Skip to Content

BRANCICO XL 300 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE FUMARATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Brancico XL 200 mg, 300 mg or 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 Brancico XL is and what it is used for
2. What you need to know before you take
Brancico XL
3. How to take Brancico XL
4. Possible side effects
5. How to store Brancico XL
6. Contents of the pack and other information
1. What Brancico XL is and what it is used for
Brancico XL contains a substance called quetiapine.
This belongs to a group of medicines called
antipsychotics. Brancico 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 Brancico 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 Brancico XL
even when you feel better.
2. What you need to know before you take
Brancico XL
Do not take Brancico 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 Brancico XL if the above applies to
you. If you are not sure, talk to your doctor or
pharmacist before taking Brancico XL.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Brancico 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
Brancico 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, Brancico XL should
not be taken because the group of medicines
that Brancico 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 apnea”) and
are taking medicines that slow down the normal
activity of the brain (“depressants”).
• You have or have had a condition where you
can’t completely empty your bladder (urinary
retention), have an enlarged prostate, a
blockage in your intestines, or increased
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 alcohol or drug abuse.
Tell your doctor immediately if you experience any
of the following after taking Brancico 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 Brancico 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
Brancico XL. You and your doctor should check
your weight regularly.
Children and Adolescents
Brancico XL is not for use in children and
adolescents below 18 years of age.
Other medicines and Brancico XL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Do not take Brancico 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, medicines that can
cause an imbalance in electrolytes (low levels of
potassium or magnesium) such as diuretics
(water pills) or certain antibiotics (medicines 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.
Brancico XL with food, drink and alcohol
• Brancico 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 Brancico XL and
alcohol can make you sleepy.
• Do not drink grapefruit juice while you are
taking Brancico 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 Brancico XL during pregnancy
unless this has been discussed with your doctor.
Brancico 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 Brancico 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
Brancico 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.
Brancico 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 Brancico 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
Brancico 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.
Elderly
If you are elderly your doctor may change your
dose.
Use in children and adolescents under
18 years
Brancico XL should not be used by children and
adolescents aged under 18 years.
If you take more Brancico XL than you should
If you take more Brancico 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
Brancico XL tablets with you.
If you forget to take a dose of Brancico 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 Brancico XL
If you suddenly stop taking Brancico 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 Brancico XL (may lead to falls);
• Discontinuation symptoms (symptoms which
occur when you stop taking Brancico 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.
• 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.
• 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):
• 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 Brancico 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.
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:
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 Brancico XL
Keep this medicine out of the sight and reach of
children.
Do not use Brancico XL after the expiry date
which is stated on the container after EXP. The
expiry date refers to the last day of that month.
Brancico 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 Brancico XL contains
The active substance is quetiapine. Brancico XL
tablets contain 200 mg, 300 mg or 400 mg of
quetiapine (as quetiapine fumarate).
The other ingredients are:
Tablet core: lactose anhydrous, Methacrylic acid –
ethyl acrylate copolymer (1:1), type A, maltose,
magnesium stearate and talc.
Tablet coating: Methacrylic acid – ethyl acrylate
copolymer (1:1), type A, triethyl citrate.
What Brancico XL looks like and contents of
the pack
The 200 mg prolonged-release tablets are white
to off white, oblong biconvex and engraved with
‘200’ on one side, 15.2 mm in length, 7.7 mm in
width and 4.8 mm in thickness.
The 300 mg prolonged-release tablets are white
to off white, oblong biconvex and engraved with
‘300’ on one side and 18.2 mm in length, 8.2 mm
in width and 5.4 mm in thickness.
The 400 mg prolonged-release tablets are white
to off white, oval biconvex and engraved with
‘400’ on one side and 20.7 mm in length, 10.2 mm
in width and 6.3 mm in thickness.
Brancico XL prolonged-release tablets are
available as PVC/PCTFE- Aluminium foil blisters
packed in a cardboard box.
The pack sizes are: 10, 30, 50, 60, 100, and
180 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Zentiva, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Manufacturer:
Pharmathen International S.A, Sapes Industrial
Park Block 5, Rodopi, 69300, Greece or
Pharmathen S.A, 6, Dervenakion str., Pallini,
Attiki, 153 51, Greece
This leaflet was last revised in April 2016
’Zentiva’ is a registerd trademark © 2016 Zentiva

000000

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide