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AstraZeneca UK Limited

Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
Telephone: +44 (0)1582 836 000
Fax: +44 (0)1582 838 000
Medical Information Direct Line: 0800 783 0033
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +44 (0)1582 837 837
Medical Information Fax: +44 (0)1582 838 003

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 21/03/2014
SPC SEROQUEL 25 mg, 100 mg, 150 mg, 200 mg, 300 mg film-coated tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 21/03/2014 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11-Mar-2014
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



- Section 4.2 – reduction in dose titration for the elderly and replace Quetiapine with Seroquel
- Section 4.3 –
remove the section names for see other sections.

- Section 4.4 – Update the section heading in line with QRD

                        Replace seroquel with quetiapine in a number of places

                        Remove the section names for see other sections in a number of places

                        Addtion of certain adverse events seen in a higher frequency or have different implications in children and adolesents than adults

                        Inclusion of bipolar depression as an indication seen to have an increased incidence of extrapyramidal symptoms

                        Paragraph heading Concomitant illness replaced with Dysphagia

- Section 4.5 – Administrative changes to improve readability

                        Replace seroquel with quetiapine in a number of places

                        Remove the section names for see other sections in a number of places

                        Inclusion of Lithium and seroquel Xl study results

- Section 4.8- Addition of not known as an ADR frequency

                    Administrative changes to improve readability

                    Remove the section names for see other sections in a number of places in the table footer

                    Addition of Extrapyrimidal symptoms and Syncope to Common Nervous system disorders, removal of Syncope from Uncommon.

                    Moving Rhinitis to Common Respiratory, thoracic and mediastinal disorders from Uncommon.

                    Removal of Extrapyramidal symptoms from the children and adolescents frequency table, as it is the same as in adults

                    Addition of Syncope as a Common Nervous system disorder

                    Addition of Rhinitis as a Common Respiratory, thoracic and mediastinal disorder

                    Addition of Vomiting as a Very Common Gastrointestinal disorder

                    Addition of Adverse event reporting details

- Section 4.9 –Remove the section names for see other sections in a number of places

- Section 5.1 – Therapeutic classification replaced with ATC code and administrative changes

                       Details of results of a 6-week lithium study with seroquel XL v’s Seroquel XL and placebo added to Clinical efficacy and Clinical Safety

                       Children and adolescents Clinical efficacy a short study in bipolar depression efficacy was not demonstrated.

                       Under Clinical Efficacy removal of studies in children and adolescents for Safety, Extrapyrimidal Symptoms, Weight Gain and Suicide/Suicidal thoughts or clinical worsening

            Addition of adolescent and paediatric studies Under Clinical Safey and Long-term safety

- Section 6.1 –Correction to excipients names
- Section 10 - Updated date of revision

Updated on 26/11/2012 and displayed until 21/03/2014
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12-Nov-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.2

 

New Paragraph at start of section.

 

Different dosing schedules exist for each indication. It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition.

 

 

Section 4.4


New Paragraph at start of section.

 

As Seroquel has several indications, the safety profile should be considered with respect to the individual patient’s diagnosis and the dose being administered.

 

Information regarding depressive episodes and suicide related events updated.

 

Paragraphs regarding Extrapyramidal symptoms and Tardive dyskinesia updated.

 

Paragraph relating to orthostatic hypotension and related dizziness added.

 

Paragraph relating to Seizures updated.

 

Paragraph relating to Metabolic Risk updated.

 

Paragraph relating to Withdrawal updated.

 

Paragraph relating to Pancreatitis added

 

Pancreatitis has been reported in clinical trials and during post marketing experience. Among post marketing reports, while not all cases were confounded by risk factors, many patients had factors which are known to be associated with pancreatitis such as increased triglycerides (see Section 4.4 Lipids), gallstones, and alcohol consumption.

 

 

Section 4.5


Information regarding
valproate updated.

 

 

Section 4.8


F
requencies of adverse events table and footnotes amended.

 

Paragraphs on short term placebo controlled clinical trials updated and moved to section 5.1.

 

 

Section 4.9

 

Information regarding overdose updated.

 

 

Section 5.1

 

Information regarding Schizophrenia and Bipolar Disorder updated.

 

New paragraphs added re Clinical safety

 

 

Section 10

 

Date of Revision updated to 12th November 2012.

Updated on 26/04/2012 and displayed until 26/11/2012
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Removal of Black Triangle
Date of revision of text on the SPC:   19-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 1

Removal of Black Triangle.


