Patient Information Leaflet: Information for the User

Seroquel 50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets

quetiapine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Seroquel prolonged-release tablets are and what they are used for
What you need to know before taking Seroquel prolonged-release tablets
How to take Seroquel prolonged-release tablets
Possible side effects
How to store Seroquel prolonged-release tablets
Contents of the pack and other information

1. What Seroquel prolonged-release tablets are and what they are used for

Seroquel prolonged-release tablets contain a substance called quetiapine. This substance
belongs to a group of medicines known as antipsychotics. Seroquel prolonged-release tablets
can be used to treat several conditions, such as the following:

Bipolar depression and major depressive episodes associated with major depressive disorder: you may feel sad or depressed, guilty, without energy, with loss of appetite or difficulty sleeping.
Mania: you may feel highly excited, euphoric, restless, enthusiastic or hyperactive, or have poor judgment, including aggressive or destructive behaviour.
Schizophrenia: you may experience hearing or sensing things that are not actually present, believe things that are not true, or feel unusually suspicious, anxious, confused, guilty, tense or depressed.

When Seroquel prolonged-release tablets are taken to treat major depressive episodes associated with major depressive disorder, they must be used in addition to another medicine indicated for the treatment of this condition.
Your doctor may continue to prescribe Seroquel prolonged-release tablets even after you start feeling better.

2. What you should know before taking Seroquel prolonged-release tablets

Do not take Seroquel prolonged-release tablets:

if you are allergic to quetiapine or to 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
- azole antifungals (for fungal infections)
- erythromycin or clarithromycin (for infections)
- nefazodone (for depression)

If you have any doubts, consult your doctor or pharmacist before taking Seroquel prolonged-release tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Seroquel prolonged-release tablets:

if you or someone in your family has or has previously had heart problems, such as irregular heartbeat, weakened heart muscle, or inflammation of the heart, or if you are taking medicines that may affect your heartbeat.
if your blood pressure is low.
if you have had a stroke, especially if you are elderly.
if you have liver problems.
if you have had seizures (epileptic fits).
if you have diabetes or are at risk of developing diabetes. In this case, your doctor may monitor your blood sugar levels while you are taking Seroquel prolonged-release tablets.
if you know you have previously had low levels of white blood cells in your blood (whether caused by medicines or not).
if you are an elderly person with dementia (loss of some brain functions). In this case, you should not take Seroquel prolonged-release tablets, as this class of medicines, to which Seroquel prolonged-release tablets belong, may increase the risk of stroke or, in some cases, the risk of death in elderly patients with dementia.
if you are an elderly person with Parkinson’s disease/parkinsonism.
if you or someone in your family has a history of conditions related to blood clots, as medicines of this type may increase the risk of blood clot formation.
if you have or have previously had a condition (called "sleep apnea") in which you stop breathing for short periods during normal sleep and are taking medicines that slow down normal brain activity ("depressants").
if you have or have previously had a condition in which you are unable to empty your bladder completely (urinary retention), have an enlarged prostate, intestinal blockage, or increased pressure inside the eye. These conditions may sometimes be caused by medicines (called "anticholinergics") that affect how nerve cells function and are used to treat certain medical conditions.
if you have a history of alcohol or drug abuse.
if you suffer from depression or other conditions treated with antidepressants. Taking these medicines together with Seroquel prolonged-release tablets may lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Seroquel prolonged-release tablets").

Inform your doctor immediately if you experience any of the following symptoms after taking
Seroquel prolonged-release tablets:

Fever associated with severe muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be required.
Uncontrollable movements, mainly of the face or tongue.
Dizziness or a strong feeling of drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
Seizures (epileptic fits).
Persistent and painful erection (Priapism).
Rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor should check your heart and, if necessary, refer you immediately to a cardiologist.

The following conditions may be caused by the type of medicine you are taking.
Inform your doctor as soon as possible if you experience:

Fever, flu-like symptoms, sore throat, or any other infection, as these could be signs of a very low white blood cell count, which may require discontinuation of Seroquel prolonged-release tablets and/or additional treatment.
Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as these may lead to a more serious intestinal blockage.
Suicidal thoughts and worsening depression. If you are depressed, you may sometimes feel the need to harm yourself or to kill yourself. These feelings may be stronger at the beginning of treatment, as these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also worsen if you suddenly stop taking the medicine. You are more likely to experience such feelings if you are a young adult. Data from clinical trials have shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults with depression under the age of 25.

