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, and you may also feel hopeless, guilty, or worthless, or have difficulty sleeping or concentrating.
• mania: a condition where you feel very excited, elated, or irritable, or 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
• certain antifungal medicines
• 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, weakened heart muscle, 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 before and during treatment with Questax XR.
• you have had a decrease in white blood cell count (which may make you more prone to infections).
• you are an elderly person 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 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 you are taking medicines that slow down your normal brain activity (such as 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 can be caused by medicines called anticholinergics, which affect the way your 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 in your face and tongue
• dizziness or excessive drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
• seizures (convulsions)
• prolonged and painful erections (priapism)
• rapid or irregular heartbeat, even when resting, palpitations, shortness of breath, chest pain, or unexplained fatigue. Your doctor will need to check 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 experience thoughts of self-harm or suicide. These thoughts may worsen at the start of treatment, as the medicine starts to work, usually within the first two weeks, but sometimes later.

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 of age.

Questax XR with other medicines

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

• certain medicines for HIV infection
• antifungal medicines (such as azole derivatives)
• erythromycin or clarithromycin (antibiotics)
• nefazodone (an antidepressant)

Tell your doctor if you are taking any of the following medicines:

• antiepileptic medicines (such as phenytoin or carbamazepine)
• medicines for high blood pressure
• barbiturates (sedatives)
• thioridazine or lithium (other antipsychotic medicines)
• medicines that affect your heart rhythm, such as those that can disrupt the balance of electrolytes (such as diuretics or certain antibiotics)
• medicines that can cause constipation
• medicines (called anticholinergics) that affect the way your nerve cells work, used to treat certain conditions.

Taking Questax XR with food, drink, and alcohol

• Food can affect the way Questax XR works. Take the tablets at least one hour before a meal or before going to bed.
• Be careful with the amount of alcohol you drink. The combined effect of Questax XR and alcohol can 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

Effects on laboratory tests

Taking Questax XR may affect the results of some urine tests for methadone or tricyclic antidepressants. If this happens, a more specific test may be needed.

Questax XR contains lactose

If you have been told 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 before going to bed).
• 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.

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 if you are an elderly patient.

Children and adolescents

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

Overdose

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

Forgot to take Questax XR

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 Questax XR

If you stop taking Questax XR suddenly, you may experience difficulty sleeping, nausea, headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may need to gradually reduce your 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, headache, or dry mouth
• drowsiness (may decrease as you continue taking Questax XR)
• withdrawal symptoms (such as difficulty sleeping, nausea, headaches, diarrhea, vomiting, dizziness, or irritability) when stopping Questax XR. Your doctor may need to gradually reduce your dose over 1 to 2 weeks.
• weight gain
• abnormal muscle movements. These can include difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• changes in blood tests for fat (triglycerides and total cholesterol)

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

• rapid heartbeat
• feeling of a rapid or irregular heartbeat
• constipation or stomach upset
• weakness
• swelling of arms or legs
• low blood pressure when standing up, which can 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 enzyme levels in the blood
• increase in prolactin levels in the blood. Elevated prolactin levels can rarely cause the following problems: breast swelling and unexpected production of milk, or irregular or absent menstrual periods in women.

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

• seizures
• allergic reactions, including skin rashes, swelling, or difficulty breathing
• unpleasant sensations in the legs (restless legs syndrome)
• difficulty swallowing
• uncontrolled movements, especially in the face and tongue
• sexual dysfunction
• diabetes
• changes in the electrical activity of the heart (prolonged QT interval)
• slow heart rate, which can occur when starting treatment and may be associated with low blood pressure and fainting
• difficulty urinating
• fainting (which can 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 and unexpected production of milk
• irregular or absent menstrual periods
• blood clots in the veins, especially in the legs, which can dislodge and travel to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.
• sleepwalking, talking, eating, or performing other activities while asleep
• low body temperature (hypothermia)
• pancreatitis (inflammation of the pancreas)
• a condition where you experience three or more of the following symptoms: increased waist circumference, high triglycerides, low HDL cholesterol, 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 obstruction
• 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 can cause difficulty breathing or shock
• sudden swelling of the skin, usually around the eyes, mouth, and throat (angioedema)
• severe skin condition with blisters, sores, or peeling skin (Stevens-Johnson syndrome)
• abnormal production of a hormone that controls the amount of urine produced
• muscle breakdown and muscle pain (rhabdomyolysis)

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

• skin rash with irregular red patches (erythema multiforme)
• severe skin condition with blisters, sores, or peeling skin (toxic epidermal necrolysis)
• withdrawal symptoms in newborn babies whose mothers took Questax XR during the last trimester of pregnancy
• a condition where you experience a skin rash, fever, and swollen lymph nodes, with changes in blood tests (DRESS syndrome). If you experience any of these symptoms, stop taking Questax XR and contact your doctor immediately.

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. Elevated prolactin levels can rarely cause the following problems: breast swelling and unexpected production of milk, or irregular or absent menstrual periods in girls.
• increased appetite
• vomiting
• abnormal muscle movements. These can include 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 can 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: [email protected]. 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 which is stated on the carton 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: lactose, methacrylic acid - ethyl acrylate copolymer (1:1) type A, crystalline maltose, magnesium stearate, and talc (tablet core); methacrylic acid - ethyl acrylate copolymer (1:1) type A, and triethyl citrate (tablet coating).

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 blister packs of 10, 30, 50, 60, 100, and 180 tablets.

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

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