Quetiapine Mabo 400 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Quetiapine MABO 400 mg prolonged-release tablets EFG

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 must not be given 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 side effects.
5. How to store Quetiapine MABO prolonged-release tablets.
6. Contents of the pack and other information.

1. What Quetiapine MABO extended-release tablets are and what they are used for

Quetiapine MABO contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Quetiapine 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 very excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, which may include 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 Quetiapine MABO extended-release tablets are being used to treat major depressive episodes in major depressive disorder, they are taken in addition to another medicine you are already taking for this condition.

Your doctor may continue prescribing Quetiapine MABO even after you start feeling better.

2. What you need to know before starting Quetiapina 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 medicines for HIV,
  • azole-type medicines (for fungal infections),
  • erythromycin or clarithromycin (for infections),
  • nefazodone (for depression).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapine MABO, if:

• You, or a family member, has or has had any heart problems, for example, heart rhythm disorders, weakening of the 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 (convulsion).
• You have diabetes or are at risk of developing diabetes. In this case, 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 (whether or not caused by other medicines).
• You are an elderly person with dementia (loss of brain functions). 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 the risk of death, in these individuals.
• You or a family member has a history of blood clots, as medicines such as this have been associated with blood clot formation.
• 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 tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor if you experience these symptoms.

Contact 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 fatigue. 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 feeling very drowsy. This may increase the risk of accidental injuries (falls) in elderly patients.

• Seizures (convulsions).

• 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 your depression

If you are depressed, you may sometimes have thoughts of 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 stop your medication abruptly. 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 relative 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

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 medicines.

Do not take Quetiapine MABO 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).

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 potassium or magnesium levels), such as diuretics ("water pills") or certain antibiotics (medicines for treating infections).
• Medicines that may cause constipation.
• If you have depression or other conditions treated with antidepressants. Using these medicines together with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and quetiapine").

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

Taking Quetiapine MABO 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 if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may occur in newborns whose mothers 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

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 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).
• 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 tablets with you.

You may also call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of 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 the missed tablet.

If you stop taking Quetiapine MABO

If you stop taking Quetiapine MABO abruptly, you may have difficulty sleeping (insomnia), or feel nauseous, or experience headache, diarrhoea, 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 gets 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 go away over time as you continue taking this medicine) (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking the medicine), including 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, restlessness, 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 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 (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly patients).
• Fever.
• Changes in 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 blood. Increases in prolactin hormone may, in rare cases, lead to the following:
  • Swelling of the breasts 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.
• Involuntary 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 extreme drowsiness or dizziness (a disorder known as "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged, painful erection (priapism).
• Breast swelling and unexpected milk production (galactorrhoea).
• 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: increased fat around the abdomen, decreased "good" cholesterol (HDL-C), increased levels of a type of blood fat 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 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 blistering condition affecting the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Rupture of muscle fibres and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

Adverse effects not known (frequency cannot be estimated from available data):

• Skin rashes with irregular red spots (erythema multiforme).
• Sudden, 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), swollen 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.
• 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 heart rhythm problems that can be serious and, in severe cases, may 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, decreases in the number of certain types of blood cells, decreased number of red blood cells, increased blood creatine phosphokinase (a substance found in muscles), decreased sodium levels in blood, and increased levels of prolactin hormone in blood. Increases in prolactin hormone may, in rare cases, lead to the following:

• Swelling of the breasts 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 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 blood. Increases in prolactin hormone may, in rare cases, lead to the following:
  • Swelling of the breasts 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, restlessness, 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 kind of 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 is 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 your pharmacy’s SIGRE collection point. If you have any doubts, ask your pharmacist how to properly 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 MABO

• The active substance is quetiapine. Each prolonged-release tablet contains 400 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, and polysorbate 80.

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

The tablets are white, oblong, biconvex, film-coated, and marked with “Q 400” on one side.

They are presented 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 revision of the leaflet: June 2024

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