Skip to Content

UK Edition. Click here for US version.

QUELENTO XL 200 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE FUMARATE / QUETIAPINE FUMARATE / QUETIAPINE FUMARATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Quetiapine Teva 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 Quetiapine Teva is and what it is used for
2.
What you need to know before you take Quetiapine Teva
3.
How to take Quetiapine Teva
4.
Possible side effects
5.
How to store Quetiapine Teva
6.
Contents of the pack and other information
1.

What Quetiapine Teva is and what it is used for

Quetiapine Teva contains a substance called quetiapine. This belongs to a group of medicines called
anti-psychotics. Quetiapine Teva 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 Quetiapine Teva 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 Quetiapine Teva even when you feel better.
2.

What you need to know before you take Quetiapine Teva

Do not take Quetiapine Teva:
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)

REG0211176

Version 0.4

Approved

Page 1 of 10

Do not take Quetiapine Teva if the above applies to you. If you are not sure, talk to your doctor or
pharmacist before taking Quetiapine Teva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quetiapine Teva 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 Quetiapine Teva.
 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, Quetiapine Teva
should not be taken because the group of medicines that Quetiapine Teva 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 “anticholinergics”) that affect the way nerve cells function in order to treat certain medical
conditions
Tell your doctor immediately if you experience any of the following after taking Quetiapine Teva:
 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 Quetiapine Teva 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

REG0211176

Version 0.4

Approved

Page 2 of 10

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
Quetiapine Teva is not for use in children and adolescents below 18 years of age.
Other medicines and Quetiapine Teva
Tell your doctor if you are taking, or have recently taken or might take any other medicines.
Do not take Quetiapine Teva 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.
Quetiapine Teva with food, drink and alcohol
 Quetiapine Teva 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 Quetiapine
Teva and alcohol can make you sleepy.
 Do not drink grapefruit juice while you are taking Quetiapine Teva. 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 for advice before taking this medicine. You should not take Quetiapine Teva during
pregnancy unless this has been discussed with your doctor. Quetiapine Teva should not be taken if you
are breast-feeding.

REG0211176

Version 0.4

Approved

Page 3 of 10

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 Teva 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 Quetiapine Teva

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 Quetiapine Teva. 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
Quetiapine Teva should not be used by children and adolescents aged under 18 years.
If you take more Quetiapine Teva than you should
If you take more Quetiapine Teva 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
Quetiapine Teva tablets with you.
If you forget to take a dose of Quetiapine Teva
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 Quetiapine Teva
If you suddenly stop taking Quetiapine Teva, 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.

REG0211176

Version 0.4

Approved

Page 4 of 10

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 you get any of the following serious side effects, stop taking Quetiapine Teva and go to your
doctor or to the nearest hospital straight away:
Common side effects (may affect up to 1 in 10 people):
Thoughts of suicide and worsening of your depression
Uncommon side effects (may affect up to 1 in 100 people):
Sudden fever, especially with sore throat and other flu-like symptoms. These can be signs of
an abnormal low concentration of white blood cells.
Signs of skin reactions such as skin rash, hives, lumps, redness, itching, maybe with swelling
of the face, eyelids, and lips. This could additionally lead to difficulty in breathing, dizziness or
shock.
Fits or seizures
Uncontrollable movements, mainly of your face or tongue (tardive dyskinesia)
Feeling your heart is pounding or racing together with dizziness or fainting. This can be
signs of serious heart rhythm problems and in severe cases may be fatal.
Rare side effects (may affect up to 1 in 1,000 people):
Severe pain and/or swelling and redness in one of your legs; sudden severe pain in the chest
which may reach the left arm or sudden breathlessness. These can be signs of blood clots in the
veins.
Severe upper stomach pain, often radiating to the back, sometimes together with nausea and
vomiting. This can be a sign of inflammation of the pancreas.
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.
Yellowing of the skin and eyes (jaundice), dark coloured urine, especially together with
unusual tiredness or fever (signs of a hepatitis).
A long lasting and painful erection.
A combination of fever, sweating, stiff muscles, feeling very drowsy or faint (a disorder called
“neuroleptic malignant syndrome’’).
Very rare side effects (may affect up to 1 in 10,000 people):
Severe skin reactions with rash or blisters, irregular red spots or patches and/or peeling of the
skin, maybe around mouth, eyes or genitals and often together with sudden fever or flu-like
symptoms. These reactions may develop quickly.
Unexplained muscle pain, tenderness or weakness. These might be early signs of potentially
severe muscle degradation.
Other possible side effects
Very common side effects (may affect more than 1 in 10 people):
 Dizziness (may lead to falls), headache, dry mouth.

