Coversyl Arginine 10mg
- Name:
Coversyl Arginine 10mg
- Company:
Servier Laboratories Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/03/19
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Servier Laboratories 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 20 March 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 20 March 2019 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 29 May 2018 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 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 29 May 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 18 December 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 18 December 2017 PIL
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 14 November 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 14 November 2017 SmPC
Reasons for updating
- 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
6.5 Nature and contents of container has been modified.
Updated on 8 November 2016 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- 4.4 Special warnings and precautions for use
Hypersensitivity/Angioedema: Addition of concomitant use of mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus)
- 4.5 Interaction with other medicinal products and other forms of interaction
Concomitant use not recommended (see section 4.4):Addition of: Racecadotril and mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus)
- 4.8 Undesirable effects
Tabulated list of adverse reactions
Skin and Subcutaneous Tissue Disorders: Addition of: Psoriasis aggravation
Updated on 4 November 2016 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
Updated on 23 April 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 22 April 2015 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 11 February 2015 SmPC
Reasons for updating
- Change to paediatric information
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 5 February 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 2 April 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 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 6.6 - Special precautions for disposal and other handling
- Change due to harmonisation of SPC
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 February 2012 SmPC
Reasons for updating
- Change to MA holder contact details
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 15 February 2012 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 20 January 2011 SmPC
Reasons for updating
- Change to product name
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 September 2010 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 2: QUALITATIVE AND QUANTITATIVE COMPOSITION
"Excipient : 145.16 mg lactose monohydrate" has been added.
Section 6.1 List of excipients
„Macrogol 6000" appears as an excipient instead of "Macrogol"
Section 6.5 Nature and contents of container
Now reads as:
"White polypropylene tablet container equipped with a polyethylene flow reducer and a white opaque stopper containing a dessicant gel.
Box of 5, 10, 14, 20, 30, 50, 60 (60 or 2 containers of 30), 90 (90 or 3 containers of 30 ), 100 (100 or 2 containers 50), 120 (120 or 4 containers of 30) or 500 tablets (500 or 10 containers of 50)."
Updated on 17 September 2010 PIL
Reasons for updating
- Introduction of new pack/pack size
Updated on 1 October 2009 SmPC
Reasons for updating
- 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
Updated on 24 September 2009 PIL
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 10 September 2009 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The following has been added to section 4.4:
Pregnancy:
ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
The following has been added to section 4.6:
Pregnancy:
The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors is contra-indicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive ; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Exposure to ACE inhibitor therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see sections 4.3 and 4.4).
.Lactation:
Because no information is available regarding the use of perindopril during breastfeeding, perindopril 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 September 2009 SmPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.4 - Special precautions for storage
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Perindopril Arginine added at beginning, also information on lactose added
Section 6.4:
text in bold added; Keep container tightly closed in order to protect from moisture
Section 6.5:
Nature and contents of container information updated
Updated on 26 August 2009 PIL
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 1 May 2007 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 5.1 - Pharmacodynamic properties
- 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
Updated on 1 May 2007 PIL
Reasons for updating
- Change to, or new use for medicine
Updated on 14 December 2006 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 14 December 2006 PIL
Reasons for updating
- New PIL for new product