Seroquel 200mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Quetiapine fumarate
Available from:
CST Pharma Ltd
ATC code:
N05AH04
INN (International Name):
Quetiapine fumarate
Dosage:
200mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04020100; GTIN: 5055946805436

PACKAGE LEAFLET: INFORMATION FOR THE USER

Seroquel

®

200mg Tablets

(quetiapine fumarate)

Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

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 only. Do not pass it on

to others. It may harm them, even if their signs of illness are the

same as yours.

If you get any side effects talk to your doctor or pharmacist. This

includes any possible side effects not listed in this leaflet. See

section 4.

The name of your medicine is Seroquel 200mg Tablets but will be

referred to as Seroquel throughout this leaflet. Please note that the

leaflet also contains information about other strengths Seroquel 25mg,

100mg and 300mg Tablets.

What is in this leaflet

What Seroquel is and what it is used for

What you need to know before you take Seroquel

How to take Seroquel

Possible side effects

How to store Seroquel

Contents of the pack and other information

Seroquel contains a substance called quetiapine. This belongs to a

group of medicines called anti-psychotics. Seroquel can be used to

treat several illnesses, such as:

Bipolar depression: where you feel sad. You may find that you feel

depressed, feel guilty, lack energy, lose your appetite or can’t sleep.

Mania: where you may feel very excited, elated, agitated,

enthusiastic or hyperactive or have poor judgment including being

aggressive or disruptive.

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.

Your doctor may continue to prescribe Seroquel even when you are

feeling better.

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 medicines (for fungal infections)

Erythromycin or clarithromycin (for infections)

Nefazodone (for depression).

If you are not sure, talk to your doctor or pharmacist before taking

Seroquel.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Seroquel:

if you, or someone in your family, 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

medicines that may have an impact on the way your heart beats.

if you have low blood pressure.

if you have had a stroke, especially if you are elderly.

if you have problems with your liver.

if you have ever had a fit (seizure).

if 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.

if 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).

if you are an elderly person with dementia (loss of brain function).

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.

if you are an elderly person with Parkinson’s disease/parkinsonism.

if 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.

if you have or have had a condition where you stop breathing for

short periods during your normal nightly sleep (called 'sleep

apnoea') and are taking medicines that slow down the normal

activity of the brain ('depressants').

if you have or have had a condition where you can’t completely

empty your bladder (urinary retention), have an enlarged prostate, a

blockage in your intestines, or increased pressure inside your eye.

These conditions are sometimes caused by medicines (called 'anti-

cholinergics') that affect the way nerve cells function in order to treat

certain medical conditions.

if you have a history of alcohol or drug abuse.

Tell your doctor immediately if you experience any of the following after

taking Seroquel:

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 a severe sense of feeling sleepy. 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.

Tell your doctor as soon as possible if you have:

A fever, flu-like symptoms, sore throat, or any other infection, as

this could be a result of a very low white blood cell count, which

may require Seroquel to be stopped and/or treatment to be given.

Constipation along with persistent abdominal pain, or constipation

which has not responded to treatment, as this may lead to a more

serious blockage of the bowel.

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.

Drug Rash with Eosinophilia and Systemic Symptoms

(DRESS).

Widespread rash, high body temperature, liver enzyme elevations, blood

abnormalities (eosinophilia), enlarged lymph nodes and other body

organs involvement (Drug Rash with Eosinophilia and Systemic

Symptoms which is also known as DRESS or drug hypersensitivity

syndrome).

Stop using Seroquel if you develop these symptoms and contact your

doctor or seek medical attention immediately.

Weight gain

Weight gain has been seen in patients taking Seroquel. You and your

doctor should check your weight regularly.

Children and adolescents

Seroquel is not for use in children and adolescents below 18 years of

age.

Other medicines and Seroquel

Tell your doctor if you are taking, have recently taken or might take any

other medicines.

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

Some medicines for HIV.

Azole medicines (for fungal infections).

Erythromycin or clarithromycin (for infections).

Nefazodone (for depression).

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

Epilepsy medicines (like phenytoin or carbamazepine).

High blood pressure medicines.

Barbiturates (for difficulty sleeping).

