Login

Odrik 2mg Hard Capsules

*
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Trandolapril

    *Additional information is available within the SPC or upon request to the company

Updated on 26 November 2020

File name

ie-pl-odrik-0.5mg1mg2mg-TIB-Kom-CRN009W7Q-clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 16 November 2020

File name

ie-spc-odrik-2mg-TIB-excipients-CRN009Y00-clean.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)

Updated on 16 November 2020

File name

ie-pl-odrik-0.5mg1mg2mg-TIB-excipients-CRN009Y00-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 12 April 2019

File name

IE-PIL-Odrik-28Mar2019-CRN008VDN-clean.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 28 March 2019

File name

IE-PIL-Odrik-28Mar2019-CRN008VDN-clean.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 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 28 March 2019

File name

IE-SmPC-Odrik 2mg-28Mar2019-CRN008VDN-clean.pdf

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)

Updated on 03 July 2018

File name

IE-SmPC-Odrik 2mg-CRN2199539-clean.docx

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)

Updated on 03 July 2018

File name

IE-PIL-Odrik-CRN2199539-emc.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 02 June 2017

Reasons for updating

  • New SPC for new product

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

Updated on 02 June 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

7. MARKETING AUTHORISATION HOLDER

Mylan IRE Healthcare Limited
Unit 35/36
Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland
BGP Products Ireland Limited
4051 Kingswood Drive
Citywest Business Campus
Dublin 24
Ireland


10. DATE OF REVISION OF THE TEXT

October 2016May 2017

Updated on 02 June 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

7. MARKETING AUTHORISATION HOLDER

Mylan IRE Healthcare Limited
Unit 35/36
Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland
BGP Products Ireland Limited
4051 Kingswood Drive
Citywest Business Campus
Dublin 24
Ireland


10. DATE OF REVISION OF THE TEXT

October 2016May 2017

Updated on 31 May 2017

File name

PIL_11487_735.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 May 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 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

4.4 Special warnings and precautions for use

Angioneurotic oedema

ItAngioedema has been reported with ACE inhibitors, including trandolapril. ACE inhibitors have been shown to cause a higher rate of angioedema in black patients than in non-black patients. The risk for angioedema may be increased in patients taking concomitant mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) therapy (see section 4.5).

Hyperkalaemia:

Hyperkalaemia may occur during treatment with ACE-inhibitors, especially in patients with renal impairment or diabetes mellitus.

Risk factors for the development of hyperkalaemia include renal insufficiency, potassium-sparing diuretics, the concomitant use of agents to treat hypokalaemia, diabetes mellitus and/or left ventricular dysfunction after myocardial infarction; or the concomitant use of other active substances associated with increases in serum potassium (e.g. co-trimoxazole also known as trimethoprim/sulfamethoxazole).

4.5 Interaction with other medicinal products and other forms of Interaction

Co-trimoxazole (trimethoprim/sulfamethoxazole)

Patients taking concomitant co-trimethoprim/sulfamethoxazole) may be at increased risk for hyperkalaemia (see section 4.4).

Other

Coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may increase the risk for angioedema) (see section 4.4).


10. DATE OF REVISION OF THE TEXT

March 2017May 2017

Updated on 26 May 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 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

Angioneurotic oedema

ItAngioedema has been reported with ACE inhibitors, including trandolapril. ACE inhibitors have been shown to cause a higher rate of angioedema in black patients than in non-black patients. The risk for angioedema may be increased in patients taking concomitant mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) therapy (see section 4.5).

Hyperkalaemia:

Hyperkalaemia may occur during treatment with ACE-inhibitors, especially in patients with renal impairment or diabetes mellitus.

Risk factors for the development of hyperkalaemia include renal insufficiency, potassium-sparing diuretics, the concomitant use of agents to treat hypokalaemia, diabetes mellitus and/or left ventricular dysfunction after myocardial infarction; or the concomitant use of other active substances associated with increases in serum potassium (e.g. co-trimoxazole also known as trimethoprim/sulfamethoxazole).

4.5 Interaction with other medicinal products and other forms of Interaction

Co-trimoxazole (trimethoprim/sulfamethoxazole)

Patients taking concomitant co-trimethoprim/sulfamethoxazole) may be at increased risk for hyperkalaemia (see section 4.4).

Other

Coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may increase the risk for angioedema) (see section 4.4).


10. DATE OF REVISION OF THE TEXT

March 2017May 2017

Updated on 13 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

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

Free text change information supplied by the pharmaceutical company

Section 4.4:
- Addition of warning in patients with creatinine clearance less than 30ml/min and patients receiving a diuretic treatment

-  Angioneurotic oedema: Addition of 'extremities' as another example of swelling

-  Paediatric population: Addition of a general statement for this patient population

 

Section 4.5: Addition of the interaction with mTOR (mammalian target of rapamycin)

Section 4.8: Revision of some current AE's into different MedRA System organ class and addition of new AE's

Updated on 13 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

Free text change information supplied by the pharmaceutical company

Section 4.4:
- Addition of warning in patients with creatinine clearance less than 30ml/min and patients receiving a diuretic treatment

-  Angioneurotic oedema: Addition of 'extremities' as another example of swelling

-  Paediatric population: Addition of a general statement for this patient population

 

Section 4.5: Addition of the interaction with mTOR (mammalian target of rapamycin)

Section 4.8: Revision of some current AE's into different MedRA System organ class and addition of new AE's

Updated on 20 April 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

Transfer of MAH from Abbott to BGP

Updated on 20 April 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Transfer of MAH from Abbott to BGP

Updated on 23 February 2015

Reasons for updating

  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Comprehensive changes throughout entire document

Updated on 23 February 2015

Reasons for updating

  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

Comprehensive changes throughout entire document

Updated on 19 May 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 4.9 - 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

Changes to the SPC as a result of TIB CSP (issued Aug 13)

Updated on 19 May 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 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Changes to the SPC as a result of TIB CSP (issued Aug 13)

Updated on 16 August 2013

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

- Change from joint SPC to individual SPCs
- Update to section 4.4: Changes to text regarding Anaphylactoid Reactions and LDL-Apheresis
- Update to section 4.5: Addition of text regarding cimetidine and injectable gold

Updated on 16 August 2013

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

- Change from joint SPC to individual SPCs
- Update to section 4.4: Changes to text regarding Anaphylactoid Reactions and LDL-Apheresis
- Update to section 4.5: Addition of text regarding cimetidine and injectable gold