Mirvaso 3mg/g Gel
- Name:
Mirvaso 3mg/g Gel
- Company:
Galderma International S.A.S. c/o Galderma (U.K) 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: 16/09/20

XPIL
Package leaflet: Information for the patient
Package leaflet: Information for the patient
1. What Mirvaso is and what it is used for
1. What Mirvaso is and what it is used for
2. What you need to know before you use Mirvaso
2. What you need to know before you use Mirvaso
3. How to use Mirvaso
3. How to use Mirvaso
4. Possible side effects
4. Possible side effects
5. How to store Mirvaso
5. How to store Mirvaso
6. Contents of the pack and other information
6. Contents of the pack and other information
Click on this link to Download PDF directly
Galderma International S.A.S. c/o Galderma (U.K) 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 16 September 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
Free text change information supplied by the pharmaceutical company
Various administrative changes
Updated on 10 February 2020 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- File format updated to PDF
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 13 July 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 13 July 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
Section 4.8 - addition of bradycardia and dizziness
Section 10 - date of revision of the text updated
Updated on 3 July 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 3 July 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 13 February 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 30 January 2017 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 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Information about exacerbation of rosacea
Section 6.5 - Change to packaging formnat
Updated on 19 December 2016 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 24 November 2016 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 18 January 2016 PIL
Reasons for updating
- Change to side-effects
Updated on 15 January 2016 SPC
Reasons for updating
- 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
Updated on 3 August 2015 SPC
Reasons for updating
- 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
4.4 Special warnings and precautions for use
Mirvaso should not be applied on irritated skin or open wounds. In case of severe irritation or contact allergy, the treatment with the medicinal product should be discontinued.
Treatment with the medicinal product should start on a small area of the face to test the tolerance.
Erythema and Flushing
The effect of Mirvaso begins to diminish hours after application. In some patients, erythema and flushing were reported to return with greater severity than was present at baseline. Most of the cases were observed within the first 2 weeks of starting the treatment (see section 4.8).
The onset of flushing relative to application of Mirvaso varied, ranging from approximately 30 minutes to several hours (see section 4.8).
In the majority of these cases, erythema and flushing resolved after discontinuation of Mirvaso.
In case worsening of erythema occurs, Mirvaso should be discontinued. Symptomatic measures, such as cooling, NSAID and antihistamines, may help in alleviating symptoms.
Recurrences of aggravated erythema and flushing have been reported after re-administration of Mirvaso. Prior to resuming treatment after temporary discontinuation due to aggravated erythema or flushing, it is advisable to first ensure restoration of the skin barrier function, if necessary, and perform a test application on a small area of the face before full facial application is resumed.
It is important to inform the patient not to exceed the recommended dose and frequency of application: once daily use in a thin layer.
Mirvaso should not be applied close to the eyes.
Updated on 3 August 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 21 January 2015 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - MA number
- 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
6.5 Nature and contents of container
[2g]
Polyethylene (PE)/Aluminium (Al)/ Polyethylene
(PE) laminated plastic tubes with a high density
polyethylene (HDPE) head and polypropylene (PP)
closure.
[10; 30g]
Polyethylene (PE)/Aluminium (Al)/ Polyethylene
(PE) laminated plastic tubes with a high density
polyethylene (HDPE) head and polypropylene (PP)
child resistant closure.
Or
[2g]
Polyethylene (PE)/Copolymer/Aluminium
(Al)/Copolymer/Polyethylene (PE) polyfoil plastic
tubes (kind of laminate) with a high density
polyethylene (HDPE) head and polyethylene (PE)
child resistant closure
[
10 g; 30g]
Polyethylene (PE)/Copolymer/Aluminium
(Al)/Copolymer/Polyethylene (PE) polyfoil plastic
tubes (kind of laminate) with a high density
polyethylene (HDPE) head and polypropylene (PP)
child resistant closure
8. MARKETING AUTHORISATION NUMBER(S)
Polyethylene (PE)/Aluminium (Al)/ Polyethylene
(PE) laminated plastic tubes :
EU/1/13/904/001
EU/1/13/904/002
EU/1/13/904/003
Polyethylene (PE)/Copolymer/Aluminium
(Al)/Copolymer/Polyethylene (PE) polyfoil plastic
tubes :
EU/1/13/904/004
EU/1/13/904/005
EU/1/13/904/006
Updated on 16 January 2015 PIL
Reasons for updating
- Addition of information on reporting a side effect.
- Change to date of revision
- Introduction of new pack/pack size
Updated on 12 March 2014 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 7 March 2014 PIL
Reasons for updating
- New PIL for new product