Kventiax 200 mg tabletki povlekane

Package Leaflet: Information for the Patient

Kventiax 25 mg Coated Tablets

Kventiax 100 mg Coated Tablets

Kventiax 200 mg Coated Tablets

Kventiax 300 mg Coated Tablets

Quetiapine

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Kventiax and what is it used for
• 2. Important information before taking Kventiax
• 3. How to take Kventiax
• 4. Possible side effects
• 5. How to store Kventiax
• 6. Contents of the pack and other information

1. What is Kventiax and what is it used for

Kventiax contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics.
Kventiax is used to treat several diseases, such as:

• Depressive episodes in bipolar disorder: a state in which the patient feels sad, very depressed, lacks energy, loses appetite, feels guilty or cannot sleep;
• Mania: a state in which the patient is very excited, agitated, overactive, full of enthusiasm or overly active or has impaired critical judgment, is aggressive or troublesome;
• Schizophrenia: a state in which the patient hears and sees unreal voices and images, takes non-existent things for real, is overly suspicious, anxious, confused, feels guilty, is tense or depressed.

Even if the patient feels better, the doctor may recommend continuing treatment with Kventiax.

2. Important information before taking Kventiax

When NOT to take Kventiax

• certain medicines used to treat HIV infections,
• azole group medicines (used to treat fungal infections),
• erythromycin or clarithromycin (antibiotics used to treat infections),
• nefazodone (a medicine used to treat depression). In case of doubt, consult a doctor or pharmacist before taking Kventiax.

Warnings and precautions

Before starting to take Kventiax, inform your doctor or pharmacist if:

• the patient or a family member has or has had any heart problems, such as arrhythmias, heart muscle weakness, or myocarditis, or if the patient is taking or has taken any medicines that may affect heart function;
• the patient has low blood pressure;
• the patient has had a stroke, especially if the patient is elderly;
• the patient has liver problems;
• the patient has ever had a seizure;
• the patient has diabetes or is at risk of diabetes; in this case, the doctor may check blood sugar levels during treatment with Kventiax;
• the patient has ever had a low white blood cell count (regardless of whether it was caused by taking other medicines or not);
• the patient is elderly and has dementia (loss of brain function). In these patients, Kventiax should not be used, as medicines in the same class as Kventiax may increase the risk of stroke and, in some cases, death;
• the patient is elderly and has Parkinson's disease/parkinsonism;
• the patient or a family member has had blood clots, as medicines in this class may promote their formation;
• the patient has had a condition in which they stopped breathing for a short time while sleeping at night (called "sleep apnea") and is taking medicines that weaken normal brain activity (antidepressants);
• the patient has had a condition in which they could not empty their bladder (urinary retention), has an enlarged prostate, intestinal obstruction, or increased eye pressure. These disorders are often caused by medicines (so-called anticholinergic medicines) that affect the function of nerve cells, administered in the treatment of certain diseases;
• the patient has been addicted to alcohol or drugs in the past;
• the patient has depression or other conditions that are treated with antidepressants. Taking these medicines with Kventiax may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "Kventiax and other medicines").

Inform your doctor immediately if, after taking Kventiax, the following symptoms occur:

• occurring together: high temperature (fever), muscle stiffness, increased sweating, or decreased consciousness (a condition called malignant neuroleptic syndrome). Immediate medical attention may be necessary;
• uncontrolled movements, mainly in the face or tongue muscles;
• dizziness or excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• seizures (epileptic seizures);
• prolonged and painful erections (priapism);
• rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, refer the patient to a cardiologist immediately.

All these symptoms may occur during treatment with medicines in this therapeutic class.
Inform your doctor immediately if the patient experiences:

• simultaneously fever, flu-like symptoms, sore throat, or any other infection, as this may be a consequence of a very low white blood cell count in the blood; in this connection, it may be necessary to discontinue Kventiax and/or administer appropriate treatment;

with this, it may be necessary to discontinue Kventiax and/or administer appropriate treatment;

• constipation combined with persistent abdominal pain or persistent constipation despite treatment, as this may lead to a more severe bowel obstruction.

Suicidal thoughts and worsening depression

Patients with depression may sometimes have thoughts of self-harm or suicide.
Such symptoms or behavior may worsen at the beginning of treatment, as the medicines usually start to work only after about 2 weeks, and sometimes later. Symptoms may worsen if the patient suddenly stops taking the medicine. These symptoms are more likely to occur in young adult patients. Clinical trial data show an increased risk of suicidal thoughts and/or suicidal behavior in people under 25 years of age with depression.
Seek immediate medical attention if thoughts of self-harm or suicidal thoughts occur. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet. The patient may ask to be informed if they notice that the depression has worsened or if there are worrying changes in their behavior.

