Quetiapine Accord: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful. If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Quetiapina Accord prolonged-release tablets are and what they are used for
What you need to know before taking Quetiapina Accord prolonged-release tablets
How to take Quetiapina Accord prolonged-release tablets
Possible side effects
How to store Quetiapina Accord prolonged-release tablets
Contents of the pack and other information

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

Quetiapine Accord prolonged-release tablets contain a substance called quetiapine, which belongs to a group of medicines known as antipsychotics. Quetiapine Accord prolonged-release tablets can be used to treat several conditions, such as:

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

When Quetiapine 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 should know before taking Quetiapina Accord prolonged-release tablets

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

if you are taking any of the following medicines:
certain medicines used to treat HIV
azole medicines (for fungal infections)
erythromycin or clarithromycin (for infections)
nefazodone (for depression). Do not take Quetiapina Accord prolonged-release tablets if any of the above applies to you. If you have any doubts, speak with your doctor or pharmacist before taking Quetiapina Accord prolonged-release tablets.

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

if you, or someone in your family, have or have had any heart problems, for example, heart rhythm problems, or if you are taking any medicine that may affect the way your heart beats.
if you have low blood pressure.
if you have had a stroke, particularly if you are elderly.
if you have liver problems.
if you have ever had seizures (epileptic fits).
if you know you have previously had low levels of white blood cells in your blood (whether or not caused by other medicines).
if you have diabetes or are at risk of developing diabetes. In this case, your doctor may monitor your blood sugar levels while you are taking Quetiapina Accord prolonged-release tablets.
if you or someone in your family has had blood clots, because medicines like this have been associated with blood clot formation.
if you are an elderly person with dementia (loss of brain function). In this case, Quetiapina Accord prolonged-release tablets must not be taken, as the group of medicines to which Quetiapina Accord prolonged-release tablets belong may increase the risk of stroke, and in some cases, the risk of death, in elderly patients with dementia.

Inform your doctor immediately if, after taking Quetiapina Accord prolonged-release
tablets, you experience any of the following:

A combination of fever, severe muscle stiffness, sweating, or reduced level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be required.
Uncontrollable movements, especially of the face or tongue.
Dizziness or a strong feeling of drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
Seizures (epilepsy).
Prolonged and painful erection (priapism).

These conditions may be caused by this type of medicine.
Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may be
more intense at the beginning of treatment, as all these medicines take time to work, usually about two weeks, but sometimes longer. These thoughts may also increase if you suddenly stop taking the medicine. You are more likely to have such thoughts if you are a young adult. Clinical study data have shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults under 25 years of age with depression.
If at any time you think about harming yourself or committing suicide, contact your doctor or go to the hospital immediately. You may find it helpful to tell a family member or close friend that you are depressed, and ask them to read this leaflet. You may also ask them to inform you if they think your depression is getting worse, or if they are concerned about changes in your behaviour.
Weight gain has been observed in patients treated with Quetiapina Accord prolonged-release tablets.
You and your doctor should monitor your weight regularly.
Other medicines and Quetiapina Accord prolonged-release tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Quetiapina Accord prolonged-release tablets if you are taking any of the following
medicines:

Certain medicines used to treat HIV
Azole medicines (for fungal infections)
Erythromycin or clarithromycin (for infections)
Nefazodone (for depression). Inform 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 sleep difficulties)
Thioridazine (another antipsychotic medicine)
Medicines that affect the way your heart beats, for example, medicines that may cause an imbalance in electrolytes (low levels of potassium or magnesium), such as diuretics ("water pills") or certain antibiotics (medicines used to treat infections)

Before stopping any of your medicines, consult your doctor or pharmacist.
Taking Quetiapina Accord prolonged-release tablets with food, drinks and alcohol

