SUTENT 12.5mg, 25mg, 37.5mg and 50mg Hard Capsules

  • Name:

    SUTENT 12.5mg, 25mg, 37.5mg and 50mg Hard Capsules

  • Company:
    info
  • Active Ingredients:

    Sunitinib malate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/11/19

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Summary of Product Characteristics last updated on medicines.ie: 8/10/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
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Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
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Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
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Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
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Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
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1 - 0 of 227 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 19 November 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change of distributor details

Updated on 8 October 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 8 October 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 February 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 February 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:
Inclusion of the ADR colitis (colitis ischaemic and colitis ulcerative) to the Undesirable Effects Table.

Addition of aortic aneurysms and dissections to Warnings and Precautions section and Undesirable Effects Table.

Updated on 15 January 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 15 January 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:
Inclusion of pediatric data as a result of the Pediatric Implementation Plan (PIP) in sections 4.2, 4.8, 5.1 and 5.2.

Updated on 23 October 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 18 October 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC section 7: Marketing authorisation holder change to Pfizer EEIG.

Updated on 26 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 26 March 2018 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.9 - Overdose
  • 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 8 - Marketing authorisation number(s)

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:
Section 1, 3, 4.1, 4.2, 4.5,4.6, 4.7, 4.9, 5.1, 5.2 and 5.3 , 8 – editorial updates.
Section 4.4 editorial and AE update
Setion 4.8 editorial, AE update, and new information on long term safety.

Updated on 23 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 23 March 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 22 January 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 22 January 2018 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: SPC sections 4.5 and 5.2

Updated on 25 May 2017 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.1 and 5.1 based on the final CSR of study A6181202.

Updated on 24 May 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 18 November 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - 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
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Formatting and editorial changes to align with QRD affects Sections: 2, 3, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3, 6.1 and 6.6

Updated on 11 November 2016 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 29 March 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 8 - MA number

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

4.2    Posology and method of administration – subsection on paediatric population updated in line with data.

 

4.8    Undesirable effects -  new section added on paediatric population.

 

5.1   Pharmacodynamic properties – new section added on paediatric population from Study ADVL0612.

5.2   Pharmacokinetic properties - new section added on paediatric population from Study ADVL0612.

 

8.   MARKETING AUTHORISATION NUMBER(S) – Section updated with the current QRD template.

Updated on 24 March 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 28 July 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

4.4    Special warnings and precautions for use – new subsection added for Thrombotic Microaniopathy (TMA) and associated data.

 

4.8    Undesirable effects -  updated to include only frequencies in line with CDS and updated to include TMA.

 

5.1   Pharmacodynamic properties - Minor formatting changes were made throughout document for format consistency i.e. the numbering of tables was corrected

Updated on 23 July 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 20 April 2015 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 5.1 Pharmacodynamic Properties

Subsection Pancreatic neuroendocrine tumours (pNET) has been updated with new data.

Updated on 30 March 2015 PIL

Reasons for updating

  • Change to MA holder contact details
  • Change to improve clarity and readability

Updated on 20 February 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use – cardiac section updated to  Replace “myocardial disorders” in the list of cardiovascular events in Section 4.4 with “myocardial ischemia and myocardial infarction”.

QT interval prolongation section updated with safety change.

Section 4.8 Undesirable effects – Updated with new side effects under cardiac disorders section.

Section 4.9 Overdose - Updated to delete ‘A few’ from ‘A few case of overdose have been reported’.

Updated on 17 February 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to side-effects

Updated on 5 September 2014 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

3.    PHARMACEUTICAL form

Section corrected to remove “and” from the sentences.

4.2    Posology and method of administration

Information on elderly patients updated in line with CDS.

4.4   Special warnings and precautions for use

Section updated to include statement on hypertension and new information on hypoglycaemia. Also section updated to correct typographic errors.

4.8    Undesirable effects

Section updated with data and changes made to frequency grouping.  List of side effect terms have been updated in line with CDS. Statements on endocrine disorders, cardiac disorders, respiratory disorders, gastrointestinal disorders and renal disorders have been deleted. Statement on metabolism and nutrition disorders has been updated to include hypoglycaemic events. Statement on cholecystitis has been deleted under the heptobiliary disorders section.

4.9   Overdose

Section updated to improve clarity and readability.

5.1   Pharmacodynamic properties

Section updated to improve clarity and readability. Also to correct typographic errors.

Updated on 28 August 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 7 August 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to Sections 4.8 & 5.3

 

Updated on 1 August 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 28 February 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to sections 4.4 and 4.8 of SPC and PIL regarding necrotizing fasciitis mouth pain, ADR frequency revision and removal of  inverted black triangle symbol ▼ next to the pNET indication.

