Mycobutin Capsules
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 October 2024
File name
Reg SPC MY 13_0 IE - clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 October 2024
File name
Reg PIL MY 12_0 150mg IE - clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 23 July 2024
File name
Reg PIL MY 11_1 150mg IE - clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 23 July 2024
File name
Reg SPC MY 12_2 IE - clean.pdf
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 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC has been updated as follows:
Section ‘4.2 Posology and method of administration’ has been updated with minor editorial
changes.
Section ‘4.3 Contraindications’ has been updated to add additional statement on the concomitant
use with rilpivirine.
Section ‘4.4 Special warnings and precautions’ has been updated to include a statement on anti-
hepatitis C virus medicines.
Section ‘4.5 Interaction with other medicinal products and other forms of interaction’, Table 1 has
been updated.
Section ‘4.8 Undesirable effect’ has been updated to add the HPRA website details.
Section ‘6.1 List of excipients’ has been updated with the correct spelling for Sulfate.
Updated on 14 February 2023
File name
DEC202111522_Reg SPC MY 11_1 IE_clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 February 2021
File name
DEC202111522_Reg SPC MY 11_1 IE_clean.pdf
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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 February 2021
File name
DEC202111522_Reg PIL MY 10_1 150mg IE_clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 19 February 2021
File name
DEC202110915_Reg PIL MY 9_1 150mg IE_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 17 February 2021
File name
DEC202110915_Adv SPC MY 10_2 IE_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 February 2021
File name
DEC202110915_Reg PIL MY 9_1 150mg IE_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
Updated on 23 February 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 February 2015
Reasons for updating
- 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
The SPC has been updated as follows.
Section 4.5 has been revised to recommend a reduction in indinavir dose when rifabutin and indinavir are co-administered.
Section 4.8 has been revised to remove shock and add anaphylactic shock as an adverse drug reaction as seen with other antibiotics of the same class.
QRD v9 changes made throughout the SPC.
Section 10 date of revision of textUpdated on 19 February 2015
File name
PIL_11656_911.pdf
Reasons for updating
- New PIL for new product
Updated on 19 February 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 08 July 2013
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 07 December 2011
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 07 December 2011
Reasons for updating
- Change to side-effects
- Change to drug interactions
Updated on 28 July 2011
Reasons for updating
- 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
Updated on 12 July 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7 and 8 updated with new details
Updated on 11 July 2011
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 03 May 2011
Reasons for updating
- 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 9 and 10 has been updated
Updated on 18 October 2010
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 10 September 2008
Reasons for updating
- Change to warnings or special precautions for use
Updated on 09 September 2008
Reasons for updating
- 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
Text edited to align with the company Core Data: Clostridium difficile associated diarrhoea.
Updated on 12 May 2008
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
- 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
The sections that have changed are as follows:
Section 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3,
These sections have been amended to bring the SPC in line with the core data sheet.
Section 10 has been updated to the last date of approval.
Updated on 02 January 2007
Reasons for updating
- Change to MA holder contact details
Updated on 21 December 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 15 November 2006
Reasons for updating
- 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
Updated on 05 September 2006
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363