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QUETIAPINE 25MG FILM-COATED TABLETS

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

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PAGE 1: FRONT FACE (INSIDE OF REEL)

Package leaflet: Information for the patient
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 Film-coated Tablets is and what it is used for
2. What you need to know before you take Quetiapine Film-coated Tablets
3. How to take Quetiapine Film-coated Tablets
4. Possible side effects
5. How to store Quetiapine Film-coated Tablets
6. Contents of the pack and other information

1

What Quetiapine Film-coated Tablets is and what it is used for

Pharma code 76 (001101)
First bar is 105mm from top edge.

• Quetiapine contains a substance called quetiapine. This belongs to a group of
medicines called antipsychotics.
Quetiapine can be used to treat several illnesses, such as:
• Bipolar depression: 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.
Your doctor may continue to prescribe quetiapine even when you are feeling better.

2

What you need to know before you take Quetiapine Film-coated
Tablets

Do not take Quetiapine Film-coated Tablets:
• 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).
If you are not sure, talk to your doctor or pharmacist before taking Quetiapine Film-coated
Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking quetiapine 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.
• 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
Film-coated Tablets should not be taken because the group of medicines that
Quetiapine Film-coated Tablets 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 “anti-cholinergics”) that affect the way nerve cells function in order
to treat certain medical conditions.
• You have a history of alcohol or drug abuse.
Tell your doctor immediately if you experience any of the following after taking Quetiapine:
• 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 Film-coated Tablets
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 Film-coated Tablets. You and
your doctor should check your weight regularly.
Children and adolescents
Quetiapine is not for use in children and adolescents below 18 years of age.
Other medicines and Quetiapine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take Quetiapine Film-coated Tablets 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 Film-coated Tablets with food, drink and alcohol
• Quetiapine Film-coated Tablets can be taken with or without food
• Be careful how much alcohol you drink. This is because the combined effect of
Quetiapine Film-coated Tablets and alcohol can make you sleepy.
• Do not drink grapefruit juice while you are taking Quetiapine Film-coated Tablets. 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 Quetiapine Film-coated Tablets during pregnancy unless this has
been discussed with your doctor. Quetiapine Film-coated Tablets 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
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you
• It is an offence to drive if this medicine affects your ability to drive.
However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or dental problem
• You have taken it according to the instructions given by the prescriber or in the
information provided with the medicine
• It was not affecting your ability to drive safely.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive
while taking this medicine.
Quetiapine Film-coated Tablets contains lactose
Quetiapine Film-coated Tablets 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.
Quetiapine Film-coated Tablets contains E110 (sunset yellow FCF aluminium lake)
This medicinal product contains sunset yellow FCF aluminium lake (E110) and may cause
allergic reactions.
Effect on Urine Drug Screens
If you are having a urine drug screen, taking Quetiapine Film-coated Tablets 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 Film-coated Tablets

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, at bedtime or twice a day, depending on your
illness
• Swallow your tablets whole with a drink of water
• You can take your tablets with or without food
• Do not drink grapefruit juice while you are taking quetiapine. 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 should not be used by children or adolescents aged under 18 years.
If you take more Quetiapine Film-coated Tablets than you should
If you take more Quetiapine Film-coated Tablets 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 Film-coated Tablets with you.
If you forget to take a dose of Quetiapine Film-coated Tablets
If you forget to take a dose, take it as soon as you remember, If unless 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.

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Quetiapine 25 mg Film-coated Tablets
Quetiapine 100 mg Film-coated Tablets
Quetiapine 150 mg Film-coated Tablets
Quetiapine 200 mg Film-coated Tablets
Quetiapine 300 mg Film-coated Tablets

PAGE 2: REAR FACE (OUTSIDE OF REEL)

