In case of severe irritation or contact allergy, the treatment with the medicinal product should be discontinued.Exacerbation of rosacea symptoms is very common in patients treated with Mirvaso. Children aged less than 2 years.Patients receiving monoamine oxidase (MAO) inhibitor therapy (for example selegiline or moclobemide) and patients on tricyclic (such as imipramine) or tetracyclic (such as maprotiline, mianserin or mirtazapin) antidepressants which affect noradrenergic transmission.Mirvaso should not be applied on irritated skin (including following laser therapy) or open wounds. subjects responding with a 2-grade reduction on both baseline CEA score and baseline PSA score on Day 29. This site uses cookies. Repeated doses within the same 24 hour period could result in side effects, such as low blood pressure , drowsiness or sleepiness.

It is important not to exceed the maximum daily dose of 1g (5 pea sized amounts applied to the whole face).If your symptoms worsen during treatment with Mirvaso (increased redness, or burning), stop treatment and make an appointment to see your doctor – see also warnings and precautions.You must avoid the eyes, eyelids, lips, mouth, and the inside of the nose. See also instructions ‘How to use Mirvaso’.Up to 1 in 6 patients experience the return of their redness worse than it was initially. Mirvaso gel is used to treat facial rosacea (enlarged facial blood vessels) in adults. This is because its effects on your unborn baby are unknown.You should not use this medicine during breast-feeding.If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.Mirvaso has no significant influence on the ability to drive and use machines.Always use this medicine exactly as your doctor has told you.
No dose adjustment is necessary.Mirvaso has not been studied in patients with hepatic and renal impairment.The safety and efficacy of Mirvaso in children and adolescents aged less than 18 years have not been established. By reporting side effects you can help provide more information on the safety of this medicine.Keep this medicine out of the sight and reach of children.Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. If you do not experience worsening of redness or burning, continue with the usual treatment (see section 3).In case of worsening or unexpected redness, discontinue the treatment and contact your doctor.If any of the above applies to you, talk to your doctor since this medicine may not be suitable for you.Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy has not been established for this age group. Ask your pharmacist how to throw away medicines you no longer use. For the full list of excipients, see section 6.1. These measures will help protect the environment.Mirvaso is a white to light yellow, opaque gel. Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. The expiry date refers to the last day of that month.This medicine does not require any special storage condition.Do not throw away any medicines via wastewater or household waste. See paragraph “How to use Mirvaso” above.To avoid spilling, do not squeeze the tube while opening or closing.Push down on the cap and turn counter clockwise (turn to the left). This includes any possible side effects not listed in this leaflet.You can also report side effects directly (see details below).

This means that every gram of Mirvaso gel contains 3.3mg of the active ingredient. Continue typing to refine. Risk of symptom exacerbation However, in the long term open label study, the efficacy and safety of Mirvaso, as described above, was not affected by the concomitant use of cosmetics or other medicinal products (e.g. Of these, 539 completed 29 days of treatment and had data available to be included in the efficacy analysis at Day 29, with the majority being Caucasians between 18 and 65 years of age.The primary endpoint was expressed in terms of composite success i.e. The studies were conducted in 553 randomised subjects aged 18 years and older who were treated once daily for 4 weeks with either Mirvaso or vehicle. Back to top Do not freeze.Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a high density polyethylene (HDPE) head and polyethylene (PE) child resistant closurePolyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes with a high density polyethylene (HDPE) head and polypropylene (PP) child resistant closure.Multidose container with airless pump system with child resistant closure.Polypropylene (PP) / Thermoplastic Polyolefin (TPO) / high density polyethylene (HDPE) and polypropylene (PP) child resistant closure.Pack sizes: 1 tube of 2 g,10 g or 30 g; 1 pump of 30 g.Tour Europlaza, 20 avenue André Prothin – La Défense 4Polyethylene (PE)/Copolymer/Aluminium (Al)/Copolymer/Polyethylene (PE) polyfoil tubes: EU/1/13/904/004Polypropylene (PP) / Thermoplastic Polyolefin (TPO) / high density polyethylene (HDPE) and polypropylene (PP) child resistant closure.Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, UKTo bookmark a medicine you must sign up and log in.To view the changes to a medicine you must sign up and log in.