Thioridazine or Lithium (other anti-psychotic medicines).

Medicines that have an impact on the way your heart beats, for

example, drugs that can cause an imbalance in electrolytes (low

levels of potassium or magnesium) such as diuretics (water pills) or

certain antibiotics (drugs to treat infections).

Medicines that can cause constipation.

Medicines (called 'anti-cholinergics') that affect the way nerve cells

function in order to treat certain medical conditions.

Before you stop taking any of your medicines, please talk to your doctor

first.

Seroquel with food, drink and alcohol

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 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 or breast-feeding, think you may be pregnant or

planning to have a baby ask your doctor for advice before taking this

medicine. You should not take Seroquel during pregnancy unless this

has been discussed with your doctor. Seroquel should not be taken if

you are breast-feeding.

The following symptoms which can represent withdrawal 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.

Seroquel contains lactose

Seroquel contains lactose which is a type of sugar. If you have been

told by your doctor that you have an intolerance to some sugars, talk to

your doctor before taking this medicine.

Effect on Urine Drug Screens

If you are having a urine drug screen, taking Seroquel may cause

positive results for methadone or certain drugs for depression called

tricyclic antidepressants (TCAs) when some test methods are used,

even though you may not be taking methadone or TCAs. If this

happens, a more specific test can be performed.

Always take this medicine exactly as your doctor has told you. Check

with your doctor or pharmacist if you are not sure. Your doctor will

decide on your starting dose. The maintenance dose (daily dose) will

depend on your illness and needs but will usually be between 150mg

and 800mg.

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.

You can take your tablets with or without food.

Do not drink grapefruit juice while you are taking Seroquel. It can

affect the way the medicine works.

Do not stop taking your tablets even if you feel better, unless your

doctor tells you.

Liver problems

If you have liver problems your doctor may change your dose.

Elderly people

If you are elderly your doctor may change your dose.

Use in children and adolescents

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 dizzy and experience abnormal heart beats. Contact your

doctor or nearest hospital straight away. Keep the Seroquel with you.

2.

What you need to know before you take Seroquel

1.

What Seroquel is and what it is used for

3.

How to take Seroquel

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 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

If you suddenly stop taking Seroquel, you may be unable to sleep

(insomnia), or 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 medicine, ask your

doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not

everybody gets them.

Very common: may affect 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.

Abnormal muscle movements. These include difficulty starting

muscle movements, shaking, feeling restless or muscle stiffness

without pain.

Changes in the amount of certain fats (triglycerides and total

cholesterol).

Common: may affect up to 1 in 10 people

Rapid heart beat.

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).

Increased levels of sugar in the blood.

Blurred vision.

Abnormal dreams and nightmares.

Feeling more hungry.

Feeling irritated.

Disturbance in speech and language.

Thoughts of suicide and worsening of your depression.

Shortness of breath.

Vomiting (mainly in the elderly).

Fever.

Changes in the amount of thyroid hormones in your blood.

Decreases in the number of certain types of blood cells.

Increases in the amount of liver enzymes measured in the blood.

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 breasts and unexpectedly

produce breast milk.

Women to have no monthly periods or irregular periods.

Uncommon: may affect up to 1 in 100 people

Fits or seizures.

Allergic reactions that may include raised lumps (weals), swelling of

the skin and swelling around the mouth.

Unpleasant sensations in the legs (also called restless legs

syndrome).

Difficulty swallowing.

Uncontrollable movements, mainly of your face and tongue.

Sexual dysfunction.

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.

Difficulty in passing urine.

Fainting (may lead to falls).

Stuffy nose.

Decrease in the amount of red blood cells.

Decrease in the amount of sodium in the blood.

Worsening of pre-existing diabetes.

Rare: may affect up to 1 in 1,000 people

A combination of high temperature (fever), sweating, stiff muscles,

feeling very drowsy or faint (a disorder called 'neuroleptic malignant

syndrome').

Yellowing of the skin and eyes (jaundice).

Inflammation of the liver (hepatitis).

A long-lasting and painful erection (priapism).

Swelling of breasts and unexpected production of breast milk

(galactorrhoea).

