QUETIAPINA 200 mg Extended-Release Tablets

Зміст інструкції

1. Quetiapina Accord 50mg prolonged-release tablets, 200mg prolonged-release tablets, 300mg prolonged-release tablets, 400mg prolonged-release tablets
   1. What is Quetiapina Accord prolonged-release tablets and what are they used for
   2. What you need to know before taking Quetiapina Accord extended-release tablets
   3. How to take Quetiapina Accord prolonged-release tablets
   4. Possible side effects
   5. How to store Quetiapina Accord prolonged-release tablets
   6. Contents of the pack and other information
2. Quetiapina Accord 150 mg prolonged-release tablets
   1. What is Quetiapina Accord 150 mg prolonged-release tablets and what are they used for
   2. How to take Quetiapina Accord 150 mg prolonged-release tablets
   3. Possible side effects
   4. How to store Quetiapina Accord 150 mg prolonged-release tablets
   5. Package contents and other information

Quetiapina Accord 50mg prolonged-release tablets, 200mg prolonged-release tablets, 300mg prolonged-release tablets, 400mg prolonged-release tablets

Generic medicine
Read this leaflet carefully before taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful. If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Quetiapina Accord prolonged-release tablets are and what they are used for
• 2. What you need to know before you take Quetiapina Accord prolonged-release tablets
• 3. How to take Quetiapina Accord prolonged-release tablets
• 4. Possible side effects
• 5. How to store Quetiapina Accord prolonged-release tablets
• 6. Contents of the pack and other information

1. What is Quetiapina Accord prolonged-release tablets and what are they used for

Quetiapina Accord prolonged-release tablets contain a substance called quetiapine, which belongs to a
group of medicines called antipsychotics. Quetiapina Accord prolonged-release tablets can be
used to treat various illnesses, such as:

• Schizophrenia: you may have the feeling of hearing or seeing things that do not actually exist, being convinced of things that are not true or feeling unusually suspicious, anxious, confused, guilty, tense or depressed.
• Mania: you may feel very excited, euphoric, agitated, enthusiastic or hyperactive or have poor judgment, including aggressive or destructive behaviors.
• Bipolar depression and major depressive episodes in major depressive disorder: you may feel sad. You may feel depressed, guilty, lacking energy, may lose your appetite or be unable to sleep.

When Quetiapina Accord prolonged-release tablets are taken to treat major depressive
episodes in major depressive disorder, they are taken in addition to another medicine used to
treat this condition.

2. What you need to know before taking Quetiapina Accord extended-release tablets

Do not take Quetiapina Accord extended-release tablets:
If you are allergic (hypersensitive) to quetiapine or any of the other ingredients of this medicine (See
section 6: Further information)

• you are taking any of the following medicines:
• some medicines for the treatment of HIV
• azole medicines (for infections caused by fungi)
• erythromycin or clarithromycin (for infections)
• nefazodone (for depression). Do not take Quetiapina Accord extended-release tablets if the above applies to you. If you have any doubts, talk to your doctor or pharmacist before taking Quetiapina Accord extended-release tablets.

Warnings and precautions
Speak to your doctor or pharmacist or nurse before takingQuetiapina Accord
extended-release tablets

• You yourself, or someone in your family, has or has had any heart problems, such as heart rhythm problems or if you take any medicine that can affect how 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 convulsions (fits).
• You know you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
• You have diabetes or are at risk of developing diabetes. In this case, your doctor may check your blood sugar levels while you are taking Quetiapina Accord extended-release tablets.
• You or someone in your family has had blood clots, because medicines like these have been associated with the formation of blood clots.
• You are an elderly person with dementia (loss of brain function). In this case, Quetiapina Accord extended-release tablets should not be taken because the group of medicines to which Quetiapina Accord extended-release tablets belongs may increase the risk of stroke, and in some cases, the risk of death, in elderly patients with dementia.

Tell your doctor immediately if you experience any of the following after taking Quetiapina Accord extended-release
tablets:

• A combination of fever, severe muscle stiffness, sweating or a reduced level of consciousness (a condition called “neuroleptic malignant syndrome”). Immediate medical treatment may be needed.
• Uncontrollable movements, especially of the face or tongue.
• Dizziness or a strong feeling of sleepiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• Convulsions (fits).
• A prolonged and painful erection (priapism).

These conditions may be caused by this type of medicine.

