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ALAQUET XL 150 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE FUMARATE

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Alaquet XL 50 mg
prolonged-release tablets
Alaquet XL 150 mg
prolonged-release tablets
Alaquet XL 200 mg
prolonged-release tablets
Alaquet XL 300 mg
prolonged-release tablets
Alaquet XL 400 mg
prolonged-release tablets
(quetiapine)
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 Alaquet XL is and what it is
used for
2. What you need to know before you
take Alaquet XL
3. How to take Alaquet XL
4. Possible side effects
5. How to store Alaquet XL
6. Contents of the pack and
other information

1. What Alaquet XL is and what
it is used for
Alaquet XL contains a substance called
quetiapine. This belongs to a group
of medicines called anti-psychotics.
Alaquet XL can be used to treat several
illnesses, such as:
• Bipolar depression and major
depressive episodes in major
depressive disorder: 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.
When Alaquet 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
Alaquet XL even when you feel better.

2. What you need to know
before you take Alaquet XL

TBC
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Do not take Alaquet XL:
• 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 Alaquet XL if the above
applies to you. If you are not sure, talk
to your doctor or pharmacist before
taking Alaquet XL.
Warnings and precautions
Talk to your doctor or pharmacist
before taking Alaquet XL 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 Alaquet XL.
• 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, Alaquet XL should not
be taken because the group of
medicines that Alaquet 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.
• 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).
• You have or have had a condition
where you cannot completely empty
your bladder (urinary retention), have
an enlarged prostate, a blockage in
your intestines or increase 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.
• You have a history of problems with
alcohol or drug use.
Tell your doctor immediately if you
experience any of the following
after taking Alaquet XL:
• 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
Alaquet XL 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

Quetiapine Fumarate 400 mg,300 mg,200 mg,

Description 50 mg,150 mg 60,10,100,30
Component Type LeafletInsert
Affiliate Item Code 869837
Superceded Affiliate Item Code 817665
TrackWise PR No. 869837
MA No. N/A
Packing Site/Printer N/A
Supplier Code N/A

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
Alaquet XL is not for use in children
and adolescents below 18 years of age.
Other medicines and Alaquet XL
Tell your doctor if you are taking,
have recently taken or might take any
other medicines, including medicines
obtained without a prescription and
herbal medicines.
Do not take Alaquet XL 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.

Alaquet XL with food, drink
and alcohol
• Alaquet XL can be affected by food
and you should therefore take your
tablets at least one hour before a
meal or prior to bedtime.
• Be careful how much alcohol you
drink. This is because the combined
effect of Alaquet XL and alcohol can
make you sleepy.
• Do not drink grapefruit juice while
you are taking Alaquet XL. 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 Alaquet XL during
pregnancy unless this has been
discussed with your doctor. Alaquet
XL 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 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.
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 Alaquet XL
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.
• Do not split, chew or crush the tablets.
• Swallow your tablets whole with a
drink of water.
• Take your tablets without food (at least
one hour before a meal or at bedtime,
your doctor will tell you when).
• Do not drink grapefruit juice while
you are taking Alaquet XL. 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
Alaquet XL should not be used by
children and adolescents aged under
18 years.
If you take more Alaquet XL than
you should
If you take more Alaquet XL 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 Alaquet XL tablets with you.
If you forget to take a dose of
Alaquet 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 Alaquet XL
If you suddenly stop taking Alaquet XL,
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.

Date: 13 APR 2016

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 278704
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

TBC
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Package leaflet: Information for the patient

1

Time: 09:05
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 148 x 826 mm

Body Text Size 10.5 pt
Min Text Size used 10 pt

Sign-offs

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

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 your
medicine) (may lead to falls)
• Discontinuation symptoms
(symptoms which occur when you
stop taking this medicine) 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 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
• 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
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):
• Fits or seizures
• Allergic reactions that may include
raised lumps (weals), swelling of the
skin and swelling around the mouth
• Combination of fever, flu-like
symptoms, sore throat, or any
other infection with very low white
blood cell count, a condition called
neutropenia.
• Unpleasant sensations in the legs
(also called restless legs syndrome)
• Difficulty swallowing
• Uncontrollable movements, mainly of
your face or 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 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
• 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 quetiapine during
their pregnancy

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, pharmacist or nurse.
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
By reporting side effects you can help
provide more information on the
safety of this medicine.