Section 10

Date of revision updated to 19th April 2012.
Updated on 20/02/2012 and displayed until 26/04/2012
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company



Section 4.6


The word Seroquel has been replaced with the word quetiapine.

 

New paragraph added

 

Neonates exposed to antipsychotics (including quetiapine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress or feeding disorder. Consequently, newborns should be monitored carefully.

 

Paragraph 2 replaced with following text:

 

There have been published reports of quetiapine excretion into human breast milk, however the degree of excretion was not consistent. Women who are breast feeding should therefore be advised to avoid breast feeding while taking quetiapine.


Section 4.8

 

Additional section added to table after Musculoskeletal and connective tissue disorders

 

Pregnancy, puerperium and perinatal conditions

 

Unknown:        Drug withdrawal syndrome neonatal 27

 

New footnote added (27)

 

(27)   See Section 4.6.

 

 

Section 10

 

Date of revision changed to 13th February 2012

Updated on 17/11/2011 and displayed until 20/02/2012
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company



Section 5.1

 

Clinical Efficacy

 

Paragraph 8 amended to:

 

In all short-term placebo-controlled monotherapy trials in patients with a baseline neutrophil count ≥1.5 X 109/L, the incidence of at least one occurrence of a shift to neutrophil count <1.5 X 109/L, was 1.9% in patients treated with quetiapine compared to 1.3% in placebo-treated patients. The incidence of shifts to >0.5 - <1.0 X 109/L was the same (0.2%) in patients treated with quetiapine as with placebo-treated patients. In all clinical trials (placebo-controlled, open-label, active comparator) in patients with a baseline neutrophil count ≥1.5 X 109/L, the incidence of at least one occurrence of a shift to neutrophil count <1.5 X 109/L was 2.9% and to <0.5 X 109/L was 0.21% in patients treated with quetiapine.

 

 

Section 10

 

Date of revision chagned to 25th October 2011.

Updated on 30/08/2011 and displayed until 17/11/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company



Added to table in 4.8:


·        
Decreased haemoglobin

·         Somnambulism

·         Palpitations

·         Dyspnea

·         Decreases in total T4, free T4, total T3, free T3 and increases in TSH

·         Vomiting

·         Pyrexia

·         Hypothermia


Also Hepatitis frequency changed;


Paragraph on thyroid hormones updated (under the table in section 4.8);


4.9 Overdose section – additional paragraph inserted;


Date of revision changed to 28th June 2011 

Updated on 04/03/2011 and displayed until 30/08/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company



Section 4.2

Additional text under the heading for Elderly.

 

Section 4.3

Change of text in first paragraph to:  Hypersensitivity to the active substance or to any of the excipients of this product.

Section 4.4

Additional text under the heading ‘Suicide/suicidal thoughts or clinical worsening’

In addition, physicians should consider the potential risk of suicide-related events after abrupt cessation of quetiapine treatment, due to the known risk factors for the disease being treated.

 

Section 4.4

Additional text under the heading ‘Cardiovascular disease’

A slower titration regimen could be considered in patients with underlying cardiovascular disease.

 

Section 4.4

New heading ‘Weight’ with new text

Weight

Weight gain has been reported in patients who have been treated with quetiapine, and should be monitored and managed as clinically appropriate as in accordance with utilised antipsychotic guidelines (see Section 4.8 Undesirable effects and 5.1 Pharmacodynamic properties).

 

Section 4.4

Change of text under the heading ‘Hyperglycaemia’

 

Section 4.4

New heading ‘Metabolic Risk’ with new text

Metabolic Risk

Given the observed changes in weight, blood glucose (see hyperglycaemia) and lipids seen in clinical studies, there may be possible worsening of the metabolic risk profile in individual patients, which should be managed as clinically appropriate (see also Section 4.8 Undesirable effects).

Section 4.4

Change of text under heading ‘QT Prolongation’

 

Section 4.5

Change in text

It is also not recommended to consume grapefruit juice while on quetiapine therapy.

 

Section 4.5

Additional paragraph

Formal interaction studies with commonly used cardiovascular medicinal products have not been performed.

Section 4.8

Change to table and  additional footnotes 19and 20

 

Additional text 2nd paragraph after footnotes:

(e.g. akathisia, extrapyramidal disorder, tremor, dyskinesia, dystonia, restlessness, muscle contractions involuntary, psychomotor hyperactivity and muscle rigidity)

 

Section 10

Revision date of text: 18 February 2011

Updated on 16/02/2010 and displayed until 04/03/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company



Section 1

Name change to include strengths and formulation.

