Reasons for adding or updating:

• Change to section 6.5 - Nature and contents of container
• Change to section 10 - Date of revision of the text

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:



The key changes are:

 

Section 6.5  has been amended to reflect the new ODT standard blister packaging presentation.

Reasons for adding or 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 10 - Date of revision of the text

Date of revision of text on the SPC: 01-Dec-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

 Section 4.3 àThe following statement has been added

<…>

The co-administration of PDE5 inhibitors, including vardenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).

Section 4.5 àThe following statement has been added under “Effect of vardenafil on other medicinal products”

<…>

Riociguat

Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.

There was no evidence of favourable clinical effect of the combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including vardenafil, is contraindicated (see section 4.3).

Reasons for adding or updating:

• Change to section 4.8 - Undesirable effects
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 5.2 - Pharmacokinetic properties
• Change to section 9 - Date of first authorisation/renewal of the authorisation

Date of revision of text on the SPC: 09-Apr-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

 

·        Changes to the list of local representatives;

·        Name change of the FR local representative in the PIL ;

·        Adoption of the latest QRD template v9.0;

·        To add text on reporting of suspected adverse reactions.  These changes affects section 4.8, 5.1 and 5.2 of the SmPC and section 2, 4 and 6 of the leaflet.

 

 

Reasons for adding or updating:

• Change to section 4.8 - Undesirable effects
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 21-Jan-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

·        Addition of  haematuria, haematospermia and penile haematoma in section 4.8 (Undesirable effects) of the SmPC.

·        Date of revision of the text updated, section 10 of the SmPC. 

Reasons for adding or 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

Date of revision of text on the SPC: 19-Mar-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

·        To update the information given in section 4.2. (Posology and method of administration) of the SmPC and section 3. (How to take Levitra orodispersible tablets) of the PIL to harmonize this information for both Levitra film-coated and orodispersible tablets.

·        In addition, minor editorial corrections were made to the SmPC (section 4.5) and PIL (Section 2).

Reasons for adding or 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 10 date of revision of the text

Date of revision of text on the SPC: 21-Feb-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes to the SmPC are:

·        To update the information given in section 4.4. (Special warnings and precautions for use) and section 4.5. (Interaction with other medicinal products and other forms of interaction), to add information on the concomitant use with alfuzosin.

Reasons for adding or updating:

• Change to section 7 - Marketing Authorisation Holder
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Jul-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 (MAH) this is now Bayer Pharma AG (previously Bayer Schering Pharma AG)
Section 10 - Revision date is now 1 July 2011

Reasons for adding or updating:

• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 20-Apr-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes to the SmPC are:

Section 10 (Date of revision of the text) has been corrected to 20^th April 2011.

Reasons for adding or updating:

• Change to section 6. 3 - Shelf Life
• Change to section 6. 5 - Nature and Contents of Container
• Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 24-Mar-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.3 (Shelf life) - amended to reflect change in shelf life from 30 months to 3 years

Section 6.5 (Nature & Contents of container) - addition of Alu/Alu blister 8 tablet pack size + addition of Alu/Alu blister in blister holder, 1, 2, 4 or 8 tablet pack sizes.

Section 8 (Marketing Authorisation number(s)) - Addition of new MA numbers for additional pack sizes

Section 10 - Date of revision of text - amended to 24/03/11(ED decision date)

Reasons for adding or updating:

• New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO