Kventiax Sr

Leaflet accompanying the packaging: patient information

Kventiax SR, 50 mg, prolonged-release tablets

Kventiax SR, 150 mg, prolonged-release tablets

Kventiax SR, 200 mg, prolonged-release tablets

Kventiax SR, 300 mg, prolonged-release tablets

Kventiax SR, 400 mg, prolonged-release tablets

Quetiapine

You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Kventiax SR and what is it used for

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

• depressive episodes in bipolar disorder and major depressive episodes in major depression: a state where the patient feels sad; the patient may feel deeply depressed, guilty, lacking energy, losing appetite, or unable to sleep;
• mania: a state where the patient is very excited, agitated, restless, enthusiastic, or overly active, or has impaired critical judgment, is aggressive, or troublesome;
• schizophrenia: a state where the patient hears and sees unreal voices and images, takes non-existent things for real, is overly suspicious, worried, confused, has a sense of guilt, is tense, or deeply depressed.

When Kventiax SR is used to treat major depressive episodes in major depression, it will be used as an adjunctive treatment to another medicine taken for this disease.
Even if the patient feels better, the doctor may recommend continuing treatment with Kventiax SR.

2. Important information before taking Kventiax SR

When not to take Kventiax SR

• 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:
• certain medicines used to treat HIV;
• 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, you should consult your doctor or pharmacist before taking Kventiax SR.

Warnings and precautions

Before starting to take Kventiax SR, you should discuss it with your doctor or pharmacist if:

• the patient or a family member of the patient has or has had any heart disorders, 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 disease;
• the patient has had a seizure (epilepsy);
• the patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may check the patient's blood sugar levels during treatment with Kventiax SR;
• the patient has had a low white blood cell count in the past (regardless of whether it was caused by taking other medicines or not);
• the patient is an elderly person with dementia (brain function disorders). In such a case, Kventiax SR should not be taken, as antipsychotic medicines, including Kventiax SR, may increase the risk of stroke and, in some cases, the risk of death in elderly patients with dementia;
• the patient is an elderly person with Parkinson's disease/parkinsonism;
• the patient or their family members have had blood clots, as medicines in this group may contribute to their formation;
• the patient has had or has a condition where they stopped breathing for a short time while sleeping at night (a condition called "sleep apnea") and is taking medicines that weaken normal brain activity (antidepressants);
• the patient has had or has a condition where 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 to treat 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. The use of these medicines with Kventiax SR may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "Kventiax SR and other medicines").

You should immediately inform your doctor if, after taking Kventiax SR, you experience symptoms such as:

• occurring together: high fever, muscle stiffness, increased sweating, or decreased consciousness (a disorder 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, immediately refer the patient to a cardiologist. All these symptoms may occur during treatment with medicines in this therapeutic group.

You should immediately inform your doctor if you experience:

• 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 regard, it may be necessary to discontinue Kventiax SR and/or apply 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 or worsening depression

Patients with depression may sometimes have thoughts of self-harm or suicide.
Such symptoms or behaviors may worsen at the beginning of treatment, as antidepressant medicines usually start to work after about 2 weeks, and sometimes later. Symptoms may worsen if the patient suddenly stops taking the medicine. The above symptoms are more likely to occur in young adult patients. Data from clinical trials show an increased risk of suicidal thoughts and (or) suicidal behaviors in people under 25 years of age with depression.
You should immediately contact your doctor or go to the hospital if you experience thoughts of self-harm or suicidal thoughts. It may be helpful to inform relatives or friends about your depression and ask them to read this leaflet. You can ask them to inform you if they notice that your depression has worsened or if there are worrying changes in your 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 lead to death. 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, you should discontinue Kventiax SR and seek immediate medical attention.

Weight gain

Patients taking Kventiax SR have been observed to gain weight. Both the patient and the doctor should regularly check the patient's weight.

