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.

• You should 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, and you may also feel hopeless, irritable, and anxious, and have difficulty sleeping.
• mania: a condition where you feel very excited, elated, agitated, enthusiastic, or hyperactive, and have difficulty controlling your behavior.
• schizophrenia: a condition where you may hear or see things that are not there, believe things that are not true, or feel unusually suspicious or anxious.

When Questax XR is used to treat major depressive episodes in major depression, it is taken in addition to another medicine.

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 heart problems, such as irregular heart rhythm, weakened heart muscle, or inflammation of the heart muscle, or if you are taking 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).
• 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 patient with dementia (a progressive loss of cognitive function). You should not take Questax XR, as it may increase the risk of stroke or death.
• you are an elderly patient 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 normal brain activity (sedatives).
• you have a condition where you cannot empty your bladder completely, or you have an enlarged prostate, a blockage in your intestines, or increased pressure in your eyes. These conditions may be worsened by medicines called anticholinergics, which affect the functioning of nerve cells.
• 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), which may require immediate medical attention.
• uncontrolled movements, mainly of the face and tongue
• dizziness or excessive sleepiness, which may increase the risk of falls in elderly patients.
• seizures (epileptic fits)
• prolonged and painful erections (priapism)
• rapid or irregular heartbeat, even at rest, palpitations, shortness of breath, chest pain, or unexplained fatigue. Your doctor will need to examine your heart and may refer you to a cardiologist if necessary.

These symptoms may be caused by taking medicines like Questax XR.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes have thoughts of harming themselves or committing suicide. These thoughts may worsen when first taking antidepressants, as these medicines may take up to two weeks to start working.

Weight gain

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

Children and adolescents

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

Questax XR with other medicines

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

Taking Questax XR with food and drink

• Food may affect the way Questax XR works, so take your tablets at least one hour before a meal or at bedtime.
• Be careful with the amount of alcohol you drink.
• 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Questax XR may cause drowsiness. 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 drugs (e.g., methadone or tricyclic antidepressants). If you are taking Questax XR and have a urine test, tell your doctor or the laboratory staff that you are taking this medicine.

Questax XR contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact 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. Check with your doctor or pharmacist if you are not sure.

• Take the tablets 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, as directed by your doctor).
• Do not drink grapefruit juice while taking Questax XR.
• Do not stop taking your tablets, even if you feel better, unless your doctor tells you to.

Liver problems

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

Elderly patients

Your doctor may need to adjust your dose.

Children and adolescents

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

Overdose

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

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, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten dose.

Stopping treatment

Do not stop taking Questax XR suddenly, as this may cause withdrawal symptoms such as insomnia, nausea, headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may need to gradually reduce your dose before stopping treatment.

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, headache, or dry mouth
• feeling sleepy - this may disappear after a few days of treatment
• withdrawal symptoms (symptoms that occur when you stop taking the medicine), such as insomnia, nausea, headache, diarrhea, vomiting, dizziness, or irritability
• weight gain
• abnormal muscle movements, such as difficulty starting movement, tremors, restlessness, or muscle stiffness without pain
• changes in blood tests for fats (triglycerides and total cholesterol)

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

• rapid heartbeat
• palpitations
• constipation or stomach upset
• weakness
• swelling of the hands or feet
• low blood pressure when standing up, which may cause dizziness or fainting
• high blood sugar
• blurred vision
• unusual dreams or nightmares
• increased appetite
• irritability
• speech or language problems
• suicidal thoughts or worsening of depression
• shortness of breath
• vomiting (mainly in elderly patients)
• fever
• changes in thyroid hormone levels in the blood
• decrease in the number of certain types of blood cells
• increase in liver enzymes in the blood
• increase in prolactin levels in the blood, which may lead to breast swelling or unexpected milk production in men and women, or irregular periods in women

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

• seizures
• allergic reactions, including skin rash, swelling, or itching
• unpleasant feelings in the legs (restless legs syndrome)
• difficulty swallowing
• uncontrolled movements, mainly of the face and tongue
• sexual dysfunction
• diabetes
• changes in the electrical activity of the heart (QT prolongation)
• slow heartbeat, which may be associated with low blood pressure and fainting
• difficulty urinating
• fainting (which may lead to falls)
• stuffy nose
• decrease in red blood cell count
• decrease in sodium levels in the 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)
• liver inflammation
• prolonged and painful erections (priapism)
• breast swelling or unexpected milk production
• irregular periods
• 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)
• pancreatitis
• a condition where you have three or more of the following symptoms: increased waist size, low "good" cholesterol, high triglycerides, high blood pressure, and high blood sugar (metabolic syndrome)
• a combination of fever, flu-like symptoms, sore throat, or any other infection, with a very low white blood cell count (agranulocytosis)
• intestinal blockage
• increase in creatine kinase levels in the blood (a substance from muscles)

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

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

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

• skin rash with irregular red patches (erythema multiforme)
• severe allergic reaction with symptoms such as fever, blistering of the skin, and peeling of the skin (toxic epidermal necrolysis)
• withdrawal symptoms in newborn babies whose mothers took Questax XR during the last trimester of pregnancy
• skin rash with eosinophilia and systemic symptoms (DRESS). A widespread rash, high fever, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (DRESS is also known as drug rash with eosinophilia and systemic symptoms)

Side effects in children and adolescents

The same side effects that occur in adults can also occur in children and adolescents.

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

• increase in prolactin levels in the blood, which may lead to breast swelling or unexpected milk production in boys and girls, or irregular periods in girls
• increased appetite
• vomiting
• abnormal muscle movements, such as difficulty starting movement, tremors, restlessness, or muscle stiffness without pain
• high blood pressure

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

• weakness, fainting (which 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 via phone: 22 49-21-301, fax: 22 49-21-309, or email: ndl@urpl.gov.pl.

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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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, and engraved with "50" on one side, with a diameter of 7.1 mm and a thickness of 3.2 mm.
• 150 mg prolonged-release tablets are white or off-white, oval, biconvex, and engraved with "150" on one side, with a length of 13.6 mm, a width of 6.6 mm, and a thickness of 4.2 mm.
• 200 mg prolonged-release tablets are white or off-white, oval, biconvex, and engraved with "200" on one side, with a length of 15.2 mm, a width of 7.7 mm, and a thickness of 4.8 mm.
• 300 mg prolonged-release tablets are white or off-white, oval, biconvex, and engraved with "300" on one side, with a length of 18.2 mm, a width of 8.2 mm, and a thickness of 5.4 mm.
• 400 mg prolonged-release tablets are white or off-white, oval, biconvex, and engraved with "400" on one side, with a length of 20.7 mm, a width of 10.2 mm, and a thickness of 6.3 mm.
• 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, please contact 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