Sporanox 100mg Capsules
*Company:
Janssen Sciences IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 24 October 2023
File name
PI-Sporanox-capsules-Ireland-English-WS 209-CCDS v17 + v18-RFI.pdf
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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update is inline with addition of drug interaction with voclosporin
Updated on 24 October 2023
File name
PIL-Sporanox-capsules-Ireland-English-WS 209-CCDS v17 + v18.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Free text change information supplied by the pharmaceutical company
Change is inline with addition of drug interaction with voclosporin
Updated on 09 March 2023
File name
PI-Sporanox-capsules-Ireland-English-WS 189-CCDSv17 - clean.pdf
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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 March 2023
File name
PI-Sporanox-capsules-Ireland-English-WS 189-CCDSv17.pdf
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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 March 2023
File name
PIL-Sporanox-capsules-Ireland-English-WS 189-CCDSv17 - Cl.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 24 January 2023
File name
PIL-Sporanox-capsules-Ireland-English-WS 178-CCDSv15-16.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 24 January 2023
File name
PI-Sporanox-capsules-Ireland-English-WS 178-CCDSv15-16.pdf
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 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 November 2020
File name
Ire Sporanox caps PIL C20 04Nov20 clean EDMS-ERI-155211326_7.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Free text change information supplied by the pharmaceutical company
Updated PIL inline with CCDS and removed duplicate infomration.
Updated on 09 November 2020
File name
Ire Sporanox caps SmPC C17 04Nov20 clean EDMS-ERI-155211328_9.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated SmPC in line with current CCDS and remove duplicate information.
Updated on 02 September 2020
File name
Ire Sporanox caps PIL C19 21May20 clean EDMS-ERI-155211326_5.0.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
CCDS Revisions to SmPC and Corresponding Revisions to PIL
Updated on 02 September 2020
File name
Ire Sporanox caps SmPC C16 21May20 clean EDMS-ERI-155211328_5.0.pdf
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 4.9 - Overdose
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
CCDS Revisions to SPC and Corresponding Revisions to PIL
Updated on 02 September 2020
File name
IE-Sporanox Caps-PIL-C18-29mar19-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
CCDS Revisions mainly to SmPC Sections 4.5, 4.6, 4.9 & 5.3 and Corresponding Revisions to PIL
Updated on 12 April 2019
File name
IE-Sporanox Caps-PIL-C18-29mar19-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 12 April 2019
File name
IE-Sporanox Caps-SPC-C15-29mar19-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 July 2018
File name
Sporanox Caps SPC-C14-13jul18-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
4.2 Posology and Method of Administration
Sporanox is for oral administration and must be taken immediately after a meal for maximal absorption. The capsules must be swallowed whole.
Treatment schedules in adults for each indication are as follows:
Short-Term Usage
|
Indication |
Dose |
|
Vulvovaginal candidosis |
200 mg twice daily for 1 day or 200 mg once daily for 3 days. |
|
Pityriasis versicolor |
200 mg once daily for 7 days |
|
Tinea corporis, tinea cruris |
100 mg once daily for 2 weeks or 200 mg once daily for 7 days |
|
Tinea pedis, tinea manuum |
100 mg once daily for 4 weeks |
|
Oral candidosis |
100 mg once daily for 2 weeks |
|
Fungal keratitis |
200 mg once daily for 3 weeks |
Treatment should not exceed 4 weeks.
Long Term Usage
....
Paediatric population(below 12 years):
Clinical data on the use of Sporanox Capsules in paediatric patients are limited. The use of Sporanox Capsules in paediatric patients is not recommended unless it is determined that the potential benefit outweighs the potential risks. (See Section 4.4)The safety and efficacy of Sporanox in children and adolescents aged under 18 years has not been established. Currently available data are described in sections 4.8 and 5.2 but no recommendation on a posology can be made.
4.4 Special warnings and precautions for use
Paediatrics population
Clinical data on the use of Sporanox Capsules in paediatric patients are limited. The use of Sporanox Capsules in paediatric patients is not recommended unless it is determined that the potential benefit outweighs the potential risks.Safety and effectiveness of Sporanox in paediatric patients below the age of 18 years has not been established (see sections 4.8 and 5.2).
Updated on 16 July 2018
File name
Sporanox PIL C17-13jul18-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 6 - date of revision
Updated on 05 June 2015
File name
PIL_8597_261.pdf
Reasons for updating
- New PIL for new product
Updated on 05 June 2015
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 29 April 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 April 2015
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 28 April 2015
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 28 November 2014
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.5: Interactions added to table; sufentanil, apixaban, bilastine, sunitinib, simeprevir, riociguat
4.8: Tremor added to 'Nervous system disorders'
5.1: MIC breakpoint information added for Aspergillus terreus in Breakpoints table.
Candida dubliniensis added to Commonly susceptible species table and Candida tropicalise replaced with Candida guillermondi
5.3: Sentence added; Itraconazole has been shown to cross the placenta in a rat model.