Severe skin reactions (SCAR)

During treatment with this medicine, very rare cases of severe skin reactions (SCAR, Severe Cutaneous Adverse Reactions) have been reported, which can be life-threatening or fatal. These reactions usually occur as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals
• Toxic epidermal necrolysis (TEN), a more severe form causing widespread peeling of the skin
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzyme activity)
• Acute generalized exanthematous pustulosis (AGEP), small blisters filled with pus
• Erythema multiforme (EM), a skin rash with red, itchy, irregular patches

If such symptoms occur, discontinue Kventiax and seek medical attention immediately.

Weight gain

Patients taking Kventiax may experience weight gain. The doctor will regularly check the patient's weight.

Children and adolescents

Kventiax is not intended for use in children and adolescents under 18 years of age.

Kventiax and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Do not take Kventiax if you are taking any of the following medicines:

• certain medicines used to treat HIV infections,
• azole group medicines (used to treat fungal infections),
• erythromycin or clarithromycin (antibiotics used to treat infections),
• nefazodone (a medicine used to treat depression).

Inform your doctor about taking any of the following medicines:

• antiepileptic medicines (such as phenytoin or carbamazepine),
• antihypertensive medicines,
• barbiturates (medicines used to treat sleep disorders),
• thioridazine or lithium (other antipsychotic medicines),
• medicines that affect heart rhythm, such as medicines that may cause electrolyte disturbances (decreased potassium or magnesium levels), such as diuretics or certain antibiotics (used to treat infections),
• medicines that may cause constipation,
• medicines (so-called anticholinergic medicines) that affect the function of nerve cells, administered in the treatment of certain diseases,
• antidepressant medicines. These medicines may interact with Kventiax and may cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, consult a doctor.

Do not stop taking other medicines without consulting a doctor.

Taking Kventiax with food, drink, and alcohol

• Kventiax can be taken with or without food.
• Be careful when drinking alcoholic beverages. Taking Kventiax with alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Kventiax, as it may affect the action of Kventiax.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Do not take Kventiax during pregnancy, unless your doctor recommends it. Kventiax should not be taken during breastfeeding.
In newborns whose mothers took Kventiax during the last trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur, which may indicate withdrawal syndrome: shaking, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If you notice such symptoms in your child, consult a doctor.

Driving and using machines

Kventiax may cause drowsiness. Do not drive or operate machinery until you are sure how the medicine affects you.

Kventiax contains lactose and sodium

Kventiax contains lactose, a type of sugar. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

Effect on urine tests for drugs

Taking Kventiax may cause false-positive results in some urine tests for methadone or certain tricyclic antidepressants. If this happens, a more specific testing method should be used.

3. How to take Kventiax

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The doctor will decide on the initial dose. The maintenance dose (daily dose) of Kventiax depends on the disease and the patient's needs, but it is usually between 150 mg and 800 mg.

• Tablets should be taken once a day before bedtime or twice a day, depending on the disease the patient is suffering from.
• Swallow the tablets whole with water.
• The medicine can be taken with or without food.
• Do not drink grapefruit juice while taking Kventiax. It may affect the action of Kventiax.
• Even if the patient feels better, do not stop taking the medicine unless the doctor decides to do so.

Liver function disorders

If the patient has liver problems, the doctor may recommend changing the dose of Kventiax.

Elderly patients

If the patient is elderly, the doctor may recommend changing the dose of Kventiax.

Use in children and adolescents

Kventiax should not be used in patients under 18 years of age.

Taking a higher dose of Kventiax than recommended

If a higher dose of Kventiax than prescribed by the doctor is taken, drowsiness, dizziness, irregular heartbeat may be felt. Seek immediate medical attention or go to the nearest hospital. Take the medicine packaging with you.

Missing a dose of Kventiax

Take the missed dose as soon as you remember. However, if it is close to the time for the next dose, wait and take the medicine at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Kventiax treatment

If Kventiax treatment is stopped abruptly, difficulty sleeping (insomnia) or nausea, headache, diarrhea, vomiting, dizziness, or irritability may occur. The doctor may recommend gradually reducing the dose before stopping treatment.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Very common: may affect more than 1 in 10 people

• Dizziness (may lead to falls), headache, dry mouth.
• Feeling drowsy (usually subsides over time while taking Kventiax) (may lead to falls).
• Withdrawal symptoms (symptoms that occur after stopping the medicine), including insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability. It is recommended to gradually stop taking the medicine over at least 1-2 weeks.
• Weight gain.
• Abnormal muscle contractions; may be difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• Changes in blood levels of certain fatty substances (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Rapid heartbeat.
• Irregular heartbeat - feeling of rapid or irregular heartbeat.
• Constipation, stomach upset (indigestion).
• Weakness.
• Swelling of hands or feet.
• Low blood pressure when standing up, which may cause dizziness or fainting (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 depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in thyroid hormone levels in the blood.
• Decreased levels of certain types of blood cells.
• Increased liver enzyme levels in the blood.
• Increased levels of the hormone prolactin in the blood; increased prolactin levels may lead to:
• breast swelling in both men and women and unexpected milk production,
• absence or irregular menstrual periods in women.

