Konverge Plus film-coated tablets
- Name:
Konverge Plus film-coated tablets
- Company:
A. Menarini Pharmaceuticals Ireland Ltd
- Active Ingredients:
Amlodipine besilate, Hydrochlorothiazide, 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: 21/05/19
(Click to Download)XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1. What Konverge Plus is and what it is used for
1. What Konverge Plus is and what it is used for
2. What you need to know before you take Konverge Plus
2. What you need to know before you take Konverge Plus
3. How to take Konverge Plus
3. How to take Konverge Plus
4. Possible side effects
4. Possible side effects
5. How to store Konverge Plus
5. How to store Konverge Plus
6. Contents of the pack and other information
6. Contents of the pack and other information
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A. Menarini Pharmaceuticals Ireland Ltd
Company Products
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 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 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
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 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 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 SmPC
Reasons for updating
- New SmPC 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 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 4.8 - 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 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, minor administrative changes.
Updated on 4 August 2016 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 12 April 2016 SmPC
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
Updated on 12 April 2016 PIL
Reasons for updating
- Correction of spelling/typing errors
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 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 4.6 - 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 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 25 November 2014 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
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)
Updated on 28 October 2014 SmPC
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 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 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 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 4.5 - 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 SmPC
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 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
Updated on 17 January 2012 PIL
Reasons for updating
- New PIL for new product