Login

Spedra 50 mg, 100 mg and 200 mg tablets

*
Pharmacy Only: Prescription

  • Company:

    A. Menarini Pharmaceuticals Ireland Ltd

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Avanafil

    *Additional information is available within the SPC or upon request to the company

qrcode image

Scan the QR code or enter an email to access and share this medicine:

Updated on 20 May 2024

File name

ie-smpc PSUSA Clean April 24.pdf

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)

Updated on 20 May 2024

File name

ie-uk leaflet combined PSUSA clean April 24.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

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  • Individual PILs superseded by joint PIL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

$0The following updates have been approved:$0$04.6       Fertility,pregnancy and lactation$0$0Fertility$0$0New statement added: In a clinical trial performed in healthyvolunteers and adult males with mild erectile dysfunction, thedaily administration of avanafil 100 mg oral doses over a period of 26 weekswas not associated with any untoward effects on sperm concentration, count,motility, or morphology.$0$0Statement removed: Currently, no data onspermatogenesis on healthy adult males and adult males with mild ED areavailable.$0$04.8       Undesirableeffects$0$0$0$0Update to the numbers of subjects exposed to Spedra duringthe clinical development programme from 2436 to 2566.$0$0Epistaxis added as an Adverse reaction under Respiratory,thoracic and mediastinal disorders as ‘Rare’.$0$0$0

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 6.3 - update the shelf life from 30 months to 48 months.

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

None provided

Updated on 05 June 2014

Reasons for updating

  • New PIL for new product

A. Menarini Pharmaceuticals Ireland Ltd

A