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Maxidex 0.1% w/v Eye Drops, Suspension

*
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):

    Dexamethasone

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

Updated on 24 May 2022

File name

Maxidex Reg PIL_PF20-0250 and PF21-0115_Nov 2021_TBI13Feb2022_clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 27 August 2021

File name

Maxidex Reg PIL_PF20-0250_Aug 2021_TBI 13Feb2022_clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents

Updated on 26 August 2021

File name

Maxidex Eye Drops Suspension_REG SPC PF20-0250_clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 March 2021

File name

Maxidex Eye Drops Suspension_REGSPC PF20-0140 Feb 2021 clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 05 March 2021

File name

Maxidex REGPIL PF20-0140 Feb 2021 TBI by 26.08.2021 clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 12 October 2020

File name

Maxidex REG PILPF20-0044 March 2020IPHA.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 17 January 2020

File name

Maxidex REG PIL 641008 Clean IPHA.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 14 November 2018

File name

641008_IE_p1_LFT_IPHA.pdf

Reasons for updating

  • Change to marketing authorisation holder

Updated on 01 August 2018

File name

REG_SPC_Maxidex Eye Drops Suspension_PF18-02203clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 September 2017

File name

PIL_8794_771.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 07 September 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

- Section 4,4 and 4,8 updated

Updated on 07 September 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 30 May 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 7,8 and 10 updated following the approval of transfer of MAH from Alcon to Novartis.

Updated on 26 May 2017

Reasons for updating

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

Updated on 17 October 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

- Spc updated in line with Company core data sheet update. Updated sections 4.2, 4.3, 4.4, 4.5, 4,6 and section 4.8.

Updated on 14 October 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions

Updated on 09 January 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

    Section 4.8 updated

Updated on 08 January 2015

Reasons for updating

  • Change to drug interactions

Updated on 07 August 2014

Reasons for updating

  • Improved electronic presentation

Updated on 01 July 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 – 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

Section 4.2 - Updated to add Nasolacrimal statement

Section 4.3 – Updated information on herpes

 

Section 4.4 – Added information on risk of ocular hypertension in pediatric patients and corticosteroid-induced raised intraocular pressure in pre-disposed patients. Added warning regarding Concomitant use of topical NSAIDs and topical steroids

 

Section 4.5 - Added warning regarding Concomitant use of topical NSAIDs and topical steroids

 

Section 4.6 – Added “unless the clinical condition of the woman requires treatment with MAXIDEX.”

 

Section 4.8 – Added adverse event reporting information

Updated on 18 June 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 16 August 2013

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update of the MAH address and revision date

Updated on 13 August 2013

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 20 May 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 and 4.4 Amended, in addtion to section 10

Updated on 16 May 2013

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 10 June 2011

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In Section 6.3, Shelf life, the shelf life of the product has  been changed to 20 months, this is following a quality update.

In Section 10, Date of revision of the text, the date of revision is updated.

Updated on 28 April 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 06 April 2011

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In Section 4.3, Contraindications, ‘Acute, untreated purulent bacterial infections’ is added, and the whole section is reformatted.

In Section 4.4, Special warnings and precautions for use, additional safety information on corticosteroid usage and prolonged use of topical ophthalmic corticosteroids has been added, and the whole section is reformatted.

In Section 4.5, Interactions with other medicinal products and other forms of interaction, the following statement is added – ‘If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.’

In Section 4.6, Pregnancy and lactation, additional safety information on the use of Maxidex in pregnancy and during breast-feeding has been added.

In Section 4.7, Effects on ability to drive and use machines, the following statements are added – ‘Maxidex has no or negligible influence on the ability to drive and use machines. As with any topical ophthalmic medicinal product, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.’

In Section 4.8, Undesirable effects, the section is replaced with a summary of the safety profile, a tabulated list of adverse reactions, and a description of selected adverse reactions

In Section 4.9, Overdose, the following statement has been added – ‘An ocular overdose of Maxidex can be flushed from the eye(s) with lukewarm water.’

In Section 5.3, Preclinical data, additional preclinical data has been added.

In Section 10, Date of revision of the text, the date of revision is updated.

Updated on 04 June 2008

Reasons for updating

  • 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 9 Date of Renewal

Updated on 18 May 2005

Reasons for updating

  • Improved electronic presentation

Updated on 27 January 2005

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)