Kventiax sr

Patient Information Leaflet

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
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• 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 the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Kventiax SR is and what it is 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 pack and other information

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

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

• depressive episodes in bipolar affective disorders and severe depressive episodes in major depression: a condition in which the patient feels sadness; the patient may experience profound sadness (depression), feelings of guilt, lack of energy, loss of appetite, or inability to sleep;
• mania: a condition in which the patient is highly excited, agitated, overactive, enthusiastic, or excessively active, has impaired judgment, or is aggressive or troublesome;
• schizophrenia: a condition in which the patient hears and sees unreal voices and images, believes in non-existent things, is excessively suspicious, anxious, confused, feels guilt, is tense, or severely depressed.

When Kventiax SR is used to treat severe depressive episodes in major depression, it will be used as an adjunctive treatment to another medicine taken for this condition.
Even if you start feeling better, your doctor may advise you to continue 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 currently taking:
• certain medicines used to treat HIV infection;
• azole antifungals (used in fungal infections);
• erythromycin or clarithromycin (antibiotics used to treat infections);
• nefazodone (a medicine used to treat depression).

If in doubt, consult a doctor or pharmacist before taking Kventiax SR.
Warnings and precautions
Before starting treatment with Kventiax SR, discuss with your doctor or pharmacist if:

• the patient or a family member has or has had any heart problems, such as irregular heartbeat, weakened heart muscle, 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 elderly;
• the patient has liver disease;
• the patient has ever had seizures (epilepsy);
• the patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may monitor the patient's blood sugar levels during treatment with Kventiax SR;
• the patient has previously had a low white blood cell count (regardless of whether it was caused by other medicines or not);
• the patient is an elderly person with dementia (impaired brain function). In this case, Kventiax SR should not be used, as antipsychotic medicines like Kventiax SR may increase the risk of stroke and, in some cases, death in elderly patients with dementia;
• the patient is elderly and suffers from Parkinson’s disease/parkinsonism;
• the patient or a family member has had blood clots, as medicines of this class may increase the risk of clot formation;
• the patient has had or currently has a condition where breathing stops temporarily during sleep (a condition called "sleep apnoea") and is taking medicines that reduce normal brain activity (antidepressants);
• the patient has had or currently has difficulty emptying the bladder (urinary retention), an enlarged prostate, intestinal obstruction, or increased eye pressure. These conditions are often caused by medicines (so-called anticholinergic medicines) affecting nerve cell function, used in the treatment of certain diseases;
• the patient has previously been addicted to alcohol or drugs;
• the patient has depression or other conditions treated with antidepressants. Taking these medicines together with Kventiax SR may lead to serotonin syndrome, a potentially life-threatening condition (see "Kventiax SR and other medicines").

Immediately inform the doctor if any of the following symptoms occur after taking Kventiax SR:

• high fever, muscle stiffness, excessive sweating, and/or reduced consciousness occurring together (a condition known as neuroleptic malignant syndrome). Immediate medical attention may be required;
• uncontrolled movements, mainly of the facial muscles or tongue;
• dizziness or excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients;
• seizures (epileptic fits);
• prolonged and 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 immediately to a cardiologist. These symptoms may occur during treatment with medicines of this therapeutic class.

Immediately inform the doctor if the patient experiences:

• fever together with flu-like symptoms, sore throat, or any other infection, as this may be due to a very low white blood cell count; treatment with Kventiax SR may need to be discontinued and/or appropriate treatment initiated;
• constipation accompanied by persistent abdominal pain or persistent constipation despite treatment, as this may lead to severe intestinal obstruction.

Suicidal thoughts or worsening depression
Patients with depression may sometimes experience thoughts of self-harm or suicide.
These symptoms or behaviours may worsen at the beginning of treatment, as antidepressant medicines usually take about 2 weeks, or sometimes longer, to take effect. Symptoms may worsen if the patient suddenly stops taking the medicine. These effects are more likely in young adult patients. Clinical trial data show an increased risk of suicidal thoughts and/or behaviours in people under 25 years of age with depression.
Seek immediate medical help or go to hospital if thoughts of self-harm or suicidal thoughts occur. It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. The patient may ask them to inform him or her if they notice worsening depression or concerning changes in behaviour.

