Quetiapine Tarbis 400 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

QuetiapinaTarbis 400 mg prolonged-release tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: where you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including aggressive or violent behavior.
• 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 being used to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medicine you are 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 apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

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

• You, or a family member, have or have had heart problems, such as 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 function). In this case, 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 such 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”).

Contact 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 condition known as “neuroleptic malignant syndrome”). Immediate medical treatment may be necessary.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or feel very drowsy. 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.

Tell 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 your depression

If you are depressed, you may sometimes have thoughts of harming yourself or committing 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. Clinical trial data 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 committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a close friend or family member 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 taking any of the following medicines:

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

Inform 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 electrolyte imbalance (low levels of potassium or magnesium), such as diuretics (medicines to increase urination) 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 tone, 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, so you should take your tablets at least one hour before a meal or before bedtime.
• Be cautious about the amount of alcohol you consume. 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 plan 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 withdrawal syndrome, may occur in newborns of mothers who have taken 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 ability. 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 called tricyclic antidepressants (TCAs) when certain analytical methods are used, even if you are not taking methadone or TCAs. If this occurs, a more specific test can be performed.

3. How to take Quetiapine Tarbis

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will decide 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 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 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 nearest hospital immediately. Take the quetiapine tablets with you. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and 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 suddenly, you may have difficulty sleeping (insomnia), or may feel nauseous, or may experience headache, diarrhoea, vomiting, dizziness or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment.

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

4. Possible adverse effects

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

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

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (this may go away 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. A 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, restlessness, or painless muscle rigidity.
• 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, beating fast, or having irregular beats.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This may make you feel dizzy or faint (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling hungrier.
• Feeling irritable.
• Speech and language disorder.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in levels of thyroid hormones in the blood.
• Decreased number of certain types of blood cells.
• Increases in liver enzyme levels measured in blood.
• Increases in the amount of prolactin hormone in blood. Increases in prolactin hormone may, in rare cases, lead to the following:
  • In both men and women: breast enlargement and unexpected milk production.
  • In women: absence of menstrual periods or irregular periods.

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

• Epileptic fits or seizures.
• 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.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the heart's electrical activity seen on ECG (prolongation of QT interval).
• 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 called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and 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 the bloodstream to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical help.
• Walking, talking, eating, or other activities while asleep.
• Decrease in body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called "metabolic syndrome") where 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 levels of creatine phosphokinase (a substance from 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) 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.
• Breakdown of muscle fibres and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

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

• Skin rashes with irregular red spots (erythema multiforme).
• Sudden and 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 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 using 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 consisting of small red or purple spots.

The class of medicines to which quetiapine belongs can cause problems with heart rhythm 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 levels of thyroid hormones in your blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased number of red blood cells, increased blood levels of creatine phosphokinase (a substance found in muscles), decreased levels of sodium in blood, and increased levels of prolactin hormone in blood. Increases in prolactin hormone may, in rare cases, lead to the following:

• In both men and women: breast enlargement and unexpected milk production.
• 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 have not been observed in adults:

Very common adverse effects (may affect more than 1 in 10 people): Increase in the level of a hormone called prolactin in the blood. Increases in prolactin hormone may, in rare cases, lead to the following:

• • In both boys and girls: breast enlargement and unexpected milk production.
  • In girls: absence of menstrual periods or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, restlessness, or painless muscle rigidity.
• 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 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 refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. 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 400 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.

Appearance of the product and contents of the pack

The tablets of this medicine are white and are marked with “Q 400” on one side.

Available pack sizes are:

• Aluminium/PVC/Aclar blister pack. 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 review of the leaflet: July 2024

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