Quentiax: detailed information

Package leaflet: Information for the user

Quentiax 25 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets, 300 mg film-coated tablets

quetiapine
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What this leaflet contains:

What Quentiax is and what it is used for
What you need to know before taking Quentiax
How to take Quentiax
Possible side effects
How to store Quentiax
Contents of the pack and other information

1. What Quentiax is and what it is used for

Quentiax contains a substance called quetiapine. This belongs to a group of medicines called antipsychotics. Quentiax can be used to treat serious conditions such as:

Bipolar depression: for which you may feel sad, depressed, guilty, lack energy, lose your appetite and/or be unable to sleep.
Mania: you may feel highly excited, euphoric, agitated, enthusiastic or hyperactive, or have poor judgment, including being aggressive or disruptive.
Schizophrenia: when you may hear or experience things that are not there, believe things that are not real, or feel unusually suspicious, anxious, confused, guilty, tense or depressed.

Your doctor may continue to prescribe Quentiax even when you start to feel better.

2. What you should know before taking Quentiax

Do not take Quentiax

if you are allergic to quetiapine or to any of the excipients of this medicine (listed in section 6).
if you are taking any of the following medicines:
- certain medicines for the treatment of HIV.
- azole medicines (for fungal infections).
- erythromycin or clarithromycin (for infections).
- nefazodone (for depression).

Do not take Quentiax if any of the above apply to you. If you have any doubts, contact your doctor or pharmacist before taking Quentiax.

Warnings and precautions

Talk to your doctor or pharmacist before taking Quentiax if:

you or someone in your family has or may have any heart problems, for example, heart rhythm problems, weakened heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect how your heart beats;
you have low blood pressure;
you have had a stroke, especially if you are elderly;
you have liver problems;
you have ever had seizures;
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 this applies to you, you should not take Quentiax, as the group of medicines to which Quentiax belongs may increase the risk of stroke or, in some cases, the risk of death in elderly patients with dementia;
you are an elderly person with Parkinson’s disease/parkinsonism;
you or someone else in your family 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 you stop breathing for short periods during your normal sleep (called "obstructive sleep apnea") and you are taking medicines that reduce normal brain activity ("depressants");
you have or have had a condition in which the bladder cannot be completely emptied (urinary retention), have an enlarged prostate, a blockage in your intestine, or increased pressure inside the eye. These conditions are sometimes caused by medicines (called "anticholinergics") that affect how nerve cells work in treating certain medical conditions;
you have previously had a history of alcohol or drug abuse;
you suffer from depression or other conditions treated with antidepressants. The use of these medicines together with Quentiax may lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Quentiax").

Inform your doctor immediately if, after taking Quentiax, you experience any of the following:

a combination of fever, severe muscle stiffness, sweating, or reduced level of consciousness (a disorder called "neuroleptic malignant syndrome"). Immediate medical treatment may be required;
uncontrollable movements, mainly of the face or tongue;
dizziness or a strong feeling of sleepiness. This may increase the risk of accidental injury (falls) in elderly patients;
seizures (fits);
a painful and prolonged erection (priapism);
a fast or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained tiredness. Your doctor will need to check your heart and, if necessary, refer you immediately to a cardiologist.

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 this could be due to a very low white blood cell count, which may require discontinuation and/or treatment;
constipation with persistent abdominal pain or constipation that has not responded to treatment, as this could lead to a more serious bowel obstruction.

Suicidal thoughts or worsening depression

If you are depressed, you may sometimes have thoughts of self-harm or suicide. These may increase at the beginning of treatment, as these medicines take time to work, usually about two weeks, but sometimes longer. These thoughts may also increase if you stop treatment abruptly. You are more likely to have these thoughts if you are a young adult. Data from clinical trials have shown a higher risk of suicidal thoughts and/or suicidal behaviour in young adults under 25 years of age with depression.

