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QUETIAPINE 300 MG FILM-COATED TABLET

Active substance(s): QUETIAPINE HEMIFUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Quetiapine 100 mg Film-coated Tablets
Quetiapine 150 mg Film-coated Tablets
Quetiapine 200 mg Film-coated Tablets
Quetiapine 300 mg Film-coated 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 any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Quetiapine is and what it is used for
2. What you need to know before you take
Quetiapine
3. How to take Quetiapine
4. Possible side effects
5. How to store Quetiapine
6. Contents of the pack and other information

• Azole medicines (medicines used to treat fungal
infections).
• Erythromycin or clarithromycin (medicines used
to treat bacterial infections).
• Nefazodone (medicine used to treat

Quetiapine contains the active substance
depression).
quetiapine. This belongs to a group of medicines
Tell your doctor if you are taking any of the
called antipsychotics. Quetiapine can be used to
following medicines:
treat several illnesses, such as:
• Epilepsy medicines (like phenytoin or

carbamazepine).
• Schizophrenia: where you may hear or feel
• High blood pressure medicines.
things that are not there, believe things
• Barbiturates (medicines used to treat difficulty
that are not true or feel unusually suspicious,
sleeping).
anxious, confused, guilty, tense or depressed.
• Thioridazine or lithium (other anti-psychotic
• Mania: where you may feel very excited, elated, medicines).
agitated, enthusiastic or hyperactive or have
• Medicines that have an impact on the way your
poor judgment including being aggressive or
heart beats, for example, drugs that can cause
disruptive.
an imbalance in electrolytes (low levels of
• Bipolar depression: where you feel

potassium or magnesium) such as diuretics
sad. You may find that you feel depressed, feel (water pills) or certain
guilty, lack energy, lose your appetite or can’t
antibiotics (medicines used to treat bacterial
sleep.
infections).
• Medicines that can cause constipation.
Your doctor may continue to prescribe Quetiapine
Before you stop taking any of your medicines,
even when you are feeling better.
please talk to your doctor or pharmacist first.

1

What Quetiapine is and what it is used
for

2

What you need to know before you take
Quetiapine

Do not take Quetiapine
• 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 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 Quetiapine if the above applies to
you. If you are not sure, talk to your doctor or
pharmacist before taking Quetiapine.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Quetiapine 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
Quetiapine.
• 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, Quetiapine
should not be taken because the group of
medicines that Quetiapine 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 Quetiapine:
• 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 Quetiapine to be topped and/or
s
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
Quetiapine. You and your doctor should check
your weight regularly.
Children and adolescents
Quetiapine is not for use in children and
adolescents below 18 years of age.
Other medicines and Quetiapine
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. Do not take Quetiapine if you are
taking any of the following medicines:
• Some medicines used to treat HIV infections.

Quetiapine 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 Quetiapine and
alcohol can make you sleepy.
• Do not drink grapefruit juice while you are
taking Quetiapine. 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 Quetiapine 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 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.
Quetiapine 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.
Quetiapine contains lactose
Lactose 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
Quetiapine.
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 Quetiapine
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure. Medicinal products
containing lower strengths of quetiapine are
available for doses not realizable/practicable with
this medicine.
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.
You will take your tablets once a day, at bedtime
or twice a day, depending on your illness.
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
Quetiapine should not be used by children and
adolescents aged under 18 years.
Method of administration
For oral use.
• Swallow your tablets with a drink of water.
• You can take your tablets with or without food.
• Do not drink grapefruit juice while you are
taking Quetiapine. 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 Quetiapine than you should
If you take more Quetiapine 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.
If you forget to take Quetiapine
If you forget to take a dose. 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 Quetiapine
If you suddenly stop taking Quetiapine, 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.
Continued on the next page >>

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Quetiapine immediately and
contact your doctor at once 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:
• combination of high temperature (fever),
sweating, stiff muscles, feeling very

drowsy or faint (a disorder


called “neuroleptic malignant syndrome”)
• 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
• 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 serious blistering condition of the skin, mouth,
eyes and genitals (Stevens-Johnson syndrome)
• severe allergic reaction (anaphylaxis), which
may cause difficulty in breathing or shock
• rapid swelling of the skin, usually around the
eyes, lips and throat (angioedema)

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
This 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
or pharmacist. This includes any possible side
effects not listed in this leaflet.You can also report
side effects directly via 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

Not known, frequency of these side effects
How to store Quetiapine
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).
Keep this medicine out of the sight and reach of
• skin rash with irregular red spots (erythema
children.
multiforme)
Do not use Quetiapine after the expiry date which
is stated on the carton and on the blister/on the
The class of medicines to which Quetiapine
label of the bottle. The expiry date refers to the
belongs can cause heart rhythm problems, which
last day of that month.
can be serious and in severe cases may be fatal.
You may experience any of the other reported
side effects listed below according to the
frequencies:
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 Quetiapine (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
• 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)

Plastic bottles: Do not use after 6 months have
elapsed from first opening.
This medicine does not require any special
storage conditions.

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 protect the environment.

6 Contents of the pack and other
information

What Quetiapine contains
The active substance is quetiapine.
Quetiapine 100 mg film-coated tablets
Each film-coated tablet contains 100 mg
quetiapine (as quetiapine fumarate).Quetiapine
150 mg film-coated tablets
Each film-coated tablet contains 150 mg
quetiapine (as quetiapine fumarate).
Quetiapine 200 mg film-coated tablets
Each film-coated tablet contains 200 mg
Common, may affect up to 1 in 10 people:
quetiapine (as quetiapine fumarate).
• rapid heartbeat
Quetiapine 300mg film-coated tablets
• feeling like your heart is pounding, racing or has Each film-coated tablet contains 300 mg
skipped beats
quetiapine (as quetiapine fumarate).
• constipation, upset stomach (indigestion)
• feeling weak
The other ingredients are:
• swelling of arms or legs
• Tablet core:
• low blood pressure when standing up. This may calcium hydrogen phosphate dihydrate,
make you feel dizzy or faint (may lead to falls).
microcrystalline cellulose, lactose monohydrate,
• increased levels of sugar in the blood
magnesium stearate, povidone (K 29/32),
• blurred vision
silica colloidal hydrated, sodium starch
• abnormal dreams and nightmares
glycolate (type A).
• feeling more hungry
• Tablet coating:
• feeling irritated
hypromellose, lactose monohydrate, macrogol
• disturbance in speech and language
4000, titanium dioxide (E 171).
• thoughts of suicide and worsening of your
Quetiapine 100 mg film-coated tablets and
depression
Quetiapine 150 mg film-coated tablets also
• shortness of breath
contain iron oxide yellow (E 172).
• vomiting (mainly in older people)
What Quetiapine looks like and contents of
• fever
the pack
• changes in the amount of thyroid hormones in
Quetiapine 100 mg film-coated tablets are yellow
your blood
and round (8.8 mm diameter). They have a score
• decreases in the number of certain types of
line on one side and can be divided into four
blood cells
equal doses.
• increases in the amount of liver enzymes
measured in the blood
Quetiapine 150 mg film-coated tablets are cream
• increases in the amount of the hormone
coloured and round (10.5 mm diameter). They
prolactin in the blood. Increases in the

have a score line on one side and can be divided
hormone prolactin could in rare cases lead to
into two equal doses.
the following:
- men and women to have swelling of breasts
Quetiapine 200 mg film-coated tablets are white
and unexpectedly produce breast milk
and round (11.5 mm diameter). They have a score
- women to have no monthly period or irregular line on one side and can be divided into four
periods
equal doses.
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)
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
Not known, frequency cannot be estimated from
the available data:
• symptoms of withdrawal may occur

in newborn babies of mothers who have
used Quetiapine 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 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

Quetiapine 300 mg film-coated tablets are white
and oval (18 mm length and 8.8 mm width).
They have a score line on both sides and can be
divided into two equal doses.
Quetiapine 100 mg film-coated tablets are
available in
• blister packs containig 6, 10, 20, 30, 50, 60, 90,
100, 120 or 180 film-coated tablets
• perforated unit dose blister packs containing
1x100 lm-coated tablets
fi
• plastic bottles with screw caps and desiccant
containing 100, 120, 250 or 500 film-coated
tablets.
Quetiapine 150 mg film-coated tablets are
available in
• blister packs containing 6, 10, 20, 30, 50, 60,
90, 100,120 or 180 film-coated tablets
• plastic bottles with screw caps and desiccant
containing 100, 250 or 500 film-coated tablets.
Quetiapine 200 mg film-coated tablets are
available in
• blister packs containing 6, 10, 20, 30, 50, 60,
90, 100, 120 or 180 film-coated tablets
• perforated unit dose blister packs containing
1x100 lm-coated tablets
fi
• plastic bottles with screw caps and desiccant
containing 100, 250 or 500 film-coated tablets.
Quetiapine 300 mg film-coated tablets are
available in
• blister packs containg 6, 10, 20, 30, 50, 60, 90,
100,120 or 180 film-coated tablets
• perforated unit dose blister packs containing
1x100 film-coated tablets
• plastic bottles with screw caps and desiccant
containing 100, 120, 250 or 500 film-coated
tablets.
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
Salutas Pharma GmbH, Otto-von-Guericke-Allee
1, 39179 Barleben, Germany
Salutas Pharma GmbH, Dieselstrasse 5, 70839
Gerlingen, Germany
Lek Pharmaceuticals d.d., Verovškova 57, 1526
Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2D, 9220
Lendava, Slovenia
LEK S.A.,Ul. Podlipie 16 C, 95 010 Strykow,
Poland
LEK S.A.,Ul. Domaniewska 50 C, 02-672
Warszawa, Poland
This leaflet was last revised in 06/2015.

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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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