Simquel Xr

Leaflet accompanying the packaging: patient information

Symquel XR, 50 mg, prolonged-release tablets

Symquel XR, 200 mg, prolonged-release tablets

Symquel XR, 300 mg, prolonged-release tablets

Symquel XR, 400 mg, prolonged-release tablets

Quetiapine

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Symquel XR and what is it used for
• 2. Important information before taking Symquel XR
• 3. How to take Symquel XR
• 4. Possible side effects
• 5. How to store Symquel XR
• 6. Contents of the packaging and other information

1. What is Symquel XR and what is it used for

Symquel XR contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics. Symquel XR can be used to treat certain diseases, such as:

• depression in bipolar affective disorder or episodes of severe depression in severe depressive disorder, when the patient feels strong sadness or despair, has a sense of guilt, lack of energy and appetite, or cannot sleep.
• mania: when the patient is highly excited, remains in a state of euphoria, is agitated, full of enthusiasm, overactive, or has limited critical judgment, including being aggressive or exhibiting destructive behavior.
• schizophrenia: when the patient hears or feels things that do not exist; believes in things that are not true or is overly suspicious, anxious, confused, has a sense of guilt, tension, or depression.

If Symquel XR is used to treat episodes of severe depression in severe depressive disorders, the doctor will recommend taking another medicine for this condition as well. If there is no improvement in the patient's condition or if it worsens, they should contact their doctor.

2. Important information before taking Symquel XR

When not to take Symquel 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 from the azole group (used to treat fungal infections);
• erythromycin or clarithromycin (used to treat bacterial infections);
• nefazodone (used to treat depression).

If any of the above situations apply to the patient, they should not take Symquel XR. If in doubt, the patient should consult their doctor or pharmacist before taking Symquel XR.

Warnings and precautions

Before starting treatment with Symquel XR, the patient should discuss with their doctor, pharmacist, or nurse if:

• the patient or a family member has or has had any heart problems, such as arrhythmias, weakness, or inflammation of the heart muscle, or if the patient is taking medicines that may affect heart function;
• the patient has low blood pressure;
• the patient has had a stroke in the past, especially if they are elderly;
• the patient has liver function disorders;
• the patient has had seizures (epilepsy) in the past;
• the patient has been diagnosed with a low white blood cell count (regardless of whether it was caused by taking other medicines or not);
• the patient has diabetes or is at risk of developing diabetes, in which case the doctor may order a blood sugar test while taking Symquel XR;
• the patient or a family member has had blood clots, as taking medicines like this one is associated with the formation of blood clots;
• the patient is elderly with dementia (age-related cognitive impairment). Such a person should not take Symquel XR, as medicines in the same group as Symquel XR may increase the risk of stroke and, in some cases, the risk of death in elderly patients with dementia;
• the patient is elderly and has been diagnosed with Parkinson's disease/Parkinsonism;
• the patient has or has had a condition characterized by short pauses in breathing during normal sleep at night (so-called sleep apnea) and is taking medicines that slow down brain function (so-called depressants);
• the patient has or has had a condition characterized by the inability to completely empty the bladder (urinary retention), has an enlarged prostate, intestinal obstruction, or increased eye pressure. These symptoms may be caused by medicines (so-called anticholinergic medicines) that affect the function of nerve cells and are used to treat certain diseases;
• the patient has or has had problems with alcohol or drug abuse;
• if the patient has depression or other conditions that are being treated with antidepressant medicines. Taking these medicines with Symquel XR may lead to the development of a life-threatening condition called serotonin syndrome (see "Symquel XR and other medicines").

The patient should immediately inform their doctor if they experience symptoms such as:

• fever with muscle stiffness, excessive sweating, or decreased level of consciousness (a condition called malignant neuroleptic syndrome). Immediate medical attention may be necessary;
• involuntary movements, especially of the face or tongue;
• dizziness or a feeling of extreme drowsiness. This may increase the risk of injuries (falls) in elderly patients;
• seizures;
• prolonged and painful erection (priapism);
• rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, immediately refer the patient to a cardiologist.

All these symptoms may occur during treatment with medicines in this therapeutic group. The patient should inform their doctor as soon as possible if they experience:

• fever, flu-like symptoms, sore throat, or any other infection, as these may be caused by a very low white blood cell count, which may require discontinuation of Symquel XR and/or initiation of appropriate treatment.
• constipation with persistent abdominal pain or constipation that does not improve with treatment, as this may lead to severe intestinal obstruction.

