Questax xr

Package leaflet: Information for the user

Questax XR, 600 mg, prolonged-release tablets
Quetiapinum
Please read all of this leaflet carefully before taking this medicine, because
it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Questax XR is and what it is used for
2. What you need to know 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 Questax XR is and what it is used for

Questax XR contains an active substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Questax XR may be used in the treatment of the following conditions:

• Major depressive episodes in bipolar affective disorder, when the patient feels profound sadness, depression, guilt, lack of energy and appetite, or has difficulty sleeping.
• Mania: a condition in which the patient is highly excited, elated, overactive, enthusiastic, or excessively active, has impaired judgment, or is aggressive or troublesome.
• Schizophrenia: a condition in which the patient hears and sees unreal voices and images, believes in non-existent things, is excessively suspicious, anxious, confused, feels guilt, is tense, or severely depressed.

Even if the patient feels better, the doctor may recommend continuing treatment with Questax XR.

2. Information before taking Questax XR

When not to take Questax XR

• If the patient is allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6)
• If the patient is taking any of the following medicines:
• certain medicines used to treat HIV infection,
• medicines belonging to the azole group (used in fungal infections),
• erythromycin or clarithromycin (medicines used to treat infections),
• nefazodone (a medicine used to treat depression).

Do not take Questax XR if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before taking Questax XR.

Warnings and precautions

Before starting to take Questax XR, discuss this with your doctor or pharmacist. In particular, inform them if:

• The patient or a family member has or has had any heart problems, such as heart rhythm disorders, weakened heart muscle or myocarditis, or if the patient is taking or has taken any medicines that could affect heart function.
• The patient has low blood pressure.
• The patient has had a stroke – this is especially important for elderly patients.
• The patient has liver problems.
• The patient has previously experienced seizures (epilepsy).
• The patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may monitor the patient's blood sugar levels during treatment with Questax XR.
• The patient has previously had a low white blood cell count (with or without taking other medicines).
• If the patient is an elderly person with dementia (progressive loss of brain function). In such cases, the patient 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 patients with dementia.
• If the patient is an elderly person with Parkinson's disease/parkinsonism.
• The patient or their family has a history of blood clots, as medicines in this group are associated with their development.
• The patient has or has had a condition involving brief episodes of stopped breathing during sleep (called "sleep apnoea") and is taking medicines that reduce normal brain activity ("sedatives").
• The patient has or has had a condition in which the bladder cannot be completely emptied (urinary retention), has an enlarged prostate, intestinal blockage, or increased pressure inside the eye. These conditions are sometimes caused by medicines called anticholinergics, whose therapeutic action changes the way nerve cells function.
• The patient has previously abused alcohol or drugs.

Immediately inform the doctor if any of the following symptoms occur after taking Questax XR:

• Fever, severe muscle stiffness, excessive sweating, or reduced consciousness occurring together (a condition known as "neuroleptic malignant syndrome"). Immediate medical help may be required.
• Uncontrolled movements, especially of the face and tongue,
• Dizziness or excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (epileptic fits).
• Prolonged and painful erection (priapism).
• Fast or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, immediately refer the patient to a cardiologist.

These symptoms may be caused by taking medicines in this group.

Immediately inform the doctor if the patient experiences:

• Fever together with flu-like symptoms, sore throat, or any other infection, as this may be due to a very low number of white blood cells in the blood; therefore, treatment with Questax XR may need to be discontinued and/or appropriate treatment initiated.
• Constipation accompanied by persistent abdominal pain, or persistent constipation despite treatment, as this may lead to a serious intestinal blockage.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment, as medicines in this group usually start to work only after about two weeks, or sometimes later.

These thoughts may also worsen if the patient suddenly stops taking the medicine. Such thoughts are more common in young adults. Clinical trial data show an increased risk of suicidal thoughts and/or suicidal behaviour in young adults with depression under the age of 25.

