Questax xr

Package leaflet: Information for the user

Questax XR, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg, prolonged-release tablets
Quetiapinum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, 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.

Leaflet contents

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

1. What Questax XR is and what it is used for

Questax XR contains an active substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Questax XR can be used in the treatment of the following conditions:

• bipolar depression and severe depressive episodes in major depression: a condition in which the patient feels sadness. The patient may also feel low mood, guilt, lack of energy and appetite, or inability to sleep.
• mania: a condition in which the patient is highly excited, elated, overactive, enthusiastic, or excessively active, or has impaired judgment, 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 Questax XR is used in the treatment of severe depressive episodes in major depression, it is used as an adjunctive therapy to another medicine taken for this condition.
Even if the patient feels better, the doctor may recommend continuing treatment with Questax XR.

2. Important information before taking Questax XR

When not to take Questax XR

• 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 for HIV infection,
• azole antifungals (used in fungal infections),
• erythromycin or clarithromycin (medicines used in infections),
• nefazodone (a medicine used to treat depression).

Do not take Questax XR if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before taking Questax XR.

Warnings and precautions

Before starting treatment with Questax XR, discuss this with your doctor or pharmacist. In particular, inform them if:

• the patient or a family member has or has had any heart problems, such as heart rhythm disorders, 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 in elderly patients.
• the patient has liver problems.
• the patient has previously experienced 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 Questax XR.
• the patient has previously had a low white blood cell count (with or without taking other medicines).
• if the patient is an elderly person with dementia (progressive loss of brain function). In this case, the patient should not take Questax XR, as medicines of this class may increase the risk of stroke and, in some cases, increase the risk of death in elderly patients with dementia.
• if the patient is an elderly person with Parkinson's disease/parkinsonism.
• the patient or their family has a history of blood clots, as medicines of this class have been associated with their formation.
• the patient has or has had a condition involving brief episodes of stopped breathing during sleep (called "sleep apnea") and is taking medicines that slow down normal brain activity ("sedatives").
• the patient has or has had a condition involving inability to fully empty the bladder (urinary retention), enlarged prostate, intestinal blockage, or increased pressure inside the eye. These conditions may sometimes be caused by medicines called anticholinergics, whose therapeutic effect in certain disorders alters the functioning of nerve cells.
• the patient has previously abused alcohol or drugs.

Immediately inform the doctor if any of the following symptoms occur after taking Questax XR:

• fever, severe muscle stiffness, excessive sweating, or reduced consciousness (a condition known as "neuroleptic malignant syndrome"). Immediate medical attention may be required.
• uncontrolled movements, especially of the facial muscles and 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, breathing difficulties, 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 taking medicines of this 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; therefore, discontinuation of Questax XR and/or appropriate treatment may be necessary.
• constipation accompanied by persistent abdominal pain, or persistent constipation despite treatment, as this may lead to serious intestinal blockage.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes have thoughts of self-harm or suicide. These symptoms or behaviors may worsen at the beginning of treatment, as medicines of this class usually take about two weeks, or sometimes longer, to start working.

These thoughts may also worsen if the patient suddenly stops taking the medicine. Such thoughts occur more frequently in young adults. Clinical trial data show an increased risk of suicidal thoughts and/or suicidal behavior in young adults with depression under the age of 25.

Contact a doctor immediately 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 behavior.

Weight gain

Weight gain has been observed in patients taking Questax XR. The patient and their doctor should regularly monitor the patient's body weight.

Children and adolescents

Questax XR is not intended for use in children and adolescents under 18 years of age.

Questax XR and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Do not take Questax XR if the patient is taking any of the following medicines:

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

Tell the doctor if the patient is taking any of the following medicines:

• antiepileptic medicines (e.g. phenytoin or carbamazepine),
• medicines for high blood pressure,
• barbiturates (medicines used for insomnia),
• thioridazine or lithium (other antipsychotic medicines),
• medicines affecting heart rhythm, for example, medicines that may disturb electrolyte balance (reduced potassium and magnesium levels), such as diuretics (causing increased urine excretion) or certain antibiotics (medicines fighting infections),
• medicines that may cause constipation,
• medicines (called "anticholinergics") that affect the functioning of nerve cells to treat certain disorders.