Thoughts of suicide and worsening of depression
If you are depressed, you may sometimes have thoughts of harming yourself or of killing yourself. These thoughts may be
more intense at the beginning of treatment, because all these medicines take time to work, usually about
two weeks, but sometimes even longer. These thoughts may also be increased if you
suddenly stop taking the medicine. You are more likely to think this way if you are a
young adult. Information provided by clinical studies has shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression.
If you think of harming yourself or of killing yourself at any time, contact your doctor or go to the hospital immediately.
You may find it helpful to tell a relative or close friend that you feel depressed, and invite them to
worsening, or if they are concerned about changes in your behavior.
Weight gain has been observed in patients treated with Quetiapina Accord extended-release tablets.
You and your doctor will need to check your weight regularly.

Other medicines and Quetiapina Accord extended-release tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take Quetiapina Accord extended-release tablets if you are taking any of the following
medicines:

• Some medicines for the treatment of HIV
• Azole medicines (for infections caused by fungi).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression). Tell your doctor if you are taking any of the following medicines:
• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine (another antipsychotic medicine).
• Medicines that affect how 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 some antibiotics (medicines to treat infections).

Before stopping taking any of your medicines, consult your doctor or pharmacist.

Taking Quetiapina Accord extended-release tablets with food, drinks and alcohol

• Taking Quetiapina Accord extended-release tablets may be affected by food and you should therefore take the tablets at least one hour before a meal or in the evening before bedtime.
• Be careful about the amount of alcohol you drink, because the combined effect of Quetiapina Accord extended-release tablets and alcohol can cause you to feel sleepy.
• Do not drink grapefruit juice when taking Quetiapina Accord extended-release tablets, as it can affect how the medicine works.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask
your doctor or pharmacist for advice before taking this medicine.
You should not take Quetiapina Accord extended-release tablets during pregnancy without first
discussing this with your doctor. You should not take Quetiapina Accord extended-release tablets during
breastfeeding.
The following symptoms may occur in newborns of mothers who have used Quetiapina Accord
extended-release tablets in the last trimester (last three months of pregnancy): tremor, muscle stiffness
and/or weakness, sleepiness, agitation, breathing problems, and difficulty feeding. If your baby
develops any of these symptoms, you may need to contact your doctor.

Driving and using machines
Your tablets may cause drowsiness. Do not drive vehicles or use tools or machines until
you know how the tablets affect you.

Quetiapina Accord extended-release tablets contains lactose
Quetiapina Accord extended-release tablets contains lactose, which is a type of sugar. If your doctor has
diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Effect on urine drug tests
If you are undergoing urine drug testing, taking quetiapine may cause positive results for
methadone or for some antidepressant drugs called tricyclic antidepressants (TCAs) when using
certain methods, even if you are not taking tricyclic antidepressants or methadone. In this case, a more specific test can be performed.

3. How to take Quetiapina Accord prolonged-release tablets

Always take this medicine exactly as your doctor or pharmacist has told you. The recommended dose (daily dose) depends on your condition and your needs, but will generally be between
150 mg and 800 mg.

• Take the tablets once a day.
• Swallow the tablets whole with a glass of water.
• Do not divide, chew or crush the tablets.
• Take the tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when to do so).
• Do not drink grapefruit juice while taking Quetiapina Accord prolonged-release tablets, as it may affect the way the medicine works.
• Do not stop taking the tablets, even if you feel better, unless your doctor tells you to do so.

Liver problems
Your doctor may change your dose if you have liver problems.

Elderly people
Your doctor may adjust the dose if you are elderly.

Use in children and adolescents
Quetiapina Accord prolonged-release tablets should not be used for children and adolescents under the age of 18 years.

If you take more Quetiapina Accord prolonged-release tablets than you should
If you take more Quetiapina Accord prolonged-release tablets than prescribed by your doctor, you may experience
drowsiness, dizziness and abnormal heartbeats. Contact your doctor or the nearest hospital immediately.
Bring the pack of Quetiapina Accord prolonged-release tablets with you.

If you forget to take Quetiapina Accord prolonged-release tablets
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 the scheduled time. Do not take a double dose to make up for a missed dose.

If you stop taking Quetiapina Accord prolonged-release tablets
If you suddenly stop taking Quetiapina Accord prolonged-release tablets, you may not
be able to sleep (insomnia), feel unwell (nausea) or may have headache,
diarrhea, feeling sick (vomiting), dizziness or irritability. Your doctor may suggest you gradually reduce the
dose before stopping treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of these side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

If any of the following side effects occur, stop taking Quetiapina Accord
prolonged-release tablets and contact your doctor or the nearest hospital immediately as
urgent medical attention may be needed:

• Convulsions or seizures.
• Allergic reactions which can include raised, mottled skin (welts), swelling of the skin and swelling around the mouth.
• Uncontrollable movements, particularly of the face and tongue (tardive dyskinesia).

