Konverge 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 07 September 2022
File name
Konverge SPC 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 September 2022
File name
Konverge 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 - pulmonary oedema warning added under "if you take more than you should"
Section 6 - date of revision updated
Updated on 07 April 2022
File name
Konverge SPC 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 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 10 December 2020
File name
ie-spc Konverge clean 03-12-2020.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.5 - Information added regarding interactions with mTOR inhibibitors
Section 4.9 - reporting of side effects to HPRA updated
Section 6.1 and 6.5 - update to ingredients and pack details
Updated on 10 December 2020
File name
ie-pil Konverge clean 03-12-2020.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Section 2 - Sirolimus, temsirolimus, everolimus added within interactions with other medications
Section 4 - reporting of side effects to HPRA updated
Section 6 - update to ingredients and pack details
Section 6 - Other information - countries list updated
Section 6 - Change to date of revision
Updated on 10 December 2020
File name
ie-spc Skudexa tabs clean 19-10-20.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
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 with other medications updated to include information on mTOR inhibitors
Section 4.8 - reporting of side effects to HPRA updated
Section 6.1 and 6.5 - update to ingredients and pack details
Updated on 10 December 2020
File name
ie-pl Skudexa Clean 9-11-20.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Section 2 - Sirolimus, temsirolimus, everolimus added within interactions with other medications
Section 4 - reporting of side effects to HPRA updated
Section 6 - update to ingredients and pack details
Section 6 - Other information - countries list updated
Section 6 - Change to date of revision
Updated on 03 July 2019
File name
ie-pil Konverge clean 13-6-19.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 27 July 2018
File name
ie-pil Konverge approved clean 17-7-18.pdf
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
File name
ie-spc Konverge approved clean 17-7-18.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 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
File name
PIL_14444_329.pdf
Reasons for updating
- New PIL for new product
Updated on 22 November 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 November 2016
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
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 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, amend ‘older people’ to ‘elderly’ and other minor administrative changes.
Updated on 04 August 2016
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 18 December 2014
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 medoxomil ‘Concomitant 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 18 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
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)
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
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 28 October 2014
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 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 14 November 2013
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
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
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
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
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
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
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
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 07 October 2010
Reasons for updating
- Change of contraindications
- Change to date of revision
Updated on 02 February 2010
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 02 February 2010
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
Reasons for updating
- New PIL for new product
Updated on 01 October 2009
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)