PROSPECTO: INFORMATION FOR THE USER

Seroquel Prolong300 mgextended-release tablets

quetiapine

Read this prospect carefully before starting to take the medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What Seroquel Prolong is and for what it is used

2.What you need to know before starting to take Seroquel Prolong

3.How to take Seroquel Prolong

4.Possible adverse effects

5.Storage of Seroquel Prolong

6.Contents of the package and additional information

Seroquel Prolong contains a substance called quetiapina. It belongs to a group of medicines called antipsychotics. Seroquel Prolong can be used to treat several diseases,suchas:

• Bipolar depression and major depressive episodes in major depressive disorder:for which you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite or cannot sleep.
• Mania: for which you may feel very excited, euphoric, agitated, enthusiastic or hyperactive or present poor judgment which includes being aggressive or violent.
• Schizophrenia: for which you may hear or feel things that are not there, believe things that are not true or feel abnormally suspicious, anxious, confused, guilty, tense or depressed.

When using Seroquel Prolong to treat major depressive episodes in major depressive disorder, this will be taken in addition to another medicine that is being used to treat this disease.

Your doctor may continue prescribing Seroquel Prolong even when you are feeling better.

Do not take Seroquel Prolong:

• if you are allergic to quetiapine or any of the other ingredients in this medicine (see section 6)
• if you are taking any of the following medicines:

-Some HIV medicines

-Azole-type medicines (for fungal infections)

-Erythromycin or clarithromycin (for infections)

-Nefazodone (for depression)

If you are unsure, consult your doctor or pharmacist before taking Seroquel Prolong.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Seroquel Prolong:

• if you, or a family member, have or have had any heart problems, for example, irregular heart rhythm, heart muscle weakness or inflammation of the heart, or if you are taking any medicine that may affect your heart rhythm.
• if you have low blood pressure.
• if you have had a stroke, especially if you are elderly.
• if you have liver problems.
• if you have ever had a seizure (convulsion).
• if you have diabetes or are at risk of developing diabetes. Your doctor may monitor your blood sugar levels while you are taking Seroquel Prolong.
• if you know that you have had low white blood cell counts (which may or may not have been caused by other medicines).
• if you are an elderly person with dementia (loss of brain function). If so, do not take Seroquel Prolong because the group of medicines to which Seroquel Prolong belongs may increase the risk of stroke or, in some cases, death in these people.
• if you are an elderly person with Parkinson's disease or parkinsonism.
• if you or a family member has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
• if you have or have had a condition in which your breathing is interrupted for short periods of time during normal sleep (called "sleep apnoea") and you are taking medicines that decrease normal brain activity ("depressants").
• if you have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, a bowel obstruction or high pressure inside your eye. These conditions may be caused by medicines (called "anticholinergics") that affect how nerve cells work to treat certain medical conditions.
• if you have a history of alcohol or drug abuse.
• if you have depression or other conditions that are treated with antidepressants.
• The use of these medicines with Seroquel Prolong may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Seroquel Prolong").

Inform your doctor immediately if after taking Seroquel Prolong you experience any of the following::

• A combination of fever, intense muscle stiffness, sweating or a decrease in consciousness (a condition called "neuroleptic malignant syndrome"). You may need immediate medical treatment.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).

• A prolonged and painful erection (priapism).
• Fast and irregular heartbeats, even when at rest, palpitations, breathing problems, chest pain or unexplained fatigue. Your doctor will examine your heart and, if necessary, refer you to a cardiologist immediately.

These conditions may be caused by this type of medicine.

Inform your doctor as soon as possible if you have:

• Fever, symptoms similar to the flu, sore throat, or any other infection, as it could be a consequence of very low white blood cell counts and require discontinuation of Seroquel Prolong treatment and/or additional treatment.
• Constipation with persistent abdominal pain, or constipation that has not responded to treatment, as it may lead to a more severe bowel obstruction.
• Thoughts of suicide and worsening of depression

If you are depressed, sometimes you may think about harming yourself or committing suicide. This may increase at the beginning of treatment, as all these medicines take time to take effect, usually around two weeks but sometimes longer. These thoughts may also increase if you stop taking your medication abruptly. You may be more likely to think this way if you are a young adult. Information from clinical trials has shown an increased risk of thoughts of suicide and/or suicidal behavior in young adults under 25 years old with depression.

If you ever think about harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a close family member or friend that you are depressed, and ask them to read this leaflet. You may ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior.

Severe skin reactions (SCARs)

Very rarely, severe skin reactions (SCARs) have been reported with the use of this medicine, which may put your life at risk or be fatal. These usually manifest as:

• Stevens-Johnson syndrome (SSJ), a generalised rash with blisters and skin peeling, particularly around the mouth, nose, eyes and genitals.
• Toxic epidermal necrolysis (NET), a more severe form that causes extensive skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with a rash, fever, swollen lymph nodes and abnormal blood test results (including increased white blood cell count and elevated liver enzymes).
• Generalised acute pustular psoriasis (AGEP), small pus-filled blisters.
• Erythema multiforme (EM), skin rashes with irregular red patches that itch.