Do not stop taking any medicine without first consulting your doctor.

Taking Questax XR with food, drink, and alcohol

• Food may affect the action of Questax XR; therefore, tablets should be taken at least one hour before a meal or immediately before bedtime.
• Be cautious with alcohol consumption. This is because the combined effect of Questax XR and alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Questax XR. It may affect how the medicine works.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.

Questax XR should not be taken during pregnancy unless discussed with a doctor. Questax XR should not be taken during breastfeeding.

Newborns whose mothers took Questax XR during the third trimester of pregnancy (the 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 sucking difficulties. If any of these symptoms occur in the newborn, it may be necessary to contact a doctor.

Driving and operating machinery

The medicine may cause drowsiness. Do not drive or operate machinery until the patient knows how the medicine affects them.

Effect on urine drug screening tests

Taking Questax XR may cause false positive results in certain tests for methadone or certain tricyclic antidepressants (TCA), even though the patient is not taking these drugs. If this occurs, a more specific testing method should be used.

Questax XR contains lactose.

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Questax XR

This medicine should always be taken exactly as directed by the physician or pharmacist.
In case of doubt, consult your doctor or pharmacist.
The initial dose is determined by the doctor. The maintenance dose (daily dose) depends on
the condition being treated and the individual patient's 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 one hour before a meal, or before going to bed; your doctor will specify the exact timing).
• Do not drink grapefruit juice while taking Questax XR. It may affect how the medicine works.
• Do not stop taking the tablets even if you start to feel better, unless otherwise decided by your doctor.

Liver function disorders
If the patient has liver problems, the doctor may adjust the dose.
Elderly patients
In elderly patients, the doctor may adjust the dose.
Use in children and adolescents
Questax XR should not be used in children and adolescents under 18 years of age.
Taking more Questax XR than recommended
If you take more Questax XR than prescribed by your doctor, symptoms such as drowsiness, dizziness, or heart rhythm disturbances may occur. Seek immediate medical advice or go to the nearest hospital. Bring the Questax XR packaging with you.
Missed dose of Questax XR
If you miss a dose, take it as soon as possible. However, 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 Questax XR
If you stop taking Questax XR suddenly, you may experience difficulty sleeping (insomnia), nausea or headache, diarrhoea, vomiting, dizziness, or irritability.
Your doctor may advise you to gradually reduce 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 reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.

Very common (occurring in more than 1 in 10 people):

• dizziness (which may lead to falls), headache or dry mouth;
• drowsiness – this may decrease with continued use of Questax XR (may lead to falls);
• withdrawal symptoms (symptoms occurring after discontinuation of Questax XR), i.e. difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness or irritability. Gradual discontinuation of the medicine over a period of at least 1 to 2 weeks is recommended.
• weight gain;
• abnormal muscle movements, including difficulty initiating movement, tremor, restlessness or painless muscle stiffness;
• changes in blood levels of certain lipids (triglycerides and total cholesterol).

Common (may occur in up to 1 in 10 patients):

• increased heart rate;
• sensation of strong or rapid heartbeat, palpitations, irregular heartbeat;
• constipation or gastrointestinal symptoms (dyspepsia);
• fatigue;
• swelling of the arms or legs;
• 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 of irritability;
• speech and language disturbances;
• suicidal thoughts and worsening of depression;
• shortness of breath;
• vomiting (mainly in elderly patients);
• fever;
• changes in blood levels of thyroid hormones;
• decreased number of certain types of blood cells;
• increased levels of liver enzymes in blood;
• increased prolactin (hormone) levels in blood. Increased prolactin levels may rarely lead to the following conditions:
  • breast enlargement and unexpected milk production, in both women and men;
  • absence or irregular menstruation in women.