Updated on 25 February 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 18 July 2013 PIL

Reasons for updating

  • Change to date of revision
  • Addition of marketing authorisation holder

Updated on 22 April 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 22 April 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 4.8

Updated on 26 February 2013 SmPC

Reasons for 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 revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

                              Addition of the ADR “thyroiditis”.

o   Submission of a cumulative review of Nervous System Disorders SOC
o   Addition of the ADR “Blood uric acid increase” .

o   Revision of existing sections for “Infections”.

o   Revision of existing sections for “Skin and tissues disorders,” “Cardiac disorders,” and “Tumour Lysis Syndrome”

o   Revision of information for “Heamorrhages” and “Venous Thromboembolic Events” 

o   Corrections of typos, editorial changes, improvement in the language

Updated on 26 February 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 23 January 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

To include “Oesophagitis” in the Sutent Product Information (SmPC Section 4.8 Undesirable Effects)

Updated on 28 November 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.4 & 4.8 - To add the terms "erythema multiforme," "Stevens-Johnson Syndrome (SJS)," and "Toxic Epidermal Necrolysis (TEN)," including information on a causal relationship and case fatality rate

Updated on 2 April 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC Addition of Skin and tissues disorders: pyoderma gangrenosum to Section 4.4 and Section 4.8

Updated on 29 March 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 27 January 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 18 January 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4, 4.8 and 5.3 have been revised

Updated on 13 January 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 1 September 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 – Under haematological disorders the following sentence was added; Anaemia has been observed to occur early as well as late during treatment with sunitinib; Grade 3 and 4 cases have been reported.  The Thyroid dysfunction section was also re-worded.
Section 4.8 – Side effects section table 4 has been updated, the term “not known” has been replaced with “uncommon” and the following heading was added with an additional side effect “Respiratory, thoracic and mediastinal disorders – Uncommon – Haemoptysis”

Updated on 25 August 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details

Updated on 14 January 2011 SmPC

Reasons for 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 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 – The following sentence was amended “Use of SUTENT in the paediatric population is not recommended.”
Section 4.4 – The following sections were updated; Haematological disorders, Cardiac disorders, QT interval prolongation, thyroid dysfunction, hepatotoxicity and renal function. The following new sections have been added to 4.4; Arterial thromboembolic events, Impaired wound healing and Osteonecrosis of the Jaw (ONJ).
Section 4.5 – Following sentence added “Interaction studies have only been performed in adults.”
Section 4.6 – heading changes only in this section.
Section 4.8 
Section 4.9 – The following additional sentence has been added “A few cases of overdose have been reported; these cases were associated with adverse reactions consistent with the known safety profile of sunitinib, or without adverse reactions.”
Section 5.1 – Heading update.
Section 5.3 – The Carcinogenicity section was updated.

Updated on 12 January 2011 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to MA holder contact details

Updated on 7 December 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 7 December 2010 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC Section 4.1 Therapeutic indications

Updated on 3 December 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 13 August 2010 PIL

Reasons for updating

  • Change to further information section

Updated on 13 August 2010 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2:

Renal Insufficiency section has been updated

Section 5.2:

Special population- Renal impairment section has been updated

Updated on 4 May 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4: Special warnings and precautions for use
Section 4.8: Undesirable effects
Section 5.1: Pharmacodynamic properties
Section 6.3: Shelf life - change the shelf life of the Sutent capsules from 24 to 36 months.

Updated on 27 April 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 16 November 2009 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

To amend the SPC section 5.1 with the CRS of pivotal study A6181004 in GIST patients.

Updated on 15 September 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Revision of the SmPC,

Section 4.4 to include Hypersensitivity/angioedema and Fistula

Section 4.8, post marketing experience section, to include Hypersensitivity/angioedema and Fistula

Updated on 15 September 2009 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 7 September 2009 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 16 June 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 6 - Pharmaceutical particulars

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



Section 1: Name of Product with new strength

Section 2: Qualitative and quantitative composition with new strength

Section 3: Pharmaceutical Form with new strength

Section 6: Pharmaceutical Particulars with new strength

Updated on 15 June 2009 PIL

Reasons for updating

  • Change to further information section
  • Introduction of new strength
  • Improved electronic presentation

Updated on 20 February 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Pulmonary Events: update to section 4.4
Haematological: update to section 4.4 
Venous Thromboembolic Events: update to section 4.4 - adding the fatal events. 
Infection and infestations: To update SmPC section 4.8 by adding pneumonia events

Updated on 20 February 2009 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 3 September 2008 PIL

Reasons for updating

  • Change to side-effects

Updated on 2 September 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4 – addition of text under sub-headings, haemorrhage, cardiovascular, QT interval prolongation, hypothyroidism, pancreatic and hepatic function

4.8 – addition of text and reformatting of tables and addition of text to adverse reactions from post-marketing experience

Updated on 5 February 2008 PIL

Reasons for updating

  • Addition of marketing authorisation holder
  • Change due to harmonisation of patient information leaflet
  • Change to warnings or special precautions for use

Updated on 4 February 2008 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.1 – reformatting

4.2 – Dose adjustments and reformatting

4.4 – addition of text under sub-headings, haemorrhage, gastrointestinal events, hypertension, cardiovascular, QT interval prolongation, hypothyroidism, pancreatic and hepatic function

4.8 – addition of text and reformatting of tables and addition of text to adverse reactions from post-marketing experience 

6.5 – description for blister pack added

Updated on 30 August 2007 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 3 - Typing errors
Section 10 - Typing errors

Updated on 5 July 2007 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 February 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 15 February 2007 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 13 February 2007 PIL

Reasons for updating

  • Change to date of revision
  • Addition of joint PIL covering all presentations
  • Addition of marketing authorisation holder

Updated on 12 February 2007 SmPC

Reasons for 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2     Posology and method of administration – Hepatic insufficiency subheading

4.4     Special warnings and precautions for use - QT prolongation and Pancreatic function

4.8     Undesirable effects – last sentence in first paragraph added

5.2     Pharmacokinetic properties organ function impairment

Updated on 7 August 2006 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 2 August 2006 PIL

Reasons for updating

  • New PIL for new product