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Servier Laboratories Ireland Ltd

Block 2, West Pier Business Campus, Old Dunleary Road, Dun Laoghaire, Co. Dublin,
Telephone: +353 1 663 8110
Fax: +353 1 663 8120
Summary of Product Characteristics last updated on medicines.ie: 14/11/2017
SPC Coversyl Arginine 5mg

When a pharmaceutical company changes an SPC or PIL, 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 14/11/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01-Nov-2017
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 08/11/2016 and displayed until 14/11/2017
Reasons for adding or 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
Date of revision of text on the SPC:   24-Oct-2016
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 22/04/2015 and displayed until 08/11/2016
Reasons for adding or 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
Date of revision of text on the SPC:   07-Apr-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


$0In section 4.3(Contraindications), the following text (bold font) has been added: "Concomitant use of Coversyl arginine with aliskiren-containingproducts in patients with diabetes mellitus or renal impairment (GFR< 60 ml/min/1.73m²) (see sections 4.5 and 5.1)."$0$0In section 4.4 (Special warnings and precautions for use), additionalinformation in relation to "Dual blockade of therenin-angiotensin-aldosterone system" has been added.$0$0In section 4.5 (Interaction with other medicinal products and other forms ofinteraction), the following text has been inserted:$0$0“Clinical trial data has shown that dual blockade of therenin-angiotensin-aldosterone-system (RAAS) through the combined use ofACE-inhibitors, angiotensin II receptor blockers or aliskiren is associatedwith a higher frequency of adverse events such as hypotension, hyperkalaemiaand decreased renal function (including acute renal failure) compared to theuse of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).”$0$0In section 5.1 (Pharmacodynamic properties), clinical trial data has been inserted.$0$0$0$0$0$0$0
Updated on 11/02/2015 and displayed until 22/04/2015
Reasons for adding or updating:
  • Change to paediatric information
Date of revision of text on the SPC:   01-Jan-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In section 4.2 ( Posology andmethod of administration) -The safety and efficacy of perindopril in childrenand adolescents aged below 18 years have not been established.$0$0$0$0
Updated on 02/04/2014 and displayed until 11/02/2015
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change due to harmonisation of SPC
  • Change to section 4.3 - Contraindications
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   23-Jan-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

$0$0Throughout the SPC, "COVERSYL arginine" has been changed to "Coversyl arginine".$0$0In section 4.2, "adolescents" has been defined as (less than 18 years). The method of administration has been updated to state "Coversyl arginine is recommended to be taken once daily in the morning before a meal".$0$0In section 4.3, the following contra-indication has been added: Concomitant use with Aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m²).$0$0In section 4.4, a warning has been added for "Dual blockade of the renin-angiotensin-aldosterone system (RAAS)".$0$0In section 4.5, the section "Drugs inducing hyperkalaemia" has been added, replacing the same information elsewhere in this section.   "Concomitant use contra-indicated" has been updated to include Aliskiren for diabetics. "Concomitant use not recommended" has been updated regarding concomitant therapy with ACE inhibitor and angiotensin-receptor blocker, and estramustine. "Concomitant use which requires special care" now includes antidiabetic agents, baclofen and non-potassium-sparing diuretics. The following headings have been added: "Concomitant use which requires some care", "Concomitant use to take into account".$0$0In section 4.6, the sentence "There was no effect on reproductive performance or fertility" has been added. $0$0In section 4.8, the format has changed and the undesirable effects have been tabulated in accordance with MedRA class and frequency. The section "Reporting of suspected adverse reactions" has been added.$0$0In section 5.1, the headings have been updated to include "Mechanism of action" and "Clinical efficacy and safety" as subheadings.$0$0In section 5.2, the following headings have been added: Absorption, Distribution, Elimination, Special population.$0$0In section 5.3, the following statement was added: "Fertility was not impaired either in male or in female rats."$0$0In section 6.6, "no special requirements" replaces the previous statement of "Medicines no longer required should not be disposed of via the waste water or the municipal sewage system. Return them to a pharmacy or ask your pharmacist how to dispose of them in accordance with the national regulations/requirements. These measures will help to protect the environment."$0$0$0$0
Updated on 16/02/2012 and displayed until 02/04/2014
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   31-Jan-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

$0Change of MAHaddress from:$0$0LesLaboratoires Servier$0$022, rueGarnier$0$092200Neuilly-sur-Seine$0$0France$0$0to:$0$0Les Laboratoires Servier$0$050, rue Carnot$0$092284 Suresnes cedex$0$0France$0
Updated on 21/01/2011 and displayed until 16/02/2012
Reasons for adding or updating:
  • Change to product name
Date of revision of text on the SPC:   14-May-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Product name amended to read "Coversyl Arginine 5mg film-coated tablets"
Updated on 21/09/2010 and displayed until 21/01/2011
Reasons for adding or 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
Date of revision of text on the SPC:   31-May-2010
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: 72.58 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: 

“ 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 10/09/2009 and displayed until 21/09/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   20-May-2009
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 02/09/2009 and displayed until 10/09/2009
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-May-2008
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 2:

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 01/05/2007 and displayed until 02/09/2009
Reasons for adding or 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Amendment to include new indication in stable coronary artery disease.
Updated on 14/12/2006 and displayed until 01/05/2007
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Perindopril arginine