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QUESERY XL 200 MG PROLONGED RELEASE TABLETS

Active substance(s): QUETIAPINE HEMIFUMARATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

SZ00000LT000

Quesery XL 200 mg
Prolonged-release Tablets
Quesery XL 300 mg
Prolonged-release Tablets
Quesery XL 400 mg
Prolonged-release Tablets
quetiapine

Read all of this leaflet carefully before you start using 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, 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 side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Quesery XL are and what they are used for
2. What you need to know before you take Quesery XL
3. How to take Quesery XL
4. Possible side effects
5. How to store Quesery XL
6. Contents of the pack and other information

1. What Quesery XL are and what they are used for

Quesery XL contains the active substance quetiapine. This belongs to a
group of medicines called anti-psychotics. Quesery 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 canʼt sleep.

When Quesery 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 Quesery XL even when you feel better.

2. What you need to know before you take Quesery XL

Do not take Quesery XL if
• you are allergic to quetiapine or any of the other ingredients of this
medicine (listed in section 6).
• you are taking any of the following medicines:
- some medicines used to treat HIV infections
- azole medicines (medicines used to treat fungal infections)
- erythromycin or clarithromycin (medicines used to treat bacterial
infections)
- nefazodone (medicine used to treat depression).

Do not take Quesery XL if the above applies to you. If you are not sure, talk
to your doctor or pharmacist before taking Quesery XL.

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Warnings and precautions
Talk to your doctor or pharmacist before taking Quesery 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 older.
• 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 Quesery 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 older person with dementia (loss of brain function). If you
are, Quesery XL should not be taken because the group of medicines
that Quesery XL belongs to may increase the risk of stroke, or in some
cases the risk of death, in older 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.

Tell your doctor immediately if you experience any of the following after
taking Quesery 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 sever sense of feeling sleepy. This could increase the risk
of accidental injury (fall) in older people.
• 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
Quesery 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 Quesery XL. You and your
doctor should check your weight regularly.
Children and adolescents
Quesery XL is not for use in children and adolescents below 18 years.

Other medicines and Quesery XL
Tell your doctor if you are taking, have recently taken or might take any
other medicines.

Do not take Quesery XL if you are taking any of the following medicines:
• Some medicines used to treat HIV infections
• Azole medicines (medicines used to treat fungal infections)
• Erythromycin or clarithromycin (medicines used to treat bacterial
infections)
• Nefazodone (medicine used to treat depression).

Tell your doctor if you are taking any of the following medicines:
• Epilepsy medicines (like phenytoin or carbamazepine)
• High blood pressure medicines
• Barbiturates (medicines used to treat difficulty sleeping)
• Thioridazine or lithium (other anti-psychotic medicines)
• 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 (medicines used to treat bacterial infections).
• Medicines that can cause constipation.

Before you stop taking any of your medicines, please talk to your doctor first.
Quesery XL with food, drink and alcohol
• Food: see section 3 under ʻMethod of administrationʼ.
• Be careful how much alcohol you drink. This is because the combined
effect of Quesery XL and alcohol can make you sleepy.
• Do not drink grapefruit juice while you are taking Quesery 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 Quesery XL during pregnancy unless this has been
discussed with your doctor. The following symptoms which can represent
withdrawal may occur in newborn babies, of mothers who have used
Quesery 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.
Quesery XL should not be taken if you are breast-feeding.

Driving and using machines
Your tablets may make you feel sleepy and dizzy. Do not drive or use any
tools or machines until you know how the tablets affect you.

Quesery XL contains lactose
Quesery XL Prolonged-release Tablets contain 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 Quesery 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 Quesery XL

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.

Quesery XL is 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).

The recommended dose is:
Adults
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.
Older people
If you are older your doctor may change your dose.

Patients with liver problems
If you have liver problems your doctor may change your dose.

Use in children and adolescents
Quesery XL should not be used by children and adolescents aged under
18 years.

Method of administration:
Oral use.
• 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.
• Quesery XL can be affected by food. 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 Quesery XL. It can
affect the way the medicine works.