If at any time you notice that you are having thoughts of self-harm or suicide,
contact your doctor or go to the hospital immediately. You may find it helpful to inform a family member
or close friend that you suffer from depression, and ask them to read this leaflet.
You may ask them to alert you if they think your depression is worsening or if they are concerned about
any changes in your behaviour.
Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions (SCARs), which may be potentially life-threatening or fatal, have
been reported very rarely during treatment with this medicine. These commonly include:

Stevens-Johnson syndrome (SJS), a widespread skin rash with blisters and peeling of the skin, 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), characterised by flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes)
Acute Generalized Exanthematous Pustulosis (AGEP), small pustules filled with pus
Erythema multiforme (EM), a skin rash with irregular red, itchy patches

Stop using Seroquel prolonged-release tablets if you develop any of these symptoms and contact your
doctor or seek immediate medical help.
Weight gain
Weight gain has been reported in patients treated with Seroquel prolonged-release tablets. It is important that your body weight is monitored regularly by both you and your doctor.
Children and adolescents
Seroquel prolonged-release tablets must not be used in children and adolescents under 18 years of age.
Other medicines and Seroquel prolonged-release tablets
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Do not take Seroquel prolonged-release tablets if you are taking any of the following medicines:

Certain medicines for HIV.
Azole antifungals (for fungal infections).
Erythromycin or clarithromycin (for infections).
Nefazodone (for depression).

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

Medicines for epilepsy (such as phenytoin or carbamazepine).
Medicines for high blood pressure.
Barbiturates (for sleep disorders).
Thioridazine or lithium (other antipsychotic medicines).
Medicines that affect heart rhythm, for example, medicines that may cause an electrolyte imbalance (low levels of potassium or magnesium) such as diuretics (pills that increase urine production) or certain antibiotics (medicines for treating infections).
Medicines that may cause constipation.
Medicines (called "anticholinergics") that affect how nerve cells function and are used to treat certain medical conditions.
Antidepressants. These medicines may interact with Seroquel prolonged-release tablets and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38°C (serotonin syndrome). Consult your doctor if you experience these symptoms.

Do not stop taking any medicine without first discussing it with your doctor.
Seroquel prolonged-release tablets with food, drinks and alcohol

The effect of Seroquel prolonged-release tablets may be influenced by food; therefore, you should take the tablets at least one hour before a meal or before going to sleep.
Be cautious about the amount of alcohol you consume. This is important because the combined effect of Seroquel prolonged-release tablets and alcohol may increase drowsiness.
Do not drink grapefruit juice while taking Seroquel prolonged-release tablets, as it may affect the action of the medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor before taking this medicine.
You must not take Seroquel prolonged-release tablets during pregnancy without first discussing it with
your doctor. Seroquel prolonged-release tablets must not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, have been observed in newborns of mothers who took Seroquel during the third trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.
Driving and using machines
The tablets may cause drowsiness. Do not drive or operate any tools or machinery until you know how the tablets affect you.
Seroquel prolonged-release tablets contain lactose
Seroquel prolonged-release tablets contain lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Seroquel prolonged-release tablets contain sodium
Seroquel 50 mg prolonged-release tablets, Seroquel 150 mg prolonged-release tablets, and Seroquel 200 mg prolonged-release tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".
Seroquel 300 mg prolonged-release tablets and Seroquel 400 mg prolonged-release tablets contain 27 mg of sodium (the main component of table salt) per tablet. This corresponds to 1.35% of the maximum daily dietary intake recommended for an adult.
Effect on urine drug screening tests
If you are undergoing a urine drug screening test, taking Seroquel may lead to false-positive results for methadone or certain antidepressant medicines called tricyclic antidepressants (TCA) when certain testing methods are used, even if you are not taking methadone or TCAs. If this occurs, more specific tests should be performed.

3. How to take Seroquel prolonged-release tablets

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor will decide the most appropriate starting dose for you. The maintenance dose (daily dose) will depend on the type of illness and your individual needs, but is usually between 150 mg and 800 mg.

You must take the tablets once daily.
The tablets must not be split, chewed, or crushed.
You must swallow the tablets whole, with a glass of water.
Take the tablets away from meals (at least one hour before a meal or at bedtime; your doctor will advise you on the appropriate time).
Do not drink grapefruit juice while taking Seroquel prolonged-release tablets, as it may affect the medicine's action.
Do not stop taking the tablets even if you feel better, unless your doctor tells you otherwise.

