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Fucidin Ointment

*
Pharmacy Only: Prescription

  • Company:

    LEO Pharma

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Sodium Fusidate

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

Updated on 31 January 2023

File name

spc-fucidin ointment-May 2017.pdf

Reasons for updating

  • Document format updated

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

Updated on 26 May 2022

File name

Package leaflet - Fucidin ointment-August 2021.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

a new manufacturing site added and change to the date of the text revision

Updated on 15 November 2019

File name

ie-pl-fucidin ointment-Tech changes (Packrat).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 12 May 2017

File name

PIL_8466_523.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 12 May 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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 1, 2, 4.1, 4.2, 4.6, 4.7, 4.8, 5.1, 6.1, 6.3 & 9: Editorial & QRD updates only with no change to the meaning of the text.

Section 6.4: Update of storage condition from ‘Do not store above 30°C’ to ‘No special storage condition’.

Section 10: Date of revision updated to May 2017

Updated on 12 May 2017

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 19 November 2015

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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 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

Sections 1, 4.2, 4.4, 4.6, 4.7, 4.8, 5.1, 5.2 updated in line with the latest version of the QRD template. Section 3 updated in line with the description on the finished product specification.

Sections 2, 5.3, 6.1, 6.3, 6.4, 6.5, 7 of the SmPC updated with minor editorial changes to correct the formatting of the text.

Updated on 13 November 2015

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 01 September 2014

Reasons for updating

  • Change to side-effects

Updated on 24 September 2013

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 6.6 - Special precautions for disposal and other handling
  • 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

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Known effect has been added:
 

Each gram of ointment contains 20 mg sodium fusidate.

 

Excipients with known effect:  

Contains cetyl alcohol  4 mg/g and wool fat (lanolin) 46 mg/g

 

For the full list of excipients, see section 6.1

4.3 Contraindications

This section has been reworded in line with the CCSI.
 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special Warnings and Precautions for Use

 

This section has been reworded and updated. 

Bacterial resistance among Staphylococcus aureus has been reported to occur with the use of topical Fucidin®. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance.

 

Fucidin® ointment contains cetyl alcohol and wool fat (lanolin). These excipients may cause local skin reactions (e.g. contact dermatitis).  Fucidin® ointment contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. 

 

When Fucidin® ointment is used on the face; care should be taken to avoid the eyes as the excipients may cause conjunctival irritation.

4.5 Interaction with other medicinal products and other forms of interaction

 
New text has been added. None known has been removed.

No interaction studies have been performed.  Interactions with systemically administered medicinal products are considered minimal as the systemic absorption of topical Fucidin® is negligible.

 

4.6 Fertility, pregnancy and lactation

Fertility wording has been added, the preganncy section has been reworded and so has the breast-feeding section as well. It has also been reworded from lactation to breast feeding.
 

Fertility:

There are no clinical studies with topical Fucidin® regarding fertility. No effects in women of childbearing potential are anticipated, since systemic exposure following topically applied fusidic acid/sodium fusidate is neglibible.

 

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to topically applied fusidic acid/sodium fusidate is negligible.  Topical Fucidin® can be used during pregnancy. 

 

Breast-feeding

No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied fusidic acid/sodium fusidate to the breast-feeding woman  is negligible. Topical Fucidin® can be used during breast-feeding but it is recommended to avoid applying topical Fucidin® on the breast.  


4.8 Undesirable effects

Section 4.8 has been completely re-written according to the latest version of the CCSI. 
 

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.

 

Based on pooled data from clinical studies including 4724 patients who received Fucidin® cream or Fucidin® ointment,  the frequency of undesirable effects is 2.3%

The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by various application site conditions such as pain and irritation, which all occurred in less than 1% of patients.

 

Hypersensitivity and angioedema have been reported.

