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 alpha₂-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

If 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.

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 be 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 use 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.

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.

If 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
• worsening of rosacea

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
• 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°C. Do not refrigerate below 2°C.

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.

Or

A PE/Al/PE copolymer polyfoil plastic tubes with a HDPE head and PE childresistant 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 is distributed in New Zealand by:

Healthcare Logistics’
58 Richard Pearce Drive
Airport OaksAuckland
Telephone 0800 174 104

Made in France

Australian Registration Number: AUST R 212325

® Registered Trademark

This leaflet updated in March 2019

Published by MIMS May 2019

1 Name of Medicine

Brimonidine (as tartrate).

2 Qualitative and Quantitative Composition

One gram of Mirvaso gel contains 5 mg of brimonidine tartrate equivalent to brimonidine 3.3 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Mirvaso gel is a white to light-yellow opaque gel.

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Dose and Method of Administration

Once daily application. Cutaneous use only.
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.
Mirvaso should be applied in five small pea-size amounts, the total estimated to be no more than 1 g, are applied to the main areas of the face (i.e. forehead, chin, nose, each cheek) once daily after the usual cleansing routine. No more than 1 g of gel per day should be used, and application to the eyes, eyelids, lips, mouth and membrane of the inner nose should also be avoided.
For optimal facial treatment, it is recommended that application is smooth and even across all areas of the face (forehead, chin, nose and both cheeks) to avoid accidental omission of areas, and minimise noticeable contrast between treated and untreated areas.
Mirvaso should be applied to the face only. Hands should be washed immediately after applying Mirvaso.
Other creams or lotions such as cosmetics and sunscreen may be applied after the application of Mirvaso. These products should not be applied immediately before the daily application of Mirvaso; they may be used only after the applied Mirvaso has dried.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients; children under 18 years of age; therapy with concomitant monoamine oxidase inhibitor (MAOI), tricyclic or tetracyclic antidepressants, which affect noradrenergic transmission.

4.4 Special Warnings and Precautions for Use

A definite diagnosis of rosacea should be made before treatment with Mirvaso is considered.
Mirvaso should not be applied on irritated skin (including following laser therapy) or open wounds.
If severe irritation or contact allergy occurs, treatment with Mirvaso should be discontinued.
The concomitant use of systemic alpha adrenergic receptor agonists may potentiate the undesirable effects of this class of medicinal products and should be used with caution 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 Sjogren's syndrome.
This product is not for use in the paediatric population. Keep out of reach of children.
Exacerbation of rosacea symptoms was reported in patients treated with Mirvaso. Treatment should be initiated with a small amount of gel and the dose increased gradually, based on tolerability and response to treatment.
The medicinal product contains methyl hydroxybenzoate (E218) which may cause allergic reactions (possibly delayed), and propylene glycol which may cause skin irritation.

Erythema and flushing.

Phototoxicity.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No interaction studies have been performed.
Monoamine oxidase (MAO) inhibitors may interfere with the metabolism of brimonidine and potentially result in an increased systematic side effect such as hypotension.
Mirvaso is contraindicated in 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 mirtazapine) antidepressants which affect noradrenergic transmission (see Section 4.3 Contraindications).
Brimonidine can also interact with tricyclic and tetracyclic antidepressants affecting the metabolism and uptake of circulating amines. It is not known whether the concurrent use of these agents with Mirvaso in humans can lead to resulting interference with the vasoconstrictive effect.
Although specific drug-drug interactions studies have not been conducted with Mirvaso, the possibility of an additive or potentiating effect with central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered.
No data on the level of circulating catecholamines after Mirvaso administration are available. Thus, caution is advised in patients taking medications which can affect the metabolism and uptake of circulating amines (e.g. chlorpromazine, methylphenidate, reserpine).
Brimonidine may cause clinically insignificant decreases in blood pressure in some patients. Caution is therefore advised when using medicinal products such as anti-hypertensives and/or cardiac glycosides concomitantly with brimonidine.
Caution is advised when initiating (or changing the dose of) a concomitant systemic substance (irrespective of pharmaceutical form) which may interact with alpha-adrenergic receptor agonist or interfere with their activity, i.e. agonists or antagonists of the adrenergic receptor, e.g. (isoprenaline, prazosin).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No specific studies on the effects of Mirvaso on the ability to drive and use machinery have been performed, however, no cases of fatigue and/or drowsiness were reported with Mirvaso during clinical trials. In addition, given the pharmacology and pharmacokinetics demonstrated with Mirvaso gel, negligible or no impact on driving and using machinery is expected when Mirvaso is used as recommended.

4.8 Adverse Effects (Undesirable Effects)

Overall, Mirvaso gel was shown to be well tolerated, with the most commonly (i.e. ≥ 1%) reported adverse drug reactions being erythema, pruritus, flushing and skin burning sensation, all occurring in 1.2 to 3.3% of patients. Adverse reactions were usually transient, mild to moderate in severity, and usually did not require discontinuation of treatment.
No meaningful differences in the safety profiles were observed between elderly subject population and subjects 18 to 65 years of age.
Rosacea was also experienced at a common frequency rate.

Erythema and flushing.

Adverse effects.

Open-label, long-term study.

Allergic contact dermatitis.

Post-marketing experience.

Vascular disorders.

Reporting suspected adverse effects.

4.9 Overdose

No information is available on overdose in adults with Mirvaso. However, serious adverse effects following inadvertent ingestion of Mirvaso by two young children of one clinical study subject have been reported. The children experienced symptoms consistent with previously reported oral overdoses of α₂-agonist in young children. Both children were reported to have made a full recovery within 24 hours.
Oral overdoses of other α₂-agonists have been reported to cause symptoms such as hypotension, asthenia, vomiting, lethargy, sedation, bradycardia, arrhythmias, miosis, apnoea, hypotonia, hypothermia, respiratory depression and seizure.
Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained. In the event of accidental application to the eyes, flush with a topical ocular irrigant.
For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

The pharmacodynamics (PD) of Mirvaso have been primarily undertaken in Caucasian subjects and the effect of race or gender on the PD is unknown.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

The pharmacokinetics (PK) of Mirvaso have been primarily undertaken in Caucasian subjects and the effect of race or gender on the PK is unknown.

Absorption and distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Carbomer 934P, methyl hydroxybenzoate (E218) phenoxyethanol; glycerol; titanium dioxide; propylene glycol; sodium hydroxide; purified water.
See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
Do not refrigerate below 2°C.

6.5 Nature and Contents of Container

Pack sizes.

2 g (sample pack).

10 g and 30 g (trade packs).

2 g (sample pack).

10 g and 30 g (trade packs).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription medicine.

Summary Table of Changes