If you develop these symptoms, stop using Seroquel Prolong and contact your doctor or seek medical attention immediately.

Weight gain

Weight gain has been observed in patients taking Seroquel Prolong. You and your doctor should regularly monitor your weight.

Children and adolescents

Seroquel Prolong should not be used in children and adolescents under 18 years of age.

Other medicines and Seroquel Prolong

Inform your doctor if you are taking, have taken recently or may need to take any other medicine.

Do not take Seroquel Prolong if you are using any of the following medicines:

• Some HIV medicines.
• Azole-type medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

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

• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty falling asleep).
• Thioridazine or lithium (other antipsychotic medicines).
• Medicines that affect your heart rhythm, for example, medicines that may cause an imbalance of electrolytes (low potassium or magnesium levels) such as diuretics (medicines for urination) or certain antibiotics (medicines for treating infections).
• Medicines that may cause constipation.
• Medicines (called "anticholinergics") that affect how nerve cells work to treat certain medical conditions.
• Antidepressants. These medicines may interact with Seroquel Prolong and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension and a body temperature above 38°C (serotonin syndrome). Contact your doctor when you experience these symptoms.

Before stopping any of your medicines, consult your doctor first.

Taking Seroquel Prolong with food, drinks and alcohol

• Seroquel Prolong may be affected by food, so take your tablets at least one hour before a meal or before bedtime.
• Be careful with the amount of alcohol you drink. This is because the combined effect of Seroquel Prolong and alcohol may make you drowsy.
• Do not take orange juice while taking Seroquel Prolong. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medicine. Do not take Seroquel Prolong during pregnancy unless your doctor has advised you to. Do not use Seroquel Prolong if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may appear in newborn babies of mothers who have used Seroquel in the last trimester (last three months of their pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and operating machinery

These tablets may make you feel drowsy. Do not drive or operate tools or machinery until you know how the tablets affect you.

Seroquel Prolong contains lactose

Seroquel Prolong contains lactose, a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Seroquel Prolong contains sodium

Seroquel Prolong 300 mg prolonged-release tablets contain 27 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 1.35% of the recommended maximum daily sodium intake for an adult.

Effect on drug detection tests in urine

If you are having a drug detection test in urine, taking Seroquel may produce positive results for methadone or certain antidepressant medicines called tricyclic antidepressants (TCAs) when using some analysis methods, although you may not be taking methadone or TCAs. If this occurs, a more specific test may be performed.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your illness and your needs, but it will usually be between 150mg and 800mg.

• You will take your tablets once a day.
• Do not break, chew, or crush the tablets.
• Swallow your tablets whole with the help of water.
• Take the tablets without food (at least one hour before a meal or before going to bed, your doctor will tell you when).
• Do not take grapefruit juice while taking Seroquel Prolong. It may affect how the medication works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to.

Liver problems

If you have liver problems, your doctor may change your dose.

Older adults

If you are an older adult, your doctor may change your dose.

Use in children and adolescents

Seroquel Prolong should not be used in children and adolescents under 18 years of age.

If you take more Seroquel Prolong than you should

If you take more Seroquel Prolong than your doctor prescribed, you mayfeel drowsy, feel dizzyand experience abnormal heartbeats. Contact your doctoror the nearest hospital immediately. Bring your Seroquel Prolong tablets with you.You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Seroquel Prolong

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait until then. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Seroquel Prolong

If you stop taking Seroquel Prolong abruptly,you may be unable to sleep (insomnia), or you may feel nausea, or you may experience headaches, diarrhea,vomiting, dizziness, or irritability.Your doctor may suggest reducing the dose gradually before stopping treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

Very common:may affect more than 1 in 10 people

• Dizziness (which could lead to falls), headache, dry mouth.
• Feeling drowsy (which may disappear over time as you continue to take Seroquel Prolong), (which could lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking Seroquel Prolong), which include insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability.It is recommended to taper off over a period of at least 1 to 2 weeks.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, feeling restless or rigid without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common:may affect up to 1 in 10 people

• Palpitations.
• Feeling like your heart is beating strongly, beating fast, or having irregular heartbeats.
• Constipation, indigestion.
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This may make you feel dizzy or faint (which could lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling hungrier.
• Feeling irritable.
• Speech and language disorders.
• Thoughts of suicide and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increases in the amount of liver enzymes measured in the blood.
• Increases in the amount of prolactin hormone in the blood. Prolactin increases may, in rare cases, lead to the following:

• Both in men and women, breast swelling and unexpected milk production.
• In women, not having a menstrual period or having irregular periods.

Uncommon:may affect up to 1 in 100 people

• Seizures or convulsions.

• Allergic reactions that may include hives, skin swelling, and swelling around the mouth.

