Package Insert: Information for the Patient

Quetiapina Normon 25 mg Film-Coated Tablets EFG

Quetiapina

Read this package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only 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,evenifthey are not listed in this package insert. See section 4.

QuetiapinaNormoncontains a substance called quetiapine. It belongs to a group of medicines called antipsychotics.Quetiapina Normoncan be used to treat various illnesses, 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 prescribingQuetiapina Normoneven when you are feeling better.

Do not takeQuetiapina Normon:

• If you are allergic (hypersensitive) to quetiapine or to 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).

If you are unsure, consult your doctor or pharmacist before taking Quetiapina Normon.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Quetiapina Normon 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 medicine that may affect your heart rhythm.
• 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. 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 medicines).
• You are an elderly person with dementia (loss of brain function). If so, do not take quetiapine because the group of medicines to which quetiapine 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 has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
• You have or have had a condition in which your breathing is interrupted by short periods of time during normal sleep (called "sleep apnea") and are taking medicines that decrease normal brain activity ("depressants").
• You have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, a bowel obstruction, 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 have depression or other conditions that are treated with antidepressants. The use of these medicines with Quetiapina Normon may cause serotonin syndrome, a potentially life-threatening condition (see "Use of Quetiapina Normon with other medicines").

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

• A combination of fever, intense muscle stiffness, sweating, or a decrease in level of consciousness (a condition called "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).
• A prolonged and painful erection (priapism).
• Fast 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 medicine.

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 a very low white blood cell count 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 bowel obstruction.

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 medicines take time to become effective, usually around two weeks but sometimes longer. These thoughts may also increase if you stop taking your medication abruptly.This may be more likely 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 years old with depression.

If you ever think about 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 ask them to tell you if they think your depression is getting worse, or if they are concerned 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 may put your life at risk or be fatal. These usually manifest as:

• Stevens-Johnson syndrome (SSJ), a generalised rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (NET), a more severe form that causes extensive skin peeling.
• 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).
• Generalised acute pustular psoriasis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red patches that itch.

If you develop these symptoms, stop using Quetiapina 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

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

Use of Quetiapina Normon with other medicines

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

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

• Some medicines for HIV.
• 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 falling asleep).
• Thioridazine or Lithium (other antipsychotic medicines).
• Medicines that affect your heart rhythm, for example, medicines that may cause an imbalance of electrolytes (low potassium or magnesium) such as diuretics (medicines to urinate) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells work, to treat certain medical conditions.
• Antidepressants. These medicines may interact with Quetiapina Normon 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 medicines, consult your doctor first.

Taking Quetiapina Normon with food, drinks, and alcohol

• Quetiapina Normon can be taken with or without food.
• Be careful with the amount of alcohol you drink. This is because the combined effect of Quetiapina Normon and alcohol may make you drowsy.
• Do not take grapefruit juice while taking Quetiapina Normon. It may affect how the medicine 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 medicine. Do not take Quetiapina Normon during pregnancy, unless your doctor has advised you to. Do not use Quetiapina Normon 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 their pregnancy): tremor, muscle stiffness, and/or weakness, drowsiness, agitation, respiratory problems, and feeding difficulties. 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.

Effect on drug detection tests in urine

If you are having a drug detection test in urine, taking quetiapine may produce positive results for methadone or certain antidepressant medicines 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.

Quetiapina Normon contains lactose and sodium

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

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

Follow exactly the administration instructions of 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 your needs, but it will normally 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 takingQuetiapina Normon. 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

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

If you take moreQuetiapinaNormonthan you should

If you take moreQuetiapina Normonthan your doctor prescribed, you mayfeel drowsy, feel dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Bring yourQuetiapina Normontablets with you.

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

If you forget to takeQuetiapinaNormon

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 withQuetiapinaNormon

If you stop takingQuetiapina Normonabruptly, you maybe unable to sleep (insomnia), or you mayfeel nausea,oryou may experience headaches, diarrhea,vomiting, dizziness,or irritability.Your doctor may suggest reducing the dose gradually before interrupting treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can 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 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.Thismay make you 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 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 liver enzymes measured in the blood.
• Increases in prolactin hormone levels in the blood. Elevated prolactin levels 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 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 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.
• Worsening of pre-existing diabetes.
• Confusion.

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 levels of creatine phosphokinase in the blood (a substance found in muscles).

Very rare side effects(may affect up to 1 in 10,000 people):

• Severe skin rash, blisters, or red spots.

• Severe allergic reaction (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) (see section 2).
• Incorrect secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Not known (frequency cannot be estimated from available data)

• Rashes on the skin with irregular red patches (erythema multiforme) (see section 2).
• Rapid appearance of areas of skin with red spots and small blisters (pustulosis exanthemática generalizada aguda (AGEP)) (see section 2).
• Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis)(see section 2).
• Medication reaction with eosinophilia and systemic symptoms (DRESS), which includes flu-like symptoms, rash, 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 newborn babies of mothers who have taken quetiapine during pregnancy.
• Stroke.
• Heart 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 whichQuetiapina Normonbelongs may cause heart rhythm problems that can be serious and, in severe cases, fatal.

Some side effects are only seen when a blood test is done. 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 numbers of certain types of blood cells, decreased red blood cell count, increased creatine-phosphocinase in the blood (a substance found in muscles), decreased sodium levels in the blood, and increased prolactin hormone levels in the blood. Elevated prolactin levels 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.

Additional 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 prolactin levels 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 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 could lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 usethis medicationafter 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 medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofQuetiapina Normon

The active ingredient is quetiapine. The tablets contain 25 mg of quetiapine (as quetiapine fumarate).

The other components are:

Tablet core: lactose monohydrate (lactose), calcium dihydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A) from potato (potato starch), croscarmellose sodium, povidone, magnesium stearate, anhydrous colloidal silica.

Tablet coating: hydroxypropyl methylcellulose (hypromellose), titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), and macrogol 6000.

Appearance ofQuetiapina Normonand contents of the packaging

The tablets are pink, round, and biconvex.

They are presented in PVC/Aluminum blisters, in packs of 6, 60, and 250 tablets.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Normon, S.A.

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

Date of the last review of this leaflet:June 2024

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/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/71553/P_71553.html