Skip to Content

UK Edition. Click here for US version.

EBESQUE XL 400 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE FUMARATE

View full screen / Print PDF » Download PDF ⇩
Transcript
INFORMATION FOR THE USER

Ebesque XL 50 mg prolonged-release tablets
Ebesque XL 200 mg prolonged-release tablets
Ebesque XL 300 mg prolonged-release tablets
Ebesque XL 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 Ebesque XL is and what it is used for
2. What you need to know before you take Ebesque XL
3. How to take Ebesque XL
4. Possible side effects
5. How to store Ebesque XL
6. Contents of the pack and other information
1. WHAT EBESQUE XL IS AND WHAT IT IS USED FOR
Ebesque XL contains a substance called quetiapine. This belongs to a group of medicines called antipsychotics.
Ebesque XL can be used to treat several illnesses, such as
• Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad or
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 Ebesque 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 Ebesque XL even when you feel better.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EBESQUE XL
Do not take Ebesque 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)
• Medicines for an infection (like erythromycin or clarithromycin)
• Nefazodone (for depression)
Do not take Ebesque XL if the above applies to you. If you are not sure, talk to your doctor or pharmacist before
taking Ebesque XL.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ebesque XL, 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 an older person.
- 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 Ebesque 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 older person with dementia (loss of brain function). If you are, Ebesque XL should not be taken
because the group of medicines that Ebesque XL belongs to may increase the risk of stroke, or in some
cases the risk of death, in older people with dementia.
- You or someone else in your family has a history of blood clots, as medicines like these have been
associated with formation of blood clots.
Tell your doctor immediately if you experience any of the following after taking Ebesque 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
older 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 other infection, as this could be a result of a very low white blood
cell count, which may require Ebesque 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
Ebesque XL is not for use in children and adolescents below 18 years of age.
Other medicines and Ebesque XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Ebesque 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 (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).
• Medicines that can cause constipation.
Before you stop taking any of your medicines, please talk to your doctor or pharmacist first.
Ebesque XL with food and drink
- Ebesque 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 Ebesque XL and alcohol can
make you sleepy.
- Do not drink grapefruit juice while you are taking Ebesque 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 Ebesque XL during pregnancy
unless this has been discussed with your doctor. Ebesque 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.
Ebesque XL contains lactose.
Ebesque XL contains lactose which is a type of sugar. If you have been told by your doctor that you have an
intolerance to some sugars, talk to your doctor before taking this medicine.
Effect on Urine Drug Screens
If you are having a urine drug screen, taking Ebesque XL 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 EBESQUE 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.
Method of administration
- 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 Ebesque 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.
Older people
If you are an older person your doctor may change your dose.
Use in children and adolescents
Ebesque XL should not be used by children and adolescents aged under 18 years.
If you take more Ebesque XL than you should
If you take more Ebesque 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. Take the Ebesque XL tablets with you.
If you forget to take Ebesque 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 Ebesque XL
If you suddenly stop taking Ebesque XL, 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 (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 Ebesque XL) (may lead to falls).
- Discontinuation symptoms (symptoms which occur when you stop taking Ebesque 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.
- 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 heart beat.
- 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:
• men and women to have swelling of breasts and unexpectedly produce breast milk.
• 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 the 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 disease
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 a type of 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.
- A combination of fever, flu-like symptoms, sore throat or other infection with a very reduced number of white
blood cells (a disease called “agranulocytosis”).
- Bowel obstruction.
- Increased blood creatine phosphokinase (a substance from 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) that 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 fibres and pain in muscles (rhabdomyolysis).
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 taken Ebesque XL during pregnancy.
- Worsening of pre-existing diabetes.
The class of medicines to which Ebesque XL belongs can cause heart rhythm problems, which can be serious and
in severe cases 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.
Children and adolescents
The same effects that may occur in adults may also occur in children and adolescents.
The following side effects have been seen more often or only 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. 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.
- Vomiting.
- Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless
or muscle stiffness without pain.
- Increase in blood pressure.
The following side effects have been seen more often in children and adolescents:
Common (may affect up to 1 in 10 people)
- Feeling weak. Fainting (may lead to falls).
- Stuffy nose.
- Feeling irritated.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet.
You can also report side effects directly via 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 EBESQUE 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 carton and blister after EXP. The expiry date
refers to the last day of that month.
For Ebesque XL 50 mg:
Do not store above 30°C.
For Ebesque XL 200/300/400 mg:
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater. 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

8039450-7803

What Ebesque XL contains
- The active substance is quetiapine.
Each tablet contains either 50 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
- The other ingredients are:
Core
Lactose monohydrate, cellulose microcrystalline, magnesium oxide light, carrageenan lambda,
povidone (K-30), magnesium stearate
Film-coating
Carrageenan lambda, titanium dioxide (E171), macrogol 400.
The 50 mg tablets contain additionally: Ferric oxide yellow (E172) and Ferric oxide red (E172).
The 200 and 300 mg tablets contain additionally: Ferric oxide yellow (E172).
Imprinting:
Black ink (contains shellac glaze, iron oxide black (E172) and propylene glycol).
What Ebesque XL looks like and contents of the pack
Ebesque XL 50 mg: Light pink to pink coloured, capsule shaped, biconvex, prolonged-release tablets, printed with
‘305’ with black ink.
Ebesque XL 200 mg: Yellow coloured, capsule shaped, biconvex, prolonged-release tablets, printed with ‘243’
with black ink.
Ebesque XL 300 mg: Pale yellow coloured, capsule shaped, biconvex, prolonged-release tablets, printed with
‘244’ with black ink.
Ebesque XL 400 mg: White to off-white, capsule shaped, biconvex, prolonged-release tablets, printed with ‘245’
with black ink.
Pack sizes: 10, 50, 60, 100 prolonged-release tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Dallas Burston Ashbourne Ltd
The Rectory, Braybrooke Road
Arthingworth, Market Harborough
LE16 8JT, United Kingdom
Telephone: (01858) 525643
Fax: (01858) 525383
Email: enquiries@medinformation.co.uk
Manufacturer:
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
County Oak Way
Crawley
West Sussex, RH11 7XA
United Kingdom
Telephone: (01293) 574180
Fax: (01293) 533003
Email: drugsafety@torrentpharma.co.uk
This text was last revised in 09/2015
PROOF 15/09/15

SIZE: 160 x 655 mm_Front/Back Side

REMARK: Folding Length 38 mm

Expand view ⇕

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