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QUETHARTIC XL 300 MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE FUMARATE / QUETIAPINE FUMARATE

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Quethartic XL (Quetiapine) - UK - PIL

Review - 2

Quethartic XL
prolonged-release tablets
PM-0000

Weight gain
Weight gain has been seen in patients taking Quethartic XL. You and your doctor should check
your weight regularly.
Package leaflet: Information for the user

Quethartic XL 50 mg prolonged-release tablets
Quethartic XL 300 mg prolonged-release tablets
Quethartic 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 Quethartic XL is and what it is used for
2. What you need to know before you take Quethartic XL
3. How to take Quethartic XL
4. Possible side effects
5. How to store Quethartic XL
6. Contents of the pack and other information

Children and Adolescents
Quethartic XL is not for use in children and adolescents below 18 years of age.
Other medicines and Quethartic XL
Tell your doctor or pharmacists if you are taking, have recently taken or might take any other
medicines.
Do not take Quethartic 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 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
• 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.

Quethartic XL contains a substance called quetiapine. This belongs to a group of medicines
called anti-psychotics. Quethartic 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 Quethartic XL prolonged-release tablet 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 Quethartic XL even when you are feeling better.

2. What you need to know before you take Quethartic XL

Quethartic XL with food, drink and alcohol
• Quethartic XL prolonged-release tablet 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 Quethartic
XL and alcohol can make you sleepy.
• Do not drink grapefruit juice while you are taking this medicine. 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.
Do not take Quethartic XL during pregnancy unless this has been discussed with your doctor.
Do not take Quethartic XL if you are breast-feeding.
The following symptoms which can represent withdrawal may occur in newborn babies of mothers
that have used Quethartic 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.

Do not take Quethartic 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).

Driving and using machines
Your Quethartic XL tablets may make you feel sleepy. Do not drive or use any tools or machines
until you know how the tablets affect you.

If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Effect on Urine Drug Screens
If you are having a urine drug screen, taking Quethartic XL may cause positive results for
methadone or certain medicines 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.

Warnings and precautions
Talk to your doctor before taking Quethartic 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
• 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 Quethartic 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, you should not
take Quethartic XL because the group of medicines that Quethartic 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
• 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 Quethartic XL:
• A combination of fever, severe muscle stiffness, sweating or a lowered level of
consciousness (a disorder called “neuroleptic malignant syndrome”). You may need an
immediate medical treatment
• 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 you to stop taking Quethartic XL
and/or receive treatment
• 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

Quethartic XL contains lactose
Quethartic XL prolonged-release tablet 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.

3. How to take Quethartic 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 usually 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 glass 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 Quethartic 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.
Elderly people
If you are elderly your doctor may change your dose.
Use in children and adolescents
Quethartic XL should not be used by children and adolescents aged under
18 years.
If you take more Quethartic XL than you should
If you take more Quethartic 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 tablets with you.
If you forget to take Quethartic 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 Quethartic XL
If you suddenly stop taking Quethartic 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.

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.

Size : 240 x 520 mm, Colour:
Minimum Font Size 9 pt
Date: 03/01/17

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Very common: may affect more than 1 in 10 people
• Dizziness (may lead to falls), headache, dry mouth
• Feeling sleepy, which may lead to falls (this may go away with time, as you keep taking
Quethartic XL)
• Discontinuation symptoms (symptoms which occur when you stop taking Quethartic 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) in the blood

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1. What Quethartic XL is and what it is used for

Quethartic XL (Quetiapine) - UK - PIL

Common: 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 hungrier
• 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 sensation 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
• Worsening of pre-existing diabetes
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 the fat around your abdomen, a decrease in “good
cholesterol” (HDL-C), an increase in a type of fat in your blood called trigylcerides, 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 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) 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 fibers and pain in muscles (rhabdomyolysis)

Review - 2

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 MHRA 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 Quethartic 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 container after EXP. The
expiry date refers to the last day of that month.
This medicine 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 to protect the
environment.

6. Contents of the pack and other information
What Quethartic XL contains
• The active substance is quetiapine. Each tablet contains either 50 mg, 300 mg or 400 mg
of quetiapine (as quetiapine fumarate).
• The other ingredients are:
Tablet core: Microcrystalline cellulose, Lactose monohydrate, Sodium citrate, Hypromellose,
Magnesium Stearate
Tablet coating: Hypromellose, Macrogol 400, Titanium Dioxide (E171). The 50 mg and 300 mg
tablets also contain: Iron Oxide Yellow (E172). The 50 mg tablets contain: Iron Oxide Red (E172).
What Quethartic XL looks like and contents of the pack
Quethartic XL 50 mg tablets are peach, bi-convex, capsule shaped, coated tablets, of
dimension about 16.5 mm X 6.6 mm, debossed “AI001” on one side and plain on other side.
Quethartic XL 300 mg tablets are pale yellow, bi-convex, capsule shaped, coated tablets, of
dimension about 19.1 mm X 8.1 mm, debossed “AI004” on one side and plain on other side.
Quethartic XL 400 mg tablets are white to off white, bi-convex, capsule shaped, of dimension
about 20.5 mm X 9.3 mm, coated tablets, debossed “AI005” on one side and plain on other
side.
PVC-Aclar/Aluminium blisters in cartons of 10, 14, 20, 28, 30, 50, 56, 60, 90, 98 and 100
tablets.
White, plastic (HDPE) bottle with a child-resistant plastic (polypropylene) screw cap containing
60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer:
Amneal Netherlands B.V.
Emmaplein 4Ds Hertogenbosch 5211VW
The Netherlands
Amneal Nordic ApS
Kanalholmen 14-18
2650 Hvidovre
Denmark
This leaflet was last revised in January-2017

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 were taking
Quethartic XL during their pregnancy
The class of medicines to which Quethartic 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.
Additional 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

Size : 240 x 520 mm, Colour:
Minimum Font Size 9 pt
Date: 03/01/17

Black,

Key line(Not to Print)

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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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