MIRVASO

Main information

  • Trade name:
  • MIRVASO brimonidine 3.3 mg/g (as tartrate) gel tube
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MIRVASO brimonidine 3.3 mg/g (as tartrate) gel tube
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212325
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212325

MIRVASO brimonidine 3.3 mg/g (as tartrate) gel tube

ARTG entry for

Medicine Registered

Sponsor

Galderma Australia Pty Ltd

Postal Address

PO Box 502,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

4/08/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. MIRVASO brimonidine 3.3 mg/g (as tartrate) gel tube

Product Type

Single Medicine Product

Effective date

23/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

MIRVASO is indicated for the treatment of facial erythema of rosacea in adult patients

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Tube

Other plastic

laminate/Al

2 Years

Store below 25

degrees Celsius

Child resistant closure

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

2 g Physician's sample pack

(S4) Prescription Only Medicine

10 g

(S4) Prescription Only Medicine

30 g

(S4) Prescription Only Medicine

Components

1. MIRVASO brimonidine 3.3 mg/g (as tartrate) gel tube

Dosage Form

Route of Administration

Topical

Visual Identification

White to light yellow opaque gel

Active Ingredients

brimonidine tartrate

5 mg/g

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 23.11.2017 at 08:36:56 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

MIRVASO Consumer Medicine Information version 6

Page 1 of 3

MIRVASO

Gel

Brimonidine 3.3mg/g

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about

MIRVASO

. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and benefits

Your doctor has weighed the risks of

you using

MIRVASO

against the

benefits they expect it will have for you.

If you have any concerns about taking

this medicine, ask your doctor or

pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What MIRVASO is used

for

MIRVASO

contains the active

ingredient brimonidine tartrate that

belongs to a group of substances known

as alpha

-adrenergic receptor agonists.

MIRVASO

is used for treating skin of

the face affected by redness due to

rosacea in adult patients.

When applied to the skin,

MIRVASO

gel passes through the skin and acts

specifically on the blood vessels of the

face to decrease the redness of rosacea.

Ask your doctor if you have any

questions about why MIRVASO has

been prescribed for you.

Your doctor may have prescribed it for

another reason.

MIRVASO

is not addictive.

MIRVASO

is available only with a

doctor’s prescription.

Before you use

MIRVASO

When you must not use it

Do not use MIRVASO:

for any child or adolescents under 18

years of age

if you are breast-feeding

if you are taking medicines for

depression called monoamine

oxidase inhibitors (eg. Nardil,

Parnate) or tricyclic antidepressants

(such as imipramine) or tetracyclic

antidepressants (such as maprotiline,

mianserin or mirtazapine).

if you have an allergy to any

medicine containing brimonidine

tartrate

if you have an allergy to any of the

ingredients listed at the end of this

leaflet

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or

other parts of the body

rash, itching or hives of the skin

redness of skin

In case of discomfort and symptoms

such as heat, itchiness or rash in the

medicated or surrounding area,

discontinue treatment with

MIRVASO.

Do not use MIRVASO after the use by

(expiry) date printed on the pack or if

the packaging is torn or shows signs of

tampering.

If it has expired or is damaged, return it to

your pharmacist for disposal.

Before you start to use it

Tell your doctor if you have or have

had any of the following medical

conditions:

heart problems

kidney problems

liver problems

depression

circulatory problems

decreased blood flow of the brain or

the heart

decreased blood flow of the hands,

feet or skin

blood pressure disorders

Sjögren’s syndrome (a chronic

autoimmune disease in which a

person’s white blood cells attack

their moisture-producing glands)

Tell your doctor if you have allergies to

any other medicines, preservatives,

foods or dyes.

MIRVASO

contains methyl

hydroxybenzoate which may cause

allergic reactions (possibly delayed), and

propylene glycol which may cause skin

irritation.

Tell your doctor if you are pregnant or

plan to become pregnant.

Your doctor can discuss with you the

risks and benefits involved.

MIRVASO should not be used on

broken or irritated skin or on/close to

the mucosal areas such as:

eyes or eyelids

mouth

lips

membranes of the inner nose

or vagina

MIRVASO

comes into contact with

these areas, the area should be rinsed

immediately with plenty of water.

Mirvaso should not be used as a

lubricant or toothpaste

If you have not told your doctor about

any of the above, tell him/her before

you start using MIRVASO.

Taking other medicines

Tell your doctor or pharmacist if you

are taking any other medicines,

including any that you get without a

prescription from your pharmacy,

supermarket or health food shop.

MIRVASO Consumer Medicine Information version 6

Page 2 of 3

Some substances or medicines and

MIRVASO

may interfere with each

other. These include:

some antidepressant medicines

called tricyclic and tetracyclic

antidepressants (eg. amitriptyline or

Endep and maprotiline, mianserin or

mirtazapine) or monoamine oxidase

inhibitors (MAOIs, eg. Nardil,

Parnate) as they could result in

dangerously low blood pressure

anaesthetic or sedative medicines ,

opiates or daily consumption of

alcohol

some medicines for psychosis (eg.

chlorpromazine or Largactil) or for

hyperactivity (eg. methylphenidate

or Ritalin)

cardiac glycosides (e.g. digoxin),

used to treat heart problems.

blood pressure lowering medicine

such as beta-blockers or calcium

channel blockers (e.g. propranolol,

amlodipine).

These medicines may be affected by

MIRVASO

or may affect how well it

works. You may need different amounts

of your medicines, or you may need to

take different medicines.

Your doctor or pharmacist has more

information on medicines to be careful

with or avoid whilst using

MIRVASO

How to use MIRVASO

Follow all directions given to you by

your doctor or pharmacist carefully.

They may differ from the information

contained in this leaflet.

If you do not understand the

instructions on the box/tube, ask your

doctor or pharmacist for help.

How to use it

MIRVASO

is only intended for use on

the skin in adults.

It is recommended that

MIRVASO

applied once per day after your usual

cleansing routine, and before any

cosmetics or sunscreen are applied.

These products may be used only after

the applied

MIRVASO

has dried

Treatment should be initiated with a

smaller amount of gel (less than the

maximum) for at least one week with a

gradual increase in the amount of gel

based on tolerability and response.

Apply a small, pea size amount of

MIRVASO

to each of the five areas of

the face (ie. forehead, chin, nose, each

cheek) avoiding the eyes, eyelids, lips,

mouth and membranes of the inner nose.

Product should be applied smoothly and

evenly across your face in a thin layer.

Mirvaso should be applied to the face

only.

Hands should be washed after

applying

MIRVASO.

Mirvaso should not be applied on

irritated skin (including following

laser therapy)

How much to use

Five small pea size amounts of

MIRVASO

is the maximum daily

recommended dose.

Do not to exceed the recommended

maximum dose (1g of gel in total

weight or 5 pea sized amounts) and

frequency of application (once daily

use in a thin layer).

Any increase in the daily amount

applied and/or frequency of daily

application of Mirvaso should be

avoided, since the safety of higher daily

doses or repeated daily application has

not been assessed.

How to open the tube with a

child-resistant cap

To avoid spillage, do not squeeze the

tube while opening or closing. Push

down on the cap and turn in a counter

clockwise (to the left) a quarter of a

turn.

How to close the tube with a

child-resistant cap

Align grooves on the cap and tube. Push

down and turn clockwise (to the right) a

quarter turn.

How long to use it

Your doctor will tell you how long to

MIRVASO

Do not use MIRVASO for longer than

your doctor tells you.

If you use

MIRVASO

for longer than

your doctor tells you, the chance of side

effects may increase.

If you are not sure how long to use

MIRVASO, talk to your doctor.

What to do if it swallowed

Immediately telephone your doctor or

Poisons Information Centre

(telephone 13 11 26 in Australia or

0800 764766 in New Zealand), or go to

Accident & Emergency at your

nearest hospital, if you think that you

or anyone else may have swallowed

MIRVASO. Do this even if there are

no signs of discomfort or poisoning,

such as low blood pressure, fatigue,

vomiting, somnolence, decreased or,

irregular heartbeats, pupil

contraction, slow-low-breathing

frequency, floppiness, low body

temperature or convulsions. You may

need urgent medical attention. Keep

these telephone numbers handy.

While you are using

MIRVASO

Things you must do

Tell all doctors and pharmacists who

are treating you that you are using

MIRVASO.

