Mirvaso 3mgg gel

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Brimonidine tartrate

Tillgänglig från:

Galderma (UK

ATC-kod:

D11AX21

INN (International namn):

Brimonidine tartrate

Dos:

3mg/1gram

Läkemedelsform:

Gel

Administreringssätt:

Cutaneous

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 13060300; GTIN: 5020465200895

Bipacksedel

3 mg/g gel
BRIMONIDINE
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, who 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 taking

Produktens egenskaper

OBJECT 1
MIRVASO 3MG/G GEL
Summary of Product Characteristics Updated 07-Jul-2017 | Galderma
(U.K) Ltd
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.
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).
_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.
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, chin, nose
and both cheeks) avoiding the eyes, eyelids, lips, mouth and membrane
of the inne