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Pred Mild

*
Pharmacy Only: Prescription

  • Company:

    AbbVie Limited

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Prednisolone Acetate

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

Updated on 17 December 2024

File name

Pred Mild SPC IE - December 2024.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Boron warning was updated inline with current regulations. Eyelid ptosis was added as an undesirable effects. Excipients names were corrected.

Updated on 16 December 2024

File name

Pred Mild PIL IE - December 2024.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains

Free text change information supplied by the pharmaceutical company

The document was updated to reflect a recent CCDS update to include eye lid drooping. Updates were made in the other sections to inline with QRD requirement.

Updated on 08 April 2022

File name

Pred Mild SPC IE..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 08 April 2022

File name

Pred Mild PIL IE.pdf

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 31 March 2021

File name

Pred Mild SPC IE -V6.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 2 (qualitative and quantitative composition), boric acid 1% w/v was added as an excipient with known effect.

In section 4.4 (special warnings and precautions for use), information regarding excipient boron was added.  Pred Mild should not be used in children less than 12 years old because of safety concerns over impairment of fertility.

In section 4.8 (undesirable effects), HPRA contact details were updated.

In section 10 (date of revision of the text), the revision date was updated to February 2021.

Updated on 31 March 2021

File name

Pred Mild PIL IE - V6.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 10 May 2018

Reasons for updating

  • New SPC for new product

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

Updated on 05 February 2018

File name

PIL_7974_698.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 05 February 2018

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8 (undesirable effects), eye pain was added.
  • In section 10 (date of revision of text), the revised date was added.

Updated on 05 February 2018

Reasons for updating

  • Change to section 6 - date of revision
  • Change to section 2 - what you need to know - warnings and precautions

Updated on 05 December 2017

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.4 (special warnings and precautions for use), a visual disturbance warning was added.

In section 4.8 (undesirable effects), a note was added to see section 4.4 for further information on blurred vision.

In section 10 (date of the revision of the text), the date of revision was updated to September 2017.

Updated on 04 December 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 17 February 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.5 (Interaction with other medicinal products and other forms of interaction) - update to indicate the increased risk of systemic side effects from co-treatment with CYP3A inhibitors, including cobicistat-containing products, following PRAC recommendation on signals adopted at the PRAC meeting in October 2016 and published by EMA in November 2016. The following wording, as requested by PRAC, has been added:

 Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

 -In section 10 (Date of revision of the text) - the date of revision of the text is February 2017

Updated on 16 February 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 23 October 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

To update SPC in line with CCDS V3

Updated on 23 October 2014

Reasons for updating

  • Change of contraindications
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision

Updated on 14 December 2009

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5 - Pharmacological properties
  • 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



Summary of Changes to Pred Mild® Irish Summary of Product Characteristics (SPC)

 

The current Pred Mild® SPC is dated November 2009

This supersedes SPC dated February 2008

 

 

Section Number

Subject

Change

4.2

Posology and method of administration

Text added

Shake well before use

Safety and effectiveness in paediatric patients have not been established. No posology can be recommended.

 

To reduce possible systemic absorption, it may be recommended that the lacrimal sac be compressed at the medial canthus (punctal occlusion) for 1 minute. This should be performed immediately following the instillation of each drop

4.4

Special warnings and precautions for use

Text added

Safety and effectiveness have not been demonstrated in children of the age group two years or below.

 

Systemic adverse events may occur with extensive use of topical steroids; punctal occlusion may be recommended (see Section 4.2).

 

Pred Mild contains benzalkonium chloride, which is irritant to the eye and could cause discoloration of soft (hydrophilic) contact lenses. The patient should avoid contact with contact lenses and therefore be instructed to remove them before Pred Mild is used and then wait for at least 15 minutes before reinsertion.

 

Pred Mild contains sodium metabisulphite, a sulphite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes. Sulphite sensitivity is seen more frequently in asthmatic patients.

 

 

4.6

Pregnancy and lactation

Text added

Administration of corticosteroids to pregnant animals has been associated with abnormalities of foetal development therefore this product should be used with caution during pregnancy only if the potential benefit outweighs the potential risk to the foetus.

4.7

Effects on ability to drive and use machines

Text added

Upon instillation, patients may experience transient blurred vision which may impair the ability to drive or use machinery. If affected, patients should not drive or use machinery until their vision has cleared.

 

Text deleted

Non known

4.8

Undesirable effects

Text added

Frequency categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from available data).

 

Immune system disorders

Not known:        Hypersensitivity,

                        Urticaria

 

Nervous system disorders

Not known:        Headache

 

Eye disorders   

Not known:       Intraocular pressure increased*

                        Cataract (including subcapsular)*           

Eye penetration (scleral or corneal perforation) *   

                        Eye infection fungal*

                        Eye infection viral*

                        Eye irritation

                        Vision blurred/Visual impairment            

Mydriasis

 

Gastrointestinal disorders

Not known:        Dysgeusia

Skin and subcutaneous tissue disorders

Not known:        Pruritus,

                        Rash

 

Systemic side effects may occur rarely with extensive use of topical steroids.*

 

* See Section 4.4 for further information.

 

Text deleted

The following events have been reported since the product was marketed:

Eye irritation.

Increased intraocular pressure which may be associated with optic nerve damage and defects in the visual fields.

Posterior subcapsular cataract formation.

Secondary ocular infections from fungi or viruses liberated from ocular tissues. Perforation of the globe when used in conditions where there is thinning of the cornea or sclera.

 

5.1

Pharmacodynamic properties

Text added

Pharmacotherapeutic group: corticosteroids,

ATC code: S01BA04

10

Date of revision of text

Text added

September 2009

Replaces

February 2008

 

 

Updated on 09 December 2009

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 24 June 2008

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 Added:
The following events have been reported since the product was marketed: Eye irritation.
Section 10 Changed to: 27th February 2008

Updated on 12 June 2008

Reasons for updating

  • Change to date of revision

Updated on 30 August 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • 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

Due to the extent of changes please follow the link below:
 

Updated on 28 August 2007

Reasons for updating

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

Updated on 16 August 2005

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

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

Updated on 09 August 2004

Reasons for updating

  • New PIL for new product

Updated on 27 August 2003

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

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