Odrik 1mg Hard Capsules
*Company:
Mylan IRE Healthcare 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 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-1mg-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 1mg-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 1mg-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 30 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 30 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
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
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
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
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 4.8 - Undesirable effects
- 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
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 4.8 - Undesirable effects
- 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
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
- 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
- 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
Mylan IRE Healthcare Ltd
Address:
Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0)1707 853000 press 1