• 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 Film-coated Tablets during their pregnancy
The class of medicines to which Quetiapine Film-coated Tablets 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
Possible side effects
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
Like all medicines, this medicine can cause side effects, although not everybody gets them. 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
Very common: may affect more than 1 in 10 people
amount of sodium in the blood and increases in the amount of the hormone prolactin in
• Decreased level of haemoglobin (protein in red blood cells that carries oxygen)
the blood.
• Dizziness (may lead to falls), headache, dry mouth
• Feeling sleepy (this may go away with time, as you keep taking Quetiapine Film-coated Increases in the hormone prolactin could in rare cases lead to the following:
Tablets) (may lead to falls)
• Men and women to have swelling of breasts and unexpectedly produce breast milk.
• Discontinuation symptoms (symptoms which occur when you stop taking Quetiapine
• Women to have no monthly period or irregular periods.
Film-coated Tablets) include not being able to sleep (insomnia), feeling sick (nausea),
Your doctor may ask you to have blood tests from time to time.
headache, diarrhoea, being sick (vomiting), dizziness and irritability. Gradual
Additional side effects in children and adolescents
withdrawal over a period of at least 1 to 2 weeks is advisable.
The same side effects that may occur in adults may also occur in children and adolescents.
• Putting on weight
The following side effects have been seen more often in children and adolescents or
• Abnormal muscle movements. These include difficulty starting muscle movements,
have not been seen in adults:
shaking, feeling restless or muscle stiffness without pain
Very common: may affect more than 1 in 10 people
• Changes in the amount of certain fats (triglycerides and total cholesterol)
• Increase in the amount of a hormone called prolactin in the blood. Increases in the
Common: may affect up to 1 in 10 people
hormone prolactin could in rare cases lead to the following:
• Rapid heartbeat
- boys and girls to have swelling of breasts and unexpectedly produce breast milk
• Feeling like your heart is pounding, racing or has skipped beats
- girls to have no monthly period or irregular periods.
• Indigestion
• Increased appetite
• Constipation, upset stomach (indigestion)
• Vomiting.
• Feeling weak
• Abnormal muscle movements. These include difficulty starting muscle movements,
• Swelling of arms or legs
shaking, feeling restless or muscle stiffness without pain
• Low blood pressure when standing up. This may make you feel dizzy or faint (may lead • Increase in blood pressure.
to falls)
Common: may affect up to 1 in 10 people
• Increased levels of sugar in the blood
• Feeling weak, fainting (may lead to falls)
• Blurred vision
• Stuffy nose
• Abnormal dreams and nightmares
• Feeling irritated.
• Feeling more hungry
Reporting of side effects
• Feeling irritated
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
• Disturbance in speech and language
possible side effects not listed in this leaflet.
• Thoughts of suicide and worsening of your depression
You can also report side effects directly via the Yellow Card Scheme at:
• Shortness of breath
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
• Vomiting (mainly in the elderly)
information on the safety of this medicine.
• Fever
• Changes in the amount of thyroid hormones in your blood
• Changes in the number of certain types of blood cells
How to store Quetiapine Film-coated Tablets
• Increases in the amount of liver enzymes measured in the blood
Keep this medicine out of the sight and reach of children.
• Increases in the amount of the hormone prolactin in the blood. Increases in the
Do not use this medicine after the expiry date which is stated on the carton and bottle or
hormone prolactin could in rare cases lead to the following:
• Men and women to have swelling of breasts and unexpectedly produce breast milk. blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
• Women to have no monthly period or irregular periods.
Do not throw away any medicines via wastewater or household waste. Ask your
Uncommon: may affect up to 1 in 100 people
pharmacist how to throw away medicines you no longer use. These measures will help
• Fits or seizures
protect the environment.
• Allergic reactions that may include raised lumps (weals), swelling of the skin and
swelling around the mouth
• Combination of fever, flu-like symptoms, sore throat, or any other infection with very
Contents of the pack and other information
low white blood cell count, a condition called neutropenia
What Quetiapine Film-coated Tablets contains
• Unpleasant sensations in the legs (also called restless legs syndrome)
• The active substance is quetiapine. Each film-coated tablet contains 25, 100, 150, 200,