If you have thoughts of self-harm or suicide, contact your doctor at once or go immediately to the hospital. It may help to tell a friend or relative about these symptoms and ask them to read this leaflet. You may also ask them to let you know if they think your symptoms are getting worse or if they are concerned about any changes in your behaviour.

Severe cutaneous adverse reactions (SCAR)

Very rarely, severe cutaneous adverse reactions (SCAR) that may be life-threatening or fatal have been reported with this medicine.

These commonly present as:

Stevens-Johnson Syndrome (SJS): widespread rash with blisters 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): flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes);
Acute Generalized Exanthematous Pustulosis (AGEP): small pus-filled blisters;
Erythema Multiforme (EM): rash with irregular red, itchy spots.

Stop using Quentiax and contact your doctor or seek immediate medical help if you develop any of these symptoms.

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 take any other medicines.

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

certain medicines for HIV;
azole medicines (for fungal infections);
erythromycin or clarithromycin (for infections);
nefazodone (for depression).

Inform 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 (other antipsychotic medicines);
medicines that may affect how your heart beats, for example, medicines that may cause an electrolyte imbalance (low levels of potassium or magnesium) such as diuretics (medicines that increase urine production) or certain antibiotics (medicines used to treat infections);
medicines that may cause constipation;
medicines (called "anticholinergics") that affect how nerve cells work in treating certain medical conditions;
antidepressants. These medicines may interact with Quentiax and may cause symptoms such as involuntary 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 medicine, inform your doctor.

Quentiax with food, drinks, and alcohol

Quentiax can be taken regardless of meals.
Be cautious about the amount of alcohol you consume. 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not take Quentiax during pregnancy unless you have discussed it with your doctor. You must not take Quentiax while breastfeeding.

In newborns whose mothers have used Quentiax during the third trimester (last three months of pregnancy), the following symptoms may occur, which may require medical attention: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.

If your baby develops any of these symptoms, you may need to contact your doctor.

Driving and using machines

This medicine may make you feel drowsy. Do not drive or operate any tools or machinery until you know how this medicine affects you.

Quentiax contains lactose and sodium

Quentiax contains lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, inform your doctor before taking this medicine.

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

Effects on drug testing in urine

If you undergo drug testing in urine, taking Quentiax may cause positive results for methadone or certain antidepressants called tricyclic antidepressants, even if you are not taking these medicines, depending on the type of test used. If this occurs, a more specific test can be performed.

3. How to take Quentiax

Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, you must consult your doctor or pharmacist.
Your doctor will determine the starting dose. The maintenance dose (daily dose) will depend on the type of
illness you have and your individual needs, but will generally be between 150 mg and 800 mg.

You will take the tablets once daily at bedtime or twice daily, depending on your condition.
Swallow the tablets whole with a glass of water.
You may take the tablets regardless of meals.
Do not drink grapefruit juice while taking Quentiax. It may affect how the medicine works.
Do not stop taking the 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
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, experience abnormal heartbeats, or feel dizzy. Contact your doctor or go to the nearest hospital. Take the Quentiax tablets with you.
If you forget to take Quentiax
If you forget a dose, take it as soon as you remember. If it is almost time for your next dose, wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Quentiax
If you stop treatment with Quentiax abruptly, you may have difficulty sleeping (insomnia), feel unwell (nausea), or experience headache, diarrhoea, vomiting, dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 people

Dizziness (which may lead to falls), headache, dry mouth.
Drowsiness (this may wear off over time while continuing to take your Quentiax tablets); drowsiness may lead to falls.
Withdrawal symptoms (symptoms occurring when you stop taking Quentiax) include inability to fall asleep (insomnia), feeling unwell (nausea), headache, diarrhoea, vomiting, dizziness, and irritability. Gradual discontinuation over a period of at least 1-2 weeks is recommended.
Weight gain.
Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless, or painless muscle stiffness.
Changes in the levels of certain blood fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

