QUETIAPINE TARBIS 300 mg PROLONGED-RELEASE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Quetiapine Tarbis 300 mg prolonged-release tablets EFG

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

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

This medicine contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine can be used to treat several diseases, such as:

• Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite or cannot sleep.
• Mania: where you may feel very excited, elated, 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.

When this medicine is used to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medicine that is being used to treat this disease.

Your doctor may continue to prescribe you this medicine even when you are feeling better.

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

Do not take Quetiapine Tarbis

• if you are allergic (hypersensitive) 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
  • azole-type medicines (for fungal infections)
  • erythromycin or clarithromycin (for infections)
  • nefazodone (for depression)

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if:

• You, or a family member, have or have had heart problems, such as problems with your 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. If so, your doctor may monitor your blood sugar levels while you are taking this medicine.
• You know you have had low white blood cell counts in the past (which may or may not have been caused by other medicines).
• You are an elderly person with dementia (loss of brain function). If so, you should not take quetiapine because the group of medicines it belongs to may increase the risk of stroke, or in some cases the risk of death, in these people.
• 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.
• You have depression or other conditions that are treated with antidepressants. The use of these medicines with Quetiapine Tarbis may cause a condition called serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Quetiapine Tarbis").

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

• A combination of fever, severe muscle stiffness, sweating or a decrease in consciousness level (a disorder called "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 injury (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 tiredness. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

These disorders may be caused by this type of medicine.

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 this medicine 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 blockage of the intestine.

Thoughts of suicide and worsening of your 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 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 help 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.

Weight gain

Weight gain has been observed in patients taking quetiapine. 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 Quetiapine Tarbis with other medicines

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

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

• Some medicines for HIV.
• Azole-type medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Neafazodone (for depression).

Tell 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, 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.
• Antidepressants. These medicines may interact with Quetiapine Tarbis and you may experience symptoms such as involuntary muscle contractions and rhythmic movements of the muscles, 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.

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

Taking Quetiapine Tarbis with food, drinks and alcohol

• This medicine 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 this medicine and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking quetiapine. It may affect the way the medicine works.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 this medicine during pregnancy, unless your doctor has told you to. You should not use this medicine if you are breast-feeding.

The following symptoms, which may represent a withdrawal syndrome, may appear in newborn babies 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

This medicine may cause symptoms such as drowsiness, dizziness or changes in vision, and may reduce your reaction ability. These effects, as well as the disease itself, may impair your ability to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Effect on urine drug screening tests

If you are undergoing a urine drug screening test, taking this medicine may produce positive results for methadone or certain antidepressant medicines 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.

3. How to take Quetiapine Tarbis

Follow exactly the administration instructions of this medicine given by your doctor. If you are not sure, 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 water.
• Take the tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when).
• Do not drink grapefruit juice while taking this medicine. It may affect the way 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 people

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

Use in children and adolescents

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

If you take more Quetiapine Tarbis than you should

If you take more medicine 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 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 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 forgotten tablet.

If you stop taking Quetiapine Tarbis

If you stop taking this medicine abruptly, you may experience insomnia, or you may feel nauseous, or you may experience headache, diarrhea, vomiting, dizziness or irritability. Your doctor may suggest gradually reducing the dose 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, quetiapine can cause adverse effects, although not all people suffer from them.

Very Common Adverse Effects(may affect more than 1 in 10 people):

• Dizziness (which could lead to falls), headache, dry mouth.
• Feeling of drowsiness (which may disappear over time as you continue taking this medicine) (which could lead to falls).
• Discontinuation symptoms (symptoms that occur when you stop taking quetiapine) 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).

Common 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 of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing up. This can make you feel dizzy or faint (which could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Disorder of speech and language.
• Suicidal thoughts and worsening of your 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 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):

• 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 heart's electrical activity seen on an ECG (prolongation of the QT interval).
• Slower than normal heart rate that can 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 Adverse 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 disorder called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Breast swelling and unexpected milk production (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 condition (called "metabolic syndrome") where you may suffer from a combination of three 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.
• Increase in creatine phosphokinase in the blood (a substance found in muscles).

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 condition of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

Unknown Frequency(frequency cannot be estimated from the available data):

• Skin rash with irregular red spots (erythema multiforme).
• Sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during their pregnancy.
• Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs involved (drug rash with those symptoms, also known as DRESS). If you develop these symptoms, stop using quetiapine and contact your doctor or seek immediate medical attention.
• Cardiac muscle disorder (cardiomyopathy)
• Cardiac muscle inflammation (myocarditis)
• Vascular inflammation (vasculitis), often with a skin rash with small red or purple spots.

The class of medicines to which quetiapine belongs can cause heart rhythm problems that can be serious and, in severe cases, potentially fatal.

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, increase in liver enzymes, decrease in the number of certain types of blood cells, decrease in the number of red blood cells, increase in creatine phosphokinase in the blood (a substance found in muscles), decrease in the amount of sodium in the blood, and 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 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 Common Adverse Effects (may affect more than 1 in 10 people):Increase in the 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 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.

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

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (website: www.notificaRAM.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Quetiapine Tarbis

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

This medicine does not require special storage conditions.

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

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 Quetiapine Tarbis

• The active ingredient is quetiapine. Each prolonged-release tablet contains 300 mg of quetiapine (as fumarate).
• The other ingredients (excipients) are: hypromellose, cellulose, microcrystalline, sodium citrate anhydrous, magnesium stearate, titanium dioxide (E-171), macrogol 400, polysorbate 80, yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172).

Appearance of the Product and Package Contents

The tablets of this medicine are light yellow in color and have "Q 300" engraved on one side.

The available packages are:

• Aluminum/PVC/Aclar blister pack. Package containing 60 tablets.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle Strasse 3

D-89143 Blaubeuren-Weiler

Germany

or

Teva UK

Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

United Kingdom

Date of the Last Revision of the 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/