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SEROQUEL XL 150 MG PROLONGED RELEASE TABLETS

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

Very Common (affects more than 1 in 10 people):
 Increase in blood pressure.
The following side effects have been seen more often in children and adolescents:
Very Common (affects more than 1 in 10 people):
 Increase in the amount of a hormone called prolactin, in the blood. Increases in the
hormone prolactin could in rare cases lead to the following:
– boys and girls to have swelling of breasts and unexpectedly produce breast milk
– girls to have no monthly period or irregular periods.
 Increased appetite.
 Abnormal muscle movements. These include difficulty starting muscle movements,
shaking, feeling restless or muscle stiffness without pain.
5. How to store Seroquel XL






Do not store above 30°C. Store in the original package.
Keep your Seroquel XL tablets in a safe place, where children cannot see or reach
them.
Do not use Seroquel XL after the expiry date which is stated on the container. The
expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
If the tablets become discoloured or show any other signs of deterioration, you
should seek the advice of your pharmacist.
6. Further information

What Seroquel XL contains
 Each prolonged release tablet contains 150 mg of quetiapine (as quetiapine
fumarate).
 The other ingredients are microcrystalline cellulose, sodium citrate, lactose
monohydrate, magnesium stearate, hypromellose, macrogol 400 and titanium
dioxide (E171).
What Seroquel XL looks like and contents of the pack
Seroquel XL is white, bi-convex prolonged release, film-coated capsule shaped tablets
marked with XR 150 on one side.
Pack size is 60 blister tablets.
PL 27777/0010

Seroquel XL 150mg prolonged release Tablets

Seroquel XL 150mg prolonged-release Tablets
(quetiapine fumarate)

The following side effect has been seen only in children and adolescents:




PACKAGE LEAFLET: INFORMATION FOR THE USER

POM

Manufacturer
The tablets are manufactured by AstraZeneca UK Ltd, Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, United Kingdom and procured from within the EU
by the Product Licence Holder Vital Supplies Limited, 6 Enterprise Court, Witham,
Essex CM8 3YS and repackaged by OPD Laboratories Ltd, Unit 6 Colonial Way,
Watford, Herts WD24 4PR.
Seroquel is a Trade Mark of the AstraZeneca group of companies.
Leaflet revision and update date (ref): 14/12/2012
You can also get information on mental health from the following national
organisations:
• MIND (National Association for Mental Health): Mindinfoline: 0845 7660163
• RETHINK (Formerly the National Schizophrenia Fellowship) Advice Service: 0208
9746814
• National Schizophrenia Fellowship (Scotland): 0131 662 4359
• SANELINE Helpline: 0845 7678000

This medicine is available using the above name but will be referred to as Seroquel XL
throughout the following patient information leaflet. Please note that the leaflet also
contains information about other strengths (Seroquel XL 50mg, 200mg, 300mg,
400mg prolonged release Tablets).
Read all of this leaflet carefully before you start taking this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
 If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Seroquel XL is and what it is used for
2. Before you take Seroquel XL
3. How to take Seroquel XL
4. Possible side effects
5. How to store Seroquel XL
6. Further information
1. What Seroquel XL is and what it is used for
Seroquel XL contains a medicine called quetiapine. This belongs to a group of
medicines called anti-psychotics.
Seroquel XL can be used to treat several illnesses, such as:
 Schizophrenia: where you may hear or feel things that are not there, believe things
that are not true or feel unusually suspicious, anxious, confused, guilty, tense or
depressed.
 Mania: where you may feel very excited, elated, agitated, enthusiastic or
hyperactive or have poor judgment including being aggressive or disruptive.
 Bipolar depression and major depressive episodes in major depressive disorder:
where you may feel sad all the time or you may find that you feel depressed, feel
guilty, lack energy, lose your appetite or can’t sleep.
When Seroquel XL is being taken to treat major depressive episodes in major
depressive disorder, it will be taken in addition to another drug being used to treat this
illness.
Your doctor may continue to prescribe Seroquel XL even when you are feeling better.
2. Before you take Seroquel XL
Do not take Seroquel XL if:
 you are allergic (hypersensitive) to quetiapine or any of the other ingredients of
Seroquel XL (see section 6: Further information)
 you are taking any of the following medicines:
– protease inhibitors, such as nelfinavir (for HIV infection)
– azole medicines (for fungal infections)
– medicines for an infection (like erythromycin or clarithromycin)
– nefazodone (for depression).
Do not take Seroquel XL if the above applies to you. If you are not sure, talk to your
doctor or pharmacist before taking Seroquel XL.
Take special care with Seroquel XL
Before you take your medicine, tell your doctor if:
 You, or someone in your family, have or have had any heart problems such as a
very fast heart beat or prolonged QT on an ECG (heart tracing), or if you are taking
any medicines that may have an impact on the way your heart beats.
 You have low blood pressure.
 You have had a stroke.
 You have problems with your liver.
 You have ever had a fit (seizure).
 You know that you have had low levels of white blood cells in the past (which may
or may not have been caused by other medicines).
 You have diabetes or have a risk of getting diabetes. If you do, your doctor may
check your blood sugar levels while you are taking Seroquel XL.
 You are an elderly person with dementia. If you are, Seroquel XL should not be taken
because the group of medicines that Seroquel XL belongs to may increase the risk of
stroke, or in some cases the risk of death, in elderly people with dementia.
 You or someone else in your family has a history of blood clots, as medicines like
these have been associated with formation of blood clots.
Tell your doctor immediately if you experience:
 A combination of fever, severe muscle stiffness, sweating or a lowered level of
consciousness (a disorder called “neuroleptic malignant syndrome”). Immediate
medical treatment may be needed.
 Uncontrollable movements, mainly of your face or tongue.
 Dizziness or feeling very drowsy. This could increase the risk of accidental injury
(fall) in elderly patients.
 Fits (seizures).
 A long-lasting and painful erection (Priapism).
These conditions can be caused by this type of medicine.
Thoughts of suicide and worsening of your depression
If you are depressed you may sometimes have thoughts of harming or killing yourself.
These may be increased when first starting treatment, since these medicines all take
time to work, usually about two weeks but sometimes longer. These thoughts may
also be increased if you suddenly stop taking your medication. You may be more likely
to think like this if you are a young adult. Information from clinical trials has shown an
increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less
than 25 years with depression.
If you have thoughts of harming or killing yourself at any time, contact your doctor or
go to a hospital straight away. You may find it helpful to tell a relative or close friend
that you are depressed, and ask them to read this leaflet. You might ask them to tell
you if they think your depression is getting worse, or if they are worried about changes
in your behaviour.

