Psicotric Retard 600 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Psicotric Retard 600 mg prolonged-release tablets

Quetiapine

Read the 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 should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Psicotric Retard 600 mg is and what it is used for
2. What you need to know before taking Psicotric Retard 600 mg
3. How to take Psicotric Retard 600 mg
4. Possible adverse effects
5. How to store Psicotric Retard 600 mg
6. Contents of the pack and other information

1. What Psicotric Retard 600 mg is and what it is used for

Psicotric Retard 600 mg contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. This medicine can be used to treat several conditions, such as:

• Major depressive episodes in bipolar disorder. You may feel depressed, guilty, lack energy, lose your appetite, or be unable to sleep.
• Mania: during which you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including being aggressive or violent.
• Schizophrenia: during which you may hear or sense 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 this medicine even after you start feeling better.

2. What you need to know before taking Psicotric Retard 600 mg

Do not take Psicotric Retard 600 mg:

• If you are allergic (hypersensitive) to quetiapine or to any of the other components of this medicine, (listed in section 6).
• If you are taking any of the following medicines:
  • some HIV medications
  • azole-type medicines (for fungal infections)
  • erythromycin or clarithromycin (for infections)
  • nefazodone (for depression).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Psicotric Retard 600 mg if:

• You, or a family member, have or have had any heart problems, for example, heart rhythm problems, weakening of the heart muscle, or heart inflammation, 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. If so, 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 (which may or may not have been caused by other medicines).
• You are an elderly person with dementia (loss of brain function). If so, you should not take quetiapine, as the group of medicines to which this medicine belongs may increase the risk of stroke or, in some cases, the risk of death in these individuals.

. If you are an elderly person with Parkinson's disease/parkinsonism.

• You or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.

. You have or have had a disorder in which you stop breathing for short periods during normal nighttime sleep (called “sleep apnea”) and you are taking medicines that slow down normal brain activity (“depressants”).

• You have or have had a disorder in which you cannot completely empty your bladder (urinary retention), prostate enlargement, intestinal obstruction, or increased eye pressure. These disorders are sometimes caused by medicines (called "anticholinergics") that affect nerve cell function and are used to treat certain conditions.
• You have a history of alcoholism or drug abuse.
• If you suffer from depression or other conditions treated with antidepressants.

The use of these medicines together with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see Other medicines and Psicotric Retard 600 mg).

Inform your doctor immediately if, after taking Psicotric Retard 600 mg, 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.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (epileptic fits).
• A prolonged and painful erection (priapism).

. Rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.

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 count of white blood cells and may require stopping treatment with quetiapine and/or additional treatment.
• Constipation together 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. These thoughts 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 behavior 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 family member or friend that you are depressed and ask them to read this leaflet. You may also ask them to let you know if they think your depression is getting worse or if they are concerned about changes in your behavior.

Serious skin adverse reactions (SCARs)

Very rarely, serious skin adverse reactions (SCARs), which may be life-threatening or fatal, have been reported with the use of this medicine. These commonly manifest as:

? Stevens-Johnson syndrome (SJS), a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.

? Toxic epidermal necrolysis (TEN), a more severe form causing extensive skin peeling.

? Drug reaction with eosinophilia and systemic symptoms (DRESS), characterized by flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes).

• Acute generalized exanthematous pustulosis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), a skin rash with irregular spots causing itching.

If you develop any of these symptoms, stop using Psicotric Retard 600 mg and contact your doctor or seek immediate medical attention.

Weight gain

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

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

Other medicines and Psicotric Retard 600 mg

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

Do not take Psicotric Retard 600 mg if you are using any of the following medicines:

• Some HIV medications.
• 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 (medicines to increase urination) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.

. Medicines (called “anticholinergics”) that affect nerve cell function and are used to treat certain conditions.

. Antidepressants. These medicines may interact with quetiapine and you may experience symptoms such as involuntary rhythmic muscle contractions, including eye movement control muscles, 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.

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

Taking Psicotric Retard 600 mg with food, drinks, and alcohol

• This medicine may be affected by food, and 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 this medicine and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking this medicine. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

You should not take this medicine during pregnancy unless advised by your doctor. You should not use this medicine while breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may occur in newborns of mothers who have used 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 tablets may make you feel drowsy. Do not drive or operate tools or machinery until you know how these 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 testing methods are used, even if you are not taking methadone or TCAs. If this occurs, a more specific test can be performed.

Psicotric Retard 600 mg contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Psicotric Retard 600 mg

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine your initial dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but it will usually be between 150 mg and 800 mg.

