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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Questax XR is and what it is used for
• 2. Before you take 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 the active substance quetiapine, which belongs to a group of medicines called antipsychotics. Questax XR can be used to treat several conditions, such as:

• bipolar depression and major depressive episodes in major depression: a condition where you feel sad, guilty, or worthless, and may lose interest in activities you previously enjoyed.
• mania: a condition where you feel very excited, elated, or irritable, and may have difficulty sleeping or concentrating.
• schizophrenia: a condition where you may hear or see things that are not there, believe things that are not true, or feel suspicious or withdrawn.

When Questax XR is used to treat major depressive episodes in major depression, it is taken in combination with another medicine. Even if you feel better, your doctor may recommend that you continue taking Questax XR.

2. Before you take Questax XR

Do not 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.
• medicines for fungal infections (azoles).
• erythromycin or clarithromycin (antibiotics).
• nefazodone (an antidepressant).

Do not take Questax XR if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Questax XR.

Warnings and precautions

Before taking Questax XR, tell your doctor or pharmacist if:

• you or someone in your family has or has had any heart problems, such as irregular heart rhythm, heart failure, or inflammation of the heart muscle, or if you are taking any medicines that may affect your heart.
• 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).
• you have diabetes or are at risk of developing diabetes. Your doctor may check your blood sugar levels while you are taking Questax XR.
• you have had a decrease in white blood cell count (which may be caused by other medicines).
• you are an elderly person with dementia (a progressive loss of mental abilities). You should not take Questax XR, as it may increase the risk of stroke or death.
• you are an elderly person with Parkinson's disease.
• you or a family member have a history of blood clots, as medicines like Questax XR may increase the risk of blood clots.
• you have a condition where you stop breathing for short periods during sleep (sleep apnea) and are taking medicines that slow down your normal brain activity (sedatives).
• you have a condition where you cannot fully empty your bladder (urinary retention), have an enlarged prostate, or have a blockage in your intestines. These conditions may be worsened by medicines called anticholinergics, which affect the way nerve cells work.
• you have a history of alcohol or drug abuse.

Tell your doctor immediately if you experience any of the following

symptoms:

• a combination of fever, stiff muscles, sweating, and altered mental status (a condition called neuroleptic malignant syndrome). You may need urgent medical attention.
• uncontrolled movements, especially of the face and tongue.
• dizziness or excessive sleepiness. This may increase the risk of falls in elderly patients.
• seizures (convulsions).
• prolonged and painful erection (priapism).
• rapid or irregular heartbeat, even at rest, palpitations, shortness of breath, chest pain, or unexplained fatigue. Your doctor will need to check your heart and may refer you to a cardiologist.

These symptoms may be caused by taking medicines like Questax XR. Tell your doctor immediately if you experience:

• a combination of fever, flu-like symptoms, sore throat, or any other infection, as this may be a sign of a very low white blood cell count; your doctor may need to stop Questax XR and prescribe appropriate treatment.
• constipation with abdominal pain or persistent constipation despite treatment, as this may lead to a serious blockage of the intestines.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes have thoughts of harming themselves or committing suicide. These thoughts may worsen when taking medicines like Questax XR, especially when treatment starts or when the dose is changed. These thoughts are more common in young adults under 25 years old.

Weight gain

Weight gain has been seen in patients taking Questax XR. You and your doctor should check your weight regularly.

Children and adolescents

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

Questax XR with other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including:

• medicines for HIV infection.
• medicines for fungal infections (azoles).
• erythromycin or clarithromycin (antibiotics).
• nefazodone (an antidepressant).

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 (sedatives).
• thioridazine or lithium (other antipsychotic medicines).
• medicines that affect heart rhythm, such as those that may alter the balance of electrolytes (e.g., diuretics or certain antibiotics).
• medicines that may cause constipation.
• medicines that affect the way nerve cells work (anticholinergics), used to treat certain conditions.