Liver problems
If you have liver problems, your doctor may adjust your dose.
Elderly
If you are elderly, your doctor may adjust your dose.
Use in children and adolescents
Seroquel prolonged-release tablets must not be used in children and adolescents under 18 years of age.
If you take more Seroquel prolonged-release tablets than you should
If you take more Seroquel prolonged-release tablets than prescribed, you may feel drowsy, experience dizziness, or notice an abnormal heartbeat. Contact your doctor or the nearest hospital immediately, and take the Seroquel prolonged-release pack with you.
If you forget to take Seroquel prolonged-release tablets
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait and take the next dose at the scheduled time. Do not take a double dose to make up for the missed tablet.
If you stop taking Seroquel prolonged-release tablets
If you suddenly stop treatment with Seroquel prolonged-release tablets, you may experience difficulty sleeping (insomnia), feel unwell (nausea), or develop headache, diarrhoea, malaise (vomiting), dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Very common: may affect more than 1 in 10 people

Dizziness (which may cause falls), headache, dry mouth.
Drowsiness (which fades over time as treatment with Seroquel continues) (may lead to falls).
Withdrawal symptoms (symptoms occurring when you stop taking Seroquel), including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual discontinuation of the medicine over a period of at least 1 to 2 weeks is recommended.
Increase in body weight.
Abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling of restlessness, or painless muscle stiffness.
Changes in the levels of certain fats (triglycerides and total cholesterol) in the blood.

Common: may affect up to 1 in 10 people

Fast heartbeat.
Sensation of rapid or forceful heartbeat, or awareness of irregular heartbeats.
Constipation, stomach discomfort (indigestion).
Feeling of weakness.
Swelling of arms or legs.
Low blood pressure upon standing (orthostatic hypotension). This may cause dizziness or fainting (which may lead to falls).
Increased blood sugar levels.
Blurred vision.
Abnormal dreams and nightmares.
Increased feeling of hunger.
Irritability.
Speech and language disturbances.
Suicidal thoughts and worsening of depression.
Shortness of breath (dyspnoea).
Vomiting (especially in elderly patients).
Fever.
Changes in levels of thyroid hormones in the blood.
Decreased number of certain types of blood cells.
Increased levels of liver enzymes in the blood.
Increased levels of the hormone prolactin in the blood. Elevated prolactin levels may, in rare cases, lead to the following:
o Breast enlargement and unexpected production of breast milk in both men and women.
o Absence or irregularity of menstrual cycles in women.

Uncommon: may affect up to 1 in 100 people

Seizures or epileptic fits.
Allergic reactions including swelling (hives), skin swelling, and swelling around the mouth.
Unpleasant sensations in the legs (also known as restless legs syndrome).
Difficulty swallowing.
Uncontrollable movements, mainly of the face or tongue.
Sexual dysfunction.
Diabetes.
Changes in the heart's electrical activity seen on ECG (prolongation of QT interval).
Slowing of the normal heart rate may occur when starting 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 (anaemia).
Reduced sodium levels in the blood.
Worsening of pre-existing diabetes.
Confusion.

Rare: may affect up to 1 in 1,000 people

High body temperature (fever) associated with sweating, muscle stiffness, marked drowsiness or fainting (a condition called "neuroleptic malignant syndrome").
Yellowing of the skin and eyes (jaundice).
Inflammation of the liver (hepatitis).
Prolonged and painful erection (priapism).
Breast enlargement and unexpected milk production from the mammary gland (galactorrhoea).
Menstrual disorders.
Blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, contact your doctor immediately.
Sleepwalking and other related events (such as sleep-talking and sleep-related eating disorders).
Decreased body temperature (hypothermia).
Inflammation of the pancreas.
A condition (called "metabolic syndrome") in which you may have a combination of 3 or more of the following symptoms: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a blood fat called triglycerides, high blood pressure, and increased blood sugar levels.
Combination of fever, flu-like symptoms, sore throat or other infections with a very low white blood cell count, a condition known as agranulocytosis.
Intestinal obstruction.
Increased blood levels of creatine phosphokinase (a substance from muscles).

Very rare: may affect up to 1 in 10,000 people

Severe skin rash, blisters or red patches on the skin.
Severe allergic reaction (called anaphylaxis) which may cause breathing difficulties or shock.
Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).
Severe condition characterised by blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome). See section 2.
Inappropriate secretion of the hormone controlling urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
Muscle fibre damage and muscle pain (rhabdomyolysis).

Not known: frequency cannot be estimated from the available data

Skin rash associated with appearance of irregular red patches (erythema multiforme). See section 2.
Rapid appearance of red, inflamed skin areas with small pustules (small blisters filled with white/yellow fluid called Acute Generalized Exanthematous Pustulosis (AGEP)). See section 2.
Sudden, severe allergic reaction with symptoms such as fever, blistering of the skin and skin peeling (toxic epidermal necrolysis). See section 2.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), consisting of flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased white blood cells (eosinophilia) and increased liver enzymes). See section 2.
Withdrawal symptoms may occur in newborns of mothers who have used Seroquel prolonged-release tablets during pregnancy.
Stroke.
Heart muscle disorder (cardiomyopathy).
Inflammation of the heart muscle (myocarditis).
Inflammation of blood vessels (vasculitis), often with a rash showing small red or purple bumps.

The class of medicines to which Seroquel prolonged-release tablets belong may cause problems with heart rhythm, which can be serious and, in some cases, fatal.

Some side effects are detectable only through blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in blood levels of thyroid hormones, increased liver enzymes, decreased number of certain blood cells, reduced number of red blood cells, increased serum creatine phosphokinase (a substance found in muscles), reduced sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Increased levels of prolactin hormone may, in rare cases, lead to the following consequences:

Breast enlargement and unexpected milk production from the mammary gland in both men and women.
Absence or irregularity of menstrual cycles in women.

Your doctor will therefore prescribe periodic blood tests.

Additional side effects in children and adolescents

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

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

Very common: may affect more than 1 in 10 people

Increased blood levels of a hormone called prolactin. In rare cases, these increased prolactin levels may cause the following conditions:
o Breast enlargement and unexpected milk production from the mammary gland in boys and girls.
o Absence or irregularity of menstrual cycles in girls.
Increased appetite.
Vomiting.
Abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling of restlessness, or painless muscle stiffness.
Increased blood pressure.

Common: may affect up to 1 in 10 people

Weakness, fainting (may lead to falls).
Nasal congestion.
Irritability.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Seroquel prolonged-release tablets

Keep this medicine out of the sight and reach of children.
Do not use Seroquel prolonged-release tablets after the expiry date stated on the
pack after the abbreviation EXP. The expiry date refers to the last day of that
month.
Seroquel prolonged-release tablets do not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Seroquel prolonged-release tablets contain
The active substance is quetiapine. Seroquel prolonged-release tablets contain 50 mg, 150 mg,
200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
The other components are:
Tablet core: microcrystalline cellulose, sodium citrate, lactose monohydrate, magnesium
stearate, hypromellose.
Tablet coating: hypromellose, macrogol, titanium dioxide (E171).
The 50 mg, 200 mg and 300 mg tablets also contain yellow iron oxide (E172), and the
50 mg tablets additionally contain red iron oxide (E172).

Description of the appearance of Seroquel prolonged-release tablets and package contents
All prolonged-release tablets are oval-shaped and marked with the inscription "XR" and the dosage strength. The 50 mg tablets are peach-coloured; the 150 mg tablets are white; the 200 mg tablets are yellow; the 300 mg tablets are light yellow; and the 400 mg tablets are white.
Pack sizes containing 10, 30, 60, 60x1, 100 and 100x1 tablets are registered for all strengths. Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturers
AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire
SK10 2NA
United Kingdom
AstraZeneca AB
Gärtunavägen
Södertälje 151 85
Sweden
Klocke Pharma-Service GmbH
Straßburger Str. 77
77767 Appenweier
Germany
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany

This medicinal product is authorised in the European Economic Area Member States under the following trade names:

| COUNTRY | TRADE NAME | |---------|------------| | Austria | Seroquel XR | | Belgium | Seroquel XR | | Croatia | Seroquel XR | | Cyprus | Seroquel XR | | Denmark | Seroquel Prolong | | Estonia | Seroquel XR | | Finland | Seroquel Prolong | | France | Xeroquel LP | | Germany | Seroquel Prolong®50 mg Retardtabletten,
Seroquel Prolong®150 mg Retardtabletten,
Seroquel Prolong®200 mg Retardtabletten,
Seroquel Prolong®300 mg Retardtabletten,
Seroquel Prolong®400 mg Retardtabletten | | Greece | Seroquel XR | | Hungary | Seroquel XR | | Iceland | Seroquel Prolong | | Ireland | Seroquel XR | | Italy | Seroquel compresse a rilascio prolungato | | Latvia | Seroquel XR | | Lithuania | Seroquel XR | | Luxembourg | Seroquel XR | | Netherlands | Seroquel XR
Quetiapine XR AstraZeneca | | Norway | Seroquel Depot | | Portugal | Seroquel SR | | Slovakia | Seroquel XR | | Slovenia | Seroquel SR | | Spain | Seroquel Prolong | | Sweden | Seroquel Depot | | United Kingdom | Seroquel XL |

