Bactroban Nasal Ointment
- Name:
Bactroban Nasal Ointment
- Company:
GlaxoSmithKline (Ireland) Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
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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 12 February 2021 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 22 January 2021 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 22 January 2021 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 6 - date of revision
Updated on 20 February 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 March 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 13 March 2017 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
Updated on 4 December 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 4 December 2015 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
- Change to MA holder contact details
Updated on 17 July 2015 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 2 July 2015 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
· Section 2 – Update to qualitative and quantitative composition statement
· Section 4.2 – Minor QRD update
· Section 4.4 - Amendments to the current approved text for the nasal ointment formulation for consistency with the text for the ointment formulation:
“This mupirocin nasal ointment formulation is not suitable for ophthalmic use.”
· Section 4.6 – Minor QRD update
· Section 4.8 – Addition of the term ‘anaphylaxis’; Updated HPRA details; QRD and minor editorial updates
· Section 4.9 - Updated statements and management of overdose
· Section 10 – Date of revision update
Updated on 2 July 2015 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change to, or new use for medicine
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Addition of information on reporting a side effect.
- Correction of spelling/typing errors
Updated on 7 April 2014 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 5.3 - Preclinical safety data
- 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
Changes to:
Section 4.4 - Special warnings and precautions for use,
Section 4.6 - Pregnancy and lactation,
Section 4.7 - Effects on ability to drive and use machines,
Section 4.8 - Undesirable effects,
Section 5.3 - Preclinical safety data,
Section 6.6 - Special precautions for disposal
Updated on 4 April 2014 PIL
Reasons for updating
- Change to side-effects
Updated on 9 September 2013 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
Updated on 19 June 2013 SPC
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
Section 4.1 -Therapeutic indications,
Section 5.1 - Pharmacodynamic properties
Updated on 30 August 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 6 May 2010 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.9 - Overdose
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
1. Name of the Medicinal Product
Bactroban Nasal Ointment 2%w/w
4.3 Contraindications
Bactroban nasal ointment should not be given to patients with a history of hypersensitivity to any of the constituents.
Hypersensitivity to mupirocin or any of the excipients (see section 6.1).
4.4 Special Warnings and Special Precautions for Use
Care should be taken to avoid the eyes.
In the rare event of a possible sensitisation reaction or severe local irritation occurring with the use of Bactroban Nasal Ointment, treatment should be discontinued, the product should be wiped off and appropriate alternative therapy for the infection instituted.
Should a possible sensitisation reaction or severe local irritation occur with the use of Mupirocin Nasal Ointment, treatment should be discontinued, the product should be wiped away and appropriate therapy instituted.
As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms.
Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.
4.5 Interaction with Other Medicinal Products and Other Forms of Interaction
It is not known whether or not the product interacts with other medicaments.
No drug interactions have been identified.
4.6 Pregnancy and Lactation
This product should not be used during pregnancy and lactation unless considered essential by the physician.
Pregnancy: Adequate human data on the use during pregnancy are not available. However animal studies have not identified any risk to pregnancy or embryo-foetal development.
Lactation: Adequate human and animal data on use during lactation are not available.
Pregnancy
Reproduction studies on mupirocin in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on its use during pregnancy, mupirocin should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.
Lactation
There is no information on the excretion of mupirocin in milk
4.7 Effects on Ability to Drive and Use Machines
No adverse effects on the ability to drive or operate machinery have been observed identified.
4.9 Overdose
The toxicity of mupirocin is very low. In the event of overdose accidental ingestion, symptomatic treatment should be given.
Updated on 16 September 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 - Pharmaceutical particulars
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SUMMARY OF PRODUCT CHARACTERISTICS CHANGES (MARKED IN RED)
1. Name of the Medicinal Product
Bactroban Nasal Ointment 2%w/w
2. Qualitative and Quantitative Composition
Mupirocin 2.0% w/w as mupirocin calcium
For a full list of excipients, see section 6.1
6. Pharmaceutical Particulars
6.1 List of Excipients
White soft paraffin
Mixed diglycerinester of fatty acids (Softisan 649)
Updated on 26 August 2008 SPC
Reasons for updating
- 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
Updated on 8 July 2008 PIL
Reasons for updating
- Addition of manufacturer
Updated on 4 August 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 14 December 2004 SPC
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
- Change to section 6.2 - Incompatibilities
- 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)
Updated on 10 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 3 July 2003 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 19 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)