The intake of Quetiapina Accord prolonged-release tablets may be affected by food; therefore, take the tablets at least one hour before a meal or in the evening before going to bed.
Be cautious about the amount of alcohol you drink, because the combined effect of Quetiapina Accord prolonged-release tablets and alcohol may cause drowsiness.
Do not drink grapefruit juice when taking Quetiapina Accord prolonged-release tablets, as it may affect how the medicine works.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your
doctor or pharmacist for advice before taking this medicine.
You must not take Quetiapina Accord prolonged-release tablets during pregnancy without first discussing it with your doctor. You must not take Quetiapina Accord prolonged-release tablets while breast-feeding.
The following symptoms may occur in newborns of mothers who have taken Quetiapina Accord
prolonged-release tablets during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. 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 or use tools or machines until you know how these tablets affect you.
Quetiapina Accord prolonged-release tablets contain lactose
Quetiapina Accord prolonged-release tablets contain lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Effect on urine drug screening tests
If you undergo urine drug screening tests, taking quetiapine may result in positive test results for methadone or for certain antidepressants called tricyclic antidepressants (TCA) when certain testing methods are used, even if you are not taking tricyclic antidepressants or methadone. In such cases, a more specific test can be performed.

3. How to take Quetiapina Accord prolonged-release tablets

Always take this medicine exactly as instructed by your doctor or pharmacist. The recommended dose (daily dose) depends on your condition and individual needs, but will generally range between 150 mg and 800 mg.

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

Liver problems
Your doctor may adjust your dose if you have liver problems.
Elderly patients
Your doctor may adjust the dose if you are elderly.
Use in children and adolescents
Quetiapina Accord prolonged-release tablets must not be used in children and adolescents under 18 years of age.
If you take more Quetiapina Accord prolonged-release tablets than you should
If you take more Quetiapina Accord prolonged-release tablets than prescribed, you may experience drowsiness, dizziness or abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Take the Quetiapina Accord prolonged-release tablets pack 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 for your 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 stop taking Quetiapina Accord prolonged-release tablets suddenly, you may have difficulty sleeping (insomnia), feel unwell (nausea), or experience headache, diarrhoea, malaise (vomiting), dizziness or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform 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 you may require urgent medical treatment:
Uncommon (may affect up to 1 in 100 patients):

Seizures or epileptic fits.
Allergic reactions which may include raised, itchy skin rashes (hives), skin swelling, and swelling around the mouth.
Uncontrollable movements, especially of the face and tongue (tardive dyskinesia).

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

A combination of high temperature (fever), sweating, muscle stiffness, extreme tiredness 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).
Blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, seek immediate medical attention.

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

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

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

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

Common: may affect 1 in 10 patients

Fast heartbeat.
Sensation that the heart is pounding, racing or skipping beats.
Stuffy nose.
Constipation, stomach ache (indigestion).
Feeling of weakness, fainting (may lead to falls).
Swelling of arms and legs.
Low blood pressure when standing up. This may cause dizziness or fainting (may lead to falls).
Increased blood sugar levels.
Blurred vision.
Abnormal dreams and nightmares.
Increased appetite.
Irritability.
Speech and language disorders.
Suicidal thoughts and worsening of depression.
Shortness of breath.
Vomiting (especially in elderly patients).
Fever.

Uncommon: may affect 1 in 100 patients

Unpleasant sensations in the legs (also known as restless legs syndrome).
Difficulty swallowing.
Sexual dysfunction.
Diabetes.
Change in the electrical activity of the heart seen on ECG (QT prolongation).
Slower than normal heartbeat, which may occur when starting treatment and may be associated with low blood pressure and fainting.

Rare: may affect 1 in 1,000 patients

Breast swelling and unexpected production of milk from the breast (galactorrhea).
Menstrual disorder.
Walking, talking, eating or performing other activities while asleep.
Decreased body temperature (hypothermia).
Inflammation of the pancreas (pancreatitis).
A condition (called "metabolic syndrome") in which you have 3 or more of the following: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a blood fat called triglycerides, high blood pressure, and increased blood sugar.

