QUETIAPINE 300 MG FILM-COATED TABLET

Active substance: 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.

What is in this leaflet:
1. What Quetiapine is and what it is used for
2. What you need to 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

1

What Quetiapine is and what it is
used for

Quetiapine contains the active substance quetiapine. It
belongs to a group of medicines called antipsychotics.

Quetiapine can be used to treat several illnesses, such
as
• schizophrenia
Symptoms include:
- hallucinations, such as hearing unexplained voices
- strange and frightening thoughts
- changes in your behaviour
- feeling alone and confused
• manic episodes associated with a disease called
bipolar disorder
Symptoms are:
- feeling very “high” or excited
- needing less sleep than usual
- being more talkative with racing thoughts or ideas
- feeling more irritable than usual
• depressive episodes associated with a disease
called bipolar disorder
Symptoms are:
- feeling very “down” or sad
- feeling guilty
- lacking energy
- losing appetite
- can not sleep.
Your doctor may continue to prescribe Quetiapine even
when you are feeling better to prevent your symptoms
from returning.

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 take any of the following medicines:
- medicines to treat HIV infections with active
substance names ending in “navir”
- medicines to treat fungal infections with active
substance names ending in “azole” such as
ketoconazole
- erythromycin and clarithromycin: medicines to
treat bacterial infections
- nefazodone: a medicine to treat depression.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Quetiapine if you
• have poor circulation in the heart or brain, or other
conditions inclined to cause low blood pressure.
• have or have had diseases of the heart and/or
blood vessels (or a family history of heart problems),
such as heart failure or irregular heart beat, especially
an abnormality known as “prolonged QT-interval”.
• are taking any medicines that may have an impact on
the way your heart beats.
• have had a stroke previously, especially if you are
elderly.
• are an elderly 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 elderly people with dementia.
• have had low levels of white blood cells previously
which may or may not have been caused by other
medicines.
• have ever suffered from convulsions.
• have diabetes mellitus, tend to have high blood
sugar levels or are at risk of developing diabetes
mellitus.
If you do, your doctor may check your blood sugar
levels while you are taking Quetiapine.
• have high cholesterol values and so called
triglyceride levels, which are certain fats, in your blood.
This might be associated with inflammation of your
pancreas.
• have experienced considerable weight gain during
an earlier treatment with a medicine belonging to the
same group as Quetiapine does.
• have a liver function disorder.
See section “3 How to take Quetiapine”.
• or someone else in your family has a history of blood
clots, as medicines like these have been associated
with formation of blood clots.
Inform your doctor or pharmacist immediately if you
experience any of the following after taking Quetiapine:
• involuntary movements or abnormal movements
especially of the tongue, mouth and face while taking
this medicine.
If so your doctor might reduce your dose or
discontinue treatment.
• a combination of fever, accelerated breathing,
excessive sweating, changes in consciousness or
stiff muscles.
Immediate medical treatment may be needed.
• dizziness or a severe sense of feeling sleepy.
This could increase the risk of accidential injury (fall)
in elderly patients.
• fits or seizures.
• a long-lasting and painful erection.
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 under 18 years
Do not give this medicine to children and adolescents
below 18 years of age, due to a lack of data to support
use in ths age group.
Other medicines and Quetiapine
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

The following medicines can particularly influence or be
influenced by Quetiapine:
• medicines which must not be taken together with
Quetiapine - see section 2 “Do not take Quetiapine”:
- medicines to treat HIV infections with active
substance names ending in “navir”
- medicines to treat fungal infections with active








substance names ending in “azole” such as
ketoconazole
- erythromycin and clarithromycin: medicines
to treat bacterial infections
- nefazodone: a medicine to treat depression.
medicines which reduce quetiapine levels in the blood
and itʼs effect, such as:
- carbamazepine and phenytoin: medicines to treat
epilepsy or other illnesses.
Your doctor may consider prescribing another
medicine to treat epilepsy or adjust your Quetiapine
dose.
- thioridazine: a medicine to treat psychiatric
disorders.
medicines which act on the central nervous system
medicines that have an impact on the way your heart
beats, for example
- medicines that can cause an imbalance in
electrolytes (low levels of potassium or magnesium
in your blood) such as diuretics (water pills)
- certain antibiotics, medicines to treat bacterial
infections
medicines which influence hepatic enzymes such as:
- rifampicin: a medicine to treat tuberculosis or
certain other infections
- barbiturates: medicines to treat sleeplessness.

Before you stop taking any of your medicines, please
talk to your doctor or pharmacist first.

Quetiapine with food, drink and alcohol
Quetiapine can be taken with or without food. Do not
drink alcohol during treatment with Quetiapine, the
combined effect might make you feel drowsy. 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.

• Pregnancy
Do not take Quetiapine if you are pregnant unless
your doctor has told you to.
The following symptoms 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.
• Breast-feeding
You should not take Quetiapine when breast-feeding.
Driving and using machines
Only drive or operate machines if your doctor has
approved it.
This will depend upon how this therapy affects you,
because Quetiapine may make you feel sleepy and
dizzy and thus impair your mental alertness.

