Kvelux Sr

Package Leaflet: Information for the Patient

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

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What Kvelux SR is and what it is 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 pack and other information

1. What Kvelux SR is and what it is 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 several diseases, such as:
depression associated with bipolar 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 suspiciousness, 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 prescribe 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 infections;
• azole medicines (used to treat fungal infections);
• erythromycin or clarithromycin (medicines used to treat infections);
• nefazodone (a medicine used to treat depression).

Do not take Kvelux SR if any of the above situations apply to you. If in doubt, consult your doctor or pharmacist before taking the medicine.

Warnings and precautions

Before starting to take Kvelux SR, discuss with your doctor if:
you or a family member currently have or have had heart problems (e.g., heart rhythm disturbances), weakness, or inflammation of the heart muscle, or if you are taking medicines that may affect heart function;
you have low blood pressure;
you have had a stroke in the past, especially if you are elderly;
you have liver problems;
you have had seizures in the past;
you have diabetes or are at risk of developing diabetes; in this case, your doctor may monitor your blood sugar levels while taking Kvelux SR;
you have had a low white blood cell count in the past (which may have been caused by taking other medicines);
you are elderly and have dementia (impaired brain function); in this case, do not take Kvelux SR, as medicines in this group may increase the risk of stroke or, in some cases, the risk of death in such patients;
you are elderly and have been diagnosed with Parkinson's disease/parkinsonism;
you or a family member have had blood clots in the past, as taking medicines like Kvelux SR may be associated with the formation of blood clots;
you have or have had a condition that causes short pauses in breathing during normal sleep at night (so-called sleep apnea) and are taking medicines that slow down brain function (so-called depressants);
you have or have had a condition that makes it difficult to completely empty the bladder (urinary retention), have 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 that affect the function of nerve cells;
you have had problems with alcohol or drug abuse in the past.
if you have depression or other conditions that are being treated with antidepressant medicines. Taking these medicines with Kvelux SR may lead to the development of a potentially life-threatening condition called serotonin syndrome (see "Kvelux SR and other medicines").

Inform your doctor immediately if you experience any of the following symptoms after taking Kvelux SR.

Fever with significant muscle stiffness, sweating, or consciousness disturbances (a condition called "neuroleptic malignant syndrome"). Immediate medical attention may be required.
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 or 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.
These symptoms may be caused by medicines of this type, such as Kvelux SR.
Inform your doctor as soon as possible if you 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 respond to treatment, as it may lead to severe intestinal obstruction.

Suicidal thoughts and worsening depression

Patients with depression may sometimes have thoughts of self-harm or suicide. Such thoughts may worsen at the beginning of treatment with antidepressant medicines, as it may take some time for them to start working, usually around 2 weeks or sometimes longer. These thoughts may also worsen if the patient suddenly stops taking the medicine. The likelihood of such thoughts is higher in young adults. Clinical studies have shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression.
If you experience thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately. It may also be helpful to inform a family member or friend about your depression and ask them to read this package leaflet. You can also ask them to pay attention if they notice a worsening of your depression or a change in your 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 usually appear 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

If you experience any of these symptoms, stop taking Kvelux SR and contact your doctor or seek medical attention immediately.

Weight gain

Patients taking Kvelux SR have experienced weight gain. You should have your weight checked regularly.

Children and adolescents

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

Kvelux SR and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Kvelux SR if you are 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).
Inform your doctor in particular if you 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 may cause electrolyte imbalance (low potassium or magnesium levels), such as diuretics or certain antibiotics (medicines used to treat bacterial infections).
medicines that may cause constipation;
medicines used to treat certain diseases that affect the function of nerve cells (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 stiffness, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, consult your doctor.
Before stopping any of these medicines, consult your doctor first.

Kvelux SR with food, drink, and alcohol

Food may affect the action of Kvelux SR, so take the tablets at least 1 hour before a meal or before bedtime.
Be careful with the amount of alcohol you drink, as Kvelux SR in combination with alcohol may cause drowsiness.
Do not drink grapefruit juice while taking Kvelux SR, as it may affect the action of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Kvelux SR during pregnancy, unless you have discussed it with your doctor.
Do not take Kvelux SR while breastfeeding.
In newborns of mothers who took Kvelux SR during the last trimester (last three months) of pregnancy, the following symptoms may occur: tremors, stiffness, and/or weakness of the muscles, drowsiness, agitation, breathing difficulties, and feeding problems. These may be withdrawal symptoms. If your baby experiences any of these symptoms, you may need to contact your doctor.

Driving and using machines

Kvelux SR may cause drowsiness. Do not drive or operate machinery until you know how the medicine affects you.

Effect on laboratory tests

Kvelux SR may cause positive results in tests for detecting methadone or certain antidepressant medicines (so-called tricyclic antidepressants) in urine, even in people who are not taking methadone or these medicines. In such cases, more specific tests can be performed.

