QUETIAPINE NORMON 200 mg PROLONGED-RELEASE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Quetiapine Normon 200mg prolonged-release tablets EFG

Quetiapine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.,keep this leaflet. You may need to read it again..

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Quetiapine Normon and what is it used for
2. What you need to know before you take Quetiapine Normon
3. How to take Quetiapine Normon
4. Possible side effects
5. Storage of Quetiapine Normon
6. Pack contents and further information

1. What is Quetiapine Normon and what is it used for

Quetiapine Normon contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine Normon can be used to treat several diseases, such as:

• Bipolar depression and major depressive episodes in major depressive disorder: for which you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite or cannot sleep.
• Mania: for which you may feel very excited, euphoric, agitated, enthusiastic or hyperactive or show poor judgment including 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 Quetiapine Normon prolonged-release tablets are used to treat major depressive episodes in major depressive disorder, they will be taken in addition to another medicine that is being used to treat this disease.

Your doctor may continue to prescribe Quetiapine Normon even when you are feeling better.

2. What you need to know before you take Quetiapine Normon

Do not takeQuetiapine Normon:

• If you are allergic (hypersensitive) 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.
  • Medicines of the azole type (for fungal infections).
  • Erythromycin or clarithromycin (for infections).
  • Nefazodone (for depression).

If you are in doubt, consult your doctor or pharmacist before taking Quetiapine Normon.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapine Normon if:

• You, or a family member, have or have had any heart problems, such as problems with the heartbeat, weakening of the heart muscle or inflammation of the heart, 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 that you have had low white blood 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 to which Quetiapine Normon belongs may increase the risk of stroke, or in some cases the risk of death, in these people.
• You are an elderly person with Parkinson's disease/parkinsonism.
• You or a family member have a history of blood clots, as medicines like this one have been associated with the formation of blood clots.
• You have or have had a condition in which your breathing stops for short periods during normal nighttime sleep (called "sleep apnea") and are taking medicines that reduce normal brain activity ("depressants").
• You have or have had a condition in which you cannot empty your bladder completely (urinary retention), have an enlarged prostate, a blockage in your intestine, or high pressure inside your eye. These conditions may be caused by medicines (called "anticholinergics") that affect how nerve cells work to treat certain medical conditions.
• You have a history of alcohol or drug abuse.
• If you suffer from depression or other conditions that are treated with antidepressants. The use of these medicines together with Quetiapine Normon may cause serotonin syndrome, a potentially life-threatening condition (see "Using Quetiapine Normon with other medicines").

Tell your doctor immediately if after taking Quetiapine Normon you experience any of the following:

• A combination of fever, severe muscle stiffness, sweating, or a decrease in the level of consciousness (a disorder called "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This can increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Fast and irregular heartbeats, even when you are at rest, palpitations, breathing problems, chest pain, or unexplained fatigue. Your doctor should examine your heart and if necessary, refer you to a cardiologist immediately.

These disorders can 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 it could be a consequence of a very low white blood cell count and require interruption of treatment with quetiapine and/or additional treatment.
• Constipation along with persistent abdominal pain, or constipation that has not responded to treatment, as it could lead to a more serious intestinal blockage.

Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes think of harming yourself or committing suicide. This may increase when you first start treatment, as all these medicines take time to work, usually around two weeks but sometimes more. These thoughts can also increase if you stop taking your medication abruptly. You are 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 of age with depression.

If at any time you think of harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a close relative 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 worried about changes in your behavior.

Severe skin reactions (SCARs)

With the use of this medicine, very rare severe skin reactions (SCARs) have been reported, which can be life-threatening or fatal. These are commonly manifested as:

• Stevens-Johnson syndrome (SSJ), a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (NET), a more severe form that causes extensive peeling of the skin.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including an increase in the number of white blood cells (eosinophilia) and elevated liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pus-filled blisters.
• ERYthema multiforme (EM), skin rashes with irregular red patches that itch.

