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MINTRELEQ XL 300 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE FUMARATE

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Package leaflet: Information for the user

Mintreleq XL 50 mg, 150 mg, 200 mg, 300 mg, 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 Mintreleq XL is and what it is used for
2. What you need to know before you take
Mintreleq XL
3. How to take Mintreleq XL
4. Possible side effects
5. How to store Mintreleq XL
6. Contents of the pack and other information

1. What Mintreleq XL is and what it is
used for
Mintreleq XL contains a substance called
quetiapine. This belongs to a group of medicines
called antipsychotics. Mintreleq 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 Mintreleq XL is being taken to treat major
depressive episodes in major depressive disorder,
it will be taken in addition to another medicine
being used to treat this illness.
Your doctor may continue to prescribe Mintreleq
XL even when you feel better.

2. What you need to know before you
take Mintreleq XL
Do not take Mintreleq 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 Mintreleq XL if the above applies to
you. If you are not sure, talk to your doctor or
pharmacist before taking Mintreleq XL.
Warnings and precautions
Talk to your doctor before taking Mintreleq 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
Mintreleq 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, Mintreleq XL
should not be taken because the group of
medicines that Mintreleq 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 Mintreleq 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 Mintreleq 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
Mintreleq XL. You and your doctor should check
your weight regularly.

Children and Adolescents
Mintreleq XL is not for use in children and
adolescents below 18 years of age.
Other medicines and Mintreleq XL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Do not take Mintreleq 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).
In particular, 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, medicines
that can cause an imbalance in electrolytes
(low levels of potassium or magnesium) such
as diuretics (water pills) or certain antibiotics
(medicines to treat infections).
• Medicines that can cause constipation.
Before you stop taking any of your medicines,
please talk to your doctor first.
Mintreleq XL with food, drink and alcohol
• Mintreleq XL can be affected by food and you
should therefore take your tablets at least one
hour before a meal or at bedtime.
• Be careful how much alcohol you drink. This
is because the combined effect of Mintreleq XL
and alcohol can make you sleepy.
• Do not drink grapefruit juice while you are
taking Mintreleq 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 Mintreleq XL during
pregnancy unless this has been discussed with
your doctor. Mintreleq 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 Mintreleq XL 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
Mintreleq 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.
Mintreleq XL contains lactose
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product.

3. How to take Mintreleq XL
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.
• 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 Mintreleq 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 to.
Patients with liver problems
If you have liver problems your doctor may
change your dose.
Older people
If you are elderly your doctor may change your
dose.
Use in children and adolescents (under 18
years)
Mintreleq XL should not be used by children and
adolescents aged under 18 years.
If you take more Mintreleq XL than you
should
If you take more Mintreleq 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 Mintreleq XL tablets with you.
If you forget to take a dose of Mintreleq 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 dose.
If you stop taking Mintreleq XL
If you suddenly stop taking Mintreleq 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 or dry
mouth.
• Feeling sleepy - this may go away with time, as
you keep taking Mintreleq XL (may lead to falls).
• Discontinuation symptoms (symptoms which
occur when you stop taking Mintreleq 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 heartbeat.
• Feeling like your heart is pounding, racing or
has skipped beats.
• Constipation or 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):
• Worsening of pre-existing diabetes.
• 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 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 used
quetiapine during their pregnancy.
The class of medicines to which Mintreleq XL
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:
- 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.
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 (Website:
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 Mintreleq XL
Keep this medicine out of the sight and reach of
children.
Do not use Mintreleq XL after the expiry date
which is stated on the container after EXP. The
expiry date refers to the last day of that month.
Mintreleq 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 further
information
What Mintreleq XL contains
• The active substance is quetiapine. Mintreleq 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: lactose anhydrous, Methacrylic
acid – ethyl acrylate copolymer (1:1), type A
crystalline maltose, magnesium stearate and
talc.
Tablet coating: Methacrylic acid – ethyl
acrylate copolymer (1:1), type A, triethyl citrate.
What Mintreleq XL looks like and contents
of the pack
• The 50 mg prolonged-release tablets are white
to off white, round biconvex, engraved with
‘50’ on one side, 7.1 mm in diameter and 3.2 mm
in thickness.
• The 150 mg prolonged-release tablets are
white to off white, oblong biconvex and
engraved with ‘150’ on one side, 13.6 mm
in length, 6.6 mm in width and 4.2 mm in
thickness.
• The 200 mg prolonged-release tablets are
white to off white, oblong biconvex and
engraved with ‘200’ on one side, 15.2 mm
in length, 7.7 mm in width and 4.8 mm in
thickness.
• The 300 mg prolonged-release tablets are
white to off white, oblong biconvex and
engraved with ‘300’ on one side and 18.2 mm
in length, 8.2 mm in width and 5.4 mm in
thickness.
• The 400 mg prolonged-release tablets are
white to off white, oval biconvex and
engraved with ‘400’ on one side and 20.7 mm
in length, 10.2 mm in width and 6.3 mm in
thickness.
• Mintreleq XL prolonged-release tablets are
available as PVC/PCTFE- Aluminium foil blisters
packed in a cardboard box.
The pack sizes are:
Mintreleq XL 50 mg: 10, 20, 30, 50, 56, 60 and
100 tablets.
Mintreleq XL 150 mg: 10, 20, 30, 50, 56, 60 and
100 tablets.
Mintreleq XL 200 mg: 10, 20, 30, 50, 56, 60 and
100 tablets.
Mintreleq XL 300 mg: 10, 20, 30, 50, 56, 60 and
100 tablets.
Mintreleq XL 400 mg: 10, 20, 30, 50, 56, 60 and
100 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
CEB Pharma Limited
The North Suite, Avro House,
49 Lancaster Way Business Park,
Ely, Cambridgeshire,
CB6 3NW
Manufacturer:
Pharmathen S.A.
6 Dervenakion Str,
Pallini
Attiki
15351
Greece
Or
Pharmathen International S.A.
Sapes Industrial Park Block 5
Rodopi
69300
Greece
This leaflet was last revised in 01/2015

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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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