Kvelux Sr

Leaflet accompanying the packaging: patient information

Kvelux SR, 50 mg, prolonged-release tablets

Kvelux SR, 150 mg, prolonged-release tablets

Kvelux SR, 200 mg, prolonged-release tablets

Kvelux SR, 300 mg, prolonged-release tablets

Kvelux SR, 400 mg, prolonged-release tablets

Quetiapine

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Kvelux SR contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics. Kvelux SR can be used to treat certain diseases, such as:
depression associated with bipolar affective disorder and episodes of severe depression
in the course of severe depressive disorder, where the patient feels sad or depressed, has a sense of guilt, lacks energy, has lost appetite, or cannot sleep.
mania, where the patient may feel strong excitement, elation, agitation, enthusiasm, or show excessive activity or falsely assess the situation, with aggression or destructive behavior;
schizophrenia, where the patient may hear or feel non-existent things, have false beliefs, or feel unusual suspicion, anxiety, disorientation, guilt, tension, or depression.
If Kvelux SR is used to treat episodes of severe depression associated with severe depressive disorder, the doctor will recommend taking another medicine for this condition.
The doctor may decide to continue taking Kvelux SR, even if the patient feels better.

2. Important information before taking Kvelux SR

When not to take Kvelux 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 any of the following medicines:

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

Kvelux SR should not be taken if any of the above situations apply to the patient.
In case of doubts, the patient should consult a doctor or pharmacist before taking the medicine.

Warnings and precautions

Before starting to take Kvelux SR, the patient should discuss it with their doctor if:
the patient or their relative currently has or has had heart rhythm disorders (e.g., heart rhythm disturbances), heart weakness, or inflammation of the heart muscle, or if the patient is taking medicines that may affect heart function;
the patient has low blood pressure;
the patient has had a stroke in the past, especially if they are elderly;
the patient has liver function disorders;
the patient has had seizures in the past;
the patient has diabetes or is at risk of developing diabetes; in this case, the doctor may monitor the patient's blood sugar levels during treatment with Kvelux SR;
the patient has had a low white blood cell count in the past (which may have been caused by taking other medicines);
the patient is elderly and has dementia (impaired brain function); in this case, Kvelux SR should not be taken, as medicines in this group may increase the risk of stroke or, in some cases, the risk of death in such patients;
the patient is elderly and has Parkinson's disease/parkinsonism;
the patient or their relative has had blood clots in the past, as taking medicines like Kvelux SR may be associated with the formation of blood clots;
the patient has or has had a disorder characterized by short pauses in breathing during normal sleep at night (so-called sleep apnea) and is taking medicines that slow down brain function (so-called depressants);
the patient has or has had a disorder characterized by inability to completely empty the bladder (urinary retention), has an enlarged prostate, intestinal obstruction, or increased eye pressure. These symptoms may sometimes be caused by medicines (so-called anticholinergic medicines) used to treat certain diseases and affecting nerve cell function;
the patient has had problems with alcohol or drug abuse in the past.
if the patient has depression or other conditions that are treated with antidepressant medicines. Taking these medicines with Kvelux SR may lead to the development of serotonin syndrome, a life-threatening condition (see "Kvelux SR and other medicines").

The patient should immediately inform their doctor if they experience any of the following symptoms after taking Kvelux SR.

Fever with significant muscle stiffness, sweating, or consciousness disorders (a disorder called "malignant neuroleptic syndrome"). Immediate medical attention may be necessary.
Involuntary movements, especially of the face or tongue.
Dizziness or severe drowsiness. In elderly patients, this may increase the risk of accidental injury (due to falls).
Seizures.
Prolonged, painful erection (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.
These symptoms may be caused by medicines of this type, such as Kvelux SR.
The patient should seek medical attention as soon as possible if they experience:
fever, flu-like symptoms, sore throat, or other infections, as they may be caused by a very low white blood cell count, which may require discontinuation of Kvelux SR and/or appropriate treatment;
constipation with persistent abdominal pain or constipation that does not improve with treatment, as it may lead to severe intestinal obstruction.