• Take the 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 this medicine. It may affect how the medicine 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 adjust your dose.

Elderly patients

If you are elderly, your doctor may adjust your dose.

Use in children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

If you take more Psicotric Retard 600 mg than you should

If you take more Psicotric Retard 600 mg than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring the tablets of this medicine with you.

You may also call the Toxicology Information Service at telephone number: 915620420, stating the name of the medicine and the amount taken.

If you forget to take Psicotric Retard 600 mg

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 Psicotric Retard 600 mg

If you stop taking Psicotric Retard 600 mg abruptly, you may have difficulty sleeping (insomnia), or may experience nausea, headache, diarrhea, 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 quetiapine) (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), 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, beating rapidly, or having irregular 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 (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased hunger.
• Feeling irritable.
• Speech and language disorder.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in levels of thyroid hormones in the blood.
• Decreased number of certain types of blood cells.
• Increases in liver enzyme levels measured in blood.
• Increases in blood levels of prolactin hormone. Increases in prolactin hormone may rarely lead to the following:

o In both men and women: breast swelling and unexpected milk production.

o 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.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the electrical activity of the heart seen on ECG (prolongation of the QT interval).
• Slower than normal heart rate, which 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 adverse effects (may affect up to 1 in 1,000 people):

• A combination of high temperature (fever), sweating, muscle stiffness, and feeling very drowsy or dizzy (a disorder called “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 (galactorrhoea).
• Menstrual disorder.
• 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 medical help immediately.
• Walking, talking, eating, or other activities while asleep.
• Decreased 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: increased abdominal fat, 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 blood levels of 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 condition with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Rupture of muscle fibers and muscle pain (rhabdomyolysis).

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

• Skin rashes with irregular red spots (erythema multiforme). See section 2.

. Rapid appearance of red, pustular areas on the skin (small blisters filled with white/yellow fluid), known as Acute Generalized Exanthematous Pustulosis (AGEP). See section 2.

• Sudden, severe allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis). See section 2.
  • Drug reaction with eosinophilia and systemic symptoms (DRESS), characterized by flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes). See section 2.
  • Withdrawal symptoms in newborns of mothers who used quetiapine during pregnancy.
  • Stroke.
  • 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.

The class of medicines to which this medicine belongs may cause problems with heart rhythm that can be serious and, in severe cases, may be fatal.

Some adverse effects are only detected by blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in your blood, increased liver enzymes, decreases in the number of certain types of blood cells, decreased number of red blood cells, increased blood levels of creatine phosphokinase (a substance found in muscles), decreased blood sodium levels, and increased blood levels of prolactin hormone. Increases in prolactin hormone may, in rare cases, lead to the following:

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

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

Additional 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 blood levels of a hormone called prolactin. Increases in prolactin hormone may, in rare cases, lead to the following:
  • In both boys and girls: breast swelling and unexpected milk production.
  • 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 (may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of adverse effects

If you experience any 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. Conservation of Psicotric Retard 600 mg

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

Do not use this medicine after the expiry date which is stated on the container after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions. Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Psicotric Retard 600 mg

The active substance is quetiapine. The tablets contain 600 mg of quetiapine (as quetiapine fumarate).

The other components are:

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

Tablet coating: methacrylic acid – ethyl acrylate copolymer (1:1), type A, triethyl citrate.

Appearance of Psicotric Retard 600 mg, and contents of the packaging

The 600 mg prolonged-release tablets are white or almost white, oval-shaped, biconvex, with "600" engraved on one side.

They are supplied in aluminum/PVC/PCTFE blisters within a cardboard box.

Pack sizes are: 10, 20, 30, 50, 60 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Manufacturer

Pharmathen International, S.A.

Industrial Park Sapes Rodopi Prefecture Block Nº 5

Rodopi 69300

Greece

or

Pharmathen, S.A.

Dervenakion 6 Str.

Pallini Attiki, 15351

Greece

or

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Straße 23

40764 Langenfeld

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark	Quetamed
Poland	Questax XR
Czech Republic	Questax Prolong
France	Quetiapine Neuraxpharm LP 600 mg, prolonged-release tablet
Slovakia	Questax XR 600 mg prolonged-release tablets
Hungary	Questax XR 600 mg retard tablet
Spain	Psicotric Retard 600 mg prolonged-release tablets
Germany	Quetiapin-neuraxpharm 600 mg Retardtabletten

Date of the most recent review of this leaflet: June 2024

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