Questax Xr

Package Leaflet: Information for the User

Questax XR, 50 mg, 150 mg, 200 mg, 300 mg, 400 mg, prolonged-release tablets
Quetiapine

Read this leaflet carefully before taking this medicine.

• 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. 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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, which belongs to a group of medicines called antipsychotics. Questax XR can be used to treat several diseases, such as:

• bipolar depression and major depressive episodes in major depression: a state where the patient feels sad. The patient may also feel depressed, guilty, lack energy and appetite, or have difficulty sleeping.
• mania: a state where the patient is very excited, agitated, restless, enthusiastic, or overly active, or has impaired critical judgment, is aggressive, or troublesome.
• schizophrenia: a state where the patient hears and sees unreal voices and images, takes non-existent things for real, is overly suspicious, anxious, confused, has a sense of guilt, is tense, or severely depressed.

When Questax XR is used to treat major depressive episodes in major depression, it is used as an adjunctive therapy to another medicine taken for this disease.
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 you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines:
• certain medicines for HIV infection,
• azole derivatives (used for fungal infections),
• erythromycin or clarithromycin (medicines used for infections),
• nefazodone (a medicine used for depression).

Do not take Questax XR if any of the above situations apply to you. If in doubt, consult your 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, tell them if:

• you or a family member have or have had any heart problems, such as heart rhythm disturbances, heart muscle weakness, or heart muscle inflammation, or if you are taking or have taken any medicines that may affect heart function.
• you have low blood pressure.
• you have had a stroke, especially if you are elderly.
• you have liver problems.
• you have had a seizure (epilepsy) in the past.
• you have diabetes or are at risk of developing diabetes. In such cases, your doctor may check your blood sugar levels during treatment with Questax XR.
• you have had a decrease in white blood cell count (related or unrelated to taking other medicines) in the past.
• you are an elderly person with dementia (progressive loss of brain function). In this case, you 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.
• you are an elderly person with Parkinson's disease/parkinsonism.
• you or your family members have had blood clots in the past, as medicines in this group are associated with their formation.
• you have or have had a condition of short-term cessation of breathing during nighttime sleep (called "sleep apnea") and you are taking medicines that slow down normal brain activity (so-called "sedatives").
• you have or have had a condition where you cannot completely empty your bladder, or you have an enlarged prostate, intestinal blockage, or increased eye pressure. These conditions are sometimes caused by medicines called anticholinergics, which change the way nerve cells work.
• you have abused alcohol or drugs in the past.

You should immediately inform your doctor if, after taking Questax XR, you experience any of the following symptoms:

any of the following symptoms:

• simultaneous occurrence of fever, severe muscle stiffness, excessive sweating, or decreased consciousness (a condition called "neuroleptic malignant 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. Your doctor will need to examine your heart and, if necessary, refer you to a cardiologist immediately.

These symptoms may be caused by taking medicines in this group.
You should immediately inform your doctor if you experience:

• simultaneous fever, flu-like symptoms, sore throat, or any other infection, as this may be a consequence of a very low white blood cell count in the blood; in this case, it may be necessary to discontinue Questax XR and/or apply appropriate treatment.
• constipation along with 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. Clinical trial data show an increased risk of suicidal thoughts and/or suicidal behavior in young adults with depression under the age of 25.
You should immediately contact your doctor or go to the hospital if you experience thoughts of self-harm or suicidal thoughts. It may be helpful to inform your relatives or friends about your depression and ask them to read this leaflet. You can ask them to inform you if they notice that your depression has worsened or if there are any worrying changes in your behavior.

Weight gain

Weight gain has been observed in patients taking Questax XR.
You and your doctor should regularly monitor your 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 you are taking now or have taken recently, 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,
• azole derivatives (used for fungal infections),
• erythromycin or clarithromycin (medicines used for infections),
• nefazodone (a medicine used for 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 medicines 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 to treat certain diseases.

Before stopping treatment with any medicine, consult your 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 you consume. 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 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 your doctor or pharmacist before taking this medicine.
Questax XR should not be taken during pregnancy, unless discussed with your 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, you may need to contact a doctor.