Suicidal thoughts and depression

Patients with depression may sometimes have thoughts of self-harm or suicide. Such thoughts may become more frequent at the beginning of treatment with antidepressant medicines, as it may take some time for them to start working, usually about 2 weeks, or sometimes longer. These thoughts may also become more frequent if the patient suddenly stops taking the medicine. The likelihood of such thoughts is higher in young adults. Clinical trials have shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression.
If the patient experiences thoughts of self-harm or suicide, they should contact their doctor or go directly to the hospital. It may be helpful to inform a relative or friend about the depression and ask them to read this leaflet. The patient can also ask them to pay attention if they notice an increase in depression or a change in behavior.
Severe skin reactions (SCARs)
During treatment with this medicine, very rare severe skin reactions have been reported, which can be life-threatening or fatal. They most often manifest 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) includes flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes)
• Acute generalized exanthematous pustulosis (AGEP), small blisters filled with a white-yellow fluid
• Erythema multiforme (EM), a skin rash with itchy red irregular patches

In case of these symptoms, the patient should stop taking Kvelux SR and immediately contact their doctor or seek medical attention.

Weight gain

Patients taking Kvelux SR have been observed to gain weight. The patient's weight should be regularly monitored.

Children and adolescents

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

Kvelux SR and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Kvelux SR should not be taken if the patient is taking any of the following medicines:
certain medicines used to treat HIV infection;
azole medicines (used to treat fungal infections);
erythromycin or clarithromycin (medicines used to treat infections);
nefazodone (a medicine used to treat depression).
In particular, the patient should inform their doctor if they are taking:
antiepileptic medicines (such as phenytoin or carbamazepine);
medicines used to treat high blood pressure;
barbiturates (medicines used to treat insomnia);
thioridazine or lithium (other antipsychotic medicines);
medicines that affect heart function, such as those that can cause electrolyte imbalance (low potassium or magnesium levels), such as diuretics or certain antibiotics (medicines used to treat bacterial infections).
medicines that can cause constipation;
medicines used to treat certain diseases, affecting nerve cell function (so-called anticholinergic medicines).
antidepressant medicines. These medicines may interact with Kvelux SR and 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, the patient should consult their doctor.
Before stopping any of these medicines, the patient should first consult their doctor.

Kvelux SR with food, drink, and alcohol

Food may affect the action of Kvelux SR, so the tablets should be taken at least 1 hour before a meal or before bedtime.
The patient should be careful with the amount of alcohol they consume, as Kvelux SR in combination with alcohol may cause drowsiness.
During treatment with Kvelux SR, the patient should not drink grapefruit juice, as it may affect the action of this medicine.

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.
Kvelux SR should not be taken during pregnancy, unless it has been discussed with the doctor.
Kvelux SR should not be taken during breastfeeding.
In newborns of mothers who took Kvelux SR in the last trimester (last three months) of pregnancy, the following symptoms may occur: tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. These may be withdrawal symptoms. If the child experiences any of these symptoms, it may be necessary to contact a doctor.

Driving and using machines

Kvelux SR may cause drowsiness. The patient should not drive or operate tools or machines until they know how their body reacts to the medicine.

Effect on urine drug tests

Kvelux SR may cause positive results in tests detecting methadone or certain medicines used to treat depression (so-called tricyclic antidepressants), performed by certain methods, even in people who do not receive methadone or such medicines. In such cases, more specific tests can be performed.

Kvelux SR contains lactose

If the patient has been diagnosed with intolerance to certain sugars in the past, they should contact their doctor before taking the medicine.

3. How to take Kvelux SR

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will determine the initial dose. The maintenance dose (daily dose) depends on the type of disease and the patient's needs, but it usually ranges from 150 mg to 800 mg.
The tablets should be taken once a day.
The tablets should not be divided, chewed, or crushed.
The tablets should be swallowed whole, with a glass of water.
The tablets should not be taken during meals (at least 1 hour before a meal or before bedtime). The doctor will advise on this.
During treatment with Kvelux SR, the patient should not drink grapefruit juice, as it may affect the action of the medicine.
The patient should not stop taking the tablets without the doctor's advice, even if they feel better.

Liver function disorders

Patients with liver function disorders may have their dose adjusted by the doctor.