5. How to store Alaquet XL
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
container after EXP. The expiry date
refers to the last day of that month.
Alaquet XL does not require any
special storage conditions.
Do not throw away any medicines
via wastewater 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 Alaquet XL contains
• The active substance is quetiapine.
Each tablet contains 50 mg, 150 mg,
200 mg, 300 mg or 400 mg of
quetiapine (as quetiapine fumarate).
• The other ingredients are:
Tablet core: hypromellose 2910,
hypromellose 2208, microcrystalline
cellulose, anhydrous sodium citrate,
magnesium stearate.
Tablet coating: titanium dioxide (E171),
hypromellose 2910, macrogol 400,
polysorbate 80. The 50 mg, 200 mg
and 300 mg tablets contain yellow iron
oxide (E172) and red iron oxide (E172).
The 50 mg and 300 mg tablets also
contain black iron oxide (E172).
What Alaquet XL looks like and
contents of the pack
All strengths of Alaquet XL prolongedrelease tablets are biconvex, oblong
film-coated tablets.
50 mg tablets are brown coloured,
with embossing “Q 50” on one side;
150 mg tablets are white coloured,
with embossing “Q 150” on one side;
200 mg tablets are yellow coloured,
with embossing “Q 200” on one side;
300 mg tablets are light yellow
coloured, with embossing “Q 300” on
one side;
400 mg tablets are white coloured,
with embossing “Q 400” on one side.
This medicine is available in plastic
bottles containing 60 prolongedrelease tablets, or blister strips in
cartons, containing:
• 50 mg: 10, 10x1 (unit dose with
perforated blister), 30, 30x1 (unit
dose with perforated blister), 60 or
60x1 (unit dose with perforated
blister) prolonged-release tablets
• 150 mg: 30, 30x1 (unit dose with
perforated blister), 60 or 60x1 (unit
dose with perforated blister)
prolonged-release tablets
• 200 mg: 10, 10x1 (unit dose with
perforated blister), 30, 30x1 (unit dose
with perforated blister), 60, 60x1 (unit
dose with perforated blister), 100 or
100x1 (unit dose with perforated
blister) prolonged-release tablets
• 300 mg: 10, 10x1 (unit dose with
perforated blister), 30, 30x1 (unit dose
with perforated blister), 60, 60x1(unit
dose with perforated blister), 100 or
100x1 (unit dose with perforated
blister) prolonged-release tablets
• 400 mg: 10, 10x1 (unit dose with
perforated blister), 30, 30x1 (unit dose
with perforated blister), 60, 60x1 (unit
dose with perforated blister), 100 or
100x1 (unit dose with perforated
blister) prolonged-release tablets

Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire,
EN6 1TL, UK
Manufacturer
Merckle GmbH,
Ludwig-Merckle-Strassse,
3 D-89143 (Blaubeuren), Germany
Teva UK Limited, Brampton
Road, Hamden Park BN22 9AG
(Eastbourne, East Sussex), UK
Mylan Hungary Kft
H-2900 Komárom
Mylan utca 1
Hungary

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

Quetiapine Fumarate 400 mg,300 mg,200 mg,

Description 50 mg,150 mg 60,10,100,30
Component Type LeafletInsert
Affiliate Item Code 869837
Superceded Affiliate Item Code 817665
TrackWise PR No. 869837
MA No. N/A
Packing Site/Printer N/A
Supplier Code N/A

This leaflet was last revised in
869837
May 2016

Date: 13 APR 2016

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 278704
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

1

Time: 09:05
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 148 x 826 mm

Body Text Size 10.5 pt
Min Text Size used 10 pt

Sign-offs

v1/May 2015

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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