Seroquel 100 mg film-coated tablets

Package Leaflet: Information for the User

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Seroquel 100 mg film-coated tablets

quetiapine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet Contents

1. What Seroquel is and what it is used for
2. What you need to know before taking Seroquel
3. How to take Seroquel
4. Possible side effects
5. How to store Seroquel
6. Contents of the pack and other information

1. What Seroquel is and what it is used for

Seroquel contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Seroquel can be used to treat several conditions, such as:

• Bipolar depression: when you feel sad. You may feel depressed, guilty, lack energy, lose your appetite, or be unable to sleep.
• Mania: when you may feel overly excited, euphoric, restless, enthusiastic, or hyperactive, or have poor judgment, which may include being aggressive or violent.
• Schizophrenia: when 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 after you start feeling better.

2. What you need to know before taking Seroquel

Do not take Seroquel:

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

• if you are taking any of the following medicines:

  • Some medicines for HIV
  • Azole-type medicines (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, heart rhythm disorders, weakening of the heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect your heartbeat.
• 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 (epileptic fit).
• if you have diabetes or are at risk of developing diabetes. If so, your doctor may monitor your blood sugar levels while you are taking Seroquel.
• if you know you have previously had low levels of white blood cells (which may or may not have been caused by other medicines).
• if you are an elderly person with dementia (loss of brain function). In this case, you should not take Seroquel because the group of medicines to which Seroquel belongs may increase the risk of stroke, or in some cases the risk of death, in these individuals.
• if you are an elderly person with Parkinson's disease/parkinsonism.
• if you or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.
• if you have or have had a condition in which your breathing stops for short periods during normal nighttime sleep (called “sleep apnea”) and you are taking medicines that reduce normal brain activity (“depressants”).
• if you have or have had a condition in which you cannot fully empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside your eye. These conditions can sometimes be caused by medicines (called “anticholinergics”) that affect how nerve cells function, 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 may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Seroquel”).

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

• A combination of fever, severe muscle stiffness, sweating, or decreased level of consciousness (a disorder known as “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 injury (falls) in elderly patients.

• Seizures (epileptic fits).

• A prolonged and painful erection (priapism).

• Rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.

These disorders may be caused by this type of medicine.

Inform your doctor as soon as possible if you have:

• Fever, flu-like symptoms, sore throat, or any other infection, as this could be due to a very low count of white blood cells and may require stopping treatment with Seroquel and/or additional treatment.
• Constipation together with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more serious intestinal blockage.
• Suicidal thoughts and worsening of your depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This risk may increase at the beginning of treatment, as all these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also increase if you suddenly stop taking your medication. You may be more likely to have such thoughts if you are a young adult. Clinical trial data have shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults under 25 years of age with depression.

If at any time you 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 also ask them to inform you if they think your depression is getting worse or if they are concerned about changes in your behaviour.

Serious cutaneous adverse reactions (SCARs)

Very rarely, serious skin reactions (SCARs) that may be life-threatening or fatal have been reported with this medicine. These commonly present as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blistering 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), characterized by flu-like symptoms with rash, fever, swollen lymph nodes, 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), skin rashes with itchy, irregular red spots.

If you develop any of these symptoms, stop using Seroquel and contact your doctor or seek immediate medical attention.

Weight gain

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

Children and adolescents

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

Other medicines and Seroquel

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

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

• Some medicines for HIV.
• 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 sleeping).
• Thioridazine or Lithium (other antipsychotic medicines).
• Medicines that affect your heartbeat, for example, medicines that may cause an electrolyte imbalance (low levels of potassium or magnesium), such as diuretics (medicines to increase urine production) or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Medicines (called “anticholinergics”) that affect how nerve cells function, used to treat certain medical conditions.
• Antidepressants. These medicines may interact with Seroquel and you may experience symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome). Contact your doctor if you experience these symptoms.

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

Taking Seroquel with food, drinks, and alcohol

• Seroquel may be taken with or without food.

• Be cautious about the amount of alcohol you consume. This is because the combined effect of Seroquel and alcohol may make you drowsy.

• Do not drink grapefruit juice while taking Seroquel. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. You should not take Seroquel during pregnancy unless advised by your doctor. You should not use Seroquel if you are breastfeeding.

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

Driving and using machines

This medicine may make you feel drowsy. Do not drive or operate tools or machinery until you know how this medicine affects you.

Seroquel contains lactose

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

Seroquel contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

Effect on Urine Drug Screening Tests

If you are undergoing a urine drug screening test, taking Seroquel may produce positive results for methadone or certain antidepressant medicines known as tricyclic antidepressants (TCAs) when certain testing methods are used, even if you are not taking methadone or TCAs. If this occurs, a more specific test can be performed.

3. How to take Seroquel

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

• You will take your tablets once daily at bedtime or twice daily, depending on your condition.
• Swallow your tablets whole with water.
• You may take the tablets with or without food.
• Do not drink grapefruit juice while taking Seroquel. It may affect how the medicine 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 adjust your dose.

Elderly patients

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 than you should

If you take more Seroquel than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Take the Seroquel tablets with you. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine 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 stop taking Seroquel

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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.

