Quetiapine Normon 200 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Quetiapine Normon 200 mg prolonged-release tablets EFG

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 only and must 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 effects not listed in this leaflet. See Section 4.

Leaflet contents:

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

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

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

• Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: where you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, which may include aggressive or violent behaviour.
• Schizophrenia: where 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.

When Quetiapina Normon extended-release tablets are used to treat major depressive episodes in major depressive disorder, they are taken in addition to another medicine you are already using for this condition.

Your doctor may continue prescribing Quetiapina Normon even after you start feeling better.

2. What you need to know before taking Quetiapina Normon

Do not take Quetiapina 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:

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

If you have any doubts, consult your doctor or pharmacist before taking Quetiapina Normon.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Quetiapina Normon if:

• You, or a family member, have or have had heart problems, for example, heart rhythm disorders, weakened 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 (epileptic fit).
• 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). In this case, you should not take quetiapine, as the group of medicines to which Quetiapina Normon belongs may increase the risk of stroke or, in some cases, the risk of death in these individuals.
• 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 have been associated with blood clot formation.
• You have or have had a condition in which your breathing stops for short periods during normal sleep (called "sleep apnea") and you are taking medicines that reduce normal brain activity ("depressants").
• You have or have had a condition in which you cannot completely empty your bladder (urinary retention), an enlarged prostate, intestinal obstruction, or increased pressure inside your eye. These conditions can sometimes be caused by medicines (called "anticholinergics") that affect how nerve cells function, used to treat certain medical conditions.
• You have a history of alcohol or drug abuse.
• You or a family member have a history of depression or other conditions treated with antidepressants. Using these medicines together with Quetiapina Normon may cause serotonin syndrome, a potentially life-threatening condition (see "Taking Quetiapina Normon with other medicines").

Inform your doctor immediately if, after taking Quetiapina Normon, 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 along 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 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 suddenly stop taking your medication. You may be more likely to have such thoughts if you are a young adult. Data from clinical trials 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 ask them to inform you if they think your depression is getting worse or if they are concerned about changes in your behavior.

Serious skin adverse reactions (SCARs)

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

• Stevens-Johnson syndrome (SJS), a widespread rash with blistering 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 pustules filled with pus.
• Erythema multiforme (EM), skin eruptions with irregular red patches that itch.

If you develop any of these symptoms, stop using Quetiapina Normon 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

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

Taking Quetiapina Normon with other medicines

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

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

• Certain 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 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 ("water pills") or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells function, used to treat certain medical conditions.
• Antidepressants. These medicines may interact with Quetiapina Normon, and you may experience symptoms such as involuntary rhythmic muscle contractions, including of the eye movement 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 Quetiapina Normon prolonged-release tablets with food, drinks, and alcohol

• Quetiapina Normon 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 Quetiapina Normon and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking Quetiapina Normon. It may 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 must not take Quetiapina Normon during pregnancy unless advised by your doctor. You must not use Quetiapina Normon while breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may occur in newborns of mothers who have taken quetiapine during the third trimester (last three months of pregnancy): tremor, muscle rigidity 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 the 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.

Quetiapina 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 with him 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 exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. Your doctor will determine your starting dose. The maintenance dose (daily dose) will depend on your condition and individual 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 water.

• Take the 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 taking Quetiapine Normon. It may 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 adjust your dose.

Elderly patients

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

Use in children and adolescents

Quetiapine Normon must 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 prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Take the Quetiapine Normon tablets 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 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 missed tablet.

If you stop taking Quetiapine Normon

If you stop taking Quetiapine Normon abruptly, you may have difficulty sleeping (insomnia), or feel nauseous, or experience headache, diarrhoea, vomiting, dizziness or irritability. Your doctor may advise you to gradually reduce 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 could lead to falls), headache, dry mouth.

• Drowsiness (which may decrease over time as you continue taking quetiapine), (which could 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 discontinuation 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 rigidity.

• Changes in levels of certain fats (triglycerides and total cholesterol).

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

• Fast heartbeat.

• Feeling that your heart is pounding, beating rapidly, or having irregular heartbeats.

• Constipation, upset stomach (indigestion).

• Feeling weak.

• Swelling of arms or legs.

• Low blood pressure when standing. This may 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.

• 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 enzymes measured in blood.

• Increases in blood levels of the hormone prolactin. Increases in prolactin levels may, in rare cases, lead to the following:

  • In both men and women: breast enlargement and unexpected milk production.
  • 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.

• Involuntary movements, mainly of the face or tongue.

• Sexual dysfunction.

• Diabetes.

• Changes in the heart's electrical activity seen on ECG (prolongation of QT interval).

• Slower than normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting.

• Difficulty urinating.

• Fainting (which could lead to falls).

• Stuffy nose.

• Decreased number of red blood cells in the blood.

• Decreased sodium levels 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, and feeling very drowsy or dizzy (a disorder known as “neuroleptic malignant syndrome”).

• Yellowing of the skin and eyes (jaundice).

• Inflammation of the liver (hepatitis).

• Prolonged and painful erection (priapism).

• Breast enlargement and unexpected milk production (galactorrhoea).

• Menstrual disorders.

• 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”) in which 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 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 blistering condition affecting the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).

• Inappropriate secretion of a hormone that controls urine volume.

• Muscle fiber breakdown 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 skin areas with small pustules (small blisters filled with white/yellow fluid known as Acute Generalized Exanthematous Pustulosis (AGEP)) (see section 2).
• Sudden and 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), consisting of 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 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 blood vessels (vasculitis), often with a skin rash showing small red or purple spots.

The class of medicines to which Quetiapina Normon belongs can cause problems with heart rhythm that may be serious and, in severe cases, could 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, decreased numbers of certain types of blood cells, decreased number of red blood cells, increased blood creatine phosphokinase (a substance found in muscles), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Increases in prolactin levels may, in rare cases, lead to the following:

• In both men and women: breast enlargement 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 levels may, in rare cases, lead to the following:
  • In both boys and girls: breast enlargement 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 rigidity.
• Increased blood pressure.

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

• Feeling weak, fainting (which could lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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. Storage of Quetiapine Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quetiapine Normon

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

The other components are:

Tablet core: monohydrate lactose (lactose), hypromellose, sodium chloride, povidone K-30, talc, magnesium stearate (E572).

Tablet coating: Opadry Yellow 03B52117 (composition: hypromellose 6 cP (E464), titanium dioxide (E171), macrogol (E553b), yellow iron oxide (E172)).

Appearance of Quetiapine Normon and contents of the pack

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

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

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

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

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