Uncommon (may occur in up to 1 in 100 patients):

• seizures;
• allergic reactions, including skin rash (blisters), skin swelling and swelling around the mouth;
• unpleasant sensations in the legs (known as restless legs syndrome);
• difficulty swallowing;
• uncontrolled movements, particularly in the facial muscles and tongue;
• sexual dysfunction;
• diabetes;
• changes in the electrical activity of the heart observed 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 blood;
• decreased sodium levels in blood;
• worsening of pre-existing diabetes.

Rare (may occur in up to 1 in 1,000 patients):

• symptoms including high temperature (fever), excessive sweating, muscle stiffness, severe drowsiness or near-fainting (a condition known as neuroleptic malignant syndrome);
• yellowing of the skin and whites of the eyes (jaundice);
• hepatitis;
• prolonged and painful erection (priapism);
• breast enlargement and unexpected milk production (galactorrhoea);
• menstrual disorders;
• blood clots in veins, especially in the legs (symptoms include leg swelling, pain and redness), 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, talking, eating or performing other activities during sleep;
• decreased body temperature (hypothermia);
• pancreatitis;
• a condition (known as "metabolic syndrome") in which at least 3 of the following occur together: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased blood levels of lipids (triglycerides), high blood pressure, and increased blood glucose levels;
• concurrent occurrence of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count – a condition known as agranulocytosis;
• intestinal obstruction;
• increased creatine kinase activity in blood (a substance derived from muscles).

Very rare (may occur in up to 1 in 10,000 patients):

• severe rash, blisters or red spots on the skin;
• severe allergic reaction (known as anaphylaxis), which may cause breathing difficulties or shock;
• sudden swelling of the skin, usually around the eyes, mouth and throat (angioedema);
• severe condition with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome);
• inappropriate secretion of the hormone regulating urine volume;
• breakdown of muscle fibres and muscle pain (rhabdomyolysis).

Unknown (frequency cannot be estimated from available data):

• skin rash with irregular red lesions (erythema multiforme);

• serious, sudden allergic reaction with symptoms such as fever, blistering of the skin and skin peeling (toxic epidermal necrolysis);

• withdrawal symptoms may occur in newborns whose mothers took Questax XR during the last trimester of pregnancy;

• drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (this condition is also known as DRESS or drug hypersensitivity syndrome). If a patient experiences these symptoms, treatment with quetiapine should be discontinued and immediate medical advice should be sought or medical help obtained;

• 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 group of medicines to which Questax XR belongs may cause heart rhythm disturbances, which may be serious and, in severe cases, may even lead to death.

Some adverse reactions can only be detected through laboratory blood tests. These include changes in blood levels of certain lipids (triglycerides and total cholesterol) or glucose, changes in blood levels of thyroid hormones, increased liver enzyme levels in blood, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine kinase levels in blood (a substance derived from muscles), decreased sodium levels in blood, and increased blood levels of the hormone prolactin. Increased prolactin levels may rarely lead to the following conditions:

• in men and women – breast enlargement and unexpected milk production;
• absence or irregular menstruation in women.

Your doctor may recommend periodic monitoring tests.

Adverse reactions in children and adolescents

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

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

Very common (occurring in more than 1 in 10 people):

• increased blood levels of the hormone prolactin. Increased prolactin levels may rarely lead to the following conditions:
  • in boys and girls – breast enlargement and unexpected milk production;
  • in girls – absence of menstruation or irregular periods;
• increased appetite;
• vomiting;
• abnormal muscle movements, including difficulty initiating movement, tremor, restlessness or painless muscle stiffness;
• increased blood pressure.

Common (may occur in up to 1 in 10 patients):

• fatigue, fainting (which may lead to falls);
• nasal congestion;
• feeling of irritability.