Seek immediate medical advice or go to hospital if thoughts of self-harm or suicidal thoughts occur. It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. The patient may ask them to inform him or her if they notice worsening depression or concerning changes in behaviour.

Severe cutaneous adverse reactions (SCARs)

During treatment with Questax XR, severe cutaneous adverse reactions (SCARs), which may be life-threatening or fatal, have been very rarely reported. These usually manifest as:

• Stevens-Johnson syndrome (SJS), widespread blistering and peeling rash, particularly around the mouth, nose, eyes, and genitals;
• Toxic epidermal necrolysis (TEN), a more severe form causing extensive skin peeling;
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes);
• Acute Generalised Exanthematous Pustulosis (AGEP), small pustules filled with pus;
• Erythema multiforme, a skin rash with itchy-red, irregular patches. If the patient experiences any of these symptoms, treatment with Questax XR should be stopped immediately and the patient should contact their doctor or seek immediate medical help.

Weight gain

Weight gain has been observed in patients taking Questax XR. The patient and their doctor should regularly monitor the patient's body 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 the patient is currently taking, has recently taken, or plans to take.

Do not take Questax XR if the patient is taking any of the following medicines:

• certain medicines used to treat HIV infection,
• medicines belonging to the azole group (used in fungal infections),
• erythromycin or clarithromycin (medicines used to treat infections),
• nefazodone (a medicine used to treat depression).

Tell the doctor if the patient is 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 affecting heart rhythm, for example medicines that may disturb electrolyte balance (reduced potassium and magnesium levels), such as diuretics (causing increased urine production) or certain antibiotics (medicines fighting infections),
• medicines that may cause constipation,
• medicines (called "anticholinergics") that affect the way nerve cells function, used in the treatment of certain diseases.

Do not stop taking any medicine without first consulting a doctor.

Taking Questax XR with food, drink and alcohol

• Food may affect the action of Questax XR, therefore tablets should be taken at least one hour before a meal or immediately before bedtime.
• Be cautious with alcohol consumption, as the combined effect of Questax XR and alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Questax XR. It may affect how the medicine works.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before taking this medicine.

Questax XR should not be taken during pregnancy unless discussed with a doctor.

Questax XR should not be taken during breastfeeding.

Newborns whose mothers took Questax XR during the third trimester of pregnancy (the last three months of pregnancy) may experience the following symptoms, which may indicate withdrawal syndrome: tremors, muscle stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If any of these symptoms occur in a newborn, it may be necessary to contact a doctor.

Driving and using machines

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

Effect on urine drug screening tests

In patients taking quetiapine, urine tests may show the presence of methadone or antidepressant medicines (tricyclic antidepressants), even if the patient has not taken them. These results must be confirmed with more specific tests.

Questax XR contains lactose.

If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Questax XR

This medicine should always be taken exactly as prescribed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
Your doctor will determine the starting dose. The maintenance dose (daily dose) depends on the condition being treated and the individual patient's needs, but usually ranges from 150 mg to 800 mg.

• Take the medicine once daily.
• Do not split, chew or crush the tablets.
• Swallow the tablets whole with water.
• Take the tablets on an empty stomach (at least one hour before a meal, or before going to bed; your doctor will specify the exact timing).
• Do not drink grapefruit juice during treatment with Questax XR, as it may affect how the medicine works.
• Do not stop taking the tablets even if you feel better, unless otherwise instructed by your doctor.

Liver function disorders
If you have liver problems, your doctor may adjust your dose.
Elderly patients
In elderly patients, your doctor may adjust the dose.
Use in children and adolescents
Questax XR should not be used in children and adolescents under 18 years of age.
Taking more Questax XR than recommended
If you take more Questax XR than prescribed, you may experience drowsiness, dizziness, or heart rhythm disturbances. Seek immediate medical advice from your doctor or go to the nearest hospital. Bring the medicine package with you.
If you miss a dose of Questax XR
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed dose.
Stopping Questax XR
If you stop taking Questax XR suddenly, you may experience difficulty sleeping (insomnia), nausea or headache, diarrhoea, vomiting, dizziness or irritability.
Your doctor may recommend gradually reducing the dose before stopping treatment completely.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.

