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Bactroban Nasal Ointment

*
Pharmacy Only: Prescription

  • Company:

    GlaxoSmithKline (Ireland) Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Mupirocin Calcium

    *Additional information is available within the SPC or upon request to the company

Updated on 07 July 2022

File name

ie-pl-bactroban-nasaloint-issue8draft1-clean-meds.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 01 September 2021

File name

ie-pl-bactroban-nasaloint-issue7draft1-working copy-clean-meds.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 12 February 2021

File name

ie-pl-bactroban-nasaloint-issue6draft1-working copy-clean-medsie.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 22 January 2021

File name

ie-spc-bactrobannasaloint-issue5draft1-working copy-clean-meds.pdf

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

File name

ie-pl-bactroban-nasaloint-issue5draft1-working copy-clean-meds.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 6 - date of revision

Updated on 20 February 2019

File name

ie-pl-bactroban-nasaloint-issue4draft2.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 13 March 2017

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

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

Section 5.1 – summary of change: Update to the information regarding Mupirocin breakpoints.

Updated on 04 December 2015

File name

PIL_8133_109.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 December 2015

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to MA holder contact details

Updated on 17 July 2015

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

Change to address of the MA Holder

Updated on 17 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 02 July 2015

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 02 July 2015

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 07 April 2014

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 04 April 2014

Reasons for updating

  • Change to side-effects

Updated on 09 September 2013

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

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

Changes to:

Section 4.1 -Therapeutic indications,
Section 5.1 - Pharmacodynamic properties

Updated on 30 August 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 06 May 2010

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

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

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

Section 10:
 
Revision Date: September 2004

Updated on 08 July 2008

Reasons for updating

  • Addition of manufacturer

Updated on 04 August 2005

Reasons for updating

  • Improved electronic presentation

Updated on 14 December 2004

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

Reasons for updating

  • New PIL for medicines.ie

Updated on 03 July 2003

Reasons for updating

  • Improved electronic presentation

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

Updated on 19 June 2003

Reasons for updating

  • New SPC for medicines.ie

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