Reporting of adverse reactions

If any adverse reactions occur in a patient, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can 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.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected]. Reporting adverse reactions helps to provide more information on the safety of the medicine. Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store Questax XR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the EXP abbreviation. The expiry date refers to the last day of the specified month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the Package and Other Information

What Questax XR Contains

• The active substance is quetiapine. Questax XR contains 50 mg, 150 mg, 200 mg, 300 mg, or 400 mg of quetiapine (as quetiapine fumarate).
• Other ingredients are:
  Tablet core: Lactose, methacrylic acid and ethyl acrylate copolymer (1:1), type A, crystalline maltose, magnesium stearate, and talc.
  Tablet coating: Methacrylic acid and ethyl acrylate copolymer (1:1), type A, triethyl citrate.

What Questax XR Looks Like and Contents of the Pack

• Prolonged-release tablets 50 mg are white or off-white, round, biconvex, engraved with the code "50" on one side, with a diameter of 7.1 mm and a thickness of 3.2 mm.
• Prolonged-release tablets 150 mg are white or off-white, oblong, biconvex, engraved with the code "150" on one side, measuring 13.6 mm in length, 6.6 mm in width, and 4.2 mm in thickness.
• Prolonged-release tablets 200 mg are white or off-white, oblong, biconvex, engraved with the code "200" on one side, measuring 15.2 mm in length, 7.7 mm in width, and 4.8 mm in thickness.
• Prolonged-release tablets 300 mg are white or off-white, oblong, biconvex, engraved with the code "300" on one side, measuring 18.2 mm in length, 8.2 mm in width, and 5.4 mm in thickness.
• Prolonged-release tablets 400 mg are white or off-white, oblong, biconvex, engraved with the code "400" on one side, measuring 20.7 mm in length, 10.2 mm in width, and 6.3 mm in thickness.

Questax XR prolonged-release tablets are available in PVC/PCTFE/Aluminium blister packs contained in cardboard boxes. Available pack sizes:
Questax XR 50 mg: 10, 30, 50, 60, 100 and 180 tablets
Questax XR 150 mg: 10, 30, 50, 60, 100 and 180 tablets
Questax XR 200 mg: 10, 30, 50, 60, 100 and 180 tablets
Questax XR 300 mg: 10, 30, 50, 60, 100 and 180 tablets
Questax XR 400 mg: 10, 30, 50, 60, 100 and 180 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str. 23
40764 Langenfeld
Germany

Manufacturers:
Pharmathen SA
6 Dervenakion Str
15351 Pallini
Greece
Pharmathen International S.A.
Sapes Industrial Park Block 5
69300 Rodopi
Greece
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str. 23
40764 Langenfeld
Germany

For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Domaniewska 37
02-672 Warsaw
[email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Quetamed
Poland: Questax XR
Czech Republic: Questax Prolong
France: Quetiapine Neuraxpharm LP 50, LP 150, LP 200, LP 300, LP 400 mg comprimé à libération prolongée
Slovakia: Questax XR 50 mg tablety s predĺženým uvoľňovaním
Questax XR 150 mg tablety s predĺženým uvoľňovaním
Questax XR 200 mg tablety s predĺženým uvoľňovaním
Questax XR 300 mg tablety s predĺženým uvoľňovaním
Questax XR 400 mg tablety s predĺženým uvoľňovaním
Hungary: Questax XR 50 mg retard tabletta
Questax XR 150 mg retard tabletta
Questax XR 200 mg retard tabletta
Questax XR 300 mg retard tabletta
Questax XR 400 mg retard tabletta
Italy: Quetiapina Neuraxpharm
Spain: Quetiapina Qualigen Farma 50 mg comprimidos de liberación prolongada EFG
Quetiapina Qualigen Farma 150 mg comprimidos de liberación prolongada EFG
Quetiapina Qualigen Farma 200 mg comprimidos de liberación prolongada EFG
Quetiapina Qualigen Farma 300 mg comprimidos de liberación prolongada EFG
Quetiapina Qualigen Farma 400 mg comprimidos de liberación prolongada EFG