Fast heartbeat.
Sensation of rapid or forceful heartbeat, or awareness of missed heartbeats.
Constipation, stomach discomfort (indigestion).
Feeling of weakness.
Swelling of the arms or legs.
Low blood pressure when standing up. This may cause dizziness or fainting (may lead to falls).
Increased blood sugar levels.
Blurred vision.
Unusual dreams and nightmares.
Increased feeling of hunger.
Feeling of irritation.
Speech and language disorders.
Suicidal thoughts and worsening of depression.
Shortness of breath.
Vomiting (mainly in elderly patients).
Fever.
Changes in the levels of thyroid hormones in the blood.
Decrease in the number of certain types of blood cells.
Increase in liver enzymes measured in the blood.
Increase in the level of the hormone prolactin in the blood. Elevated prolactin levels may, in rare cases, lead to the following:
Both men and women may experience breast enlargement and unexpected production of breast milk.
Women may experience absent or irregular menstrual cycles.

Uncommon: may affect up to 1 in 100 people

Seizures or fits.
Allergic reactions which may include swellings (hives), skin swelling, and swelling around the mouth.
Unpleasant sensation 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).
A slowing of the normal heart rate may occur when starting treatment and may be associated with low blood pressure and fainting.
Difficulty urinating.
Fainting (may cause falls).
Nasal congestion.
Reduction in the number of red blood cells.
Reduction in the amount of sodium in the blood.
Worsening of pre-existing diabetes.
Confusion.

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

A combination of high temperature (fever), sweating, rigid muscles, and drowsiness or fainting (a condition called "neuroleptic malignant syndrome").
Yellowing of the skin and eyes (jaundice).
Inflammation of the liver (hepatitis).
Painful and prolonged erection (priapism).
Breast enlargement and unexpected milk production (galactorrhea).
Menstrual disorders.
Blood clots in the veins, particularly in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through the blood vessels to the lungs causing chest pain and breathing difficulties. If you notice any of these symptoms, consult a 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 symptoms: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a blood fat called triglycerides, high blood pressure, and increased blood sugar levels.
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 derived from muscles).

Very rare: may affect up to 1 in 10,000 people

Severe skin rash, blisters, or red patches on the skin.
Severe allergic reaction (called anaphylaxis) which may cause breathing difficulties or shock.
Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
Severe condition characterized by blister formation on the skin, in the mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
Inappropriate secretion of a hormone that controls urine volume.
Rupture of muscle fibres and muscle pain (rhabdomyolysis).

Not known: frequency cannot be estimated from the available data

Skin rash associated with appearance of irregular red patches (erythema multiforme). See section 2.
Rapid appearance of areas of red skin dotted with small pustules (small blisters filled with white/yellow fluid called Acute Generalized Exanthematous Pustulosis (AGEP). See section 2.
Sudden, severe allergic reaction with symptoms such as fever, blistering of the skin, and skin peeling (toxic epidermal necrolysis). See section 2.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), consisting of flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes). See section 2.
Withdrawal symptoms may occur in newborns of mothers who 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 raised spots.

The class of medicines to which Quentiax belongs can cause problems with heart rhythm, which may be serious and, in severe cases, fatal.

Some side effects are only detectable through blood tests. These include changes in the levels of certain blood fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels, increased liver enzymes, decreased number of certain types of blood cells, reduced number of red blood cells, increased serum creatine phosphokinase (a substance from muscles), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood.

Elevated levels of prolactin hormone may, in rare cases, lead to the following consequences:

Breast enlargement and unexpected milk production from the mammary gland in both men and women.
Absence or irregularity of menstrual cycles in women.

Your doctor may ask you to have regular blood tests.

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 were not reported in adults:

Very common: may affect more than 1 in 10 people

Increase in the level of a hormone called prolactin in the blood. In rare cases, these increases in prolactin levels may cause the following conditions:
Breast enlargement and unexpected milk production from the mammary gland in boys and girls.
Absence or irregularity of menstrual cycles in girls.
Increased appetite.
Vomiting.
Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless, or painless muscle stiffness.
Increased blood pressure.

