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Ibugel 5% w/w Gel

*
Pharmacy Only: Prescription

  • Company:

    Dermal Laboratories (Ireland) Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Ibuprofen

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

Updated on 20 June 2024

File name

IBUG-IPHA.PIL GP24-23-1a.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 June 2024

File name

IBUG-IPHA-SPC.pdf

Reasons for updating

  • 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 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, the following text has been added:

“Do not use during pregnancy or lactation.”


In section 4.4 Special warnings and precautions for use, the following text has been added:

“Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with the use of ibuprofen (see section 4.8). Most of these reactions occur within the first month. 

If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately and an alternative treatment considered (as appropriate).”


In section 4.6 Fertility, pregnancy and lactation, the following text has been added:

“Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed, and the duration of labour increased. Ibuprofen appears in breast milk in very low concentrations, but is unlikely to affect breast fed infants adversely.”


In section 4.8 Undesirable effects, the following highlighted text has been added to the table:


System Organ Class

Frequency

Adverse reaction

Skin and subcutaneous tissue disorders

 

Very rare

Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis)

Not known

Photosensitivity reactions

Skin rash

Pruritus

Skin irritation

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

Acute generalised exanthematous pustulosis (AGEP)

In section 10 Date of revision of the text, the date has changed to “June 2024”.

Updated on 23 January 2023

File name

IBUG-IPHA.SPC.pdf

Reasons for updating

  • Document format updated

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

Updated on 15 June 2022

File name

IBUG-IPHA.PIL.GP24-22-1.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 22 April 2021

File name

IBUG-IPHA.PIL.GP9-21-1.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 31 March 2021

File name

IBUG-IPHA.PIL.TEXT.ie-pl-clean-rfi.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 31 March 2021

File name

IBUG-IPHA.SPC.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 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

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

Updated on 17 February 2021

File name

IBUG-IPHA.PILGP9-20-1.pdf

Reasons for updating

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

Updated on 17 December 2020

File name

IBUG-IPHA.SPC.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 31 August 2018

File name

IBUG-IPHA.SPC.21.04.15.23.04.15.pdf

Reasons for updating

  • File format updated to PDF

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

Free text change information supplied by the pharmaceutical company

File format updated to PDF

Updated on 23 April 2015

File name

PIL_8664_494.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 April 2015

Reasons for updating

  • New SPC for new product

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

Updated on 23 April 2015

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
  • Improved electronic presentation

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, the following text has been added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.  Website: www.hpra.ie; E-mail: medsafety@hpra.ie.



In section 10 Date of revision of the text, the date has changed to "April 2015"

Updated on 23 April 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 01 September 2014

Reasons for updating

  • Change to date of revision
  • Removal/change of distributor

Updated on 18 September 2012

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.2 - Posology and method of administration
  • 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 4.2 (Posology and method of administration) the following text has been added "Adults, including the elderly, and children over 12 years"
and the following text has been removed: "The same dosage and dosage schedule applies to all age groups, although ..."

In section 4.6 (Pregnancy and lactation) the following text has been added "Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during pregnancy.  The onset of labour may be delayed, and the duration of labour increased.  Ibuprofen appears in breast milk in very low concentrations, but is unlikely to affect breast fed infants adversely."

In section 4.8 (Undesirable effects) the following text has changed: "Mild skin rashes, itching or irritation may occur at the site of application, but are very rare (based on spontaneous reporting).  Susceptible patients may experience the following side effects with ibuprofen, but these are very rare (based on spontaneous reporting) when ibuprofen is administered topically."

In section 10 (Date of revision of text) the date has changed to " September 2012"

Updated on 14 September 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 16 March 2011

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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

In section 1 (Name of the Medicinal Product) "Gel" has been added.

In section 2 (Qualitative and Quantitative Composition) the text has changed to: "Each gram of gel contains 50 mg ibuprofen (5.0% w/w).  Excipients: also contains propylene glycol 2.0% w/w.  For a full list of excipients, see section List of excipients."

In section 9 (Renewal of the Authorisation) the date has changed to "19 September 2010"

In section 10 (Date of Revision of the Text) the date has changed to "February 2011"

Updated on 15 March 2011

Reasons for updating

  • Change to further information section
  • Change to dosage and administration
  • Introduction of new pack/pack size
  • Change to product name

Updated on 11 March 2009

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 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) the following text has been added:  "Experimental data suggest that oral ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1)."
 
In section 5.1 (Pharmacodynamic properties) the following text has been added:
"Experimental data suggest that oral ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use."
 
In section 10 (Date of revision of the text) the date has changed to:
"February 2009"
 
 

Updated on 11 March 2009

Reasons for updating

  • Change to drug interactions

Updated on 22 October 2008

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.5 (Interaction with other medicinal products and other forms of interaction) : The following text has been added: "Concurrent aspirin or other NSAIDS may result in an increased incidence of adverse reactions."
 
In Section 4.8 (Undesirable effects) : The following text has been added: "Occasionally mild skin rashes, itching or irritation may occur at the site of application."
 
In Section 10 (Date of revision of the text) : The date has changed to "August 2008."

Updated on 12 August 2008

Reasons for updating

  • Change due to user-testing of patient information

Updated on 13 August 2007

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Section 4.4 - Special warnings and precautions for use: The text 'For external use only' has been removed.
 
Section 6.5 - Nature and contents of container: The text 'This is supplied as an original pack (OP)' has been removed.

Updated on 18 August 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Section 1 - Name of the medicinal product: Changed from "IBUGEL" to "IBUGEL 5% w/w"
 
Section 4.4 - Special warnings and precautions for use: Text added "The excipient propylene glycol may on rare occasions cause skin irritation in sensitive people."
 
Section 6.1 - List of excipients: "IMS" deleted and replaced with "Industrial Methylated Spirit"
 
Section 6.6 - Instructions for use and handling: "No special instructions" changed to "No special requirements."
 
Section 9 - Renewal of authorisation: Changed to "19 September 2005"
 
Section 10 - Date of revision of the text: Changed to "December 2005"
 
 

Updated on 16 August 2005

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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)

Updated on 07 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 June 2003

Reasons for updating

  • New SPC for medicines.ie

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