Mirvaso 3mg/g Gel 30g

Rosacea Doctor Service

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. Enlarged blood vessels are thought to be the key factor in causing the redness of rosacea and by reducing the size of these vessels the symptoms of rosacea are successfully treated.

• Mirvaso acts to narrow these blood vessels again which reduces the excess blood flow and redness.
• Mirvaso can be used with other medical treatments of Rosacea and with cosmetic products.

In clinical trials it was demonstrated that Mirvaso is safe and effective at reducing redness with effects being seen as quickly as 30 minutes after application. Mirvaso remained effective throughout a yearlong study with

Mirvaso is suitable for adults aged 18 years or over

• It is not suitable for pregnant or breast eeding women or for application on open wounds.

A good self care guide and information for rosacea is available on the NHS website.

NHS - Rosacea

Things you can do to help

Rosacea is not caused by poor hygiene and it's not contagious. But there are things you can try to help with symptoms.

If you know that a trigger, for example alcohol or spicy food, makes symptoms worse, try to avoid it as much as possible.

If you have rosacea:

• wear a high SPF sunscreen of at least SPF 30 every day
• try to avoid heat, sunlight or humid conditions if possible
• try to cover your face in cold weather
• use gentle skincare products for sensitive skin
• clean your eyelids at least once a day if you have blepharitis
• take steps to manage stress.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you develop severe irritation or contact allergy (e.g. allergic reaction, rash), uncommon side effects, stop using Mirvaso and see your doctor.

Mirvaso may also cause the following other side effects:

Common side effects (may affect up to 1 in 10 people):

• skin redness, burning feeling of the skin or itching
• flushing

Uncommon side effects (may affect up to 1 in 100 people):

• worsening of rosacea
• skin rash, skin pain or discomfort, skin irritation or inflammation, dry skin, warm skin sensation, tingling or sensation of pins and needles
• acne
• swelling of the eyelid
• feeling hot
• feeling cold in hands and feet
• headache
• dry mouth
• nasal congestion.

For a full list of side effects, read the Patient Information Leaflet.

If you get any side effects, talk to your doctor, our Rightdose pharmacists or nurse. This includes any possible side effects not listed in this leaflet.

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Before taking any medication, it is important to read the Patient Information Leaflet. You can find information leaflets for your medicines by typing them into the search bar at medicines.org, or by contacting us.

Patient Information Leaflet Mirvaso 3mg/g Gel

Keep this medicine out of the sight and reach of children.

Mirvaso with alcohol

Tell your doctor if you consume alcohol regularly as this could affect your treatment with this medicine.

Pregnancy and breastfeeding

The use of Mirvaso is not recommended during pregnancy. This is because its effects on your unborn baby are unknown. You should not use this medicine during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

Mirvaso has no significant influence on the ability to drive and use machines.

Mirvaso contains:

• Methylparahydroxybenzoate which may cause allergic reactions (possibly delayed).
• Propylene glycol whichmay cause skin irritation.

How to store Mirvaso

• Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any special storage condition.
• Do not freeze.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Mirvaso Gel should be applied once every 24 hours providing when flushing is present.

You should wash your hands immediately after applying this medicine.

Directions:

• A small pea sized amount should be placed on the 5 areas of the face: forehead, chin, nose and cheeks.
• The gel should then be applied smoothly and evenly as a thin layer across the entire face avoiding the lips, eyes, eyelids, mouth and inside the nostrils. Should any gel get onto these areas, wash them immediately with plenty of water.

Mirvaso can be used with other medical treatments of Rosacea and with cosmetic products.

Further Important Information about Mirvaso Gel

• Mirvaso is intended for adults and only for use on the skin of the face.
• Do not use this medicine on other parts of your body, especially moist body surfaces, e.g. your eyes, mouth, nose or vagina.
• Do not swallow.
• Mirvaso is recommended to be applied to the face once a day only.

Keep Mirvaso gel away from children.

• Do not apply any other skin medicines or cosmetics immediately before the daily application of Mirvaso.
• You should use these products only after the applied Mirvaso has dried.

Do not use Mirvaso:

• if you are allergic to brimonidine or any of the other ingredients of this medicine
• 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 these medicines may result in a fall in blood pressure.

Warnings and precautions

Talk to your doctor, before using Mirvaso if:

• you have kidney or liver problems or have had them in the past.
• you have depression, decreased blood flow to the brain or the heart, fall in blood pressure on standing up, decreased blood flow to the hands, feet or skin, or Sjögren’s syndrome (a chronic disease in which the body’s natural defence - the immune system - attacks the moisture-producing glands).
• you have problems with your heart or circulation.
• the skin of your face is irritated or has open wounds.

If any of the above apply to you, talk to your doctor since this medicine may not be suitable for you.

Children and adolescents

• Do not give this medicine to children and adolescents under the age of 18 years because the safety and efficacy has not been established for this age group. This is particularly important in children under the age of 2 years.

Other medicines and Mirvaso

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, because these medicines could affect your treatment with Mirvaso or Mirvaso could affect your treatment with these medicines.

Ingredients:

The active substance is brimonidine. One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate.

The other ingredients are carbomer, methylparahydroxybenzoate (E218), phenoxyethanol, glycerol, titanium dioxide, propylene glycol, sodium hydroxide, purified water.

What Mirvaso looks like and contents of the pack

Mirvaso is a white to light yellow, opaque gel. It is supplied in tubes containing 2, 10 or 30 grams of gel.Pack size of 1 tube. Not all pack sizes may be marketed.