PATIENT INFORMATION LEAFLET

QUETIAPINE QUALIGEN 300 mg prolonged-release tablets EFG

Read this 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 only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

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

3. How to take Quetiapine Qualigen

4. Possible side effects

5. Storage of Quetiapine Qualigen

6. Contents of the pack and additional information

Quetiapina Qualigen contains a substance called quetiapine. It belongs to a group of medications called antipsychotics. Quetiapina Qualigen can be used to treat various 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 cannot sleep.

·Mania: for which you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or exhibit poor judgment, which may include being aggressive or violent.

·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 using Quetiapina Qualigen prolonged-release tablets to treat major depressive episodes in major depressive disorder, this medication will be taken in addition to another medication that is being used to treat this condition.

Your doctor may continue prescribing Quetiapina Qualigen even when you are feeling better.

Do not take Quetiapina Qualigen:

·If you are allergic to quetiapine or any of the other components of this medication (listed in section 6).

·If you are taking any of the following medications:

-Some medications for HIV.

-Azole-type medications (for fungal infections).

-Eritromycin or clarithromycin (for infections).

-Nefazodone (for depression).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapina Qualigen if:

·You, or a family member, have or have had any heart problems, for example, heart rhythm problems, heart muscle weakness, or heart inflammation, or if you are taking any medication that may affect your heart rate.

·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. Your doctor may monitor your blood sugar levels while you are taking quetiapine.

·You know that you have had low white blood cell counts (which may or may not have been caused by other medications) in the past.

·You are an elderly person with dementia (loss of brain function). If so, do not take quetiapine, as the group of medications to which Quetiapina Qualigen 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 medications like this have been associated with blood clot formation.

·If you have depression or other conditions treated with antidepressants.

The use of these medications with Quetiapina Qualigen may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Quetiapina Qualigen").

Inform your doctor immediately if, after taking Quetiapina Qualigen, you experience any of the following:

·A combination of fever, intense muscle rigidity, sweating, or decreased consciousness (a condition known as "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 injuries (falls) in elderly patients.

·Seizures (convulsions).

·Prolonged and painful erection (priapism).

·Fast and irregular heartbeats, even when at rest, palpitations, respiratory problems, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately.

These conditions may be caused by this type of medication.

Inform your doctor as soon as possible if you have:

·Fever, symptoms similar to the flu, sore throat, or any other infection, as it could be a consequence of very low white blood cell counts and require discontinuation of quetiapine treatment and/or additional treatment.

·Constipation along with persistent abdominal pain, or constipation that has not responded to treatment, as it may lead to a more severe intestinal blockage.

Thoughts of suicide and worsening of depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This may increase at the beginning of treatment, as all these medications take time to take effect, 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 behavior in adults under 25 years old with depression.

Inform your doctor immediately if, at any time, you think about harming yourself or committing suicide. It may be helpful to tell a close family member or friend that you are depressed, and ask them to read this leaflet. You may ask them to tell you if they think your depression is worsening, 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 regularly monitor your weight.

Children and adolescents

Quetiapina Qualigen should not be used in children and adolescents under 18 years old.

Other medications and Quetiapina Qualigen

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Do not take Quetiapina Qualigen if you are using any of the following medications:

·Some medications for HIV.

·Azole-type medications (for fungal infections).

·Eritromycin or clarithromycin (for infections).

·Nefazodone (for depression).

Inform your doctor if you are using any of the following medications:

·Medications for epilepsy (such as phenytoin or carbamazepine).

·Medications for high blood pressure.

·Barbiturates (for difficulty sleeping).

·Thioridazine or Lithium (other antipsychotic medications).

·Medications that affect your heart rate, for example, medications that may cause an imbalance of electrolytes (low potassium or magnesium) such as diuretics (medications for urination) or certain antibiotics (medications for treating infections).

·Medications that may cause constipation.

·Antidepressants. These medications may interact with Quetiapina Qualigen and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those 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 the use of any of your medications, consult your doctor first.

Quetiapina Qualigen with food, drinks, and alcohol

·Quetiapina Qualigen may be affected by food, so take your tablets at least one hour before a meal or before bedtime.

·Be careful with the amount of alcohol you consume. This is because the combined effect of Quetiapina Qualigen and alcohol may cause drowsiness.

·Do not take grapefruit juice while taking Quetiapina Qualigen. It may affect how the medication works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take Quetiapina Qualigen during pregnancy, unless your doctor has advised you to do so. Do not use Quetiapina Qualigen if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may appear in newborn babies of mothers who have used quetiapine in the last trimester (last three months of pregnancy): tremors, muscle rigidity, and/or weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and operating machinery

Quetiapine may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Effect on Urine Drug Detection Tests

If you are undergoing a urine drug detection test, taking quetiapine may produce positive results for methadone or certain antidepressant medications known as tricyclic antidepressants (TCAs) when using certain analysis methods, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Quetiapina Qualigen contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your illness and your needs, but it will normally be between 150 mg and 800 mg.

·You will take your tablets once a day.

·Do not break, chew, or crush the tablets.

·Swallow your tablets whole with the help of water.

·Take your tablets without food (at least one hour before a meal or before going to bed, your doctor will tell you when).

·Do not take grapefruit juice while taking Quetiapina Qualigen. It may affect how the medication 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.

Older adults

If you are an older adult, your doctor may change your dose.

Use in children and adolescents

Quetiapina Qualigen should not be used in children and adolescents under 18 years of age.

If you take more Quetiapina Qualigen than you should

If you take more Quetiapina Qualigen than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Bring your Quetiapina Qualigen tablets with you. You can also call the Toxicological Information Service, Tf: 915620420, indicating the medication and the amount taken.

