Seroquel Prolong 200 mg prolonged-release tablets

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Seroquel Prolong 200 mg prolonged-release 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 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 display poor judgment, including aggressive or violent behavior.
• 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 is taken in addition to another medicine you are already taking for 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:

• 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 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 (convulsion).
• 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). If so, you should not take Seroquel Prolong because the group of medicines to which Seroquel Prolong belongs may increase the risk of stroke, or in some cases the risk of death, in these people.
• 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 completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside your eye. These conditions may 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.
• The use of 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 called “neuroleptic malignant syndrome”). Immediate medical treatment may be required.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Rapid or irregular heartbeats, 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 discontinuation of treatment with Seroquel Prolong 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 have thoughts of harming yourself or committing suicide. These thoughts 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. Data from clinical trials 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 cutaneous adverse reactions (SCARs)

Very rarely, serious skin adverse 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), consisting 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).
• Acute generalized exanthematous pustulosis (AGEP), small pustules filled with pus.
• Erythema multiforme (EM), skin rashes with irregular red spots that itch.

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 medicine.

Do not take Seroquel Prolong 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).

Tell 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 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 and rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, 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, so 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 must not take Seroquel Prolong during pregnancy unless advised by your doctor. You must not use Seroquel Prolong if you are breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may occur in newborns of mothers who have taken Seroquel during the third trimester (last three months of pregnancy): tremor, muscle rigidity 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 these tablets affect you.

Seroquel Prolong contains lactose

Seroquel Prolong 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 Prolong contains sodium

Seroquel Prolong 200 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 antidepressants called tricyclic antidepressants (TCAs) when certain analytical methods are used, even though you may not be taking methadone or TCAs. If this occurs, a more specific test can be performed.

3. How to take Seroquel Prolong

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 determine your initial 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 a day.
• Do not split, chew, or crush the tablets.
• Swallow your tablets whole with water.
• Take the tablets without food (at least one hour before a meal or at bedtime; your doctor will tell 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 telephone number: 91 562 04 20, stating 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 until then. 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, 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 (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, restlessness 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 strongly, beating rapidly, or having 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.

• Feeling hungrier.

• 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 enzyme levels measured in blood.

• Increases in the amount of prolactin hormone in blood. 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.
• Involuntary movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart 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).
• Nasal congestion.
• 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, 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 the 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”) where 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.

• 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 the available data

• Skin rashes with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance of red skin areas dotted 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), characterised 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). 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 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 thyroid hormone levels in the blood, increased liver enzymes, decreases in the number of certain blood cells, decreased red blood cell count, increased blood creatine phosphokinase (a substance found in muscles), decreased sodium levels in blood, and increased levels of prolactin hormone in blood. 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 were not observed in adults:

Very common: may affect more than 1 in 10 people

• Increase in the level of a hormone called prolactin in the 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, restlessness or painless muscle rigidity.

• Increased blood pressure.

Common: may affect up to 1 in 10 people

• Feeling weak, fainting (could lead to falls).
• Nasal congestion.
• 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 must 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 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 Prolong

• The active substance is quetiapine. Seroquel Prolong tablets contain 200 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) and yellow iron oxide (E172).

Appearance of Seroquel Prolong and contents of the pack

All prolonged-release tablets are capsule-shaped and marked with "XR" and the dosage strength. The 200 mg tablets are yellow.

They are available in packs of 10, 30, 60, 60x1, 100 and 100x1 tablets. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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® 200 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: October 2021

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