Quetiapine Normon 200 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Quetiapine Normon 200 mg film-coated 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 be harmful to 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 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 side 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: when you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: when you may feel very excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, which may include being aggressive or violent.
• Schizophrenia: when 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 prescribing Quetiapina Normon even after you start feeling better.

2. What you need to know before taking Quetiapine Normon

Do not take Quetiapine Normon:

• 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 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 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, for example, heart rhythm disorders, 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 (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). 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 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 nighttime 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), have 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 have depression or other conditions treated with antidepressants. Using these medicines together with Quetiapine Normon may cause serotonin syndrome, a potentially life-threatening condition (see “Use of Quetiapine Normon with other medicines”).

Inform your doctor immediately if, after taking Quetiapine 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 feel very drowsy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (epileptic fits).
• A prolonged and painful erection (priapism).
• Fast or irregular heartbeats, even at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. 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 discontinuation of 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. This 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. 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 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 blistering and peeling of the skin, 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 cell count (eosinophilia) and elevated liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pustules filled with pus.
• Erythema multiforme (EM), skin eruptions with irregular red spots that itch.

If you develop any of these symptoms, stop using Quetiapine 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

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

Use of Quetiapine Normon with other medicines

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

Do not take Quetiapine 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 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 for urination) or certain antibiotics (medicines for treating 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 Quetiapine Normon and you may experience symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movement, 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 Quetiapine Normon with food, drinks, and alcohol

• Quetiapine Normon can be taken with or without food.
• Be cautious about the amount of alcohol you consume. This is because the combined effect of Quetiapine Normon and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking Quetiapine Normon. It may affect how the medicine works.

Pregnancy and breastfeeding

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 advised by your doctor. You should not use Quetiapine Normon if you are 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 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.

Quetiapine Normon contains lactose and sodium

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.

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 dosage instructions for this medicine as given by your doctor. 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 will usually range between 150 mg and 800 mg.

• You will take your tablets once daily at bedtime or twice daily, depending on your condition.
• Swallow your tablets whole with water.
• You may take the tablets with or without food.
• 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 do so.

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 your Quetiapine Normon tablets with you.

You may also call the Toxicology Information Service at telephone number: 915620420, stating 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 have difficulty sleeping (insomnia), or may experience nausea, headache, diarrhoea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 diminish over time as you continue taking quetiapine) (may lead to falls).
• Withdrawal symptoms (symptoms occurring when you stop taking quetiapine), including inability to sleep (insomnia), nausea, headache, diarrhea, 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 up. This may make you feel dizzy or faint (may lead to falls).

• Increased blood sugar levels.

• Blurred vision.

• Abnormal dreams and nightmares.

• Increased appetite.

• 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.

• Increased levels of liver enzymes in blood tests.

• Increased levels of prolactin hormone in blood. Elevated prolactin levels may, in rare cases, lead to:

  • Breast enlargement and unexpected milk production in both men and women.
  • In women, absence of menstrual periods or irregular periods.

Uncommon adverse effects (may affect up to 1 in 100 people):

• 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 the 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 (may 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 extreme drowsiness or dizziness (a condition called "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 (galactorrhea).

• Menstrual disorders.

• Blood clots in 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 immediate medical help.

• Walking, talking, eating, or performing other activities while asleep.

• Decreased body temperature (hypothermia).

• Inflammation of the pancreas.

• A condition (called "metabolic syndrome") in which you may have 3 or more of the following: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased blood fats called triglycerides, increased blood pressure, and increased 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 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) (see section 2).

• Inappropriate 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)

• 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, 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 may occur 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 Quetiapine Normon belongs may cause heart rhythm problems that can be serious and, in severe cases, may be fatal.

Some adverse effects are only detected through 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 red blood cell count, increased blood creatine phosphokinase (a substance found in muscles), decreased sodium levels in the blood, and increased levels of prolactin hormone in the blood. Elevated prolactin levels may, in rare cases, lead to:

• Breast enlargement and unexpected milk production in both men and women.
• 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 were not observed in adults:

Very common adverse 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:
  • Breast enlargement and unexpected milk production in both boys and girls.
  • 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 (may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of adverse effects

If you experience any adverse effect, consult 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 the sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, 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 fumarate).

The other components are:

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

Tablet coating: hypromellose (hydroxypropyl methylcellulose), titanium dioxide (E-171), and macrogol 6000.

Appearance of Quetiapine Normon and contents of the pack

The tablets are white or almost white, elongated and biconvex.

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

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/

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 outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71556/P_71556.html