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ATROLAK XL 400 MG PROLONGED-RELEASE TABLET

Active substance(s): QUETIAPINE HEMIFUMARATE

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PACKAGE LEAFLET: INFROMATION FOR THE
USER

Atrolak XL 200 mg
Atrolak XL 300 mg
Atrolak XL 400 mg
Prolonged-release Tablet
Quetiapine

Read all of this leaflet carefully before you
start taking this medicine.
- 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. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
- 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.
- The name of your medicine is ‘Atrolak XL
Prolonged-release Tablets’ but in the rest of the
leaflet it will be called ‘Atrolak XL’.
In this leaflet:
1. What Atrolak XL are and what they are used for
2. Before you take Atrolak XL
3. How to take Atrolak XL
4. Possible side effects
5. How to store Atrolak XL
6. Further information

1. What Atrolak XL are and what
they are used for
Atrolak XL contains a substance called
quetiapine. This belongs to a group of medicines
called anti-psychotics. Atrolak 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 ay 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 Atrolak 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 Atrolak XL
even when you are feeling better.

2. Before you take Atrolak XL
Do not take Atrolak XL if:
- You are allergic (Hypersensitive) to Quetiapine
or any of the other ingredients of Atrolak 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 Atrolak XL if the above applies to you.
If you are not sure than talk to your doctor or
pharmacist before you take Atrolak XL.
Take special care with Atrolak 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 Atrolak
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, Atrolak XL should not
be taken because the group of medicines that
Atrolak XL belongs to may increase the risk of
stroke, or in some cases the risk of death, in
elderly people with dementia.
Tell your doctor immediately if you
experience:
- 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.
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 has been seen in patients taking
Atrolak XL. You and your doctor should check your
weight regularly.
Taking other medicines:
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 Atrolak 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.
- Rifampicin (for tuberculosis).
- 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).
Before you stop taking any of your medicines,
please talk to your doctor or pharmacist first.
If you have a urine drug screen, taking Quetiapine
prolonged release could cause positive results for
methadone or drugs for depression called tricyclic
antidepressants (TCAs), even though you may not
be taking methadone or TCAs. The result will
need to be confirmed by a more specific test.
Taking Atrolak XL with food and drink
- Atrolak 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 Atrolak XL and
alcohol can make you sleepy.
- Do not drink grapefruit juice while you are taking
Atrolak XL. It can affect the way the medicine
works.
Pregnancy and breast-feeding
If you are pregnant, trying to get pregnant, or
breast-feeding, talk to your doctor or pharmacist
before taking Atrolak XL.
You should not take Atrolak XL during pregnancy
unless this has been discussed with your doctor.
The following symptoms 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.
Atrolak XL should not be taken if you are
breast-feeding.
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 Atrolak XL
Atrolak 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
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 Atrolak XL
Always take Atrolak 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 drink grapefruit juice while you are taking
Atrolak 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.
Atrolak XL are available in 3 different strengths
and each strength is a different colour.
- Even though the dose might stay the same, it
might be supplied as different strength tablets.
For example one 400 mg tablet (white) or two
200 mg tablets (yellow).
- So don’t be surprised if the colour of your tablets
changes from time to time.
Liver problems
If you have liver problems your doctor may change
your dose.
Elderly people
If you are elderly your doctor may give you a lower
dose.

Children and adolescents under 18 years
Atrolak XL should not be used by children and
adolescents aged under 18 years.
If you take more Atrolak XL than you should
If you take more Atrolak 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
Atrolak XL with you.
If you forget to take a dose of Atrolak 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 Atrolak XL
If you suddenly stop taking Atrolak 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 product, ask your doctor or pharmacist.

4. Possible Side Effect

The class of medicines to which Atrolak 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, decreases in the number of
certain types of blood cells, decrease in the
amount of sodium in the blood, changes in the
amount of thyroid hormones in the blood,
increased blood creatine phosphokinase (a
substance in the muscles) 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.