Elderly patients

Elderly patients may have their dose adjusted by the doctor.
Use in children and adolescents(under 18 years of age)
Kvelux SR should not be taken by children and adolescents under 18 years of age.

Taking a higher dose of Kvelux SR than recommended

If the patient takes a higher dose of Kvelux SR than recommended, they may experience drowsiness, dizziness, and abnormal heartbeat. They should immediately contact their doctor or the nearest hospital. They should take the tablets with them.

Missing a dose of Kvelux SR

If the patient misses a dose, they should take it as soon as they remember. If it is almost time for the next dose, they should wait until then. They should not take a double dose to make up for the missed dose.

Stopping treatment with Kvelux SR

After suddenly stopping treatment with Kvelux SR, the patient may experience: insomnia, nausea, or headache, diarrhea, vomiting, dizziness, or irritability.
The doctor may recommend gradually reducing the dose before completely stopping the medicine.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Kvelux SR can cause side effects, although not everybody gets them.
Very common side effects(may affect more than 1 in 10 people):
dizziness (may lead to falls), headache, dry mouth
feeling drowsy (may resolve during continued treatment with Kvelux SR and may lead to falls)
withdrawal symptoms (symptoms that occur after stopping treatment with Kvelux SR), including difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, and irritability. It is recommended to gradually stop the medicine over at least 1 to 2 weeks.
weight gain
abnormal muscle movements, including difficulty starting movement, tremors, feeling restless or stiff muscles without pain
changes in the levels of certain lipids (triglycerides and total cholesterol)
Common side effects(may affect up to 1 in 10 people):
rapid heartbeat
feeling of palpitations, very fast or irregular heartbeats
constipation or indigestion
feeling weak
swelling of hands or feet
low blood pressure when standing up. This may cause dizziness or fainting (which may lead to falls)
increased blood sugar levels
blurred vision
vivid dreams and nightmares
increased appetite
feeling irritable
speech and language disorders
suicidal thoughts or depression
shortness of breath
vomiting (mainly in elderly patients)
fever
changes in thyroid hormone levels in the blood
decreased white blood cell count
increased liver enzyme activity in the blood
increased prolactin levels in the blood, which may rarely cause:

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

Uncommon side effects(may affect up to 1 in 100 people):
seizures
allergic reactions, including hives and itching
unpleasant sensations in the legs (so-called restless legs syndrome)
difficulty swallowing
uncontrolled movements, mainly of the face or tongue
sexual function disorders
diabetes
heart function disorders, as seen in ECG (QT interval prolongation)
slower than normal heart function, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting
difficulty urinating
fainting (which may lead to falls)
nasal congestion
decreased red blood cell count
decreased sodium levels in the blood
worsening of existing diabetes control
confusion
Rare side effects(may affect up to 1 in 1,000 people):
simultaneous occurrence of symptoms such as high fever, sweating, muscle stiffness, and altered consciousness (a disorder called "malignant neuroleptic syndrome")
yellowing of the skin and eyes (jaundice)
liver inflammation
prolonged and painful erection (priapism)
breast swelling and unexpected milk production (galactorrhea)
menstrual disorders
blood clots in the veins, especially in the legs, which can travel through the blood vessels to the lungs, causing chest pain and breathing difficulties. If the patient experiences any of these symptoms, they should seek medical attention immediately.
walking, talking, eating, and other activities during sleep
decreased body temperature (hypothermia)
pancreatitis
a condition called "metabolic syndrome", in which the patient may have three or more of the following symptoms: fat accumulation in the abdominal area, decreased "good" cholesterol (HDL) levels, increased triglyceride levels in the blood, high blood pressure, and increased blood sugar levels.
simultaneous occurrence of fever, flu-like symptoms, sore throat, or other infections, with a very low white blood cell count (a condition called agranulocytosis)
intestinal obstruction
increased creatine kinase activity in the blood (an enzyme found in muscles)
Very rare side effects(may affect up to 1 in 10,000 people):
severe skin reactions, blisters, or red patches on the skin
severe allergic reaction (anaphylaxis), which can cause breathing difficulties or shock
sudden swelling of the skin, usually around the eyes, lips, and throat (angioedema)
severe skin reaction with blisters, peeling, and skin lesions (Stevens-Johnson syndrome). See section 2.
abnormal hormone secretion, which can cause:
disorders of water balance in the body (SIADH)
muscle breakdown and muscle pain (rhabdomyolysis)
Side effects with unknown frequency(frequency cannot be estimated from available data):
skin rash with irregular red patches (erythema multiforme)
sudden appearance of areas of red skin with small blisters (acute generalized exanthematous pustulosis (AGEP)). See section 2.
severe, sudden allergic reaction with symptoms such as fever and blisters on the skin, as well as peeling (toxic epidermal necrolysis) drug reaction with eosinophilia and systemic symptoms (DRESS) includes flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes). See section 2.
withdrawal symptoms in newborns whose mothers took Kvelux SR during pregnancy
stroke
heart muscle disorders (cardiomyopathy)
heart inflammation (myocarditis)
inflammation of blood vessels (vasculitis), often with a skin rash with small red or purple spots

