PATIENT INFORMATION LEAFLET

Qudix 300 mg Film-Coated Tablets EFG

Quetiapine

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 and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Qudix contains a substance called quetiapina. It belongs to a group of medications called antipsychotics. Qudix may be used to treat several diseases, such as:

• Bipolar depression: for which you feel sad. You may find that you feel depressed, guilty, lacking in energy, have a loss of appetite, or cannot sleep.
• Mania: for which you may feel extremely 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.

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

Do not take Qudix:

• If you are allergic (hypersensitive) to quetiapine or to any of the other components of Qudix (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).

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

Warnings and precautions

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

• You have depression or other conditions treated with antidepressants. The use of these medications with Qudix may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Qudix").
• You, or a family member, have or have had any heart problems, for example, irregular heart rhythm, 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 had a seizure (convulsion).
• You have diabetes or are at risk of developing diabetes. If so, your doctor may monitor your blood sugar levels while taking quetiapine.
• You know you have had low white blood cell counts (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 Qudix belongs may increase the risk of stroke or, in some cases, death in these people.
• You or a family member has a history of blood clots, as medications like these have been associated with blood clot formation.

Inform your doctor immediately if after takingQudixyou experience any of the following::

• A combination of fever, intense muscle stiffness, sweating, or decreased consciousness (a condition known as "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• 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).
• Rapid 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, flu-like symptoms, 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 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 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 obtained from clinical trials has shown an increased risk of suicidal thoughts and/or 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.

Weight gain

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

Children and adolescents

Qudixshould not be used in children and adolescents under 18 years of age.

Use ofQudixwith other medications

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

Do not take Qudix 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 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 Qudix and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38 °C (serotonin syndrome). Contact your doctor when you experience these symptoms.

Before stopping any of your medications, consult your doctor first.

Taking Qudix with food, drinks, and alcohol

• Qudix can be taken with or without food.
• Be careful about the amount of alcohol you consume. This is because the combined effect of Qudix and alcohol may make you drowsy.
• Do not take grapefruit juice while taking Qudix. It may affect how the medication works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor before using this medication. Do not take Qudix during pregnancy, unless you have consulted your doctor. Do not use Qudix 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): tremor, muscle stiffness, 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

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

Qudix contains lactose

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

Effect on drug detection tests in urine

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

Follow exactly the administration instructions for 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 needs, but will usually be between 150 mg and 800 mg.

• You will take your tablets once a day, at bedtime, or twice a day, depending on your illness.
• Swallow your tablets whole with the help of water.
• You can take the tablets with or without food.
• Do not take grapefruit juice while taking Qudix. 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

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

If You Take More Qudix Than You Should

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

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If You Forget to Take Qudix

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 dose.

If You Interrupt Treatment with Qudix

If you stop taking Qudix 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 medications, this medication may cause side effects, although not everyone will experience them.

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

• Dizziness (which may lead to falls), headache, dry mouth.
• Sensation of drowsiness (which may disappear over time as you continue to take quetiapine), (which 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, feeling restless or stiff 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.
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This may cause dizziness or fainting (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased hunger.
• Feeling irritable.
• Speech and language disorders.
• 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.
• Decreased number of certain types of blood cells.
• Increased levels of liver enzymes measured in the blood.
• Increased levels of prolactin hormone in the blood. Elevated levels of prolactin hormone may, in rare cases, lead to:

• In men and women, breast swelling and unexpected milk production.
• In women, absence of menstrual period or irregular periods.

Uncommon side effects(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 heart 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 (which may lead to falls).
• Stuffy nose.
• Decreased number of red blood cells in the blood.
• Decreased sodium levels 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).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Breast swelling 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 attention immediately.
• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (known as "metabolic syndrome") in which you may have 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, increased blood pressure, and increased blood sugar levels.
• A combination of fever, symptoms similar to the flu, 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 rash, blisters, or red spots on the skin.
• Severe allergic reaction (known as anaphylaxis) that may cause difficulty breathing or shock.
• Quick swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A severe condition of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Incorrect secretion of a hormone that controls urine volume.
• Rhabdomyolysis, a condition in which muscle fibers break down and cause muscle pain.
• Worsening of pre-existing diabetes.

Unknown (frequency cannot be estimated from available data)

• Rashes on the skin with irregular red spots (erythema multiforme).
• Severe and sudden allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).
• Some symptoms of withdrawal may occur in newborns of mothers who have used quetiapine during pregnancy.
• Drug rash with eosinophilia and systemic symptoms (DRESS), a condition characterized by a generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs. If you develop these symptoms, stop taking quetiapine and contact your doctor or seek medical attention immediately.
• Cardiomyopathy, a disorder of the heart muscle.
• Myocarditis, inflammation of the heart muscle.
• Vasculitis, inflammation of the blood vessels, often with a skin rash of small red or purple spots.

The class of medications to which Qudix belongs may cause serious heart rhythm problems that can be life-threatening in severe cases.

Some side effects are only observed when a blood test is performed. 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, increased liver enzymes, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase in the blood (a substance found in muscles), decreased sodium levels in the blood, and increased levels of prolactin hormone in the blood. Elevated levels of prolactin hormone may, in rare cases, lead to:

• In men and women, breast swelling and unexpected milk production.
• In women, absence of menstrual period or 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 levels of a hormone called prolactin in the blood. Elevated levels of prolactin hormone may, in rare cases, lead to:
• • In children and adolescents, breast swelling and unexpected milk production.

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• • In girls, absence of menstrual period or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless or stiff without pain.
• Increased blood pressure.

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

• Feeling weak, fainting (which may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt

ask your pharmacist how to dispose of the packaging and the medicines you no longer

need. In this way, you will help protect the environment.

Composition of Qudix

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

The other components are:

Tablet core: lactose monohydrate (lactose), microcrystalline cellulose, povidone, sodium carboxymethyl starch (Type A) (potato starch), glycerol dibehenate, anhydrous colloidal silica, and magnesium stearate.

Coating:lactose monohydrate (lactose), hypromellose, titanium dioxide (E171), and macrogol 4000.

Appearance of Qudix and content of the packaging

The tablets are oblong, biconvex, scored on one face, and white in color. The tablets can be divided into equal doses.

They are presented in packs of 60 tablets.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization

Adamed Laboratorios, S.L.U.

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

28023 Aravaca – Madrid

Manufacturer responsible

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

08970 Sant Joan Despí - Barcelona

Date of the last review of this leaflet:June 2024

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