Rare (may affect up to 1 in 1,000 people):

• A combination of high temperature (fever), sweating, muscle stiffness, feeling confused or fainting (a condition called “neuroleptic malignant syndrome”).
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• A prolonged and painful erection (priapism).
• Blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the leg), which can travel to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.

Very rare (may affect up to 1 in 10,000 people):

• Severe allergic reaction (called anaphylaxis) which may cause difficulty breathing or shock.
• Rapid swelling under the skin, usually around the eyes, lips and throat (angioedema).
• Severe blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).

Other possible side effects:
Very common: may affect more than 1 in 10 people

• Dizziness (which may cause falls), headache, dry mouth.
• Sleepiness (this may disappear as time passes with continued treatment with Quetiapina Accord prolonged-release tablets) (which may cause falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to sleep (insomnia), feeling unwell (nausea), headache, diarrhoea, feeling sick (vomiting), dizziness and irritability. Gradual discontinuation over a period of at least 1-2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements, including difficulty starting a muscle movement, tremor, feeling restless or muscle stiffness without pain.

Common: may affect up to 1 in 10 people

• Fast heartbeat.
• Feeling that your heart is racing, pounding or fluttering.
• Blocked nose.
• Constipation, indigestion.
• Feeling weak, fainting (which may cause falls).
• Swelling of the arms and legs.
• Low blood pressure when standing up, which can cause dizziness or fainting (which may cause falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Irritability.
• Speech and language disorders
• Thoughts of suicide and worsening of depression.
• Shortness of breath.
• Vomiting (especially in the elderly).
• Fever.

Uncommon: may affect up to 1 in 100 people

• Unpleasant sensations in your legs (also called restless legs syndrome).
• Difficulty swallowing.
• Sexual dysfunction.
• Diabetes.
• Changes in the electrical activity of your heart visible on an ECG (QT prolongation).
• A slower heartbeat than normal, which can occur when you start treatment and may be associated with low blood pressure and fainting.

Rare: may affect up to 1 in 1,000 people

• Swelling of the breasts and unexpected production of milk from the breasts (galactorrhoea).
• Menstrual disorder.
• Walking, talking, eating or doing other activities while asleep.
• Decreased body temperature (hypothermia).
• Inflammation of the pancreas (pancreatitis).
• A condition (called “metabolic syndrome”) in which you have a combination of 3 or more of the following: increased fat around the abdomen, a decrease in “good” cholesterol (HDL-C), increased levels of a type of fat in the blood called triglycerides; high blood pressure and increased blood sugar.

Very rare: may affect up to 1 in 10,000 people

• Worsening of pre-existing diabetes.
• Severe rash, blistering or red patches on the skin.
• Inappropriate secretion of a hormone that controls the volume of urine.
• Breakdown of muscle tissue and pain in the muscles (rhabdomyolysis).

Not known: frequency cannot be estimated from the available data

• Skin rashes with irregular red patches (erythema multiforme).
• Severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).

The class of medicines to which Quetiapina Accord prolonged-release tablets belongs can cause
heart rhythm problems, which can be serious and life-threatening in severe cases.
Some side effects can only be detected by blood tests. These include
changes in the amount of certain fats (triglycerides and total cholesterol) or sugars in the blood, changes
in the amount of thyroid hormones in the blood, increased liver enzymes, decreases in the number of certain types of
blood cells, decreased number of red blood cells, increased levels of creatine phosphokinase
(a substance in the muscles) in the blood, decreased levels of sodium in the blood and increased levels
of the hormone prolactin in the blood. Increases in the hormone prolactin may, in rare cases, have the
following consequences:

• Enlargement of the breasts and unexpected production of milk from the breasts in both men and women.
• Absence or irregularity of menstrual periods in women.

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 can occur in adults can also occur in children and
adolescents.
The following side effects have been observed more often in children and adolescents:

Very common: may affect more than 1 in 10 people

• Increased blood pressure.

The following side effects have been observed more often in children and adolescents

Very common: may affect more than 1 in 10 people

• Increased amount of a hormone called prolactin in the blood. In rare cases, increased levels of the hormone called prolactin can cause:
• Enlargement of the breasts and unexpected production of milk from the breasts in both boys and girls.
• Absence or irregularity of menstrual periods in girls.
• Increased appetite.
• Vomiting.

Common: may affect up to 1 in 10 people

• Feeling tired, fainting (which can cause falls);
• Blocked nose
• Feeling irritated

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Quetiapina Accord prolonged-release tablets

• 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 label, the carton and the blister after EXP. The expiry date refers to the last day of that month.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
• Quetiapina Accord prolonged-release tablets does not require any special storage conditions.