Weight gain has been seen in patients taking Seroquel XL. You and your doctor
should check your weight regularly.

4. Possible side effects
Like all medicines, Seroquel XL can cause side effects, although not everybody gets them.

Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines
because it may affect the way the medicines work. This includes medicines obtained
without a prescription and herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following
medicines:
 Epilepsy medicines (like phenytoin or carbamazepine).
 High blood pressure medicines.
 Rifampicin (for tuberculosis).
 Barbiturates (for difficulty sleeping).
 Thioridazine (another anti-psychotic medicine).
 Medicines that affect the heart, for example, drugs that can cause an imbalance in
some of the chemicals in your blood such as diuretics (water pills) or certain
antibiotics.
Before you stop taking any of your medicines, please talk to your doctor or pharmacist
first.
If you have a urine drug screen, taking Seroquel XL could cause positive results for
methadone or drugs for depression called tricyclic antidepressants (TCAs), even
though you may not be taking methadone or TCAs. The result will need to be
confirmed by a more specific test.
Taking Seroquel XL with food and drink
 Seroquel XL should be taken without food, at least one hour before a meal or at
bedtime.
 Be careful how much alcohol you drink. This is because the combined effect of
Seroquel XL and alcohol can make you sleepy.
 Do not drink grapefruit juice while you are taking Seroquel XL. It can affect the way
the medicine works.
Pregnancy and breast-feeding
If you are pregnant, trying to get pregnant, or breast-feeding, talk to your doctor or
pharmacist before taking Seroquel XL.
The following symptoms may occur in newborn babies of mothers that have used
Seroquel XL in the last trimester (last three months of their pregnancy): shaking,
muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and
difficulty in feeding. If your baby develops any of these symptoms you may need to
contact your doctor.
Driving and using machines
Your tablets may make you feel sleepy. Do not drive or use any tools or machines until
you know how the tablets affect you.
Hospital - If you go into hospital, tell the medical staff that you are taking Seroquel XL.
Important information about some of the ingredients of Seroquel XL
Seroquel XL contains lactose which is a type of sugar. If you have been told by your
doctor or pharmacist that you cannot tolerate or digest some sugars, talk to your
doctor before taking this medicine.
If you have been on other medication for this condition, and that medication has
stopped your periods, changing to Seroquel XL may allow them to return.
3. How to take Seroquel XL
Always take Seroquel XL exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure. Your doctor will decide on your starting
dose and may gradually increase it. When you are on your regular dose you will
usually be taking between 150 mg and 800 mg each day. It will depend on your illness
and needs.
 You will take your tablets once a day.
 Swallow your tablets whole with a drink of water.
 Do not split, chew or crush the tablets.
 Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Seroquel XL tablets are available in 5 different strengths.
 Even though the dose might stay the same, it might be supplied as different
strength tablets. For example one 400 mg tablet (white) or two 200 mg tablets
(yellow).
 So don’t be surprised if the colour of your tablets changes from time to time.
Liver problems
If you have liver problems your doctor may give you a lower dose.
Elderly people
If you are elderly your doctor may give you a lower dose.
Children and adolescents under 18 years
Seroquel XL should not be used by children and adolescents aged under 18 years.
If you take more Seroquel XL than you should
If you take more Seroquel XL than prescribed by your doctor, you may feel sleepy, feel
faint or dizzy and have palpitations (a pounding heart beat). Contact your doctor or
nearest hospital straight away. Take the Seroquel XL tablets with you.
If you forget to take a dose of Seroquel XL
If you forget to take a dose, take it as soon as you remember. If it is almost time to
take the next dose, wait until then. Do not take a double dose to make up for a
forgotten tablet.
If you stop taking Seroquel XL
If you suddenly stop taking Seroquel XL, you may feel nauseous or vomit, or be
unable to sleep or have jerky movements, or your original illness might come back.
Your doctor may suggest you reduce the dose gradually before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.

