Kventiax 300 mg tabletki povlekane

Leaflet accompanying the packaging: patient information

Kventiax 25 mg coated tablets

Kventiax 100 mg coated tablets

Kventiax 200 mg coated tablets

Kventiax 300 mg coated tablets

Quetiapine

It is very important to read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the 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 packaging 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 antipsychotic medicines.
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, 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

• if the patient is allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking any of the following medicines:
• certain medicines used to treat HIV infections,
• azoles (used to treat fungal infections),
• erythromycin or clarithromycin (antibiotics used to treat infections),
• nefazodone (a medicine used to treat depression). In case of doubts, the doctor or pharmacist should be consulted before taking Kventiax.

Warnings and precautions

Before starting to take Kventiax, the doctor or pharmacist should be informed 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 their family members have had blood clots, as medicines in this class may contribute to 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").

The doctor should be informed immediately if the patient experiences symptoms such as:

• 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 fits);
• 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.
The doctor should be informed 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 case, it may be necessary to discontinue Kventiax and/or administer appropriate treatment;

with regard to this, discontinuation of Kventiax and/or administration of appropriate treatment may be necessary;

• constipation accompanied by persistent abdominal pain or persistent constipation despite treatment, as this may lead to a more severe intestinal blockage.

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 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.
The doctor or hospital should be contacted immediately 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 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 skin peeling, especially around the mouth, nose, eyes, and genitals
• Toxic epidermal necrolysis (TEN), a more severe form causing widespread skin peeling
• 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, Kventiax should be discontinued and medical help should be sought 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

The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Kventiax should not be taken if the patient is taking any of the following medicines:

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

The doctor should be informed 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 can cause electrolyte disturbances (decreased potassium or magnesium levels), such as diuretics or certain antibiotics (used to treat infections),
• medicines that can cause constipation,
• medicines (so-called anticholinergic medicines) that affect the function of nerve cells, administered in the treatment of certain diseases,
• antidepressants. These medicines may interact with Kventiax and may cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, the doctor should be consulted.

Other medicines should not be stopped without consulting the doctor.

Taking Kventiax with food, drink, and alcohol

• Kventiax can be taken with or without food.
• Caution should be exercised when consuming alcoholic beverages. Taking Kventiax with alcohol may cause drowsiness.
• Grapefruit juice should not be consumed while taking Kventiax, as it may affect the action of Kventiax.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Kventiax should not be taken during pregnancy, unless the 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: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If such symptoms are noticed in the child, the doctor should be consulted.

Driving and using machines

Kventiax may cause drowsiness. The patient should not drive or operate machines until they are sure how the medicine affects them.

Kventiax contains lactose and sodium

Kventiax contains lactose, a type of sugar. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "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

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted. 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.
• Tablets should be swallowed whole, with a glass of water.
• The medicine can be taken with or without food.
• Grapefruit juice should not be consumed while taking Kventiax, as it may affect the action of Kventiax.
• Even if the patient feels better, they should 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 a dose change.

Elderly patients

If the patient is elderly, the doctor may recommend a dose change.

Use in children and adolescents

Kventiax should not be taken by patients under 18 years of age.

Taking a higher dose of Kventiax than recommended

In case of taking a higher dose of Kventiax than prescribed by the doctor, the patient may experience drowsiness, dizziness, irregular heartbeat. The doctor or the nearest hospital should be contacted immediately. The packaging of the medicine should be taken along.

Missing a dose of Kventiax

A missed dose should be taken as soon as the patient remembers. However, if it is almost time for the next dose, the patient should wait and take the medicine at the usual time. A double dose should not be taken to make up for a missed dose.

Stopping Kventiax treatment

If Kventiax treatment is stopped suddenly, the patient may experience difficulty sleeping (insomnia) or nausea, headache, diarrhea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before stopping treatment.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

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 (which 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; this may be difficulty starting a 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 - a feeling of rapid or irregular heart rhythm.
• 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 glucose 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) on the skin, 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, the doctor should be contacted 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).
• Intestinal 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 swelling of the skin, usually around the eyes and mouth, as well as the throat (angioedema).
• Severe skin disorder with blisters, peeling skin, and mucous membrane lesions (Stevens-Johnson syndrome). See section 2.
• Abnormal secretion of the hormone that controls the amount of urine excreted.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

Unknown: frequency cannot be estimated from available data

• Skin rash with irregular red 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 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.
• Withdrawal symptoms 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 a laboratory. These include changes in the levels of certain fatty substances (triglycerides and total cholesterol) or glucose 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 a 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 any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 can help gather more information on the safety of the medicine.

5. How to store Kventiax

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the packaging after the abbreviation "EXP". The expiry date refers to the last day of the specified month.
The batch number is stated on the packaging after the abbreviation "Lot".
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging 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 (in the form of quetiapine hemifumarate).
• 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 what the packaging contains

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 about this medicine, the local representative of the marketing authorization holder should be contacted:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:13.04.2025