Seroquel Prolong 50 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Seroquel Prolong 50 mg prolonged-release tablets

quetiapine

Read the entire 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, 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

• Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: where you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or show poor judgment, including aggressive or violent behaviour.
• Schizophrenia: where you may hear or sense things that are not there, believe things that are not true, or feel abnormally suspicious, anxious, confused, guilty, tense, or depressed.

When Seroquel Prolong is used to treat major depressive episodes in major depressive disorder, it will be taken in addition to another medicine you are already using to treat this condition.

Your doctor may continue prescribing Seroquel Prolong even after you start feeling better.

2. What you need to know before taking Seroquel Prolong

Do not take Seroquel Prolong:

• 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:

• Certain 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 Prolong.

Warnings and precautions

Talk to 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, heart rhythm problems, 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 Prolong.
• 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 functions). In this case, you should not take Seroquel Prolong, as the group of medicines to which Seroquel Prolong belongs may increase the risk of stroke or, in some cases, death in such 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 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 completely 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 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, severe muscle stiffness, sweating, or decreased level of consciousness (a disorder known as “neuroleptic malignant syndrome”). Immediate medical treatment may be necessary.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or feeling very sleepy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Rapid or irregular heartbeat, even at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. 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 Prolong and/or additional treatment.
• Constipation along 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 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 stop your medication abruptly. 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 have thoughts of 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 inform you if they think your depression is getting worse or if they are concerned about changes in your behaviour.

Serious skin adverse reactions (SCARs)

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

• Stevens-Johnson syndrome (SJS), a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form causing extensive skin peeling.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), 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 eruptions with irregular red, itchy spots.

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

Weight gain

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

Children and adolescents

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

Other medicines and Seroquel Prolong

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

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

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

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

• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or Lithium (other antipsychotic medicines).
• Medicines that affect your heartbeat, for example, medicines that may cause an electrolyte imbalance (low potassium or magnesium levels) 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 Prolong, and you may experience symptoms such as involuntary 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 Prolong with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

The following symptoms, which may represent withdrawal syndrome, may occur in newborns whose mothers have taken 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

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 certain sugars, consult your doctor before taking this medicine.

Seroquel Prolong contains sodium

Seroquel Prolong 50 mg prolonged-release tablets contain 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 Prolong

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine 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.
• Do not split, chew, or crush the tablets.
• Swallow the tablets whole with water.
• Take the tablets without food (at least one hour before a meal or at bedtime; your doctor will advise you when).
• Do not drink grapefruit juice while taking Seroquel Prolong. 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 Prolong must 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 prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Take your Seroquel Prolong tablets with you. You may also call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine 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 and take the next dose at the regular time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Seroquel Prolong

If you stop taking Seroquel Prolong abruptly, you may have difficulty sleeping (insomnia), feel nauseous, or experience headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing 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 gets them.

Very common: may affect more than 1 in 10 people

• Dizziness (could lead to falls), headache, dry mouth.
• Drowsiness (which may disappear over time as you continue taking Seroquel Prolong), (could lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking Seroquel Prolong), including inability to sleep (insomnia), feeling nauseous, headache, diarrhoea, vomiting, dizziness, and irritability. 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 painless muscle rigidity.
• 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 has irregular beats.

• Constipation, upset stomach (indigestion).

• Feeling weak.

• Swelling of arms or legs.

• Low blood pressure when standing. This may make you feel dizzy or faint (could 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 blood.

• Decrease in number of certain types of blood cells.

• Increases in liver enzyme levels measured in blood.

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

• In both men and women: breast enlargement and unexpected milk production.

• In women: absence of menstrual periods or irregular periods.

Uncommon: may affect up to 1 in 100 people

• Epileptic 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.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the heart's electrical activity seen on ECG (prolongation of 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 (could lead to falls).
• Blocked nose.
• Decrease in the number of red blood cells in blood.
• Decrease in sodium levels 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 and painful erection (priapism).

• Breast enlargement and unexpected milk production (galactorrhoea).

• 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 medical help immediately.

• 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 experience a combination of 3 or more of the following effects: 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 levels.

• 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 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 and 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 consists of 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 Prolong 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 Prolong belongs can cause heart rhythm problems that may be serious and, in severe cases, could be fatal.

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

• In both men and women: breast enlargement and unexpected milk production.
• 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 levels of a hormone called prolactin in blood. Increases in prolactin hormone could, in rare cases, lead to the following:
  • In both boys and girls: breast enlargement and unexpected milk production.
  • 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 painless muscle rigidity.
• Increased blood pressure.

Common: may affect up to 1 in 10 people

• Feeling weak, fainting (could lead to falls).
• Blocked 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 Prolong

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 is the last day of the month indicated.

Seroquel Prolong does not require any special storage conditions.

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

6. Package contents and other information

Composition of Seroquel Prolong

• The active substance is quetiapine. Seroquel Prolong tablets contain 50 mg 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), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of Seroquel Prolong and contents of the pack

All extended-release tablets are capsule-shaped and marked with "XR" and the dosage strength. The 50 mg tablets are peach-coloured.

They are available in packs of 10, 30, 60, 60x1, 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 Limited
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 authorised in the European Economic Area Member States under the following trade names:

MEMBER STATE TRADE NAME

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

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

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