Children and adolescents

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

Kventiax SR and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should not take Kventiax SR if you are taking any of the following medicines:

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

You should tell your doctor if you are taking:

• antiepileptic medicines (such as phenytoin or carbamazepine);
• antihypertensive medicines;
• barbiturates (medicines used to treat sleep disorders);
• thioridazine or lithium salts (other antipsychotic medicines);
• medicines that affect heart rhythm, such as those that may disrupt electrolyte balance (decrease potassium and magnesium levels), such as diuretics (which increase urine production) or certain antibiotics (which treat infections);
• medicines that may cause constipation;
• medicines (so-called anticholinergic medicines) that affect the function of nerve cells, administered to treat certain diseases;
• antidepressant medicines. These medicines may interact with Kventiax SR and may cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, you should consult your doctor.

Before stopping treatment with any medicine, you should consult your doctor.

Taking Kventiax SR with food, drinks, and alcohol

• Food may affect the action of Kventiax SR, and therefore, tablets should be taken at least 1 hour before a meal or before bedtime.
• During treatment with Kventiax SR, you should be cautious when consuming alcoholic beverages, as the combined effect of Kventiax SR and alcohol may cause drowsiness.
• While taking Kventiax SR, you should not drink grapefruit juice. It may affect the way the medicine works.

Pregnancy and breastfeeding

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

Driving and operating machines

Kventiax SR may cause drowsiness. You should not drive or operate machines until you know how the medicine affects you.

Kventiax SR contains lactose and sodium

Kventiax SR contains lactose, which is a type of sugar. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.
50 mg, prolonged-release tablets:
The medicine contains 8.44 mg of sodium (the main component of table salt) in each tablet. This corresponds to 0.42% of the maximum recommended daily sodium intake in the diet for adults.
150 mg, prolonged-release tablets:
The medicine contains 14.53 mg of sodium (the main component of table salt) in each tablet. This corresponds to 0.73% of the maximum recommended daily sodium intake in the diet for adults.
200 mg, prolonged-release tablets:
The medicine contains 19.38 mg of sodium (the main component of table salt) in each tablet. This corresponds to 0.97% of the maximum recommended daily sodium intake in the diet for adults.
300 mg, prolonged-release tablets:
The medicine contains 29.06 mg of sodium (the main component of table salt) in each tablet. This corresponds to 1.45% of the maximum recommended daily sodium intake in the diet for adults.
400 mg, prolonged-release tablets:
The medicine contains 23.46 mg of sodium (the main component of table salt) in each tablet. This corresponds to 1.17% of the maximum recommended daily sodium intake in the diet for adults.

Effect on urine tests for drug detection

Taking Kventiax SR may cause false-positive results in some urine tests for methadone or certain tricyclic antidepressants (TCA), even if you are not taking these medicines. If this happens, a more specific testing method should be used.

3. How to take Kventiax SR

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
The initial dose will be determined by your doctor. The maintenance dose (daily dose) will depend on the severity of the disease and the needs of the individual patient, but it usually ranges from 150 mg to 800 mg.

• The medicine should be taken once a day.
• Tablets should not be divided, chewed, or crushed.
• Tablets should be swallowed whole, with a glass of water.
• Tablets should be taken without food (at least 1 hour before a meal or before bedtime; the doctor will specify exactly when to take the medicine).
• While taking Kventiax SR, you should not drink grapefruit juice. It may affect the way the medicine works.
• You should not stop taking the tablets even if you feel better, unless your doctor decides otherwise.

Liver function disorders

Your doctor may recommend changing the dosing regimen in patients with liver function disorders.

Elderly patients

In elderly patients, your doctor may recommend changing the dose of the medicine.

Use in children and adolescents

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

Taking a higher dose of Kventiax SR than recommended

If you take a higher dose of Kventiax SR than prescribed by your doctor, you may experience drowsiness, dizziness, or irregular heartbeat. You should immediately consult your doctor or go to the nearest hospital. You should take the packaging of the medicine with you.

Missing a dose of Kventiax SR

If you miss a dose of Kventiax SR, you should take it as soon as possible. However, if it is almost time for the next dose, you should wait and take the medicine at the usual time. You should not take a double dose to make up for the missed dose.