 

Additionally black triangle monitoring:  preventing recurrence in bipolar disorder

 

Section 4.1

Information regarding Recurrence Prevention.

 

Section 4.2

Additional new text regarding Recurrence Prevention

 

Section 4.2

Paediatric information

 

Section 4.2

Additional new text:

Renal impairment

Dosage adjustment is not necessary in patients with renal impairment.

 

Change of text:

Hepatic impairment

Quetiapine is extensively metabolised by the liver. Therefore, SEROQUEL should be used with caution in patients with known hepatic impairment, especially during the initial dosing period. Patients with known hepatic impairment should be started with 25 mg/day. The dosage should be increased daily with increments of 25 - 50 mg/day until an effective dosage, depending on the clinical response and tolerability of the individual patient.

 

Section 4.3

Additional new text.

 

Section 4.4

Paediatric information  - Children and adolescents (10 to 17 years of age)

 

Section 4.4

Additional text under the heading Cardiovascular:

“Dose reduction or more gradual titration should be considered if this occurs.”

 

Additional text under the heading Extrapyramidal symptoms
In placebo controlled clinical trials of adult patients quetiapine was associated….”

 

Change of text under the heading Tardive dyskinesia

 

Additional text under the heading Severe neutropenia

“There is no apparent dose relationship. During post-marketing experience, resolution of leucopenia and/or neutropenia has followed cessation of therapy with SEROQUEL.”

Change of text under the heading Interactions

 

Additional text under the heading Lipids

To include HDL

 

Additional text under the heading Elderly patients with dementia-related psychosis

New text: third paragraph.

 

Additional new text under the headings Concomitant illness and Venous thromboembolism

 

New text under the heading Additional Information

 

Section 4.5

Change of text throughout section

 

Section 4.6

Change of text.

 

Section 4.7

Change of text.

 

Section 4.8

Additional text 2nd paragraph:

‘As with other antipsychotics, weight gain, syncope,…..’

 

Change/additional text in frequencies table.

Change of text to footnotes 4, 9, 11, 12 and change of text to footnote 18

 

Section 4.8

Additional new text regarding Paediatric information  - Children and adolescents (10 to 17 years of age)

Including table and footnotes.

 

Section 5.1

Change of text throughout section

 

Additional new text regarding Paediatric information  - Children and adolescents (10 to 17 years of age)

 

Section 5.2

Change of text

 

Additional new text regarding Paediatric information  - Children and adolescents (10 to 17 years of age)

 

Section 5.3

Change of text

 

Section 10

New revision date of text: 22 January 2010
Updated on 18/09/2009 and displayed until 16/02/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 4.8 and 5.1
Includes information regarding prolactin, weight gain, irritability, increased appetite and galactorrhea.

Section 10
Revision date of text: 9 September 2009
Updated on 21/08/2009 and displayed until 18/09/2009
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 4.1
Change to sentence:
Treatment of major depressive episodes in bipolar disorder.

Section 4.4
New additional text first 2 paragraphs to include information regarding suicidality.

Section 4.8
additional side effects 'Psychiatric disorders':- abnormal dreams and nightmares
In the investigation section of the table - Uncommon: platelet count decreased 13
Rare: Elevations in blood creatine phosphokinase 14

Section 4.9
change of text to section regarding overdose.

Section 10
Revision date: 28 July 2009
Updated on 27/03/2009 and displayed until 21/08/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.4

New text on QT Prolongation

QT Prolongation

In clinical trials and use in accordance with the SPC, quetiapine was not associated with a persistent increase in absolute QT intervals. However, with overdose (see section 4.9) QT prolongation was observed. As with other antipsychotics, caution should be exercised when quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation. Also, caution should be exercised when quetiapine is prescribed with medicines known to increase QTc interval, and concomitant neuroleptics, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia (see Section 4.5).

 

Additionally, change of text for sub heading Acute withdrawal reactions

Acute withdrawal reactions

Acute withdrawal symptoms such as insomnia, nausea, headache, diarrhoea, vomiting, dizziness and irritability have been described after abrupt cessation of Seroquel. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. Gradual withdrawal over a period of at least one to two weeks is advisable (see section 4.8).

Additional new last paragraph to section 4.4

Lipids
Increases in triglycerides and cholesterol have been observed in clinical trials with quetiapine (see section 4.8). Lipid increases should be managed as clinically appropriate.

 

Section 4.5

New additional last paragraph text to section

Caution should be exercised when quetiapine is used concomitantly with drugs known to cause electrolyte imbalance or to increase QTc interval.