Suicidal thoughts or worsening depression

Patients with depression may sometimes think about self-harm or suicide. This is especially true at the beginning of treatment with antidepressant medicines, as these medicines usually start working only after 2 weeks, sometimes later. Suicidal thoughts may worsen in patients who suddenly stop taking their medicines. The likelihood of such thoughts is higher in young adults. Clinical studies have shown an increased risk of suicidal thoughts and/or behaviors in young patients under the age of 25 with depression. If the patient experiences thoughts of self-harm or suicidal thoughts, they should immediately contact their doctor or go to the hospital. It may be helpful to inform friends and family members about the depression and its symptoms and ask them to read this leaflet and inform the patient if they notice any worsening of depression or worrying changes in the patient's behavior. Severe skin reactions(SCAR) have been very rarely reported during treatment with Symquel XR, which can be life-threatening or lead to death. They usually manifest as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals;
• Toxic epidermal necrolysis (TEN), a more severe form causing widespread skin peeling;
• Drug reaction with eosinophilia and systemic symptoms (DRESS); a rash with flu-like symptoms, fever, lymph node enlargement, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes);
• Acute generalized exanthematous pustulosis (AGEP) - small blisters filled with pus
• Erythema multiforme (EM) - a skin rash with irregular, itchy, red patches

If the patient experiences these symptoms, they should stop taking Symquel XR and immediately contact their doctor or seek medical attention.

Weight gain

Patients taking Symquel XR have experienced weight gain. The patient should regularly check their weight, either alone or with their doctor.

Children and adolescents

Symquel XR is not intended for use in children and adolescents under the age of 18.

Symquel XR and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should not take Symquel XR if they are taking any of the following medicines:

• certain medicines used to treat HIV;
• medicines from the azole group (used to treat fungal infections);
• erythromycin or clarithromycin (used to treat bacterial infections);
• nefazodone (used to treat depression).

The patient should tell their doctor if they are taking any of the following medicines:

• antiepileptic medicines (such as phenytoin or carbamazepine);
• antihypertensive medicines;
• barbiturates (medicines used to treat sleep disorders);
• thioridazine or lithium (other antipsychotic medicines);
• medicines that affect heart rhythm, such as medicines that cause electrolyte disturbances (decreasing potassium or magnesium levels), such as diuretics (urine-inducing) or certain antibiotics (medicines used to treat infections);
• medicines that may cause constipation;
• medicines used to treat certain diseases, affecting the function of nerve cells (so-called anticholinergic medicines);
• antidepressant medicines. These medicines may interact with Symquel XR and may cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, the patient should consult their doctor.

The patient should not stop taking other medicines without consulting their doctor or pharmacist.

Symquel XR with food, drink, and alcohol

• Taking food may affect the action of the medicine, so Symquel XR should be taken at least 1 hour before a meal or immediately before bedtime.
• The patient should be careful with the amount of alcohol they consume. Taking Symquel XR and alcohol at the same time may cause drowsiness.
• The patient should not drink grapefruit juice while taking Symquel XR, as it may affect the action of the medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The patient should not take Symquel XR during pregnancy, unless it has been agreed upon with their doctor. Symquel XR should not be used during breastfeeding. In newborns whose mothers took Symquel XR during the last trimester of pregnancy (during the last three months of pregnancy), the following symptoms may occur, which may be symptoms of withdrawal: tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing difficulties, feeding difficulties. If the child experiences any of these symptoms, the patient should contact their doctor.

Driving and using machines

This medicine may cause drowsiness. The patient should not drive vehicles or operate machines until they know how they react to the medicine.

Symquel XR contains lactose monohydrate

Symquel XR contains lactose monohydrate, a type of sugar. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Symquel XR contains sodium

Symquel XR contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Effect on urine tests for drug presence

In patients taking Symquel XR, urine tests for drug presence performed by some methods may indicate the presence of methadone or certain antidepressant medicines (tricyclic antidepressants), even if the patient is not taking these medicines. It is recommended to perform these tests using other methods to confirm the results.

3. How to take Symquel XR

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. The doctor will determine the initial dose for the patient. The usual maintenance dose is between 150 mg and 800 mg per day, depending on the patient's symptoms and needs.

• The tablets should be taken once a day.
• The tablets should be swallowed whole, with water.
• The tablets should not be divided, chewed, or crushed.
• The tablets should be taken without food (at least 1 hour before a meal or immediately before bedtime, as directed by the doctor).
• The patient should not drink grapefruit juice while taking Symquel XR, as it may affect the action of the medicine.
• The patient should not stop taking the medicine without consulting their doctor, even if they feel better.

Patients with liver function disorders

The doctor may recommend changing the dosage of Symquel XR in patients with liver function disorders.

Elderly patients

The doctor may recommend changing the dosage of Symquel XR in elderly patients.

Use in children and adolescents

Symquel XR should not be used in children and adolescents under the age of 18.

Taking a higher dose of Symquel XR than recommended

If the patient takes a higher dose of Symquel XR than recommended, they may experience drowsiness, dizziness, or irregular heartbeat. The patient should immediately contact their doctor or go to the nearest hospital. The patient should take the packaging of Symquel XR with them.

