Pred Mild
- Name:
Pred Mild
- Company:
Allergan Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/02/18

XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1. What PRED MILD is and what it is used for
1. What PRED MILD is and what it is used for
2. Do not use PRED MILD
2. Do not use PRED MILD
3. How to use PRED MILD
3. How to use PRED MILD
4. Possible Side Effects
4. Possible Side Effects
5. How to store PRED MILD
5. How to store PRED MILD
6. Contents of the pack and other information
6. Contents of the pack and other information

Print ViewKeyword Search SPC
1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Allergan Ltd

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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 10 May 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 February 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 February 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 5 February 2018 SPC
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 5 February 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to section 2 - what you need to know - warnings and precautions
Updated on 5 December 2017 SPC
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 4.8 (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 4 December 2017 PIL
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 SPC
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 PIL
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 SPC
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
Updated on 23 October 2014 PIL
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 SPC
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
|
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.
|
5.1 |
Pharmacodynamic properties |
Text added Pharmacotherapeutic group: corticosteroids, ATC code: S01BA04 |
10 |
Date of revision of text |
Text added September 2009 Replaces
|
Updated on 9 December 2009 PIL
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 24 June 2008 SPC
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
Updated on 12 June 2008 PIL
Reasons for updating
- Change to date of revision
Updated on 30 August 2007 SPC
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
Updated on 28 August 2007 PIL
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 SPC
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 9 August 2004 PIL
Reasons for updating
- New PIL for new product
Updated on 27 August 2003 SPC
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 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)