Like all medicines, Atrolak XL can cause side
effects, although not everybody gets them.

The following side effects are only observed in
children and adolescents:

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.

Very common (affect more than 1 in 10
patients):
- Increase in blood pressure.

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 Atrolak XL) (may lead 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.

The following adverse events were observed
more frequently in children and adolescents than
in adults:

Common (affects less than 1 in 10 patients):
- Rapid heartbeat
- Feeling like your heart is pounding, racing or has
skipped beats.
- Stuffy nose
- Constipation, upset stomach (indigestion)
- Feeling weak, fainting (may lead to falls)
- 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 muscle movements. These include
difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain
- 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
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 (Tardive dyskinesia).
- Sexual dysfunction.
- Alteration of the heart rhythm (called
‘prolongation of QT interval’, seen on ECG,
electrical activity of the heart)
- Worsening of pre-existing diabetes.
- Deficiency in the number or quality of red blood
cells (Anaemia)
Rare (affects less than 1 in 1000 patients):
- A combination of high temperature (fever), long
lasting sore throat or mouth ulcers, faster
breathing, sweating, stiff muscles, feeling very
drowsy or faint, large increase in blood pressure
or heartbeat (a disorder called “neuroleptic
malignant syndrome”).
- Yellowing of the skin and eyes (jaundice).
- A long-lasting and painful erection (priapism).
- Swelling of breasts and unexpected production
of breast milk (galactorrhoea).
- Menstrual disorder.
- Inflammation of the liver (hepatitis).
- Inflammation of the pancreas (pancreatitis).
- Body temperature decreased (hypothermia).
- Sleep walking, sleep talking and sleep related
eating 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.
- A combination of medical disorders that, when
occurring together, increase the risk of
developing cardiovascular disease and diabetes
(Metabolic syndrome)
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 include difficulty in breathing,
dizziness, collapse or shock.
- Rapid swelling of the skin, usually around the
eyes, lips and throat (angioedema).
- Inappropriate secretion of a hormone that
controls urine volume.
- Breakdown of muscle fibers and pain in muscles
(rhabdomyolysis).
Frequency not known (cannot be estimated
from the available data)
- toxic epidermal necrolysis (Lyell’s syndrome
which is a blistering and peeling of the skin) and
erythema multiforme (blisters or lesions).

Very common (affect more than 1 in 10
patients):
- Increase in the amount of hormone call 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.
- Abnormal muscle movement. These include
difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.
Common (affects less than 1 in 10 patients):
- Feeling irritated
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any side
effects not listed in this leaflet.

5. How to store Atrolak XL
- This medicinal product does not require any
special storage conditions.
- Keep out of the reach and sight of children.
- Do not use Atrolak 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. Further information
What Atrolak XL contain
The active substance is Quetiapine (as
Hemifumarate). Each Atrolak 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 (E572), Hypromellose 6
cP (E464), Titanium dioxide (E171), Macrogol
(E553b). The 200mg and 300mg tablet also
contain iron oxide yellow (E172).
What Atrolak XL looks like and contents of the
pack
Atrolak XL 200mg is Yellow coloured, round
shaped, biconvex film coated tablets, debossed
with ‘I2’ on one side and plain on other.
Atrolak XL 300mg is Light yellow coloured, round
shaped, biconvex film coated tablets, debossed
with ‘Q300’ on one side and plain on other.
Atrolak XL 400mg is 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
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow,
Middlesex, HA1 4 HF, United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow,
Middlesex, HA1 4 HF, United Kingdom
Or
Cemelog-BRS Ltd.,
H-2040 Budaors, Vasut u. 13,
Hungary
Or
Pharmacare Premium Ltd.,
HHF 003, Hal Far Industrial Estate, Birzebbugia,
BBG 3000,
Malta.
This leaflet was last updated in 11/2012.

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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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