• Unpleasant sensations in the legs (also known as restless leg syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart seen on an ECG (prolongation of the QT interval).
• Slower than normal heart rate that may occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which could lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells in the blood.
• Decrease in the amount of sodium in the blood.
• Worsening of pre-existing diabetes.
• Confusion.

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

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or dizzy (a condition known as "neuroleptic malignant syndrome").

• Yellowing of the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).

• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical help immediately.
• Walking, talking, eating, or other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (called "metabolic syndrome") where you may experience a combination of 3 or more of the following effects: increased fat around your abdomen, decreased "good" cholesterol (HDL-C), increased levels of a type of fat in the blood called triglycerides, increased blood pressure, and increased blood sugar levels.

• A combination of fever, symptoms similar to the flu, sore throat, or any other infection with a very low white blood cell count, a condition known as agranulocytosis.

• Intestinal obstruction.
• Increased creatine phosphokinase in the blood (a substance found in muscles).

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

• Severe rash, blisters, or red spots on the skin.

• Severe allergic reaction (known as anaphylaxis) that can cause difficulty breathing or shock.

• Fast swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• Severe blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Incorrect secretion of a hormone that controls urine volume.
• Rhabdomyolysis, a condition where muscle fibers break down and cause muscle pain.

Unknown:the frequency cannot be estimated from available data

• Rashes on the skin with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance of areas of skin with red spots and small blisters (pustulosis exanthemática generalizada aguda, or AGEPA). See section 2.
• Severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis). See section 2.See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which includes flu-like symptoms, rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count and elevated liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborn babies of mothers who have taken Seroquel Prolong during pregnancy.
• Stroke.
• Cardiomyopathy, a disorder of the heart muscle.
• Myocarditis, inflammation of the heart muscle.
• Vasculitis, inflammation of the blood vessels, often with a rash of small red or purple spots.

The class of medicines to which Seroquel Prolong belongs can cause serious heart rhythm problems that may be life-threatening.

Some side effects are only seen when a blood test is done. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in the blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased red blood cells, increased creatine phosphokinase in the blood (a substance found in muscles), decreased sodium in the blood, and increased prolactin hormone in the blood. Prolactin increases may, in rare cases, lead to the following:

• Both in men and women, breast swelling and unexpected milk production.
• In women, not having a menstrual period or having irregular periods.

Your doctor may ask you to have blood tests from time to time.

Additional side effects in children and adolescents

The same side effects that may occur in adults may 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:may affect more than 1 in 10 people

• Increased amount of a hormone called prolactin in the blood. Prolactin increases may, in rare cases, lead to the following:

• Both in boys and girls, breast swelling and unexpected milk production.
• In girls, not having a menstrual period or having irregular periods.

• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless or rigid without pain.
• Increased blood pressure.

Common:may affect up to 1 in 10 people

• Feeling weak, fainting (which could lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es/.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Seroquel Prolong does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Seroquel Prolong

• The active ingredient is quetiapine. Seroquel Prolong tablets contain 300mg of quetiapine (as quetiapine fumarate).
• The other components are:

Tablet core: microcrystalline cellulose, sodium citrate, lactose monohydrate (lactose), magnesium stearate, hypromellose.

Tablet coating: hypromellose, macrogol, titanium dioxide (E171) and yellow iron oxide (E172).

Appearance of Seroquel Prolong and contents of the package

All prolonged-release tablets have a capsule shape and are marked with XR and the dosage. The 300mg tablets are pale yellow.

They are presented in packages of 10, 30, 60, 60x1, 100 and 100x1 tablets. Some package sizes may not be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer responsible:

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield, Cheshire SK10 2NA

United Kingdom

or

AstraZeneca AB

Gärtunavägen

Södertälje151 85

Sweden

or

Klocke Pharma-Service GmbH

Straßburger Str. 77

77767 Appenweier

Germany

or

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Local representative:

Laboratorios Rubió, S.A.

Industria, 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

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

MEMBER STATETRADE NAME

GermanySeroquel Prolong® 300 mg Retardtabletten,

AustriaSeroquel XR

BelgiumSeroquel XR

CyprusSeroquel XR

CroatiaSeroquel XR

DenmarkSeroquel Prolong

SpainSeroquel Prolong

SlovakiaSeroquel XR

SloveniaSeroquel SR

EstoniaSeroquel XR

France Xeroquel LP

FinlandSeroquel Prolong

GreeceSeroquel XR

NetherlandsSeroquel XR

Quetiapine XR AstraZeneca

HungarySeroquel XR

IrelandSeroquel XR

IcelandSeroquel Prolong

ItalySeroquel compresse a rilascio prolungato

LatviaSeroquel XR

LithuaniaSeroquel XR

LuxembourgSeroquel XR

NorwaySeroquel Depot

PortugalSeroquel SR

United KingdomSeroquel XL

SwedenSeroquel Depot

Last review date of this leaflet:July 2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/