Label:Information for the User

Qudix Prolong400 mg prolonged-release EFG tablets

quetiapine

Read this label carefully before starting to take this medicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you, and you must not give it to others even iftheyhave the same symptomsas you,as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this label. See section 4.

This medication contains a substance called quetiapina. It belongs to a group of medications known as antipsychotics. Qudix Prolong can be used to treat various diseases, 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 very excited, euphoric, agitated, enthusiastic, or hyperactive, or present poor judgment, which includes 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 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 disease.

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

Do not takeQudix Prolong:

• 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 HIV medications
• Azole-type medications (for fungal infections)
• Erythromycin or clarithromycin (for infections)
• Nefazodone (for depression)

If you have any doubts, consult your doctor or pharmacist before taking quetiapine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Qudix Prolong if:

• You, or a family member, have or have had any heart problems, for example, irregular heart rhythms, 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 have had low white blood cell counts in the past (which may or may not have been caused by other medications).
• You are an elderly person with dementia (loss of brain function). If so, do not take quetiapine because the group of medications to which this medication belongs may increase the risk of stroke or, in some cases, death in elderly people with dementia.
• You are an elderly person with Parkinson's disease or parkinsonism.
• You or a family member has a history of blood clots, as medications like these have been associated with blood clot formation.
• You have or have had a condition in which your breathing is interrupted for short periods during normal nighttime sleep (called "sleep apnea") and are taking medications that decrease normal brain activity ("depressants").
• You have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or high pressure inside your eye. These conditions may be caused by medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.
• You have a history of alcohol or drug abuse.
• If you have depression or other conditions treated with antidepressants. The use of these medications with Qudix Prolong may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Qudix Prolong").

Inform your doctor immediately if after taking Qudix Prolong you experience any of the following effects:

• A combination of fever, intense muscle rigidity, sweating, or a decrease in consciousness (a condition called "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 a very low white blood cell count and require discontinuation of quetiapine treatment and/or additional treatment.
• Constipation with persistent abdominal pain, or constipation that has not responded to treatment, as it may lead to 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 be effective, usually around two weeks, but sometimes more.

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 obtained from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years old with depression.

If you ever think about harming yourself or committing suicide, contact your doctor or go to the 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 tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Drug reaction with eosinophilia and systemic symptoms (DRESS). Generalized rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other affected organs (drug reaction 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.

Weight gain

Weight gain has been observed in patients taking this medication. You and your doctor should monitor your weight regularly.

Children and adolescents

Qudix Prolong should not be used in children and adolescents under 18 years of age.

Other medications and Qudix Prolong

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

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

• Some HIV medications.
• Azole-type medications (for fungal infections).
• Erythromycin 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 falling asleep).
• 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.
• Medications (called "anticholinergics") that affect how nerve cells function, to treat certain medical conditions.
• Antidepressants. These medications may interact with Qudix Prolong 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.

Consult your doctor before stopping any of your medications.

Taking Qudix Prolong with food, drinks, and alcohol

• Quetiapine 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 quetiapine and alcohol may cause drowsiness.
• Do not take grapefruit juice while taking quetiapine. 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 or pharmacist before using this medication.

Do not take quetiapine during pregnancy, unless you have consulted your doctor. Do not use quetiapine 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 decrease your reaction time. These effects, as well as the underlying condition, may impair your ability 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 Drug Detection Tests in Urine

If you are undergoing a urine drug detection test, taking quetiapine may produce positive results for methadone or certain antidepressant medications called 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.

Qudix Prolong contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 disease and needs, but 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 the 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 this medication. It may affect how the medication works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to.

Patients with 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

Qudix Prolong should not be used in children and adolescents under 18 years of age.

If you take moreQudix Prolongthan you should

If you take more Qudix Prolong than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Bring your quetiapine tablets with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeQudix Prolong

If you forget a dose, take another 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 doses.

If you interrupt treatment withQudix Prolong

If you stop taking Qudix Prolong abruptly, you may be unable to sleep (insomnia) or may feel nausea, or may experience headache, diarrhea, discomfort (vomiting), dizziness, or irritability.

Your doctor may suggest reducing the dose gradually before interrupting treatment.

If you have any doubts 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(may affect more than 1 in 10 people):

• Dizziness (may lead to falls), headache, dry mouth;
• Sensation of drowsiness - may disappear over time as you continue to take this medicine (may lead to falls);
• Withdrawal symptoms (symptoms that occur when you stop taking this medicine), 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, tremors, feeling restless or muscle rigidity without pain;
• Changes in the amount of certain fats (triglycerides and total cholesterol).

