Last Updated on eMC 17-03-2017 View medicine  | Bayer plc Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:17-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The key changes are:
Error in table format.

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:01-12-2015

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

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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 underEffect of vardenafil on other medicinal products”

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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:09-04-2014

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:21-01-2013

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 4.4 - 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:21-02-2012

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:01-07-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 - MAH has been updated to 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 4.1 - Therapeutic indications
  • 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. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC:20-04-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Qualitative and quantitative composition - deletion of reference to 'trihydrate' in relation to description of the active substance.

4.1 Therapeutic indications - deletion of info.: 'Levitra is not indicated for use by women.'

- deletion of info.: 'Levitra is not indicated for use by women.'

4.2 Posology and method of administration - Section 4.2 now sub-divided more clearly, including addition of the new headings, "Posology", "Special populations", "Paediatric population" and "Method of administration", and, deletion/modification of some existing sub-headings (e.g., "Use in elderly men"....). Editorial amendment to info. describing use in the elderly population. The order of some sub-sections has been rearranged and various other minor editorial corrections have been made.

Section 4.2 now sub-divided more clearly, including addition of the new headings, "Posology", "Special populations", "Paediatric population" and "Method of administration", and, deletion/modification of some existing sub-headings (e.g., "Use in elderly men"....). Editorial amendment to info. describing use in the elderly population. The order of some sub-sections has been rearranged and various other minor editorial corrections have been made.

4.3 Contraindications - Inclusion of full nomenclature (viz., 'phosphodiesterase') for 'PDE5' and replacement of 'Agents' by 'Medicinal products'.

Inclusion of full nomenclature (viz., 'phosphodiesterase') for 'PDE5' and replacement of 'Agents' by 'Medicinal products'.

4.4 Special warnings and precautions for use - editorial replacement of 'Agents' by 'Medicinal products'. Addition of new informative sub-section headings throughout. Re-ordering of 'tolerability max dose in elderly patients' statement. Replacement of existing statement regarding, 'Safety and efficacy of combinations of vardenafil and other treatments....is not recommended.", with amended statement, 'Safety and efficacy of combinations of Levitra...... and other treatments....is not recommended." Clarification of lowest starting dose of 5 mg by addition of, 'film-coated tablets', for 'concomitant use of alpha-blockers' text. Amendment to statement on influence of, '....grapefruit juice...', to, '....grapefruit or grapefruit juice....' on plasma concentrations of vardenafil. Amendment of, 'drug', to, 'active substance', within context of gatifloxacin and QTc interval text. Additional minor editorial changes.

editorial replacement of 'Agents' by 'Medicinal products'. Addition of new informative sub-section headings throughout. Re-ordering of 'tolerability max dose in elderly patients' statement. Replacement of existing statement regarding, 'Safety and efficacy of combinations of vardenafil and other treatments....is not recommended.", with amended statement, 'Safety and efficacy of combinations of Levitra...... and other treatments....is not recommended." Clarification of lowest starting dose of 5 mg by addition of, 'film-coated tablets', for 'concomitant use of alpha-blockers' text. Amendment to statement on influence of, '....grapefruit juice...', to, '....grapefruit or grapefruit juice....' on plasma concentrations of vardenafil. Amendment of, 'drug', to, 'active substance', within context of gatifloxacin and QTc interval text. Additional minor editorial changes.

4.5 Interaction with other medicinal products and other forms of interaction - clarification that the 10 mg dose described in the context of co-administration of indinavir refers to 'film-coated tablets'. Replacement of, 'Levitra', by, 'vardenafil' within the 'co-administration of ritonavir' text. Clarification that vardenafil doses described in bulleted 'benign prostatic hyperplasia....terazosin therapy' text refer to 'film-coated tablets'. Identical clarification provided within context of 'co-administration of warfarin/digoxin/alcohol' statements. Additional minor editorial changes.

clarification that the 10 mg dose described in the context of co-administration of indinavir refers to 'film-coated tablets'. Replacement of, 'Levitra', by, 'vardenafil' within the 'co-administration of ritonavir' text. Clarification that vardenafil doses described in bulleted 'benign prostatic hyperplasia....terazosin therapy' text refer to 'film-coated tablets'. Identical clarification provided within context of 'co-administration of warfarin/digoxin/alcohol' statements. Additional minor editorial changes.

4.6 Pregnancy and lactation - correction of section title to, "Fertility, pregnancy and lactation". Inclusion of new statement, '

- correction of section title to, "Fertility, pregnancy and lactation". Inclusion of new statement, '

 

There are no fertility data available.'