Missing a dose of Symquel XR

If the patient forgets to take a dose, they should take it as soon as possible. If it is almost time for the next dose, the patient should take the medicine at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping Symquel XR

If the patient suddenly stops taking Symquel XR, they may experience difficulty sleeping, nausea, headache, diarrhea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before stopping treatment. If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Symquel XR can cause side effects, although not everybody gets them.

Very common side effects (occurring in more than 1 in 10 patients):

• dizziness (may lead to falls), headache, and dry mouth;
• drowsiness (may resolve during continued treatment with Symquel XR) (may lead to falls);
• withdrawal symptoms (symptoms that occur after stopping Symquel XR): difficulty sleeping (insomnia), nausea, headache, diarrhea, vomiting, dizziness, and irritability. It is recommended to gradually stop the medicine over a period of 1 to 2 weeks;
• weight gain;
• abnormal movements, including difficulty starting a voluntary movement, tremors, restlessness, or muscle stiffness without pain;
• changes in the levels of certain lipids (triglycerides and total cholesterol).

Common side effects (occurring in less than 1 in 10 patients):

• rapid heartbeat;
• palpitations, rapid or irregular heartbeat;
• constipation, stomach upset (indigestion);
• feeling weak;
• swelling of hands and feet;
• low blood pressure when standing up. This may cause dizziness and fainting, which may lead to falls;
• increased blood sugar levels;
• blurred vision;
• unusual dreams and nightmares;
• increased appetite;
• feeling irritable;
• speech and language disorders;
• suicidal thoughts and worsening depression;
• shallow breathing;
• vomiting (mainly in elderly patients);
• fever;
• changes in thyroid hormone levels in the blood;
• decreased levels of certain types of blood cells;
• increased liver enzyme activity in the blood;
• increased levels of the hormone prolactin in the blood, which may rarely lead to:
• breast swelling and unexpected milk production in men and women;
• absence or irregular menstrual periods in women.

Uncommon side effects (occurring in less than 1 in 100 patients):

• seizures, epileptic fits;
• allergic reactions, including the formation of lumps and skin changes, swelling of the skin and mouth area;
• unpleasant sensations in the lower limbs (also known as restless legs syndrome);
• difficulty swallowing;
• involuntary movements, mainly of the face or tongue;
• sexual disorders;
• diabetes;
• changes in the electrical activity of the heart visible on an ECG (prolonged QT interval);
• slower than normal heartbeat, which may occur at the beginning of treatment and be associated with low blood pressure and fainting;
• difficulty urinating;
• fainting (may lead to falls);
• nasal congestion;
• decreased red blood cell count;
• decreased sodium levels in the blood;
• worsening control of existing diabetes.

Rare side effects (occurring in less than 1 in 1000 patients):

• simultaneous occurrence of high body temperature (fever), sweating, muscle stiffness, or drowsiness (a condition called malignant neuroleptic syndrome);
• yellowing of the skin and eyes (jaundice);
• liver inflammation;
• prolonged and painful erection (priapism);
• breast swelling and unexpected milk production (galactorrhea);
• menstrual disorders;
• blood clots, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, the patient should immediately contact their doctor;
• walking, talking, eating, or performing other activities while sleeping;
• decreased body temperature (hypothermia);
• pancreatitis;
• a condition called metabolic syndrome, in which the patient may experience a combination of three or more of the following symptoms: accumulation of fat in the abdominal area, decreased "good" cholesterol (HDL cholesterol), increased levels of a certain type of fat (triglycerides) in the blood, high blood pressure, and increased blood sugar levels;
• simultaneous occurrence of fever with flu-like symptoms, sore throat, or other infections, with a very low white blood cell count (a condition called agranulocytosis).
• intestinal obstruction;
• increased activity of creatine kinase in the blood (an enzyme produced in muscles).

Very rare side effects (occurring in less than 1 in 10,000 patients):

• severe rash, blisters, or red patches on the skin;
• severe reactions (anaphylactic reaction), which can cause breathing difficulties or shock;
• sudden swelling of the skin, especially around the eyes, lips, and throat (angioedema);
• severe condition characterized by the formation of blisters in the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome);
• abnormal release of the hormone that controls urine volume;
• muscle fiber breakdown and muscle pain (rhabdomyolysis).

Frequency not known (cannot be estimated from available data)

• skin rash with irregular red patches (erythema multiforme). See section 2;
• sudden appearance of areas of red skin with small blisters (acute generalized exanthematous pustulosis (AGEP)). See section 2;
• severe, sudden allergic reaction with symptoms such as fever, rash, and blisters on the skin, and peeling of the skin (toxic epidermal necrolysis). See section 2;
• drug reaction with eosinophilia and systemic symptoms (DRESS). A widespread rash, high fever, increased liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms is also known as DRESS or hypersensitivity syndrome). If the patient experiences these symptoms, they should stop taking Symquel XR and immediately contact their doctor or seek medical attention;
• withdrawal symptoms in newborns whose mothers took Symquel XR during pregnancy;
• stroke;
• heart muscle disorders (cardiomyopathy);
• heart muscle inflammation;
• blood vessel inflammation (vasculitis), often with a skin rash with small, red, or purple spots.

Medicines in the same group as Symquel XR may cause heart rhythm disorders, which can be severe and, in some cases, life-threatening. Some side effects are only visible in blood test results. These include increased levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in the blood, decreased levels of certain types of blood cells, decreased red blood cell count, increased activity of creatine kinase in the blood, decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Increased prolactin levels in the blood may rarely lead to:

• breast swelling and unexpected milk production in men and women;
• absence or irregular menstrual periods in women.

The doctor may recommend regular blood tests.

Side effects in children and adolescents

The same side effects as in adults can also occur in children and adolescents. The following side effects have been observed more frequently in children and adolescents or have not been observed in adults:

Very common side effects (occurring in more than 1 in 10 patients):

• increased levels of the hormone prolactin in the blood, which may rarely lead to:
• breast swelling and unexpected milk production in both boys and girls;
• in girls, it may lead to cessation or irregularity of menstrual periods;
• increased appetite;
• vomiting;
• abnormal movements, including difficulty starting a voluntary movement, tremors, restlessness, or muscle stiffness without pain;
• increased blood pressure.

Common side effects (occurring in less than 1 in 10 patients):

• feeling weak, fainting (may lead to falls);
• nasal congestion;
• feeling irritable.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Symquel XR

• The medicine should be stored out of sight and reach of children.
• The patient should not use this medicine after the expiration date stated on the carton and blister pack after EXP. The expiration date refers to the last day of the month stated.
• The patient should not use this medicine if they notice any visible signs of deterioration.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
• There are no special precautions for storing the medicine.

6. Contents of the packaging and other information

What Symquel XR contains

• The active substance of Symquel XR is quetiapine. Each prolonged-release tablet of Symquel XR contains 50, 200, 300, or 400 mg of quetiapine (in the form of quetiapine fumarate).
• The medicine also contains: Tablet core: lactose monohydrate, hypromellose (K4M), sodium chloride, povidone K30, talc, magnesium stearate. The 50 mg tablets also contain microcrystalline cellulose. Tablet coating: titanium dioxide (E 171), macrogol. The 50 mg tablets also contain polyvinyl alcohol, talc, and iron oxide red (E 172). The 50 mg, 200 mg, and 300 mg tablets contain iron oxide yellow (E 172). The 200 mg, 300 mg, and 400 mg tablets also contain hypromellose 6cP.

What Symquel XR looks like and contents of the pack

Symquel XR prolonged-release tablets, 50 mg: peach-colored, round, biconvex, film-coated tablets with "Q50" embossed on one side and smooth on the other. Symquel XR prolonged-release tablets, 200 mg: yellow, round, biconvex, film-coated tablets with "I2" embossed on one side and smooth on the other. Symquel XR prolonged-release tablets, 300 mg: light yellow, round, biconvex, film-coated tablets with "Q300" embossed on one side and smooth on the other. Symquel XR prolonged-release tablets, 400 mg: white, round, biconvex, film-coated tablets with "I4" embossed on one side and smooth on the other. The packaging contains: 10, 30, 50, 60, and 100 tablets and is registered for all strengths. Not all pack sizes may be marketed.

Marketing authorization holder

Symphar Sp. z o.o., ul. Koszykowa 65, 00-667 Warsaw

Manufacturer/Importer

Terapia S.A., Str. Fabricii nr. 124, Cluj Napoca, Romania; Symphar Sp. z o.o., ul. Chełmżyńska 249, 04-458 Warsaw; Laboratori Fundació Dau, C/ C, 12-14 Pol. Ind. Zona, Franca, 08040 Barcelona, Spain; Elpen Pharmaceutical Co. Inc., Marathonos Ave. 95, Pikermi Attiki, 19009, Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Member State

Marketing authorization holder

Greece: Secuelia XR 50 mg / 200 mg / 300 mg / 400 mg δισκίo παρατεταμένης αποδέσμευσης; Netherlands: Quetiapine Edest 50 mg / 200 mg / 300 mg / 400 mg tabletten met verlengde afgifte; Poland: Symquel XR; Romania: Uniquet 50 mg / 200 mg / 300 mg / 400 mg comprimate cu eliberare prelungită

Date of last revision of the leaflet:July 2024