Package Insert: Information for the Patient

Psicotric 300 mg Film-Coated Tablets EFG

Quetiapine

Read this package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Psiotriccontains a substance called quetiapine. It belongs to a group of medications called antipsychotics.Psiotriccan be used to treat various diseases, such as:

• Bipolar depression: by which you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite or cannot sleep.
• Mania: by which you may feel very excited, euphoric, agitated, enthusiastic or hyperactive or present poor judgment which includes being aggressive or violent.
• Schizophrenia: by 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 Psiotric even when you feel better.

Do not takePsicotric:

• If you are allergic (hypersensitive) to quetiapine or to any of the other components of Psicotric coated tablets (including those 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 takePsicotricif the above applies to you. If you are unsure, consult your doctor or pharmacist before takingPsicotric.

Warnings and precautions

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

• 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 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).
• You are an elderly person with dementia (loss of brain function). If so, do not take quetiapine because the group of medications to which Psicotric 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.
• You have depression or other conditions treated with antidepressants.

The use of these medications with Psicotric may cause serotonin syndrome, a potentially life-threatening condition (see “Other medications and Psicotric”).

Inform your doctor immediately if after taking Psicotric you experience any of the following:

• A combination of fever, intense muscle stiffness, sweating, or a decrease in 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).
• Rapid and irregular heartbeats, even when at rest, palpitations, respiratory problems, chest pain, or unexplained fatigue. Your doctor will 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 may 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 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 thoughts of suicide and/or suicidal behavior in young adults under 25 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 can 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

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

Use of Psicotric with other medications

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

Do not take Psicotric 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:

• Antiepileptic medications (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 levels) such as diuretics (medications for urination) or certain antibiotics (medications for treating infections).
• Medications that may cause constipation.
• Antidepressants. These medications may interact with Psicotric 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 a 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 Psicotric with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Do not take Psicotric during pregnancy, unless you have consulted your doctor. Do not use Psicotric 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.

Psicotric contains lactose and sodium

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

Psicotric contains less than 23 mg of sodium (1mmol) per tablet, which is essentially “sodium-free”.

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 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.

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 condition 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 condition.
• Swallow your tablets whole with the help of water.
• You can take the tablets with or without food.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to.
• Do not take grapefruit juice while taking Psicotric. It may affect how the medication works.

Liver problems

If you have liver problemsyour doctor may change your dose.

Older adults

If you are an older adultyour doctor may change your dose.

Use in children and adolescents

Psiotric should not be used inchildren and adolescents under 18 years of age.

If you take more Psicotric than you should

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

You can also call the Toxicological Information Service, Phone: 915620420, indicating the medication and the amount taken

If you forget to take Psicotric

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 interrupt treatment with Psicotric

If you stop taking Psicotric 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 may cause side effects, although not everyone will experience them.

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

• Dizziness (which could lead to falls), headache, dry mouth.
• Sensation of drowsiness (which may disappear over time as you continue to take quetiapine), (which could 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 least1 to2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremor, feeling restless or rigid 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 you to feel dizzy or faint (which could 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 increases 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.

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 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 (which could 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").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (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 help immediately.
• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• Inflammation of the pancreas.
• 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, 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 rash, blisters, or red spots on the skin.
• Severe allergic reaction (anaphylaxis) that may cause difficulty breathing or shock.
• Fast skin swelling, usually around the eyes, lips, and throat (angioedema).
• A severe condition of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

Unknown (frequency cannot be estimated from available data)

• Rashes on the skin with irregular red spots (erythema multiforme).
• Sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).
• Babies born to mothers who have used quetiapine during pregnancy may experience withdrawal symptoms.
• Drug 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 (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 medical attention immediately.
• 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 Psicotric belongs may cause heart rhythm problems that can be serious and, in severe cases, fatal.

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 blood sugar, 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, increased 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 increases 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. Prolactin increases 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 starting muscle movements, tremors, feeling restless or rigid without pain.
• Increased blood pressure.

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

• Feeling weak, fainting (which could 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 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.

No special storage conditions are required.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Psicotric

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

The other components are:

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

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

Appearance of Psicotric and contents of the packaging

The tablets are white, biconvex, oblong, and scored on one side. The tablet can be divided into equal doses.

They are presented in packaging of 60 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona, Spain

Responsible manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona, Spain

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 for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/