Ganfort SD

To update the Product Information in line with the latest QRD template. 

To update the Product Information in line with the latest QRD template. 

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

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.

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.

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

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