Package Insert: Information for the User

Seroquel 25 mg Film-Coated Tablets

quetiapine

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others 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 package insert. See section 4.

1. What is Seroquel and for what it is used

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

3. How to take Seroquel

4. Possible adverse effects

5. Storage of Seroquel

6. Contents of the package and additional information

Seroquel contains a substance called quetiapina.It belongs to a group of medications called antipsychotics. Seroquel can be used to treat various diseases, such as:

• Bipolar depression: for which you may feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or cannot sleep.
• Mania: for which you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or exhibit poor judgment, which may include 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.

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

Do not take Seroquel:

• if you are allergic to quetiapine or any of the other ingredients in this medication (listed in section 6)

• if you are taking any of the following medications:
• • Some HIV medications
  • Azole-type medications (for fungal infections)
  • Erythromycin or clarithromycin (for infections)
  • Nefazodone (for depression)

If you have any doubts, consult your doctor or pharmacist before taking Seroquel.

Warnings and precautions

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

• if you, or a family member, have or have had any heart problems, for example, irregular heart rhythm, heart muscle weakness, or heart inflammation, or if you are taking any medication that may affect your heart rate
• 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
• if you know you have had low white blood cell counts (which may or may not have been caused by other medications)
• if you are an elderly person with dementia (loss of brain function). If so, do not take Seroquel because the group of medications to which Seroquel 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 medications like these have been associated with blood clot formation
• if you have or have had a condition in which your breathing is interrupted for short periods during normal nighttime sleep (called "sleep apnea") and are taking medications 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, intestinal obstruction, or high pressure inside your eye. These conditions may be caused by medications (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 treated with antidepressants

The use of these medications with Seroquel may cause serotonin syndrome, a potentially life-threatening condition (see "Other medications and Seroquel")

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

• A combination of fever, intense muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary
• 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)
• Prolonged and painful erection (priapism)
• Fast and irregular heartbeats, even when at rest, palpitations, respiratory problems, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you to a cardiologist immediately

These conditions may be caused by this type of medication

Inform your doctor as soon as possible if you have:

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

If you are depressed, you may sometimes think about harming yourself or committing suicide. This may increase at the beginning of treatment, as all these medications take time to be effective, usually around two weeks but sometimes more. 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 with depression

If you ever think about harming yourself or committing suicide, contact your doctor or go to the 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 can ask them to tell you if they think your depression is getting worse, or if they are concerned about changes in your behavior

Severe cutaneous adverse reactions (SCARs)

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

• Stevens-Johnson syndrome (SSJ), a generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals
• Toxic epidermal necrolysis (TEN), a more severe form that causes extensive skin peeling
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count and elevated liver enzymes)
• Generalized 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 and contact your doctor or seek medical attention immediately

Weight gain

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

Children and adolescents

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

Other medications and Seroquel

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

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

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

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

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

Before stopping any of your medications, consult your doctor first

Taking Seroquel with food, drinks, and alcohol

• Seroquel can be taken with or without food
• Be careful with the amount of alcohol you consume. This is because the combined effect of Seroquel and alcohol may make you drowsy

• Do not take grapefruit juice while taking Seroquel. It may affect how the medication works

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take Seroquel during pregnancy, unless you have consulted your doctor. Do not use Seroquel if you are breastfeeding

The following symptoms, which may represent withdrawal syndrome, may appear in newborns of mothers who have used Seroquel in the last trimester (last three months of pregnancy): tremors, muscle stiffness, and/or weakness, drowsiness, agitation, respiratory problems, and feeding difficulties. 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 contains lactose

Seroquel 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 medication

Seroquel contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; that is, it is essentially "sodium-free"

Effect on drug detection tests in urine

If you are undergoing a drug detection test in urine, taking Seroquel may produce positive results for methadone or certain antidepressant medications 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 needs, but will usually be between 150 mg and 800 mg.

