Spedra 50 mg, 100 mg and 200 mg tablets

  • Name:

    Spedra 50 mg, 100 mg and 200 mg tablets

  • Company:
    info
  • Active Ingredients:

    Avanafil

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/08/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 1/8/2019

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A. Menarini Pharmaceuticals Ireland Ltd

A

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Medicine Name Drynol 10 mg orodispersible tablets Active Ingredients Bilastine
Medicine Name Drynol 2.5 mg/ml oral solution Active Ingredients Bilastine
Medicine Name Drynol 20 mg tablets Active Ingredients Bilastine
Medicine Name Eklira Genuair 322 micrograms inhalation powder Active Ingredients Aclidinium Bromide
Medicine Name Fastum 2.5% w/w gel Active Ingredients Ketoprofen
Medicine Name Frovex Active Ingredients Frovatriptan succinate monohydrate
Medicine Name Keral 25 mg granules for oral solution Active Ingredients Dexketoprofen trometamol
Medicine Name Keral 25mg Tablets Active Ingredients Dexketoprofen trometamol
Medicine Name Keral 50 mg/2ml Solution for injection/infusion Active Ingredients Dexketoprofen trometamol
Medicine Name Konverge film-coated tablets Active Ingredients Amlodipine besilate, olmesartan medoxomil
Medicine Name Konverge Plus film-coated tablets Active Ingredients Amlodipine besilate, Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Nebilet Active Ingredients Nebivolol hydrochloride
Medicine Name Nebilet Plus 5 mg / 12.5 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Nebivolol hydrochloride
Medicine Name Nebilet Plus 5 mg / 25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Nebivolol hydrochloride
Medicine Name Omesar 10mg, 20mg and 40mg Film-Coated Tablets Active Ingredients olmesartan medoxomil
Medicine Name Omesar Plus 20 mg/12.5 mg & 20 mg/25 mg Film-coated tablets Active Ingredients Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Omesar Plus 40 mg/12.5 mg & 40 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Osteofos D3 Active Ingredients Calcium phosphate, Colecalciferol (Vitamin D3)
Medicine Name Priligy 30 mg and 60 mg film-coated tablets Active Ingredients Dapoxetine hydrochloride
Medicine Name Ranexa prolonged-release tablets Active Ingredients Ranolazine
Medicine Name Skudexa 75 mg/25 mg film-coated tablets Active Ingredients Dexketoprofen trometamol, Tramadol Hydrochloride
Medicine Name Spedra 50 mg, 100 mg and 200 mg tablets Active Ingredients Avanafil
1 - 0 of 29 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 1 August 2019 PIL

Reasons for updating

  • XPIL Created

Updated on 1 August 2019 SmPC

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 PIL

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 1 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 1 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 February 2018 SmPC

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 1 February 2018 PIL

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 6 April 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 31 March 2016 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 31 March 2016 SmPC

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 19 January 2016 SmPC

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 PIL

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 29 September 2015 PIL

Reasons for updating

  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision

Updated on 29 September 2015 SmPC

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 28 May 2015 PIL

Reasons for updating

  • Change to date of revision

Updated on 24 March 2015 SmPC

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 5 February 2015 SmPC

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 5 February 2015 PIL

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 4 September 2014 SmPC

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 5 June 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 June 2014 SmPC

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