PACKAGE LEAFLET

Package leaflet: information for the user

Seroquel 25 mg, 100 mg, 200 mg, 300 mg film-coated tablets

quetiapine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Seroquel film-coated tablets are and what they are used for
What you need to know before taking Seroquel film-coated tablets
How to take Seroquel film-coated tablets
Possible side effects
How to store Seroquel film-coated tablets
Contents of the pack and other information

1. What Seroquel film-coated tablets are and what they are used for

Seroquel film-coated tablets contain a substance called quetiapine. This substance
belongs to a group of medicines known as antipsychotics. Seroquel film-coated tablets
may be used to treat several conditions, such as the following:

Bipolar depression: you may feel sad, depressed, guilty, lacking energy, with reduced appetite or difficulty sleeping.
Mania: you may feel highly excited, euphoric, agitated, enthusiastic or hyperactive, or have poor judgment, including aggressive or destructive behaviour.
Schizophrenia: you may experience sensations of hearing or seeing things that are not actually present, believe things that are not true, or feel unusually suspicious, anxious, confused, guilty, tense or depressed. Your doctor may continue to prescribe Seroquel film-coated tablets even if you are feeling better.

2. What you should know before taking Seroquel film-coated tablets

Do not take Seroquel film-coated tablets:

if you are allergic to quetiapine or to 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 virus
- azole antifungals (for fungal infections)
- erythromycin or clarithromycin (for infections)
- nefazodone (for depression). If in doubt, consult your doctor or pharmacist before taking Seroquel film-coated tablets.

Warnings and precautions
Talk to your doctor or pharmacist before taking Seroquel film-coated tablets:

if you or someone in your family has or has previously had heart problems, such as irregular heartbeat, weakened heart muscle, or inflammation of the heart, or if you are taking medicines that may affect your heartbeat.
if your blood pressure is low.
if you have had a stroke, especially if you are elderly.
if you have liver problems.
if you have had seizures (epileptic fits).
if you have diabetes or are at risk of developing diabetes. In this case, your doctor may monitor your blood sugar levels while you are taking Seroquel film-coated tablets.
if you know you have previously had low levels of white blood cells in your blood (whether caused by medicines or not).
if you are an elderly person with dementia (loss of some brain functions). In this case, you should not take Seroquel film-coated tablets, as this class of medicines to which Seroquel belongs may increase the risk of stroke, or in some cases the risk of death in elderly patients with dementia.
if you are an elderly person with Parkinson’s disease/parkinsonism.
if you or someone in your family has a history of blood clotting disorders, as medicines of this type may increase the risk of blood clots.
if you have or have previously had a condition (called “sleep apnea”) where you stop breathing for short periods during normal nighttime sleep, and you are taking medicines that slow down normal brain activity (“depressants”).
if you have or have previously had a condition where you are unable to empty your bladder completely (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside the eye. These conditions may sometimes be caused by medicines (called “anticholinergics”) that affect how nerve cells function and are used to treat certain medical conditions.
if you have a history of alcohol or drug abuse.
if you suffer from depression or other conditions treated with antidepressants. The use of these medicines together with Seroquel film-coated tablets may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Seroquel film-coated tablets”). Inform your doctor immediately if you experience any of the following symptoms after taking Seroquel film-coated tablets:
Fever associated with severe muscle stiffness, sweating, or decreased level of consciousness (a condition called “neuroleptic malignant syndrome”). Immediate medical treatment may be required.
Uncontrollable movements, mainly of the face or tongue.
Dizziness or a strong feeling of drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
Seizures (epileptic fits).
Persistent and painful erection (priapism).
Rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor will need to check your heart and, if necessary, refer you immediately to a cardiologist. The following conditions may be caused by the type of medicine you are taking. Inform your doctor as soon as possible if you experience:
Fever, flu-like symptoms, sore throat, or any other infection, as these may be signs of a very low white blood cell count, which may require discontinuation of Seroquel and/or additional treatment.
Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as these may lead to a more serious intestinal blockage.
Suicidal thoughts and worsening depression If you are depressed, you may sometimes feel the urge to harm yourself or commit suicide. These feelings may be stronger at the beginning of treatment, as these medicines take time to work, usually about two weeks but sometimes longer. These thoughts may also intensify if you suddenly stop taking the medicine. You are more likely to experience such feelings if you are a young adult. Clinical trial data have shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults with depression under 25 years of age. If at any time you notice having thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately. You may find it helpful