6. Contents of the pack and other information

What the medicine containsQuetiapina Accord prolonged-release tablets
The active ingredient is quetiapine (as hemifumarate). Each Quetiapina Accord prolonged-release tablet contains 50 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
The other ingredients are:
Tablet core: Lactose monohydrate, Hypromellose, Sodium chloride, Povidone K-30, Talc and Magnesium
stearate. The 50 mg tablet also contains microcrystalline cellulose silicated (Silicon Dioxide &
Microcrystalline Cellulose).
Tablet coating:.
Titanium dioxide (E171), Macrogol (E1521). The 50 mg tablet also contains Polyvinyl alcohol (E1203),
Talc (E553b) and Red iron oxide (E172). The 50 mg, 200 mg and 300 mg tablets also contain Yellow iron oxide (E172). The 200 mg, 300 mg and 400 mg tablets also contain Hypromellose 6cP (E464).

Description of the appearance of Quetiapina Accord prolonged-release tablets and contents of the
pack
Quetiapina Accord prolonged-release 50 mg tablets are biconvex, film-coated tablets, peach-coloured, round in shape, with ‘Q50’ imprinted on one side and plain on the other.
Quetiapina Accord prolonged-release 200 mg tablets are biconvex, film-coated tablets, yellow in colour, round in shape, with ‘I2’ imprinted on one side and plain on the other.
Quetiapina Accord prolonged-release 300 mg tablets are biconvex, film-coated tablets, pale yellow in colour, round in shape, with ‘Q300’ imprinted on one side and plain on the other.
Quetiapina Accord prolonged-release 400 mg tablets are biconvex, film-coated tablets, white in colour, round in shape, with ‘I4’ imprinted on one side and plain on the other.
Packs with blisters in PVC/PVDC-Alu. Packs of 10, 30, 50, 60 and 100 tablets per pack are
registered for Quetiapina Accord prolonged-release 200 mg, 300 mg and 400 mg.
Packs with blisters in PVC/PVDC-Alu or OPA/Alu/PVC-Alu. Packs of 6, 10, 20, 28, 30, 50, 60,
90 and 100 tablets per pack are registered for Quetiapina Accord prolonged-release 50
mg.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF,
United Kingdom
GAP S.A.,
46, Agissilaou str.
Agios Dimitrios,
Athens, 17341
Greece
Pharmacare Premium Ltd
HHF 003, Hal Far Industrial Estate, Birzebbugia, BBG 3000
Malta
Quetiapina Accord 50 mg prolonged-release tablets:
ARROW GENERIQUES- LYON,
26 avenue Tony Garnier,
LYON, 69007,
France

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Name of
Member
State
:

Name of the medicinal product
AT Quetiapine Accord 50mg/200mg/300mg/400mg Retardtabletten
BE Quetiapin Accord Helathcare 50mg/ 200mg/300mg/400 mg Comprimés à liberation
prolongée/Tabletten met verlengde afgifte/Retardtabletten
BG Quetiapine Accord 50mg/200mg/300mg/400mg Prolonged-release Tablets
CY Quetiapine Accord 50mg/ 200mg/300 mg/400 mg Prolonged-release Tablets
CZ Quetiapine Accord 50mg/200mg/300mg/400mg tablety s prodlouženým uvolňováním
DE QuetiapinAccord 50mg/200mg/300mg/400mg Retardtabletten
DK Quetiapin Accord 50mg/200mg/300mg/400mg Depottabletter
EE Quetiapine Accord
EL Matepil 50mg/200mg/300mg/400mg δισκία παρατεταμένης αποδέσμευσης
ES Quetiapine Accord 50mg/200mg/300mg/400mg comprimidos de liberación prolongada
EFG
FI Quetiapine Accord 50mg/200mg/300mg/400mg depottabletit
FR QUETIAPINE ARROW LP 50mg prolonged-release tablet
HU Quetiapine Accord 50mg/200mg/300mg/400mg retard tabletta
IE Notiabolfen XL 50mg/200 mg/ 300 mg/ 400 mg prolonged-release Tablet
IT Quetiapina Accord 50mg/200mg/300mg/400mg compresse a rilascio prolungato
LV Quetiapine Accord 50mg/200mg/300mg/400mg ap ilgstošās darbības tabletes
LT Quetiapine Accord 50mg/200mg/300mg/400mg pailginto atpalaidavimo tabletės
MT Atrolak XL50mg/ 200 mg/ 300 mg/ 400 mg prolonged-release Tablet
NL Quetiapine Accord 50mg/200mg/300mg/400mg tabletten met verlengde afgifte
NO Quetiapine Accord
PL Atrolak
PT Quetiapina Accord 50mg/200mg/300mg/400mg comprimidos de libertação prolongada
RO Quetiapină Accord 50mg/200mg/300mg/400mg comprimate cu eliberare prelungită
SE Quetiapine Accord 50mg/200mg/300mg/400mg depottabletter
SI Kvetiapin Accord 50mg/200mg/300mg/400mg tablete s podaljšanim sproščanjem
SK Quetiapine Accord 50mg/200mg/300mg/400mg Filmom obalené tablet s predĺženým
uvoľňovaním
UK Atrolak XL 50mg/ 200 mg/ 300 mg/ 400 mg prolonged-release Tablet

