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Konverge Plus film-coated tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/10/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 22/10/2020

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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 22 October 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The changes are as follows:

  • To add signals on choroidal effusion with hydrochlorothiazide
  • To add the interaction of amlodipine with Mechanistic Target of Rapamycin (mTOR) Inhibitors  

Updated on 22 October 2020 SPC

Reasons for updating

  • 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 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 changes are as follows:

  • Section 4.4:to add signals on choroidal effusion with hydrochlorothiazide
  • Section 4.5 to add the interaction of amlodipine with Mechanistic Target of Rapamycin (mTOR) Inhibitors  

Updated on 21 May 2019 PIL

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

Updated on 21 May 2019 SPC

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

Sections 4.4, 4.8 and 5.1 of the SmPC are updated to implement the PRAC signal recommendations on skin cancer with hydrochlorothiazide.
 

Updated on 14 June 2018 SPC

Reasons for updating

  • 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 4.6 - 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The main changes to the SmPC are as follows:

Section 4.4 Special warnings and precaution of use - Addition of information on the sodium content in line with the EU excipient guideline.

Section 4.5 Interaction with other medicinal products - Update to the statements for amlodipine on CYP3A4 inhibitors, CYP3A4 known inducers and tacrolimus.

Section 4.6 Pregnancy and breastfeeding - Breastfeeding statement re amlodipine

Section 4.8 Undesirable effects - For amlodipine, extrapyramidal disorder and toxic epidermal necrolysis added as frequency not known 

Updated on 14 June 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 28 March 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 28 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 March 2017 SPC

Reasons for updating

  • 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 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 are to the following sections:

 

Section 4.4 Special warnings and precaution of use

Warning re acute myopia and secondary angle-closure glaucoma with hydrochlorothiazide have been added.

 

Section 4.5 Interaction with other medicinal products

Effects of amlodipine with tacrolimus and cyclosporine have been added.

 

Section 4.8 Undesirable effects

Frequency of side-effects for amlodipine have been amended: 

·         Uncommon to common: visual disturbance, palpitations, dyspnoea, altered bowel habits, dyspepsia, muscle spasm, asthenia.

·         Very rare to uncommon: arrhythmia, cough,  urticaria

·         Common to very common: oedema

In addition, acute myopia and acute angle-closure glaucoma have been added with the frequency – not known - for hydrochlorothiazide.

Updated on 28 March 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 4 August 2016 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 4 August 2016 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Section 4.4: Special warnings and precautions for use

 

Sprue-like enteropathy:

In very rare cases severe, chronic diarrhoea with substantial weight loss has been reported in patients taking olmesartan few months to years after drug initiation, possibly caused by a localized delayed hypersensitivity reaction. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, and in the absence of other apparent etiologies, olmesartan treatment should be immediately discontinued and should not be restarted. If diarrhoea does not improve during the week after the discontinuation, further specialist (e.g. a gastro-enterologist) advice should be considered.

 

Also, minor administrative changes.

Updated on 12 April 2016 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 12 April 2016 SPC

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Minor amendments to the SmPC to align to the QRD template eg to replace the term 'older people' with 'elderly'.

Updated on 19 March 2015 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 16 December 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 16 December 2014 SPC

Reasons for updating

  • 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 25 November 2014 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 25 November 2014 SPC

Reasons for updating

  • 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 be renewed (B)

Updated on 28 October 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 28 October 2014 SPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 8 February 2013 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 30 January 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 29 January 2013 SPC

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Updated on 19 June 2012 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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

The SmPC has been updated to bring it into line with the following:

 

  • the outcome of the EU Article 30 procedure for “Norvasc and associated names” (medicinal products for human use which contain the active substance “amlodipine”);
  • the latest version of the Core Safety Profile (CSP) for Amlodipine
  • the Olmesartan/Amlodipine CSP of 19 December 2011
  • version 2.0 of the QRD template (formatting changes)

Updated on 19 June 2012 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 17 January 2012 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 January 2012 SPC

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