Quetiapine Tarbis 50 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

QuetiapinaTarbis 50 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

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

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

This medicine contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Quetiapine may be used to treat several conditions, 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 are unable to sleep.
• Mania: for which you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including aggressive or violent behavior.
• 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 this medicine is used to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medicine you are already using for this condition.

Your doctor may continue prescribing this medicine even after you start feeling better.

2. What you need to know before taking Quetiapine Tarbis

Do not take Quetiapine Tarbis

• if you are allergic (hypersensitive) to quetiapine 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
  • 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 in any doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

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

• You, or a family member, have or have had any heart problems, for example, irregular heartbeat, weakened heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect your heartbeat.
• 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 (epileptic fit).
• 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 previously had low levels of white blood cells (which may or may not have been caused by other medicines).
• You are an elderly person with dementia (loss of brain functions). If so, you should not take quetiapine, as the group of medicines it belongs to may increase the risk of stroke, or in some cases the risk of death, in these individuals.
• You or a family member have a history of blood clots, as medicines like this have been associated with blood clot formation.
• You suffer from depression or other conditions treated with antidepressants. Using these medicines together with Quetiapine Tarbis may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Quetiapine Tarbis").

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

• A combination of fever, severe muscle stiffness, sweating, or decreased level of consciousness (a disorder known as "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feel very sleepy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (epileptic fits).
• A prolonged and painful erection (priapism).
• Fast or irregular heartbeats, even at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.

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 this could be due to a very low count of white blood cells and may require stopping treatment with this medicine and/or additional treatment.
• Constipation together with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more serious intestinal blockage.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. This may increase at the beginning of treatment, as all these medicines take time to work, usually about two weeks but sometimes longer. These thoughts may also increase if you suddenly stop taking your medication. You may be more likely to have such thoughts if you are a young adult. Data from clinical trials have shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults under 25 years of age with depression.

If at any time you have thoughts of harming yourself or of 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 inform 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

This medicine must 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, have recently taken, or might need to take any other medicine.

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).
• Nefazodone (for depression).

Tell your doctor if you are taking any of these 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 heartbeat, for example, medicines that may cause an imbalance in electrolytes (low levels of potassium or magnesium), such as diuretics (medicines to increase urine production) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Antidepressants. These medicines may interact with Quetiapine Tarbis and you may experience symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor if 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 therefore you should take your tablets at least one hour before a meal or before bedtime.
• 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 drink grapefruit juice while taking quetiapine. 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. You should not take this medicine during pregnancy unless advised by your doctor. You should not use this medicine if you are breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may occur in newborns whose mothers have used quetiapine during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. 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 vision disturbances, and may reduce your reaction time. These effects, as well as the illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed 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 known as tricyclic antidepressants (TCAs) when certain analytical methods are used, even though you may not be taking methadone or TCAs. If this occurs, a more specific test can be performed.

3. How to take Quetiapine Tarbis

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. Your doctor will determine your starting dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but will usually be between 150 mg and 800 mg.

• You will take your tablets once daily.
• Do not split, chew, or crush the tablets.
• Swallow the tablets whole with water.
• Take the tablets without food (at least one hour before a meal or at bedtime; your doctor will advise you when to take them).
• Do not drink grapefruit juice while taking this medicine. 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 adjust your dose.

Elderly patients

If you are elderly, your doctor may adjust your dose.

Use in children and adolescents

This medicine must 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 prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Take the quetiapine tablets with you. You may also call the Toxicology Information Service at: 91 562 04 20, stating the name of 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 missed tablet.

If you stop taking Quetiapine Tarbis

If you stop taking this medicine abruptly, you may have difficulty sleeping (insomnia), or may experience nausea, headache, diarrhoea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, quetiapine may cause adverse effects, although not everyone experiences them.

Very common adverse effects (may affect more than 1 in 10 people):

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which may disappear over time as you continue taking this medicine) (which may lead to falls).
• Discontinuation symptoms (symptoms that occur when you stop taking quetiapine) include inability to sleep (insomnia), feeling nauseous, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, feeling restless, or painless muscle stiffness.
• Changes in levels of certain fats (triglycerides and total cholesterol).

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

• Fast heartbeat.
• Feeling as if your heart is pounding, racing, or having irregular beats.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing up. This may make you feel dizzy or faint (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased hunger.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in levels of thyroid hormones in blood.
• Decrease in the number of certain types of blood cells.
• Increases in liver enzyme levels measured in blood.
• Increases in blood levels of the hormone prolactin. Elevated prolactin levels may, in rare cases, lead to:
  • Breast enlargement and unexpected milk production in both men and women.
  • In women, absence of menstrual periods or irregular periods.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Epileptic seizures or convulsions.
• Allergic reactions which may include raised, itchy rashes (hives), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrollable movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the heart's electrical activity seen on ECG (QT interval prolongation).
• Slower than normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which may lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells in blood.
• Decrease in the amount of sodium in blood.

Rare adverse effects (may affect up to 1 in 1,000 people):

• A combination of high temperature (fever), sweating, muscle stiffness, and feeling very drowsy or dizzy (a disorder known as "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged, painful erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhoea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you experience 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 (called "metabolic syndrome") in which you may experience a combination of 3 or more of the following effects: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a type of fat in the blood called triglycerides, increased blood pressure, and increased 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 known as agranulocytosis.
• Intestinal obstruction.
• Increased blood creatine phosphokinase (a muscle substance).

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) which may cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A serious condition with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Rupture of muscle fibers and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

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

• Skin rashes with irregular red patches (erythema multiforme).
• Sudden, severe allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis).
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy. Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (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 immediate medical attention.
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of blood vessels (vasculitis), often with a skin rash showing small red or purple spots.

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

Some adverse effects are only detected through blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased red blood cell count, increased blood creatine phosphokinase (a substance found in muscles), decreased sodium levels in blood, and increased blood levels of the hormone prolactin. Elevated prolactin levels may, in rare cases, lead to:

• Breast enlargement and unexpected milk production in both men and women.
• In women, absence of menstrual periods or 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 may occur in adults may also occur in children and adolescents.

The following adverse effects have been observed more frequently in children and adolescents, or were not observed in adults:

Very common adverse effects (may affect more than 1 in 10 people): Increased levels of a hormone called prolactin in blood. Elevated prolactin levels may, in rare cases, lead to:

• • Breast enlargement and unexpected milk production in both boys and girls.
  • In girls, absence of menstrual periods or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless, or painless muscle stiffness.
• Increased blood pressure.

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

• Feeling weak, fainting (which may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (website: www.notificaRAM.es). By reporting adverse effects, you can help provide 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 any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quetiapine Tarbis

• The active substance is quetiapine. Each prolonged-release tablet contains 50 mg of quetiapine (as fumarate).
• The other components (excipients) are: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate, titanium dioxide (E-171), polyethylene glycol 400, polysorbate 80, yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172).

Appearance of the medicine and contents of the pack

The tablets of this medicine are brown and are marked with “Q 50” on one side.

Available pack sizes are:

• Aluminium/PVC/Aclar blister. Pack 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 most recent revision of the leaflet: July 2024

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