Quetiapina Accord 150 mg prolonged-release tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 7. What Quetiapina Accord 150 mg prolonged-release tablets is and what it is used for
• 8. What you need to know before you take Quetiapina Accord 150 mg prolonged-release tablets
• 9. How to take Quetiapina Accord 150 mg prolonged-release tablets
• 10. Possible side effects
• 11. How to store Quetiapina Accord 150 mg prolonged-release tablets
• 12. Contents of the pack and other information

1. What is Quetiapina Accord 150 mg prolonged-release tablets and what are they used for

Quetiapina Accord 150 mg prolonged-release tablets contain a substance called quetiapine, which
belongs to a group of medicines called antipsychotics. Quetiapina Accord 150 mg prolonged-release tablets can be used to treat various illnesses, such as:

• Schizophrenia: you may feel you hear or sense things that are not really there, believe things that are not true, or feel unusually suspicious, anxious, confused, guilty, tense or depressed.
• Mania: you may feel very excited, euphoric, agitated, enthusiastic or hyperactive or have poor judgement, including aggressive or destructive behaviour.
• Bipolar depression and major depressive episodes in major depressive disorder: you may feel sad. You may feel depressed, guilty, have no energy, may lose your appetite or be unable to sleep.

When Quetiapina Accord 150 mg prolonged-release tablets are taken to treat major depressive episodes
in major depressive disorder, they are taken in addition to another medicine used to
treat this condition.
The doctor may continue to prescribe Quetiapina Accord even if you feel better.

• 2.What you need to know before you take Quetiapina Accord 150 mg prolonged-release tabletsDo not take Quetiapina Accord 150 mg prolonged-release tablets:If you are allergic (hypersensitive) to quetiapine or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines:
• some medicines for the treatment of HIV
• azole medicines (for infections caused by fungi)
• erythromycin or clarithromycin (for infections)
• nefazodone (for depression).

Do not take Quetiapina Accord 150 mg prolonged-release tablets if the above applies to you. If you have
any doubts talk to your doctor or pharmacist before taking Quetiapina Accord 150 mg prolonged-release tablets.

Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Quetiapina Accord 150 mg
prolonged-release tablets if:

• You yourself, or someone in your family, has or has had any problems with the heart, such as irregular heartbeat or weakening of the heart muscle or inflammation of the heart if you are taking any medicine that can have an impact on how your heart beats.
• You have low blood pressure.
• You have had a stroke, particularly if you are elderly.
• You have problems with your liver.
• You have ever had convulsions (fits).
• You have diabetes or are at risk of developing diabetes. In this case, your doctor may check your blood sugar levels while you take Quetiapina Accord 150 mg prolonged-release tablets.
• You know you have had low levels of white blood cells in your blood in the past (whether or not this was caused by other medicines).
• You are an elderly person with dementia (loss of brain function). In this case, Quetiapina Accord 150 mg prolonged-release tablets should not be taken because the group of medicines to which Quetiapina Accord 150 mg prolonged-release tablets belongs can increase the risk of stroke, and in some cases, the risk of death, in elderly patients with dementia.
• You or someone in your family has had blood clots, because medicines like these have been associated with the formation of blood clots.
• You have or have had a condition (“sleep apnoea”) where you stop breathing for short periods during normal sleep and are taking medicines that slow down normal brain activity (“depressants”).
• You have or have had a condition where you are unable to completely empty your bladder (urinary retention), have an enlarged prostate, a blockage of the intestines, or increased pressure inside the eye. These conditions are sometimes caused by medicines (“anticholinergics”), which affect how nerve cells work and are used to treat some medical conditions.
• You have a history of drug or alcohol abuse.

Tell your doctor immediately if you develop any of the following while taking Quetiapina Accord 150 mg prolonged-release
tablets:

• A combination of fever, severe muscle stiffness, sweating or a reduced level of consciousness (a condition called “neuroleptic malignant syndrome”). Immediate medical attention may be needed.
• Uncontrollable movements, especially of the face or tongue.
• Dizziness or a strong feeling of sleepiness. This could increase the risk of accidental injuries (falls) in elderly patients.
• Convulsions (fits).
• A prolonged and painful erection (priapism).

