QUELENTO XL 400 MG PROLONGED-RELEASE TABLETS

Active substance: QUETIAPINE FUMARATE

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SONDATE XL 50mg, 200mg, 300mg & 400mg prolonged-release tablets
PL 00289/1506-1509
UK/H/4674/01-04/DC

Version 3d1

PACKAGE LEAFLET: INFORMATION FOR THE USER
QUELENTO XL 50 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets
Quetiapine
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
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.
In this leaflet:
1.
What QUELENTO XL is and what it is used for
2.
Before you take QUELENTO XL
3.
How to take QUELENTO XL
4.
Possible side effects
5.
How to store QUELENTO XL
6.
Further information

1.

WHAT QUELENTO XL IS AND WHAT IT IS USED FOR

QUELENTO XL contains a substance called quetiapine. This belongs to a group of medicines called
anti-psychotics. QUELENTO XL can be used to treat several illnesses, such as:
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.
Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have
poor judgment including being aggressive or disruptive.
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.
When QUELENTO 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 give you QUELENTO XL when you are feeling better.

2.

BEFORE YOU TAKE QUELENTO XL

Do not take QUELENTO XL:
if you are allergic (hypersensitive) to quetiapine or any of the other ingredients of QUELENTO
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).
Do not take QUELENTO XL if the above applies to you. If you are not sure, talk to your doctor or
pharmacist before taking QUELENTO XL.

SONDATE XL 50mg, 200mg, 300mg & 400mg prolonged-release tablets
PL 00289/1506-1509
UK/H/4674/01-04/DC

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Take special care with QUELENTO XL
Before you take your medicine, tell your doctor if:
You, or someone in your family, have or have had any heart problems, for example heart
rhythm problems 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 QUELENTO 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, QUELENTO XL
should not be taken because the group of medicines that QUELENTO 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:
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.
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 has been seen in patients taking quetiapine. You and your doctor should check your
weight regularly.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription and herbal medicines.
Do not take QUELENTO XL if you are taking any of the following medicines:
Some medicines for HIV.
Azole medicines (for fungal infections).
Erythromycin or clarithromycin (for infections).

SONDATE XL 50mg, 200mg, 300mg & 400mg prolonged-release tablets
PL 00289/1506-1509
UK/H/4674/01-04/DC

Version 3d1

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 (another anti-psychotic medicine).
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).
Before you stop taking any of your medicines, please talk to your doctor first.
Taking QUELENTO XL with food and drink
QUELENTO 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 QUELENTO
XL and alcohol can make you sleepy.
Do not drink grapefruit juice while you are on QUELENTO XL treatment. It can affect the
way the medicine works.
Pregnancy and breast-feeding
If you are pregnant, trying to get pregnant, or breast-feeding, talk to your doctor before taking
QUELENTO XL. You should not take QUELENTO XL during pregnancy unless this has been
discussed with your doctor. QUELENTO XL should not be taken if you are breast-feeding.
The following symptoms 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 taking quetiapine and have a urine drug screen, some test methods may cause positive
results for methadone or TCAs (drugs for depression called tricyclic antidepressants), even though you
may not be taking methadone or TCAs. If this happens, a more specific test can be performed.
3.

HOW TO TAKE QUELENTO XL

Always take QUELENTO XL exactly as your doctor has told you. You should 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 QUELENTO XL treatment. 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

SONDATE XL 50mg, 200mg, 300mg & 400mg prolonged-release tablets
PL 00289/1506-1509
UK/H/4674/01-04/DC