to inform a relative or close friend that you suffer from depression and ask them to read
this leaflet. You may ask them to alert you if they think your depression is worsening or if they are concerned about any changes in your
behaviour.
Serious skin adverse reactions (SCARs)
Serious skin adverse reactions (SCARs), which may be potentially fatal, have been reported very rarely during treatment with this medicine. These commonly include:

Stevens-Johnson syndrome (SJS), a widespread rash with blisters and skin peeling, 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), consisting of flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes)
Acute Generalized Exanthematous Pustulosis (AGEP), small pustules filled with pus
Erythema multiforme (EM), a rash with irregular red, itchy spots Discontinue Seroquel if you develop any of these symptoms and contact your doctor or seek immediate medical attention. Weight gain Weight gain has been reported in patients treated with Seroquel film-coated tablets. Your body weight should be monitored regularly by you and your doctor. Children and adolescents Seroquel must not be used in children and adolescents under 18 years of age.

Other medicines and Seroquel film-coated tablets
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Do not take Seroquel film-coated tablets if you are taking any of the following medicines:

Certain medicines for HIV virus.
Azole antifungals (for fungal infections).
Erythromycin or clarithromycin (for infections).
Nefazodone (for depression). Inform your doctor if you are taking any of the following medicines:
Medicines for epilepsy (such as phenytoin or carbamazepine).
Medicines for high blood pressure.
Barbiturates (for sleep disorders).
Thioridazine or Lithium (other antipsychotic medicines).
Medicines that affect heart rhythm, for example medicines that may cause electrolyte imbalance (low levels of potassium or magnesium), such as diuretics (pills that increase urine production) or certain antibiotics (medicines for treating infections).
Medicines that may cause constipation.
Medicines (called “anticholinergics”) that affect how nerve cells function and are used to treat certain medical conditions.
Antidepressants. These medicines may interact with Seroquel film-coated tablets and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38°C (serotonin syndrome). Consult your doctor if you experience these symptoms.

Do not stop taking any medicine without first discussing it with your doctor.
Seroquel film-coated tablets with food, drinks and alcohol

Seroquel can be taken regardless of meals.
Be cautious about the amount of alcohol you consume. This is important because the combined effect of Seroquel and alcohol may increase drowsiness.
Do not drink grapefruit juice while taking Seroquel, as it may affect the medicine’s action.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. You should not take Seroquel during pregnancy without first discussing it with your doctor. Seroquel must not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, have been observed in newborns of mothers who took Seroquel film-coated tablets during the third trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.
Driving and using machines
The tablets may cause drowsiness. Do not drive or operate any tools or machinery until you know how the tablets affect you.
Seroquel contains lactose
Seroquel film-coated tablets contain lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Seroquel contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
Effect on urine screening tests
If you need to undergo a urine screening test, taking Seroquel may lead to false-positive results for methadone or certain antidepressants called tricyclic antidepressants (TCA), when certain testing methods are used, even if you are not taking methadone or TCAs. In such cases, more specific tests should be performed.

3. How to take Seroquel film-coated tablets

Take this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist. Your doctor will decide the most appropriate starting dose for you. The maintenance dose (daily dose) will depend on the type of illness and individual needs, but is usually between 150 mg and 800 mg.

You will take the tablets either once daily, in the evening before going to bed, or twice daily, depending on the type of condition.
Swallow the tablets whole with a glass of water.
You may take the tablets regardless of meals.
Do not drink grapefruit juice while taking Seroquel, as it may affect the medicine's action.
Do not stop taking the tablets even if you feel better, unless your doctor tells you it is safe to do so.

Liver problems
If you have liver problems, your doctor may adjust your dose.

Elderly
If you are elderly, your doctor may adjust your dose.

Use in children and adolescents
Seroquel must not be used in children and adolescents under 18 years of age.

If you take more Seroquel film-coated tablets than you should
If you take more Seroquel than prescribed by your doctor, you may feel drowsy, experience dizziness, or notice an abnormal heartbeat. Contact your doctor or the nearest hospital immediately, and take the Seroquel packaging with you.

