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, you may also feel tired, lose your appetite, and have trouble sleeping.
• mania: a condition where you feel very excited, elated, agitated, enthusiastic, or hyperactive.
• 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.
• if you are taking any of the following medicines:
• certain medicines for HIV infection,
• medicines for fungal infections (azoles),
• erythromycin or clarithromycin (medicines for infections),
• nefazodone (a medicine for depression).

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 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 in the past (with or without taking other medicines).
• you are an elderly patient with dementia (a progressive loss of cognitive function). You should not take Questax XR, as medicines like this one may increase the risk of stroke or death in elderly patients with dementia.
• you are an elderly patient with Parkinson's disease/parkinsonism.
• you or a family member have a history of blood clots, as medicines like this one may increase the risk of blood clots.
• you have a condition where you stop breathing for short periods during sleep (sleep apnea) and take medicines that slow down your normal brain activity (sedatives).
• you have a condition where you cannot empty your bladder fully (urinary retention), have an enlarged prostate, have a blockage in your intestines, or have increased pressure in your eyes. These conditions can be caused by medicines with anticholinergic effects, 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 a lowered level of consciousness (a condition called neuroleptic malignant syndrome). You may need urgent medical attention.
• uncontrolled movements, mainly of the face and tongue,
• dizziness or excessive drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
• seizures (epileptic fits),
• 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, if necessary, refer you to a cardiologist.

These symptoms may be caused by taking medicines like this one.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes have thoughts of harming themselves or committing suicide. These thoughts may worsen at the start of treatment, as the medicine starts to work, usually within the first two weeks, or 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,
• medicines for fungal infections (azoles),
• erythromycin or clarithromycin (medicines for infections),
• nefazodone (a medicine 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 for insomnia),
• thioridazine or lithium (other antipsychotic medicines),
• medicines that affect your heart rhythm, such as those that may alter the balance of electrolytes (e.g., diuretics or certain antibiotics),
• medicines that may cause constipation,
• medicines with anticholinergic effects, which affect the way nerve cells work.

Taking Questax XR with food, drink, and alcohol

• Food may affect the way Questax XR works. Take your tablets at least one hour before a meal or just before bedtime.
• Be careful when drinking alcohol while taking Questax XR, as the combined effect 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 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

Taking Questax XR may affect the results of some urine tests for methadone or tricyclic antidepressants (TCAs). 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 your tablets once a day.
• Do not split, chew, or crush the tablets.
• Swallow the tablets whole with water.
• Take your 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 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. 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, wait and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping Questax XR

Do not stop taking Questax XR suddenly, as you may experience 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(affects more than 1 in 10 people):

• dizziness (which may lead to falls), headache, or dry mouth;
• drowsiness (which may lead to falls);
• withdrawal symptoms (symptoms that occur when you stop taking Questax XR), such as insomnia, nausea, headache, 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 movements. These can include difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• changes in the levels of certain fats (triglycerides and total cholesterol) in your blood.

Common(affects up to 1 in 10 people):

• rapid heartbeat,
• palpitations, irregular heartbeat, or changes in heart rhythm,
• constipation or stomach problems (indigestion),
• weakness,
• swelling of the arms or legs,
• low blood pressure when standing up, which may cause dizziness or fainting (which may lead to falls),
• high blood sugar levels,
• blurred vision,
• abnormal 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: breast enlargement or unexpected production of milk in men and women, and absence or irregularity of menstrual periods in women.

Uncommon(affects up to 1 in 100 people):

• seizures (epileptic fits),
• 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, mainly of the face and tongue,
• sexual dysfunction,
• diabetes,
• changes in the electrical activity of the heart (prolonged QT interval),
• slow heart rate, which may occur when starting treatment and 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 your blood,
• worsening of existing diabetes.

Rare(affects up to 1 in 1,000 people):

• a combination of high fever, sweating, stiff muscles, and lowered consciousness (neuroleptic malignant syndrome),
• yellowing of the skin and eyes (jaundice),
• liver inflammation,
• prolonged and painful erections (priapism),
• breast enlargement or unexpected production of milk in men and women,
• irregular menstrual periods,
• blood clots in the veins, especially in the legs, which can dislodge, travel to the lungs, and cause chest pain and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.
• walking, talking, eating, or performing other activities while asleep,
• low body temperature (hypothermia),
• pancreatitis,
• a condition characterized by the presence of three or more of the following symptoms: increased waist circumference, decreased "good" cholesterol (HDL-C), increased triglycerides, high blood pressure, and high blood sugar levels.
• 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 your blood (a substance from your muscles).

Very rare(affects 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 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).

Unknown(frequency cannot be estimated from the available data):

• skin rash with irregular red patches (erythema multiforme),
• severe skin condition with blistering of the skin, mouth, eyes, and genitals (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 enzyme levels, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (DRESS), also known as drug hypersensitivity syndrome.

Side effects in children and adolescents

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

Very common(affects more than 1 in 10 people):

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

Common(affects up to 1 in 10 people):

• weakness, fainting (which may lead to falls),
• 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 the contact details listed below. 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: 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, engraved with "50" 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, engraved with "150" 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, engraved with "200" 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, engraved with "300" 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, engraved with "400" 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.

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.

Date of last revision of the leaflet: 04.2022