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BIQUELLE XL 300 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE / QUETIAPINE FUMARATE

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Package leaflet: Information for the user

Biquelle XL 50mg, 150mg, 200mg,
300mg, 400mg
prolonged-release tablets

Children and Adolescents
Biquelle XL is not for use in children and
adolescents below 18 years of age.

Other medicines and Biquelle XL
Tell your doctor or pharmacist if you are taking,
Quetiapine
have recently taken or might take any other
medicines.
Read all of this leaflet carefully before you
Do not take Biquelle XL if you are taking any of the
start taking this medicine because it contains
following medicines:
important information for you.
• Some medicines for HIV.
• Keep this leaflet. You may need to read it again.
• Azole medicines (for fungal infections).
• If you have any further questions, ask your doctor
• Erythromycin or clarithromycin (for infections).
or pharmacist.
• Nefazodone (for depression).
• This medicine has been prescribed for you only.
In particular, tell your doctor if you are taking any of
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours. the following medicines:
• Epilepsy medicines (like phenytoin or
• If you get any side effects, talk to your doctor, or
carbamazepine).
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
• High blood pressure medicines.
• Barbiturates (for difficulty sleeping).
What is in this leaflet
• Thioridazine or Lithium (other anti-psychotic
1. What Biquelle XL is and what it is used for
medicines).
2. What you need to know before you take
• Medicines that have an impact on the way your
Biquelle XL
heart beats, for example, medicines that can
3. How to take Biquelle XL
cause an imbalance in electrolytes (low levels of
4. Possible side effects
potassium or magnesium) such as diuretics
5. How to store Biquelle XL
(water pills) or certain antibiotics (medicines to
treat infections).
6. Contents of the pack and other information
• Medicines that can cause constipation.
Before you stop taking any of your medicines,
1. What Biquelle XL is and what it is
please talk to your doctor first.
used for
Biquelle XL contains a substance called quetiapine.
This belongs to a group of medicines called
antipsychotics. Biquelle 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 Biquelle XL is being taken to treat major
depressive episodes in major depressive disorder, it
will be taken in addition to another medicine being
used to treat this illness.
Your doctor may continue to prescribe Biquelle XL
even when you feel better.

2. What you need to know before you
take Biquelle XL
Do not take Biquelle 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 Biquelle XL if the above applies to you.
If you are not sure, talk to your doctor or
pharmacist before taking Biquelle XL.
Warnings and precautions
Talk to your doctor before taking Biquelle 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 Biquelle
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, Biquelle XL should not
be taken because the group of medicines that
Biquelle 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.
Tell your doctor immediately if you
experience any of the following after taking
Biquelle 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 Biquelle 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 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
Biquelle XL. You and your doctor should check your
weight regularly.

Biquelle XL with food, drink and alcohol
• Biquelle XL can be affected by food and you
should therefore take your tablets at least one
hour before a meal or at bedtime.
• Be careful how much alcohol you drink. This is
because the combined effect of Biquelle XL and
alcohol can make you sleepy.
• Do not drink grapefruit juice while you are
taking Biquelle 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 Biquelle XL during pregnancy
unless this has been discussed with your doctor.
Biquelle 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 Biquelle XL 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
Biquelle XL 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.
Biquelle XL contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. How to take Biquelle XL
Always take this medicine exactly as your doctor or
pharmacist 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 Biquelle 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 to.
Patients with liver problems
If you have liver problems your doctor may change
your dose.
Older patients
If you are elderly your doctor may change your dose.
Use in children and adolescents
(under 18 years)
Biquelle XL should not be used by children and
adolescents aged under 18 years.
If you take more Biquelle XL than you should
If you take more Biquelle 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
Biquelle XL tablets with you.
If you forget to take a dose of Biquelle 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 dose.
If you stop taking Biquelle XL
If you suddenly stop taking Biquelle XL, 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.

4. Possible side effects
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 or
dry mouth.
• Feeling sleepy - this may go away with time, as
you keep taking Biquelle XL (may lead to falls).
• Discontinuation symptoms (symptoms which
occur when you stop taking Biquelle XL) 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 or 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.
• 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.
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.
• 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):
• Worsening of pre-existing diabetes.
• 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.
The class of medicines to which Biquelle XL 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.

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
(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 Biquelle XL
Keep this medicine out of the sight and reach
of children.
Do not use Biquelle XL after the expiry date which is
stated on the container after EXP. The expiry date
refers to the last day of that month.
Biquelle 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 further
information
What Biquelle XL contains
• The active substance is quetiapine. Biquelle XL
tablets contain 50mg, 150mg, 200mg, 300mg or
400mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:
Tablet core: lactose anhydrous, Methacrylic acid
– ethyl acrylate copolymer (1:1), type A,
crystalline maltose, magnesium stearate and talc.
Tablet coating: Methacrylic acid – ethyl acrylate
copolymer (1:1), type A, triethyl citrate.
What Biquelle XL looks like and contents
of the pack
- The 50mg prolonged-release tablets are white to
off white, round biconvex, engraved with ‘50’ on
one side, 7.1mm in diameter and 3.2mm in
thickness.
- The 150mg prolonged-release tablets are white to
off white, oblong biconvex and engraved with
‘150’ on one side, 13.6mm in length, 6.6mm in
width and 4.2mm in thickness.
- The 200 mg prolonged-release tablets are white
to off white, oblong biconvex and engraved with
‘200’ on one side, 15.2mm in length, 7.7mm in
width and 4.8mm in thickness.
- The 300mg prolonged-release tablets are white to
off white, oblong biconvex and engraved with
‘300’ on one side and 18.2mm in length, 8.2mm
in width and 5.4mm in thickness.
- The 400mg prolonged-release tablets are white to
off white, oval biconvex and engraved with ‘400’
on one side and 20.7mm in length, 10.2mm in
width and 6.3mm in thickness.
- Biquelle XL prolonged-release tablets are available
as PVC/PCTFE- Aluminium foil blisters packed in a
cardboard box.
Pack sizes:
Biquelle XL 50mg: 10, 30, 50, 56, 60 and
100 tablets.
Biquelle XL 150mg: 10, 30, 50, 56, 60 and
100 tablets.
Biquelle XL 200mg: 10, 30, 50, 56, 60 and
100 tablets.
Biquelle XL 300mg: 10, 30, 50, 56, 60 and
100 tablets.
Biquelle XL 400mg: 10, 30, 50, 56, 60 and
100 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Pharmathen S.A.
6 Dervenakion Str.
Pallini
Attiki
15351
Greece
Manufacturer:
Pharmathen S.A.
6 Dervenakion Str.
Pallini
Attiki
15351
Greece
or
Pharmathen International S.A.
Sapes Industrial Park Block 5
Rodopi
69300
Greece
Distributed by:
Aspire Pharma Ltd
Bellamy House
Winton Road
Petersfield
Hampshire
GU32 3HA
This leaflet was last revised in 11/2014.

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:
1010269-P1.6

Artwork for:
Aspire Pharma Limited
Product name:
Biquelle XL All strengths
Size:
PL/PA no:
Type: Leaflet
Artwork dimensions: 170mm x 600mm
Profile supplied: Yes
Date of first artwork: 24 September 2014
Reason for request: Text edits
Version no: 1.6
Date of revision:
20 November 2014
Colours:
As swatch(es)
Font(s):
9pt Tahoma
Artwork software:
InDesign CS6
BAC ref: R701

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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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