Driving and using machines

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

Effect on urine screening tests for drugs

Taking Questax XR may cause false-positive results in some urine tests for methadone or certain tricyclic antidepressants (TCAs), even if you are not taking these medicines. If this happens, a more specific testing method should be used.

Questax XR contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Questax XR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The initial dose is determined by your 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; your doctor will specify when to take the medicine).
• Do not drink grapefruit juice while taking Questax XR. It may affect the way the medicine works.
• Do not stop taking the tablets even if you feel better, unless your doctor decides otherwise.

Liver function disorders

If you have liver problems, your doctor may change the dose.

Elderly patients

In elderly patients, the doctor may change the dose.

Use in children and adolescents

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

Overdose of Questax XR

In case of overdose, drowsiness, dizziness, or heart rhythm disturbances may occur. Immediately consult your doctor or go to the nearest hospital. Take 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, 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

If you suddenly stop taking Questax XR, you may experience difficulty sleeping (insomnia), nausea, or headaches, diarrhea, vomiting, dizziness, or irritability.
Your doctor may recommend gradually reducing the dose before stopping treatment.
If you have any further questions about taking this medicine, ask your 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 disappear as you continue taking 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 taking 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 fatty substances (triglycerides and total cholesterol).
• Common(occurring in less than 1 in 10 people):
• rapid heartbeat,
• feeling of strong heartbeat, rapid heartbeat, irregular heartbeat,
• constipation or stomach symptoms (indigestion),
• weakness,
• swelling of the arms or legs,
• low blood pressure when standing up, which may cause dizziness or fainting (may lead to falls);
• high blood sugar levels,
• blurred vision,
• abnormal dreams and nightmares,
• increased appetite,
• feeling irritable,
• speech and language 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 hormone levels in the blood; An increase in prolactin hormone levels may rarely lead to the following disorders: breast swelling and unexpected milk production in both men and women, absence or irregular menstrual periods in women.

Uncommon(occurring in less than 1 in 100 people):

• seizures,
• allergic reactions, including: hives (blisters) on the skin, skin swelling, and swelling around the mouth,
• unpleasant sensations in the legs (called "restless legs syndrome"),
• difficulty swallowing,
• uncontrolled movements, mainly in the face and tongue,
• sexual dysfunction,
• diabetes,
• changes in the electrical activity of the heart (prolonged QT interval),
• slower than normal heart rate, which may occur when starting treatment and may be associated with low blood pressure and fainting,
• difficulty urinating,
• fainting (may lead to falls),
• stuffy nose,
• decrease in red blood cell count,
• decrease in sodium levels in the blood,
• worsening of existing diabetes.

Rare(occurring in less than 1 in 1000 people):

• a combination of: high fever, excessive sweating, muscle stiffness, or decreased consciousness (a condition called "neuroleptic malignant syndrome"),
• yellowing of the skin and whites of the eyes (jaundice),
• liver inflammation,
• prolonged and painful erection (priapism),
• breast swelling and unexpected milk production (galactorrhea),
• menstrual disorders,
• blood clots in the veins, especially in the legs, which can move with the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, you should immediately contact your doctor.
• walking, talking, eating, or performing other activities while asleep,
• decreased body temperature (hypothermia).
• pancreatitis,
• a condition (called "metabolic syndrome") in which three or more of the following symptoms occur: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides, high blood pressure, and increased blood sugar levels.
• simultaneous occurrence of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count in the blood - a condition called agranulocytosis,
• intestinal obstruction,
• increased creatine kinase activity in the blood (a substance derived from muscles).

Very rare(occurring in less than 1 in 10,000 people):

• severe rash, blisters, or red spots on the skin,
• severe allergic reaction (called anaphylaxis), which may cause difficulty breathing or shock,
• sudden swelling of the skin, usually around the eyes, mouth, and throat (angioedema),
• severe skin disorder with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome),
• abnormal secretion of the hormone that controls urine production,
• muscle breakdown and muscle pain (rhabdomyolysis).

