Fucidin Suspension
- Name:
Fucidin Suspension
- Company:
LEO Pharma
- Active Ingredients:
- 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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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
LEO Pharma
Company Products
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
- Improved presentation of PIL
- Change to section 4 - possible side effects
Updated on 14 July 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 11 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 11 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
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 SmPC
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
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
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 1 September 2014 PIL
Reasons for updating
- Change to side-effects
Updated on 13 January 2014 SmPC
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 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 21 March 2012 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 24 August 2011 PIL
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 SmPC
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 2011Updated on 22 July 2011 PIL
Reasons for updating
- Change to storage instructions
Updated on 18 July 2011 SmPC
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 SmPC
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 4.4 - 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 PIL
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 SmPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - 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
Updated on 30 August 2007 PIL
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 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
Updated on 7 September 2005 PIL
Reasons for updating
- Change to date of revision
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 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 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 20 December 2004 SmPC
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 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 26 August 2003 SmPC
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 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)