If you develop these symptoms, stop using Quetiapine Normon and contact your doctor or seek medical attention immediately.

Weight gain

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

Children and adolescents

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

Using Quetiapine Normon with other medicines

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

Do not take Quetiapine Normon if you are using any of the following medicines:

• Some medicines for HIV.
• Medicines of the azole type (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Tell 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, such as medicines that can cause an imbalance in electrolytes (low potassium or magnesium levels) such as diuretics (medicines to urinate) or certain antibiotics (medicines to treat infections).
• Medicines that can cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells work to treat certain medical conditions.
• Antidepressants. These medicines can interact with Quetiapine Normon and you may experience symptoms such as involuntary muscle contractions and rhythmic movements of the muscles, including the muscles 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.

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

Taking Quetiapine Normon prolonged-release tablets with food, drinks, and alcohol

• Quetiapine Normon may be affected by food and should be taken 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 Quetiapine Normon and alcohol can make you drowsy.
• Do not drink grapefruit juice while taking Quetiapine Normon. It can affect how the medicine works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. You should not take Quetiapine Normon during pregnancy, unless your doctor has told you to. You should not use Quetiapine Normon if you are breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may appear in newborns of mothers who have used quetiapine in the last trimester (last three months of pregnancy): tremors, 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 using machines

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

Effect on urine drug detection tests

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

Quetiapine Normon prolonged-release tablets contain lactose and sodium

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

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

3. How to take Quetiapine Normon

Follow the instructions for administration of this medicine exactly 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 disease and needs but 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 the help of water.
• Take the tablets without food (at least one hour before a meal or at bedtime, your doctor will indicate when).

• Do not drink grapefruit juice while taking Quetiapine Normon. It can affect how 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

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

If you take more Quetiapine Normon than you should

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

You can also call the Toxicology Information Service, phone: 915620420, indicating the medicine and the amount taken.

If you forget to take Quetiapine Normon

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 forgotten tablet.

If you stop taking Quetiapine Normon

If you stop taking Quetiapine Normon abruptly, you may be unable to sleep (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 other 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 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 recommended.
• 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 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:
• • Both in men and women, having swollen breasts and unexpected milk production.
  • 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 swollen hives, skin swelling, and swelling around the mouth.

• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart seen on the ECG (prolongation of the QT interval).
• Slower than normal heart rate that can occur at the start of treatment and can 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.
• Confusion.

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 of 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 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 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.
• Increased 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.
• Rupture of muscle fibers and muscle pain (rhabdomyolysis).

Unknown Frequency (cannot be estimated from available data)

• Red spots on the skin with irregular edges (erythema multiforme) (see section 2).
• Rapid appearance of red skin areas with small pus-filled bumps (small blisters filled with white/yellow liquid known as Acute Generalized Exanthematous Pustulosis (AGEP)) (see section 2).
• Sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis) (see section 2).
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes) (see section 2).
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.
• Stroke.
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of the blood vessels (vasculitis), often with a skin rash with small red or purple spots.

The class of medicines to which Quetiapina Normon belongs may 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 the 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.

Additional 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 or pharmacist, 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 Quetiapina Normon

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.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofQuetiapina Normon

The active ingredient is quetiapine. The tablets contain 200 mg of quetiapine (as quetiapine hemifumarate).

The other ingredients are:

Core of the tablet: lactose monohydrate (lactose), hydroxypropyl methylcellulose (hypromellose), sodium chloride, povidone K-30, talc, magnesium stearate (E572).

Coating of the tablet: opadry yellow 03B52117 (composition: hydroxypropyl methylcellulose (hypromellose) 6cP (E464), titanium dioxide (E171), macrogol (E553b), yellow iron oxide (E172)).

Appearance ofQuetiapina Normonand Package Contents

The tablets are yellow, round, and biconvex, film-coated, engraved with the inscription "Q200" on one side and smooth on the other side.

They are presented in Al/PVC/PVDC blisters, in packages of 60 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

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/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76833/P_76833.html