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ATROLAK XL 50 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE HEMIFUMARATE

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Package leaflet: Information for the user

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.

Quetiapine

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.

Atrolak XL 50 mg
Atrolak XL 200 mg
Atrolak XL 300 mg
Atrolak XL 400 mg
Prolonged-release Tablets
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 or nurse.
- 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 of 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. What Atrolak XL is and what it is used for
2. What you need to know before you take
Atrolak XL
3. How to take Atrolak XL
4. Possible side effects
5. How to store Atrolak XL
6. Contents of the pack and other information

1. What Atrolak XL is and what it
is 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 feel sad. 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.
You must talk to a doctor if you do not feel better
or if you feel worse.

2. What you need to know
before you take Atrolak XL
Do not take Atrolak 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 Atrolak XL if the above applies to
you. If you are not sure.Talk to your doctor or
pharmacist before taking Atrolak XL.
Warnings and precautions
Talk to your doctor or pharmacist or nurse
before taking Atrolak XL
- 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 any of the following after taking
Atrolak 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.
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.

Weight gain has been seen in patients taking
Atrolak XL. You and your doctor should check
your weight regularly.
Other medicines and Atrolak XL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
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.
- 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.
Atrolak XL with food, drink and alcohol
- 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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
askyour doctor or pharmacist advice before
taking this medicine.You should not take Atrolak
XL during pregnancy unless this has been
discussed with your doctor. Atrolak XL should not
be taken if you are breast-feeding.
The following symptoms may occur in newborn
babies of mothers that have used Atrolak 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.
Atrolak XL contains Lactose
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, talk to
your doctor before taking this medicine.
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 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 recommended 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.
Liver problems
If you have liver problems your doctor may
change your dose.
Elderly people
If you are elderly your doctor may change your
dose.
Use in children and adolescents
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. Contact
your doctor or nearest hospital straight away.
Keep the Atrolak XL with you.

If you forget to take 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 medicine, ask your doctor or pharmacist or
nurse.

4. Possible side effect
Like all medicines, this medicine 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.

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.
Additional 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:
Very common: may affect more than 1 in 10
people
• Increase in blood pressure.
The following side effects have been seen more
often in children and adolescents:

Very common: may affect more than 1 in 10
people
- 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.

Very common: may affect more than 1 in 10
people
• Increase in the amount of a hormone called
prolactin in the blood. Increase 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.
• Abnormal muscle movement. These include
difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.

Common: may affect up to 1 in 10 people
- 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 lead 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 and language.
- Thoughts of suicide and worsening of your
depression
- Shortness of breath
- Vomiting (mainly in the elderly)
- Fever

If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any side
effects not listed in this leaflet.

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.
- Worsening of pre-existing diabetes.
- Change in electrical activity of the heart seen on
ECG (QT prolongation).
- Slow heartbeat
Rare: may affect up to 1 in 1,000 people
- A combination of high temperature (fever), long
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 (pancreatitis).
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).
- 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)
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, 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

You can also report any side effects directly via
the Yellow Card Scheme at:
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 Atrolak 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 label, carton
and blister after EXPe. The expiry date refers to
the last day of that month.
- Do not use this medicine if you notice
description of the visible signs of deterioration
- Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how throw away medicines you no
longer use. These measures will help to protect
the environment.
- Atrolak XL does not require any special storage
conditions.

6. Contents of the pack and
other information
What Atrolak XL contains
- The active substance is quetiapine. Each
Atrolak XL contains either 50 mg, 200 mg, 300
mg or 400 mg of quetiapine (as quetiapine
fumarate).
- The other ingredients are:
Tablet core: Lactose monohydrate,
Hypromellose, Sodium chloride, Povidone K-30,
Talc and Magnesium stearate. The 50 mg tablet
also contains silicified microcrystalline cellulose
(Siliciumdioxide & Microcrystalline Cellulose).
Tablet coating: Titanium dioxide (E171), Macrogol
(E 1521). The 50 mg tablet also contains Poly
(Vinyl alcohol) (E1203), Talc (E553b) and Iron
oxide red (E172). The 50mg, 200mg and 300mg
tablet also contain iron oxide yellow(E172). The
200 mg, 300 mg and 400 mg also contains
Hypromellose 6 cP (E464)
What Atrolak XL looks like and contents of
the pack
Atrolak XL 50 mg is Peach colored, round
shaped, biconvex film coated tablets, debossed
with ‘Q50’ on one side and plain on the other
Atrolak XL 200 mg is Yellow coloured, round
shaped, biconvex film coated tablets, debossed
with ‘I2’ on one side and plain on other
Atrolak XL 300 mg is Light yellow coloured, round
shaped, biconvex film coated tablets, debossed
with ‘Q300’ on one side and plain on other.
Atrolak XL 400 mg is White coloured, round
shaped, biconvex, film coated tablets debossed
with ‘I4’ on one side and plain on other.
PVC/PVDC-Alu blister pack. Pack sizes of 10,
30, 50, 60 and 100 tablets per pack are
registered for Atrolak XL 200 mg, 300 mg and
400 mg.
PVC/PVDC-Alu blister pack or OPA/Alu/PVC –
Alu blister pack. Pack size of 6, 10, 20, 28, 30,
50, 60, 90 and 100 tablets per pack are
registered for Atrolak XL 50mg.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom
Or
Cemelog-BRS Ltd.,
Akron utea 1. (Camel Park),
Budaörs, 2040
Hungary
Or
Pharmacare Premium Ltd.,
HHF 003, Hal Far Industrial Estate, Birzebbugia,
BBG 3000,
Malta.
This leaflet was last revised in 06/2013.

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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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