Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
brimonidine tartrate
Galderma International
D11AX21
brimonidine
Other dermatological preparations
Skin Diseases
Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients.
Revision: 13
Authorised
2014-02-20
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MIRVASO 3 MG/G GEL brimonidine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Mirvaso is and what it is used for 2. What you need to know before you use Mirvaso 3. How to use Mirvaso 4. Possible side effects 5. How to store Mirvaso 6. Contents of the pack and other information 1. WHAT MIRVASO IS AND WHAT IT IS USED FOR Mirvaso contains the active substance brimonidine which belongs to a group of medicines commonly referred to as “alpha agonists”. It is applied to the skin of the face to treat redness due to rosacea in adult patients. Redness of the face due to rosacea is caused by high levels of blood flow in the facial skin, which is the result of enlargement (dilation) of the small blood vessels of the skin. When applied, Mirvaso acts to narrow these blood vessels again which reduces the excess blood flow and redness. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MIRVASO DO NOT USE MIRVASO: - if you are allergic to brimonidine or any of the other ingredients of this medicine (listed in section 6). - in children below 2 years of age, as they may be at greater risk of side effects from any of the medicine absorbed through the skin. - if you are taking certain medicines used for depression or Parkinson’s disease including so-called monoamine oxidase (MAO) inhibitors (for example selegiline or moclobemide) or tricyclic antidepressants (such as imipramine) or tetracyclic antidepressants (such as maprotiline, mianserin or mirtazapin). Use of Mirvaso when tak Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Mirvaso 3 mg/g gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate. Excipient(s) with known effect: One gram of gel contains 1 mg methylparahydroxybenzoate (E218) and 55 mg propylene glycol (E1520). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel. White to light yellow opaque aqueous gel. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mirvaso is indicated for the symptomatic treatment of facial erythema of rosacea in adult patients. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. _Special populations_ _Elderly patients_ The experience of use of Mirvaso in patients aged above 65 years is limited (see also section 4.8). 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 Mirvaso is contraindicated in children aged less than 2 years because of serious systemic safety risk (see section 4.3). Safety concerns related to the systemic absorption of brimonidine have also been identified for the age group 2 to 12 years (see section 4.9). 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, Przeczytaj cały dokument