Very rare: may affect 1 in 10,000 patients

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

Not known: frequency cannot be estimated from the available data

Skin rash with irregular red spots (erythema multiforme).
Sudden, severe allergic reaction with symptoms such as fever, skin blisters and skin peeling (toxic epidermal necrolysis).

The class of medicines to which Quetiapina Accord prolonged-release tablets belong may cause heart rhythm problems, which can be serious and, in severe cases, fatal.
Some side effects are only detectable through blood tests. These include changes in levels of certain blood fats (triglycerides and total cholesterol) or blood sugar, changes in levels of thyroid hormones in the blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased red blood cell count, increased blood levels of creatine phosphokinase (a substance found in muscles), decreased blood sodium levels, and increased blood levels of the hormone prolactin. Elevated prolactin levels may, in rare cases, lead to the following consequences:

Breast enlargement and unexpected milk production from the breast 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 may occur in adults can also occur in children and adolescents.
The following side effects have been observed more frequently in children and adolescents:
Very common: may affect more than 1 in 10 patients

Increased blood pressure.

The following side effects have been observed more frequently in children and adolescents:
Very common: may affect more than 1 in 10 patients

Increased levels of a hormone called prolactin in the blood. In rare cases, increased levels of the hormone called prolactin may cause:
Breast enlargement and unexpected milk production from the breast in both boys and girls.
Absence or irregularity of menstrual periods in girls.
Increased appetite.
Vomiting.

Common: may affect up to 1 in 10 patients

Feeling of tiredness, fainting (may lead to falls);
Stuffy nose
Feeling irritable

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 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 via wastewater 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 do not require any special storage conditions.

6. Package contents and other information

What Quetiapina Accord prolonged-release tablets contain
The active substance 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 excipients are:
Tablet core: Lactose monohydrate, Hypromellose, Sodium chloride, Povidone K-30, Talc and Magnesium stearate. The 50 mg tablet also contains microcrystalline cellulose silicate (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 6 cP (E464).

Description of the appearance of Quetiapina Accord prolonged-release tablets and contents of the pack
Quetiapina Accord prolonged-release 50 mg tablets are film-coated, biconvex, peach-coloured, round tablets, with 'Q50' engraved on one side and smooth on the other.
Quetiapina Accord prolonged-release 200 mg tablets are film-coated, biconvex, yellow, round tablets, with 'I2' engraved on one side and smooth on the other.
Quetiapina Accord prolonged-release 300 mg tablets are film-coated, biconvex, pale yellow, round tablets, with 'Q300' engraved on one side and smooth on the other.
Quetiapina Accord prolonged-release 400 mg tablets are film-coated, biconvex, white, round tablets, with 'I4' engraved on one side and smooth on the other.
Packaging in PVC/PVDC-Alu blisters. Pack sizes of 10, 30, 50, 60 and 100 tablets per pack are authorised for Quetiapina Accord prolonged-release 200 mg, 300 mg and 400 mg.
Packaging in PVC/PVDC-Alu or OPA/Alu/PVC-Alu blisters. Pack sizes of 6, 10, 20, 28, 30, 50, 60, 90 and 100 tablets per pack are authorised 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 European Economic Area Member States under the following names:

| Member State | Name of the medicinal product | |------------------|-----------------------------------| | AT | Quetiapine Accord 50mg/200mg/300mg/400mg Retardtabletten | | BE | Quetiapin Accord Healthcare 50mg/200mg/300mg/400mg Comprimés à libération prolongée/Tabletten met verlengde afgifte/Retardtabletten | | BG | Quetiapine Accord 50mg/200mg/300mg/400mg Prolonged-release Tablets | | CY | Quetiapine Accord 50mg/200mg/300mg/400mg Prolonged-release Tablets | | CZ | Quetiapine Accord 50mg/200mg/300mg/400mg tablety s prodlouženým uvolňováním | | DE | Quetiapin Accord 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 | | 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/200mg/300mg/400mg 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 XL 50mg/200mg/300mg/400mg 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 tablety s predĺženým uvoľňovaním | | UK | Atrolak XL 50mg/200mg/300mg/400mg prolonged-release Tablet |

