Fucidin Tablets

  • Name:

    Fucidin Tablets

  • Company:
    info
  • Active Ingredients:

    Sodium Fusidate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/07/17

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Summary of Product Characteristics last updated on medicines.ie: 10/7/2017
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LEO Pharma

LEO Pharma

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1 - 0 of 40 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 14 July 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Improved presentation of PIL

Updated on 14 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 10 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 10 July 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Additional text

In exceptional circumstances, where prolonged systemic Fucidin is needed, e.g. for the treatment of severe infections, the need for co-administration of HMG-CoA reductase inhibitors and systemic Fucidin should only be considered on a case by case basis and under close medical supervision.

In a few cases, serious cutaneous reactions putting life at risk such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, toxic epidermal necrolysis (Lyell’s syndrome) and Stevens-Johnson syndrome have been reported with systemic Fucidin. Patients should be advised to monitor cutaneous reactions as well as signs and symptoms suggestive of these reactions which usually appear in the first weeks of therapy. If such reactions are suspected to be due to systemic Fucidin, treatment with systemic Fucidin should be stopped and it is recommended not to reintroduce the therapy.

Section 4.8 Undesirable effects

Additional text

Not known (cannot be estimated from available data)

Not known

Toxic epidermal necrolysis (Lyell´s syndrome)f)

Stevens-Johnson syndromef)

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome f)


f) These adverse reactions were identified through post-marketing surveillance. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see section 4.4).

Section 5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Steroid antibacterials,

ATC code: J01XC01

5.3 Preclinical safety data

Amended text

There are no preclinical There are no preclinical data of relevance to the prescriber which are additional to that already included in other areas of the SPC.

Section 10 Date of Revision of the text

June 2017

Updated on 16 January 2017 SmPC

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 Corrected date of revision of text to September 2014 instead of August 2014

Updated on 23 September 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.7 - 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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

Update to SPC in line with company core data sheet and QRD template

Updated on 16 September 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change due to harmonisation of PIL

Updated on 15 September 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change due to user-testing of patient information

Updated on 14 September 2011 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • 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

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

In this section, the product is referred to now as 'Fucidin tablets', it was previously referred to as 'Fucidin administered systemically'

'Impaired liver function' has been replaced with the term 'Hepatic dysfunction'.

Section 4.5 Interaction with other medicical products and other forms of interaction

In this section, the product is referred to now as 'Fucidin tablets', it was previously referred to as 'Fucidin administered systemically'

The following wording is now approved:

'Co-administration of Fucidin® tablets and HMG-CoA reductase inhibitors such as statins may cause increased plasma concentrations of both agents. This may result in an elevation of creatinine kinase level and risk of rhabdomyolysis, muscle pain and weakness'.

This replaces the previously approved wording:

'Co-administration of Fucidin® administered systemically and HMG-CoA reductase inhibitors such as statins causes increased plasma concentrations of both agents resulting in an elevation of creatine kinase level (rhabdomyolysis), muscle weakness and pain.'

With regard to an interaction with oral anticoagulants, the following wording has been approved:

'The mechanism of this suspected interaction is unknown', this replaces the wording 'The mechanism of this suspected interaction remains unknown.'

 

Section 4.6 Fertility, Pregnancy and Lactation

This heading is now used, the previous heading was 'Pregnancy and lactation'.

In this section, the product is referred to now as 'Fucidin tablets', it was previously referred to as 'Fucidin administered systemically'

Section 4.8 Undesirable effects

The frequency listing at the beginning of this section has been removed; frequencies are now listed beside the frequency class, e.g. Uncommon (≥1/1,000 and <1/100).

The actual frequencies have also changed; each frequency is now less than or equal to ≥ the relevant frequncy, previously our frequncies were all 'less than'.

'Symptoms of general disorders' have been removed as a most frequently reported undesirable effect to Fucidin® administered orally.

The following wording has now been included:

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

Blood and lymphatic system disorders are now described as 'Frequency not known', these were previously described as 'Very rare'.

Anaphylactic reaction is now described as 'Frequency not known', it was previously described as 'Very rare'.

Drowsiness is now described as 'Common', it was previously 'Uncommon'

Dizziness is now described as 'Common'

Hyperbilirubinaemia, jaundice and hepatic enzymes increased are now described as 'Frequency not known', they were previously described as 'Rare'.

'Hepatorenal syndrome' and 'Renal failure' are now described as 'Frequency not known', it was previously described as 'Very rare'

'Cholestasis' is now described as 'Frequency not known', this undesirable effect has been introduced.

Date of Revision of the text: August 2011

August 2011

Updated on 18 July 2011 SmPC

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 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)

Free text change information supplied by the pharmaceutical company

Product Name: Fucidin® 250 mg tablets

Product strength: Each tablet contains 250 mg of sodium fusidate.

Each tablet contains 250 mg of sodium fusidate.

SmPC Section changed and description of change:

:

Section 2 Qualitative and Quantitative Composition

 

 

The following sentence regarding excipients has been added to the section: 'Excipients: Contains lactose monohydrate 71.9 mg and sodium 11 mg (per tablet).

Section 4.4. Special Warnings and Precautions for Use

 

 

The following wording has been added to the section:

'Each tablet contains 11 milligrams (mg) sodium. To be taken in to consideration by patients on a controlled diet.'

Section 9 Date of first authorisation/renewal of authorisation

 

 

The date of last renewal has been updated to 13 March 2010

Updated on 19 August 2009 PIL

Reasons for updating

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

Updated on 14 July 2009 PIL

Reasons for updating

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

Updated on 13 July 2009 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • 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 4.3 -  'Concomitant treatment with statins, see section 4.5' added
Section 4.4 -  Deleted paragraph relating to statins
Section 4.5 - Paragraph 'HMG-CoA reductase inhibitors' moved to top of section. 'Concomitant treatment with statins is therefore contraindicated, see section 4.3' added.
Section 4.8 - Information relating to Rhabdomyolysis added
Section 10 - Date of revision of the text updated to June 2009

Updated on 9 June 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 - Details of sodium content added
Date - updated to May 2009

Updated on 27 November 2008 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 4.7 - 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 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

Sections 4.3, 4.4, 4.6, 4.8, 4.9 updated in line with company core safety information
Sections 2, 4.5, 4.7, 5.1 & 6.6 updated in line with current guidelines

Updated on 12 July 2007 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change of manufacturer
  • Change to appearance of the medicine

Updated on 12 July 2007 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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

Change to Section 3- Pharmaceutical Form - tablet description changed
Change to Section 6.1 - List of excipients - New ingredient - 'all-rac-a-tocopherol'  Removed 'povidone' and  'gelatin'
Change to Section 6.4 - Changed to None
Change to Section 6.5 - Changed from strip blister to alu\blister
Change to Section 6.6 - Heading changed

Updated on 20 July 2006 SmPC

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 - date changed (Part 1 of PA revised)

Updated on 5 September 2005 PIL

Reasons for updating

  • Change to further information section

Updated on 9 August 2005 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
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder

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

Updated on 30 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 August 2003 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Updated on 26 June 2003 SmPC

Reasons for updating

  • Addition of legal category

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

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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