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EZEMBRA XL 400 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE HEMIFUMARATE / QUETIAPINE HEMIFUMARATE / QUETIAPINE HEMIFUMARATE

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Bluefish Pharmaceuticals
Reason of change
Product name

Initial Mockup Artwork (AM-17-047). Text received on 21.06.17

Ezembra XL Prolonged-release tablets

Strength

200/300/400 mg Packs

Country

United
Kingdom

Dimension

Artwork code M/QUESR/UK/P01 No. of colours

-

Manufacturer

Revision no.

01
01

Pantone Shades
Intas

Black

170 x 550 mm

Component Package
Leaflet

Artwork made to

100%
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QA

Remarks Font size: Heading 15, 13 pts.
Rest all 8.3 pts.
Date: 22.06.2017

RA

Revision
History

170 mm

United Kingdom

PACKAGE LEAFLET: INFROMATION FOR THE USER
Ezembra XL 200 mg Prolonged-release tablets
Ezembra XL 300 mg Prolonged-release tablets
Ezembra 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 the side effects, talk to your doctor or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Ezembra XL is and what it is use for
What you need to know before you take Ezembra XL
How to take Ezembra XL
Possible side effects
How to store Ezembra XL
Contents of the pack and other information

1. What Ezembra XL is and what it is used for
Ezembra XL contains a substance called quetiapine.
This belongs to a group of medicines called antipsychotics. Ezembra XL can be used to treat several
illnesses, such as:
• 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.
• Mania: where you may feel very excited, elated,
agitated, enthusiastic or hyperactive or have poor
judgment including being aggressive or disruptive.
• Bipolar depression and major depressive episodes in
major depressive disorder: where you may feel sad
all the time or you may find that you feel depressed,
feel guilty, lack energy, lose your appetite or can’t
sleep.
When Ezembra 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 Ezembra XL
even when you are feeling better.
2. What you need to know before you take Ezembra XL

550 mm

Do not take Ezembra XL if:
- You are allergic (Hypersensitive) to Quetiapine or
any of the other ingredients of Ezembra XL. (See
section 6: Further Information)
- you are taking any of the following medicines:
- Some medicines for HIV
- azole medicines (for fungal infections)
- erythromycin or clarithromycin (for infection)
- nefazodone (for depression).
Do not take Ezembra XL if the above applies to you. If
you are not sure than talk to your doctor or pharmacist
before you take Ezembra XL.
Take special care with Ezembra XL:
Before you take your medicine, tell your doctor if:
- You, or someone in your family, have or have had
any heart problems, for example heart rhythm
problems 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 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 have diabetes or have a risk of getting diabetes.
If you do, your doctor may check your blood sugar
levels while you are taking Ezembra XL.
- 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 are an elderly person with dementia (loss of
brain function). If you are, Ezembra XL should not
be taken because the group of medicines that
Ezembra XL belongs to may increase the risk of
stroke, or in some cases the risk of death, in elderly
people with dementia.
- if 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”).
- if 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.
- if you have a history of alcohol or drug abuse.
Tell your doctor immediately if you experience:
- 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 sever 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
medicines.
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 Ezembra 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. 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 has been seen in patients taking Ezembra
XL. You and your doctor should check your weight
regularly.
Children and adolescents:
Ezembra XL is not for use in children and adolescents
below 18 years of age.
Other medicine and Ezembra XL:
Please tell your doctor if you are taking or have recently
taken any other medicines because it may affect the
way the medicines work. This includes medicines that
you buy without a prescription and herbal medicines.
Do not take Ezembra XL if you are taking any of the
following medicines:
- Some medicines for HIV which are strong inhibitors
of cytochrome P450 (CYP) 3A4.
- 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 (another anti-psychotic medicine).
- 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 or pharmacist first.
Ezembra XL with food and, drink and alcohol
- Ezembra 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 Ezembra XL and
alcohol can make you sleepy.
- Do not drink grapefruit juice while you are taking
Ezembra XL. It can affect the way the medicine
works.
Pregnancy, breast-feeding and fertility
If you are pregnant, trying to get pregnant, or breastfeeding, talk to your doctor or pharmacist before taking
Ezembra XL.
You should not take Ezembra XL during pregnancy
unless this has been discussed with your doctor.
Ezembra XL should not be taken if you are breastfeeding.
The following symptoms which can represent
withdrawal may occur in newborn babies, of mothers
that have used Ezembra 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.
Important information about some of the ingredients
of Ezembra XL.
Ezembra XL 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 medicinal product
Effect on Urine Drug Screens
If you are having a urine drug screen, taking Ezembra
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.
3. How to take Ezembra XL
Always take Ezembra XL exactly as your doctor has
told you. You should 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.
- Swallow your tablets whole with a drink of water.
- Do not split, chew or crush the tablets.
- Take your tablets without food (at least one hour
before a meal or at bedtime, your doctor will tell
you when).
- Do not stop taking your tablets even if you feel
better, unless your doctor tells you.
- Do not drink grapefruit juice while you are taking
Ezembra XL. It can affect the way the medicine
works
Liver problems
If you have liver problems your doctor may change your
dose.
Elderly people
If you have liver problems your doctor may change your
dose.
Children and adolescents under 18 years
Ezembra XL should not be used by children and
adolescents aged under 18 years.
If you take more Ezembra XL than you should
If you take more Ezembra XL than prescribed by your
doctor, you may experience sleepiness, dizziness and
abnormal heart beats. Go to your doctor or nearest
hospital straight away. Take the Ezembra XL with you.

170 mm
If you forget to take a dose of Ezembra 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 Ezembra XL
If you suddenly stop taking Ezembra XL, you may
feel nauseous or vomit, or be unable to sleep or have
jerky movements, or your original illness might come
back. Your doctor may suggest you reduce the dose
gradually before stopping treatment.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
Not all dosing regimes are practical/possible with
the present strengths of Ezembra XL and other
authorised products containing quetiapine are
available
4. Possible Side Effects
Like all medicines, Ezembra XL can cause side effects,
although not everybody gets them.
If any of the following side effects get serious, or if
you notice side effects not listed in this leaflet, please
tell your doctor or pharmacist:

550 mm

Very common (affects more than 1 in 10 patients):
- Dizziness (may lead to falls), headache, dry mouth
- Feeling sleepy (this may go away with time, as
you keep taking Ezembra XL (may leads 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.
- Abnormal muscle movements. These include
difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.
Common (affects less than 1 in 10 patients):
- 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 led to falls)
- Increased levels of sugar in the blood.
- Blurred vision
- Abnormal dreams and nightmares
- Feeling more hungry
- Feeling irritated
- Disturbance in speech or 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 (affects less than 1 in 100 patients):
- 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.
- Uncontrolled movements, mainly of your face or
tounge.
- Sexual dysfunction.
- Diabetes
- Worsening of pre-existing 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 (affects less than 1 in 1000 patients):
- 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 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” (HDLC), an increase
in a type of fat in your blood called trigylcerides,
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 muscles).
Very rare (affect less than 1 in 10,000 patients):
- 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 (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 Ezembra XL during
their pregnancy.
The class of medicines to which Ezembra 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.
Therefore, your doctor may ask you to have blood
tests from time to time.
Children and adolescent:
The same side effects that may occur in adults can
also be present in children and adolescents.
The following side effects are only observed in
children and adolescents:
Very common (affect more than 1 in 10 patients):
- Increase in blood pressure.
- Increase in the amount of hormone called prolactin
in the blood. Increasing amount of hormone call
prolactin in rare cases can 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.
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 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 Ezembra XL
-

This medicinal product does not require any
special storage conditions
Keep this medicine out of the sight and reach of
children.
Do not use Ezembra XL after the expiry date which
is stated on the container and blister after EXP. The
expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6. Contents of the pack and other information
What Ezembra XL contains
The active substance is Quetiapine (as Hemifumarate).
Each Ezembra XL contains either 200 mg, 300 mg or
400 mg of quetiapine (as quetiapine hemifumarate).
The other ingredients are Lactose monohydrate,
Hypromellose, Sodium chloride, Povidone K-30, Talc,
Magnesium stearate (E470b), Hypromellose 6 cP
(E464), Titanium dioxide (E171), Macrogol 400. The
200 mg and 300 mg tablet also contain iron oxide yellow
(E172).
What Ezembra XL looks like and contents of the
pack
Quetiapine Prolonged-release Tablets 200 mg are
Yellow coloured, round shaped, biconvex film coated
tablets, debossed with ‘I2’ on one side and plain on
other.
Quetiapine Prolonged-release Tablets 300 mg are Light
yellow coloured, round shaped, biconvex film coated
tablets, debossed with ‘Q300’ on one side and plain on
other.
Quetiapine Prolonged-release Tablets 400 mg are White
coloured, round shaped, biconvex, film coated tablets
debossed with ‘I4’ on one side and plain on other.
Pack sizes of 10, 30, 50, 60 and 100 tablets per pack
are registered for all strengths. Not all pack sizes may
be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bluefish Pharmaceuticals AB
Gavlegatan 22
113 30 Stockholm, Sweden
Manufacturer:
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
United Kingdom
Cemelog-BRS Ltd
H2040 Budaörs, Vasút u. 13., Hungary
Pharmacare Premium Ltd
HHF 003, Hal Far Industrial Estate
Birzebbugia, BBG 3000, Malta
Bluefish Pharmaceuticals AB
Gavlegatan 22
113 30 Stockholm, Sweden.
This leaflet was last updated in {06/2017}.

Expand Transcript

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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