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.
Your doctor will tell you how many tablets you
should take and how long you should continue to
take them.
Medicinal products containing lower strengths of
quetiapine are available for doses not realizable/
practicable with this medicine.

The recommended dose is:
Adults
• To treat schizophrenia
Take the following total daily doses divided into two
separate doses per day.
- Day 1: 50 mg quetiapine
- Day 2: 100 mg quetiapine
- Day 3: 200 mg quetiapine
- Day 4: 300 mg quetiapine
- After day 4: Your doctor will gradually increase the
total daily dose from 300 mg to 450 mg quetiapine.
Depending on your individual response and
tolerance, the total daily dose may vary between
150 mg and 750 mg quetiapine.

• To treat manic episodes
Take the following total daily doses divided into two
separate doses per day.
- Day 1: 100 mg quetiapine
- Day 2: 200 mg quetiapine
- Day 3: 300 mg quetiapine
- Day 4 and following days: 400 mg quetiapine
- From day 6: Your doctor may gradually increase
the daily dose up to a maximum of 800 mg
quetiapine. The daily dose increase should not
exceed 200 mg quetiapine.
Depending on your individual response and
tolerance, the total daily dose may vary between
200 mg and 800 mg quetiapine.

• To treat depressive episodes
Take the following doses once daily every evening at
bedtime.
- Day 1: 50 mg quetiapine
- Day 2: 100 mg quetiapine
- Day 3: 200 mg quetiapine
- Day 4 and following days: 300 mg quetiapine
Average dose: 300 mg quetiapine per day.
Elderly Patients over 65 years
Lower doses and slower dose increases may be
sufficient for this age group.

Patients with impaired liver function
Starting dose: 25 mg quetiapine per day.
This dose is increased slowly by 25 mg to 50 mg
quetiapine each day until the optimal dose is reached.
Children and adolescents under 18 years
Quetiapine should not be used by children and
adolescents aged under 18 years.

Method of administration
For oral use. Swallow the tablets with a glass of water
preferably at the same time each day.

Continued on the next page >>

If you take more Quetiapine than you should
If you have accidentally taken too much Quetiapine
contact your doctor or a hospital at once. Always
take the tablets, leaflet and/or carton with you so the
doctor will know what you took.
Immediate medical care is necessary if the following
signs occur: drowsiness, sedation, rapid heart beat and
low blood pressure.

If you forget to take Quetiapine
If you forget a dose continue by taking your next dose at
the usual time. Do not take a double dose to make up
for a forgotten dose.

If you stop taking Quetiapine
Do not stop taking Quetiapine unless advised by your
doctor, as this may harm the success of therapy.
If you suddenly stop taking the tablets, symptoms such
as nausea, headache, diarrhoea, vomiting, dizziness,
irritability and sleeplessness might occur. To avoid such
symptoms, it is important to reduce the dose gradually
according to your doctorʼs instructions.
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 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 (tardive dyskinesia). This can occur during or
after a prolonged course of treatment.

Rare side effects, may affect up to 1 in 1,000 people:
• combination of fever, persistent sore throat or mouth
ulcers, faster breathing, sweating, muscle stiffness
and reduced consciousness – all of these are
symptoms of a severe 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
Very rare side effects, may affect up to 1 in 10,000
people:
• severe rash, blisters, or red patches on the skin
(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)

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 Quetiapine belongs can
cause heart rhythm problems, which can be serious and
in severe cases may be fatal.
You may experience any of the reported side effects
listed below according to the frequencies:
Very common, may affect more than 1 in 10 people:
• dizziness (may lead to falls)
• feeling sleepy (this may go away with time as you
keep taking Quetiapine, may lead to falls)
• headache
• dry mouth
These symptoms usually occur when beginning therapy
and gradually disappear as treatment continues.
• increased values for fats called triglycerides and total
cholesterol (predominantly LDL cholesterol) in the
blood
• decreased values for fats called HDL cholesterol in
the blood
• discontinuation symptoms such as nausea,
headache, diarrhoea, vomiting, dizziness, irritability
and sleeplessness.
These occur when you suddenly stop taking
Quetiapine. Gradual withdrawal over a period of at
least 1 to 2 weeks is advisable
• weight gain
• decrease of a certain protein called haemoglobin in
your blood.

Common, may affect up to 1 in 10 people:
• particularly at the beginning of treatment:
- rapid heart beat
- fainting (may lead to falls)
- fall in blood pressure especially when sitting or
standing up after lying down.
This can cause dizziness (may lead to falls) and
increased heart beat
• feeling like your heart is pounding, racing or has
skipped beats
• decrease in the total number of white blood cells and
of a specific subgroup called neutrophils
This leads to an increased susceptibility to infections
and may occur after therapy has ended. It is
temporary and not severe
• increase in the number of certain blood cells called
eosinophilic granulocytes.
This indicates that your bodyʼs immune system is
highly activated
• stuffy nose
• indigestion, constipation
• feeling weak
• swelling of arms or legs due to accumulation of fluid
in the tissues
• blurred vision
• abnormal muscle movements which include difficulty
starting muscle movements, shaking, feeling restless
or muscle stiffness without pain
• temporary increase of the liver enzymes called ALT
and AST in the blood
• temporary increase of the liver enzyme called
gamma-GT in the blood
• increase in the amount of sugar in the blood
• increase in the amount of a hormone called prolactin
in the blood
This can 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
• decrease in the amount of thyroid gland hormones in
the blood
• increase in the amount of a hormone which stimulates
the hormone production by the thyroid gland
• abnormal dreams and nightmares
• increased appetite
• feeling irritated
• disturbance in speech and language
• thoughts of suicide and worsening of your depression
• shortness of breath
• vomiting, mainly in the elderly
• fever.
Uncommon, may affect up to 1 in 100 people:
• decrease in the number of certain blood cells called
thrombocytes and platelets.
This can lead to an increased tendency to bruise and
to bleed
• deficiency in red blood cells
• allergic reactions that may include raised lumps (weals),
swelling of the skin and swelling around the mouth
• heart rhythm disorder known as “QT-prolongation”
and seen on ECG
• slow heartbeat
• unpleasant sensations in the legs, so called “restless
legs syndrome”
• difficulty swallowing
• sexual dysfunction
• decrease in the amount of sodium in the blood
• diabetes mellitus or worsening of pre-existing
diabetes mellitus
• decrease in the amount of a specific hormone
produced by the thyroid gland, called triiodothyroxine,
in the blood
• deficiency in thyroid gland function.
Rare, may affect up to 1 in 1,000 people:
• jaundice
• increase of an enzyme called creatine phosphokinase

in the blood
• swelling of breasts and unexpected production of
breast milk
• menstrual disorder
• hepatitis
• walking, talking, eating or other activities while you
are asleep
• decrease in body temperature
• inflammation of the pancreas
• serious decrease in the number of certain white blood
cells called agranulocytosis. This may occur at any
time during treatment
• metabolic syndrome. This is a combination of
metabolic risk factors such as high blood pressure,
obesity, high cholesterol and insulin resistance and
requires appropriate medical treatment.
Very rare, may affect up to 1 in 10,000 people:
• inappropriate secretion of a hormone that controls
urine volume
• breakdown of muscle fibres and pain in muscles.

Not known, frequency cannot be estimated from the
available data
• decrease in the number of certain white blood cells
(neutropenia).

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, changes in the
number of certain types of blood cells, increased blood
creatine phosphokinase (a substance in the muscle),
decrease in the amount of sodium in the blood and
increases in the amount of a hormone called prolactin in
the blood. Thus your doctor may ask you to have blood
tests from time to time.

Additional side effects in children and adolescents (10 to
17 years)
The same side effects that may occur in adults may also
occur in children and adolescents.
The following side effect has been seen only 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:
• increase in the amount of a hormone called prolactin
in the blood.
This can 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 movements which include difficulty
starting muscle movements, shaking, feeling restless
or muscle stiffness without pain.
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.

5

How to store Quetiapine

Keep this medicine out of the sight and reach of
children.

Do not use Quetiapine after the expiry date which is
stated on the carton and on the blister/on the label of the
bottle. The expiry date refers to the last day of that month.
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 to protect the environment.

6

Contents of the pack and other
information

What Quetiapine contains
The active substance is quetiapine.
Each film-coated tablet contains 100, 150, 200 or
300 mg quetiapine (as quetiapine fumarate).

The other ingredients are:
• Tablet core:
calcium hydrogen phosphate dihydrate,
microcrystalline cellulose, lactose monohydrate,
magnesium stearate, povidone (K 29/32), silica
colloidal hydrated, sodium starch glycolate (type A).
• Tablet coating:
hypromellose, lactose monohydrate, macrogol 4000,
titanium dioxide (E171).
Quetiapine 100 and 150 mg Film-coated Tablets also
contain iron oxide yellow (E172).

What Quetiapine looks like and contents of the pack
Quetiapine 100 mg film-coated tablets are yellow and
round (8.8 mm diameter). They have a score line on one
side and can be divided into four equal doses.
Quetiapine 150 mg film-coated tablets are cream
coloured and round (10.5 mm diameter). They have a
score line on one side and can be divided into two equal
doses.
Quetiapine 200 mg film-coated tablets are white and
round (11.5 mm diameter). They have a score line on
one side and can be divided into four equal doses.
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 containing 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.
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
film-coated tablets
• 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 containing 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
UK: Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Malta: Sandoz d.d., Verovškova 57, 1000 Ljubljana,
Slovenia.

Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany or Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen, Germany or Lek
Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana,
Slovenia or Lek Pharmaceuticals d.d., Trimlini 2D, 9220
Lendava, Slovenia or LEK S.A.,Ul. Podlipie 16 C,
95 010 Strykow, Poland or LEK S.A.,Ul. Domaniewska
50 C, 02-672 Warszawa, Poland.
This leaflet was last revised in 08/2013.

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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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