Common: may affect up to 1 in 10 people

Weakness, fainting (may cause falls).
Nasal congestion.
Irritability.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Quentiax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after SCAD/EXP.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
HDPE tablet container:
The shelf life after first opening is 3 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Quentiax contains

The active substance is quetiapine. Each tablet contains 25 mg, 100 mg, 150 mg, 200 mg or 300 mg of quetiapine (as quetiapine hemifumarate).
The excipients are: monohydrate lactose, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, povidone, sodium starch glycolate (type A), magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172) (only in 25 mg and 100 mg tablets) and red iron oxide (E172) (only in 25 mg tablets) in the film coating. See section 2 "Quentiax contains lactose and sodium".

Description of the appearance of Quentiax and pack sizes

The 25 mg tablets are round, light red film-coated tablets with a bevelled edge.
The 100 mg tablets are round, brown/yellow film-coated tablets.
The 150 mg tablets are round, white film-coated tablets with a bevelled edge.
The 200 mg tablets are round, white film-coated tablets.
The 300 mg tablets are oblong, white film-coated tablets.

Quentiax film-coated tablets are available in packs of 6 (only 25 mg tablets), 10, 20, 30, 30 x 1, 50, 60, 90, 98, 100, 100 x 1, 120 (only 150 mg and 300 mg tablets), 180 (only 150 mg and 300 mg tablets) or 240 (only 150 mg and 300 mg tablets) tablets in blister packs, and 250 tablets (only 100 mg and 200 mg tablets) in a container (HDPE).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy:
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

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

Member State Name	Medicinal Product Name
Austria, Denmark, Iceland, Sweden, Norway	Quetiapin Krka
Belgium, Netherlands	Quetiapine Krka
Bulgaria, Czech Republic, Estonia, Latvia, Lithuania, Poland, Romania, Slovakia	Kventiax
Germany	Quetiapin TAD
Spain, Italy	Quentiax
United Kingdom (Northern Ireland)	Quetiapine
Greece	Quetiapine TAD

Patient information leaflet

Quentiax 50 mg prolonged-release tablets, 150 mg prolonged-release tablets, 200 mg prolonged-release tablets, 300 mg prolonged-release tablets, 400 mg prolonged-release tablets

quetiapine
Generic medicinal product
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Quentiax is and what it is used for
What you need to know before taking Quentiax
How to take Quentiax
Possible side effects
How to store Quentiax
Contents of the pack and other information

1. What Quentiax is and what it is used for

Quentiax contains a substance called quetiapine. This substance belongs to a group of medicines known as antipsychotics. Quentiax can be used to treat several conditions, such as the following:

Bipolar depression and major depressive episodes associated with major depressive disorder: you may feel sad or depressed, guilty, lack energy, have loss of appetite, or have difficulty sleeping.
Mania: you may feel highly excited, euphoric, agitated, enthusiastic or hyperactive, or have poor judgment, including states of aggression or agitation.
Schizophrenia: you may experience hearing or sensing things that are not actually present, believe things that are not true, or feel unusually suspicious, anxious, confused, guilty, tense or depressed.

When Quentiax is taken to treat major depressive episodes associated with major depressive disorder, it must be used in addition to another medicine indicated for the treatment of this condition.
Your doctor may continue to prescribe Quentiax even if you feel better.

2. What you should know before taking Quentiax

Do not take Quentiax

if you are allergic 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 virus
azole antifungals (for fungal infections)
erythromycin or clarithromycin (for infections)
nefazodone (for depression).

