Konverge film-coated tablets

  • Name:

    Konverge film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Amlodipine besilate, olmesartan medoxomil

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/07/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 24/7/2018

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A. Menarini Pharmaceuticals Ireland Ltd

A

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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
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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 3 July 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 27 July 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 July 2018 SmPC

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 are as follows:

4.4 Special warnings and precautions for use

 Added: This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

Updated information about interactions with CYP3A4 inhibitors and inducers.

Updated information about interaction with Tacrolimus

4.6       Fertility, pregnancy and lactation

Updated information about excretion of Amlodipine in human milk.

4.8       Undesirable effects

Added adverse event "Extrapyramidal disorder", frequency "not known", in Amlodipine AE column

Added adverse event "Toxic Epidermal Necrolysis", frequency "not known", in Amlodipine AE column 

Updated on 22 November 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 22 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 November 2016 SmPC

Reasons for updating

  • 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 5.2 - Pharmacokinetic 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 4.5 Interactions

Addition of information on interaction with tacrolimus and cyclosporine.

 

Section 4.8 Undesirable effects

Update to frequencies as follows for amlodipine:

Very common: Oedema

Common: Visual disturbance, palpitations, dyspnoea, altered bowel habits, dyspepsia, muscle spasm, asthenia.

Uncommon: Arrhythmia, cough, urticaria.

 

Correct spelling of anti-hypertensive in sections 4.5, 4.6 and 4.7 and typo in section 5.2.

Updated on 22 November 2016 PIL

Reasons for updating

  • 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 SmPC

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, amend ‘older people’ to ‘elderly’ and other minor administrative changes.

Updated on 4 August 2016 PIL

Reasons for updating

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

Updated on 18 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

Updated on 18 December 2014 SmPC

Reasons for updating

  • 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 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 4.3 Contraindications

New contra-indication added on the concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment.

 

Section 4.4 Special warnings and precautions

New warning added regarding the dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is not recommended,

 

Section 4.5 Interactions with other medicinal products and other forms of interaction

New interaction added under possible interactions related to olmesartan medoxomilConcomitant use not recommended’: ACE-inhibitors, angiotensin II receptor blockers or aliskiren.

 

 

Section 5.1 Pharmacodynamic properties

Details of two studies added with details about the use of combination of an ACE-inhibitor with an angiotensin II receptor blocker.

Information added on a further study to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.

 

Section 10 Date of revision of the text

Updated to December 2014

 

Updated on 25 November 2014 SmPC

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)

Free text change information supplied by the pharmaceutical company

Section 4.5 Interaction with other medicinal products

Interaction with colesevelam added

 

Section 10 Date of revision of the text

Date of revision updated to November 2014

Updated on 25 November 2014 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

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 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 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 Special warnings and precautions for use

Information on Sprue-like enteropathy added

 

Section 4.8 Undesirable effects

  • Sprue-like enteropathy added as a very rare side-effect
  • Reporting of suspected adverse reactions – updated with HPRA details

Section 5.1 Pharmacodynamic properties

Information on the risk of cardiovascular mortality in patients with Type II - diabetes following the outcome of ORIENT/ROADMAP studies.


Section 10 Date of revision of the text

Date of revision updated to Oct 2014

Updated on 14 November 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of renewal of authorisation
  • 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

The changes to the SmPC mainly relate to aligning to the current QRD template eg to amend the wording for the elderly to 'older people', and add reporting of suspected adverse reactions under section 4.8 Undesirable effects with local contact details for Ireland. 

Updated on 14 November 2013 PIL

Reasons for updating

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

Updated on 15 November 2012 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 4.5 - 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
  • 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

Updates to:

 

Section 4.2 Posology and method of administration:

  • Elderly – increase of the dose should take place with care added.
  • Hepatic impairment – additional information on use of amlodipine including - amlodipine should be initiated at the lowest dose and titrated slowly in patients with impaired liver function. Use of Konverge in patients with severe hepatic impairment is contraindicated.

Section 4.4 Special warnings and precautions

  • Hepatic impairment – additional information on use of amlodipine including - amlodipine should be initiated at the lower end of the dosing range and caution should be used, both on initial treatment and when increasing the dose.
  • Heart failure – additional information on the use of calcium channel blockers like amlodipine including - calcium channel blockers should be used with caution in patients with heart failure.

Section 4.5 Interaction with other medicinal products and other forms of interaction

  • Additional information on effects of other medicinal products on amlodipine - CYP3A4 inhibitors, CYP3A4 inducers, grapefruit/grapefruit juice and dantrolene.
  • New information on effect of amlodipine on other medicinal products – simvastatin added

Section 4.6 Fertility, pregnancy and lactation

  • Information on Fertility added.

Section 4.7 Effects on ability to drive and use machines

  • Caution is recommended especially at the start of treatment added

Section 4.8 Undesirable effects

  • Single cases of extrapyramidal syndrome have been reported in patients treated with amlodipine added.

Section 5.1 Pharmacodynamic properties

  • New information added on trial for treatment to prevent heart attack trial (ALLHAT)

Section 5.2 Pharmacokinetic properties

  • Updated information on amlodipine and its absorption and distribution, metabolism and elimination, and clinical data in patients with hepatic impairment.

 Section 5.3 Preclinical safety data

  • Updated information on amlodipine and reproductive toxicology, impairment of fertility, carcinogenesis and mutagenesis.

.

Updated on 13 November 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to dosage and administration

Updated on 23 February 2012 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

Update to section 6.3 Shelf life: Shelf life extended from 4 to 5 years.

Updated on 17 March 2011 SmPC

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 4.7 - 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 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 sections 4.2, 4.3, 4.4, 4.5, 4.7, 4.8, 5.1, 5.2 for the following reasons:

 

- Implementation of the EU Guideline on Summary of Product Characteristics (SmPC) and QRD formatting template

- A material change occurs in section 4.8, due to the altered way of estimating adverse reaction frequencies described in the new SmPC guideline.

- Adaptation of information on the active substance amlodipine to be in line with the current EU Core Safety Profile (CSP) for amlodipine.

Updated on 17 March 2011 PIL

Reasons for updating

  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 12 October 2010 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 be renewed (B)

Free text change information supplied by the pharmaceutical company


Update to section 6.3: Shelf life updated from 3 years to 48 months

Updated on 7 October 2010 PIL

Reasons for updating

  • Change of contraindications
  • Change to date of revision

Updated on 2 February 2010 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • 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

4.3 Contraindications

Lactation contra-indication removed

 

4.6 Pregnancy and lactation

 

Pregnancy – minor changes to the wording.

 

Lactation – Wording amended to remove contra-indication. 

New statement added:  Because no information is available regarding the use of olmesartan and amlodipine during breast-feeding, Konverge is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. 

 

Updated on 2 February 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to information about pregnancy or lactation

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