vasculitis (inflammation of blood vessels), often with a skin rash of small red or purple spots.

The class of medicines to which quetiapine belongs 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 numbers of certain types of blood cells, decreased red blood cells, increased creatine phosphokinase in the blood (a substance found in muscles), decreased sodium in the blood, and increased prolactin hormone in the blood. Prolactin increases may, in rare cases, lead to the following:

• 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 amount of a hormone called prolactin in the blood. Prolactin increases may, in rare cases, lead to the following:
• • 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):

• Sensation of weakness, fainting (which could lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and the

medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications you no longer need. In this way, you will help protect the environment.

Composition ofQuetiapina Tarbis

The active ingredient is quetiapine. The tablets contain 25 mg of quetiapine (as quetiapine hemifumarate).

The other components are:

Tablet core: lactose monohydrate (lactose), microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A) from potato (potato starch), glycerol dibehenate, anhydrous colloidal silica, and magnesium stearate.

Tablet coating:lactose monohydrate (lactose), hypromellose, titanium dioxide (E171), macrogol 4000, and iron oxide red (E172).

Appearance ofQuetiapina Tarbisand content of the container

The tablets are pink, biconvex, and round.

They are presented in PVC/Aluminum and Aluminum/Aluminum blisters, in containers of6 and 60tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma, S.L

Gran Via Carlos III, 94

08028 Barcelona (Spain)

Responsible for manufacturing

Laboratorios Lesvi, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona)

Amarox Pharma B.V.

Rouboslaan 32

2252TR Voorschoten

Netherlands

Last review date of this leaflet: July 2024

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