QUESTAX 600 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Questax XR, 600 mg, prolonged-release tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Questax XR and what is it used for
4. Important information before taking Questax XR
   1. When not to take Questax XR
   2. Warnings and precautions
   3. Inform your doctor immediately if you experience any of the following symptoms after taking Questax XR
   4. Suicidal thoughts and depression
   5. Severe skin reactions (SCARs)
   6. Weight gain
   7. Children and adolescents
   8. Questax XR and other medicines
   9. Taking Questax XR with food, drink, and alcohol
   10. Pregnancy and breastfeeding
   11. Driving and using machines
   12. Effect on urine screening tests for drugs
   13. Questax XR contains lactose
5. How to take Questax XR
   1. Liver function disorders
   2. Elderly patients
   3. Use in children and adolescents
   4. Taking a higher dose of Questax XR than prescribed
   5. Missing a dose of Questax XR
   6. Stopping treatment with Questax XR
6. Possible side effects
   1. Additional side effects in children and adolescents
   2. Reporting side effects
7. How to store Questax XR
8. Contents of the pack and other information
   1. What Questax XR contains
   2. What Questax XR looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: 11/2021

Leaflet accompanying the packaging: information for the user

Questax XR, 600 mg, prolonged-release tablets

Quetiapine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Questax XR contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics. Questax XR can be used to treat the following conditions, such as:

• Major depressive episodes in bipolar disorder, when the patient feels deep sadness, depression, has a sense of guilt, lack of energy and appetite or cannot sleep.
• Mania: a state in which the patient is very excited, agitated, stimulated, full of enthusiasm or overly active, or has impaired critical judgment, is aggressive or troublesome.
• Schizophrenia: a state in which the patient hears and sees unreal voices and images, takes non-existent things for real, is overly suspicious, concerned, confused, has a sense of guilt, is tense or severely depressed.

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,
• medicines belonging to the azole group (used for fungal infections),
• erythromycin or clarithromycin (medicines used for infections),
• nefazodone (a medicine used to treat depression).

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

Warnings and precautions

Before starting to take Questax XR, discuss it 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 arrhythmias, heart muscle weakness, 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 had a seizure (epilepsy) in the past.
• The patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may check the patient's blood sugar levels during treatment with Questax XR.
• The patient has had a decrease in the number of white blood cells (related or unrelated to taking other medicines) in the past.
• 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 in this group may increase the risk of stroke and, in some cases, increase the risk of death in elderly people with dementia.
• If the patient is an elderly person with Parkinson's disease/parkinsonism.
• If the patient or their family members have had blood clots in the past, as medicines in this group are associated with their formation.
• If the patient has or has had a condition of short-term cessation of breathing during nighttime sleep (called "sleep apnea") and is taking medicines that slow down normal brain activity ("sedatives").
• If the patient has or has had a condition in which they cannot completely empty the bladder, has an enlarged prostate, intestinal blockage, or increased intraocular pressure. These conditions are sometimes caused by medicines called anticholinergics, which change the way nerve cells work.
• If the patient has abused alcohol or drugs in the past.

Inform your doctor immediately if you experience any of the following symptoms after taking Questax XR

if you experience any of the following symptoms:

• Simultaneous occurrence of fever, severe muscle stiffness, increased sweating, or impaired consciousness (a condition called "malignant neuroleptic syndrome"). Immediate medical attention may be necessary.
• Uncontrolled movements, mainly in the face and tongue,
• Dizziness or excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (epileptic seizures).
• Prolonged and painful erection (priapism).
• Rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, refer the patient to a cardiologist immediately.

These symptoms may be caused by the use of medicines in this group.
Inform your doctor immediately if you experience:

• Simultaneous fever, flu-like symptoms, sore throat, or any other infection, as this may be a consequence of a very low number of white blood cells in the blood; in this case, it may be necessary to discontinue the use of Questax XR and/or apply appropriate treatment.
• Constipation accompanied by persistent abdominal pain, or persistent constipation despite treatment, as this may lead to a serious intestinal blockage.