Uncommon: may affect up to 1 in 100 people

• Seizures.
• Allergic reactions, including hives (hives), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly in the face or tongue muscles.
• Sexual function disorders.
• Diabetes.
• Changes in the electrical activity of the heart visible on an ECG (QT interval prolongation).
• Slower than normal heart rate, which may occur when starting treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Stuffy nose.
• Decreased red blood cell count.
• Decreased sodium levels in the blood.
• Worsening of existing diabetes.
• Confusion.

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

• A combination of symptoms: high temperature (fever), excessive sweating, muscle stiffness, or decreased consciousness (a condition called malignant neuroleptic syndrome).
• Yellowing of the skin and eyes (jaundice).
• Hepatitis.
• Prolonged and painful erections (priapism).
• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorders.
• Blood clots in the veins, especially in the legs, which can move with the blood to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, seek medical attention immediately.
• Walking, eating, or performing other activities while sleeping.
• Low body temperature (hypothermia).
• Pancreatitis.
• A condition (called "metabolic syndrome") in which there is a combination of three or more of the following symptoms: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides, high blood pressure, and increased blood sugar levels.
• Simultaneous occurrence of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count in the blood (a condition called agranulocytosis).
• Bowel obstruction.
• Increased creatine kinase levels in the blood (a substance derived from muscles).

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

• Severe skin reactions, blisters, or red spots on the skin.
• Severe allergic reactions (anaphylaxis) with symptoms such as difficulty breathing or shock.
• Rapidly developing skin swelling, usually around the eyes and mouth, as well as the throat (angioedema).
• Severe skin reaction with blisters, peeling of the skin, and mucous membrane lesions (Stevens-Johnson syndrome). See section 2.
• Abnormal secretion of the hormone that controls the amount of urine excreted.
• Muscle breakdown and muscle pain (rhabdomyolysis).

Unknown: frequency cannot be estimated from available data

• Skin rash with red, itchy, irregular patches (erythema multiforme). See section 2.
• Sudden appearance of areas of red skin with small pus-filled blisters (acute generalized exanthematous pustulosis (AGEP)). See section 2.
• Severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzyme activity). See section 2.
• Symptoms of withdrawal may occur in newborns whose mothers took Kventiax during pregnancy.
• Stroke
• Heart muscle disorders (cardiomyopathy).
• Myocarditis.
• Vasculitis (inflammation of blood vessels), often with a skin rash with small red or purple spots.

Medicines in the same class as Kventiax may cause heart rhythm disorders, which can have serious consequences and, in severe cases, lead to death.
Some side effects can only be detected by blood tests in the laboratory. These include changes in the levels of certain fatty substances (triglycerides and total cholesterol) or sugar in the blood, changes in thyroid hormone levels in the blood, increased liver enzyme levels in the blood, decreased levels of certain types of blood cells, decreased red blood cell count, increased creatine kinase activity in the blood (a substance derived from muscles), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Increased prolactin levels may lead to:

• breast swelling in both men and women and unexpected milk production,
• absence or irregular menstrual periods in women.

The doctor may order periodic blood tests.

Additional side effects in children and adolescents

The same side effects as those observed in adults may also occur in children and adolescents.
The following side effects have been observed more frequently or exclusively in children and adolescents:

Very common: may affect more than 1 in 10 people

• Increased levels of the hormone prolactin in the blood. This may rarely lead to:
• breast swelling and unexpected milk production in both girls and boys,
• absence or irregular menstrual periods in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle contractions, including difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Kventiax

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 refers to the last day of the month stated.
The batch number is stated on the packaging after "Lot".
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Kventiax contains

• The active substance of Kventiax is quetiapine. Each coated tablet contains 25 mg, 100 mg, 200 mg, or 300 mg of quetiapine (as quetiapine hemifumarate).
• The other ingredients are: lactose monohydrate, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, povidone, sodium carboxymethylcellulose (type A), magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172) (only in 25 mg and 100 mg tablets), and red iron oxide (E 172) (only in 25 mg tablets) in the tablet coating. See section 2 "Kventiax contains lactose and sodium".

What Kventiax looks like and contents of the pack

25 mg: round, light red, coated tablets with beveled edges
100 mg: round, yellow-brown, coated tablets
200 mg: round, white, coated tablets
300 mg: white, capsule-shaped, coated tablets
Packaging: 30, 60, or 90 coated tablets in blisters in a cardboard box

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

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

In order to obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500
Date of last revision of the leaflet:13.04.2025