Quetiapine Mabo 50 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Quetiapine MABO 50 mg prolonged-release tablets EFG

Read the entire 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 effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Quetiapine MABO prolonged-release tablets are and what they are used for.
2. What you need to know before taking Quetiapine MABO prolonged-release tablets.
3. How to take Quetiapine MABO prolonged-release tablets.
4. Possible adverse effects.
5. How to store Quetiapine MABO prolonged-release tablets.
6. Contents of the pack and other information.

1. What Quetiapina MABO prolonged-release tablets are and what they are used for

Quetiapina MABO contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Quetiapina MABO can 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, which may include 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 Quetiapina MABO prolonged-release tablets are being used to treat major depressive episodes in major depressive disorder, they will be taken in addition to another medicine you are already taking for this condition.

Your doctor may continue to prescribe Quetiapina MABO even after you are feeling better.

2. What you need to know before taking Quetiapine MABO prolonged-release tablets

Do not take Quetiapine MABO

• If you are allergic (hypersensitive) to the active substance or to any of the other components of Quetiapine MABO (listed in section 6).
• • If you are taking any of the following medicines:
  • some HIV medicines,
  • azole-type medicines (for fungal infections),
  • erythromycin or clarithromycin (for infections),
  • nefazodone (for depression).

Do not take Quetiapine MABO if any of the above applies to you. If you have any doubts, consult your doctor or pharmacist before taking Quetiapine MABO.

Warnings and precautions

Talk to your doctor or pharmacist before starting Quetiapine MABO if:

• You or a family member has or has 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 quetiapine.
• 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 to which Quetiapine MABO belongs may increase the risk of stroke or, in some cases, death in these individuals.
• You or a family member has 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. The use of these medicines together with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and quetiapine").

Inform your doctor immediately if, after taking Quetiapine MABO, 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.

• Fast or irregular heartbeat, 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.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or excessive drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
• Seizures (epileptic fits).
• A prolonged and painful erection (priapism).

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 white blood cell count and may require discontinuation of quetiapine treatment and/or additional treatment.
• Constipation along 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 think about harming yourself or committing suicide. This risk 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 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 close friend or family member that you are depressed and ask them to read this leaflet. You may also ask them to inform 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 quetiapine. You and your doctor should monitor your weight regularly.

Children and adolescents

Quetiapine MABO must not be used in children and adolescents under 18 years of age.

Other medicines and Quetiapine MABO

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

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

• Some HIV medicines.
• Azole-type medicines (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 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 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.

Do not stop taking any of your medicines without first consulting your doctor.

Taking Quetiapine MABO prolonged-release tablets with food, drinks, and alcohol

• Quetiapine MABO may be affected by food; therefore, 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 Quetiapine MABO and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking Quetiapine MABO. It may affect how the medicine works.

Pregnancy and breastfeeding

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 Quetiapine MABO during pregnancy unless advised by your doctor. You should not use Quetiapine MABO while breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may occur in newborns whose mothers have taken quetiapine during the third trimester (last three months of pregnancy): tremor, muscle rigidity 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

These medicines may make you feel drowsy. Do not drive or operate tools or machinery until you know how the tablets affect you.

Effect on Urine Drug Screening Tests

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

Quetiapine MABO contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is essentially "sodium-free."

3. How to take Quetiapine MABO prolonged-release tablets

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will decide your initial 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 your 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).
• Do not drink grapefruit juice while taking Quetiapine MABO. 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.

Use in elderly patients

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

Use in children and adolescents

Quetiapine MABO must not be used in children and adolescents under 18 years of age.

If you take more Quetiapine MABO than you should

If you take more Quetiapine MABO than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Take the Quetiapine MABO tablets with you. You may also call the Toxicology Information Service at telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Quetiapine MABO

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 a missed tablet.

If you stop taking Quetiapine MABO

If you stop taking Quetiapine MABO suddenly, you may have difficulty sleeping (insomnia), or feel nauseous, or experience headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing 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, this medicine can cause adverse effects, although not everyone will experience them.

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

• Dizziness (could lead to falls), headache, dry mouth.
• Drowsiness (which may disappear over time as you continue taking this medicine) (could lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking the medicine), including inability to sleep (insomnia), feeling nauseous, headache, diarrhea, vomiting, dizziness, and irritability. Gradual discontinuation 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 stiffness.
• Changes in the 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 skipping 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 (could 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 patients).

• Fever.

• Changes in the levels of thyroid hormones in the blood.

• Decrease in the number of certain types of blood cells.

• Increases in liver enzyme levels measured in blood.

• Increased levels of prolactin hormone in the blood. Increases in prolactin hormone could, 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):

• 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 (prolongation of the 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 (could lead to falls).
• Nasal congestion.
• 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, 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 and painful erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhea).
• Menstrual disorders.
• 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 notice any of these symptoms, seek immediate medical help.
• 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 creatine phosphokinase in blood (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.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

Adverse effects with unknown frequency (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).

• 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 showing small red or purple spots.

• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.

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

Some adverse effects are only detected by blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in the blood, increased liver enzymes, decreases in the number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase in blood (a substance found in muscles), decreased sodium levels in blood, and increased prolactin hormone levels in blood. Increases in prolactin hormone could, 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 were not 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 could, 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 stiffness.

• Increased blood pressure.

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

• Feeling weak, fainting (could lead to falls).
• Nasal congestion.
• Feeling irritable.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Quetiapine MABO prolonged-release tablets

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

Store in the original container to protect from moisture.

This medicine does not require any special storage temperature.

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. Return any unused medicines and their containers to a pharmacy's SIGRE collection point. 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 package and other information

Composition of Quetiapine MABO prolonged-release tablets

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

Appearance of Quetiapine MABO prolonged-release tablets and contents of the pack

The tablets are brown, oblong, biconvex, film-coated, and marked with "Q 50" on one side.

They are available in aluminum/PVC/PVDC blisters, in packs of 60 tablets.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

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: June 2024

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