Version 3d1

If you have liver problems your doctor may change your dose.
Elderly people
If you are elderly your doctor may change your dose.
Children and adolescents under 18 years
QUELENTO XL should not be used by children and adolescents aged under 18 years.
If you take more QUELENTO XL than you should
If you take more QUELENTO XL than prescribed by your doctor, you may experience sleepiness,
dizziness and abnormal heart beats. Contact your doctor or nearest hospital straight away.
Keep the QUELENTO XL tablets with you.
If you forget to take a dose of QUELENTO 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 QUELENTO XL
If you suddenly stop taking QUELENTO 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 product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, QUELENTO XL 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 (affects more than 1 patient in 10):
Dizziness (may lead to falls), headache, dry mouth.
Feeling sleepy (this may go away with time, as you keep taking QUELENTO XL) (may lead
to falls).
Discontinuation symptoms (symptoms which occur when you stop taking QUELENTO XL)
include not being able to sleep (insomnia), feeling sick (nausea), headache, diarrhoea, being
sick (vomiting), dizziness, and irritability. Gradual withdrawal over a period of at least 1 to 2
weeks is advisable.
Putting on weight.
Common (affects 1 to 10 patients in 100):
Rapid heartbeat.
Feeling like your heart is pounding, racing or has skipped beats.
Stuffy nose.
Constipation, upset stomach (indigestion).
Feeling weak, fainting (may lead to falls).
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.

SONDATE XL 50mg, 200mg, 300mg & 400mg prolonged-release tablets
PL 00289/1506-1509
UK/H/4674/01-04/DC

Version 3d1

Abnormal muscle movements. These include difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.
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 (affects 1 to 10 patients in 1,000):
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.
Worsening of pre-existing diabetes.
Change in electrical activity of the heart seen on ECG (QT prolongation).
Rare (affects 1 to 10 patients in 10,000):
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
Very rare (affects less than 1 patient in 10,000):
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).
Inappropriate secretion of a hormone that controls urine volume.
Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).
Not known (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)
The class of medicines to which QUELENTO XL belongs can cause heart rhythm problems, which
can be serious and in severe cases may be fatal.

SONDATE XL 50mg, 200mg, 300mg & 400mg prolonged-release tablets
PL 00289/1506-1509
UK/H/4674/01-04/DC

Version 3d1

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), decreases in the number of certain types of blood cells, decrease in the amount of
sodium 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.
Children and adolescents
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 (affects more than 1 patient in 10):
Increase in blood pressure.
The following side effects have been seen more often in children and adolescents:
Very Common (affects more than 1 patient in 10):
Increase in the amount of a hormone called prolactin, in the blood. Increases in the hormone
prolactin could in rare cases lead to the following:
- Boys and girls to have swelling of breasts and unexpectedly produce breast milk.
- Girls to have no monthly period or irregular periods.
Increased appetite.
Abnormal muscle movements. These include difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.

5.

HOW TO STORE QUELENTO XL

Keep out of the reach and sight of children.
Do not use QUELENTO XL after the expiry date which is stated on the container after EXP. The
expiry date refers to the last day of that month.
QUELENTO XL does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What QUELENTO XL contains
The active substance is quetiapine. QUELENTO XL tablets contain 50 mg, 200 mg, 300 mg or
400 mg of quetiapine (as quetiapine fumarate).
The other ingredients are:
Tablet core: hypromellose, cellulose microcrystalline, sodium citrate anhydrous, magnesium stearate.

SONDATE XL 50mg, 200mg, 300mg & 400mg prolonged-release tablets
PL 00289/1506-1509
UK/H/4674/01-04/DC

Version 3d1

Tablet coating: titanium dioxide (E171), hypromellose, 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 QUELENTO XL looks like and contents of the pack
All strengths of QUELENTO 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; 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 and 400 mg tablets are white coloured,
debossed “Q 400” on one side, plain on the other.
Packs of 10, 20, 30, 50, 50x1 (hospital pack), 56 (calendar pack), 60, 90 and100 tablets are registered
for all strengths. Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom
Manufacturer:
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
OR*
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
OR*
Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, 74770 Opava-Komarov, Czech Republic
OR*
Teva Operations Sp. z.o.o., ul. Mogilska 80. 31-546, Krakow, Poland
OR*
TEVA PHARMA S.L.U., C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain
OR*
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany
OR*
CT Arzneimittel GmbH, Graf-Arco-Stra8e 3, 89079 UIm, Germany
This leaflet was last revised in November 2012

PL 00289/1506
PL 00289/1507
PL 00289/1508
PL 00289/1509
*

Only the paragraph containing the details of the current batch release site will be included in the printed version of the PIL

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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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