If you forget to take Quetiapina Qualigen

If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Quetiapina Qualigen

If you stop taking Quetiapina Qualigen abruptly, you may be unable to sleep (insomnia), or you may feel nausea, or you may experience headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest reducing the dose gradually before stopping treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

·Dizziness (may lead to falls), headache, dry mouth.

·Sensation of drowsiness (which may disappear over time as you continue to take quetiapine), (may lead to falls).

·Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), which include insomnia, nausea, headache, diarrhea, 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, sensation of restlessness or muscle rigidity without pain.

·Changes in the amount of certain fats (triglycerides and total cholesterol).

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

·Fast heart rate.

·Feeling like your heart is beating strongly, rapidly, or irregularly.

·Constipation, indigestion.

·Sensation of weakness.

·Swelling of arms or legs.

·Low blood pressure when standing. This may cause you to feel dizzy or faint (may lead to falls).

·Increased blood sugar levels.

·Blurred vision.

·Abnormal dreams and nightmares.

·Feeling hungrier.

·Feeling irritable.

·Speech and language disorder.

·Thoughts of suicide and worsening of 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 liver enzymes measured in the blood.

·Increases in prolactin hormone in the blood. Increases in prolactin hormone may, in rare cases, lead to:

oBoth men and women having breast swelling and unexpected milk production.

oWomen not having a menstrual period or having irregular periods.

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

·Seizures or convulsions.

·Allergic reactions that may include raised, itchy, swollen patches (hives), skin swelling, and swelling around the mouth.

·Unpleasant sensations in the legs (also known as restless leg syndrome).

·Difficulty swallowing.

·Uncontrolled movements, mainly of the face or tongue.

·Sexual dysfunction.

·Diabetes.

·Prolongation of the QT interval seen on the ECG.

·Slower than normal heart rate that may occur at the start of treatment and may be associated with low blood pressure and fainting.

·Difficulty urinating.

·Fainting (may 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 side 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 condition known as "neuroleptic malignant syndrome").

·Yellowish discoloration of the skin and eyes (jaundice).

·Inflammation of the liver (hepatitis).

·Prolonged and painful erection (priapism).

·Swelling of the breasts and unexpected milk production (galactorrhea).

·Menstrual disorder.

·Clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may 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.

·Decreased body temperature (hypothermia).

·Inflammation of the pancreas.

·A condition (known as "metabolic syndrome") where you may experience a combination of 3 or more of the following effects: increased fat around your abdomen, decreased "good" cholesterol (HDL-C), increased triglycerides in the blood, increased blood pressure, and increased blood sugar levels.

·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 the blood (a substance found in muscles).

Very rare side effects (may affect up to 1 in 10,000 people):

·Severe skin rash, blisters, or red patches.

·Severe allergic reaction (anaphylaxis) that may cause difficulty breathing or shock.

·Quick swelling of the skin, usually around the eyes, lips, and throat (angioedema).

·Severe skin condition known as Stevens-Johnson syndrome.

·Abnormal secretion of a hormone that controls urine volume.

·Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

·Worsening of pre-existing diabetes.

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

·Red, irregular patches on the skin (erythema multiforme).

·Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).

·Symptoms of withdrawal in newborn babies of mothers who have used quetiapine during pregnancy.

·Medication-induced rash with eosinophilia and systemic symptoms (DRESS, for its acronym in English). Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other organs involved (medication-induced rash with eosinophilia and systemic symptoms, also known as DRESS). If you develop these symptoms, stop using quetiapine and contact your doctor or seek medical attention immediately.

·Cardiac muscle disorder (cardiomyopathy)

·Inflammation of the heart muscle (myocarditis)

·Inflammation of blood vessels (vasculitis), often with a skin rash of small, red, or purple spots.

The class of medicines to which Quetiapine Qualigen belongs can cause serious heart rhythm problems that may be life-threatening.

Some side effects are only seen when a blood test is done. 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 the blood, increases in liver enzymes, decreases in the number of certain types of blood cells, decreases in the amount of red blood cells, increases in creatine phosphokinase in the blood (a substance found in muscles), decreases in the amount of sodium in the blood, and increases in the amount of prolactin hormone in the blood. Increases in prolactin hormone may, in rare cases, lead to:

·Both men and women having breast swelling and unexpected milk production.

·Women not having a menstrual period or having irregular periods.

Your doctor may ask you to have blood tests from time to time.

Side effects in children and adolescents

The same side effects that may occur in adults may also occur in children and adolescents.

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

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

·Increased amount of a hormone called prolactin in the blood. Increases in prolactin hormone may, in rare cases, lead to:

-Both boys and girls having breast swelling and unexpected milk production.

-Girls not having a menstrual period or having irregular periods.

·Increased appetite.

·Vomiting.

·Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, sensation of restlessness or muscle rigidity without pain.

·Increased blood pressure.

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

·Sensation of weakness, fainting (may lead to falls).

·Stuffy nose.

·Feeling irritable.

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Thismedication does not require any special storage temperature. Store in the original packaging to protect from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofQuetiapina Qualigen

The active ingredient is quetiapine. The tablets contain 300 mg of quetiapine (as quetiapine fumarate).

The other components are:

Tablet core: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate

Tablet coating: hypromellose, 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 content of the container

The tablets are yellowclear and have "Q300" engraved on one side.

It is presented in a PVC/PVDC – Aluminum blister, in containers of 10, 30, 50, 60, and 100 tablets.

It is presented in a white opaque high-density polyethylene bottle provided with a white opaque polypropylene cap with desiccant, in containers of 60 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle Strasse 3

D-89143 Blaubeuren-Weiler

Germany

Teva UK

Brampton Road,HampdenPark, Eastbourne,East Sussex, BN22 9AG

United Kingdom

Last review date of this leaflet: June 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/