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QUETIAPINE TABLETS 200MG

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Seroquel 100mg Tablets/Quetiapine Tablets 100mg
Seroquel 200mg Tablets/Quetiapine Tablets 200mg
(quetiapine fumarate)
Your medicine is known by the above names but will be referred to as
Seroquel throughout this:

Patient Information Leaflet
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 is and what it is used for
2) Before you take Seroquel
3) How to take Seroquel
4) Possible side-effects
5) How to store Seroquel
6) Further information

1) What Seroquel is and what it is used for
Seroquel contains a medicine called quetiapine. This belongs to a group of
medicines called anti-psychotics. Seroquel 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: 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.
Your doctor may continue to prescribe Seroquel even when you are feeling
better.

2) Before you take Seroquel
Do not take Seroquel if
 you are allergic (hypersensitive) to quetiapine or any of the other
ingredients of Seroquel (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 if the above applies to you. If you are not sure, talk to
your doctor or pharmacist before taking Seroquel.
Take special care with Seroquel
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, especially if you are elderly.
 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.
 You are an elderly person with dementia. If you are, Seroquel should not
be taken because the group of medicines that Seroquel 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. You and your
doctor should check your weight regularly.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently
taken, any other medicines because it may affect the way the medicines
work. This includes medicines that you buy without a prescription and
herbal medicines.
In particular, tell your doctor 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
first.
If you have a urine drug screen, taking Seroquel 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 with food and drink
 Seroquel can be taken with or without food.
 Be careful how much alcohol you drink. This is because the combined
effect of Seroquel and alcohol can make you feel sleepy.
 Do not drink grapefruit juice while you are taking Seroquel. 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 before taking Seroquel.
The following symptoms may occur in newborn babies, of mothers that
have used Seroquel 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.
Important information about some of the ingredients of Seroquel
Seroquel 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 may allow them to return.

3) How to take Seroquel
Always take Seroquel 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, at bedtime or twice a day,
depending on your illness.
 Swallow your tablets whole with a drink of water.
 Do not stop taking your tablets even if you feel better, unless your doctor
tells you.
Seroquel tablets come in 5 different strengths and each strength is a
different colour or shape.
 Even though the dose might stay the same, it might be supplied as
different strength tablets. For example, one 300 mg tablet (white) or two
150 mg tablets (pale 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 should not be used by children and adolescents aged under 18
years.
If you take more Seroquel than you should
If you take more Seroquel 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
tablets with you.
If you forget to take a dose of Seroquel
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 dose.

If you stop taking Seroquel
If you suddenly stop taking Seroquel, you may be unable to sleep
(insomnia), you may feel sick (nausea), or you may experience headache,
diarrhoea, being sick (vomiting), dizziness or irritability. 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.

4) Possible side effects
Like all medicines, Seroquel can cause side effects, although not everybody
gets them.
If any of the following happen, stop taking Seroquel 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)
(may lead to falls).
 Discontinuation symptoms (symptoms which occur when you stop taking
Seroquel) 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.
 Indigestion or constipation.
 Feeling weak
 Swelling of arms or legs.
 High blood sugar.
 Low blood pressure when standing. This may make you feel dizzy or faint
(may lead to falls).
 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 causes 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 (cannot be estimated from the available data):
 Skin rash with irregular red spots (erythema multiforme).
The class of medicines to which Seroquel belongs can cause heart rhythm
problems, which can be serious and in severe cases may be 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 the 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 any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Children and adolescents
The same side effects that may occur in adults may also occur in children
and adolescents. The following side effect has been seen only 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
 Store your tablets below 300C. Keep Seroquel Tablets in their original
package.
 If your doctor stops your treatment, take any leftover tablets back to the
pharmacy.
 Do not take your tablets after the expiry date which is stated on the
container. The expiry date refers to the last day of that month.
 Keep out of the sight and reach of children.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.
 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 protect the environment.

6) Further Information
What Seroquel contains:
Each tablet contains the active ingredient quetiapine fumarate equivalent to
either 100mg or 200mg quetiapine.
Seroquel 100mg Tablets also contain the following inactive ingredients:
Lactose monohydrate. hypromellose, povidone, calcium hydrogen
phosphate, sodium starch glycollate, polyethylene glycol, microcrystalline
cellulose, magnesium stearate, titanium dioxide (E171) and yellow iron
oxide (E172).
Seroquel 200mg Tablets also contain the following inactive ingredients:
Lactose monohydrate. hypromellose, povidone, calcium hydrogen
phosphate, sodium starch glycollate, polyethylene glycol, microcrystalline
cellulose, magnesium stearate, titanium dioxide (E171).
What Seroquel looks like and contents of the pack
Seroquel 100mg Tablets are yellow, round tablets coded ‘SEROQUEL 100’
on one side and plain on the reverse.
Seroquel 200mg Tablets are white, round tablets coded ‘SEROQUEL 200’
on one side and plain on the reverse.
Seroquel Tablets are available as blister packs of 60 tablets.
PL 10383/0918
PL 10383/0919

Seroquel 100mg Tablets
Seroquel 200mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Astra Zeneca UK Limited, Macclesfield,
Cheshire, UK. and procured from within the EU and repackaged by the
Product Licence Holder Primecrown Ltd, 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 28.02.2013.

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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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