Tritace 5mg Tablets *
Pharmacy Only: Prescription

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Legal 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 19 July 2021

File name

Ireland Tritace PIL 2_1626683239.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 28 June 2021

File name

Ireland Tritace PIL_1624879178.pdf

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 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • 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 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 June 2021

File name

Ireland Tritace 5mg SmPC_1624878033.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 11 February 2021

File name

Ireland Tritace PIL (1)_1613032979.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 02 February 2021

File name

IE-pil-[IE1083 Tritace 044 Del 1.25mg Italy strength - tracked]_1583396680.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 06 July 2020

File name

IE-pil-[IE1083 Tritace 044 Del 1.25mg Italy strength - tracked]_1583396680.pdf

Reasons for updating

  • XPIL Removed

Updated on 05 March 2020

File name

IE-pil-[IE1083 Tritace 044 Del 1.25mg Italy strength - tracked]_1583396680.pdf

Reasons for updating

  • Removal of one or more presentations from joint PIL

Free text change information supplied by the pharmaceutical company

Section 6 of the PIL has been updated: To delete the 1.25mg strength of Tritace (ramipril) in Italy only.

Updated on 11 September 2019

File name

Tritace 5mg tablets SmPC_1568207225.pdf

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 11 September 2019

File name

Tritace PIL_1568207164.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 06 April 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 April 2018

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 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  added:-

·         Concomitant use with sacubitril/valsartan therapy (see sections 4.4 and 4.5).

Section 4.4 Special Warnings and Precautions in Use added:-

Under sub heading  Angioedema wording added:-

·         Of angioedema

·          which may cause angioedema

·         Neprilysin (NEP) inhibitors (such as)The combination of ramipril with sacubitril/valsartan is contraindicated due to the increased risk of angioedema (see sections 4.3 and 4.5).

Section 4.5 Interaction with other medicinal products and other forms of interaction added:-

·         The concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated as this increases the risk of angioedema (see sections 4.3 and 4.4). Treatment with ramipril must not be started until 36 hours after taking the last dose of sacubitril/valsartan.

Sacubitril/valsartan must not be started until 36 hours after the last dose of Tritace.

 

Under sub heading Precautions for use added:-

·         Neprilysin (NEP) inhibitors replaces Racecadotril

·         Word potential removed and minor typographical changes to paragraph.

New sub heading added:-

·         Sacubitril/valsartan        

·         The concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated as this increases the risk of angioedema.

Updated on 04 April 2018

File name

PIL_8429_440.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 April 2018

File name

PIL_8429_440.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 April 2018

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 6 - date of revision
  • Change to other sources of information section

Updated on 31 May 2017

File name

PIL_8429_919.pdf

Reasons for updating

  • New PIL for new product

Updated on 31 May 2017

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 19 January 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 19 January 2017

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Email address for HPRA in the SPCs was stated as @hpra.i.e rather than hpra.ie. This has now been amended.

Updated on 19 January 2017

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 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 19 December 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Renewal

Updated on 18 November 2016

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 Summary of Product Characteristics (SmPC) is updated with information concerning the interaction of ramipril with racecadotrilin sections 4.4 “Special Warnings and Precautions for use” and 4.5 “Interaction with other medicinal products

The package leaflet (PL) is impacted by these changes in section 2.

Updated on 17 November 2016

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

Updated on 01 September 2015

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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 4.2, 4.3, 4.6, 4.9, 5.1, 5.2 & 6.6 have had minor updates such as changes to headings and section references.

Section 4.4 'Angioedema' paragraph has been updated to include information on increased risk in patients of mTOR inhibitors.
Section 4.5 New paragraph included at the end regarding mTOR inhibitors.
Section 4.8 Table has been updated with the following sections moved in relation to their seriousness:
- Immune system disorders
- Endocrine disorders
- Metabolism and nutrition disorders
- Psychiatric disorders
- Cardiac disorders
- Vascular disorders
- Hepatobiliary disorders
- Renal and urinary disorders
- Reproductive system and breast disorders
New paragraph on the reporting of suspected adverse reactions included.

Updated on 20 August 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 18 March 2015

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 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 4.2 updated to include reference to other sections.
Section 4.3 updated info on the concomitant use of Tritace with aliskiren containing products.
Section 4.4 updated regarding use with AIIRAs (angiotensin II receptor antagonists) and new paragraph 'Dual blockade of the renin-angiotensin-aldosterone system (RAAS)'.
Section 4.5 updated to include use with aliskiren and RAAS.
Section 4.6 'The use of ACE inhibitors' changed to 'Tritace'. AIIRA included and 'oliguria and hyperkalaemia' included.
Section 5.1 new section on 'Dual blockade of the renin-angiotensin-aldosterone system (RAAS).
Section 5.2 minor changes.

Updated on 16 March 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 26 November 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 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • 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: updated to include a new contraindication regarding aliskiren containing medicinal products in patients with diabetes or renal impairment.
Section 4.4: Special populations updated to include information regarding aliskiren containing medicinal products.
Hyperkalaemia has been updated to Electrolyte Monitoring: Hyperkalaemia - additional information that Syndrome of Inappropriate Anti-diruetic Hormone (SIADH) and subsequent hyponatremia has been observed in some patients treated with ramipril and the medical conditions that may increase the risk.
Section 4.5: updated to include a information regarding the contraindication of aliskiren containing medicinal products.
Section 4.8: Endocrine disorders included.
Section 6.5: 'Not all pack sizes may be marketed.' included.

Updated on 21 November 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to further information section

Updated on 07 November 2014

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

Type IAIN - B.II.e.5 Change in pack size of the finished product –a) Change in the number of units (e.g. tablets, ampoules, etc.) in a pack – 1. Change within the range of the currently approved pack sizes

Updated on 28 April 2014

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

Type IAIN – B.II.f.1.a.1 Change in the shelf-life or storage conditions of the finished product - Reduction of the shelf life of the finished product - As packaged for sale.

years


Updated on 16 April 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type IAIN group bulk, category A.1, application to change the name of the Marketing Authorisation Holder (MAH) in UK, Ireland and Portugal, as well as the MAH address in the UK.

Updated on 04 January 2013

Reasons for updating

  • Change to product name

Updated on 23 August 2012

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 23 August 2012

Reasons for updating

  • Improved electronic presentation

Updated on 17 August 2012

Reasons for updating

  • Improved electronic presentation

Updated on 02 February 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 23 August 2007

Reasons for updating

  • Change to marketing authorisation holder

Updated on 19 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 19 August 2004

Reasons for updating

  • New PIL for medicines.ie