Betnovate Ointment 0.1% w/w
- Name:
Betnovate Ointment 0.1% w/w
- Company:
GlaxoSmithKline (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/09/20
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GlaxoSmithKline (Ireland) Ltd
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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 21 September 2020 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Updated reporting details
Updated on 21 September 2020 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 - Undesirable Effects - updated adverse event reporting details
Section 5.3 - Pre-clinical safety data - Addition of 'intrauterine growth retardation' to effects seen in pregnant mice, rats and rabbits
Section 10 - Date of revision of the text - updated to reflect approval date
Updated on 29 October 2019 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 29 October 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 4 February 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 18 December 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 18 December 2018 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 16 January 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 16 January 2017 PIL
Reasons for updating
- Change to section 3 - use in children/adolescents
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 8 July 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 8 July 2016 SPC
Reasons for updating
- 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 4.6 - 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 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
• Some of the terminology used to describe the indications has been modified in line with the ICD-10 classification of skin diseases in order to avoid misinterpretation by non-specialist prescribers and mistranslation into other languages.
• Populations in which use is indicated included (...’indicated for adults, elderly and children over 1 year...’) as per posology and contraindication in children under 1 year of age.
•
Section 4.2: Dosage and administration:
• In line with current medical practice the frequency of application is recommended as once or twice daily. This is a reduction in the recommended frequency of dosing. A review period has been specified.
• Additional mandatory statements have been added concerning use in special populations - children, elderly and those with renal and/or hepatic impairment and aligned with other topical corticosteroids in the GSK portfolio.
• Statement for use in recalcitrant dermatoses (intermittent therapy) has been included
•
Section 4.4 Warnings and precautions:
• Inclusion of additional clarification statements as per GDS and considered informative to the reader; aligns with the other topical corticosteroids in the GSK portfolio; minor editorial updates
•
Sections 4.3, 4.6 and 4.8
• Minor grammar updates
Section 4.9: Overdose:
• Minor update to include QRD sub-headings and inclusion of statement concerning advice recommended by national poisons centre where available for further management; also aligned with other topical corticosteroids in the GSK portfolio.
•
Clinical pharmacology section:
• Section 5.1 of the SmPC has been aligned with other topical corticosteroids in the GSK portfolio; the mechanism of action has been expanded on and is as detailed in the available literature.
• Section 5.2 of the SmPC aligned with other topical corticosteroids in the GSK portfolio.
Section 5.3: Preclinical data:
Updated in line with the SmPC guideline and aligned with other topical corticosteroids in the GSK portfolio
Updated on 8 July 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 2 September 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to further information section
- Change to date of revision
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 2 September 2015 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 - 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 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.3 – Minor editorial updates
Section 4.4 – Minor QRD and editorial updates
Section 4.5 – Minor editorial updates
Section 4.6 – Minor QRD updates
Section 4.8 – QRD updates including addition of adverse reaction reporting statement
Section 4.9 – Minor QRD update
Section 5.1 – QRD and minor editorial updates
Section 5.2 – Minor editorial update
Section 6.1 – Minor editorial updates
Section 9 – Minor editorial update
Section 10 – Date of revision updated
Updated on 17 July 2015 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 July 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 20 February 2013 SPC
Reasons for 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes to:
Section 4.2 - Posology and method of administration,
Section 4.3 - Contraindications,
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.6 - Pregnancy and lactation,
Section 4.8 - Undesirable effects,
Section 4.9 - Overdose
Updated on 20 February 2013 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
Updated on 20 November 2012 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
Updated on 26 November 2009 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The minor changes are to
Section 1: Name of Product
Section 2 - Qualitative and Quantitative Composition
Section 6.1 - List of Excipients
Updated on 19 November 2009 PIL
Reasons for updating
- Change to product name
Updated on 26 August 2008 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 24 May 2005 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 7 January 2004 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 3 July 2003 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 19 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)