Mirvaso Special Precautions

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.
Erythema and flushing: The effect of Mirvaso topical gel 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 Adverse Reactions).
The onset of flushing relative to application of Mirvaso topical gel varied, ranging from approximately 30 minutes to several hours (see Adverse Reactions).
In the majority of these cases, erythema and flushing resolved after discontinuation of Mirvaso topical gel.
In case worsening of erythema occurs, Mirvaso topical gel 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 topical gel. Prior to resuming treatment after temporary discontinuation due to aggravated erythema or flushing, perform a test application on a small area of the face for at least one day 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.
Mirvaso has not been studied in patients with renal or hepatic impairment.
Any increase in the daily amount applied and/or frequency of daily application of the medicinal product should be avoided, since the safety of higher daily doses or repeated daily application has not been assessed.
The concomitant use of other systemic alpha adrenergic receptor agonists may potentiate the undesirable effects of this class of medicinal products in patients: with severe or unstable or uncontrolled cardiovascular disease; with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, thrombangiitis obliterans, scleroderma, or Sjögren's syndrome.
The medicinal product contains methylparahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed), and propylene glycol which may cause skin irritation.
Effects on ability to drive and use machines: Mirvaso has no or negligible influence on the ability to drive and use machines.