Duration of treatment:
This will be decided by your doctor. Do not stop taking your tablets even if
you feel better, unless your doctor tells you.

If you take more Quesery XL than you should
If you take more Quesery 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 tablets with you.

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If you forget to take Quesery 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 Quesery XL
If you suddenly stop taking Quesery 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.

STOP taking Quesery XL and contact your doctor immediately or go
to the nearest hospital if you experience any of the following serious
side effects:
Uncommon side effects, may affect up to 1 in 100 people:
• Fits or seizures
• Uncontrollable movements, mainly of your face or tongue.

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”)
• A long-lasting and painful erection (priapism)
• 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.
• A combination of fever, flu-like symptoms, sore throat, or any other
infection with very low white blood cell count (a condition called
agranulocytosis).

Very rare side effects, may affect up to 1 in 10,000 people:
• 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).

Not known, frequency of these side effects cannot be
estimated from the available data:
• Serious, sudden allergic reaction with symptoms such as fever and
blisters on the skin and peeling of the skin (toxic epidermal necrolysis).
• Skin rash with irregular red spots (erythema multiforme).

The class of medicines to which Quesery XL belongs can cause heart
rhythm problems, which can be serious and in severe cases may be fatal.

You may experience any of the following side effects listed below. If
the side effect is severe or persistent, you should contact your doctor.

Very common side effects, 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 Quesery
XL) (may lead to falls)
• Discontinuation symptoms (symptoms which occur when you stop taking
Quesery 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).

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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, 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 and language.
Thoughts of suicide and worsening of your depression.
Shortness of breath.
Vomiting (mainly in older people).
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:
• 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.
• 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.

Rare side effects, may affect up to 1 in 1,000 people:
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Swelling of breasts and unexpected production of breast milk
(galactorrhoea).
• Menstrual disorder.
• 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 three 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.
• 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.
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).
• Worsening of pre-existing diabetes.

Not known, frequency of these side effects cannot be
estimated from the available data:
• Symptoms of withdrawal may occur in newborn babies of mothers who
have used Quesery XL during their pregnancy.

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 and increase 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.
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. This

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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 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 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 Quesery 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 this medicine 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.
• After first opening of the bottle: Use within 6 months.
• 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 to protect the environment.

6. Contents of the pack and other information

What Quesery XL Prolonged-release Tablets contain
The active substance is quetiapine (as quetiapine hemifumarate).

Each Quesery XL Prolonged-release Tablet 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
(E464), titanium dioxide (E171), macrogol 6000.
Quesery XL 200 mg Prolonged-release Tablets and Quesery XL 300 mg
Prolonged-release Tablets also contain iron oxide yellow (E172).

What Quesery XL looks like and contents of the pack
Quesery XL 200 mg Prolonged-release Tablets are yellow coloured, round
shaped, biconvex film coated tablets, debossed with ʻI2ʼ on one side and
plain on other

Quesery XL 300 mg Prolonged-release Tablets are light yellow coloured,
round shaped, biconvex film coated tablets, debossed with ʻQ300ʼ on one
side and plain on other.

Quesery XL 400 mg Prolonged-release Tablets are White coloured, round
shaped, biconvex, film coated tablets debossed with ʻI4ʼ on one side and
plain on other.

Quesery XL 200mg, 300mg and 400mg Prolonged-release Tablets are
packed in PVC/PVDC-Alu blister pack and HDPE bottle pack. Pack size
blister pack: 6, 10, 20, 28, 30, 50, 60, 90, 100 and 120 tablets per pack.
Pack size bottle pack: 120 tablets (For hospital use and dose dispensing only).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16
7SR, UK.
Manufacturer
LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland Or
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia Or
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia Or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany Or S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472
Targu-Mures, Romania Or Pharmacare Premium Ltd, HHF 003, Hal Far
Industrial Estate, Birzebbugia, BBG, 3000, Malta.

This leaflet was last revised in 09/2014.

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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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