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
Please read the following information carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of 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 may be used in the treatment of certain conditions such as:
depressive episodes associated with bipolar affective disorder and major depressive episodes in major depressive disorder, in which the patient experiences sadness or low mood, feelings of guilt, lack of energy, loss of appetite, or sleep disturbances;
mania, during which the patient may experience intense excitement, elation, agitation, enthusiasm, or excessive activity, or may misjudge situations, act aggressively, or behave destructively;
schizophrenia, in which the patient may hear or sense things that do not exist, may have false beliefs, or may experience unusual suspiciousness, anxiety, disorientation, guilt, tension, or depression.
If Kvelux SR is used to treat major depressive episodes associated with major depressive disorder, your doctor will recommend taking another medicine in addition to Kvelux SR for this condition.
Your doctor may decide to continue treatment with Kvelux SR even if your condition improves.

2. Important information before using Kvelux SR

When not to use Kvelux SR
if the patient is allergic to quetiapine or to 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 antifungals (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 used if any of the above situations apply to the patient.
If in doubt, consult a doctor or pharmacist before taking this medicine.
Warnings and precautions
Before starting treatment with Kvelux SR, discuss with your doctor if:
the patient or a family member currently has or has previously had heart problems
(e.g. irregular heartbeat), heart muscle weakness or inflammation, or if the patient
is taking medicines that may affect heart function;
the patient has low blood pressure;
the patient has previously had a stroke, especially if elderly;
the patient has liver problems;
the patient has ever had seizures;
the patient has diabetes or is at risk of developing diabetes; in such cases,
the doctor may monitor blood sugar levels during treatment with Kvelux SR;
the patient has previously had a low white blood cell count (which may have been caused
by taking other medicines);
the patient is elderly and has dementia (impaired brain function); in such cases
Kvelux SR should not be used, as medicines of this class may increase the risk of stroke
or, in some cases, risk of death in such patients;
the patient is elderly and has Parkinson's disease/parkinsonism;
the patient or a family member has previously had blood clots, as using medicines such as Kvelux SR may be associated with an increased risk of blood clots;
the patient has or has previously had a condition involving brief interruptions in breathing
during normal sleep at night (so-called sleep apnoea) and is taking medicines that slow
brain function (so-called "depressants");
the patient has or has previously had difficulty completely emptying the bladder
(urinary retention), benign prostatic hyperplasia, intestinal obstruction, or increased
intraocular pressure. These symptoms may sometimes be caused by medicines (so-called
anticholinergic medicines) used to treat certain diseases and which affect nerve cell function;
the patient has previously had problems with alcohol or drug abuse.
if the patient has depression or other conditions treated with antidepressant medicines.
Using these medicines together with Kvelux SR may lead to the development of serotonin syndrome,
a potentially life-threatening condition (see "Kvelux SR with other medicines").
Contact your doctor immediately if any of the following symptoms occur after taking Kvelux SR.
Fever with marked muscle stiffness, excessive sweating, or altered consciousness
(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, immediately refer the patient to a cardiologist.
These symptoms may be caused by medicines like Kvelux SR.
Contact your doctor as soon as possible if the patient experiences:
fever, flu-like symptoms, sore throat, or other signs of infection, as these may be due to 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 resolve with treatment, as this may lead to severe intestinal obstruction.
Suicidal thoughts and worsening depression
Patients with depression may sometimes have thoughts of self-harm or suicide. These thoughts may worsen at the beginning of treatment with antidepressant medicines, as it takes time for them to start working—usually about 2 weeks, sometimes longer. Such thoughts may also increase 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 behaviour in young adults under 25 years of age with depression.
If the patient has thoughts of self-harm or suicide, contact a doctor or go directly to hospital. It may be helpful to inform a relative or friend about the depression and ask them to read this leaflet. You may also ask that person to watch for worsening depression or any concerning changes in the patient's behaviour.
Severe skin adverse reactions (SCAR)
Rarely, severe skin reactions (SCAR) have been reported during treatment with this medicine, which may be life-threatening or lead to death. These most commonly present as:

