Nebilet Plus 5 mg / 25 mg film-coated tablets

  • Name:

    Nebilet Plus 5 mg / 25 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Hydrochlorothiazide, 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: 18/06/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 18/6/2019

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A. Menarini Pharmaceuticals Ireland Ltd

A

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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)
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Medicine Name Ranexa prolonged-release tablets Active Ingredients Ranolazine
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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 18 June 2019 PIL

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 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 April 2015 PIL

Reasons for updating

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

Updated on 9 April 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 4.5 - 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 9 April 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 7 March 2013 PIL

Reasons for updating

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

Updated on 26 February 2013 SmPC

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 PIL

Reasons for updating

  • Addition of manufacturer

Updated on 14 June 2011 SmPC

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 7 June 2011 PIL

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 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 30 March 2010 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 October 2009 SmPC

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