PSICOTRIC PROLONG 150 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Psicotric Prolong

Do not take Psicotric Prolong:

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

Do not take Psicotric Prolong if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Psicotric Prolong.

Warnings and precautions

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

• You, or someone in your family, have or have had heart problems, such as problems with the heart rhythm, weakening of the heart muscle or inflammation of the heart, or if you are taking any medicine that may affect your heart beat.
• You have low blood pressure.
• You have had a stroke, especially if you are elderly.
• You have liver problems.
• You have ever had a fit (seizure).
• You have diabetes or are at risk of getting diabetes. If so, your doctor may check your blood sugar levels while you are taking quetiapine.
• You know that you have had low blood white cell counts in the past (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, because the group of medicines that Psicotric Prolong belongs to may increase the risk of stroke, or in some cases the risk of death, in these people.
• You, or someone in your family, have a history of blood clots, as medicines like these have been associated with blood clot formation.
• You suffer from depression or other conditions that are treated with antidepressants.

The use of these medicines with Psicotric Prolong may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Psicotric Prolong").

Tell your doctor immediately if, after taking Psicotric Prolong, you experience any of the following:

• A combination of high fever, stiff muscles, feeling confused, sweating and changes in breathing and heart rate (a condition called "neuroleptic malignant syndrome"). You may need urgent medical treatment.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or feeling very sleepy. This could increase the risk of accidental injury (falls) in elderly patients.
• Seizures (fits).
• A prolonged and painful erection (priapism).
• Fast or irregular heartbeats, even when you are sitting or lying down, palpitations, breathing difficulties, chest pain or unexplained tiredness. Your doctor should check your heart and, if necessary, refer you to a cardiologist immediately.

These conditions may be caused by this type of medicine.

Tell your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as this could be a result of a very low white blood cell count, and you may need to stop taking quetiapine and/or receive additional treatment.
• Constipation, along with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more serious bowel obstruction.

Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer. These thoughts may also be increased if you stop taking your medicine 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 suicidal behavior in young adults under 25 years with depression.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go to a hospital immediately. It may be helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior.

Weight gain

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

Children and adolescents

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

Other medicines and Psicotric Prolong

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

Do not take Psicotric Prolong if you are taking any of the following medicines:

• Some medicines for HIV.
• Azole type medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Tell your doctor if you are taking 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 the heart rhythm, such as medicines that can cause an imbalance in electrolytes (low potassium or magnesium levels), such as diuretics (water tablets) or certain antibiotics (medicines for infections).
• Medicines that can cause constipation.
• Antidepressants. These medicines may interact with Psicotric Prolong and you may experience symptoms such as involuntary, rhythmic muscle contractions, agitation, hallucinations, coma, excessive sweating, tremor, overactive 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 Prolong with food, drinks, and alcohol

• Psicotric Prolong may be affected by food and, therefore, you should take your tablets at least one hour before a meal or before bedtime.
• Be careful with the amount of alcohol you drink. This is because the combined effect of Psicotric Prolong and alcohol may make you feel drowsy.
• Do not drink grapefruit juice while you are taking Psicotric Prolong. It may affect the way the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not take Psicotric Prolong during pregnancy unless your doctor has advised you to do so. You should not use Psicotric Prolong if you are breastfeeding.

The following symptoms, which can represent a withdrawal syndrome, may appear in newborn babies of mothers who have used quetiapine during the last trimester (last three months of their pregnancy): shaking, stiffness and/or weakness, sleepiness, agitation, breathing problems, and feeding problems. If your newborn baby develops any of these symptoms, you may need to contact your doctor.

Driving and using machines

Quetiapine may cause symptoms such as drowsiness, dizziness, or blurred vision, and may affect your ability to react. These effects, as well as the disease itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor has assessed your response to this medicine.Effect on urine drug tests

If you are having a urine drug test, taking quetiapine may produce positive results for methadone or certain antidepressants called tricyclic antidepressants (TCAs) when some test methods are used, even though you may not be taking methadone or TCAs. If this happens, a more specific test can be performed.

Psicotric Prolong contains sodium

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

3. How to take Psicotric Prolong

Follow exactly the administration instructions given by your doctor. If you are not sure, ask 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 it will usually be between 150 mg and 800 mg.

• You will take your tablets once a day.
• Do not split, chew, or crush the tablets.
• Swallow your tablets whole with a glass of water.
• Take your tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when).
• Do not drink grapefruit juice while you are taking Psicotric Prolong. It may affect the way the medicine 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.

Elderly people

If you are an elderly person, your doctor may change your dose.

