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BIQUELLE XL 200 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE

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Biquelle XL 50mg, 150mg, 200mg,
300mg, 400mg
prolonged-release tablets
Quetiapine
start taking this medicine because it contains
important information for you.
• Keep this
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
See section 4.
not listed in this

If you have thoughts of harming or killing yourself
at any time, contact your doctor or go to a hospital
straight away. You may
it helpful to tell a
relative or close friend that you are depressed, and
ask them to read this
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.
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,
have recently taken or might take any other
medicines.
Do not take Biquelle XL if you are taking any of the
1. What Biquelle XL is and what it is used for
following medicines:
2. What you need to know before you take
• Some medicines for HIV.
Biquelle XL
• Azole medicines (for fungal infections).
3. How to take Biquelle XL

Erythromycin or clarithromycin (for infections).
4. Possible side effects
• Nefazodone (for depression).
5. How to store Biquelle XL
In particular, tell your doctor if you are taking any of
6. Contents of the pack and other information
the following medicines:
• Epilepsy medicines (like phenytoin or
1. What Biquelle XL is and what it is
carbamazepine).
used for
• High blood pressure medicines.
Biquelle XL contains a substance called quetiapine.
sleeping).
• Barbiturates (for
This belongs to a group of medicines called

Thioridazine
or
Lithium
(other
anti-psychotic
antipsychotics. Biquelle XL can be used to treat
medicines).
several illnesses, such as:
• Bipolar depression and major depressive episodes • Medicines that have an impact on the way your
heart beats, for example, medicines that can
in major depressive disorder: where you feel sad.
cause an imbalance in electrolytes (low levels of
You may
that you feel depressed, feel guilty,
potassium or magnesium) such as diuretics
lack energy, lose your appetite or can’t sleep.
(water pills) or certain antibiotics (medicines to
• Mania: where you may feel very excited, elated,
treat infections).
agitated, enthusiastic or hyperactive or have poor
judgment including being aggressive or disruptive. • Medicines that can cause constipation.
• Schizophrenia: where you may hear or feel things • Medicines (called “anti-cholinergics”) that affect
the way nerve cells function in order to treat
that are not there, believe things that are not true
certain medical conditions.
or feel unusually suspicious, anxious, confused,
Before you stop taking any of your medicines,
guilty, tense or depressed.
please talk to your doctor
When Biquelle XL is being taken to treat major
depressive episodes in major depressive disorder, it Biquelle XL with food, drink and alcohol
will be taken in addition to another medicine being
• Biquelle XL can be affected by food and you
used to treat this illness.
should therefore take your tablets at least one
Your doctor may continue to prescribe Biquelle XL
hour before a meal or at bedtime.
even when you are feeling better.
• Be careful how much alcohol you drink. This is
because the combined effect of Biquelle XL and
alcohol
can make you sleepy.
2. What you need to know before you
• Do not drink grapefruit juice while you are
take Biquelle XL
taking Biquelle XL. It can affect the way the
Do not take Biquelle XL
medicine works.
• If you are allergic to quetiapine or any of the
Pregnancy and breast-feeding
other ingredients of this medicine (listed in
If you are pregnant or breast-feeding, think you
section 6).
may
be pregnant or are planning to have a baby,
• If you are taking any of the following medicines:
ask your doctor or pharmacist for advice before
- Some medicines for HIV
taking this medicine.
- Azole medicines (for fungal infections)
You should not take Biquelle XL during pregnancy
- Erythromycin or clarithromycin (for infections)
unless this has been discussed with your doctor.
- Nefazodone (for depression)
Biquelle XL should not be taken if you are
Do not take Biquelle XL if the above applies to you. breast-feeding.
If you are not sure, talk to your doctor or
The following symptoms, which can represent
pharmacist before taking Biquelle XL.
withdrawal, may occur in newborn babies, of
mothers that have used Biquelle XL in the last
Warnings and precautions
trimester (last three months of their pregnancy):
Talk to your doctor before taking Biquelle XL if:
shaking, muscle stiffness and/or weakness,
• You, or someone in your family, have or have had sleepiness, agitation, breathing problems, and
any heart problems, for example heart rhythm
in feeding. If your baby develops any of
problems, weakening of the heart muscle or
these symptoms you may need to contact your
of the heart, or if you are taking any doctor.
medicines that may have an impact on the way
Driving and using machines
your heart beats.
• You have low blood pressure.
Your tablets may make you feel sleepy. Do not drive
• You have had a stroke, especially if you are elderly. or use any tools or machines until you know how
the tablets affect you.
• You have problems with your liver.
• You have ever had a (seizure).
Effect on Urine Drug Screens
• You have diabetes or have a risk of getting
If you are having a urine drug screen, taking
diabetes. If you do, your doctor may check your
Biquelle XL may cause positive results for
blood sugar levels while you are taking Biquelle
methadone or certain drugs for depression called
XL.
tricyclic antidepressants (TCAs) when some test
• You know that you have had low levels of white
methods are used, even though you may not be
blood cells in the past (which may or may not
taking methadone or TCAs. If this happens, a more
have been caused by other medicines).
test can be performed.
• You are an elderly person with dementia (loss of
brain function). If you are, Biquelle XL should not Biquelle XL contains lactose
be taken because the group of medicines that
Biquelle XL contains lactose which is a type of sugar.
Biquelle XL belongs to may increase the risk of
If you have been told by your doctor that you have
stroke, or in some cases the risk of death, in
an intolerance to some sugars, contact your doctor
elderly people with dementia.
before taking this medicine.
• You or someone else in your family has a history
of blood clots, as medicines like these have been
3. How to take Biquelle XL
associated with formation of blood clots.
• You have or have had a condition where you stop Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
breathing for short periods during your normal
pharmacist if you are not sure.
nightly sleep (called “sleep apnoea”) and are
taking medicines that slow down the normal
Your doctor will decide on your starting dose. The
activity of the brain (“depressants”).
maintenance dose (daily dose) will depend on your
• You have or have had a condition where you can’t illness and needs but will usually be between
completely empty your bladder (urinary
150mg and 800mg.
retention), have an enlarged prostate, a blockage • You will take your tablets once a day.
in your intestines, or increased pressure inside
• Do not split, chew or crush the tablets.
your eye. These conditions are sometimes caused
• Swallow your tablets whole with a drink of water.
by medicines (called “anti-cholinergics”) that