Stopping treatment with Kventiax SR

If you suddenly stop taking Kventiax SR, you may experience difficulty sleeping (insomnia), nausea, or headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.
If you have any further doubts about taking this medicine, you should consult 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 (may lead to falls), headache, dry mouth
• drowsiness (may resolve during treatment with Kventiax SR) (may lead to falls)
• withdrawal symptoms (symptoms that occur after stopping Kventiax SR), i.e., difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop taking the medicine over a period of at least 1-2 weeks.
• weight gain
• abnormal muscle contractions; this 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 heart rhythm)
• constipation, gastrointestinal disorders (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 (blisters) 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

• combination of symptoms: high fever, excessive sweating, muscle stiffness, or decreased consciousness (a disorder 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 difficulty breathing. If you experience any of these symptoms, you should immediately consult your doctor.
• walking, eating, or performing other activities while sleeping
• low body temperature (hypothermia)
• pancreatitis
• a condition (known as "metabolic syndrome") in which three or more of the following symptoms occur: 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 known as agranulocytosis)
• intestinal obstruction
• increased creatine kinase activity 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 spots on the skin
• severe allergic reactions (anaphylactic reaction) with 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 blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• abnormal secretion of the hormone that controls urine production
• muscle fiber breakdown and muscle pain (rhabdomyolysis).

Unknown: frequency cannot be estimated from the available data

• skin rash with irregular red patches (erythema multiforme). See section 2.
• sudden appearance of areas of red skin with small blisters (small pus-filled blisters), known as acute generalized exanthematous pustulosis (AGEP). See section 2.
• severe, sudden allergic reaction with symptoms such as fever and blistering of the skin and peeling (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 SR during pregnancy
• stroke
• heart muscle disorders (cardiomyopathy)
• heart inflammation (myocarditis)
• blood vessel inflammation (vasculitis), often with a skin rash with small red or purple spots

Medicines in the same group as Kventiax SR 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 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.

Your doctor may recommend regular check-ups.

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, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 will help to gather more information on the safety of this medicine.

5. How to store Kventiax SR

The medicine should be stored out of 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".
Store in the original packaging to protect from moisture.
There are no special storage temperature recommendations for this medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Kventiax SR contains

• The active substance of the medicine is quetiapine. Each prolonged-release tablet contains 50 mg, 150 mg, 200 mg, 300 mg, or 400 mg of quetiapine (in the form of quetiapine fumarate).
• The other ingredients are: 50 mg, 400 mg, prolonged-release tablets: hypromellose, lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, and magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E 171), and macrogol 400 in the tablet coating. See section 2 "Kventiax SR contains lactose and sodium". 150 mg, prolonged-release tablets: hypromellose, lactose monohydrate, microcrystalline cellulose, disodium phosphate dihydrate, and magnesium stearate in the tablet core, and Opadry II HP White (polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc), iron oxide red (E 172), and iron oxide yellow (E 172) in the tablet coating. See section 2 "Kventiax SR contains lactose and sodium". 200 mg, 300 mg, prolonged-release tablets: hypromellose, lactose monohydrate, microcrystalline cellulose, disodium phosphate dihydrate, and magnesium stearate in the tablet core, and Opadry II HP White (polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc) and iron oxide yellow (E 172) in the tablet coating. See section 2 "Kventiax SR contains lactose and sodium".

What Kventiax SR looks like and contents of the packaging

50 mg, prolonged-release tablets
White or almost white, slightly convex, capsule-shaped, film-coated tablets with a score line on one side; tablet dimensions: length 16.2 mm, thickness 4.0-5.2 mm
150 mg, prolonged-release tablets
Pink-orange, round, slightly convex, film-coated tablets with a score line; tablet dimensions: diameter 10 mm, thickness 4.6-6.0 mm
200 mg, prolonged-release tablets
Yellow-brown, oval, slightly convex, film-coated tablets; tablet dimensions: length 16 mm, thickness 5.6-7.1 mm
300 mg, prolonged-release tablets
Light brown-yellow, capsule-shaped, slightly convex, film-coated tablets; tablet dimensions: length 19.1 mm, thickness 5.9-7.4 mm
400 mg, prolonged-release tablets
White or almost white, capsule-shaped, slightly convex, film-coated tablets with a score line on one side; tablet dimensions: length 18.7-19.5 mm, thickness 5.5-7.1 mm
Packaging:10, 30, 50, 60, 90, and 100 prolonged-release tablets in blisters, in a cardboard box.
Not all pack sizes may be marketed.

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
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:13.04.2025