PATIENT INFORMATION LEAFLET

Seroquel 100 mg Film-Coated Tablets

quetiapine

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Seroquel is and what it is used for

2. What you need to know before you start taking Seroquel

3. How to take Seroquel

4. Possible side effects

5. Storage of Seroquel

6. Contents of the pack and additional informationl

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

• Bipolar depression: by which you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite or cannot sleep.
• Mania: by which you may feel very excited, euphoric, agitated, enthusiastic or hyperactive or present poor judgment which includes being aggressive or violent.
• Schizophrenia: by 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 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
• if you know that 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 the formation of blood clots
• if you have or have had a condition in which your breathing is interrupted by short periods of time 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 that are 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 a decrease in 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 will 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, symptoms similar to the flu, sore throat, or any other infection, as it could be a consequence of a very low white blood cell count and require discontinuation of Seroquel 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 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 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 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 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 medication, which may put your life at risk or be fatal. These usually 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 (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 rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) 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 rhythm, for example, medications that may 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

This medication may make you feel drowsy. Do not drive or operate tools or machinery until you know how the medication affects 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; 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 certain 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 rigid 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 with irregular beats.

• Constipation, indigestion.
• Sensation of weakness.

• Swelling of arms or legs.

• Low blood pressure when standing.Thismay cause you to feel dizzy or faint(may 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 liver enzymes measured in the blood.
• Increases in the amount of prolactin hormone in the blood. Prolactin increases may, in rare cases, lead to:
• • Both men and women having breast swelling and unexpected milk production.
  • Women not having a menstrual period or having irregular periods.

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).

• Prolonged and painful erection (priapism).
• Breast swelling and unexpected milk production (galactorrhea).
• Menstrual disorders.
• 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).
• 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 triglycerides in the blood, increased blood pressure, and increased blood sugar levels.

• A combination of fever, flu-like symptoms, 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 muscle substance).

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

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

• Severe allergic reaction (anaphylaxis) that can 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.
• Abnormal secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Not known: the frequency cannot be estimated from available data

• Rashes on the skin with irregular red patches (erythema multiforme). See section 2.
• Rapid appearance of skin areas with red spots and small white/yellow-filled blisters (Pustulosis Exantemática Generalizada Aguda (AGEP). See section 2.
• Sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis). See section 2.
• Medication reaction with eosinophilia and systemic symptoms (DRESS, for its English acronym), which consists of flu-like symptoms 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.
• Withdrawal symptoms may occur in newborns of mothers who have used Seroquel during pregnancy.
• Stroke.
• Cardiomyopathy (heart muscle disorder).
• Myocarditis (inflammation of the heart muscle).
• Vasculitis (inflammation of blood vessels), often with skin rash with small red or purple spots.

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

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 blood sugar, changes in the amount of thyroid hormones in the blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased red blood cell count, increased creatine phosphokinase in the blood (a muscle substance), decreased sodium in the blood, and increased prolactin hormone in the blood. Prolactin increases may, in rare cases, lead to:

• Both men and women having breast swelling and unexpected milk production.
• 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 can occur in adults can also occur in children and adolescents.

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

Very common: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:
• • Both boys and girls having breast swelling and unexpected milk production.
  • 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

• Sensation of weakness, dizziness (may lead to falls).
• Blocked 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 the 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 in the 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. By doing so, you will help protect the environment.

Composition of Seroquel

• The active ingredient is quetiapine. Seroquel tablets contain 100 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) and yellow iron oxide (E172).

Appearance of Seroquel and packaging contents

Seroquel 100 mg film-coated tablets are yellow, biconvex, round and have "SEROQUEL 100" engraved on one side.

They are available in packs of 20, 30, 60, 60x1, 90, 100 and 100x1 tablets. Only some pack sizes may be marketed.

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

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® 100 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 revision 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/