 

Undesirable effects are listed by the MedDRA system Organ Class (SOC) and the individual undesirable effects are listed starting with the most frequently reported.  Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Very common ≥ 1/10

Common ≥1/100 and <1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥ 1/10,000 and < 1/1,000

Very rare <1/10,000

 

Immune system disorders

Rare (≥1/10,000 and <1/1,000):          

Hypersensitivity

 

Eye disorders

Rare (≥1/10,000 and <1/1,000):          

Conjunctivitis

 

Skin and subcutaneous tissue disorders

Uncommon (≥1/1,000 and <1/100):

Dermatitis (incl. dermatitis contact, eczema)

Rash*

Pruritus

Erythema

* Various types of rash reactions such as erythematous, pustular, vesicular, maculo-papular and papularhave been reported.  Rash generalised has also occurred.

 

Rare (≥ 1/10,000 and < 1/1,000)

Angioedema

Urticaria

Blister

 

General disorders and administration site conditions

Uncommon ≥1/1,000 and <1/100

Application site pain (incl. skin burning sensation)

Application site irritation

 

Paediatric population

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.

 

6.6 Special precautions for disposal

The QRD statement has been added to section 6.6

No special requirements for disposal.  Any unused product or waste material should be disposed of in accordance with local requirements.

Updated on 15 August 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision

Updated on 25 July 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • 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 4.4 Special warnings and precautions for Use. The following statement has been added:

Fucidin ointment contains Butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis).


Section 6.1 List of Excipients: The following excipients have been added:

All-rac-α-tocopherol, Butylhydroxytoluene (E321)

 

Section 10. Date of (Partial) Revision of the Text: Updated to:

July 2011

Updated on 24 March 2011

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions
  • Change to date of revision

Updated on 17 February 2011

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

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 the Medicinal Product

The name has been changed from 'Fucidin® ointment' to 'Fucidin® 20 mg/g ointment'

Section 2 Qualitative and Quantitative Composition

The excipients 'cetyl alcohol 4 mg/g' and 'wool fat (lanolin) 46 mg/g' are now listed.

Section 4.6 Fertility, Pregnancy and Lactation

The heading has changed from 'Pregnancy and Lactation' to the above

Section 6.3 Shelf Life

An 'in use' shelf life has been added:

'After first opening: 3 months'

Section 6.4 Special precautions for storage

The following is now registered: 'Do not store above 30

 

oC'

 

Section 6.6 Instructions for Use and Handling

The following has been included: 'Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the enviornment.'

Updated on 22 September 2010

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 09 September 2010

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

In section 4.7, editorial change only.

In section 4.8: the text in bold denotes new text

4.8 Undesirable effects

 

Based on combined clinical data for Fucidin® cream and Fucidin® ointment, approximately 5% of patients can be expected to experience an undesirable effect.

 

The most frequently reported adverse drug reactions are various skin reactions and in particular application site reactions.

Allergic reactions and contact dermatitis have been reported.

 

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.


Immune system disorders

Rare (≥1/10,000 and <1/1,000):

Allergic reaction

 

Eye Disorders

Rare (≥1/10,000 and <1/1,000)

Conjuctival irritation

 

Skin and subcutaneous tissue disorders

Uncommon (≥1/1,000 aand <1/100):

Rash*

Irritation at site of application (incl. pain, stinging, burning and erythema)

Pruritis

Contact Dermatitis

 

*Various types of rash reactions such as erythematous, maculo-papular and pustular have been reported.

 

Frequency unknown:

Urticaria

Angioneurotic oedema

Eczema

Periorbital oedema


Section 6.5: The following text has been added:

Not all pack sizes may be marketed.

Updated on 25 February 2009

Reasons for updating

  • Correction of spelling/typing errors

Updated on 19 January 2009

Reasons for updating

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

Updated on 14 January 2009

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 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

All sections updated in line with company core safety information 02.

Updated on 24 July 2008

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 February 2006

Reasons for updating

  • Change to storage instructions

Updated on 07 February 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 not be renewed (A)

Updated on 15 September 2005

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 06 September 2005

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 08 March 2005

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 07 March 2005

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

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

Updated on 30 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 August 2003

Reasons for updating

  • 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)

Updated on 26 June 2003

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 June 2003

Reasons for updating

  • Addition of legal category

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