This leaflet was last approved on

Package leaflet: Information for the user

Quetiapina Accord 150 mg prolonged-release tablets

Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Quetiapina Accord 150 mg prolonged-release tablets is and what it is used for
What you need to know before taking Quetiapina Accord 150 mg prolonged-release tablets
How to take Quetiapina Accord 150 mg prolonged-release tablets
Possible side effects
How to store Quetiapina Accord 150 mg prolonged-release tablets
Contents of the pack and other information

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

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

Schizophrenia: You may feel as though you hear or sense things that do not actually exist, believe things that are not true, or feel unusually suspicious, anxious, confused, guilty, tense, or depressed.
Mania: You may feel extremely excited, euphoric, restless, 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, lack energy, 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.
Your doctor may continue to prescribe Quetiapina Accord even if you feel better.

What you need to know before taking Quetiapina Accord 150 mg prolonged-release tablets
Do 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:
- certain medicines used to treat HIV
- azole medicines (for fungal infections)
- erythromycin or clarithromycin (for infections)
- nefazodone (for depression).

Do not take Quetiapina Accord 150 mg prolonged-release tablets if any of the above apply to you. If you have any doubts, speak with your doctor or pharmacist before taking Quetiapina Accord 150 mg prolonged-release tablets.

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

You personally, or someone in your family, have or have had any heart problems, such as heart rhythm disorders, weakened heart muscle, or heart inflammation, or if you are taking any medicine that may affect how your heart beats.
You have low blood pressure.
You have had a stroke, particularly if you are elderly.
You have liver problems.
You have ever had seizures (epileptic fits).
You have diabetes or are at risk of developing diabetes. In this case, your doctor may monitor your blood sugar levels while you are taking Quetiapina Accord 150 mg prolonged-release tablets.
You know you have previously had low levels of white blood cells in your blood (whether caused by medicines or not).
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, as the group of medicines to which it belongs may 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, as medicines like this have been associated with blood clot formation.
You have or have had a condition (called “sleep apnea”) where you stop breathing briefly during normal nighttime sleep and are taking medicines that slow down normal brain activity (“depressants”).
You have or have had a condition where you cannot completely empty your bladder (urinary retention), have an enlarged prostate, intestinal blockage, or increased pressure inside the eye. These conditions are sometimes caused by medicines (called “anticholinergics”) that affect how nerve cells function and are used to treat certain medical conditions.
You have a history of drug or alcohol abuse.

Contact your doctor immediately if, after taking Quetiapina Accord 150 mg prolonged-release tablets, you experience any of the following:

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

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

Fever, flu-like symptoms, sore throat, or any other infection, as this could result from very low levels of white blood cells in the blood, which may require stopping Quetiapina Accord 150 mg prolonged-release tablets and/or starting another treatment.
Constipation with persistent abdominal pain or constipation unresponsive to treatment, as this may lead to a more severe intestinal obstruction.

Suicidal thoughts and worsening depression
If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may be stronger at the beginning of treatment, as all these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also increase if you suddenly stop taking the medicine. This is more likely if you are a young adult. Clinical study data have shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression.
If at any time you think about harming yourself or committing suicide, contact your doctor or go to the hospital immediately. You may find it helpful to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may also ask them to inform you if they think your depression is worsening or if they are concerned about changes in your behavior.