If any of the following happens, stop taking Seroquel XL and contact a doctor or go
to the nearest hospital straight away, as you may need urgent medical attention:
Uncommon (affects less than 1 in 100 people):
 Fits or seizures
 Allergic reactions that may include raised lumps (weals), swelling of the skin and
swelling around the mouth.
 Uncontrollable movements, mainly of your face or tongue (Tardive dyskinesia).
Rare (affects less than 1 in 1,000 people):
 A combination of high temperature (fever), sweating, stiff muscles, feeling very
drowsy or faint, large increase in blood pressure or heartbeat (a disorder called
“neuroleptic malignant syndrome”).
 Jaundice (yellowing of the skin and eyes).
 Hepatitis (inflammation of the liver).
 Priapism (a long-lasting and painful erection).
 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 in breathing.
Very rare (affects less than 1 in 10,000 people):
 Severe allergic reaction (called anaphylaxis) that may include difficulty in breathing,
dizziness and collapse.
 Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema)
 A severe rash, which may develop quickly. Symptoms may include redness,
blistering or peeling of the skin, with possible blisters in the mouth or nose.
Other possible side effects:
Very common (affects more than 1 in 10 people):
 Dizziness (may lead to falls), headache, dry mouth.
 Feeling sleepy (this may go away with time, as you keep taking Seroquel XL) (may
lead to falls).
 Discontinuation symptoms (symptoms which occur when you stop taking Seroquel
XL) include not being able to sleep (insomnia), feeling sick (nausea), headache,
diarrhoea, being sick (vomiting), dizziness and irritability. Gradual withdrawal over
a period of at least 1 to 2 weeks is advisable.
 Putting on weight.
Common (affects less than 1 in 10 people):
 Rapid heartbeat.
 Feeling like your heart is pounding, racing or has skipped beats.
 Constipation, upset stomach (indigestion).
 Feeling weak.
 Swelling of arms or legs.
 Low blood pressure when standing up. This may make you feel dizzy or faint (may
lead to falls).
 High blood sugar.
 Blurred vision.
 Abnormal muscle movements. These include difficulty starting muscle movements,
shaking, feeling restless or muscle stiffness without pain.
 Abnormal dreams and nightmares.
 Feeling more hungry.
 Feeling irritated.
 Disturbance in speech or language.
 Thoughts of suicide and worsening of your depression.
 Shortness of breath.
 Vomiting (mainly in the elderly).
 Fever.
Uncommon (affects less than 1 in 100 people):
 Restless legs.
 Difficulty swallowing.
 Sexual dysfunction.
 Fainting (may lead to falls).
 Stuffy nose.
 Development of diabetes.
 Change in electrical activity of the heart seen on ECG (QT prolongation).
 A slower than normal heart rate which may occur when starting treatment and
which may be associated with low blood pressure and fainting.
Rare (affects less than 1 in 1,000 people):
 Swelling of breasts and unexpected production of breast milk (galactorrhoea).
 Menstrual disorder.
 Walking, talking, eating or other activities while you are asleep.
 Body temperature decreased (hypothermia).
 Inflammation of the pancreas, which cause severe pain in the abdomen and back.
Very rare (affects less than 1 in 10,000 people):
 Worsening of pre-existing diabetes.
 Inappropriate secretion of a hormone that controls urine volume.
 Breakdown of muscle fibres and pain in muscles (rhabdomyolysis).
Not known (can not be estimated from the available data):
 Skin rash with irregular red spots (erythema multiforme).
The class of medicines to which Seroquel XL belongs can cause heart rhythm problems,
which can be serious and in severe cases fatal.
Some side effects are only seen when a blood test is taken. These include changes in the
amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in
the amount of thyroid hormones in your blood, increased liver enzymes, decreases in the
number of certain types of blood cells (including red blood cells), increased blood creatine
phosphokinase (a substance in the muscles), decreases in the amount of sodium in the
blood, and increases in the amount of the hormone prolactin in the blood. Increases in the
hormone prolactin could in rare cases lead to the following:
 Men and women to have swelling of breasts and unexpectedly produce breast milk.
 Women to have no monthly period or irregular periods.
Your doctor may ask you to have blood tests from time to time.
If any of the side effects get serious, or if you notice side effects not listed in this
leaflet, please tell your doctor or pharmacist.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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