Suicidal thoughts and depression

Patients with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviors may worsen at the beginning of treatment, as medicines in this group usually start working only after about two weeks, and sometimes later.
These thoughts may also worsen if the patient suddenly stops taking the medicine. This type of thought occurs more frequently in young adults. Data from clinical trials show an increased risk of suicidal thoughts and/or suicidal behavior in young adults with depression under the age of 25.
Immediately contact a doctor or go to the hospital if thoughts of self-harm or suicidal thoughts occur. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet. The patient may ask to be informed when their loved ones notice that the depression has worsened or that there are worrying changes in their behavior.

Severe skin reactions (SCARs)

During treatment with Questax XR, very rare severe skin reactions (SCARs) have been reported, which can be life-threatening or lead to death. They usually manifest as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals;
• Toxic epidermal necrolysis (TEN), a more severe form causing widespread skin peeling;
• Drug reaction with eosinophilia and systemic symptoms (DRESS); including flu-like symptoms with a rash, fever, lymph node enlargement, and abnormal blood test results (including an increased number of white blood cells (eosinophilia) and liver enzymes);
• Acute generalized exanthematous pustulosis (AGEP), small blisters filled with pus;
• Polymorphic erythema, a skin rash with irregular red patches. If the patient experiences any of these symptoms, they should discontinue the use of Questax XR and seek medical attention immediately.

Weight gain

In patients taking Questax XR, cases of weight gain have been observed. The patient and their doctor should regularly monitor the patient's weight.

Children and adolescents

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

Questax XR and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Questax XR if you are taking any of the following medicines:

• certain medicines for HIV infection,
• medicines belonging to the azole group (used for fungal infections),
• erythromycin or clarithromycin (medicines used for infections),
• nefazodone (a medicine used to treat depression).

Tell your doctor if you are 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 that affect heart rhythm, such as those that can disrupt electrolyte balance (decrease potassium and magnesium levels), such as diuretics (which increase urine production) or certain antibiotics (medicines that fight infections),
• medicines that can cause constipation,
• medicines (called "anticholinergics") that affect the way nerve cells work, used to treat certain diseases.

Before stopping treatment with any medicine, consult a doctor first.

Taking Questax XR with food, drink, and alcohol

• Food may affect the action of Questax XR, and therefore, tablets should be taken at least one hour before a meal or before bedtime.
• Be careful with the amount of alcohol consumed, as the combined effect of Questax XR and alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Questax XR, as it may affect the way the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, 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.
In newborns whose mothers took Questax XR in the last trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur, which may indicate withdrawal syndrome: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, difficulty breathing, and difficulty feeding. If any of these symptoms occur in a newborn, it may be necessary to consult a doctor.

Driving and using machines

The medicine may cause drowsiness. Do not drive or operate machines until you know how the medicine affects you.

Effect on urine screening tests for drugs

In patients taking quetiapine, urine tests may show the presence of methadone or antidepressants (from the group of tricyclic antidepressants), even if the patient is not taking them. Such results must be confirmed using more specific tests.

Questax XR contains lactose

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

3. How to take Questax XR

This medicine should always be taken exactly as prescribed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The initial dose is determined by a doctor. The maintenance dose (daily dose) depends on the disease and the patient's needs, but it usually ranges from 150 mg to 800 mg.

• The medicine should be taken once a day.
• Do not divide, chew, or crush the tablets.
• Swallow the tablets whole with water.
• Take the tablets without food (at least one hour before a meal or before bedtime; the doctor will specify exactly when to take the medicine).
• Do not drink grapefruit juice while taking Questax XR, as it may affect the way the medicine works.
• Do not stop taking the tablets even if you feel better, unless the doctor decides otherwise.

Liver function disorders

If the patient has liver problems, the doctor may change the prescribed dose.

Elderly patients

In elderly patients, the doctor may change the prescribed dose.

Use in children and adolescents

Questax XR should not be used in children and adolescents under the age of 18.

Taking a higher dose of Questax XR than prescribed

In case of taking a higher dose of Questax XR than prescribed by a doctor, drowsiness, dizziness, or heart rhythm disturbances may occur. Immediately consult a doctor or go to the nearest hospital. Take the Questax XR packaging with you.

