Skip to Content

UK Edition. Click here for US version.

QUETIAPINE 200 MG FILM-COATED TABLETS

Active substance(s): QUETIAPINE FUMARATE / QUETIAPINE HEMIFUMARATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

LABELLING

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 23 of 37

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE
PACKAGING
{BOX FOR BLISTERS}
{BOX FOR TABLET CONTAINER}
{LABEL ON TABLET CONTAINER}

1.

NAME OF THE MEDICINAL PRODUCT

{Product name} 25 mg film-coated tablets
{Product name} 100 mg film-coated tablets
{Product name} 150 mg film-coated tablets
{Product name} 200 mg film-coated tablets
{Product name} 300 mg film-coated tablets
Quetiapine

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

25 mg:
Each tablet contains 25 mg quetiapine (as quetiapine hemifumarate).
100 mg:
Each tablet contains 100 mg quetiapine (as quetiapine hemifumarate).
150 mg:
Each tablet contains 150 mg quetiapine (as quetiapine hemifumarate).
200 mg:
Each tablet contains 200 mg quetiapine (as quetiapine hemifumarate).
300 mg:
Each tablet contains 300 mg quetiapine (as quetiapine hemifumarate).

3.

LIST OF EXCIPIENTS

Also contains lactose.
See leaflet for further information.

4.

PHARMACEUTICAL FORM AND CONTENTS

film-coated tablet
Blister packs:
6 film-coated tablets (only 25 mg tablets)
10 film-coated tablets
20 film-coated tablets

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 24 of 37

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

30 film-coated tablets
30 x 1 film-coated tablet
50 film-coated tablets
60 film-coated tablets
90 film-coated tablets
98 film-coated tablets
100 film-coated tablets
100 x 1 film-coated tablet
120 film-coated tablets (only 150 mg and 300 mg tablets)
180 film-coated tablets (only 150 mg and 300 mg tablets)
240 film-coated tablets (only 150 mg and 300 mg tablets)
HDPE containers:
250 film-coated tablets (only 100 mg and 200 mg tablets)

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.
Oral use.

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

8.

EXPIRY DATE

EXP:
HDPE tablet container:
Shelf life after the first opening is 3 months.

9.

SPECIAL STORAGE CONDITIONS

10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE

11.

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

[To be completed nationally.]

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 25 of 37

1.3.1
SPC, Labeling and Package Leaflet
12.

Quetiapine hemifumarate
DK

MARKETING AUTHORISATION NUMBER(S)

[To be completed nationally.]

13.

BATCH NUMBER

Batch:

14.

GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.

INSTRUCTIONS ON USE

16.

INFORMATION IN BRAILLE

{Product name} 25 mg (on box only)
{Product name} 100 mg (on box only)
{Product name} 150 mg (on box only)
{Product name} 200 mg (on box only)
{Product name} 300 mg (on box only)

17.

UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included. (on box only)
Safety features will be implemented until 9/2/2019.
18.

UNIQUE IDENTIFIER – HUMAN READABLE DATA

SN: (on box only)
NN: (on box only)>
Safety features will be implemented until 9/2/2019.

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 26 of 37

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
{BLISTER (PVC/Alu-FOIL)}

1.

NAME OF THE MEDICINAL PRODUCT

{Product name} 25 mg film-coated tablets
{Product name} 100 mg film-coated tablets
{Product name} 150 mg film-coated tablets
{Product name} 200 mg film-coated tablets
{Product name} 300 mg film-coated tablets
Quetiapine
2.

NAME OF THE MARKETING AUTHORISATION HOLDER

[To be completed nationally.]
3.

EXPIRY DATE

EXP:
4.

BATCH NUMBER

Batch:
5.

OTHER

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 27 of 37

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

PACKAGE LEAFLET

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 28 of 37

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

Package leaflet: Information for the patient
{Product name} 25 mg film-coated tablets
{Product name} 100 mg film-coated tablets
{Product name} 150 mg film-coated tablets
{Product name} 200 mg film-coated tablets
{Product name} 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 {Product name} is and what it is used for
2.
What you need to know before you take {Product name}
3.
How to take {Product name}
4.
Possible side effects
5.
How to store {Product name}
6.
Contents of the pack and other information
1.

What {Product name} is and what it is used for

{Product name} contains a substance called quetiapine. This belongs to a group of medicines called
antipsychotics. {Product name} can be used to treat several illnesses such as:
 Bipolar depression: 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.
Your doctor may continue to prescribe {Product name} even when you are feeling better.
2.