The class of medicines to which Kvelux SR belongs may cause heart function disorders, which can be severe and life-threatening.
Some side effects are only seen in blood test results. These include changes in lipid (triglyceride and total cholesterol) or blood sugar levels, changes in thyroid hormone levels in the blood, increased liver enzyme activity, decreased or increased red blood cell count, increased creatine kinase activity in the blood (an enzyme found in muscles), decreased sodium levels, and increased prolactin levels in the blood. Increased prolactin levels may rarely cause:
breast swelling and unexpected milk production in men and women
absence or irregular menstrual periods.
The doctor may occasionally order blood tests for the patient.

Side effects in children and adolescents

The same side effects that occur in adults can also occur in children and adolescents.
The following side effects have been observed more frequently in children and adolescents or have not been reported in adults:
Very common side effects(may affect more than 1 in 10 people):
increased prolactin levels in the blood. In rare cases, this may lead to:

• breast swelling and unexpected milk production in both boys and girls
• absence or irregular menstrual periods in girls
• increased appetite
• vomiting
• abnormal muscle movements, including difficulty starting movement, tremors, feeling restless or stiff muscles without pain
• increased blood pressure

Common side effects(may affect up to 1 in 10 people):
feeling weak, fainting (which may lead to falls)
nasal congestion
irritability

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
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 can help gather more information on the safety of the medicine.

5. How to store Kvelux SR

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
There are no special storage instructions.
The medicine should not be taken if visible signs of deterioration are observed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Kvelux SR contains

The active substance is quetiapine.
Kvelux SR tablets contain 50 mg, 150 mg, 200 mg, 300 mg, or 400 mg of quetiapine (in the form of quetiapine fumarate).
The other ingredients are:
Tablet core: lactose anhydrous, methacrylic acid-ethyl acrylate copolymer (1:1), type A, magnesium stearate, crystalline maltose, and talc.
Coating: methacrylic acid-ethyl acrylate copolymer (1:1), type A, triethyl citrate.

What Kvelux SR looks like and what the pack contains

The 50 mg prolonged-release tablets are white or almost white, round, biconvex, with "50" embossed on one side, 7.1 mm in diameter, and 3.2 mm thick.
The 150 mg prolonged-release tablets are white or almost white, oval, biconvex, with "150" embossed on one side, 13.6 mm long, 6.6 mm wide, and 4.2 mm thick.
The 200 mg prolonged-release tablets are white or almost white, oval, biconvex, with "200" embossed on one side, 15.2 mm long, 7.7 mm wide, and 4.8 mm thick.
The 300 mg prolonged-release tablets are white or almost white, oval, biconvex, with "300" embossed on one side, 18.2 mm long, 8.2 mm wide, and 5.4 mm thick.
The 400 mg prolonged-release tablets are white or almost white, oval, biconvex, with "400" embossed on one side, 20.7 mm long, 10.2 mm wide, and 6.3 mm thick.
The medicine is available in blisters of PVC/PCTFE/Aluminum in a cardboard box.
The packaging contains 10, 30, 50, 56, 60, or 100 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Pharmathen S.A
6, Dervenakion str., Pallini
Attiki 153 51, Greece
Pharmathen International S.A
Sapes Industrial Park Block 5
Rodopi 69300, Greece
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

For more information about the medicine and its names in other European Economic Area countries, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:07/2024
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