If you forget to take Seroquel film-coated tablets
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait and take the next dose at the scheduled time. Do not take a double dose to make up for the missed tablet.

If you stop taking Seroquel film-coated tablets
If you stop treatment with Seroquel suddenly, you may have difficulty sleeping (insomnia), feel unwell (nausea), or experience headache, diarrhoea, malaise (vomiting), dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 people

Dizziness (which may lead to falls), headache, dry mouth.
Drowsiness (which may disappear over time while continuing treatment with Seroquel) (this may lead to falls).
Withdrawal symptoms (symptoms that occur when you stop taking Seroquel), including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual discontinuation of the medicine over a period of at least 1 or 2 weeks is recommended.
Increase in body weight.
Abnormal muscle movements, including difficulty initiating muscle movement, tremor, restlessness, or muscle stiffness without pain.
Changes in the levels of certain blood fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

Fast heartbeat.
Sensation of rapid or pounding heartbeat, or awareness of heartbeats (palpitations).
Constipation, stomach discomfort (indigestion).
Feeling of weakness.
Swelling of the arms or legs.
Low blood pressure when standing up. This may cause dizziness or fainting (which may lead to falls).
Increased blood sugar levels.
Blurred vision.
Abnormal dreams and nightmares.
Increased feeling of hunger.
Irritability.
Speech and language disorders.
Suicidal thoughts and worsening of depression.
Shortness of breath.
Vomiting (especially in elderly patients).
Fever.
Changes in the levels of thyroid hormones in the blood.
Decreased number of certain types of blood cells.
Increased levels of liver enzymes in the blood.
Increased levels of the hormone prolactin in the blood. Elevated prolactin levels may, in rare cases, lead to the following:

o Breast enlargement and unexpected milk production in both men and women.
o Women may experience absent or irregular menstrual cycles.

Uncommon: may affect up to 1 in 100 people

Seizures or epileptic fits.
Allergic reactions including swelling (hives), skin swelling, and swelling around the mouth.
Unpleasant sensation in the legs (also known as restless legs syndrome).
Difficulty swallowing.
Uncontrollable movements, mainly of the face or tongue.
Sexual dysfunction.
Diabetes.
Changes in the heart's electrical activity seen on ECG (prolongation of the QT interval).
A slowing of the normal heart rate may occur when starting treatment and may be associated with low blood pressure and fainting.
Difficulty urinating.
Fainting (may lead to falls).
Nasal congestion.
Reduction in the number of red blood cells in the blood.
Reduction in the amount of sodium in the blood.
Worsening of pre-existing diabetes.
Confusion.

Rare: may affect up to 1 in 1,000 people

High body temperature (fever) associated with sweating, muscle stiffness, marked drowsiness or fainting (a condition called "neuroleptic malignant syndrome").
Yellowing of the skin and eyes (jaundice).
Inflammation of the liver (hepatitis).
Prolonged and painful erection (priapism).
Breast enlargement and unexpected milk production from the mammary gland (galactorrhoea).
Menstrual disorders.
Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, contact your doctor immediately.
Sleepwalking and other related events (such as talking during sleep and sleep-related eating disorders).
Decrease in body temperature (hypothermia).
Inflammation of the pancreas.
A condition (called "metabolic syndrome") in which you may have a combination of 3 or more of the following symptoms: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a blood fat called triglycerides, high blood pressure, and increased blood sugar levels.
Combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count, a condition known as agranulocytosis.
Intestinal obstruction.
Increased blood levels of creatine phosphokinase (a substance from muscles).

Very rare: may affect up to 1 in 10,000 people

Severe skin rash, blisters, or red patches on the skin.
Severe allergic reaction (called anaphylaxis), which may cause breathing difficulties or shock.
Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
Severe condition characterized by blister formation on the skin, in the mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
Inappropriate secretion of the hormone that controls urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
Damage to muscle fibres and muscle pain (rhabdomyolysis).

Not known: frequency cannot be estimated from the available data

Skin rash associated with the appearance of irregular red patches (erythema multiforme). See section 2.
Rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid called acute generalised exanthematous pustulosis (AGEP)). See section 2.
Sudden severe allergic reaction with symptoms such as fever, blistering of the skin, and skin peeling (toxic epidermal necrolysis). See section 2.
Drug reaction with Eosinophilia and Systemic Symptoms (DRESS), consisting of flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and increased liver enzymes). See section 2.
Withdrawal symptoms may occur in newborns of mothers who have used Seroquel during pregnancy.
Stroke.
Heart muscle disorder (cardiomyopathy).
Inflammation of the heart muscle (myocarditis).
Inflammation of blood vessels (vasculitis), often with a skin rash showing small red or purple raised spots.