• Stevens-Johnson syndrome (SJS), widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals
• Toxic epidermal necrolysis (TEN), a more severe form causing extensive skin peeling
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes)
• Acute generalized exanthematous pustulosis (AGEP), small pustules filled with pus
• Erythema multiforme (EM), skin rash with itchy-red, irregular patches
  If any of these symptoms occur, stop taking Kvelux SR immediately and contact a doctor or seek medical help right away.
  Weight gain
  Weight gain has been observed in patients taking Kvelux SR. Body weight should be monitored 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not take Kvelux SR if the patient is taking any of the following medicines:
certain medicines used to treat HIV infection;
azole antifungals (used to treat fungal infections);
erythromycin or clarithromycin (medicines used to treat infections);
nefazodone (a medicine used to treat depression).
In particular, inform the doctor if the patient is 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, e.g. medicines 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 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 those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome). If such symptoms occur, contact a doctor.
Do not stop taking any of these medicines without first consulting a doctor.
Kvelux SR with food, drink, and alcohol
Food may affect the action of Kvelux SR; therefore, tablets should be taken at least 1 hour before a meal or before bedtime.
Be cautious with alcohol consumption, as Kvelux SR combined with alcohol may cause drowsiness.
Do not drink grapefruit juice while taking Kvelux SR, as it may affect the medicine's action.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not take Kvelux SR during pregnancy unless discussed with a doctor.
Kvelux SR should not be used during breastfeeding.
Newborns of mothers who took Kvelux SR during the third trimester (last three months) of pregnancy may experience the following symptoms: tremor, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems. These may be withdrawal symptoms.
If the baby experiences any of these symptoms, it may be necessary to contact a doctor.
Driving and operating machinery
Kvelux SR may cause drowsiness. Do not drive or operate tools or machinery until you know how this medicine affects you.
Effect on drug screening tests in urine
Kvelux SR may cause false-positive results in urine tests for methadone or certain antidepressants (tricyclic antidepressants) when certain testing methods are used, even in individuals who have not taken methadone or such medicines. In such cases, more specific tests can be performed.
Kvelux SR contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
3. How to use Kvelux SR
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The doctor will determine the initial dose. The maintenance dose (daily dose) depends on the type of illness and the patient's needs, but usually ranges from 150 mg to 800 mg.
Tablets should be taken once daily.
Do not split, chew, or crush the tablets.
Swallow the tablets whole with water.
Do not take the tablets with food (at least 1 hour before a meal or before bedtime). The doctor will provide advice on this.
Do not drink grapefruit juice while taking Kvelux SR, as it may affect the medicine's action.
Do not stop taking the tablets without the doctor's advice, even if feeling better.
Liver function impairment
The doctor may adjust the dose in patients with liver problems.
Elderly patients
The doctor may adjust the dose in elderly patients.
Use in children and adolescents (under 18 years of age)
Kvelux SR should not be used in children and adolescents under 18 years of age.
Taking more than the recommended dose of Kvelux SR
If the patient takes more than the recommended amount of Kvelux SR, symptoms such as drowsiness, dizziness, and irregular heartbeat may occur. Contact a doctor or the nearest hospital immediately. Bring the tablets with you.
Missed dose of Kvelux SR
If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed dose.
Stopping Kvelux SR
If Kvelux SR is stopped abruptly, symptoms such as difficulty sleeping (insomnia), nausea or headache, diarrhoea, vomiting, dizziness, or irritability may occur.
The doctor may recommend gradually reducing the dose before stopping the medicine completely.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.

Very common adverse reactions (may affect more than 1 in 10 people):
dizziness (may lead to falls), headache, dry mouth
drowsiness (may diminish with continued use of Kvelux SR and may lead to falls)
withdrawal symptoms (symptoms occurring after discontinuation of Kvelux SR), including
difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability.
Gradual discontinuation of the medicine over at least 1 to 2 weeks is recommended.
weight gain
abnormal muscle movements, including difficulty initiating movement, tremor, feeling of inner restlessness, or muscle stiffness without pain
changes in levels of certain lipids (triglycerides and total cholesterol)

Common adverse reactions (may affect less than 1 in 10 people):
fast heartbeat
sensation of palpitations, very rapid or irregular heartbeats
constipation or indigestion
feeling of weakness
swelling of hands or feet
low blood pressure upon standing. This may cause dizziness or fainting (which may lead to falls)
increased blood sugar levels
blurred vision
unusual dreams and nightmares
increased appetite
irritability
speech and language disturbances
suicidal thoughts or worsening of depression
shortness of breath
vomiting (mainly in elderly people)
fever
changes in thyroid hormone levels in blood
reduced number of certain types of blood cells
increased liver enzyme activity in blood
increased blood levels of prolactin hormone, which rarely may cause:

• breast enlargement and unexpected milk production in both men and women
• absence or irregular menstruation in women

Uncommon adverse reactions (may affect less than 1 in 100 people):
seizures
hypersensitivity reactions, including skin rashes and blisters, skin swelling, and swelling around the mouth
unpleasant sensations in the legs (so-called restless legs syndrome)
difficulty swallowing
involuntary movements, mainly of facial muscles or tongue
sexual dysfunction
diabetes
abnormalities in heart electrical activity observed on 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 (may lead to falls)
stuffy nose
reduced number of red blood cells
decreased sodium levels in blood
worsening control of pre-existing diabetes
confusion

