Konverge Plus film-coated tablets
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 June 2023
File name
Konverge Plus SmPC clean approved June 23.pdf
Reasons for updating
- 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
Section 5.3 - minor update to text
Section 10 - date of revision updated
Updated on 07 September 2022
File name
Konverge Plus PIL clean July 22.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 3 - Information on Non-cardiogenic pulmonary oedema added
Section 6 - Date of revision updated
Updated on 07 September 2022
File name
Konverge Plus SmPC clean July 22.pdf
Reasons for updating
- Change to section 4.9 - Overdose
- 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 4.9 - Information on Non-cardiogenic pulmonary oedema added
Section 10 - Date of revision updated
Updated on 07 April 2022
File name
Konverge Plus SmPC Clean Approved March 22.pdf
Reasons for updating
- 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 4.8 - AI Hepatitis added to Hepato-biliary disorders
Section 10 - date of revision updated
Updated on 07 April 2022
File name
Konverge Plus PIL Clean Approved March 22.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 4 - new side effect - Hepatitis added
Section 6 - date of revision updated
Updated on 31 January 2022
File name
Konverge Plus SmPC Clean Approved Jan 22.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
Konverge Plus PIL Clean Approved Jan 22.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 22 October 2020
File name
ie-pl-Konverge Plus clean approved 6-10-20.pdf
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
File name
ie-spc-Konverge Plus clean approved 6-10-20.pdf
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
File name
ie-pl-Konverge Plus clean 30-4-19.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
Updated on 21 May 2019
File name
ie-spc-Konverge Plus clean 30-4-19.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
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
File name
ie-smpc Konverge Plus 24-5-18.docx
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
File name
ie-pl-Konverge Plus clean 24-5-18.pdf
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
File name
PIL_15252_95.pdf
Reasons for updating
- New PIL for new product
Updated on 28 March 2017
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
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
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 04 August 2016
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 04 August 2016
Reasons for updating
- Change to improve clarity and readability
Updated on 12 April 2016
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
Reasons for updating
- Correction of spelling/typing errors
Updated on 19 March 2015
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 16 December 2014
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
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
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 25 November 2014
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 28 October 2014
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
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 08 February 2013
Reasons for updating
- Correction of spelling/typing errors
Updated on 30 January 2013
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
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
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
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
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
Reasons for updating
- New PIL for new product