The class of medicines to which Seroquel belongs can cause problems with heart rhythm, which may be serious and, in some cases, fatal.

Some side effects can only be detected through blood tests. These include changes in the levels of certain blood fats (triglycerides and total cholesterol) or blood sugar, changes in blood levels of thyroid hormones, increased liver enzymes, decreased number of certain types of blood cells, reduced number of red blood cells, increased serum creatine phosphokinase (a substance found in muscles), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood.

Elevated levels of prolactin hormone may, in rare cases, lead to the following consequences:

Breast enlargement and unexpected milk production from the mammary gland in both men and women.
Absence or irregularity of menstrual cycle in women.

Your doctor will therefore prescribe periodic blood tests.

Additional side effects in children and adolescents:
The same side effects observed in adults may also occur in children and adolescents. The following side effects have been reported more frequently in children and adolescents, or were not reported in adults:

Very common: may affect more than 1 in 10 people

Increased blood levels of a hormone called prolactin. In rare cases, these increased prolactin levels may cause the following conditions:
o Breast enlargement and unexpected milk production from the mammary gland in boys and girls
o Absence or irregularity of menstrual cycle in girls
Increased appetite
Vomiting
Abnormal muscle movements, including difficulty initiating muscle movement, tremor, restlessness, or muscle stiffness without pain.
Increased blood pressure.

Common: may affect up to 1 in 10 people

Weakness, fainting (may lead to falls).
Nasal congestion.
Irritability.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Seroquel film-coated tablets

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 packaging after the abbreviation EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Seroquel film-coated tablets contain

The active substance is quetiapine. Seroquel film-coated tablets contain 25 mg, 100 mg, 200 mg, or 300 mg of quetiapine (as quetiapine fumarate).
The other ingredients are: Tablet core: povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate type A, lactose monohydrate, magnesium stearate.
Film coating: hypromellose, macrogol, titanium dioxide (E171). The 25 mg and 100 mg tablets also contain yellow iron oxide (E172), and the 25 mg tablets additionally contain red iron oxide (E172).

Description of the appearance of Seroquel film-coated tablets and pack contents
Seroquel 25 mg film-coated tablets are peach-coloured, round, biconvex tablets with the imprint
“SEROQUEL 25” on one side.
Seroquel 100 mg film-coated tablets are yellow, round, biconvex tablets with the imprint
“SEROQUEL 100” on one side.
Seroquel 200 mg film-coated tablets are white, round, biconvex tablets with the imprint
“SEROQUEL 200” on one side.
Seroquel 300 mg film-coated tablets are white, oblong tablets with the imprint
“SEROQUEL” on one side and “300” on the other side.
Pack sizes of 20, 30, 60, and 100 tablets are registered for all strengths. Additionally, a pack size of 6 tablets is registered for the 25 mg strength. For the 100 mg, 200 mg, and 300 mg tablets, a pack size of 90 tablets is registered. For the 25 mg, 100 mg, 200 mg, and 300 mg tablets, pack sizes of 60x1 and 100x1 tablets are registered. Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer
AstraZeneca UK Ltd
Silk Road Business Park
Macclesfield
Cheshire
SK10 2NA
United Kingdom
AstraZeneca AB
Gärtunavägen
Södertälje 151 85
Sweden
Klocke Pharma-Service GmbH
Straßburger Str. 77
77767 Appenweier
Germany
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

| COUNTRY | TRADE NAME | |---------|------------| | Austria | Seroquel | | Belgium | Seroquel | | Croatia | Seroquel | | Cyprus | Seroquel | | Denmark | Seroquel | | Estonia | Seroquel | | Finland | Seroquel | | Germany | Seroquel® 25 mg Filmtabletten, Seroquel® 100 mg Filmtabletten, Seroquel® 200 mg Filmtabletten, Seroquel® 300 mg Filmtabletten | | Greece | Seroquel | | Iceland | Seroquel | | Ireland | Seroquel | | Italy | Seroquel | | Lithuania | Seroquel | | Luxembourg | Seroquel | | Malta | Seroquel | | Netherlands | Seroquel | | Norway | Seroquel | | Portugal | Seroquel | | Slovenia | Seroquel | | Spain | Seroquel | | Sweden | Seroquel | | United Kingdom | Seroquel |