Transiderm-Nitro 10 milligrams/24 hours Transdermal Patch *
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited
  • 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 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

Change IMB to HPRA

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 1: Change in product name from Transiderm Nitro 10mg/24hrs to Transiderm Nitro 10/24hours
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

Name changed from Transiderm -Nitro 10 Patch to Transiderm-Nitro 10mg/24hr Transidermal Patch

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