 

4.7 Effects on ability to drive and use machines - amendment of, 'machinery, to, 'machines'.

- amendment of, 'machinery, to, 'machines'.

4.8 Undesirable effects - Substantial update of existing film-coated tablets information in line with equivalent approved section 4.8 for 10 mg ODT formulation (content and editorial changes have been made).

- Substantial update of existing film-coated tablets information in line with equivalent approved section 4.8 for 10 mg ODT formulation (content and editorial changes have been made).

4.9 Overdose - Confirmation provided that 80 mg and 40 mg doses refer to 'film-coated tablets'.

- Confirmation provided that 80 mg and 40 mg doses refer to 'film-coated tablets'.

5.1 Pharmacodynamic properties - Replacement of 'Medicinal products....' with 'Urologicals, drugs...' in 'Pharmacotherapeutic group' section. Addition of new section for 10 mg ODT, "Further information on clinical trials with Levitra 10 mg orodispersible tablets" comprising four paragraphs of additional text. Correction of three data elements within existing section, "Further information on clinical trials", as follows: "...3750 men...", "...1630 patients...", and, "...over 730 patients...", respectively corrected to, "...17000 men...", "...2500 patients...", and, "...900 patients...". Correction of, 'Levitra', to 'vardenafil'. Clarification that the vardenafil referred to in 'pivotal trials'- and 'fixed dose studies' texts was in the form of 'film-coated tablets'. Multiple minor editorial corrections.

Replacement of 'Medicinal products....' with 'Urologicals, drugs...' in 'Pharmacotherapeutic group' section. Addition of new section for 10 mg ODT, "Further information on clinical trials with Levitra 10 mg orodispersible tablets" comprising four paragraphs of additional text. Correction of three data elements within existing section, "Further information on clinical trials", as follows: "...3750 men...", "...1630 patients...", and, "...over 730 patients...", respectively corrected to, "...17000 men...", "...2500 patients...", and, "...900 patients...". Correction of, 'Levitra', to 'vardenafil'. Clarification that the vardenafil referred to in 'pivotal trials'- and 'fixed dose studies' texts was in the form of 'film-coated tablets'. Multiple minor editorial corrections.

5.2 Pharmacokinetic properties - Addition of new paragraph one, describing the non-bioequivalence between 10 mg ODT and FCT formulations. Clarification that the vardenafil described in the existing two paragraphs of the 'Absorption' sub-section refers to 'Levitra film-coated tablets'. Addition of two new paragraphs of 'Absorption' info/data for the 10 mg ODT formulation. Amendment of the sub-section heading, 'Metabolism', to, 'Biotransformation', and clarification that the vardenafil described in the existing paragraphs of this sub-section refers to 'Levitra film-coated tablets'. Addition of data for mean terminal- and elimination half-life data for the 10 mg ODT formulation. Replacement of 'insufficiency' by 'impairment' in sub-section headings in 'Pharmacokinetics in special patient groups' section. Clarification that the vardenafil described in the 'elderly - hepatic clearance' text refers to 'Levitra film-coated tablets'. Addition of new paragraph describing AUC/Cmax data for elderly patients for new 10 mg ODT formulation. Editorial/typographical corrections throughout.

- Addition of new paragraph one, describing the non-bioequivalence between 10 mg ODT and FCT formulations. Clarification that the vardenafil described in the existing two paragraphs of the 'Absorption' sub-section refers to 'Levitra film-coated tablets'. Addition of two new paragraphs of 'Absorption' info/data for the 10 mg ODT formulation. Amendment of the sub-section heading, 'Metabolism', to, 'Biotransformation', and clarification that the vardenafil described in the existing paragraphs of this sub-section refers to 'Levitra film-coated tablets'. Addition of data for mean terminal- and elimination half-life data for the 10 mg ODT formulation. Replacement of 'insufficiency' by 'impairment' in sub-section headings in 'Pharmacokinetics in special patient groups' section. Clarification that the vardenafil described in the 'elderly - hepatic clearance' text refers to 'Levitra film-coated tablets'. Addition of new paragraph describing AUC/Cmax data for elderly patients for new 10 mg ODT formulation. Editorial/typographical corrections throughout.

6.1 List of excipients - minor editorial corrections - capitalization.

minor editorial corrections - capitalization.

6.5 Nature and contents of container - addition of 20 tablet pack size in current approved packaging.

- addition of 20 tablet pack size in current approved packaging.

8 Marketing Authorisation number(s) - addition of new MA no.s for additional pack sizes.

- addition of new MA no.s for additional pack sizes.

