Package leaflet: Information for the patient

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
Quetiapinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual only. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

What Symquel XR is and what it is used for
What you need to know before taking Symquel XR
How to take Symquel XR
Possible side effects
How to store Symquel XR
Contents of the pack and other information

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

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

depression in bipolar affective disorder or major depressive episodes in major depressive disorder, when the patient experiences profound sadness or despair, feelings of guilt, lack of energy and appetite, or inability to sleep;
mania: when the patient is highly excited, in a state of euphoria, overactive, full of enthusiasm, excessively active, or has impaired critical judgment, including aggressive or destructive behaviors;
schizophrenia: when the patient hears or senses things that do not exist; believes in things that are not true; or is excessively suspicious, anxious, confused, or experiences feelings of guilt, tension, or depression.

If Symquel XR is used to treat major depressive episodes in major depressive disorder, your doctor will recommend taking another medicine for this condition as well. If there is no improvement or if your condition worsens, contact your 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 in the azole group (used for fungal infections);
erythromycin or clarithromycin (used for bacterial infections);
nefazodone (used to treat depression).

If any of the situations listed above apply, do not take Symquel XR. If in any doubt, consult your doctor or pharmacist before taking Symquel XR.

Warnings and precautions

Before starting treatment with Symquel XR, discuss with your doctor, pharmacist, or nurse if:

the patient or a family member has or has had any heart problems, such as irregular heartbeat, weakened heart, 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 previously had a stroke, especially if they are elderly;
the patient has impaired liver function;
the patient has ever had seizures (epilepsy);
the patient has ever had a low white blood cell count (regardless of whether this was caused by taking other medicines or not);
the patient has diabetes or belongs to a group of patients at increased risk of developing diabetes; in this case, the doctor may recommend blood glucose monitoring during treatment with Symquel XR;
the patient or a family member has had blood clots, as use of medicines such as this one is associated with blood clot formation;
the patient is an elderly person with dementia (impaired brain function). Such individuals should not take Symquel XR, as medicines in the same class as Symquel XR may increase the risk of stroke and sometimes 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 involving brief interruptions in breathing during normal sleep at night (so-called sleep apnoea) and is taking medicines that slow down brain function (‘depressants’);
the patient has or has had difficulty completely emptying the bladder (urinary retention), benign prostatic hyperplasia, intestinal obstruction, or increased intraocular pressure. These symptoms may sometimes be caused by medicines (so-called anticholinergic medicines) that affect nerve cell function 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 treated with antidepressant medicines. Taking these medicines together with Symquel XR may lead to the development of serotonin syndrome, a potentially life-threatening condition (see “Symquel XR and other medicines”).

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

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

All of these symptoms may occur during treatment with medicines in this therapeutic class.

Inform your doctor as soon as possible if the patient experiences:

fever, flu-like symptoms, sore throat, or any other infection, as these may be due to 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 have thoughts of self-harm or suicide. This may occur especially at the beginning of treatment with antidepressant medicines, as these medicines usually take about 2 weeks, sometimes longer, to take effect. Suicidal thoughts may increase in patients who suddenly stop taking their medicines.

The likelihood of such thoughts is higher in young adults. Clinical trials have shown an increased risk of suicidal thoughts and/or behaviours in young patients under 25 years of age with depression.

If the patient experiences thoughts of self-harm or suicidal thoughts, contact a doctor immediately or go to hospital. It may be helpful to inform friends and family about the depression and its symptoms, and to ask them to read this leaflet and inform the patient if they notice worsening depression or concerning changes in behaviour.

Severe cutaneous adverse reactions (SCAR)

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

Stevens-Johnson syndrome (SJS), widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genital area;
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 generalized exanthematous pustulosis (AGEP) – small pustules filled with pus;
erythema multiforme (EM) – skin rash with irregular, itchy, red patches.

If the patient experiences any of these symptoms, stop taking Symquel XR immediately and contact the treating doctor or seek medical help without delay.

Weight gain

Patients taking Symquel XR may experience weight gain. Body weight should be monitored regularly, either by the patient or together with the doctor.

Children and adolescents

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

Symquel XR and other medicines

Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.

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

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

Inform your doctor if the patient is taking any of the following medicines:

antiepileptic medicines (such as phenytoin or carbamazepine);
antihypertensive medicines;
barbiturates (medicines used for sleep disorders);
thioridazine or lithium (other antipsychotic medicines);
medicines affecting heart rhythm, for example medicines causing electrolyte disturbances (reducing potassium or magnesium levels), such as diuretics (water tablets) or certain antibiotics (medicines used for infections);
medicines that may cause constipation;
medicines used to treat certain diseases that affect nerve cell function (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 movement muscles, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome). If such symptoms occur, contact your doctor.

Do not stop taking other medicines without consulting your doctor or pharmacist.

Symquel XR with food, drink, and alcohol

Food may affect the medicine’s action; therefore, Symquel XR should be taken at least 1 hour before a meal or immediately before bedtime.
Be cautious with alcohol consumption. Taking Symquel XR together with alcohol may cause drowsiness.
Do not drink grapefruit juice while taking Symquel XR, as it may affect the medicine’s action.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine. Do not take Symquel XR during pregnancy unless advised by a doctor. Symquel XR should not be used during breastfeeding.

Newborns whose mothers have taken Symquel XR during the third trimester of pregnancy (during the last three months of pregnancy) may experience the following symptoms, which may indicate withdrawal: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, feeding problems. If the baby shows any of these symptoms, contact a doctor.

Driving and using machines

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

Symquel XR contains lactose monohydrate

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

Symquel XR contains sodium

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

Effect on urine drug screening tests

In patients taking Symquel XR, urine drug screening tests performed by certain methods may show the presence of methadone or certain antidepressant medicines known as tricyclic antidepressants (TCA), even though the patient is not taking these medicines. It is recommended to use alternative testing methods to confirm the results.

3. How to take Symquel XR

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of
doubt, consult the doctor or pharmacist. The doctor will determine the starting dose for the
patient. The usual maintenance dose ranges from 150 mg to 800 mg per day, depending on the
patient's symptoms and needs.

Take tablets once daily.
Swallow tablets whole with water.
Do not divide, chew, or crush the tablets.
Take tablets on an empty stomach (at least 1 hour before a meal or right before bedtime, as directed by the doctor).
Do not consume grapefruit juice during treatment with Symquel XR. It may affect how the medicine works.
Do not stop treatment without consulting your doctor, even if you feel better.

Patients with liver function impairment
The doctor may recommend adjusting the dosing regimen in patients with impaired liver function.
Elderly patients
The doctor may recommend adjusting the dosing regimen in elderly patients.
Use in children and adolescents
Symquel XR should not be used in children and adolescents under 18 years of age.
Accidental overdose of Symquel XR
If an overdose of Symquel XR is taken, the patient may experience drowsiness, dizziness, or irregular heartbeat. Seek immediate medical attention by contacting a doctor or going to the nearest hospital. Bring the Symquel XR packaging with you.
Missed 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, take the next dose at the regular time. Do not take a double dose to make up for a missed dose.
Stopping Symquel XR
If treatment with Symquel XR is stopped abruptly, difficulty sleeping, nausea, headache, diarrhoea, vomiting, dizziness, or irritability may occur. The 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, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

dizziness (may lead to falls), headache, and dry mouth;
drowsiness (may diminish during continued treatment with Symquel XR) (may lead to falls);
withdrawal symptoms (symptoms occurring after discontinuation of Symquel XR): difficulty falling asleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual discontinuation of the medicine over a period of 1 to 2 weeks is recommended;
weight gain;
abnormal muscle movements, including difficulty initiating intended movement, tremors, motor restlessness, or muscle stiffness without pain;
changes in levels of certain lipids (triglycerides and total cholesterol).

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

increased heart rate;
palpitations, accelerated heartbeat, or irregular heart rhythm;
constipation, stomach discomfort (dyspepsia);
feeling of weakness;
swelling of hands and feet;
low blood pressure upon standing (orthostatic hypotension). This may cause dizziness and fainting, potentially leading to falls;
increased blood sugar levels;
blurred vision;
unusual dreams and nightmares;
increased appetite;
feeling irritable;
speech and language disturbances;
suicidal thoughts and worsening of depression;
shallow breathing;
vomiting (mainly in elderly patients);
fever;
changes in thyroid hormone levels in blood;
decreased number of certain types of blood cells;
increased liver enzyme activity in blood;
increased blood levels of the hormone prolactin, which rarely may lead to:
breast enlargement and unexpected milk production in both men and women;
absence or irregular menstruation in women.

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

seizures, epileptic fits;
allergic reactions, including lumps and skin rashes, skin swelling, and swelling around the mouth;
unpleasant sensations in the lower limbs (also known as restless legs syndrome);
difficulty swallowing;
uncontrolled movements, mainly of facial muscles or tongue;
sexual dysfunction;
diabetes;
changes in the heart's electrical activity visible on ECG (QT interval prolongation);
slower than usual 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;
decreased sodium levels in blood;
worsening of control of pre-existing diabetes.

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

simultaneous occurrence of high body temperature (fever), sweating, muscle stiffness, drowsiness or fainting (disorders known as neuroleptic malignant syndrome);
yellowing of the skin and eyes (jaundice);
hepatitis;
prolonged and painful erection (priapism);
breast enlargement and unexpected milk production (galactorrhea);
menstrual disorders;
blood clots, particularly in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through blood vessels 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 called "metabolic syndrome", in which a patient may have three or more of the following symptoms: accumulation of fat tissue around the abdomen, decreased levels of "good" cholesterol (HDL cholesterol), increased levels of a type of fat (triglycerides) in blood, high blood pressure, and increased blood sugar levels;
simultaneous occurrence of fever with flu-like symptoms, sore throat or other infection, and very low number of white blood cells (a condition known as agranulocytosis);
intestinal obstruction;
increased blood levels of creatine kinase (an enzyme produced, among others, in muscles).

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

severe rash, blisters, or red spots on the skin;
severe reactions (so-called anaphylactic reaction), which may cause breathing difficulties or shock;
sudden swelling of the skin, especially around the eyes, lips, and throat (angioedema);
severe condition with blister formation on the skin, inside the mouth, eyes, and genital organs (Stevens-Johnson syndrome);
abnormal secretion of the hormone regulating urine volume;
breakdown of muscle fibres 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 red skin areas with small blisters (small blisters filled with whitish-yellow fluid known as acute generalised exanthematous pustulosis (AGEP). See section 2;
severe, sudden allergic reaction with symptoms such as fever, rash, and blisters on the skin, and skin peeling (toxic epidermal necrolysis). See section 2;
rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (rash with eosinophilia and systemic symptoms is also known as DRESS or drug hypersensitivity syndrome). If a patient experiences these symptoms, treatment with Symquel XR should be discontinued and the patient should immediately contact their doctor or seek medical help;
withdrawal symptoms in newborns of mothers who took Symquel XR during 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 Symquel XR belongs may cause heart rhythm disturbances, which can be severe and, in some cases, may lead to death.

Some side effects are detectable only through blood tests. These include: increased levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in blood, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase activity (an enzyme present in muscles), decreased sodium levels in blood, and increased blood prolactin levels. Increased blood prolactin levels may, in rare cases, lead to:

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

Your doctor may recommend periodic blood tests.

Side effects in children and adolescents

The same side effects as in adults may also occur in children and adolescents.

The following side effects have been observed more frequently in children and adolescents or were not reported in adults:

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

increased levels of a hormone called prolactin in blood, which may in rare cases lead to:
breast enlargement and unexpected milk production in both boys and girls;
in girls, menstrual periods may stop or occur irregularly;
increased appetite;
vomiting;
abnormal muscle movements, including difficulty performing movements, tremors, restlessness, or muscle stiffness without accompanying pain;
increased blood pressure.

Common side effects (may occur in fewer than 1 in 10 people):

feeling of weakness, fainting (may lead to falls);
nasal congestion;
feeling irritable.

Reporting of side effects

If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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 authorisation holder.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Symquel XR

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on the blister pack after EXP. The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
No special storage instructions apply for this medicine.

6. Contents of the pack and other information

What Symquel XR contains

The active substance is quetiapine. Each prolonged-release tablet of Symquel XR contains 50, 200, 300, or 400 mg of quetiapine (as quetiapine fumarate).
Other ingredients are:
Tablet core: Lactose monohydrate, hypromellose (K4M), sodium chloride, povidone K30, talc, magnesium stearate. Tablets of 50 mg also contain colloidal anhydrous silica and microcrystalline cellulose.
Tablet coating: Titanium dioxide (E 171), macrogol. Additionally, 50 mg tablets contain polyvinyl alcohol, talc, and iron oxide red (E 172). Tablets of 50 mg, 200 mg, and 300 mg contain iron oxide yellow (E 172). Tablets of 200 mg, 300 mg, and 400 mg also contain hypromellose 6cP.

What Symquel XR prolonged-release tablets look 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.
Pack sizes containing 10, 30, 50, 60, and 100 tablets are registered for all strengths. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Symphar Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
Poland

Manufacturer/Importer
Terapia S.A.
Str. Fabricii nr. 124, Cluj Napoca,
Romania
Symphar Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

| Country | Name of the medicinal product | |-------------|-------------------------------------| | Greece | Secuelia XR 50 mg / 200 mg / 300 mg / 400 mg prolonged-release tablet | | Netherlands | Quetiapine Edest 50 mg / 200 mg / 300 mg / 400 mg prolonged-release tablets | | Poland | Symquel XR | | Romania | Uniquet 50 mg / 200 mg / 300 mg / 400 mg prolonged-release tablets |

Symquel xr