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

• dizziness (which may lead to falls), headache or dry mouth;
• drowsiness – this may decrease during continued treatment with Questax XR (may lead to falls);
• withdrawal symptoms (symptoms occurring after discontinuation of Questax XR), i.e. difficulty falling asleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness or irritability. Gradual discontinuation of the medicine over a period of at least 1 to 2 weeks is recommended;
• weight gain;
• abnormal muscle contractions. These may include difficulty initiating movement, tremor, restlessness or painless muscle stiffness;
• changes in blood levels of certain lipids (triglycerides and total cholesterol).

Common (may occur in up to 1 in 10 patients):

• increased heart rate;
• sensation of rapid or irregular heartbeat, palpitations;
• constipation or gastrointestinal symptoms (dyspepsia);
• fatigue;
• swelling of upper or lower limbs;
• low blood pressure upon standing, which may cause dizziness or fainting (may lead to falls);
• increased blood glucose levels;
• blurred vision;
• unusual dreams and nightmares;
• increased appetite;
• feeling of irritability;
• speech and articulation disorders;
• suicidal thoughts and worsening of depression;
• shortness of breath;
• vomiting (mainly in elderly patients);
• fever;
• changes in thyroid hormone levels in blood;
• decreased number of certain types of blood cells;
• increased liver enzyme levels in blood;
• increased prolactin (hormone) levels in blood;

Elevated prolactin levels may rarely lead to the following conditions:

• breast enlargement and unexpected milk production, in both women and men;
• absence or irregular menstruation in women.

Uncommon (may occur in up to 1 in 100 patients):

• seizures;
• allergic reactions, including skin nodules (blisters), skin swelling and swelling around the mouth;
• unpleasant sensations in the legs (known as restless legs syndrome);
• difficulty swallowing;
• involuntary movements, particularly of facial muscles and tongue;
• sexual dysfunction;
• diabetes;
• changes in cardiac electrical activity observed on ECG (prolongation of QT interval);
• slower than normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting;
• difficulty urinating;
• fainting (may lead to falls);
• nasal congestion;
• decreased number of red blood cells in blood;
• decreased sodium levels in blood;
• worsening of pre-existing diabetes.

Rare (may occur in up to 1 in 1000 patients):

• collectively: high fever, excessive sweating, muscle stiffness, strong drowsiness or near-fainting (a condition known as neuroleptic malignant syndrome);
• yellowing of the skin and whites of the eyes (jaundice);
• hepatitis;
• prolonged and painful erection (priapism);
• breast enlargement and unexpected milk production (galactorrhea);
• menstrual disorders;
• blood clots in veins, especially in the lower limbs (symptoms include leg swelling, pain and redness), which may travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, contact a doctor immediately;
• walking, talking, eating or performing other activities during sleep;
• decreased body temperature (hypothermia);
• pancreatitis;
• a condition (known as "metabolic syndrome") involving at least 3 of the following: increased abdominal fat, reduced "good" cholesterol (HDL-C), increased blood lipid levels (triglycerides), high blood pressure, and elevated blood glucose;
• concurrent occurrence of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count – a condition known as agranulocytosis;
• intestinal obstruction;
• increased blood creatine kinase activity (a substance derived from muscles).

Very rare (may occur in up to 1 in 10,000 patients):

• severe rash, blisters or red spots on the skin;
• severe allergic reaction (known as anaphylaxis), which may present as difficulty breathing or shock;
• sudden swelling of the skin, usually around the eyes, mouth and throat (angioedema);
• severe disorder with blister formation on the skin, mouth, eyes and genital organs (Stevens-Johnson syndrome);
• inappropriate secretion of a hormone regulating urine volume;
• muscle fiber breakdown and muscle pain (rhabdomyolysis).