Before stopping any medicine, talk to your doctor.

Taking Questax XR with food, drink, and alcohol

• Food may affect the way Questax XR works. Take the tablets at least one hour before a meal or at bedtime.
• Be careful with the amount of alcohol you drink. The combined effect of Questax XR and alcohol may cause sleepiness.
• 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, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Do not take Questax XR during pregnancy, unless your doctor has advised you to do so. Do not take Questax XR while breastfeeding.

Newborns whose mothers took Questax XR during the last trimester of pregnancy may experience symptoms such as trembling, stiffness, and sleepiness. If your baby experiences any of these symptoms, you should contact your doctor.

Driving and using machines

Questax XR may cause sleepiness. Do not drive or operate machinery until you know how the medicine affects you.

Effects on laboratory tests

Questax XR may affect the results of some urine tests for methadone or tricyclic antidepressants. If this happens, your doctor may need to use a more specific test.

Questax XR contains lactose

If you have been told that you have an intolerance to some sugars, talk to your doctor before taking Questax XR.

3. How to take Questax XR

Always take Questax XR exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The starting dose is determined by your doctor. The maintenance dose (daily dose) depends on your condition and needs, but is usually between 150 mg and 800 mg.

• Take Questax XR once a day.
• Do not split, chew, or crush the tablets.
• Swallow the tablets whole with water.
• Take the tablets without food (at least one hour before a meal or at bedtime; your doctor will tell you when to take it).
• Do not drink grapefruit juice while taking Questax XR.
• Do not stop taking the tablets even if you feel better, unless your doctor tells you to do so.

Liver problems

If you have liver problems, your doctor may need to adjust the dose.

Elderly patients

Your doctor may need to adjust the dose if you are an elderly patient.

Children and adolescents

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

Overdose

If you take more Questax XR than you should, you may experience sleepiness, dizziness, or changes in heart rhythm. Contact your doctor or go to the nearest hospital immediately. Take the Questax XR packaging with you.

Missed dose

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment

If you stop taking Questax XR suddenly, you may experience difficulty sleeping, nausea, headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment. If you have any further questions, 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(may affect more than 1 in 10 people):

• dizziness (which may lead to falls), headache, or dry mouth.
• feeling sleepy - this may resolve as you continue to take Questax XR (may lead to falls).
• withdrawal symptoms (symptoms that occur when you stop taking Questax XR), such as difficulty sleeping, nausea, headaches, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop taking Questax XR over a period of at least 1 to 2 weeks.
• weight gain.
• abnormal muscle movements. These can include difficulty starting movement, trembling, restlessness, or muscle stiffness without pain.
• changes in the levels of certain fats (triglycerides and total cholesterol) in your blood.

Common(may affect up to 1 in 10 people):

• rapid heartbeat.
• feeling of an irregular heartbeat, rapid heartbeat, or pauses in heartbeat.
• constipation or stomach upset (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.
• unusual dreams or nightmares.
• increased appetite.
• irritability.
• speech or language problems.
• suicidal thoughts and worsening of depression.
• shortness of breath.
• vomiting (mainly in elderly patients).
• fever.
• changes in thyroid hormone levels in your blood.
• decrease in the number of certain types of blood cells.
• increase in liver enzyme levels in your blood.
• increase in prolactin levels in your blood. Elevated prolactin levels may rarely cause the following problems:
• in men and women - breast swelling and unexpected production of milk.
• in women - absence or irregular periods.

Uncommon(may affect up to 1 in 100 people):

• seizures (convulsions).
• allergic reactions, including skin rash, swelling of the skin, and swelling around the mouth.
• unpleasant feelings in the legs (restless legs syndrome).
• difficulty swallowing.
• uncontrolled movements, especially of the face and tongue.
• sexual dysfunction.
• diabetes.
• changes in the electrical activity of the heart (prolonged QT interval) seen on an electrocardiogram (ECG).
• slow heartbeat, 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 your blood.
• worsening of existing diabetes.