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

• Fast heart rate;
• Feeling like your heart is beating strongly, rapidly, or irregularly;
• Constipation or indigestion;
• Sensation of weakness;
• Swelling of arms or legs;
• Low blood pressure when standing. This may make you 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 disorders;
• Thoughts of suicide and worsening of depression;
• Shortness of breath;
• Vomiting (mainly in older people);
• Fever;
• Changes in the amount of thyroid hormones in the blood;
• Decrease in the number of certain types of blood cells;
• Increases in the amount of liver enzymes measured in the blood;
• Increases in the amount of prolactin hormone in the blood. Prolactin hormone increases may, in rare cases, lead to:

• Swelling of the breasts and unexpected milk production in both men and women.
• Irregular or absent menstrual periods in women.

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

• Seizures or convulsions;
• Allergic reactions that may include 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;
• Change in the heart's electrical activity seen on an ECG (prolongation of the QT interval);
• 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;
• Worsening of pre-existing diabetes.

Rare(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");
• Yellowing 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 disorders;
• 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 help immediately.
• 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 fat around your abdomen, decreased "good" cholesterol (HDL-C), increased levels of a type of fat in the blood called triglycerides, high 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(may affect up to 1 in 10,000 people):

• Severe rash, blisters, or red spots on the skin;
• Severe allergic reaction (anaphylaxis) that may cause difficulty breathing or shock;
• Fast swelling of the skin, usually around the eyes, lips, and throat (angioedema);
• Severe skin blistering, mouth, eyes, or genital area (Stevens-Johnson syndrome);
• Abnormal secretion of a hormone that controls urine volume;
• Rhabdomyolysis (breakdown of muscle fibers and muscle pain).

Unknown(frequency cannot be estimated from available data):

• Rash with irregular red spots (erythema multiforme);
• Severe and sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis);
• Withdrawal symptoms may occur in newborn babies of mothers who have used quetiapine during pregnancy.
• Stroke.
• Cardiomyopathy (heart muscle disorder)
• Myocarditis (inflammation of the heart muscle)
• Vasculitis (inflammation of blood vessels), often with skin rash with small red or purple spots.

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

Some side effects are only seen when blood tests are done. These include changes in the amount of certain fats (triglycerides and total cholesterol) or blood sugar levels, changes in the amount of thyroid hormones in the blood, increased liver enzymes, decreases in the number of certain types of blood cells, decreases in the number 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. Prolactin hormone increases may, in rare cases, lead to:

• Swelling of the breasts and unexpected milk production in both men and women.
• Irregular or absent menstrual periods in women.

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

Other 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(may affect more than 1 in 10 people):

• Increased amount of a hormone called prolactin in the blood. Prolactin hormone increases may, in rare cases, lead to:

• Swelling of the breasts and unexpected milk production in both boys and girls.
• Irregular or absent menstrual periods in girls.

• Increased appetite;
• Vomiting;
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless or muscle rigidity without pain;
• Increased blood pressure;

Common(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 or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish 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 and on the blister after the abbreviation “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medications that you no longer need.By doing so, you will help protect the environment.

Composition ofQudix Prolong

• The active ingredient is quetiapine.The tablets ofQudix Prolongcontain 400mg of quetiapine (as quetiapine fumarate).
• The other components are:

Tablet core: anhydrous lactose, copolymer of methacrylic acid and ethyl acrylate (1:1) type A, crystalline maltose, magnesium stearate, and talc.

Coating of the tablet: copolymer of methacrylic acid and ethyl acrylate (1:1) Type A, triethyl citrate.

Appearance of the product and content of the container

• The prolonged-release tablets of 400 mg are white to off-white, oval, biconvex, engraved with ‘400’ on one side, 20.7 mm in length, 10.2 mm in width, and 6.3 mm in thickness.

• Qudix Prolong prolonged-release tablets are presented in PVC/PCTFE-aluminum foil blisters, in a cardboard box.

The container sizes are:

Qudix Prolong400 mg: 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Aravaca - Madrid

Spain

Responsible for manufacturing:

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No.5

69300 Rodopi

Greece

or

Pharmathen S.A.

6, Dervenakion Str

15351 Pallini Attikis

Greece

Revision date of thisleaflet:June 2024

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