If you are in any doubt, consult your doctor or pharmacist before taking Quentiax.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quentiax if:

You or someone else in your family has or has previously had heart problems, such as irregular heartbeat, weakened heart muscle, or inflammation of the heart, or if you are taking medicines that may affect your heartbeat.
Your blood pressure is low.
You have had a stroke, especially if you are elderly.
You suffer from liver problems.
You have experienced seizures (epileptic fits).
You have diabetes or are at risk of developing diabetes. In this case, 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 in your blood (whether caused by medicines or not).
You are an elderly person with dementia (loss of some brain functions). In this case, you should not take Quentiax, as this class of medicines, to which Quentiax belongs, may increase the risk of stroke, or in some cases the risk of death in elderly patients with dementia.
You are an elderly person with Parkinson’s disease/parkinsonism.
You or someone else in your family has a history of blood clots, as medicines of this type have been associated with blood clot formation.
You have or have previously had a condition in which you stop breathing for short periods during your normal night sleep (called "obstructive sleep apnoea") and you are taking medicines that reduce normal brain activity ("depressants").
You have or have previously had a condition in which you are unable to empty your bladder completely (urinary retention), have an enlarged prostate, a bowel blockage, or increased pressure inside the eye. These conditions are sometimes caused by medicines (called "anticholinergics") that affect how nerve cells work, used to treat certain medical conditions.
You have previously had a history of alcohol or drug abuse.
You suffer from depression or other conditions treated with antidepressants. The use of these medicines together with Quentiax may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Quentiax”).

Inform your doctor immediately if you experience any of the following symptoms after taking Quentiax:

A combination of high fever, muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be required.
Uncontrollable movements, mainly of the face or tongue.
Dizziness or a strong feeling of drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
Seizures (epileptic fits).
Persistent and painful erection (priapism).
You have a fast or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor will need to check your heart and, if necessary, refer you immediately to a cardiologist.

These conditions may be caused by this type of medicine.
Inform your doctor as soon as possible if you experience:

Fever, flu-like symptoms, sore throat, or any other infection, as these could be due to a very low white blood cell count, which may require that Quentiax be discontinued and/or treatment administered.
Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as these may lead to a more serious intestinal blockage.

Suicidal thoughts and worsening depression
If you are depressed, you may sometimes feel the urge to harm yourself or to die. These feelings
may be stronger at the beginning of treatment, as these medicines need time to work, usually about two weeks but sometimes longer. These thoughts may also intensify if you suddenly stop taking the medicine. You are more likely to have such feelings if you are a young adult. Data from clinical trials have indeed shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults with depression under 25 years of age.
If at any time you have thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately. You may find it helpful to inform a relative or close friend that you suffer from depression, and ask them to read this leaflet. You may ask them to alert you if they think your depression is worsening or if they are concerned about any changes in your behaviour.
Serious cutaneous adverse reactions (SCAR)
Very rarely, serious cutaneous adverse reactions (SCAR) that may be life-threatening or fatal have been reported with treatment with this medicine.
These commonly present as:

Stevens-Johnson Syndrome (SJS), a widespread rash with blisters 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), consisting of flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes)
Acute Generalized Exanthematous Pustulosis (AGEP), small blisters filled with pus
Erythema Multiforme (EM), a rash with irregular red, itchy spots

Stop taking Quentiax if you develop these symptoms and contact your doctor or seek immediate medical attention.
Weight gain
Weight gain has been reported in patients treated with Quentiax. Your weight should be monitored regularly by you and your doctor.
Children and adolescents
Quentiax must not be used in children and adolescents under 18 years of age.
Other medicines and Quentiax
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Quentiax if you are taking any of the following medicines:

Certain medicines for HIV virus.
Azole antifungals (for fungal infections).
Erythromycin or clarithromycin (for infections).
Nefazodone (for depression).

