Mirvaso

Posology One application per 24 hours, at any time suitable for the patient, for as long as facial erythema is present. The maximum daily recommended dose is 1 g of gel in total weight, which corresponds to approximately five pea sized amounts.

Treatment should be initiated with a smaller amount of gel (less than the maximum) for at least one week. The amount of gel can then be increased gradually based on tolerability and patient response. 8). No dose adjustment is necessary.

Hepatic and renal impairment Mirvaso has not been studied in patients with hepatic and renal impairment. Paediatric population The safety and efficacy of Mirvaso in children and adolescents aged less than 18 years have not been established.

No data are available. 3). 9). Mirvaso should not be used in children or adolescents aged 2 to 18 years. Method of administration Cutaneous use only. Mirvaso should be applied smoothly and evenly as a thin layer across the entire face (forehead, chin, nose and both cheeks) avoiding the eyes, eyelids, lips, mouth and membrane of the inner nose.

Mirvaso should be applied only to the face. Hands should be washed immediately after applying the medicinal product. Mirvaso can be used in conjunction with other cutaneous medicinal products for the treatment of inflammatory lesions of rosacea and with cosmetics.

These products should not be applied immediately before the daily application of Mirvaso; they may be used only after the applied Mirvaso has dried.

3% of patients in clinical studies. They are typically mild to moderate in severity, and usually do not require discontinuation of treatment. 4). Tabulated list of adverse reactions The adverse reactions are classified by System Organ Class and frequency, using the following convention: 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 the available data) and were reported with Mirvaso either in clinical studies, or during the post-marketing experience (identified by an asterix (*) in Table 1).

Table 1 – Adverse reactions System Organ Class Frequency Adverse reactions Cardiac disorders Rare Bradycardia* Nervous system disorders Uncommon Headache, paraesthesia Eye disorders Uncommon Eyelid oedema Common Flushing, pallor at the application site* Uncommon Dizziness* Vascular disorders Rare Hypotension* Respiratory, thoracic and mediastinal disorders Uncommon Nasal congestion Gastrointestinal disorders Uncommon Dry mouth Common Erythema, pruritus, rosacea, skin burning sensation Uncommon Acne, allergic contact dermatitis, contact dermatitis, dermatitis, dry skin, pain of skin, skin discomfort, rash papular, skin irritation, skin warm, swelling face*, urticaria* Skin and subcutaneous tissue disorders Rare Angioedema* General disorders and administration site conditions Uncommon Feeling hot, peripheral coldness * Adverse reactions reported from post-marketing data.

Description of selected adverse reactions Bradycardia and hypotension Post-marketing cases of bradycardia, hypotension (including orthostatic hypotension) and dizziness have been reported, some of which required hospitalisation. 4).

Other special populations Elderly patients 6 No meaningful differences in the safety profiles were observed between the elderly subject population and subjects 18 to 65 years of age. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Mirvaso should not be applied on irritated skin (including following laser therapy) or open wounds. 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.

Across all clinical studies, 16% of patients receiving Mirvaso experienced an event of symptom exacerbation. 2). 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.

8). 8). 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 4 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 maximum dose (5 pea size amounts) and frequency of application (once daily). Mirvaso should not be applied close to the eyes. Concomitant use of other systemic alpha adrenergic receptor agonists 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.

1. 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.