These conditions can be caused by this type of medicine.
Tell your doctor as soon as possible if you experience:

• Fever, flu-like symptoms, sore throat, or any other infection, as this could be the result of a very low number of white blood cells in your blood, which may require stopping Quetiapina Accord 150 mg prolonged-release tablets and/or giving another treatment.
• Constipation with persistent abdominal pain or constipation that does not respond to treatment, as this can lead to a more serious blockage of the intestines.

Thoughts of suicide and worsening of depression
If you are depressed, you may sometimes have thoughts of harming yourself or of killing yourself. These thoughts may be
more intense at the beginning of treatment, because all these medicines take time to work, usually about
two weeks, but sometimes even longer. These thoughts may also be increased if you
suddenly stop taking the medicine. You are more likely to have these thoughts if you are a
young adult. Information provided by clinical studies has shown an increased risk of thoughts
of suicide and/or suicidal behaviour in young adults under 25 years of age with depression.
If you think of harming yourself or of killing yourself at any time, contact your doctor or go immediately
to hospital. You may find it helpful to tell a relative or close friend that you feel depressed, and ask them to
watch over you and go with you to the doctor, or to contact you if they are worried about changes in your behaviour.

Weight gain
Weight gain has been observed in patients treated with Quetiapina Accord 150 mg prolonged-release
tablets. You and your doctor will need to check your weight regularly.

Children and adolescents
Quetiapina Accord 150 mg prolonged-release tablets are not indicated in children and adolescents under
the age of 18 years.

Other medicines and Quetiapina Accord 150 mg prolonged-release tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take Quetiapina Accord 150 mg prolonged-release tablets if you are taking any of the
following medicines:

• Some medicines for the treatment of HIV
• Azole medicines (for infections caused by fungi).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression). Tell your doctor if you are taking any of the following medicines:
• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for difficulty sleeping).
• Thioridazine or Lithium (another antipsychotic medicine).
• Medicines that have an impact on how your heart beats, for example, medicines that can cause an imbalance in electrolytes (low levels of potassium or magnesium), such as diuretics (water tablets) or some antibiotics (medicines for treating infections).
• Medicines that can cause constipation.
• Medicines (“anticholinergics”) that affect how nerve cells work and are used to treat some medical conditions.

Before stopping any of your medicines, consult your doctor.

Taking Quetiapina Accord 150 mg prolonged-release tablets with food, drinks and alcohol

• The absorption of Quetiapina Accord 150 mg prolonged-release tablets may be affected by food and you should therefore take the tablets at least one hour before a meal or in the evening before bedtime.
• Be careful about the amount of alcohol you drink, because the combined effect of Quetiapina Accord 150 mg prolonged-release tablets and alcohol can cause you to feel sleepy.
• Do not drink grapefruit juice when taking Quetiapina Accord 150 mg prolonged-release tablets, as it can affect how the medicine works.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning to become
pregnant ask your doctor or pharmacist for advice before taking this medicine.
Do not take Quetiapina Accord 150 mg prolonged-release tablets during pregnancy without
first discussing it with your doctor. Do not take Quetiapina Accord 150 mg prolonged-release tablets
during breastfeeding.
The following symptoms, which may represent withdrawal, can occur in newborns of mothers who
have used quetiapine in the last trimester (last three months of pregnancy): tremor, muscle stiffness and/or
weakness, sleepiness, agitation, breathing problems, and difficulty feeding. If your baby
develops any of these symptoms you may need to contact your doctor.

Driving and using machines
Your tablets may cause sleepiness. Do not drive vehicles or use tools or machines until
you know how the tablets affect you.

Quetiapina Accord 150 mg prolonged-release tablets contains lactose
Quetiapina Accord 150 mg prolonged-release tablets contains lactose, which is a type of sugar. If
your doctor has diagnosed you with an intolerance to some sugars, contact him before taking this medicine.

Effect on urine drug tests
If you are undergoing urine drug testing, taking Quetiapina Accord prolonged-release tablets
may cause positive results for methadone or for some antidepressant medicines called tricyclic antidepressants (TCAs) when using some methods, even if you are not taking tricyclic antidepressants or methadone.
In this case, a more specific test can be carried out.

3. How to take Quetiapina Accord 150 mg prolonged-release tablets

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any
doubts, ask your doctor or pharmacist.
The doctor will establish your initial dose. The maintenance dose (daily dose) will depend on your illness
and your needs, but will generally be between 150 mg and 800 mg.

