QUETIAPINE 100MG TABLETS

Active substance: QUETIAPINE FUMARATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Assessed against UK PIL dated July 2011 and to include safety warning

Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Seroquel 100mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/1018E

DATE OF PROOF:

02/11/11

DATE:

PROOF HISTORY:
v.1 - waymade - 02/11/11

DATE:

CUSTOMER:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MARCH 2011
INC SAFETY WARNING

Pg 1

Pg 4

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.
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
Keep your Seroquel tablets in the original package and do not store above 30°C.
Keep your Seroquel tablets in a safe place where children cannot see or reach them.
If your doctor stops your treatment, take any leftover tablets back to the pharmacy.
Do not use the tablets after the expiry date printed on the container. Take any tablets which are out of date
back to the pharmacy.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose
of medicines that are no longer required. These measures will help to protect the environment.

6. Further Information
Each Seroquel 100mg tablet/Quetiapine 100mg tablet contains 100mg of the active ingredient, quetiapine (as
the fumarate). The tablets are yellow, round and marked ‘SEROQUEL 100’ on one side and are plain on the
other side.
Seroquel 100mg tablets/Quetiapine 100mg tablets also contain the following:
Lactose monohydrate, magnesium stearate, microcrystalline cellulose, calcium hydrogen phosphate,
hypromellose, macrogol, povidone, sodium starch glycollate, titanium dioxide (E171) and yellow iron oxide
(E172).
Seroquel 100mg tablets/Quetiapine 100mg tablets are available as blister packs of 60 tablets.
POM

PL No: 6464/1018

This product is manufactured by AstraZeneca UK Ltd., Macclesfield, Cheshire, England and is procured from
within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex, SS14 3FR

Update
Leaflet revision and issue date (Ref.) 2.11.2011
Seroquel® is a registered trademark of AstraZeneca UK Ltd.
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 National Schizophrenia Fellowship). Advice Service: 0208 974 6814
•National Schizophrenia Fellowship (Scotland): 0131 662 4359
•SANELINE Helpline: 0845 767 8000

SEROQUEL® 100mg TABLETS/QUETIAPINE 100mg TABLETS
(quetiapine fumarate)
Patient Information Leaflet
This product is known as the above names, but will be referred to as Seroquel in this 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 gets 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.

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 the 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.

Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Seroquel 100mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/1018E

DATE OF PROOF:

02/11/11

DATE:

PROOF HISTORY:
v.1 - waymade - 02/11/11

DATE:

CUSTOMER:

Leaflet Flat Size = 296 x 317

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MARCH 2011
INC SAFETY WARNING

Pg 2

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. You may be more likely to thank 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.

Pg 3

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.

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 antipsychotic 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. It can affect the way the medicine works.
Pregnancy and breast feeding
If you are pregnant, trying to become 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 depends 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 and 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.

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 that may include difficulty in breathing, dizziness and collapse.

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

Feeling like your heart is pounding, racing or has skipped beats.

Stuffy nose.

Indigestion or constipation.
Delete

Feeling weak (may lead to falls).

Swelling of arms or legs.

High blood sugar.

Low blood pressure when standing up. 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.

Shortness of breath.

Vomiting (mainly in the elderly).

Fever.
Uncommon (affects less than 1 in 100 people):

Restless legs.
Add:

Difficulty swallowing.
* Fainting (may lead to falls).

Sexual dysfunction.

* Stuffy nose.

Rare (affects less than 1 in 1,000 people)

Swelling of the breasts and unexpected production of breast milk (galactorrhoea).

Menstrual disorder.

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

Body temperature decreased (hypothermia).
Very rare (affects less than 1 in 10,000 people)

Worsening of pre-existing diabetes.

A severe rash, blisters or red patches on the skin.

Inappropriate secretion of a hormone that controls urine volume.

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

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.

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, decreases in the number of certain types of
blood cells, decreases in the amount of sodium in the blood, changes in the amount of thyroid hormones in the
blood, increased blood creatine phosphokinase (a substance in the muscles) 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.

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

changes

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

Expand view ⇕

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.

Hide
(web4)