Quentiax 300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Quentiax 300 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, consult 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 may harm 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 Quentiax is and what it is used for
2. What you need to know before taking Quentiax
3. How to take Quentiax
4. Possible adverse effects
5. How to store Quentiax
6. Contents of the pack and other information

1. What Quentiax is and what it is used for

Quentiax contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Quentiax may 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 extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, which may include being aggressive or violent.
• Schizophrenia: when you may see, 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 Quentiax even when you are feeling better.

2. What you need to know before taking Quentiax

Do not take Quentiax

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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Quentiax if:

• You, or a family member, have or have had any heart problems, for example, irregular 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 (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 Quentiax.
• 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 Quentiax because the group of medicines to which Quentiax 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 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 apnoea”) 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, a bowel obstruction, or increased pressure inside your eye. These conditions can sometimes be caused by medicines (called “anticholinergics”) that affect how nerve cells work, 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 may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Quentiax”).

Tell your doctor immediately if, after taking quetiapine, 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. Uncontrolled movements, mainly of your face or tongue.

• Dizziness or feeling very sleepy. This may increase the risk of accidental injury (falls) in elderly patients.

• Seizures (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.

Tell 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 low white blood cell count, which may require stopping treatment with quetiapine and/or additional treatment.
• Constipation together with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more serious bowel blockage.

Suicidal thoughts and worsening of your 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 behaviour 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 let you know if they think your depression is getting worse, or if they are concerned about changes in your behaviour.

Severe cutaneous adverse reactions (SCARs)

Severe cutaneous adverse reactions (SCARs), which may be life-threatening or fatal, have very rarely been reported with quetiapine treatment. These have frequently manifested as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals
• Toxic epidermal necrolysis (TEN), a more severe condition causing extensive skin peeling
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), consisting of flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes)
• Acute Generalized Exanthematous Pustulosis (AGEP), small pustules filled with pus
• Erythema multiforme (EM), a skin rash with irregular red patches that itch

Stop taking Quentiax if you develop these symptoms and contact your doctor or seek immediate medical attention.

Weight gain

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

Children and adolescents

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

Other medicines and Quentiax

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

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

• Some medicines for HIV.

• Azole-type medicines (for fungal infections).

• Erythromycin or clarithromycin (for infections).

• Nefazodone (for depression).

Tell your doctor if you are taking any of the following medicines:

• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or lithium (another antipsychotic medicine).
• Medicines that affect your heartbeat, for example, medicines that may cause an electrolyte imbalance (low potassium or magnesium levels) such as diuretics (medicines to increase urination) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Medicines (called “anticholinergics”) that affect how nerve cells work, used to treat certain medical conditions.
• Antidepressants. These medicines may interact with quetiapine 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 tone, 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 Quentiax with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take Quentiax during pregnancy unless advised by your doctor.

You must not use Quentiax if you are breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may occur in newborn babies of mothers who have taken quetiapine during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.

Driving and using machines

Quentiax may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce your reaction ability. These effects, as well as your illness itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive or operate machinery, or engage in other activities requiring special attention, until your doctor has assessed your response to this medicine.

Quentiax contains 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 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

Effect on Urine Drug Screening Tests

If you are undergoing a urine drug screening test, taking Quentiax may produce positive results for methadone or certain antidepressant medicines known as tricyclic antidepressants (TCAs) when certain analytical methods are used, even if you are not taking methadone or TCAs. If this occurs, a more specific test can be performed.

3. How to take Quentiax

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will decide your initial 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 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 Quentiax. 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

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

If you take more Quentiax than you should

If you take more Quentiax than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Take the Quentiax tablets with you.

You may also call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Quentiax

If you forget to take Quentiax, take the missed dose as soon as you remember. If it is almost time for your next dose, wait and take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Quentiax

If you stop taking Quentiax abruptly, you may have difficulty sleeping (insomnia), 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 will experience them.

Very common: 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 Quentiax) (could lead to falls).
• Discontinuation symptoms (symptoms occurring when you stop taking Quentiax), including inability to sleep (insomnia), feeling nauseous, headache, diarrhoea, vomiting, dizziness, and irritability. 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, restlessness, or painless muscle rigidity.
• Changes in levels of certain fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Fast heartbeat.

• Feeling that your heart is pounding, beating rapidly, or beating irregularly.

• Constipation, upset stomach (indigestion).

• Feeling weak.

• Swelling of arms or legs.

• Low blood pressure when standing. This may make you feel dizzy or faint (could 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.

• Decrease in the number of certain types of blood cells.

• Increases in liver enzyme levels measured in blood.

• Increases in blood levels of prolactin hormone. Elevated 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: may affect up to 1 in 100 people

• Seizures or convulsions.
• Allergic reactions which may include raised, itchy skin rashes (hives), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrollable 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 (could lead to falls).
• Nasal congestion.
• Decrease in the number of red blood cells in the blood.
• Decrease in blood sodium levels.
• Worsening of pre-existing diabetes.
• Confusion.

Rare: may affect up to 1 in 1,000 people

• A combination of high temperature (fever), sweating, muscle stiffness, and extreme drowsiness or dizziness (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 veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel to the lungs causing chest pain and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.
• 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 a combination of 3 or more of the following: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased blood levels of a type of fat 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 creatine phosphokinase in blood (a substance from muscles).

Very rare: 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 condition with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

Frequency 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 called 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 cell count (eosinophilia) and liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who have used Quentiax 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 belongs can cause problems with heart rhythm that may be serious and, in severe cases, could 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 the 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 blood sodium levels, and increased blood levels of prolactin hormone. Elevated 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.

Other adverse effects in children and adolescents

The same side 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: may affect more than 1 in 10 people

• Increase in the level of a hormone called prolactin in the blood. Elevated 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: may affect up to 1 in 10 people

• Feeling weak, fainting (could lead to falls).
• Nasal congestion.
• 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Quentiax

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Quentiax

The active substance is quetiapine. Each film-coated tablet contains 300 mg of quetiapine (as quetiapine hemifumarate).

The other components are:

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

Tablet coating: hypromellose, titanium dioxide (E171), macrogol 4000. See section 2 "Quentiax contains lactose and sodium".

Appearance of the product and contents of the container

The 300 mg film-coated tablets are capsule-shaped and white in colour.

They are presented in aluminium/PVC blisters containing 60 tablets per box.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Or

KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

Further information about this medicinal product is available from the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., Calle Anabel Segura 10, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet: April 2025

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