Pred Forte
*Company:
AbbVie LimitedStatus:
UpdatedLegal 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
Updated on 17 December 2024
File name
Pred Forte 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Boron warning updated based on new regulations. Eyelid ptosis added as a undesirable side effect. Correction in excipient's name.
Updated on 16 December 2024
File name
Pred Forte 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 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 Forte SPC IE V6.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 not be renewed (A)
Updated on 08 April 2022
File name
Pred Forte PIL IE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 31 March 2021
File name
predforte-spc-rtq2-clean-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
- 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 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 Forte 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 26/03/2021.
Updated on 31 March 2021
File name
predforte-pil-rtq2-clean-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 05 February 2018
File name
PIL_7973_337.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 not be renewed (A)
Updated on 05 February 2018
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), eye pain was added.
- In section 10 (date of revision of the text), the revised date was added.
Updated on 05 February 2018
Reasons for updating
- 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 not be renewed (A)
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 revision date 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 not be renewed (A)
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 22 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 October 2014
Reasons for updating
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to how the medicine works
- Change to further information section
- Change to date of revision
Updated on 19 April 2010
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 adults
Section 4.2 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.
Section 4.4 Added
Systemic adverse events may occur with extensive use of topical steroids; punctal occlusion may be recommended (see Section 4.2).
The possibility of adrenal suppression should be considered with prolonged, frequent, use of high dose topical steroids, particularly in infants and children.
Section 4.8 added
The following undesirable effects have been reported following use of Pred Forte.
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
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
The possibility of adrenal suppression should be considered, particularly in infants and children.*
* See Section 4.4 for further information.
Deleted
Eye penetration (when used in conditions where there is thinning of the cornea or sclera), Intraocular pressure increased (which may be associated with optic nerve damage and defects in the visual fields), Eye infection viral (secondary), Eye infection fungal (secondary), Cataract subcapsular, Eye irritation.
Section 5.1 Added
Pharmacotherapeutic group: corticosteroids,
ATC code: S01BA04
Section 10
Deleted 15th October 2008
Added 1st April 2010
Updated on 13 April 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
Updated on 02 December 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 28 November 2008
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Summary of Changes to Pred Forte Irish Summary of Product Characteristics (SPC)
The current Pred Forte SPC is dated October 2008
This supersedes SPC dated May 2008
|
Section Number |
Subject |
Change |
|
4.2 |
Posology and method of administration |
Words (see section 4.4) deleted |
|
4.3 |
Contraindications |
Rewording of section |
|
4.4 |
Special warnings and precautions for use |
Wording added and some re-wording / organisation of existing text: Use of intraocular steroids may prolong the course and may exacerbate the severity of many viral infections on the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of the patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is mandatory. Since Pred Forte contains no antimicrobial, if infection is present appropriate measures must be taken to counteract the organism involved. Acute purulent untreated infection of the eye may be masked or activity enhanced by presence of steroid medication. As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid applications, fungal invasion must be suspected in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. Corticosteroids are not effective in mustard gas keratitis and Sjogrens keratoconjunctivitis. Wording deleted: Use in children is only recommended under medical supervision. |
|
4.6 |
Pregnancy and lactation |
Wording added: Therefore this product should be used with caution during pregnancy only if the potential benefit outweighs the potential risk to the foetus. It is not known whether topical administration of Pred Forte could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore, use is not recommended in women breast feeding infants. |
|
4.8 |
Undesirable effects |
Some wording added and expansion / rewording of existing text Wording added: Eye penetration (when used in conditions where there is thinning of the cornea or sclera) |
|
5.3 |
Preclinical safety data |
Wording added: In rabbit eyes, no toxic effects were observed after application of approx. 6 mg prednisolone acetate per day over 20 days as a 1% suspension. Also, no toxic effects were observed after a single oral administration of 500 mg/kg in rats. |
|
10 |
Date of revision of text |
Date amended from 23 May 2008 to 15th October 2008 |
Updated on 26 August 2008
Reasons for updating
- PIL re-instated
Updated on 22 August 2008
Reasons for updating
- Addition of manufacturer
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Previous SPC re-instated
Updated on 15 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 not be renewed (A)
Updated on 09 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 05 August 2004
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 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 not be renewed (A)
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)