REG0211176

Version 0.4

Approved

Page 5 of 10









Feeling sleepy (this may go away with time, as you keep taking Quetiapine Teva) (may lead to
falls).
Discontinuation symptoms (symptoms which occur when you stop taking Quetiapine Teva)
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.
Decreased level of haemoglobin (protein in red blood cells that carry oxygen)
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.
 Shortness of breath.
 Vomiting (mainly in the elderly).
 Fever.
 Changes in the amount of thyroid hormones in your blood.
 Changes 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):
 Unpleasant sensations in the legs (also called restless legs syndrome).
 Difficulty swallowing.
 Sexual dysfunction.
 Diabetes.
 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 sodium in the blood.
 Worsening of pre-existing diabetes
Rare side effects (may affect up to 1 in 1,000 people):

REG0211176

Version 0.4

Approved

Page 6 of 10









Swelling of breasts and unexpected production of breast milk (galactorrhoea).
Menstrual disorder.
Walking, talking, eating or other activities while you are asleep.
Body temperature decreased (hypothermia).
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.
Increased blood creatine phosphokinase (a substance from the muscles).

Very rare side effects (may affect up to 1 in 10,000 people):
 Inappropriate secretion of a hormone that controls urine volume.
Not known (frequency cannot be estimated from the available data)
 Symptoms of withdrawal may occur in newborn babies of mothers that have used Quetiapine
Teva during their pregnancy.
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

REG0211176

Version 0.4

Approved

Page 7 of 10

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 Quetiapine Teva

Keep this medicine out of the sight and reach of children.
Do not use Quetiapine Teva after the expiry date which is stated on the container and blister after
EXP. The expiry date refers to the last day of that month.
Quetiapine Teva 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 Quetiapine Teva contains
The active substance is quetiapine. Quetiapine Teva 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, cellulose microcrystalline, sodium citrate anhydrous, magnesium stearate.
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 Quetiapine Teva looks like and contents of the pack
-

Quetiapine Teva 50 mg prolonged-release tablets
Brown, biconvex, oblong film-coated tablets with embossing “Q50” on one side

-

Quetiapine Teva 150 mg prolonged-release tablets
White, biconvex, oblong film-coated tablets with embossing “Q150” on one side

-

Quetiapine Teva 200 mg prolonged-release tablets
Yellow, biconvex, oblong film-coated tablets with embossing “Q200” on one side

-

Quetiapine Teva 300 mg prolonged-release tablets
Light yellow, biconvex, oblong film-coated tablets with embossing “Q300” on one side

-

Quetiapine Teva 400 mg prolonged-release tablets
White, biconvex oblong film-coated tablets with embossing “Q400” on one side

Packs of 10, 20, 30, 50, 50x1 (perforated unit dose blister) (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
[To be completed nationally]

REG0211176

Version 0.4

Approved

Page 8 of 10

This medicinal product is authorised in the Member States of the EEA under the following
names:
{Name of the Member State} {Name of the medicinal product}
{Name of the Member State} {Name of the medicinal product}
This leaflet was last revised in {MM/YYYY}.
[To be completed nationally]

REG0211176

Version 0.4

Approved

Page 9 of 10

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceutical Industries LTD.
PIL clean VAR after repeat use

APPROVALS
Signed by
Udo Mey

REG0211176

Meaning of Signature
Regulatory Affairs Approval

Version 0.4

Approved

Server Date
18-Apr-2017 02:49:56 PM

Page 10 of 10

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