• Take the tablets once a day.
• You must not divide, chew or crush the tablets.
• Swallow the tablets whole with a glass of water.
• Take the tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when to do so).
• Do not drink grapefruit juice while taking Quetiapina Accord 150 mg prolonged-release tablets, as it may affect the way the medicine works.
• Do not stop taking the tablets, even if you feel better, unless your doctor tells you to do so.

Liver problems
The doctor may change your dose if you have liver problems.

Elderly people
The doctor may adjust the dose if you are elderly.

Use in children and adolescents
Quetiapina Accord 150 mg prolonged-release tablets must not be used for children and adolescents
under 18 years of age.

If you take more Quetiapina Accord 150 mg prolonged-release tablets than you should
If you take more Quetiapina Accord 150 mg prolonged-release tablets than prescribed by your doctor, you may
experience drowsiness, dizziness and abnormal heartbeats. Contact your doctor or the nearest
hospital immediately. Bring the package of Quetiapina Accord 150 mg prolonged-release tablets with you.

If you forget to take Quetiapina Accord 150 mg prolonged-release tablets
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 the scheduled time. Do not take a double dose to make up for a missed
tablet.

If you stop taking Quetiapina Accord 150 mg prolonged-release tablets
If you suddenly stop taking Quetiapina Accord 150 mg prolonged-release tablets,
you may be unable to sleep (insomnia), feel unwell (nausea) or have
headache, diarrhoea, feeling sick (vomiting), dizziness or irritability. The doctor may suggest you gradually reduce
the dose before stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Very common side effects (may affect more than 1 in 10 people):

• Dizziness (may cause falls), headache, dry mouth.
• Sleepiness (this may disappear with time, with continued treatment with quetiapine) (may cause falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), which include inability to sleep (insomnia), feeling unwell (nausea), headache, diarrhoea, feeling sick (vomiting), dizziness and irritability. Gradual discontinuation over a period of at least 1-2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements, including difficulty starting a muscle movement, tremor, feeling restless or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol)

Common side effects (may affect up to 1 in 10 people):

• Fast heartbeat.
• Feeling that the heart is pounding, racing or skipping beats.
• Constipation, stomach pain (indigestion).
• Feeling weak.
• Swelling of the arms and legs.
• Low blood pressure when standing up. This can cause dizziness or fainting (may cause falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Irritability.
• Speech and language disorders
• Thoughts of suicide and worsening of depression.
• Shortness of breath.
• Vomiting (especially in the elderly).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decreased number of certain types of blood cells.
• Increased amount of liver enzymes measured in the blood.
• Increased amount of prolactin in the blood. Increases in prolactin hormone in rare cases can cause one of the following effects:
• enlargement of the breasts and unexpected production of milk from the breasts in both men and women.
• absence or irregularity of the menstrual cycle in women.

Uncommon side effects (may affect up to 1 in 100 people):

• Convulsions or seizures.
• Allergic reactions that can include raised, bumpy skin rashes (welts), swelling of the skin and swelling around the mouth.
• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrollable movements, especially of the face and tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart visible in the ECG (QT prolongation).
• A slower heartbeat than normal, which can occur when you start treatment and which may be associated with low blood pressure and fainting.
• Difficulty urinating
• Fainting (can lead to falls).
• Stuffy nose.
• Decreased number of red blood cells.
• Decreased amount of sodium in the blood.
• Worsening of pre-existing diabetes.

Rare side effects (may affect up to 1 in 1,000 people):

• A combination of high temperature (fever), sweating, muscle stiffness, feeling extremely tired or fainting (a condition called “neuroleptic malignant syndrome”).
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).
• Swelling of the breasts and unexpected production of milk from the breasts (galactorrhea).
• Menstrual disorder.
• Blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness of the legs), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• Walking, talking, eating or performing other activities while asleep.
• Decreased body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called “metabolic syndrome”) in which you have a combination of 3 or more of the following: increased fat around the abdomen, a decrease in “good” cholesterol (HDL-C), an increase in a type of fat in the blood called triglycerides; high blood pressure and increased blood sugar.
• Combination of fever, flu-like symptoms, sore throat, or any other infection with a very low number of white blood cells, a condition called agranulocytosis.
• Bowel obstruction.
• Increased creatine phosphokinase (a substance from muscles).

Very rare side effects (may affect up to 1 in 10,000 people):

• Severe skin rash, blisters or red patches on the skin.
• Severe allergic reaction (called anaphylaxis) that may cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).
• Severe blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Not known (frequency cannot be estimated from the available data):

• Skin rashes with irregular red spots (erythema multiforme).
• Severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).
• Withdrawal symptoms may occur in newborns whose mothers have used Quetiapina Accord 150 mg prolonged-release tablets during pregnancy.

The class of medicines to which Quetiapina Accord 150 mg prolonged-release tablets belongs can cause
heart rhythm problems, which can be serious and fatal in severe cases.
Some side effects are only evident after performing a blood test. These include
changes in the amount of certain fats (triglycerides and total cholesterol) or sugars in the blood, changes
in the amount of thyroid hormones in the blood, increased liver enzymes, decreases in the number of certain types of
blood cells, decreased amount of red blood cells, increased in the blood of creatine phosphokinase
(a substance in muscles), decreased amount of sodium in the blood and increases in the amount
of the hormone prolactin present in the blood. Increases in the hormone prolactin may, in rare cases, have the
following consequences:

• Enlargement of the breasts and unexpected production of milk from the breasts in both men and women.
• Absence or irregularity of the menstrual cycle in women. The doctor may ask you to undergo blood tests from time to time.

Side effects in children and adolescents:
The same side effects that can occur in adults can also occur in children and
adolescents.
The following side effects have been observed more often in children and adolescents and have not
been observed in adults:

Very common side effects (may affect more than 1 in 10 people):

• Increased amount of prolactin in the blood. Increases in prolactin hormone in rare cases can cause one of the following effects:
• enlargement of the breasts and unexpected production of milk from the breasts in both boys and girls.
• absence or irregularity of the menstrual cycle in girls.
• Increased appetite
• Vomiting
• Abnormal muscle movements, including difficulty starting a muscle movement, tremor, feeling restless or muscle stiffness without pain.
• Increased blood pressure

Common side effects (may affect up to 1 in 10)

• Feeling tired, fainting (which can cause falls);
• Stuffy nose
• Feeling irritated

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist or nurse. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Quetiapina Accord 150 mg prolonged-release tablets

• 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 label, on the carton, on the blister and on the bottle after SCAD. The expiry date refers to the last day of that month.
• Bottle: use within 100 days of first opening.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
• This medicine does not require any particular storage conditions.

6. Package contents and other information

What the medicine containsQuetiapina Accord 150 mg prolonged-release tablets

• The active ingredient is quetiapine. Each tablet contains 150 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:

Tablet core: Lactose monohydrate, Hypromellose 3550, Hypromellose 100, Sodium chloride, Povidone
K-30, Microcrystalline cellulose, Talc and Magnesium stearate.
Tablet coating: White Opadry containing Polyvinyl alcohol, Titanium dioxide (E171),
Macrogol (3350), Talc.

Description of the appearance of Quetiapina Accord 150 mg prolonged-release tablets and package contents
Quetiapina Accord 150 mg prolonged-release tablets are biconvex, film-coated tablets, capsule-shaped, from white
to off-white in colour, chamfered with ‘AB2’ imprinted on one side and smooth on the other. The
tablet length is approximately 17.4 mm and the width is approximately 6.7 mm.
Packs of 10, 30, 50, 60 and 100 tablets in opaque white PVC/PVDC-Alu blisters or OPA/Alu/PVC blisters

• Alu. Packs of 60 and 100 tablets in opaque white HDPE bottle with opaque white child-resistant polypropylene
  closure with a tamper-evident seal. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Member State: Medicinal product name
AT Quetiapine Accord 150mg Retardtabletten
BG Quetiapine Accord 150mg prolonged-release Tablets
CY Quetiapine Accord 150mg prolonged-release Tablets
CZ Quetiapine Accord 150mg tablety s prodlouženým uvolňováním
DE Quetiapin Accord 150mg Retardtabletten
DK Quetiapin Accord
EE Quetiapine Accord
FI Quetiapine Accord 150mg depottabletit
HU Quetiapine Accord 150mg retard tabletta
IE Notiabolfen XL 150mg prolonged-release Tablet
IT Quetiapina Accord
LV Quetiapine Accord 150mg ap ilgstošās darbības tabletes
LT Quetiapine Accord 150mg pailginto atpalaidavimo tabletės
MT Atrolak XL 150mg prolonged-release Tablet
NL Quetiapine Accord 150mg tabletten met verlengde afgifte
NO Quetiapine Accord
PL Atrolak
PT Quetiapina Accord 150mg comprimidos de libertação prolongada
RO Quetiapină Accord 150mg comprimate cu eliberare prelungită
SE Quetiapine Accord 150mg depottabletter
SI Kvetiapin Accord 150mg tablete s podaljšanim sproščanjem
SK Quetiapine Accord 150mg Filmom obalené tablet s predĺženým uvoľňovaním
UK Atrolak XL 150mg prolonged-release Tablet
EL Matepil
ES Quetiapine Accord 150mg comprimidos de liberación prolongada EFG
FR QUETIAPINE ACCORD LP 150mg comprimé à libération prolongée