• You will take your tablets once a day, at bedtime, or twice a day, depending on your illness.
• Swallow your tablets whole with the help of water.
• You can take the tablets with or without food.
• Do not take grapefruit juice while taking Seroquel. 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 should not be used in children and adolescents under 18 years of age.

If you take more Seroquel than you should

If you take more Seroquel than your doctor prescribed, you may feel drowsy, feel dizzy, and experience abnormal heartbeats.Contact your doctor or the nearest hospital immediately. Bring your Seroquel 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

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 tablet.

If you interrupt treatment with Seroquel

If you stop taking Seroquel 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 (may lead to falls),headache, dry mouth.

• Sensation of drowsiness (which may disappear over time as you continue to take Seroquel),(may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking Seroquel), which include insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, feeling restless or stiff without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Fast heart rate.
• Feeling like your heart is beating strongly, rapidly, or irregularly.

• Constipation, indigestion.
• Sensation of weakness.

• Swelling of arms or legs.

• Low blood pressure when standing.Thismay make you feel dizzy or faint(may lead to falls).

• Increased blood sugar levels.

• Blurred vision.

• Abnormal dreams and nightmares.

• Increased hunger.

• Feeling irritable.
• Speech and language disorder.
• 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 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 heart activity 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 (may 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 called "neuroleptic malignant syndrome").

• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).

• Long-lasting 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 may 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).
• Inflammation of the pancreas.
• A condition (called "metabolic syndrome") in which you may have 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 called 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 (called anaphylaxis) that may cause difficulty breathing or shock.

• Quick swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A severe condition of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Incorrect secretion of a hormone that controls urine volume.
• Rhabdomyolysis, a condition in which muscle fibers break down and cause muscle pain.

Not known: 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 white/yellow-filled blisters (Pustulosis Exantemática Generalizada Aguda (AGEP). 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
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which includes symptoms similar to the flu with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes). See section 2.
• Symptoms of withdrawal in newborns of mothers who have taken Seroquel during pregnancy.
• Stroke.
• Cardiomyopathy, a disorder of the heart muscle.
• Miocarditis, inflammation of the heart muscle.
• Vasculitis, inflammation of blood vessels, often with a rash of small red or purple spots.

The class of medicines to which Seroquel 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, decreases in the number of certain types of blood cells, decreases in the amount of red blood cells, increased creatine-phosphocinase in the blood (a substance found in muscles), decreases in the amount of sodium in the blood, and 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.
• Women may not have a menstrual period or have 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.
  • Girls may not have a menstrual period or have irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless or stiff without pain.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

• Sensation of weakness, fainting (may 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.

Do not store at a temperature above 30 °C.

Medications should not be disposed of through drains or trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Seroquel

• The active ingredient is quetiapine. Seroquel tablets contain 25 mg of quetiapine (as quetiapine fumarate).

• The other components are:

Tablet core: povidone, calcium dihydrogen phosphate, microcrystalline cellulose, sodium carboxymethyl starch (Type A potato starch), lactose monohydrate (lactose), magnesium stearate.

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

Appearance of Seroquel and packaging contents

Seroquel 25 mg film-coated tablets are orange, biconvex, round, and have "SEROQUEL 25" engraved on one side.

They are available in packaging of 6, 20, 30, 60, 60x1, 100, and 100x1 tablets. Some packaging sizes may not be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer:

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield, Cheshire SK10 2NA

United Kingdom

or

AstraZeneca AB

Gärtunavägen

Södertälje 151 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 25 mg Filmtabletten

AustriaSeroquel

BelgiumSeroquel

CyprusSeroquel

CroatiaSeroquel

DenmarkSeroquel

SpainSeroquel

SloveniaSeroquel

EstoniaSeroquel

FinlandSeroquel

GreeceSeroquel

NetherlandsSeroquel

IrelandSeroquel

IcelandSeroquel

ItalySeroquel

LithuaniaSeroquel

LuxembourgSeroquel

MaltaSeroquel

NorwaySeroquel

PortugalSeroquel

United KingdomSeroquel

SwedenSeroquel

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/