Kvelux SR contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Kvelux SR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will determine the initial dose. The maintenance dose (daily dose) depends on the type of disease and the patient's needs, but it is usually between 150 mg and 800 mg.
Take the tablets once a day.
Do not divide, chew, or crush the tablets.
Swallow the tablets whole with water.
Do not take the tablets during meals (at least 1 hour before a meal or before bedtime). Your doctor will advise you on this.
Do not drink grapefruit juice while taking Kvelux SR, as it may affect the action of the medicine.
Do not stop taking the tablets without your doctor's advice, even if you feel better.

Liver problems

For patients with liver problems, the doctor may change the dose.

Elderly patients

For elderly patients, the doctor may change the dose.
Use in children and adolescents(under 18 years of age)
Do not take Kvelux SR if you are under 18 years of age.

Overdose

If you take more Kvelux SR than you should, you may experience drowsiness, dizziness, and abnormal heart rhythm. Contact your doctor or the nearest hospital immediately. Take the tablets with you.

Missed dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, wait until then to take it. Do not take a double dose to make up for a missed dose.

Stopping treatment

After stopping treatment with Kvelux SR, you may experience insomnia, nausea, or headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.
If you have any further questions about taking this medicine, ask your 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 Kvelux SR), including difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, and irritability. It is recommended to gradually stop taking the medicine over at least 1 to 2 weeks.
weight gain
abnormal movements of the muscles, 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 heart rate
feeling of palpitations, very fast or irregular heartbeats
constipation or indigestion
feeling weak
swelling of the 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
strange dreams and nightmares
increased appetite
feeling irritable
speech and language disorders
suicidal thoughts or worsening depression
shortness of breath
vomiting (mainly in elderly patients)
fever
changes in thyroid hormone levels in the blood
decreased number of a certain type of blood cell
increased activity of liver enzymes in the blood
increased levels of the hormone prolactin in the blood, which may rarely cause:
breast swelling and unexpected milk production in men and women
absence or irregular menstrual periods in women

• 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 rhythm disturbances observed in ECG (QT interval prolongation)
slower than normal heart rate, 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
confusion
Rare side effects(may affect up to 1 in 1,000 people):
a combination of high fever, sweating, stiffness of the muscles, and altered mental status (a condition called "neuroleptic malignant syndrome")
yellowing of the skin and eyes (jaundice)
liver inflammation
prolonged and painful erection (priapism)
breast swelling and unexpected milk production (galactorrhoea)
menstrual disorders
Very rare side effects(may affect up to 1 in 10,000 people):
severe skin reactions, including blisters or red patches on the skin
severe allergic reaction (anaphylaxis), which may cause difficulty breathing or shock
sudden swelling of the skin, usually around the eyes, lips, and throat (angioedema)
a severe condition with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
abnormal secretion of a hormone that controls the amount of urine excreted
breakdown of muscle fibers and muscle pain (rhabdomyolysis)
Side effects with unknown frequency(frequency cannot be estimated from the 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 blistering of the skin, as well as peeling of the skin (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 may occur in newborns of mothers who took Kvelux SR during pregnancy stroke heart muscle disorders (cardiomyopathy) heart muscle inflammation (myocarditis) blood vessel inflammation (vasculitis), often with a skin rash with small red or purple bumps

• severe skin reactions, including blisters or red patches on the skin
• severe allergic reaction (anaphylaxis), which may cause difficulty breathing or shock
• sudden swelling of the skin, usually around the eyes, lips, and throat (angioedema)
• a severe condition with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• abnormal secretion of a hormone that controls the amount of urine excreted
• breakdown of muscle fibers and muscle pain (rhabdomyolysis)

Medicines in the same class as Kvelux SR may cause heart rhythm disturbances, which can be severe and life-threatening.
Some side effects are only seen in blood test results. These include changes in the levels of certain lipids (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in the blood, increased activity of liver enzymes, decreased or increased red blood cell count, increased activity of creatine kinase in the blood (an enzyme found in muscles), decreased sodium levels, and increased levels of the hormone prolactin in the blood. Increased prolactin levels may rarely cause:
breast swelling and unexpected milk production in men and women
absence or irregular menstrual periods in women
Your doctor may occasionally order blood tests for you.

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 observed in adults:
Very common side effects(may affect more than 1 in 10 people):
increased levels of the hormone prolactin 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 movements of the muscles, 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 you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kvelux SR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP.
The expiry date refers to the last day of the month.
There are no special storage precautions.
Do not use this medicine if you notice visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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 (as 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 contents of the pack

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.
Kvelux SR is available in blisters of PVC/PCTFE/Aluminum in a cardboard box.
The pack sizes are 10, 30, 50, 56, 60, and 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 this medicine and its authorized names in other EU countries, 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 package leaflet:07/2024
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