Inform 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 sleep disorders).
Thioridazine or lithium (other antipsychotic medicines).
Medicines that affect heart rhythm, for example, medicines that may cause an electrolyte imbalance (low levels of potassium or magnesium), such as diuretics (pills that increase urine production) or certain antibiotics (medicines for treating infections).
Medicines that may cause constipation.
Medicines (called "anticholinergics") that affect how nerve cells work for the treatment of certain medical conditions.
Antidepressants. These medicines may interact with Quentiax and cause symptoms such as involuntary 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 these symptoms occur.

Do not stop taking any medicine without first discussing it with your doctor.
Quentiax with food, drinks and alcohol

The effect of Quentiax may be affected by food; therefore, you should take the tablets at least one hour before a meal or before going to bed.
Be cautious about the amount of alcohol you consume. This is important because the combined effect of Quentiax and alcohol may increase drowsiness.
Do not drink grapefruit juice while taking Quentiax, as it may affect the action of the medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Quentiax during pregnancy without first discussing it with your doctor.
Quentiax must not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, may occur in newborns whose mothers have taken Quentiax during the third trimester (the 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, contact your doctor.
Driving and using machines
The tablets may cause drowsiness. Do not drive or operate any tools or machinery until you know how the tablets affect you.
Quentiax contains lactose and sodium
Quentiax contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Extended-release 50 mg tablet:
This medicine contains 8.44 mg of sodium (the main component of table salt) per tablet. This is equivalent to 0.42% of the maximum recommended daily intake of sodium for an adult.
Extended-release 150 mg tablet:
This medicine contains 14.53 mg of sodium (the main component of table salt) per tablet. This is equivalent to 0.73% of the maximum recommended daily intake of sodium for an adult.
Extended-release 200 mg tablet:
This medicine contains 19.38 mg of sodium (the main component of table salt) per tablet. This is equivalent to 0.97% of the maximum recommended daily intake of sodium for an adult.
Extended-release 300 mg tablet:
This medicine contains 29.06 mg of sodium (the main component of table salt) per tablet. This is equivalent to 1.45% of the maximum recommended daily intake of sodium for an adult.
Extended-release 400 mg tablet:
This medicine contains 23.46 mg of sodium (the main component of table salt) per tablet. This is equivalent to 1.17% of the maximum recommended daily intake of sodium for an adult.
Effect on urine screening tests
If you need to undergo a urine screening test, taking Quentiax may lead to false-positive results for methadone or certain antidepressant medicines called tricyclic antidepressants, when certain testing methods are used, even if you are not taking methadone or tricyclic antidepressants. If this occurs, more specific tests should be performed.

3. How to take Quentiax

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Your doctor will decide the most appropriate starting dose for you. The maintenance dose (daily dose) will depend on the type of illness and individual needs, but is usually between 150 mg and 800 mg.

Take the tablets once daily.
The tablets must not be split, chewed, or crushed.
Swallow the tablets whole, with a glass of water.
Take the tablets away from meals (at least one hour before a meal or at bedtime; your doctor will tell you when).
Do not drink grapefruit juice while taking Quentiax, as it may affect the medicine's action.
Do not stop taking the tablets even if you feel better, unless your doctor tells you otherwise.

Liver problems
If you have liver problems, your doctor may adjust your dose.
Elderly
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, you may feel drowsy, experience dizziness, or notice an abnormal heartbeat. Contact your doctor or the nearest hospital immediately, and take the medicine pack with you.
If you forget to take Quentiax
If you forget to take a dose, take it 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 the missed tablet.
If you stop taking Quentiax
If you stop treatment with Quentiax suddenly, you may have difficulty sleeping (insomnia), feel nauseous, or develop headache, diarrhoea, vomiting, dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Very common: may affect more than 1 in 10 people

Dizziness (which may lead to falls), headache, dry mouth.
Drowsiness (which diminishes over time as treatment with Quentiax continues) (may lead to falls).
Withdrawal symptoms (symptoms occurring when you stop taking Quentiax), including inability to sleep (insomnia), feeling unwell (nausea), headache, diarrhoea, malaise (vomiting), dizziness, and irritability. Gradual discontinuation of the medicine over a period of at least 1 or 2 weeks is recommended.
Weight gain.
Abnormal muscle movements, including difficulty initiating muscle movement, tremor, restlessness, or painless muscle rigidity.
Changes in levels of certain blood fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