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

• a combination of high fever, sweating, stiff muscles, and altered mental status (neuroleptic malignant syndrome).
• yellowing of the skin and eyes (jaundice).
• inflammation of the liver.
• prolonged and painful erection (priapism).
• breast swelling and unexpected production of milk (in men and women).
• absence or irregular periods (in women).
• blood clots in the veins, especially in the legs, which may travel to the lungs and cause chest pain and difficulty breathing.
• walking, talking, eating, or performing other activities while asleep.
• low body temperature (hypothermia).
• inflammation of the pancreas.
• a condition where you may experience a combination of three or more of the following symptoms: increased waist size, high levels of triglycerides or cholesterol, high blood pressure, and high blood sugar levels (metabolic syndrome).
• a combination of fever, flu-like symptoms, sore throat, or any other infection, with a very low white blood cell count (agranulocytosis).
• blockage of the intestines.
• increase in creatine kinase levels in your blood (a substance that comes from muscles).

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

• severe skin rash, blisters, or red patches on the skin.
• severe allergic reaction (anaphylaxis), which may cause difficulty breathing or a rapid heartbeat.
• swelling of the skin, especially around the eyes, mouth, and throat (angioedema).
• severe skin condition with blisters, rash, and peeling skin (Stevens-Johnson syndrome).
• abnormal production of a hormone that controls the amount of water in your body.
• breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Not known(frequency cannot be estimated from available data):

• skin rash with irregular red patches (erythema multiforme).
• severe skin condition with blisters, rash, and peeling skin (toxic epidermal necrolysis).
• withdrawal symptoms in newborns whose mothers took Questax XR during the last trimester of pregnancy.
• skin rash with increased white blood cell count and symptoms such as fever, swollen lymph nodes, and enlarged liver (DRESS syndrome). This syndrome is also known as drug reaction with eosinophilia and systemic symptoms.

If you experience any of these symptoms, stop taking Questax XR and contact your doctor immediately.

• stroke.
• heart muscle problems (cardiomyopathy).
• inflammation of the heart muscle.
• inflammation of blood vessels (vasculitis), often with a skin rash and small red or purple spots.

Medicines like Questax XR may cause heart rhythm problems, which can be serious and, in severe cases, may lead to death.

Some side effects can only be detected by a blood test. These include changes in the levels of certain fats (triglycerides and cholesterol) or sugar in your blood, changes in thyroid hormone levels, increase in liver enzyme levels, decrease in the number of certain types of blood cells, decrease in red blood cell count, increase in creatine kinase levels, decrease in sodium levels, and increase in prolactin levels. Elevated prolactin levels may rarely cause the following problems:

• in men and women - breast swelling and unexpected production of milk.
• in women - absence or irregular periods.

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 seen more often or only in children and adolescents:

Very common(may affect more than 1 in 10 people):

• increase in prolactin levels in your blood. Elevated prolactin levels may rarely cause the following problems:
• in boys and girls - breast swelling and unexpected production of milk.
• in girls - absence or irregular periods.
• increased appetite.
• vomiting.
• abnormal muscle movements. These can include difficulty starting movement, trembling, restlessness, or muscle stiffness without pain.
• increase in blood pressure.

Common(may affect up to 1 in 10 people):

• weakness, fainting (may lead to falls), or stuffy nose.
• irritability.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. You can also report side effects directly to the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

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 stated on the packaging. The expiry date refers to the last day of the month.

There are no special storage instructions for this medicine.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Questax XR contains

• The active substance is quetiapine. Each tablet contains 50 mg, 150 mg, 200 mg, 300 mg, or 400 mg of quetiapine (as quetiapine fumarate).
• The 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, packaged 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
For further information, contact the representative of the marketing authorization holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Domaniewska 37
02-672 Warszawa
info-poland@neuraxpharm.com

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