Section 4.8

Additional side effects in table ‘Very common’

 

Additional references (footnotes) to table

 

New text after footnotes of table

Cases of QT prolongation, ventricular arrhythmia, sudden unexplained death, cardiac arrest and torsades de pointes have been reported very rarely with the use of neuroleptics and are considered class effects (see Section 4.4 Special warnings and special precautions for use).

 

Section 10

New revision date of text: 16 March 2009

Updated on 02/01/2009 and displayed until 27/03/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.4 – Additional new text last paragraph

Elderly patients with dementia-related psychosis

Seroquel is not approved for the treatment of patients with dementia-related psychosis.

An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Quetiapine should be used with caution in patients with risk factors for stroke.

 

Section 4.5

Interaction of quetiapine with protease inhibitors

 

Section 4.8 - Change to Table

Uncommon - Nervous system disorders

Restless leg syndrome

 

Very rare - Immune system disorders  

Anaphylactic reaction

 

Additional reference (9) under Table for

-Diabetes Mellitus

-Blood glucose increased to hyperglycaemic levels

Reference:

(9)                Calculation of frequency for these ADRs have been taken from post-marketing data only.

 

Section 5.1

Additional/change of text regarding Mechanism of Action

Section 10 – New revision date of text

10 December 2008
Updated on 27/02/2008 and displayed until 02/01/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 and section 4.8
new information added on neutropenia and hyperglycaemia.
 
Section 10
new revision date of text: 26 November 2007
Updated on 25/06/2007 and displayed until 27/02/2008
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 5.1

Change to therapeutic classification from N05A H to

Therapeutic classification: N05A H04

Change of text in the Mechanism of action:

 

Quetiapine is an atypical antipsychotic agent. Quetiapine and the active human plasma metabolite, N-desalkyl quetiapine interact with a broad range of neurotransmitter receptors. Quetiapine and N-desalkyl quetiapine exhibit affinity for brain serotonin (5HT2) and dopamine D1- and D2- receptors. Quetiapine exhibits a higher affinity for serotonin (5HT2) receptors in the brain than it does for dopamine D1 and D2 receptors in the brain. Additionally, N-desalkyl quetiapine has high affinity at serotonin 5HT1 receptors. Quetiapine and N-desalkyl quetiapine also have high affinity at histaminergic and adrenergic a1 receptors, with a lower affinity at adrenergic a2-receptors. Quetiapine has no appreciable affinity at cholinergic muscarinic or benzodiazepine receptors.

Quetiapine is active in tests for antipsychotic activity, such as conditioned avoidance. The extent to which the N-desalkyl quetiapine metabolite contributes to the pharmacological activity of Seroquel in humans is not known.

Section 5.2

Change of text throughout the section.

Section 10

New revision date of text: 30 November 2006
Updated on 01/06/2007 and displayed until 25/06/2007
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 5.1

Change to therapeutic classification from N05A H to

Therapeutic classification: N05A H04

Change of text in the Mechanism of action:

 

Quetiapine is an atypical antipsychotic agent. Quetiapine and the active human plasma metabolite, N-desalkyl quetiapine interact with a broad range of neurotransmitter receptors. Quetiapine and N-desalkyl quetiapine exhibit affinity for brain serotonin (5HT2) and dopamine D1- and D2- receptors. Quetiapine exhibits a higher affinity for serotonin (5HT2) receptors in the brain than it does for dopamine D1 and D2 receptors in the brain. Additionally, N-desalkyl quetiapine has high affinity at serotonin 5HT1 receptors. Quetiapine and N-desalkyl quetiapine also have high affinity at histaminergic and adrenergic a1 receptors, with a lower affinity at adrenergic a2-receptors. Quetiapine has no appreciable affinity at cholinergic muscarinic or benzodiazepine receptors.

Quetiapine is active in tests for antipsychotic activity, such as conditioned avoidance. The extent to which the N-desalkyl quetiapine metabolite contributes to the pharmacological activity of Seroquel in humans is not known.

Section 5.2

Change of text throughout the section.

Section 10

New revision date of text: 30 November 2006

Updated on 27/06/2005 and displayed until 01/06/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/11/2003 and displayed until 27/06/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 03/10/2002 and displayed until 24/11/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 26/09/2002 and displayed until 03/10/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 26/03/2002 and displayed until 26/09/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 10/08/2001 and displayed until 26/03/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 22/06/2001 and displayed until 10/08/2001
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 06/09/1999 and displayed until 22/06/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics