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QUETIAPINE 200MG FILM-COATED TABLETS

Active substance(s): QUETIAPINE FUMARATE

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Package leaflet: Information for the patient

Quetiapine 25 mg
Film-coated Tablets
Quetiapine 100 mg
Film-coated Tablets
Quetiapine 150 mg
Film-coated Tablets
Quetiapine 200 mg
Film-coated Tablets
Quetiapine 300 mg
Film-coated Tablets

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.

What is in this leaflet

1. What Quetiapine is and what it is used for
2. What you need to know before you
take Quetiapine
3. How to take Quetiapine
4. Possible side effects
5. How to store Quetiapine
6. Contents of the pack and other information.

1. What Quetiapine is and what it is
used for
Quetiapine contains a substance called
quetiapine. This belongs to a group of medicines
called anti-psychotics. Quetiapine 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
Quetiapine even when you are feeling better.

2. What you need to know before you
take Quetiapine
Do not take Quetiapine:

• 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)
Do not take Quetiapine if the above applies to
you. If you are not sure, talk to your doctor or
pharmacist before taking Quetiapine.

Warnings and precautions

Talk to your doctor or pharmacist before taking
Quetiapine 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.
• 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 have diabetes or have a risk of getting
diabetes. If you do, your doctor may check
your blood sugar levels while you are
taking Quetiapine.
• 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 are an elderly person with dementia (loss
of brain function). If you are, Quetiapine should
not be taken because the group of medicines
that Quetiapine 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 any of the following after taking
Quetiapine:

• 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 your medicine 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.

Weight gain

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

Children and adolescents

Quetiapine is not for use in children and
adolescents below 18 years of age.

Other medicines and Quetiapine

Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Do not take Quetiapine 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.
Before you stop taking any of your medicines,
please talk to your doctor first.

Quetiapine with food, drink and alcohol

Be careful how much alcohol you drink. This is
because the combined effect of quetiapine and
alcohol can make you sleepy.
Do not drink grapefruit juice while you are
taking Quetiapine. 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 are planning to have a
baby, ask your doctor or pharmacist for advice
before taking this medicine. You should not take
Quetiapine during pregnancy unless this has
been discussed with your doctor. Quetiapine
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 taken quetiapine 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.

Quetiapine contains lactose

Quetiapine contains lactose which is a type of
sugar. If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicine.

Effect on Urine Drug Screens

If you are having a urine drug screen, taking
Quetiapine 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.

3. How to take Quetiapine
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 150 mg and 800 mg.
• 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 Quetiapine. 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

Quetiapine should not be used by children and
adolescents aged under 18 years.

If you take more Quetiapine than you should
If you take more Quetiapine than prescribed
by your doctor, you may feel sleepy, feel dizzy
and experience abnormal heart beats. Contact
your doctor or nearest hospital straight away.
Take the container and any remaining tablets
with you.

If you forget to take a dose of Quetiapine

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 Quetiapine

If you suddenly stop taking Quetiapine, 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 medicine, ask your doctor or pharmacist.

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

If any of the following happen, stop taking
Quetiapine and contact a doctor or go to the
nearest hospital straight away, as you may
need urgent medical attention:
Very common (may affect more than 1 in
10 people):

• Abnormal muscle movements. These include
difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain

Common (may affect up to 1 in 10 people):
• Thoughts of self harm and suicide or
worsening of your depression.

Date: 31 Mar 2015
Description Quetiapine Fumarate 300/200/25/100/150 mg 60
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 607523

SAP No. n/a

Superceded Affiliate Item Code 446292
TrackWise PR No. 607523
MA No. 04569/1036, 1039
Packing Site/Printer n/a
Supplier Code 11300091 MI-06
Sign-offs

Vendor Job No. 250890
Proof No. 1
Client Market UK
Keyline/Drawing No. n/a
Barcode Info n/a

No. of colours
Colours

1

Time: 17:13
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 620 mm

Body Text Size 9.5 pt
Min Text Size used 8 pt

Uncommon (may affect up to 1 in
100 people):

• Diabetes mellitus: condition in which the body
does not produce enough insulin or else the
body tissues are not able to use the insulin
present. This leads to hyperglycaemia (too
much sugar in the blood). Symptoms may
include excessive thirst, increased appetite
with weight loss, feeling tired, drowsy, weak,
depressed, irritable and generally unwell, and
passing large amounts of urine
• 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.
• Change in electrical activity of the heart seen
on ECG (QT prolongation), which can cause a
very fast heart beat and fainting, and can cause
serious problems with the heart.
• Difficulty in passing urine.

Rare (may affect up to 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”).
• Inflammation of pancreas which causes severe
abdominal and back pain.
• Yellowing of the skin and eyes (Jaundice).
• Inflammation of the liver (Hepatitis).
• A long-lasting and painful erection (Priapism).
• 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.
• Combination of fever, flu-like symptoms,
sore throat, or any other infection with very
low white blood cell count, a condition
called agranulocytosis.
• An obstruction of the bowel, causing severe
constipation and a lack of wind (flatulence),
with swelling or pain in the stomach.

Very rare (may affect up to 1 in 10,000 people):
• Severe allergic reaction (called anaphylaxis)
that may include difficulty in breathing,
dizziness and collapse.
• A severe rash, which may develop quickly.
Symptoms may include redness, blistering or
peeling of skin particularly around the mouth,
nose, eyes and genitals (a condition known as
Stevens-Johnson syndrome).
• Rapid swelling of the skin, usually around the
eyes, lips and throat.
• Worsening of pre-existing diabetes
• Inappropriate secretion of ADH, a hormone
that causes the body to retain water and dilute
the blood, reducing the amount of sodium.
This may lead to a lower than normal level of
sodium in the blood, causing you to feel weak
and confused with aching muscles.
• Breakdown of muscle fibres causing
pain, tenderness and weakness in the
muscles (rhabdomyolysis).

Not known (frequency cannot be estimated
from the available data):

• A widespread redness of skin with blisters and
peeling on much of the body surface (toxic
epidermal necrolysis).

Other possible side effects:
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 quetiapine) (may lead to falls).
• Discontinuation symptoms (symptoms which
occur when you stop taking quetiapine)
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.
• Changes in the amount of certain fats
(triglycerides and total cholesterol).

Common (may affect up to 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).
• Increased levels of sugar in the blood.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Disturbance in speech and language.
• 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 of breasts
and unexpectedly produce breast milk.
* Women to have no monthly period or
irregular periods.

Uncommon (may affect up to 1 in
100 people):

• Unpleasant sensations in the legs (also called
restless legs syndrome).
• Difficulty swallowing.
• Sexual dysfunction.
• A slower than normal heart rate which may
occur when starting treatment and which
may be associated with low blood pressure
and fainting.
• Fainting (may lead to falls).
• Stuffy nose.
• Decrease in the amount of red blood cells.
• Decrease in the amount of sodium in
the blood.

Rare (may affect up to 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).
• A condition (called “metabolic syndrome”)
where you may 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.
• Increased blood creatine phosphokinase
(a substance from the muscles).

Not known (frequency cannot be estimated
from the available data):
• Skin rash with irregular red spots (erythema
multiforme).
• Symptoms of withdrawal may occur in
newborn babies of mothers that have taken
quetiapine during their pregnancy.

The class of medicines to which quetiapine
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 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.

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 via the website:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information
on the safety of this medicine.

5. How to store Quetiapine
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the carton after ‘Exp’. The
expiry date refers to the last day of that month.
This medicinal product does not require any
special storage conditions.
Do not throw away any medicines via waste
water or household waste. Ask your pharmacist
how to throw away medicines you no
longer use. These measures will help protect
the environment.

6. Contents of the pack and
other information
What Quetiapine Film-coated Tablets contain

• The active substance is quetiapine fumarate.
• Each 25 mg/100 mg/150 mg/200 mg/300 mg
film-coated tablet contains
25 mg/100 mg/150 mg/200 mg/300 mg
quetiapine (as quetiapine fumarate).
• The other ingredients are: lactose
monohydrate, microcrystalline cellulose,
povidone 30, magnesium stearate, sodium
starch glycolate (Type A), calcium hydrogen
phosphate dihydrate. The tablet coating
contains: hypromellose, titanium dioxide
(E171), macrogol 400 (25 mg, 150 mg, 200 mg,
300 mg tablets), macrogol 6000 (100 mg
tablets), iron oxide red (E172) (25 mg tablets),
iron oxide yellow (E172) (100 mg, 150 mg
tablets), iron oxide black (E172) (150 mg
tablets), talc (100 mg tablets), polysorbate
80 (150 mg, 200 mg, 300 mg tablets).

What Quetiapine Film-coated Tablets look
like and contents of the pack

Quetiapine tablets are film-coated tablets. The
25 mg tablet is round, peach coloured, biconvex
and engraved “Q” on one side. The 100 mg tablet
is round, yellow, biconvex, and engraved “Q” over
“100” on one side. The 150 mg tablet is round,
pale yellow and engraved “Q” over “150” on one
side. The 200 mg tablet is round, white and
engraved “Q” over “200” on one side. The 300 mg
tablet is capsule shaped, white and engraved “Q”
breakline “300” on one side. The tablet can be
divided into equal doses.
Quetiapine Film-coated Tablets are available
in blister packs and bottles of 1, 3, 6, 7, 10, 14,
20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 250, 500,
1000 tablets* and in perforated unit dose blisters
in pack sizes of 6 x 1 tablets (25 mg only) or 60 x
1 tablets (25 mg, 100 mg, 200 mg, 300 mg)
* Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan,
Potters Bar,
Hertfordshire,
EN6 1TL

Manufacturer:

Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13,
Ireland
Generics [UK] Limited,
Potters Bar,
Hertfordshire,
EN6 1TL,
United Kingdom

This leaflet was last revised in: 04/2015

Date: 31 Mar 2015
Description Quetiapine Fumarate 300/200/25/100/150 mg 60
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 607523

SAP No. n/a

Superceded Affiliate Item Code 446292
TrackWise PR No. 607523
MA No. 04569/1036, 1039
Packing Site/Printer n/a
Supplier Code 11300091 MI-06
Sign-offs

Vendor Job No. 250890
Proof No. 1
Client Market UK
Keyline/Drawing No. n/a
Barcode Info n/a

No. of colours
Colours

1

607523
11300091 MI-06

Time: 17:13
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 620 mm

Body Text Size 9.5 pt
Min Text Size used 8 pt

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.

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