Use in children and adolescents

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

If you take more Psicotric Prolong than you should

If you take more Psicotric Prolong than you have been prescribed by your doctor, you may feel drowsy, dizzy, and experience changes in your heart rhythm. Contact your doctor or the nearest hospital immediately. Take the Psicotric Prolong tablets with you. You can also contact the National Poison Centre (Tf: 915620420), indicating the medicine and the amount taken.

If you forget to take Psicotric Prolong

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 a forgotten tablet.

If you stop taking Psicotric Prolong

If you stop taking Psicotric Prolong abruptly, you may experience difficulty sleeping (insomnia), or you may feel nauseous, or you may experience headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest gradually reducing the dose before stopping treatment.

If you have any further questions on 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 all people suffer from them.

Very Common Adverse Effects (may affect more than 1 in 10 people):

• Dizziness (may lead to falls), headache, dry mouth.
• Feeling of drowsiness (which may disappear 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, diarrhea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is advised.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

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

• Fast heartbeat.
• Feeling like your heart is beating strongly, beating fast, or has skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing up. This can make you feel dizzy or faint (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Disorder of speech and language.
• Suicidal thoughts and worsening of your 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 the amount of liver enzymes measured in the blood.
• Increases in the amount of prolactin hormone in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:

o In both men and women, having swollen breasts and unexpected milk production.

o In women, not having menstrual periods or having irregular periods.

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

• Seizures or convulsions.
• Allergic reactions that can include hives, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of your face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart seen on an ECG (prolongation of the QT interval).
• Slower than normal heart rate that can 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 Adverse 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 disorder called "neuroleptic malignant syndrome").
• Yellowish color in the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Swollen breasts and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the bloodstream 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.
• Decrease in body temperature (hypothermia).
• Pancreas inflammation.
• A condition (called "metabolic syndrome") where you may suffer from a combination of 3 or more of the following effects: increased fat around your abdomen, decrease in "good" cholesterol (HDL-C), increase in a type of fat in the blood called triglycerides, increase in blood pressure, and increase in blood sugar.
• A combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count, a condition called agranulocytosis.
• Intestinal obstruction.
• Increase in creatine phosphokinase in the blood (a substance found in 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) that can cause difficulty breathing or shock.
• Rapid 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).
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

Unknown Frequency (frequency cannot be estimated from available data):

• Red, irregular skin rashes (erythema multiforme).
• Sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during their pregnancy.
• Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs involved (drug rash with eosinophilia and systemic symptoms, also known as DRESS). If you develop these symptoms, stop using quetiapine and contact your doctor or seek immediate medical attention.
• Cardiac muscle disorder (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Inflammation of blood vessels (vasculitis), often with a skin rash with small red or purple spots.

The class of medicines to which Quetiapina Qualigen belongs can cause heart rhythm problems that can be serious and, in severe cases, potentially fatal.

Some adverse 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 your blood, increase in liver enzymes, decrease in the number of certain types of blood cells, decrease in the number of red blood cells, increase in creatine phosphokinase in the blood (a substance found in muscles), decrease in the amount of sodium in the blood, and increases in the amount of prolactin hormone in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:

• Both in men and women, having swollen breasts and unexpected milk production.
• In women, not having menstrual periods or having irregular periods.

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

Adverse Effects in Children and Adolescents

The same adverse effects that can occur in adults can 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):

• Increased amount of a hormone called prolactin in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:
  • Both in boys and girls, having swollen breasts and unexpected milk production.
  • In girls, not having menstrual periods or having irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Increased blood pressure.

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

• Feeling of weakness, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritated.

Reporting of Adverse Effects

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

5. Storage of Psicotric Prolong

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

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

This medicine does not require any special storage temperature. Store in the original packaging to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Psicotric Prolong

The active ingredient is quetiapine. The tablets contain 150 mg of quetiapine (as quetiapine fumarate).

The other ingredients are:

Core of the tablet: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate

Coating of the tablet: hypromellose, titanium dioxide (E-171), macrogol 400, polysorbate 80.

Appearance of the Product and Package Contents

The tablets are white and have "Q 150" engraved on one side.

They are available in PVC/PVDC-Aluminum blisters, in packs of 10, 30, 50, 60, and 100 tablets.

They are also available in a white opaque high-density polyethylene bottle with a white opaque polypropylene cap and desiccant, in packs of 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Merckle GmbH

Ludwig-Merckle Strasse 3

D-89143 Blaubeuren-Weiler

Germany

Teva UK

Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG

United Kingdom

Date of the Last Revision of this Leaflet: June 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/