What you need to know before you take {Product name}

Do NOT TAKE {Product name}

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:
o some medicines for HIV
o azole medicines (for fungal infections)
o erythromycin or clarithromycin (for infections)
o nefazodone (for depression).

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 29 of 37

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

Do not take {Product name} if the above applies to you. If you are not sure, talk to your doctor or
pharmacist before taking {Product name}.
Warnings and precautions
Talk to your doctor or pharmacist before taking {Product name} 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 elderly
 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 {Product name}.
 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 elderly person with dementia (loss of brain function). If you are, {Product name}
should not be taken because the group of medicines that {Product name} belongs to may increase
the risk of stroke, or in some cases the risk of death, in elderly 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.
 You have or have had a condition where you stop breathing for short periods during your normal
nightly sleep (called “sleep apnoea”) and are taking medicines that slow down the normal activity
of the brain (“depressants”).
 You have or have had a condition where you can’t completely empty your bladder (urinary
retention), have an enlarged prostate, a blockage in your intestines, or increased pressure inside
your eye. These conditions are sometimes caused by medicines (called “anti-cholinergics”) that
affect the way nerve cells function in order to treat certain medical conditions.
 You have a history of alcohol or drug abuse.
Tell your doctor immediately if you experience any of the following after taking {Product name}:
 A combination of fever, severe muscle stiffness, sweating or a lowered level of consciousness (a
disorder called “neuroleptic malignant syndrome”). Immediate medical treatment may be needed.
 Uncontrollable movements, mainly of your face or tongue.
 Dizziness or a severe sense of feeling sleepy. This could increase the risk of accidental injury (fall)
in elderly patients.
 Fits (seizures).
 A long-lasting and painful erection (Priapism).
These conditions can be caused by this type of medicine.
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 {Product name} 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

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 30 of 37

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

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 {Product name}. You and your doctor should check your
weight regularly.
Children and Adolescents
{Product name} is not for use in children and adolescents below 18 years of age.
Other medicines and {Product name}
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take {Product name} 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.
 Medicines (called “anti-cholinergics”) that affect the way nerve cells function in order to treat
certain medical conditions.
Before you stop taking any of your medicines, please talk to your doctor first.
{Product name} with food, drink and alcohol
 {Product name} can be taken with or without food.
 Be careful how much alcohol you drink. This is because the combined effect of {Product name}
and alcohol can make you sleepy.
 Do not drink grapefruit juice while you are taking {Product name}. 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 {Product name}

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 31 of 37

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

during pregnancy unless this has been discussed with your doctor. {Product name} should not be taken
if you are breast-feeding.
The following symptoms which can represent withdrawal may occur in newborn babies of mothers
that have used {Product name} in the last trimester (last three months of their pregnancy): shaking,
muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
If your baby develops any of these symptoms you may need to contact your doctor.
Driving and using machines
Your tablets may make you feel sleepy. Do not drive or use any tools or machines until you know how
the tablets affect you.
{Product name} contains lactose
{Product name} contains 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 medicine.
Effect on Urine Drug Screens
If you are having a urine drug screen, taking {Product name} 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 {Product name}

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure. Your doctor will decide on your starting dose. The 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
Swallow your tablets whole with a drink of water.
You can take your tablets with or without food.
Do not drink grapefruit juice while you are taking {Product name}. It can affect the way the
medicine works.
 Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Liver problems
If you have liver problems your doctor may change your dose.
Elderly
If you are elderly your doctor may change your dose.
Use in children and adolescents
{Product name} should not be used by children and adolescents aged under 18 years.
If you take more {Product name} than you should
If you take more {Product name} 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
{Product name} tablets with you.
If you forget to take {Product name}
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.