Unknown (frequency cannot be estimated from available data):

• skin rash with irregular red lesions (erythema multiforme). See section 2;
• sudden appearance of red skin areas with small pustules (small blisters filled with whitish-yellow fluid), known as acute generalized exanthematous pustulosis (AGEP). See section 2;
• severe, sudden allergic reaction with symptoms such as fever, blistering rash and skin peeling (toxic epidermal necrolysis). See section 2;
• rash with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzyme activity). See section 2;
• withdrawal symptoms may occur in newborns whose mothers took Questax XR during the third trimester of pregnancy;
• stroke;
• disorders of the heart muscle (cardiomyopathy);
• inflammation of the heart muscle (myocarditis);
• inflammation of blood vessels (vasculitis), often with skin rash presenting as small red or purple nodules.

The group of medicines to which Questax XR belongs may cause heart rhythm disturbances, which may be serious and, in severe cases, may even lead to death.

Some adverse reactions can only be detected through laboratory blood tests. These include changes in blood levels of certain lipids (triglycerides and total cholesterol) or glucose, changes in thyroid hormone levels, increased liver enzyme levels, decreased number of certain blood cells, decreased number of red blood cells, increased blood creatine kinase levels (a substance derived from muscles), decreased sodium levels in blood, and increased prolactin hormone levels. Elevated prolactin levels may rarely lead to the following conditions:

• in men and women – breast enlargement and unexpected milk production;
• absence or irregular menstruation in women.

Your doctor may recommend periodic monitoring tests.

Additional adverse reactions in children and adolescents

The same adverse reactions observed in adults may also occur in children and adolescents.

The following adverse reactions have been observed more frequently or exclusively in children and adolescents:

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

• increased blood prolactin levels. Elevated prolactin levels may rarely lead to the following conditions:
• in boys and girls – breast enlargement and unexpected milk production;
• in girls – absence or irregular menstruation;
• increased appetite;
• vomiting;
• abnormal muscle contractions, including difficulty initiating movement, tremor, restlessness or painless muscle stiffness;
• increased arterial blood pressure.

Common (may occur in up to 1 in 10 patients):

• fatigue, fainting (may lead to falls);
• nasal congestion;
• feeling of irritability.

Reporting of adverse reactions

If any adverse reactions occur in a patient, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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, Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps to collect more information on the safety of the medicine.

Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Questax XR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of 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. Questax XR contains 600 mg of quetiapine (as quetiapine fumarate).
• Other ingredients are: Core of the tablet: lactose, copolymer of methacrylic acid and ethyl acrylate (1:1), type A, crystalline maltose, magnesium stearate and talc. Coating of the tablet: copolymer of methacrylic acid and ethyl acrylate (1:1), type A, triethyl citrate.

What Questax XR looks like and contents of the pack

• Prolonged-release tablets 600 mg are white or off-white, oval-shaped, biconvex tablets, with the inscription "600" engraved on one side.
• Questax XR prolonged-release tablets are available in PVC/PCTFE/Aluminium foil blisters packed in cardboard boxes. Pack sizes available: Questax XR, 600 mg: 10, 20, 30, 50, 60 and 100 tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany
Manufacturers:
Pharmathen International SA
Sapes Industrial Park Block 5
69300 Rodopi
Greece
Pharmathen SA
6 Dervenakion Str
15351 Pallini Attiki
Greece
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark: Quetamed
Poland: Questax XR
France: Quétiapine Neuraxpharm LP 600 mg, comprimé à libération prolongée
Slovakia: Questax XR 600 mg tablety s predĺženým uvoľňovaním
Czech Republic: Questax Prolong
Hungary: Questax XR 600 mg retard tabletta
Spain: Psicotric Prolong 600 mg comprimidos de liberación prolongada
Germany: Quetiapin-neuraxpharm 600 mg Retardtabletten