Nebilet

  • Name:

    Nebilet

  • Company:
    info
  • Active Ingredients:

    Nebivolol hydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/01/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 29/1/2019

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A. Menarini Pharmaceuticals Ireland Ltd

A

Company Products

Medicine NameActive Ingredients
Medicine Name Adenuric 120 mg film-coated tablets Active Ingredients febuxostat
Medicine Name Adenuric 80 mg film-coated tablets Active Ingredients febuxostat
Medicine Name Brimica Genuair 340 micrograms /12 micrograms inhalation powder Active Ingredients Aclidinium Bromide, Formoterol fumarate dihydrate
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 Quofenix 300 mg powder for concentrate for solution for infusion Active Ingredients Delafloxacin Meglumine
Medicine Name Quofenix 450 mg tablets Active Ingredients Delafloxacin Meglumine
Medicine Name Ranexa prolonged-release tablets Active Ingredients Ranolazine
1 - 0 of 31 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 29 January 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 29 January 2019 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.1 List of excipients - E numbers added.

Updated on 17 May 2018 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 5.1 Pharmacodynamic properties

The following sentence has been added:

Available preclinical and clinical evidence in hypertensive patients has not shown that nebivolol has a detrimental effect on erectile function. 

Section 10 Date of revision of the text

Updated to April 2018

 

Updated on 17 February 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 February 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 February 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 Undesirable effects

Add urticaria as a side-effect (frequency - not known)

Add HPRA details for the reporting of side-effects

 

Administrative amendments to align to the EU QRD template

Sections 2, 4.2, 4.3, 4.4, 9.

 

Section 10 Date of revision of the text

Updated to January 2015

Updated on 17 February 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 24 January 2012 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 24 June 2011 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 31 March 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



Addition of baclofen in section 4.5 Interactions (under combinations to be used with caution), together with minor changes to the wording of sections 2, 3 and 6.1. Date of renewal and revision of the text updated in section 9 and 10.

Updated on 30 March 2011 PIL

Reasons for updating

  • Change to storage instructions
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision

Updated on 24 July 2008 PIL

Reasons for updating

  • Change to further information section

Updated on 5 June 2008 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 12 February 2008 PIL

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability

Updated on 1 November 2007 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 - Undesirable effects - update information on immune system disorders

Updated on 23 November 2006 PIL

Reasons for updating

  • Change to packaging

Updated on 13 June 2006 PIL

Reasons for updating

  • Change to storage instructions

Updated on 13 June 2006 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to the SMPC following Marketing Authorisation renewal.
Main changes are:
Section 4.3 Contraindations for pregnancy and lactation removed.
Section 4.4 Lactose warning added.
Section 4.6 Updated pregnancy and lactation information.
Section 4.8 Updated Adverse event table for hypertension.
 

Updated on 13 June 2006 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to the SMPC following Marketing Authorisation renewal.
Main changes are:
Section 4.3 Pregnancy and lactation removed as a Contraindication
Section 4.4 Lactose warning added.
Section 4.6 Pregancy and lactation information updated.
Section 4.8 Adverse event  table for hypertension updated.
 

Updated on 3 April 2006 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 7 February 2006 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 7 February 2006 PIL

Reasons for updating

  • Change to appearance of the medicine
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration

Updated on 15 September 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 10 August 2004 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 5 August 2004 PIL

Reasons for updating

  • New PIL for new product