Transiderm-Nitro 5 milligrams/24 hours Transdermal Patch
- Name:
Transiderm-Nitro 5 milligrams/24 hours Transdermal Patch
- Company:
Novartis Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/09/19
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Novartis Ireland Limited
Company Products
When a pharmaceutical company changes any document, 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 19 September 2019 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 19 September 2019 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 29 August 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
Updated on 18 July 2018 SmPC
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 SmPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 16 September 2015 PIL
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 28 July 2015 SmPC
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 28 July 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 27 June 2013 PIL
Reasons for updating
- Change of manufacturer
Updated on 20 March 2013 PIL
Reasons for updating
- Change of contraindications
Updated on 12 March 2013 SmPC
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 24 May 2012 SmPC
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 PIL
Reasons for updating
- Change to information about driving or using machinery
- Change due to user-testing of patient information
Updated on 18 January 2012 SmPC
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 11 May 2010 SmPC
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 PIL
Reasons for updating
- Change of trade or active ingredient name
Updated on 17 July 2007 PIL
Reasons for updating
- Change of trade or active ingredient name
Updated on 12 July 2007 SmPC
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 8 February 2006 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 10 October 2005 SmPC
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 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 9 May 2005 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 6 May 2005 PIL
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 PIL
Reasons for updating
- New PIL for medicines.ie