Reasons for adding or updating:

• Change to section 2 - Qualitative and quantitative composition
• Change to section 4.2 - Posology and method of administration
• Change to section 4.3 - Contraindications
• Change to section 4.6 - Fertility, pregnancy and lactation
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 6.2 - Incompatibilities
• Change to section 6.5 - Nature and contents of container
• Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC: 01-Jan-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows:

Section 2, 4.2, 4.3, 4.6, 4.8, 5.1, 6.2 and 6.5.

Reasons for adding or updating:

• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.8 - Undesirable effects - how to report a side effect
• Change to section 6.5 - Nature and contents of container
• Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC: 01-Jul-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updates to Section 4.4, remove reference to latex; Sections 6.5 and 6.6 to update the nature and contents ofthe packs and the handling instructions.

Update to Section 4.8 to update the national reporting information for adverse events from IMB to HPRA.  See  also UK IE TI 020 for additional changes submitted in parallel. 

 

Reasons for adding or updating:

• New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:POM

Black Triangle (CHM): NO