• Drowsiness (which may decrease over time as you continue taking Seroquel), (may lead to falls).

• Withdrawal symptoms (symptoms that occur when you stop taking Seroquel), including inability to sleep (insomnia), feeling nauseous, headache, diarrhoea, vomiting, dizziness and irritability. Gradual discontinuation 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 muscle stiffness without pain.

• Changes in levels of certain fats (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Fast heartbeat.

• Feeling as if your heart is pounding, racing, or beating irregularly.

• Constipation, upset stomach (indigestion).

• Feeling weak.

• Swelling of arms or legs.

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

• Increased blood sugar levels.

• Blurred vision.

• Abnormal dreams and nightmares.

• Increased appetite.

• Feeling irritable.

• Speech and language disorders.

• Suicidal thoughts and worsening of depression.

• Shortness of breath.

• Vomiting (mainly in elderly people).

• Fever.

• Changes in levels of thyroid hormones in the blood.

• Decrease in the number of certain types of blood cells.

• Increases in liver enzymes measured in blood.

• Increases in the amount of prolactin hormone in blood. Increases in prolactin hormone could, in rare cases, lead to the following:

  • Swelling of the breasts and unexpected milk production in both men and women.
  • In women, absence of menstrual periods or irregular periods.

Uncommon: may affect up to 1 in 100 people

• Seizures or convulsions.

• Allergic reactions which may include raised, itchy rashes (hives), skin swelling, and swelling around the mouth.

• Unpleasant sensations in the legs (also known as restless legs syndrome).

• Difficulty swallowing.

• Involuntary 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).

• Slower than normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting.

• Difficulty urinating.

• Fainting (may lead to falls).

• Stuffy nose.

• Decrease in the number of red blood cells in blood.

• Decrease in the amount of sodium in 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, and feeling very drowsy or dizzy (a disorder known as “neuroleptic malignant syndrome”).

• Yellowing of the skin and eyes (jaundice).

• Inflammation of the liver (hepatitis).

• Prolonged, painful erection (priapism).

• Breast swelling and unexpected milk production (galactorrhea).

• Menstrual disorders.

• Blood clots in veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical help.

• Walking, talking, eating, or other activities while asleep.

• 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: increased abdominal fat, decreased “good” cholesterol (HDL-C), increased levels of a type of fat in the blood called triglycerides, increased blood pressure, and increased blood sugar.

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

• Severe allergic reaction (called anaphylaxis) which may cause difficulty breathing or shock.

• Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).

• A serious condition with blisters on the skin, mouth, eyes and genitals (Stevens-Johnson syndrome). See section 2.

• Inappropriate secretion of a hormone that controls urine volume.

• Breakdown of muscle fibres and muscle pain (rhabdomyolysis).

Not known: frequency cannot be estimated from available data

• Skin rashes with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid known as Acute Generalized Exanthematous Pustulosis (AGEP)). See section 2.
• Sudden, severe allergic reaction with symptoms such as fever, skin blisters and skin peeling (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which includes flu-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who 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 spots.

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

Some adverse effects are only detected by blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in levels of thyroid hormones in your blood, increases in liver enzymes, decreases in the number of certain types of blood cells, decrease in red blood cells, increased blood levels of creatine phosphokinase (a substance found in muscles), decreased sodium levels in blood, and increased levels of the hormone prolactin in blood. Increases in prolactin hormone could, in rare cases, lead to the following:

• Swelling of the breasts and unexpected milk production in both men and women.
• In women, absence of menstrual periods or irregular periods.

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

Additional adverse effects in children and adolescents

The same adverse effects that may occur in adults may also occur in children and adolescents.

The following adverse 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

• Increase in the amount of a hormone called prolactin in blood. Increases in prolactin hormone could, in rare cases, lead to the following:
  • Swelling of the breasts and unexpected milk production in both boys and girls.
  • In girls, absence of menstrual periods or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, feeling restless or muscle stiffness without pain.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Seroquel

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Seroquel

• The active substance is quetiapine. Seroquel tablets contain 100 mg of quetiapine (as quetiapine fumarate).

• The other components are:

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

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

Appearance of Seroquel and contents of the pack

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

They are available in packs of 20, 30, 60, 60x1, 90, 100, and 100x1 tablets. Only certain 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
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 brand names:

MEMBER STATE \t\tBRAND NAME
Germany \t\tSeroquel® 100 mg Filmtabletten
Austria \t\tSeroquel
Belgium \t\tSeroquel
Cyprus \t\tSeroquel
Croatia \t\tSeroquel
Denmark \t\tSeroquel
Spain \t\tSeroquel
Slovenia \t\tSeroquel
Estonia \t\tSeroquel
Finland \t\tSeroquel
Greece \t\tSeroquel
Netherlands \t\tSeroquel
Ireland \t\tSeroquel
Iceland \t\tSeroquel
Italy \t\tSeroquel
Lithuania \t\tSeroquel
Luxembourg \t\tSeroquel
Malta \t\tSeroquel
Norway \t\tSeroquel
Portugal \t\tSeroquel
United Kingdom \tSeroquel
Sweden \t\tSeroquel

Date of the most recent review of this leaflet: July 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/