Betnovate RD Ointment | Medicines.ie

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Betnovate RD Ointment

Name:
Betnovate RD Ointment
Company:
GlaxoSmithKline (Ireland) Ltd
Active Ingredients:
Betamethasone Valerate
Legal Category:
Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/02/19

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Medicine Name Betnovate C 0.1% / 3% w/w Cream	Active Ingredients Betamethasone Valerate, Clioquinol
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Medicine Name Betnovate Ointment 0.1% w/w	Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Cream	Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Ointment	Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Scalp Application 0.1% w/v Cutaneous Solution	Active Ingredients Betamethasone Valerate

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1 - 0 of 135 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 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 SmPC

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 8 July 2016 PIL

Reasons for updating

New PIL for new product

Updated on 8 July 2016 SmPC

Reasons for updating

New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 8 July 2016 SmPC

Reasons for updating

Change to section 4.1 - Therapeutic indications
Change to section 4.2 - Posology and method of administration
Change to section 4.3 - 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

Section 4.1: Indications:
• 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 SmPC

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 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 2 – Updated qualitative and quantitative composition
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 update
Section 6.1 – Minor editorial updates
Section 9 – Minor editorial update
Section 10 – Date of revision updated

Updated on 2 September 2015 PIL

Reasons for updating

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 17 July 2015 SmPC

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

Change to address of the MA Holder

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 SmPC

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 14 May 2010 PIL

Reasons for updating

Change to appearance of the medicine

Updated on 6 May 2010 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

1. TRADE NAME OF THE MEDICINAL PRODUCT

Betnovate RD (Ready Diluted) ~~Ointment~~ 0.025% w/w Ointment

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

            Betamethasone 0.025% w/w (as Betamethasone valerate).

            For a full list of excipients, see section 6.1



3.         PHARMACEUTICAL FORM

            ~~Cutaneous~~ Ointment.

A smooth, off-white soft-paraffin based ointment

Updated on 30 October 2008 SmPC

Reasons for updating

Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 21 October 2005 PIL

Reasons for updating

Change to date of revision

Updated on 4 August 2005 PIL

Reasons for updating

Improved electronic presentation

Updated on 10 August 2004 PIL

Reasons for updating

New PIL for medicines.ie

Updated on 7 January 2004 SmPC

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 SmPC

Reasons for updating

Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 19 June 2003 SmPC

Reasons for updating

New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)