Spedra 50 mg, 100 mg and 200 mg tablets
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
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 10 November 2022
File name
ie-uk leaflet combined Article 61-3 Local Rep clean - Nov 21.pdf
Reasons for updating
- Individual PILs superseded by joint PIL
Free text change information supplied by the pharmaceutical company
Joint NI and IE PIL created due to Brexit
Updated on 16 November 2021
File name
ie-uk leaflet combined Article 61-3 Local Rep clean - Nov 21.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Local rep details for United Kingdom (Northern Ireland) updated. Date of revision updated.
Updated on 12 November 2020
File name
ie-leaflet combined new blister clean 27-10-20.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
SEction 6 - Update to list of local represenatative of the Marketing Authorisation Holder.
Updated on 12 November 2020
File name
ie-smpc blister 27-10-20 clean.pdf
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to section 6.5 Nature and contents of container to add a new blister material. Also, an update to section 8 Marketing Authorisation Numbers
Updated on 01 August 2019
File name
UK-IE leaflet combined 23-4-18 approved clean.pdf
Reasons for updating
- XPIL Created
Updated on 01 August 2019
File name
Spedra_IE_SmPC_23-4-18_approved_clean.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
File format updated to pdf
Updated on 18 May 2018
File name
UK-IE leaflet combined 23-4-18 approved clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Removal of Black Inverted Triangle
Updated on 17 May 2018
File name
Spedra_IE_SmPC_23-4-18_approved_clean.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 February 2018
File name
PIL_16019_283.pdf
Reasons for updating
- New PIL for new product
Updated on 01 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 February 2018
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
Updated on 01 February 2018
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 06 April 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 31 March 2016
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
- Section 4.5 Interactions revised wording under "transporters" to add - Based on in vitro data, at clinically relevant concentrations avanafil could be an inhibitor of BCRP. At clinically relevant concentrations avanafil is not an inhibitor of OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3 and BSEP. CYP3A4 inhibitors and CYP3A4 inducers - amended spelling of name of three substances
- revised wording under "transporters" to add - Based on in vitro data, at clinically relevant concentrations avanafil could be an inhibitor of BCRP. At clinically relevant concentrations avanafil is not an inhibitor of OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3 and BSEP.
- CYP3A4 inhibitors and CYP3A4 inducers - amended spelling of name of three substances
- 6.3 Shelf life Shelf life extended from 48 to 60 months.
- Shelf life extended from 48 to 60 months.
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The changes are as follows:
SmPC
- Section 4.5 Interactions
- revised wording under "transporters" to add - Based on in vitro data, at clinically relevant concentrations avanafil could be an inhibitor of BCRP. At clinically relevant concentrations avanafil is not an inhibitor of OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3 and BSEP.
- CYP3A4 inhibitors and CYP3A4 inducers - amended spelling of name of three substances
- 6.3 Shelf life
- Shelf life extended from 48 to 60 months.
Updated on 31 March 2016
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 19 January 2016
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
- 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 following sections are updated to add a new pack size for 200 mg tablets (2 pack):
6.5 Nature and contents of container
....
200 mg tablets: PVC/PCTFE/Aluminium blisters in cartons of 2, 4, 8 and 12 tablets.
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/13/841/001-011
10. DATE OF REVISION OF THE TEXT
16 December 2015
Updated on 19 January 2016
Reasons for updating
- Change to date of revision
- Introduction of new pack/pack size
Updated on 29 September 2015
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 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 4.3 Contra-indications
New contra-indication added:
The co-administration of type 5 phosphodiesterase (PDE5) inhibitors, including avanafil, with guanylate cyclase stimulators, such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).
Section 4.5 Interaction with other medicinal products and other forms of interaction
New interaction added:
Riociguat
Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has 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 avanafil, is contraindicated (see section 4.3).
Section 10 Date of revision of the text
Updated to 18 September 2015
Updated on 29 September 2015
Reasons for updating
- Change of contraindications
- Change to drug interactions
- Change to date of revision
Updated on 28 May 2015
Reasons for updating
- Change to date of revision
Updated on 24 March 2015
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 5.1 Pharmacodynamic properties the following information has been added:
Pharmaco-therapeutic Group: Drugs used in erectile dysfunction
ATC Code: G04BE10
Updated on 05 February 2015
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 4.8 – Undesirable effects - how to report a side effect
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 Posology and method of administration
Updated posology to state: The recommended dose is 100 mg taken as needed approximately 15 to 30 minutes before sexual activity (See Section 5.1).
Section 4.8 Undesirable effects
Update on number of subjects exposed to avanafil in the clinical development programme.
Reporting of side-effects - update to the HPRA details
Section 5.1 Pharmacodynamic properties
Add information on fourth clinical study investigating the onset of action of avanafil.
Section 10 Date of revision of the text
Updated to January 2015
Administrative amendments
Sections 4.4 and 5.3
Updated on 05 February 2015
Reasons for updating
- Change of contraindications
- Change to how the medicine works
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 04 September 2014
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 10 - update the date of revision
Updated on 05 June 2014
Reasons for updating
- New SPC for new product
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 June 2014
Reasons for updating
- New PIL for new product