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 32 of 37

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

If you stop taking {Product name}
If you suddenly stop taking {Product name}, 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.
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 {Product name}) (may lead to
falls).
 Discontinuation symptoms (symptoms which occur when you stop taking {Product name}) 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 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 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 the elderly).
 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:
o Men and women to have swelling of breasts and unexpectedly produce breast milk.
o Women to have no monthly period or irregular periods.
Uncommon side effects (may affect up to 1 in 100 people):

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 33 of 37

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

 Fits or seizures.
 Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around
the mouth.
 Unpleasant sensations in the legs (also called restless legs syndrome).
 Difficulty swallowing.
 Uncontrollable movements, mainly of your face or tongue.
 Sexual dysfunction.
 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.
 Worsening of pre-existing diabetes.
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”).
 Yellowing of the skin and eyes (jaundice).
 Inflammation of the liver (hepatitis).
 A long-lasting and painful erection (priapism).
 Swelling of breasts and unexpected production of breast milk (galactorrhoea).
 Menstrual disorder.
 Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the
leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in
breathing. If you notice any of these symptoms seek medical advice immediately.
 Walking, talking , eating or other activities while you are asleep.
 Body temperature decreased (hypothermia).
 Inflammation of the pancreas.
 A condition (called “metabolic syndrome”) where you may have a combination of 3 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.
 Combination of fever, flu-like symptoms, sore throat, or any other infection with very low white
blood cell count, a condition called agranulocytosis.
 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.
 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).
 Inappropriate secretion of a hormone that controls urine volume.
 Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).
Not known (frequency cannot be estimated from the available data):
 Skin rash with irregular red spots (erythema multiforme).

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 34 of 37

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

 Serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling
of the skin (toxic epidermal necrolysis).
 Symptoms of withdrawal may occur in newborn babies of mothers that have used {Product name}
during their pregnancy.
The class of medicines to which {Product name} belongs can cause heart rhythm problems, which can
be serious and in severe cases may be fatal.
Some side effects are only seen when a blood test is taken. These include changes in the amount of
certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid
hormones in your blood, increased liver enzymes, decreases in the number of certain types of blood
cells, decrease in the amount of red blood cells, increased blood creatine phosphokinase (a substance
in the muscles), decrease in the amount of sodium in the blood and increases in the amount of the
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 side effects (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:
o boys and girls to have swelling of breasts and unexpectedly produce breast milk
o 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 national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of
this medicine.
5.

How to store {Product name}

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

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 35 of 37

1.3.1
SPC, Labeling and Package Leaflet

Quetiapine hemifumarate
DK

Do not use this medicine after the expiry date which is stated on the carton, container and blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
HDPE tablet container:
Shelf life after the first opening is 3 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 protect the environment.
6.

Contents of the pack and other information

What {Product name} contains
- The active substance is quetiapine. Each tablet contains 25 mg, 100 mg, 150 mg, 200 mg or
300 mg quetiapine (as quetiapine hemifumarate).
- The other ingredients are lactose monohydrate, dihydrate calcium hydrogen phosphate,
microcrystalline cellulose, povidone, sodium starch glycolate (type A), magnesium stearate in the
tablet core and hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172)
(only in the 25 mg and 100 mg tablets) and red iron oxide (E172) (only in the 25 mg tablets) in the
film-coating (see section 2).
What {Product name} looks like and contents of the pack
The 25 mg tablets are round, pale red film-coated tablets with bevelled edge.
The 100 mg tablets are round, yellow-brown film-coated tablets.
The 150 mg tablets are round, white film-coated tablets with bevelled edge.
The 200 mg tablets are round, white film-coated tablets.
The 300 mg tablets are capsule-shaped, white film-coated tablets.
{Product name} film-coated tablets are available in boxes of 6 (only 25 mg tablets), 10, 20, 30, 30 x 1,
50, 60, 90, 98, 100, 100 x 1, 120 (only 150 mg and 300 mg tablets), 180 (only 150 mg and 300 mg
tablets) or 240 (only 150 mg and 300 mg tablets) tablets in blisters and 250 tablets (only 100 mg and
200 mg tablets) in a container (HDPE).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally.]
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia
This medicinal product is authorised in the Member States of the EEA under the following
names:
Name of the Member State
Austria, Denmark, Sweden
Belgium, Netherlands, Norway
Bulgaria, Czech Republic, Estonia, Latvia,
Lithuania, Poland, Romania, Slovak Republic
Germany
Greece

SmPCPIL095768_1

Name of the medicinal product
Quetiapin Krka
Quetiapine Krka
Kventiax
Quetiapin TAD
Quetiapine TAD

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 36 of 37

1.3.1
SPC, Labeling and Package Leaflet
Italy, Spain
United Kingdom

Quetiapine hemifumarate
DK
Quentiax
Quetiapine

This leaflet was last revised in

SmPCPIL095768_1

21.07.2017 – Updated: 21.07.2017

CONFIDENTIAL

Page 37 of 37

+ Expand Transcript

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.

Hide