Unknown(frequency cannot be estimated from available data):

• skin rash with irregular red spots (erythema multiforme),
• severe skin disorder with blistering of the skin, mouth, eyes, and genitals (toxic epidermal necrolysis),
• withdrawal symptoms in newborns whose mothers took Questax XR in the last trimester of pregnancy,
• skin rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high body temperature, increased liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs (DRESS is also known as drug hypersensitivity syndrome). If you experience these symptoms, you should stop taking quetiapine and immediately contact your doctor.

stroke,

• heart muscle disorders (cardiomyopathy)
• heart muscle inflammation
• blood vessel inflammation (vasculitis), often with a skin rash with small red or purple spots

The group of medicines to which Questax XR belongs may cause heart rhythm disturbances, which can be serious and, in severe cases, even life-threatening.
Some side effects can only be detected by blood tests.
These include changes in the levels of certain fatty substances (triglycerides and total cholesterol) or sugar in the blood, changes in thyroid hormone levels in the blood, increased liver enzyme activity in the blood, decreased white blood cell count, decreased red blood cell count, increased creatine kinase activity in the blood (a substance derived from muscles), decreased sodium levels in the blood, and increased prolactin hormone levels in the blood. An increase in prolactin hormone levels may rarely lead to the following disorders:

• in men and women - breast swelling and unexpected milk production,
• absence or irregular menstrual periods in women. Your doctor may recommend regular check-ups.

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 hormone levels in the blood. An increase in prolactin hormone levels may rarely lead to the following disorders:
• in boys and girls - breast swelling and unexpected milk production,
• in girls - absence or irregular menstrual periods.
• increased appetite,
• vomiting,
• abnormal muscle contractions. These may include: 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, 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:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected]. By reporting side effects, you can help provide 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 (in the form of quetiapine fumarate).
• Other ingredients 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

• 50 mg prolonged-release tablets are white or off-white, round, biconvex, with "50" engraved on one side, 7.1 mm in diameter, and 3.2 mm thick.
• 150 mg prolonged-release tablets are white or off-white, oval, biconvex, with "150" engraved on one side, 13.6 mm long, 6.6 mm wide, and 4.2 mm thick.
• 200 mg prolonged-release tablets are white or off-white, oval, biconvex, with "200" engraved on one side, 15.2 mm long, 7.7 mm wide, and 4.8 mm thick.
• 300 mg prolonged-release tablets are white or off-white, oval, biconvex, with "300" engraved on one side, 18.2 mm long, 8.2 mm wide, and 5.4 mm thick.
• 400 mg prolonged-release tablets are white or off-white, oval, biconvex, with "400" engraved on one side, 20.7 mm long, 10.2 mm wide, and 6.3 mm thick.
• Questax XR prolonged-release tablets are available in PVC/PCTFE/Aluminum foil blisters packed 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 authorization holder and manufacturer

Marketing authorization holder:
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str. 23
40764 Langenfeld
Germany
Manufacturer:
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
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Domaniewska 37
02-672 Warsaw
[email protected]

This medicinal product is authorized in the Member States of the European Economic Area 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 prolonged-release tablets

Slovakia: Questax XR 50 mg prolonged-release tablets

Questax XR 150 mg prolonged-release tablets

Questax XR 200 mg prolonged-release tablets

Questax XR 300 mg prolonged-release tablets

Questax XR 400 mg prolonged-release tablets

Hungary: Questax XR 50 mg retard tablets

Questax XR 150 mg retard tablets

Questax XR 200 mg retard tablets

Questax XR 300 mg retard tablets

Questax XR 400 mg retard tablets

Italy: Quetiapina Neuraxpharm

Spain: Quetiapina Qualigen Farma 50 mg prolonged-release tablets EFG

Quetiapina Qualigen Farma 150 mg prolonged-release tablets EFG

Quetiapina Qualigen Farma 200 mg prolonged-release tablets EFG

Quetiapina Qualigen Farma 300 mg prolonged-release tablets EFG

Quetiapina Qualigen Farma 400 mg prolonged-release tablets EFG

Date of last revision of the leaflet:04.2022