Ganfort SD *

  • Company:

    Allergan Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

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

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 13 August 2021

File name

Ganfort UD PIL IE + MT v12_1628867646.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 01 April 2021

File name

Ganfort UD PIL UK + IE+MT-v11_1617311535.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 24 February 2020

File name

Ganfort UD PIL UK + IE+MT- v10_1582551283.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 February 2020

File name

Ganfort UD SPC IE v8_1582550083.pdf

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects), frequency of dizziness was updated to not known.  Adverse reactions ocular discomfort, hypertension and skin discolouration (periocular) were added.  Hypertension was removed from table 2.

In section 10 (date of the revision of the text), the revised date was updated to 13/02/2020

Updated on 27 August 2019

File name

Ganfort UD PIL UK+IE+MT - v9_1566921229.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 27 August 2019

File name

Ganfort UD SmPC IE - V7_1566921100.pdf

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects), hallucination was added (not known frequency).

In section 10 (date of the revision of text), the revised date was updated to 25/07/2019.

Updated on 28 March 2019

File name

Ganfort UD PIL UK+IE+MT-v8_1553790391.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 02 November 2018

File name

GANFORT SD PIL UK +IE V7_1541110586.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 01 November 2018

File name

Ganfort SD SPC IE V6_1541108776.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 6.3 (shelf life), shelf-life information was updated. Once the single-dose container is removed from the pouch, use within 7 days.  All single-dose containers should be kept in the pouch and discarded after 10 days from the first opening of the pouch.

In section 6.4 (special precautions for storage), storage conditions were updated.  Keep the single-dose containers in the pouch and place the pouch back in carton in order to protect against light and moisture.

In section 6.5 (nature of contents of container), available pack sizes were updated.  Cartons containing 5 single-dose containers in an aluminium foil pouch.  Cartons containing 30 or 90 single-dose containers in three or nine aluminium foil pouches respectively.  Each pouch contains 10 single-dose containers. 

In section 10 (date of revision of the text), the revised date was updated to 18th October 2018.

Updated on 01 June 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.4 (Special warnings and precautions for use) - "analogs" changed to analogues - update to correct typing error.

In section 4.6 (Fertility, pregnancy and lactation) - "Lactation" changed to "Breast-feeding" - update in line with QRD v 10.0.

In section 4.8 (Undesirable effects) - combining of Adverse Reaction Terms from both multi-dose and single-dose formulations into a single table, no change in content. Adverse reactions unique for multi-dose and single-dose formulations - indicated by footnotes. In case of overlapping terms between the tables, the higher frequency was adopted for the merged table.

In section 4.8 (Undesirable effects) - combining of Adverse Reaction Terms for Bimatoprost and Timolol monotherapy into a single table. Adverse reactions unique for timolol monotherapy and for bimatoprost monotherapy - indicated by footnotes.

In section 4.8 (Undesirable effects) - addition of asthma exacerbation and chronic obstructive pulmonary disease (COPD) exacerbation - Table 2, System Organ Class: Respiratory, thoracic and mediastinal disorders.

In section 10 (Date of revision of the text) - the date of revision of the text is 06.04.2017

Updated on 01 June 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 31 May 2017

File name

PIL_16011_226.pdf

Reasons for updating

  • New PIL for new product

Updated on 31 May 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 03 October 2016

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.4 (Special warnings and precautions for use) the heading "Hypoglycaemia/diabetes" has been replaced with "Endocrine disorders"

In section 4.8 (Undesirable effects), the following adverse reactions have been added:
- Under the SOC Immune system disorders with a frequency not known: hypersensitivity reactions including sings and symptoms of allergic dermatitis, angioedema, eye allergy
- Under the SOC Eye disorders with a frequency not known: eye swelling
-Under the SOC Cardiac disorders with a frequency not known: bradycardia
- Under the SOC Respiratory, thoracic and mediastinal disorders with a frequency not known: asthma dyspnoea

In table 2 (list of addition al adverse reactions reported with Ganfort (multi-dose formulation) that may potentially occur with Ganfort single-dose, the following adverse reactions have been added:
- Under the SOC Nervous system disorders with a frequency not known: dysguesia
- Under the SOC Eye disorders with a frequency not known: vision blurred
- Under the SOC Psychiatric disorders with a frequency not known: insomnia, nightmare
- Under the SOC Skin and subcutaneous tissue disorders with a frequency not known: alopecia

In section 10 (Date of revision of the text), the date of revision of the text is now 09/2016

Updated on 30 September 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 25 February 2016

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 14 October 2014

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to IMB/HPRA name

Updated on 06 October 2014

Reasons for updating

  • Change to MA holder contact details

Updated on 22 May 2014

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 22 May 2014

Reasons for updating

  • New PIL for medicines.ie