10 Date of revision of the text - editorial correction to text and amended date added = 20/04/11

- editorial correction to text and amended date added = 20/04/11

 

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:22-06-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Following submission to register the merger of Bayer HealthCare AG, Leverkusen into Bayer Schering Pharma AG, Berlin, the European Commission approved the following changes to the Levitra (5, 10 and 20mg) licences on the 22nd June 2009:

  • Transfer of the Marketing Authorisation Holder from "Bayer AG, Leverkusen", to "Bayer Schering Pharma AG, Berlin"
  • Change in manufacturer name from "Bayer HealthCare AG, Leverkusen" to "Bayer Schering Pharma AG, Leverkusen".

Reasons for adding or 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 10 date of revision of the text

Date of revision of text on the SPC:04-03-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 The key changes are:

  • Section 4.2 (Posology and method of administration) - Rewording of "Use in elderly men" to remove dose adjustment statements and to add that any increases to 20mg dose in this population should still be carefully considered;
  • Section 4.4 (Special warnings and precautions for use) - Addition of wording highlighting potential for lower tolerability of the 20mg dose in the elderly;
  • Section 4.8 (Undesirable effects) - Reporting of an observed higher frequency of certain side effects in the elderly vs. younger patients with 20mg dose;
  • Section 10 (Date of revision of the text) – has been updated to 4th March 2009. 

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • 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

Date of revision of text on the SPC:28-07-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Sections 4.2, 4.4 and 4.5 have been updated to include details of interaction between vardenafil and clarithromycin.
Sections 4.2 and 5.1 have been updated to document possible effects of vardenafil on QT interval in monotherapy/combination with other drugs known to prolong QT interval. 

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:17-03-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8: 

Sudden deafness" has been included in section 4.8 of the SPC with a frequency "not known". A footnote, stating that sudden decrease or loss of hearing has been reported in a small number of post-marketing and clinical trials cases with the use of PDE5 inhibitors, has also been included in section 4.8.

Section 10: Revision date is now 17 March 2008.

Reasons for adding or updating:

  • Change to section 10 date of revision of the text
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:01-11-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8: Transient Global amnesia and seizures have been added under the frequency "rare" section of undesirable effects.
Section 10: Revision date has been amended to 21 November 2007 

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC:01-11-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.5 (Interaction with other medicinal products and other forms of interaction) has been to include the following statement: 'Nicorandil is a hybrid of potassium channel opener and nitrate. Due to the nitrate component it has the potential to have serious interaction with vardenafil.'
 
Section 10 (Date of revision) has been updated to 24th November 2006. 

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC:01-07-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 (Special warnings and special precautions for use) has been updated to delete the following information: Vardenafil has not been studied in patients with spinal cord injury or other CNS disease, hypoactive sexual desire and in patients who have undergone pelvic surgery (except nerve-sparing prostatectomy), pelvic trauma or radiotherapy.

Section 5.1 (Pharmacodynamic properties) has been updated to include the results of the RESPITE study - efficacy in men with ED secondary to Spinal cord injury.   
 
Section 10 (Date of revision of the text) has been updated to '28 July 2006'. 

Reasons for adding or updating:

  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC:01-06-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.3 (Contraindications) of the SPC has been updated to contraindicate LEVITRA in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure. 

 

Section 4.4 (Special warnings and special precautions for use) of the SPC was also updated to include the following information: Visual defects and cases of non-arteritic ischaemic optic neuropathy (NAION) have been reported in connection with the intake of LEVITRA and other PDE5 inhibitors. The patient should be advised that in case of sudden visual defect, he should stop taking LEVITRA and consult a physician immediately. 

 

Section 4.8 (Undesirable effects) of the SPC has also been updated to comply with the latest SmPC guideline in terms of format: All post marketing events reported for Levitra are listed in the table under the frequency heading 'not known'. Text relating to a clinical trial looking at impairment of colour vision have been removed.

 

Section 10 (Date of revision of the text) of the SPC has been updated to ’12 June 2006’. 

Reasons for adding or updating:

  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
  • Removal of Black Triangle

Date of revision of text on the SPC:05-05-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 (Special warnings and special precautions for use) - revision of statement for alpha-blockers to allow all doses of vardenafil to be used concomitantly with any alpha-blockers (with certain precautions e.g. stable alpha-blocker therapy, start with 5 mg vardenafil).

Section 4.5 revision to include information from 4 clinical pharmacology interaction studies with alpha-blockers. 
Removal of Black triangle (as advised by MHRA). 
 
 

Reasons for adding or 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 (partial) revision of the text

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

  • Addition of Black Triangle

Reasons for adding or updating:

  • New SPC for new product