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

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

Other medicines and Quetiapina Accord 150 mg prolonged-release tablets
Inform 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:

Certain medicines used to treat HIV
Azole medicines (for fungal infections)
Erythromycin or clarithromycin (for infections)
Nefazodone (for depression)

Inform 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 sleep difficulties)
Thioridazine or lithium (another antipsychotic medicine)
Medicines that affect how your heart beats, for example, medicines that may cause an imbalance in electrolytes (low levels of potassium or magnesium), such as diuretics (water pills) or certain antibiotics (medicines for treating infections)
Medicines that may cause constipation
Medicines (called “anticholinergics”) that affect how nerve cells function and are used to treat certain medical conditions

Do not stop taking any of your medicines without first consulting 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; therefore, take the tablets at least one hour before a meal or in the evening before going to bed.
Be cautious about the amount of alcohol you drink, as the combined effect of Quetiapina Accord 150 mg prolonged-release tablets and alcohol may cause drowsiness.
Do not drink grapefruit juice while taking Quetiapina Accord 150 mg prolonged-release tablets, as it may affect how the medicine works.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Quetiapina Accord 150 mg prolonged-release tablets during pregnancy unless you have discussed it with your doctor. You should not take Quetiapina Accord 150 mg prolonged-release tablets while breastfeeding.
The following symptoms, which may represent withdrawal, may occur in newborns whose mothers have used quetiapine during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, you may need to contact your doctor.

Driving and using machines
These tablets may cause drowsiness. Do not drive or operate tools or machinery until you know how these tablets affect you.

Quetiapina Accord 150 mg prolonged-release tablets contain lactose
Quetiapina Accord 150 mg prolonged-release tablets contain lactose, 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 screening tests
If you undergo urine drug screening tests, taking Quetiapina Accord prolonged-release tablets may cause positive results for methadone or certain antidepressants called tricyclic antidepressants (TCA) when certain testing methods are used, even if you are not taking tricyclic antidepressants or methadone. In such cases, a more specific test can be performed.

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

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Your doctor will determine your starting dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but will generally range between 150 mg and 800 mg.

Take the tablets once daily.
Do not split, 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 advise you on the appropriate time).
Do not drink grapefruit juice while taking Quetiapine Accord 150 mg prolonged-release tablets, as it may affect how the medicine works.
Do not stop taking the tablets, even if you feel better, unless your doctor tells you to.

Liver problems
Your doctor may adjust your dose if you have liver problems.
Elderly patients
Your doctor may adjust the dose if you are elderly.
Use in children and adolescents
Quetiapine Accord 150 mg prolonged-release tablets must not be used in children and adolescents under 18 years of age.
If you take more Quetiapine Accord 150 mg prolonged-release tablets than you should
If you take more than prescribed by your doctor, you may experience drowsiness, dizziness, or abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Take the medicine pack of Quetiapine Accord 150 mg prolonged-release tablets with you.
If you forget to take Quetiapine 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 for your next dose, wait until the scheduled time. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Quetiapine Accord 150 mg prolonged-release tablets
If you suddenly stop taking Quetiapine Accord 150 mg prolonged-release tablets, you may have difficulty sleeping (insomnia), feel unwell (nausea), or experience headache, diarrhoea, malaise (vomiting), dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

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

Dizziness (may lead to falls), headache, dry mouth.
Drowsiness (this may disappear over time while continuing treatment with quetiapine) (may lead to falls).
Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to fall asleep (insomnia), feeling unwell (nausea), headache, diarrhoea, feeling unwell (vomiting), dizziness and irritability. Gradual discontinuation over a period of at least 1–2 weeks is recommended.
Weight gain.
Abnormal muscle movements, including difficulty initiating a movement, tremor, feeling restless or muscle stiffness without pain.
Changes in the levels 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 discomfort (indigestion).
Feeling weak.
Swelling of the arms and legs.
Low blood pressure when standing up. This may cause dizziness or fainting (may lead to falls).
Increased blood sugar levels.
Blurred vision.
Abnormal dreams and nightmares.
Increased appetite.
Irritability.
Speech and language disorders.
Suicidal thoughts and worsening of depression.
Shortness of breath.
Vomiting (especially in the elderly).
Fever.
Changes in the levels of thyroid hormones in the blood.
Decrease in the number of certain types of blood cells.
Increased levels of liver enzymes in the blood.
Increased levels of prolactin in the blood. Increases in the hormone prolactin, in rare cases, may cause one of the following:
breast enlargement and unexpected breast milk production in both men and women.
absence or irregularity of menstrual periods in women.

