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KOSTO XL 150 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE FUMARATE

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Package leaflet: Information for the user
KOSTO XL 50 mg, 150 mg, 200 mg, 300 mg AND 400 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 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 Kosto XL is and what it is used for
2.
What you need to know before you take Kosto XL
3.
How to take Kosto XL
4.
Possible side effects
5.
How to store Kosto XL
6.
Contents of the pack and other information
1.

What Kosto XL is and what it is used for

Kosto XL contains a substance called quetiapine. This belongs to a group of medicines called antipsychotics. Kosto 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 Kosto 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 Kosto XL even when you feel better.
2.

What you need to know before you take Kosto XL

Do not take Kosto 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 Kosto XL if the above applies to you. If you are not sure, talk to your doctor or
pharmacist before taking Kosto XL.
Warnings and precautions
Talk to your doctor or pharmacist before taking Kosto XL if:
 You, or someone in your family, have or have had any heart problems, for example heart
rhythm problems, weakening of the heart muscle or inflammation of the heart or if you are
taking any medicines that may have an impact on the way your heart beats.
 You have low blood pressure.
 You have had a stroke, especially if you are 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 Kosto XL.
 You know that you have had low levels of white blood cells in the past (which may or may
not have been caused by other medicines).
 You are an elderly person with dementia (loss of brain function). If you are, Kosto XL should
not be taken because the group of medicines that Kosto XL 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.
Tell your doctor immediately if you experience any of the following after taking Kosto 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 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 Kosto XL to be stopped and/or treatment to be
given.
 Constipation along with persistent abdominal pain, or constipation which has not responded to
treatment, as this may lead to a more serious blockage of the bowel.
Thoughts of suicide and worsening of your depression
If you are depressed you may sometimes have thoughts of harming or killing yourself. These may be
increased when first starting treatment, since these medicines all take time to work, usually about two
weeks but sometimes longer. These thoughts may also be increased if you suddenly stop taking your
medication. You may be more likely to think like this if you are a young adult. Information from
clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young
adults aged less than 25 years with depression.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital
straight away. You may find it helpful to tell a relative or close friend that you are depressed, and ask

them to read this leaflet. You might ask them to tell you if they think your depression is getting worse,
or if they are worried about changes in your behaviour.
Weight gain
Weight gain has been seen in patients taking quetiapine. You and your doctor should check your
weight regularly.
Children and Adolescents
Kosto XL is not for use in children and adolescents below 18 years of age.
Other medicines and Kosto XL
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Kosto 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.
Kosto XL with food, drink and alcohol
 Kosto XL can be affected by food and you should therefore take your tablets at least one hour
before a meal or prior to bedtime.
 Be careful how much alcohol you drink. This is because the combined effect of Kosto XL and
alcohol can make you sleepy.
 Do not drink grapefruit juice while you are taking Kosto 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 Kosto XL during pregnancy unless this has been discussed with your doctor.
Kosto XL 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 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.
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.
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 Kosto XL

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 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.
 Do not split, chew or crush the tablets.
 Swallow your tablets whole with a drink of water.
 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 Kosto XL. 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 people
If you are elderly your doctor may change your dose.
Use in children and adolescents
Kosto XL should not be used by children and adolescents aged under 18 years.
If you take more Kosto XL than you should
If you take more Kosto 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
Kosto XL tablets with you.
If you forget to take a dose of Kosto 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 Kosto XL
If you suddenly stop taking Kosto XL, you may be unable to sleep (insomnia), 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. If any of
the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
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 your medicine) (may lead to
falls).
 Discontinuation symptoms (symptoms which occur when you stop taking this medicine)
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 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 (may affect up to 1 in 100 people):
 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

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’’).
 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 (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).
 Worsening of pre-existing diabetes
Not known (frequency cannot be estimated from the available data)
 Skin rash with irregular red spots (erythema multiforme)
 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 quetiapine
during their pregnancy

The class of medicines to which quetiapine 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 (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 (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
at: 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 Kosto 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 container after EXP. The expiry
date refers to the last day of that month.
Kosto XL 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 Kosto XL contains
The active substance is quetiapine. Kosto XL tablets contain 50 mg, 150 mg, 200 mg, 300 mg
or 400 mg of quetiapine (as quetiapine fumarate).
The other ingredients are:
Tablet core: hypromellose 2910, hypromellose 2208, cellulose microcrystalline, sodium citrate
anhydrous, magnesium stearate.
Tablet coating: titanium dioxide (E171), hypromellose 2910, macrogol/PEG 400, polysorbate 80. The
50 mg, 200 mg and 300 mg tablets contain Iron Oxide Yellow (E172) and Iron Oxide Red (E172).
The 50 mg and 300 mg tablets also contain Iron Oxide Black (E172).
What Kosto XL looks like and contents of the pack
All strengths of Kosto XL prolonged-release tablets are capsule shaped, film-coated tablets.
50 mg tablets are brown coloured, debossed “Q 50” on one side, plain on the other;
150 mg tablets are white coloured, debossed “Q 150” on one side, plain on the other;
200 mg tablets are yellow coloured, debossed “Q 200” on one side, plain on the other;
300 mg tablets are light yellow coloured, debossed “Q 300” on one side, plain on the other;
400 mg tablets are white coloured, debossed “Q 400” on one side, plain on the other.
- PVC/Aclar – Aluminium blisters in cartons
50 mg: 10, 10x1 (unit dose with perforated blister), 20, 30, 30x1 (unit dose with perforated blister ),
50, 56 (calendar pack), 60, 60x1 (unit dose with perforated blister), 90 or 100 prolonged-release
tablets
150 mg: 10, 20, 30, 30x1 (unit dose with perforated blister ), 50, 56 (calendar pack), 60, 60x1 (unit
dose with perforated blister), 90 or 100 prolonged-release tablets
200 mg: 10, 10x1 (unit dose with perforated blister), 20, 30, 30x1 (unit dose with perforated blister ),
50, 56 (calendar pack), 60, 60x1 (unit dose with perforated blister), 90, 100 or 100x1 (unit dose with
perforated blister) prolonged-release tablets
300 mg: 10, 10x1 (unit dose with perforated blister), 20, 30, 30x1 (unit dose with perforated blister ),
50, 56 (calendar pack), 60, 60x1 (unit dose with perforated blister), 90, 100 or 100x1 (unit dose with
perforated blister) prolonged-release tablets
400 mg: 10, 10x1 (unit dose with perforated blister), 20, 30, 30x1 (unit dose with perforated blister ),
50, 56 (calendar pack), 60, 60x1 (unit dose with perforated blister), 90, 100 or 100x1 (unit dose with
perforated blister) prolonged-release tablets
-

HDPE containers contain 60 tablets

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG, UK
*OR
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany
*OR
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United
Kingdom
*OR
Teva Pharma S.L.U, C/ C, nº 4. Polígono Industrial Malpica, Zaragoza, 50016 Zaragoza, Spain
This leaflet was last revised in 10/2014.
PL 00289/1828
PL 00289/1829
PL 00289/1830
PL 00289/1831
PL 00289/1832
* Only the actual site of batch release will appear on the printed version of the leaflet

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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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