Menstrual disorder.

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. If you notice any of these symptoms seek medical advice

immediately.

Walking, talking, eating or other activities while you are asleep.

Body temperature decreased (hypothermia).

Inflammation of the pancreas.

A condition (called 'metabolic syndrome') where you have a

combination of 3 or more of the following: an increase in fat around

your abdomen, a decrease in 'good cholesterol’ (HDL-C), an

increase in a type of fat in your blood called triglycerides, high blood

pressure and an increase in your blood sugar.

Combination of fever, flu-like symptoms, sore throat, or any other

infection with very low white blood cell count, a condition called

agranulocytosis.

Bowel obstruction.

Increased blood creatine phosphokinase (a substance from the

muscles).

Very rare: may affect up to 1 in 10,000 people

Severe rash, blisters, or red patches on the skin.

A severe allergic reaction (called anaphylaxis) which may cause

difficulty in breathing or shock.

Rapid swelling of the skin, usually around the eyes, lips and throat

(angioedema).

A serious blistering condition of the skin, mouth, eyes and genitals

(Stevens-Johnson syndrome).

Inappropriate secretion of a hormone that controls urine volume.

Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).

Not known: frequency cannot be estimated from the available data

Skin rash with irregular red spots (erythema multiforme).

Serious, sudden allergic reaction with symptoms such as fever and

blisters on the skin and peeling of the skin (toxic epidermal

necrolysis).

Symptoms of withdrawal may occur in newborn babies of mothers

that have used Seroquel during their pregnancy.

Stroke.

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, decrease in the amount of red

blood cells, increased blood creatine phosphokinase (a substance in

the muscles), decrease 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.

Additional side effects in children and adolescents

The same side effects that may occur in adults may also occur in

children and adolescents.

The following side effects have been seen more often in children and

adolescents or have not been seen in adults:

Very common: may affect 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.

Vomiting.

Abnormal muscle movements. These include difficulty starting

muscle movements, shaking, feeling restless or muscle stiffness

without pain.

Increase in blood pressure.

Common: may affect up to 1 in 10 people

Feeling weak, fainting (may lead to falls).

Stuffy nose.

Feeling irritated.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This

includes any possible side effects not listed in this leaflet. You can also

report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the

Google Play or Apple App Store. By reporting side effects, you can

help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not store above 30°C.

Store in the original package.

Do not take the tablets after the expiry date which is stated on the

carton and blister labels after ‘Exp’. The expiry date refers to the last

day of that month.

If the tablets become discoloured or show any signs of deterioration,

seek the advice of your pharmacist.

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.

What Seroquel contains

Each tablet contains 200mg of the active ingredient quetiapine

(as quetiapine fumarate).

This medicine also contains: calcium hydrogen phosphate,

hydroxypropyl methylcellulose, lactose monohydrate, magnesium

stearate, microcrystalline cellulose, macrogol, povidone, sodium starch

glycollate, titanium dioxide (E171).

What Seroquel looks like and contents of the pack

The tablets are white, round biconvex, film-coated tablets, embossed

‘SEROQUEL 200’ on one side and are available in

blister packs of

60 tablets.

Manufactured by: AstraZeneca UK Ltd., Silk Road Business Park,

Macclesfield, Cheshire SK10 2NA, UK.

Procured from within the EU and repackaged by the Product

Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,

Middlesex, HA4 0NU, UK.

Seroquel

®

200mg Tablets; PL 18799/0043

Leaflet date: 31.01.2019

Seroquel is a trade mark of the AstraZeneca UK Ltd.

Blind or partially sighted?

Is this leaflet hard to see or read?

Call 0208 515 3763 to obtain the

leaflet in a format suitable for you.

You can also get information on mental health from the following

national organisations:

MIND (National Association for Mental Health).

MindinfoLine: 0845 766 0163.

RETHINK (Formerly the National Schizophrenia Fellowship). Advice

Service: 020 8974 6814.

National Schizophrenia Fellowship (Scotland): 0131 662 4359.

SANELINE Helpline: 0845 767 8000.

POM

4.

Possible side effects

5.

How to store Seroquel

6.

Contents of the pack and other information

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