Missing a dose of Questax XR

If a dose of Questax XR is missed, 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 treatment with Questax XR

After suddenly stopping treatment with Questax XR, difficulty sleeping (insomnia), nausea, or headaches, diarrhea, vomiting, dizziness, or irritability may occur.
The doctor may recommend gradually reducing the dose before stopping treatment.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Questax XR can cause side effects, although not everybody gets them.
Very common(occurring in more than 1 in 10 people):

• dizziness (which may lead to falls), headache, or dry mouth;
• feeling drowsy - may decrease with continued treatment with Questax XR (may lead to falls);
• withdrawal symptoms (symptoms that occur after stopping Questax XR), i.e., difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop the medicine over a period of at least 1 to 2 weeks;
• weight gain;
• abnormal muscle contractions. These may include: difficulty starting movement, trembling, restlessness, or muscle stiffness without pain;
• changes in blood levels of certain fats (triglycerides and total cholesterol). Common(occurring in less than 1 in 10 people):
• rapid heartbeat;
• feeling of strong heartbeat, rapid heartbeat, pauses in heart function;
• constipation or stomach symptoms (indigestion);
• weakness,
• swelling of the upper or lower limbs;
• low blood pressure when standing up, which may cause dizziness or fainting (may lead to falls);
• high blood sugar levels;
• blurred vision,
• unusual dreams and nightmares;
• increased appetite,
• feeling irritable,
• speech and speech disorders;
• suicidal thoughts and depression;
• shortness of breath,
• vomiting (mainly in elderly people);
• fever,
• changes in thyroid hormone levels in the blood;
• decrease in the number of certain types of blood cells;
• increase in liver enzyme levels in the blood;
• increase in prolactin levels in the blood; Increased prolactin levels may rarely lead to the following disorders:

in men and women - breast swelling and unexpected milk production,

Additional side effects in children and adolescents

The same side effects that occur in adults can also occur in children and adolescents.
The following side effect has been observed more frequently or exclusively in children and adolescents:
Very common(occurring in more than 1 in 10 people):

• increased prolactin levels in the blood. Increased prolactin levels may rarely lead to the following disorders:
• in boys and girls - breast swelling and unexpected milk production,
• in girls - absence of menstruation or irregular periods;
• increased appetite,
• vomiting,
• abnormal muscle contractions, including: difficulty starting movement, trembling, restlessness, or muscle stiffness without pain;
• increased blood pressure.

Common(occurring in less than 1 in 10 people):

• weakness, fainting (may lead to falls),
• stuffy nose,
• feeling irritable.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Questax XR

Keep the 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 month stated.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Questax XR contains

• The active substance of the medicine is quetiapine. Questax XR contains 600 mg of quetiapine (in the form of quetiapine fumarate).
• Other ingredients of the medicine are: Tablet core: lactose, methacrylic acid - ethyl acrylate copolymer (1:1), type A, crystalline maltose, magnesium stearate, and talc. Tablet coating: methacrylic acid - ethyl acrylate copolymer (1:1), type A, triethyl citrate.

What Questax XR looks like and contents of the pack

• The 600 mg prolonged-release tablets are white or off-white, oval, biconvex, with the inscription "600" on one side.
• Questax XR prolonged-release tablets are available in PVC/PCTFE/Aluminum foil blisters packed in cardboard boxes. Available pack sizes: Questax XR, 600 mg: 10, 20, 30, 50, 60, and 100 tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany
Manufacturer:
Pharmathen International SA
Sapes Industrial Park Block 5
69300 Rodopi
Greece
Pharmathen SA
6 Dervenakion Str
15351 Pallini Attiki
Greece
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark: Quetamed
Poland: Questax XR
France: Quétiapine Neuraxpharm LP 600 mg, prolonged-release tablet
Slovakia: Questax XR 600 mg prolonged-release tablets
Czech Republic: Questax Prolong
Hungary: Questax XR 600 mg retard tablet
Spain: Psicotric Prolong 600 mg prolonged-release tablets
Germany: Quetiapin-neuraxpharm 600 mg retard tablets

Date of last revision of the leaflet: 11/2021