Rare adverse reactions (may affect less than 1 in 1,000 people):
concurrent occurrence of symptoms such as high temperature (fever), excessive sweating, muscle rigidity, increased drowsiness or fainting (a disorder known as "neuroleptic malignant syndrome")
yellowing of the skin and eyes (jaundice)
liver inflammation
prolonged and painful penile erection (priapism)
breast enlargement and unexpected milk production (galactorrhea)
menstrual disorders
blood clots in veins, especially in legs (with symptoms such as leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, seek immediate medical help.
walking, talking, eating, or 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: accumulation of fat tissue around the abdomen, reduced levels of "good" cholesterol (HDL cholesterol), increased levels of a type of fat (triglycerides) in blood, high blood pressure, and increased blood sugar levels.
concurrent occurrence of fever with flu-like symptoms, sore throat or other infection, and very low white blood cell count (a condition called agranulocytosis)
intestinal obstruction
increased blood levels of creatine kinase (an enzyme produced, among others, in muscles)

Very rare adverse reactions (may affect less than 1 in 10,000 people):
severe rash, blisters or red spots on the skin
severe allergic reaction (called anaphylactic reaction), which may cause breathing difficulties or shock
sudden swelling of the skin, usually around the eyes, lips, and throat (angioedema)
severe condition with blister formation on the skin, inside the mouth, eyes, and genital organs (Stevens-Johnson syndrome). See section 2.
abnormal secretion of the hormone regulating urine volume
muscle fiber breakdown and muscle pain (rhabdomyolysis)

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
skin rash with irregular red patches (erythema multiforme)
sudden appearance of red skin areas with small pustules (small blisters filled with whitish-yellow fluid, known as acute generalized exanthematous pustulosis (AGEP). See section 2.
severe, sudden allergic reaction with symptoms such as fever, blister formation on the skin, and skin peeling (toxic epidermal necrolysis)
drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (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)
inflammation of the heart muscle
inflammation of blood vessels (vasculitis), often with skin rash presenting as small red or purple nodules

The class of medicines to which Kvelux SR belongs may cause heart function disorders, sometimes severe, which in serious cases may result in death.

Some adverse reactions are observed only in blood test results. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in blood, increased liver enzyme activity, reduced or increased number of red blood cells, increased blood creatine kinase activity (an enzyme present in muscles), decreased sodium levels, and increased blood prolactin levels. Increased prolactin levels may rarely cause:
breast enlargement and unexpected milk production in women and men
absence of menstruation or irregular menstrual cycles.

Your doctor may occasionally request blood tests.

Adverse reactions in children and adolescents
The same adverse reactions occurring in adults may also occur in children and adolescents.

The following adverse reactions have been observed more frequently in children and adolescents or were not reported in adults:

Very common adverse reactions (may affect more than 1 in 10 people):
increased blood levels of prolactin hormone. In rare cases, this may lead to:

• breast enlargement and unexpected milk production in both boys and girls
• absence of menstruation or irregular menstrual cycles in girls
  increased appetite
  vomiting
  abnormal muscle movements, including difficulty initiating movement, tremor, feeling of restlessness, or painless muscle stiffness
  increased blood pressure

Common adverse reactions (may affect less than 1 in 10 people):
feeling of weakness, fainting (may lead to falls)
nasal congestion
irritability

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Kvelux SR

Keep this medicine 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 stated month.
No special storage instructions are required.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must 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 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: anhydrous lactose, methacrylic acid and ethyl acrylate copolymer (1:1), type A,
magnesium stearate, crystalline maltose, and talc.
Coating: methacrylic acid and ethyl acrylate copolymer (1:1), type A, triethyl citrate.

What Kvelux SR looks like and contents of the pack
Extended-release 50 mg tablets are white or almost white, round, biconvex,
with "50" engraved on one side, 7.1 mm in diameter and 3.2 mm thick.
Extended-release 150 mg tablets are white or almost white, elongated, biconvex,
with "150" engraved on one side, 13.6 mm long, 6.6 mm wide, and 4.2 mm thick.
Extended-release 200 mg tablets are white or almost white, elongated, biconvex,
with "200" engraved on one side, 15.2 mm long, 7.7 mm wide, and 4.8 mm thick.
Extended-release 300 mg tablets are white or almost white, elongated, biconvex,
with "300" engraved on one side, 18.2 mm long, 8.2 mm wide, and 5.4 mm thick.
Extended-release 400 mg tablets are white or almost white, oval-shaped, biconvex,
with "400" engraved on one side, 20.7 mm long, 10.2 mm wide, and 6.3 mm thick.

The medicine is available in PVC/PCTFE/Aluminum foil blisters packed in a cardboard box.
Pack sizes contain 10, 30, 50, 56, 60, or 100 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers
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 detailed 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, Poland
Tel: 22 209 70 00