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Fucidin Suspension *

  • Company:

    LEO Pharma

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Fusidic Acid Hemihydrate

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

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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 15 November 2019

File name

ie-pl-fuci susp-20170714-CCSI_1573811308.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 14 July 2017

File name

PIL_8578_885.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 July 2017

Reasons for updating

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

Updated on 11 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 11 July 2017

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

Minor QRD typographical amendments throughout document.

Also

Section 4.4 Special warnings and precautions for use

Additional text added

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.

Further additional text

This medicinal product contains 1.6 mg sodium per ml suspension. To be taken into consideration by patients on a controlled sodium diet.

Section 4.8 Undesirable effects

Additional text added

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) syndromef)


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

Section 10 Date of revision of text.

Updated on 16 January 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company

In sections 2, 6.1 and 9 - amendment of typographical inconsistencies and order of excipients.

Updated on 23 September 2014

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 CCSI and QRD template

Updated on 16 September 2014

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 01 September 2014

Reasons for updating

  • Change to side-effects

Updated on 13 January 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.8 Undesirable effects

 

Nervous system disorders

 

Uncommon (≥1/1,000 and <1/100):

Headache



Musculoskeletal, connective tissue and bone disorders

 

 

Frequency not known:

Rhabdomyolysis (examples of signs and symptoms are: muscle weakness, swelling and pain, dark urine, myoglobinuria, elevated serum creatine kinase, acute renal failure, cardiac arrhythmia), see section 4.5. Rhabdomyolysis may be fatal.


Reporting of suspected adverse reactions

 

Healthcare professionals are asked to report any suspected adverse reactions preferably through the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’, in addition to the traditional post-paid ‘yellow card’ option.

 

FREEPOST

 

Pharmacovigilance Section

 

Irish Medicines Board

 

Kevin O’Malley House

 

Earlsfort Centre

 

Earlsfort Terrace

 

Dublin 2

 

Tel: +353 1 6764971

 

Fax: +353 1 6762517

Website: www.imb.ie

 

e-mail: imbpharmacovigilance@imb.ie      

 


Updated on 13 January 2014

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 21 March 2012

Reasons for updating

  • Change to name of manufacturer

Updated on 24 August 2011

Reasons for updating

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

Updated on 17 August 2011

Reasons for updating

  • 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 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology and Method of Administration

Adults:

The dose is now expressed in millilitres in addition to milligrams.

There is more detail with regard to taking the dose in divided doses; it must now be taken in 'three equally divided doses'.

Children:

The dose is now expressed in millilitres in addition to milligrams.

There is more detail with regard to taking the dose in divided doses; it must now be taken in 'three equally divided doses'.

Section 4.4 Special warnings and precautions for use

The product is now referenced as 'Fucidin suspension' in this section, it was previously described as 'Fucidin administered systemically'.

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

Section 4.6 Fertility, Pregnancy and Lactation

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

Section 4.7 Effects on ability to drive and use machines

This heading has been renamed from the previous heading of 'Effects on ability to drive and use machinery'

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'.

The following wording has now been included: 'Based on clinical data, undesirable effects occurred in approximately 15% of patients receiving Fucidin orally', this replaces ''Based on clinical data, undesirable effects occurred in approximately 5% of children receiving Fucidin orally.'

'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'.

The following wording in bold in this statement has changed:

'Haematological disorders affecting the white cell line (neutropenia, granulocytopenia,agranulocytosis) and more rarely disorders affecting the other two cell lines have been reported, either as isolated events or associated. This has been observed especially in cases of treatment with duration of more than 15 days and is reversible upon drug withdrawal'.

The word 'associated' replaces the word 'together'.

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 22 July 2011

Reasons for updating

  • Change to storage instructions

Updated on 18 July 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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



Section 2 Qualitative and Quantitative Composition

The following sentence regarding excipients has been added to the section: 'Excipients: Contains Glucise liquid 250 mg/ml, Sorbitol (E420) 100 mg/ml, Sodium 2 mg/ml and orange dry flavour (containing sucrose)

Section 6.3 Shelf life

The following wording has been added to the section and an inuse shelf life has been added to this product:

Unopened: 3 years

After first opening: 1 month

Section 6.4 Special precautions for storage

The storage conditions have been changed for this product from 'Do not store above 25C' to:

'This medicinal product does not require any special storage conditions.'

Section 9 Date of first authorisation/renewal of authorisation

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

Updated on 15 July 2009

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.3 - Contraindications
  • 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

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 14 July 2009

Reasons for updating

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

Updated on 15 October 2007

Reasons for updating

  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.2 - Incompatibilities
  • 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

Section 4.3- deleted biliary tract obstruction
 
Section 4.4- mention of theoretical risk of kernicterus, binding to bilirubin
 
Section 4.6- mention of latation. Deletion of risk of kernicterus
 
Sectio 4.7- reworded in line with guidelines
 
Section 4.8- additional detail, including incidence rates, completely reworded
 
Section 4.9- symptoms inserted
 
Section 6.2- reworded
 
Section 6.6- reworded in line with guidelines
 
Section 10-  date revised to July 2007

Updated on 30 August 2007

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability
  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to drug interactions

Updated on 20 July 2006

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 07 September 2005

Reasons for updating

  • Change to date of revision

Updated on 09 August 2005

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.1 - List of excipients
  • 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 14 February 2005

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 20 December 2004

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)

Updated on 29 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 August 2003

Reasons for updating

  • 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

  • Addition of legal category

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)