Severe skin adverse reactions (SCAR)
Very rarely, severe skin adverse reactions (SCAR, severe cutaneous adverse reactions) have been reported during treatment with this medicine, which may be life-threatening or lead to death. These reactions usually present as:

• Stevens-Johnson syndrome (SJS), widespread blistering and peeling of the skin, particularly around the mouth, nose, eyes, and genitals;
• toxic epidermal necrolysis (TEN), a more severe form causing extensive skin detachment;
• 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 enzyme activity);
• acute generalized exanthematous pustulosis (AGEP), small pustules filled with pus;
• erythema multiforme (EM), a skin rash with red, itchy, irregular patches.

If any of these symptoms occur, discontinue Kventiax SR immediately and contact a doctor or seek medical help without delay.
Weight gain
Weight gain has been observed in patients taking Kventiax SR. Both the patient and the doctor should monitor body weight regularly.
Children and adolescents
Kventiax SR is not intended for use in children and adolescents under 18 years of age.
Kventiax SR and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not take Kventiax SR if the patient is taking any of the following medicines:

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

Inform the doctor if the patient is taking:

• antiepileptic medicines (such as phenytoin or carbamazepine);
• antihypertensive medicines;
• barbiturates (medicines used for sleep disorders);
• thioridazine or lithium salts (other antipsychotic medicines);
• medicines affecting heart rhythm, for example, those that may disturb electrolyte balance (reduced potassium or magnesium levels), such as diuretics (causing increased urine production) or certain antibiotics (used to treat infections);
• medicines that may cause constipation;
• medicines (so-called anticholinergic medicines) affecting nerve cell function, used in the treatment of certain diseases;
• antidepressants. These medicines may interact with Kventiax SR and cause symptoms such as involuntary rhythmic muscle contractions (including eye movements), agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, consult a doctor.

Before stopping any medicine, contact the doctor.
Taking Kventiax SR with food, drink, and alcohol

• Food may affect the action of Kventiax SR; therefore, tablets should be taken at least one hour before a meal or before bedtime.
• Exercise caution when consuming alcohol during treatment with Kventiax SR, as the combined effect of Kventiax SR and alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Kventiax SR, as it may affect how the medicine works.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not use Kventiax SR during pregnancy unless advised by a doctor. Kventiax SR should not be used during breastfeeding.
Newborns whose mothers took Kventiax SR during the third trimester of pregnancy (last three months) may experience the following symptoms, which may indicate withdrawal syndrome: tremor, muscle stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If these symptoms are observed in the child, contact a doctor.
Driving and operating machinery
Kventiax SR may cause drowsiness. Do not drive or operate machinery until the patient knows how the medicine affects them.
Kventiax SR contains lactose and sodium
Kventiax SR contains lactose, a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
50 mg, prolonged-release tablets:
The medicine contains 8.44 mg of sodium (a main component of table salt) per tablet. This corresponds to 0.42% of the maximum recommended daily sodium intake in the adult diet.
150 mg, prolonged-release tablets:
The medicine contains 14.53 mg of sodium (a main component of table salt) per tablet. This corresponds to 0.73% of the maximum recommended daily sodium intake in the adult diet.
200 mg, prolonged-release tablets:
The medicine contains 19.38 mg of sodium (a main component of table salt) per tablet. This corresponds to 0.97% of the maximum recommended daily sodium intake in the adult diet.
300 mg, prolonged-release tablets:
The medicine contains 29.06 mg of sodium (a main component of table salt) per tablet. This corresponds to 1.45% of the maximum recommended daily sodium intake in the adult diet.
400 mg, prolonged-release tablets:
The medicine contains 23.46 mg of sodium (a main component of table salt) per tablet. This corresponds to 1.17% of the maximum recommended daily sodium intake in the adult diet.
Effect on urine drug screening tests
Taking Kventiax SR may cause false positive results in certain urine drug tests for methadone or certain tricyclic antidepressants (TCA), even if the patient is not taking these drugs. If this occurs, 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 in doubt,
consult your doctor or pharmacist.
Your doctor will determine the initial dose. The maintenance dose (daily dose) will depend on the severity of the disease and individual patient needs, but usually ranges from 150 mg to 800 mg.

• Take the medicine once daily.
• Do not divide, chew or crush the tablets.
• Swallow the tablets whole with water.
• Take the tablets on an empty stomach (at least 1 hour before a meal or before bedtime; your doctor will specify exactly when the medicine should be taken).
• During treatment with Kventiax SR, do not drink grapefruit juice. It may affect the medicine's action.
• Do not stop taking the tablets even if you start to feel better, unless otherwise decided by your doctor.

Liver function disorders
Your doctor may recommend adjusting the dosage regimen in patients with liver function disorders.
Elderly patients
In elderly patients, your doctor may recommend adjusting the dose.
Use in children and adolescents
Kventiax SR should not be used in patients under 18 years of age.
Taking more Kventiax SR than recommended
If you take more Kventiax SR than prescribed by your doctor, symptoms such as drowsiness, dizziness, or irregular heartbeat may occur. Seek immediate medical advice from a doctor or go to the nearest hospital. Take the medicine packaging with you.
Missed dose of Kventiax SR
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, wait and take the medicine at the usual time. Do not take a double dose to make up for the missed dose.
Stopping Kventiax SR
If you stop taking Kventiax SR suddenly, you may experience difficulty sleeping (insomnia), nausea or headache, diarrhoea, vomiting, dizziness or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will get them.

Very common: may affect more than 1 in 10 people

• dizziness (may lead to falls), headache, dry mouth
• somnolence (may diminish during treatment with Kventiax SR) (may lead to falls)
• withdrawal symptoms (symptoms occurring after discontinuation of Kventiax SR), i.e. difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness or irritability. Gradual discontinuation over a period of at least 1–2 weeks is recommended.
• weight gain
• abnormal muscle contractions; these may include difficulty initiating movement, tremor, motor restlessness or painless muscle stiffness
• changes in blood levels of certain lipid substances (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• rapid heartbeat
• irregular heartbeat (awareness of rapid or irregular heart rhythm)
• constipation, stomach discomfort (dyspepsia)
• weakness
• swelling of hands or feet
• low blood pressure upon standing, which may cause dizziness or fainting (may lead to falls)
• increased blood glucose levels
• blurred vision
• unusual dreams and nightmares
• increased appetite
• feeling irritable
• speech and language disturbances
• suicidal thoughts and worsening of depression
• shortness of breath
• vomiting (mainly in elderly people)
• fever
• changes in blood levels of thyroid hormones
• decreased number of certain types of blood cells
• increased levels of liver enzymes in blood tests
• increased blood levels of the hormone prolactin; elevated prolactin levels may lead to:
• breast enlargement in both men and women and unexpected milk production,
• absence or irregular menstruation in women.

Uncommon: may affect up to 1 in 100 people

• seizures
• allergic reactions, including skin rashes (blisters), skin swelling and swelling around the mouth
• unpleasant sensations in the legs (also known as restless legs syndrome)
• difficulty swallowing
• uncontrolled movements, mainly affecting facial muscles or the tongue
• sexual dysfunction
• diabetes
• changes in the heart's electrical activity seen on ECG (prolongation of QT interval)
• 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)
• nasal congestion
• decreased number of red blood cells in the blood
• decreased sodium levels in the blood
• worsening of pre-existing diabetes
• confusion.

Rare: may affect up to 1 in 1,000 people

• combination of symptoms: high temperature (fever), excessive sweating, muscle stiffness, extreme drowsiness or fainting (a condition called neuroleptic malignant syndrome)
• yellowing of the skin and eyes (jaundice)
• hepatitis (liver inflammation)
• prolonged and painful erection (priapism)
• breast enlargement and unexpected milk production (galactorrhea)
• menstrual cycle disturbances
• blood clots in veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which may travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, contact a doctor immediately.
• walking, eating or performing other activities during sleep
• low body temperature (hypothermia)
• pancreatitis (inflammation of the pancreas)
• a condition (referred to as "metabolic syndrome") in which 3 or more of the following occur simultaneously: increased abdominal fat, reduced "good" cholesterol (HDL-C), increased blood levels of lipid substances (triglycerides), high blood pressure and increased blood sugar levels
• concurrent occurrence of fever, flu-like symptoms, sore throat or any other infection with a very low number of white blood cells in the blood (a condition known as agranulocytosis)
• intestinal obstruction
• increased blood levels of creatine kinase (a substance derived from muscles).