If you feel that MIRVASO is not

helping your condition, tell your doctor

or pharmacist.

MIRVASO Consumer Medicine Information version 6

Page 3 of 3

Tell your doctor if, for any reason, you

have not used MIRVASO exactly as

prescribed.

Otherwise, your doctor may think that it

was not effective and change your

treatment unnecessarily.

If you become pregnant while using

MIRVASO, tell your doctor.

Things you must not do

Do not use MIRVASO to treat any

other complaint unless your doctor

tells you to.

Do not give your medicine to anyone

else, even if they have the same

condition as you.

Do not exceed the recommended dose

and frequency of application.

Things to be careful of

MIRVASO should not be used the

mucosal areas such as:

eyes or eyelids

mouth

lips

membranes of the inner nose

or vagina.

MIRVASO

comes into contact with

these areas, the area should be rinsed

immediately with plenty of water.

MIRVASO should not be used as a

lubricant or toothpaste.

Avoid excessive exposure to sunlight

and UV lamps.

Protect your skin when you are in the

sun, especially between 10 am and 3

pm. If outdoors, wear protective

clothing and use a non-comedogenic,

broad spectrum, SPF 50+ sunscreen

.

Ask your doctor if you are concerned

about the length of time you have been

using MIRVASO.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel well

while you are using MIRVASO.

All medicines can have side effects.

Sometimes they are serious, most of the

time they are not. You may need

medical treatment if you get some of the

side effects.

Ask your doctor or pharmacist to

answer any questions you may have.

The more common side effects of

MIRVASO include:

skin redness

itching of the skin

flushing of the skin

skin burning sensation.

too much whitening of the

application site

These side effects are usually mild

and short-lived. Tell your doctor if

you notice any of these and they

worry you.

The uncommon side effects of

MIRVASO

include:

skin discomfort, irritation, warmth

or pain

tingling or stinging at application

site

worsening of rosacea

dry skin or rash

dry mouth

swelling of the eyelids

feeling hot

headache

flu-like symptoms

nasal congestion

dizziness

swelling of skin

hives

swelling of face

upper respiratory tract infection

acne

The rare side effects of

MIRVASO

include:

low blood pressure

heart rate decrease

Some people may get other side effects

while using

MIRVASO.

Do not be alarmed by this list of

possible side effects.

You may not

experience any of them.

After using MIRVASO

Storage

MIRVASO should be stored in a cool,

dry place where the temperature stays

below 25

o

C.

Do not refrigerate below 2

Do not store it, or any other medicine,

in a bathroom or near a sink. Do not

leave them in the car or on windowsill.

Heat and dampness can destroy some

medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-

half metres (5 feet) above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop using

this medicine or the expiry date has

passed, ask your pharmacist what to do

with any medicine that is left over.

Product description

What it looks like

MIRVASO

is a white to light yellow,

opaque gel. It is supplied in either:

A PE/Al/PE laminated plastic tubes with

a HDPE head and plastic (PP) cap

containing 2 grams of gel (sample) or

with a plastic (PP) child-resistant cap

containing 10 or 30 grams (trade) of gel.

A PE/Al/PE copolymer polyfoil plastic

tubes with a HDPE head and PE child-

resistant cap containing 2 grams (sample)

or 10 or 30 grams (trade) of gel.

Not all pack sizes may be distributed in

Australia.

Ingredients

Each gram of

MIRVASO

contains

3.3mg of brimonidine as the active

ingredient.

It also contains the inactive ingredients:

glycerol

propylene glycol

carbomer 934P

phenoxyethanol

methyl hydroxybenzoate (E218)

titanium dioxide

sodium hydroxide

purified water

Sponsor/ distributor

Mirvaso is distributed in Australia by:

Galderma Australia Pty Ltd

Suite 4, 13B Narabang Way

Belrose NSW 2085

Ph 1800 800 765

MIRVASO Consumer Medicine Information version 6

Page 4 of 3

Mirvaso is distributed in New Zealand by:

Healthcare Logistics’

58 Richard Pearce Drive

Airport Oaks

Auckland

Telephone 0800 174 104

Made in France

Australian Registration Number:

AUST R 212325

® Registered Trademark

This leaflet was prepared in

August 2017

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