Transiderm-Nitro 10 milligrams/24 hours Transdermal Patch * Pharmacy Only: Prescription
Company:
Novartis Ireland LimitedStatus:
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 19 September 2019
File name
Transiderm Nitro REG PIL 6513751 PF18-195 TBI 6 Jan 2019 IPHA_1568899023.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 29 August 2018
File name
Transiderm Nitro REG PIL 6513751 PF18-195 TBI 6 Jan 2019 IPHA_1535535605.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
Updated on 18 July 2018
File name
Transiderm Nitro 10 REG SPC PF18-195 July 2018_clean IPHA.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 July 2018
File name
Transiderm Nitro 5 REG SPC PF18-195 July 2018_clean IPHA.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 September 2015
File name
PIL_8538_72.pdf
Reasons for updating
- New PIL for new product
Updated on 16 September 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 28 July 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 July 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 27 June 2013
Reasons for updating
- Change of manufacturer
Updated on 20 March 2013
Reasons for updating
- Change of contraindications
Updated on 12 March 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
1. Inclusion the following contraindications in Section 4.3:
· Severe hypotension (systolic blood pressure less than 90mmHg)
· Severe hypovolaemia
2. Addition of the following text on hypoxaemia to ‘Precautions’ in section 4.4:
Updated on 22 May 2012
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
· Section 4.8: Addition of “palpitation” and “rash generalized” as post-marketing ADR
· Section 5.1, 5.2 and 5.3: Addition of pharmacological, pharmacokinetic and pre-clinical data
Updated on 22 May 2012
Reasons for updating
- Change to information about driving or using machinery
- Change due to user-testing of patient information
Updated on 17 January 2012
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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4:
Rewording
Addition of “Removal of the patch should be considered as part of the management of patients who develop significant hypotension.”
Removal of the precaution in patient with closed angle glaucoma.
Addition precaution in patients with G6PD deficiency induced anaemia
Section 4.5 Addition of “Concurrent administration of Transiderm Nitro with amifostine and acetyl salicyclic acid may potentiate the blood lowering effects of Transiderm Nitro.”
Section 4.6: Rewording
Section 4.7: Rewording
Section 4.8: Correction of typoographical error
Section 4.9: Rewording
Updated on 06 May 2010
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 6.6: More detailed disposal instructions added: "The patch should not be used if the seal is broken. When changing the patch, the used patch should be removed, the adhesive layer folded inwards on itself and the patch disposed of safely and out of reach and sight of children. Any used or unused patches should be discarded according to local requirements or returned to the pharmacy"
Updated on 28 April 2010
Reasons for updating
- Change of trade or active ingredient name
Updated on 17 July 2007
Reasons for updating
- Change of trade or active ingredient name
Updated on 12 July 2007
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 08 February 2006
Reasons for updating
- Change to warnings or special precautions for use
Updated on 10 October 2005
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 June 2005
Reasons for updating
- Correction of spelling/typing errors
Updated on 09 May 2005
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 May 2005
Reasons for updating
- Change to warnings or special precautions for use
- Change to information about pregnancy or lactation
- Change of contraindications
- Change to date of revision
- Change to side-effects
- Change to drug interactions
Updated on 26 August 2004
Reasons for updating
- New PIL for medicines.ie