Nebilet Plus 5 mg / 12.5 mg film-coated tablets *
Pharmacy Only: Prescription

Updated on 31 January 2022

File name

Nebilet Plus Combined SmPC Clean Approved Jan 22_1643663850.pdf

Reasons for 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 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 4.4 - New section added on Acute Respiratory Toxicity 

Section 4.8 - New adverse event added - Actute Respiratory Distress Syndrome (ARDS) 

Section 10 - Date of revision updated 

Updated on 31 January 2022

File name

Nebilet Plus 5-12.5mg PIL Clean Approved Jan 22_1643663806.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2 - New warning added under "tell your doctor" regarding lung problems 

Section 4 - New adverse event added "acute respiratory distress"

Section 6 - Date of revision updated 

Updated on 20 February 2021

File name

ie-spc Nebilet Plus combined clean Approved 19-02-21_1613841908.pdf

Reasons for updating

  • 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 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 4.4  Updated with warnings for acute myopia and secondary angle-closure glaucoma

Section 4.8 - Information update for eye disorders and update to adverse event reporting details 

Section 5.1 - Minor editorial correction 

Section 6.1 -  Update to other ingredients to update the  E numbers for excipients 

Section 10 - Date of revision updated 

Updated on 20 February 2021

File name

ie-pl Nebilet Plus 5-12.5mg Clean Approved 19-02-21_1613841346.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Section 2 - Warnings regarding choroidal effussion added and added risks of previous penicillin and sulfonamide allergy. 

Section 4 - Eyes and ears section updated regarding choroidal effussion

Section 4 - Reporting of side effects section updated to delete old details and add new details for reporting requirements to HPRA

Section 6 - Update to other ingredients to update the  E numbers for excipients 

Changes to other sources of information: Iceland deleted from other member states 

Change to Section 6 Date of Revision to reflect new approval date. 

Updated on 18 June 2019

File name

ie-pl Nebilet Plus 5-12.5mg Na and PRAC clean 28-5-19_1560855550.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 June 2019

File name

ie-spc Nebilet Plus combined Na & PRAC clean 28-5-19_1560855419.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Following the outcome of the PRAC signal recommendation on skin cancer with hydrochlorothiazide, the following sections are updated: section 4.4 special warnings and precautions, section 4.8 undesirable effects; section 5.1 pharmacodynamic properties.

Section 4.4 is also updated to include a safety warning on the sodium salt.

Updated on 30 April 2015

File name

PIL_14446_964.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 April 2015

Reasons for updating

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

Updated on 09 April 2015

Reasons for updating

  • New SPC for new product

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

Updated on 09 April 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.5 Interactions - under Nebivolol, combinations to be used with caution: baclofen and amifostine are added
 

Section 4.8 Undesirable effects - urticaria added as 'not known' and details on reporting side-effects included

Administrative amendments to align to the EU QRD template - Sections 2, 4.2 and 4.6 updated.

Updated on 07 March 2013

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 26 February 2013

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

The main changes to the SmPC are as follows

Section 4.6 Fertility, pregnancy and lactation

Nebivolol

…. If treatment with beta-adrenoceptor blockers is necessary, beta1-selective adrenoceptor blockers are preferable.

Nebivolol should not be used during pregnancy unless clearly necessary. If treatment with nebivolol is considered necessary, the uteroplacental blood flow and the foetal growth should be monitored. In case of harmful effects on pregnancy or the foetus alternative treatment should be considered. The newborn infant must be closely monitored. Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days.

 

Hydrochlorothiazide - Use in lactation

…. Most beta-blockers, particularly lipophilic compounds like nebivolol and its active metabolites, pass into breast milk although to a variable extent. “

 

In addition, the SmPC has been updated to the current template.

 

Updated on 20 June 2012

Reasons for updating

  • Addition of manufacturer

Updated on 14 June 2011

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • 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

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

Free text change information supplied by the pharmaceutical company

The main changes are as follows:

 

Section 4.3 Contra-indications:

  • replace the word 'heart' with 'atrioventricular’ in the wording - Second and third degree atrioventricular block (without a pacemaker).
  • remove wording relating to during the second and third trimester of pregnancy or lactation. 

Section 4.4 Special warnings and precautions for use:

  • replace the word 'heart' with 'atrioventricular’ in the wording - in patients with first degree atrioventricular block, because of the negative effect of beta-blockers on conduction time;

Section 4.5 and section 5.1:

  • Correct the spelling of the word "sympathomimetic"

Section 4.6 Pregnancy and lactation:

  • Amend the wording to align with that agreed by the CMD/PhvWP regarding the use of hydrochlorothiazide during pregnancy and lactation. 

Updated on 07 June 2011

Reasons for updating

  • Change of contraindications
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of manufacturer

Updated on 12 April 2011

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 30 March 2010

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Section 6.3 - shelf life extended from 2 to 3 years.

Updated on 14 October 2009

Reasons for updating

  • New PIL for new product

Updated on 01 October 2009

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided