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SEOTIAPIM XL 50 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE FUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE
USER

Seotiapim XL 50 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,
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 Seotiapim XL is and what it is used for
2. What you need to know before you take Seotiapim
XL
3. How to take Seotiapim XL
4. Possible side effects
5. How to store Seotiapim XL
6. Contents of the pack and other information

1. What Seotiapim XL is and what it is used
for

Seotiapim XL contains the active substance quetiapine.
This belongs to a group of medicines called
anti-psychotics. Seotiapim 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 Seotiapim 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 Seotiapim XL
even when you feel better.

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

Do not take Seotiapim 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 Seotiapim XL if the above applies to you. If
you are not sure, talk to your doctor or pharmacist
before taking Seotiapim XL.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Seotiapim 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.
• If you have low blood pressure.
• If you have had a stroke, especially if you are older.
• If you have problems with your liver.
• If you have ever had a fit (seizure).
• If 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 Seotiapim XL.
• If 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).
• If you are an older person with dementia (loss of brain
function). If you are, Seotiapim XL should not be
taken because the group of medicines that Seotiapim
XL belongs to may increase the risk of stroke, or in
some cases the risk of death, in older people with
dementia.
• If 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 Seotiapim 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
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 Seotiapim 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.

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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 Seotiapim
XL. You and your doctor should check your weight
regularly.
Children and adolescents
Seotiapim XL is not for use in children and adolescents
below 18 years of age.
Other medicines and Seotiapim XL

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Do not take Seotiapim 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, 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.
Before you stop taking any of your medicines, please
talk to your doctor first.

Seotiapim XL with food, drink and alcohol
• Food: see section 3 under “Method of administration”
Be careful how much alcohol you drink. This is
because the combined effect of Seotiapim XL and
alcohol can make you sleepy.
• Do not drink grapefruit juice while you are taking
Seotiapim 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 Seotiapim 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 that have used Seotiapim
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.
Seotiapim 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.

Seotiapim XL contains lactose
Seotiapim 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 Seotiapim 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.

Not all dosing regimens are practical/possible with the
present strength of Seotiapim XL and other authorised
medicinal products containing quetiapine are available
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
Seotiapim 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.
• Seotiapim 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
Seotiapim 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 Seotiapim XL than you should
If you take more Seotiapim 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 Seotiapim XL with you.

If you forget to take Seotiapim 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 Seotiapim XL
If you suddenly stop taking Seotiapim 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, pharmacist or nurse.
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4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

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

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”).
• 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 (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 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 Seotiapim 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 (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 Seotiapim XL (may lead to falls).
• Discontinuation symptoms (symptoms which occur
when you stop taking Seotiapim 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, 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 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 (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 (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)

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,
pharmacist or nurse. 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 Seotiapim 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 after EXP. The expiry date refers
to the last day of that month.
• After first opening of the bottle: Use within 6 months.
• Seotiapim XL does not require any special storage
conditions.
• Do not use this medicine if you notice visible signs of
deterioration.
• 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 Seotiapim XL contains
The active substance is quetiapine. Each Seotiapim XL
50 mg Prolonged-release Tablet contains 50 mg of
quetiapine (as quetiapine fumarate).
The other ingredients are:
Tablet core:
Lactose monohydrate, Hypromellose (K4M and K100
Premium LV CR) (E464), Sodium chloride, Povidone
K-30 (E1201), Silicified Microcrystalline Cellulose
(Microcrystalline cellulose and Silica Colloidal
Anhydrous), Talc (E553b), Magnesium stearate
(E470b),
Tablet coating:
Opadry II 85F540003 Pink contains: Poly (Vinyl alcohol)
(E1203), Titanium dioxide (E171), Macrogol 3350
(E1521), Talc, Iron oxide red (E172), Iron oxide yellow
(E172).
What Seotiapim XL looks like and contents of the
pack
Quetiapine prolonged-release Tablet 50 mg is peach
coloured, round shaped, biconvex film coated tablets,
debossed with ‘Q50’ on one side and plain on the other.
White opaque PVC/PVdC-ALU blister or ALU-ALU
blister pack or HDPE bottle pack.
Pack size blister pack: 6, 10, 20, 28, 30, 50, 60, 90 and
100 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 Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Lek Pharmaceuticals d.d., Verovškova 57, 1526
Ljubljana, Slovenia or

Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava,
Slovenia or

Lek Pharmaceuticals d.d., ul. Domaniewska 50 C, 02672 Warszawa, Poland 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.

Very rare (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.

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Not known (frequency cannot be estimated from the
available data)
• Symptoms of withdrawal may occur in newborn
babies of mothers who have used Seotiapim XL
during their pregnancy.

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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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