Fast heartbeat.
Awareness of heartbeat (palpitations), rapid heartbeat, or sensation of missed beats.
Constipation, stomach discomfort (indigestion).
Feeling weak.
Swelling of arms or legs.
Low blood pressure upon standing. This may cause dizziness or fainting (which may lead to falls).
Increased blood sugar levels.
Blurred vision.
Abnormal dreams and nightmares.
Increased appetite.
Irritability.
Speech and language disturbances.
Suicidal thoughts and worsening of depression.
Shortness of breath.
Vomiting (especially in elderly patients).
Fever.
Changes in thyroid hormone levels in the blood.
Decrease in the number of certain types of blood cells.
Increases in liver enzyme levels measured in the blood.
Increases in the level of prolactin hormone in the blood. Elevated prolactin levels may, in rare cases, lead to the following:
Breast enlargement and unexpected milk production from the mammary gland in both men and women.
Absence or irregularity of menstrual cycle in women.

Uncommon: may affect up to 1 in 100 people

Seizures or epileptic fits.
Allergic reactions which may include raised lumps (rashes), swelling of the skin and area 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 electrocardiogram (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 passing urine.
Fainting (which may lead to falls).
Nasal congestion.
Decrease in the number of red blood cells.
Decrease in sodium levels in the blood.
Worsening of pre-existing diabetes.
Confusion.

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

Combination of high body temperature (fever), sweating, muscle rigidity, and pronounced drowsiness or fainting (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 from the mammary gland (galactorrhoea).
Menstrual disorders.
Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.
Walking, talking, eating, and other activities during sleep.
Decreased body temperature (hypothermia).
Inflammation of the pancreas.
A condition (called “metabolic syndrome”) in which 3 or more of the following symptoms may occur: increased abdominal fat, reduced “good cholesterol” (HDL cholesterol), increased levels of blood fats called triglycerides, high blood pressure, and increased blood sugar.
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 serum creatine phosphokinase (a substance present in muscles).

Very rare: may affect up to 1 in 10,000 people

Severe skin rash, blisters, or red patches on the skin.
Severe allergic reaction (called anaphylaxis) which may cause breathing difficulties or shock.
Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
A serious condition presenting with blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
Inappropriate secretion of antidiuretic hormone, which controls urine volume.
Muscle fibre damage and muscle pain (rhabdomyolysis).

Frequency not known: frequency cannot be estimated from the available data

Skin rash with irregular red spots (erythema multiforme). See section 2.
Rapid appearance of red skin areas covered with small pustules (small blisters filled with white/yellow fluid called 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), consisting of flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes). See section 2.
Withdrawal symptoms may occur in newborns of mothers who took 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 bumps.

The class of medicines to which Quentiax belongs may cause problems with heart rhythm, which can be serious and, in some cases, fatal.
Some side effects are detectable only through blood tests. These include changes in levels of certain blood fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in the blood, increased liver enzymes, decreased number of certain types of blood cells, decreased number of red blood cells, increased serum creatine phosphokinase (a substance present in muscles), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Elevated prolactin levels may, in rare cases, lead to the following:

Breast enlargement and unexpected milk production from the mammary gland in both men and women.
Absence or irregularity of menstrual cycle in women.

Therefore, your doctor may prescribe periodic blood tests.
Additional side effects in children and adolescents
The same side effects observed in adults may also occur in children and adolescents.
The following side 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

Increased levels of prolactin hormone in the blood. Elevated prolactin levels may, in rare cases, lead to the following:
Breast enlargement and unexpected milk production from the mammary gland in boys and girls.
Absence or irregularity of menstrual cycle in girls.
Increased appetite.
Vomiting.
Abnormal muscle movements, including difficulty initiating muscle movements, tremor, restlessness, or painless muscle rigidity.
Increased blood pressure.