10: 27 November 2014
Updated on 27 November 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 06 August 2014
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 6.5 - Nature and contents of container
- Change to section 8 - MA number
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
3: 'Capsules' changed to 'capsule'
4.2 Additional information on use in paediatrics, the elderly and patients with renal impairment
4.3 Additional information regarding co-administration with CYP3A4 substrates
4.4 Additional information on use in paediatrics, the elderly, patients with hepatic impairment, reduced gastric acidity and renal impairment. 'Interchangeability' section added and complete rewording of 'interaction potential' section.
4.5 Section entirely rewritten
4.6 Fertility information added
4.8 Section entirely rewritten
4.9 'Symptoms and signs' section added
5.1 Section entirely rewritten
5.2 Section entirely rewritten
6.1 'Sugar spheres (contains...)' changed to 'Sugar spheres (consisting of...)'
6.5 minor editorial change
8 Changed from PA 748/9/2 to PA 0748/009/002
9 'Date of first authorisation' and 'date of last renewal' added
10 25 July 2014
Updated on 30 July 2014
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 12 April 2011
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to section 10 - April 2011
Updated on 08 April 2011
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 23 March 2011
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 4.7 - 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
Change to section 4.3 - Contraindications |
Addition of Atorvastatin and Eletriptan
Women of childbearing potential taking Sporanox should use contraceptive precautions. Effective contraception should be continued until the menstrual period following the end of Sporanox therapy. |
|
Change to section 4.4 - Special warnings and precautions for use |
Use in elderly Clinical data on the use of Sporanox capsules in elderly patients is limited. Sporanox capsules should not be used in these patients unless the potential benefit outweighs the potential risks. Cross-resistance In systemic candidosis, if fluconazole-resistant strains of Candida species are suspected, it cannot be assumed that these are sensitive to itraconazole, hence their sensitivity should be tested before the start of itraconazole therapy.
Interaction potential Sporanox has a potential for clinically important drug interactions. (See section 4.5). Itraconazole should not be used within 2 weeks after discontinuation of treatment with CYP 3A4 inducing agents (rifampicin, rifabutin, phenobarbital, phenytoin, carbamazepine, Hypericum perforatum (St. John´s wort). The use of itraconazole with these drugs may lead to subtherapeutic plasma levels of itraconazole and thus treatment failure.
|
|
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction |
Hypericum perforatum (St John’s Wort), |
|
Change to section 4.7 - Effects on ability to drive and use machines |
No studies on the effects on the ability to drive and use machines have been performed. When driving vehicles and operating machinery the possibility of adverse reactions such as dizziness, visual disturbances and hearing loss (see Section 4.8), which may occur in some instances, must be taken into account. |
|
Change to section 4.8 - Undesirable effects |
*see section 4.4
|
|
Change to section 10 - Date of revision of the text |
March 2011 |
Updated on 22 March 2011
Reasons for updating
- Change to drug interactions
- Change to information about driving or using machinery
- Change to date of revision
Updated on 29 June 2010
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
|
Change to section 4.8 - Undesirable effects |
Updated into MedRA format. |
|
Change to section 10 - Date of revision of the text |
June 2010 |
Updated on 24 June 2010
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 20 April 2010
Reasons for updating
- Change to date of revision
- Improved electronic presentation
Updated on 07 November 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 06 November 2008
Reasons for updating
- Change to marketing authorisation holder address
Updated on 12 September 2008
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes to seciont 4.2, 4.4,4.8,5.1,5.2,10
Updated on 10 September 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 01 September 2008
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
Change to section 2 – quantitative and qualitative composition |
Addition of excipient warning |
|
Change to section 4.4 – Special Warnings and Precautions for Use |
Addition of excipient warning |
|
Change to section 4.5 –Interaction with other medicinal products and other forms of interaction |
Addition of fluticasone |
|
Change to section 10 – Date of revision of text |
August 2008 |
Updated on 01 September 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to date of revision
Updated on 16 July 2007
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 12 July 2007
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 4.8 - Undesirable effects
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
Change to section 2 – quantitative and qualitative composition |
Inclusion of sucrose 192 mg |
|
Change to section 4.3 – Contra-indications |
Addition of bepridil, nisoldipine and patients with CHF or history of CHF |
|
Change to section 4.4 – Special Warnings and Precautions for Use |
More info about CHF |
|
Change to section 4.5 –Interaction with other medicinal products and other forms of interaction |
Addition of bepridil, nisoldipine,fentanyl and method of digoxin interaction |
|
Change to section 4.8 – Undesirable effects |
Post marketing data updated |
|
Change to section 6.1 – List of Excipients |
Info that sugar spheres contain sucrose and maize starch |
|
Change to section 6.4 – Special Precautions for Storage |
|
|
Change to section 6.5 – Nature and Contents of Container |
Not all packs marketed |
Updated on 06 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 10 August 2004
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 August 2004
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 April 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 5.3 - Preclinical safety data
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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 be renewed (B)
Updated on 05 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)