Take your tablets without food (at least one hour
affect the way nerve cells function in order to
before a meal or at bedtime, your doctor will tell
treat certain medical conditions.
you when).
Tell your doctor immediately if you
• Do not drink grapefruit juice while you are
experience any of the following after taking
taking Biquelle XL. It can affect the way the
Biquelle XL:
medicine works.
• A combination of fever, severe muscle stiffness,
• Do not stop taking your tablets even if you feel
sweating or a lowered level of consciousness (a
better, unless your doctor tells you to.
disorder called “neuroleptic malignant syndrome”).
Patients with liver problems
Immediate medical treatment may be needed.
If you have liver problems your doctor may change
• Uncontrollable movements, mainly of your face
your dose.
or tongue.
• Dizziness or a severe sense of feeling sleepy. This
Elderly people
could increase the risk of accidental injury (fall) in
If you are elderly your doctor may change your dose.
elderly patients.
• Fits (seizures).
Use in children and adolescents
• A long-lasting and painful erection (Priapism).
Biquelle XL should not be used by children and
adolescents aged under 18 years.
These conditions can be caused by this type of
medicine.
If you take more Biquelle XL than you should
Tell your doctor as soon as possible if you have:
If you take more Biquelle XL than prescribed by
• A fever,
symptoms, sore throat, or any
your doctor, you may feel sleepy, feel dizzy and
other infection, as this could be a result of a
experience abnormal heartbeats. You may also
very low white blood cell count, which may
experience other symptoms including dry mouth,
require Biquelle XL to be stopped and/or
constipation and blurred vision. Contact your doctor
treatment to be given.
or nearest hospital straight away. Take the Biquelle
• Constipation along with persistent abdominal
XL tablets with you.
pain, or constipation which has not responded to
treatment, as this may lead to a more serious
If you forget to take a dose of Biquelle XL
blockage of the bowel.
If you forget to take a dose, take it as soon as you
remember.
If it is almost time to take the next dose,
Thoughts of suicide and worsening of your
wait until then. Do not take a double dose to make
depression
up for a forgotten dose.
If you are depressed you may sometimes have
thoughts of harming or killing yourself. These may
If you stop taking Biquelle XL
be increased when
starting treatment, since
If you suddenly stop taking Biquelle XL, you may
these medicines all take time to work, usually about be unable to sleep (insomnia) or you may feel
two weeks but sometimes longer.
sick (nausea) or you may experience headache,
These thoughts may also be increased if you
diarrhoea, being sick (vomiting), dizziness or
suddenly stop taking your medication. You may be
irritability.
more likely to think like this if you are a young
Your doctor may suggest you reduce the dose
adult. Information from clinical trials has shown an
gradually before stopping treatment.
increased risk of suicidal thoughts and/or suicidal
If you have any further questions on the use of this
behaviour in young adults aged less than 25 years
medicine, ask your doctor or pharmacist.
with depression.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common side effects
(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
starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.
• Changes in the amount of certain fats
(triglycerides and total cholesterol).
Common side effects
(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 side effects
(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 sensation in the legs (also called
restless legs syndrome).
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.
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.
• Decrease in a type of white blood cells
(called neutrophils).
Rare side effects
(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).
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
in
to the lungs causing chest pain and
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).
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.
symptoms, sore
• Combination of fever,
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 side effects
(may affect up to 1 in 10,000 people):
• Severe rash, blisters, or red patches on the skin.
• A severe reaction (called anaphylaxis) which may
in breathing or shock.
cause
• 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.
and pain in muscles
• Breakdown of muscle
(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 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 side effects
(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
starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.
• Increase in blood pressure.
Common side effects
(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
You can also report side
not listed in this
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 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.
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 other
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 200mg 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:
Aspire Pharma Ltd
Unit 4, Rotherbrook Court
Bedford Road
Hampshire
GU32 3QG, UK
Manufacturer:
Pharmathen S.A.
6 Dervenakion Str.
Pallini
Attiki
15351
Greece
or
Pharmathen International S.A.
Sapes Industrial Park Block 5
Rodopi
69300
Greece

08/2016.

1010319-P3.1

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Aspire Pharma Limited
Biquelle XL All strengths
Black
Leaflet
170mm x 600mm
Yes
24 September 2014
Piggy back version: text edits
3.1
23 August 2016
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9pt Tahoma
InDesign CS6
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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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