Common: may affect up to 1 in 10 people

Feeling weak, fainting (which may lead to falls).
Nasal congestion.
Irritability.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Quentiax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the carton after
EXP/SCAD. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Quentiax contains

The active substance is quetiapine.
Prolonged-release 50 mg tablets: Each prolonged-release tablet contains 50 mg of quetiapine (as quetiapine hemifumarate).
Prolonged-release 150 mg tablets: Each prolonged-release tablet contains 150 mg of quetiapine (as quetiapine hemifumarate).
Prolonged-release 200 mg tablets: Each prolonged-release tablet contains 200 mg of quetiapine (as quetiapine hemifumarate).
Prolonged-release 300 mg tablets: Each prolonged-release tablet contains 300 mg of quetiapine (as quetiapine hemifumarate).
Prolonged-release 400 mg tablets: Each prolonged-release tablet contains 400 mg of quetiapine (as quetiapine hemifumarate).
The other components of the 50 mg and 400 mg prolonged-release tablets are hypromellose, lactose monohydrate, microcrystalline cellulose, sodium dihydrogen citrate dihydrate and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E171) and polyethylene glycol 400 in the coating. See section 2 "Quentiax contains lactose and sodium".
The other components of the 150 mg prolonged-release tablets are hypromellose, lactose monohydrate, microcrystalline cellulose, disodium phosphate dihydrate and magnesium stearate in the tablet core, and polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol 3000, talc, red iron oxide (E172) and yellow iron oxide (E172) in the coating. See section 2 "Quentiax contains lactose and sodium".
The other components of the 200 mg and 300 mg prolonged-release tablets are hypromellose, lactose monohydrate, microcrystalline cellulose, disodium phosphate dihydrate and magnesium stearate in the tablet core, and polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol 3000, talc and yellow iron oxide (E172) in the coating. See section 2 "Quentiax contains lactose and sodium".

Description of the appearance of Quentiax and contents of the pack
50 mg prolonged-release tablets are white to almost white, capsule-shaped, slightly biconvex, film-coated tablets with bevelled edges, imprinted with "50" on one side. Tablet dimensions: length 16.2 mm, thickness 4.0–5.2 mm.
150 mg prolonged-release tablets are orange-pink, round, biconvex, film-coated tablets with bevelled edges. Tablet dimensions: diameter 10 mm, thickness 4.6–6.0 mm.
200 mg prolonged-release tablets are yellow-brown, oval, biconvex, film-coated tablets. Tablet dimensions: length 16 mm, thickness 5.6–7.1 mm.
300 mg prolonged-release tablets are light yellow-brown, capsule-shaped, biconvex, film-coated tablets. Tablet dimensions: length 19.1 mm, thickness 5.9–7.4 mm.
400 mg prolonged-release tablets are white to almost white, capsule-shaped, biconvex, film-coated tablets, imprinted with "400" on one side. Tablet dimensions: length 18.7–19.5 mm, thickness 5.5–7.1 mm.
Quentiax is available in packs containing 10, 30, 50, 60, 90 and 100 prolonged-release tablets in OPA/Al/PVC/Al blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy:
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Member State	Medicinal product name
Austria	Quetiapin HCS
Denmark, Finland, Iceland, Sweden	Quetiapin Krka
Belgium	Quetiapine Krka
Bulgaria	Kventiax SR
Czech Republic	Kventiax Prolong
Estonia, Poland, Slovakia, Slovenia	Kventiax SR
France	Quetiapine Krka LP
Greece	Arezil XR
Ireland	QuentiaxSR
Germany	Quetiapin TAD
Italy	Quentiax
Latvia, Lithuania	Kventiax
Portugal, Spain	Quetiapina Krka
Romania	Kventiax EP