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

Seizures or epileptic fits.
Allergic reactions which may include raised skin rashes (sores), skin swelling and swelling around the mouth.
Unpleasant sensations in the legs (also known as restless legs syndrome).
Difficulty swallowing.
Uncontrollable movements, especially of the face and tongue.
Sexual dysfunction.
Diabetes.
Change in the electrical activity of the heart seen on ECG (QT prolongation).
A slower than normal heartbeat, which may occur when starting treatment and may be associated with low blood pressure and fainting.
Difficulty urinating.
Fainting (may lead to falls).
Stuffy nose.
Decrease in the number of red blood cells.
Decrease in the amount of sodium in the blood.
Worsening of pre-existing diabetes.

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

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).
Breast swelling and unexpected breast milk production (galactorrhea).
Menstrual disorder.
Blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, contact a doctor 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 3 or more of the following: increased fat around the abdomen, decreased “good cholesterol” (HDL-C), increased levels of a blood fat called triglycerides, high blood pressure and increased 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.
Intestinal 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) which could cause breathing difficulties 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 fibres and muscle pain (rhabdomyolysis).

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

Skin rashes with irregular red spots (erythema multiforme).
Sudden severe allergic reaction with symptoms such as fever, skin blisters and skin peeling (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 belong can cause
heart rhythm problems, which can be serious and fatal in severe cases.
Some side effects are only evident after a blood test. These include changes in the levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in the levels of thyroid hormones in the blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased number of red blood cells, increased blood creatine phosphokinase (a substance from muscles), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Increases in the hormone prolactine, in rare cases, may lead to the following consequences:

Breast enlargement and unexpected breast milk production 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.

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 observed more frequently in children and adolescents and have not been observed in adults:
Very common side effects (may affect more than 1 in 10 people):

Increased levels of prolactin in the blood. Increases in the hormone prolactin, in rare cases, may cause one of the following:
breast enlargement and unexpected breast milk production in both boys and girls.
absence or irregularity of menstrual periods in girls.
Increased appetite.
Vomiting.
Abnormal muscle movements, including difficulty initiating a movement, tremor, feeling restless or muscle stiffness without pain.
Increased blood pressure.

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

Feeling tired, fainting (which may lead to falls).
Stuffy nose.
Feeling irritable.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 stated on the label, carton, blister and bottle after EXP. The expiry date refers to the last day of that month.
Bottle: use within 100 days of first opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Quetiapina Accord 150 mg prolonged-release tablets contain

The active substance is quetiapine. Each tablet contains 150 mg of quetiapine (as quetiapine fumarate).
The other excipients are:

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

Description of the appearance of Quetiapina Accord 150 mg prolonged-release tablets and contents of the pack
Quetiapina Accord 150 mg prolonged-release tablets are film-coated, capsule-shaped, biconvex tablets, white to off-white in colour, bevelled with 'AB2' engraved on one side and smooth on the other. The tablet is approximately 17.4 mm in length and 6.7 mm in width.
Pack sizes of 10, 30, 50, 60 and 100 tablets in opaque white PVC/PVDC-Alu or OPA/Alu/PVC Alu blisters.
Pack sizes of 60 and 100 tablets in opaque white HDPE bottles with opaque white child-resistant polypropylene caps and desiccant with sealing gasket. 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 European Economic Area Member States under the following names:

| Member State | Name of the medicinal product | |--------------|-------------------------------| | 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 prolonged-release tablets | | 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 |

This summary of product characteristics was last approved on