Very rare: may affect up to 1 in 10,000 people

• severe rash, blisters or red spots on the skin
• severe allergic reactions (called anaphylactic reactions) causing difficulty breathing or shock
• sudden swelling of the skin, usually around the eyes, mouth 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).

Unknown frequency: cannot be estimated from available data

• skin rash with irregular red patches (erythema multiforme). See section 2.
• sudden appearance of red skin areas covered with small pustules (small blisters filled with white/yellow fluid), called acute generalized exanthematous pustulosis (AGEP). See section 2.
• severe, sudden allergic reaction with symptoms such as fever, blistering of the skin and skin peeling (toxic epidermal necrolysis). See section 2.
• 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 enzyme activity). See section 2.
• withdrawal symptoms may occur in newborns whose mothers took Kventiax SR during pregnancy
• stroke
• heart muscle disorders (cardiomyopathy)
• inflammation of the heart muscle (myocarditis)
• inflammation of blood vessels (vasculitis), often with a skin rash presenting as small red or purple nodules.

Medicines to which Kventiax SR belongs may cause disturbances in heart rhythm, which can have serious consequences and, in severe cases, may lead to death.

Some adverse effects can only be detected through laboratory blood tests. These include changes in blood levels of certain lipid substances (triglycerides and total cholesterol) or blood glucose, changes in blood levels of thyroid hormones, increased blood levels of liver enzymes, decreased number of certain types of blood cells, decreased number of red blood cells, increased blood activity of creatine kinase (a substance derived from muscles), decreased blood sodium levels, and increased blood levels of the hormone prolactin. Elevated levels of this hormone may lead to:

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

Your doctor may recommend periodic monitoring tests.

Additional adverse effects in children and adolescents

The same adverse effects observed in adults may also occur in children and adolescents.

The following adverse effects have been observed more frequently or exclusively in children and adolescents:

Very common: may affect more than 1 in 10 people

• increased blood levels of the hormone prolactin. In rare cases, this may lead to:
• breast enlargement and unexpected milk production in both girls and boys
• absence or irregular menstruation in girls
• increased appetite
• vomiting
• abnormal muscle contractions, including difficulty initiating intended movement, tremor, restlessness or muscle stiffness without accompanying pain
• increased blood pressure.

Common: may affect up to 1 in 10 people

• feeling of weakness, fainting (may lead to falls)
• nasal congestion
• feeling irritable.

Reporting of adverse effects

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

5. How to store Kventiax SR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
Store in the original packaging to protect from moisture.
No special temperature storage requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Kventiax SR contains

• The active substance is quetiapine. Each prolonged-release tablet contains 50 mg, 150 mg, 200 mg, 300 mg, or 400 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:
  50 mg, 400 mg prolonged-release tablets: hypromellose, lactose monohydrate, microcrystalline cellulose, disodium hydrogen phosphate 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 hydrogen 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 hydrogen 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 pack
50 mg prolonged-release tablets
White or almost white, slightly biconvex, capsule-shaped coated tablets with bevelled edges, marked with "50" on one side; tablet dimensions: length: 16.2 mm, thickness: 4.0–5.2 mm

150 mg prolonged-release tablets
Pink-orange, round, biconvex, coated tablets with bevelled edges; tablet dimensions: diameter: 10 mm, thickness: 4.6–6.0 mm

200 mg prolonged-release tablets
Yellow-brown, oval, biconvex, coated tablets; tablet dimensions: length: 16 mm, thickness: 5.6–7.1 mm

300 mg prolonged-release tablets
Light brown-yellow, biconvex, capsule-shaped coated tablets; tablet dimensions: length: 19.1 mm, thickness: 5.9–7.4 mm

400 mg prolonged-release tablets
White or almost white, biconvex, capsule-shaped coated tablets, marked with "400" on one side; tablet dimensions: length: 18.7–19.5 mm, thickness: 5.5–7.1 mm

Pack sizes: Blister packs containing 10, 30, 50, 60, 90, or 100 prolonged-release tablets in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. 22 57 37 500