• Difficulty swallowing
300 mg quetiapine (as quetiapine fumarate).
• Uncontrollable movements, mainly of your face or tongue
• The other ingredients are calcium hydrogen phosphate, dihydrate, lactose
• Sexual dysfunction
monohydrate, povidone K-25, cellulose microcrystalline, sodium starch glycolate (type
• Diabetes
A), silica, colloidal anhydrous, magnesium stearate. The coating contains
• Change in electrical activity of the heart seen on ECG (QT prolongation)
hypromellose, titanium dioxide (E171), triacetin, 25, 100, 150, 300 mg: lactose
• A slower than normal heart rate which may occur when starting treatment and which
monohydrate, iron oxide yellow (E172), 25, 100 mg: sunset yellow FCF aluminium lake
may be associated with low blood pressure and fainting.
(E110), 200 mg: polydextrose (E1200), macrogol 8000.
• Difficulty in passing urine
• Fainting (may lead to falls)
What Quetiapine Film-coated Tablets look like and contents of the pack
• Stuffy nose
• Quetiapine 25 mg Film-coated Tablets are light-orange, round, biconvex, film-coated
• Decrease in the amount of red blood cells
tablets, engraved “25” on one side and plain on the other.
• Decrease in the amount of sodium in the blood
• Quetiapine 100 mg Film-coated Tablets are light-orange, round, biconvex, film-coated
• Worsening of pre-existing diabetes.
tablets, engraved “100” on one side and plain on the other.
Rare: may affect up to 1 in 1000 people
• Quetiapine 150 mg Film-coated Tablets are pale yellow, round, biconvex, film-coated
• A combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy
tablets, engraved “150” on one side and plain on the other.
or faint (a disorder called ‘neuroleptic malignant syndrome’)
• Quetiapine 200 mg Film-coated Tablets are white to off-white, round, biconvex,
• Yellowing of the skin and eyes (jaundice)
film-coated tablets, engraved “200” on one side and plain on the other.
• Inflammation of the liver (hepatitis)
• Quetiapine 300 mg Film-coated Tablets are pale yellow, capsule-shaped, biconvex,
• A long-lasting and painful erection (priapism)
film-coated tablets, engraved “300” on one side and plain on the other.
• Swelling of breasts and unexpected production of breast milk (galactorrhoea)
Quetiapine Film-coated Tablets is available in
• Menstrual disorder
White opaque PVC/PE/Aclar-aluminium or white opaque PVC/PVdC-aluminium Blister
• 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 • For 25 mg: pack sizes of 1, 6, 10, 20, 30, 50, 60, 90 and 100 (10 x 10) film-coated tablets,
hospital packs of 50 film-coated tablets
pain and difficulty in breathing. If you notice any of these symptoms seek medical
• For 100 mg: pack sizes of 1, 10, 20, 30, 50, 60, 90 and 100 (10 x 10) film-coated tablets,
advice immediately.
hospital packs of 50 film-coated tablets
• Walking, talking, eating or other activities while you are asleep
• For 150 mg: pack sizes of 1, 10, 20, 30, 50, 60, 90 and 100 (10 x 10) film-coated tablets,
• Body temperature decreased (hypothermia)
hospital packs of 50, 120, 180 and 240 film-coated tablets
• Inflammation of the pancreas
• For 200 mg: pack sizes of 1, 10, 20, 30, 50, 60, 90 and 100 (10 x 10) film-coated tablets,
• A condition (called ‘metabolic syndrome’) where you may have a combination of 3 or
hospital packs of 50 film-coated tablets
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 • For 300 mg: pack sizes of 1, 10, 20, 30, 50, 60, 90 and 100 (10 x 10) film-coated tablets,
hospital packs of 50, 120, 180 and 240 film-coated tablets
blood pressure and an increase in your blood sugar
HDPE bottle with white child resistant, propylene caps, with desiccant.
• Bowel obstruction
For all strengths: Pack sizes of 100 and 250 film-coated tablets.
• Increased blood creatine phosphokinase (a substance from the muscles).
• Not all pack sizes may be marketed.
Very rare: may affect up to 1 in 10 000 people
Marketing Authorisation Holder:
• Severe rash, blisters, or red patches on the skin
• A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing TEVA UK Limited, Eastbourne, BN22 9AG
or shock
Manufacturer:
• Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema)
TEVA UK Limited, Eastbourne, BN22 9AG
• A serious blistering condition of the skin, mouth, eyes and genitals (Stevens-Johnson
This leaflet was last revised in December 2016.
syndrome)
PL 00289/1068-72
• Inappropriate secretion of a hormone that controls urine volume
• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).
Not known: frequency cannot be estimated from the available data
• Skin rash with irregular red spots (erythema multiforme)
75005-M
If you stop taking Quetiapine Film-coated Tablets
If you suddenly stop taking Quetiapine Film-coated Tablets, 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.

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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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