Mirvaso

• Used to treat rosacea
• Reduces facial redness
• Gel for use on the skin
• Not to be used while pregnant or breastfeeding

Mirvaso contains the active substance brimonidine, a medicine which narrows blood vessels. The gel is used to treat a skin condition called rosacea. Characteristics of rosacea include:

• Redness in areas of the face, especially the cheeks, forehead and tip of the nose.
• Acne (spots).
• Flare ups (periods when symptoms are particularly bad).
• Most common in women and usually starts after the age of 30.

Mirvaso does not cure rosacea. When applied, Mirvaso acts to narrow blood vessels which reduces the excess blood flow and redness.

Apply a pea-sized dose thinly and evenly to the nose, chin, cheeks and forehead. Do not apply to skin around the eyes, nostrils and mouth. Wash hands after use. You must avoid the eyes, eyelids, lips, mouth and inside of the nostrils. Should any gel get onto these areas, wash them immediately with plenty of water.

The gel is intended for use on the skin of the face. Do not use this medicine on other parts of the body, especially moist surfaces (e.g., eyes, mouth, nose or vagina).

You are allowed to use other topical medicines or make-up after Mirvaso gel, but ONLY after the gel has fully dried.

Dosage

Dosage varies per person and is determined by a doctor depending on the symptoms. The general dosage guidelines are as follows:

• Adults: apply a small, peasized amount once a day.

This medicine is not suitable for use in children.

Alcohol/driving

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

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

If you use too much/forget to use/stop using Mirvaso

If you use more than the maximum daily dose within a 24-hour period, contact your doctor. See your doctor or go to a hospital emergency department right away if you, a child, or anyone else accidentally swallows Mirvaso and has any of the following symptoms: feeling dizzy from low blood pressure, vomiting, tiredness or drowsiness, decreased or irregular heartbeats, small pupils (constricted pupils), difficulty or slow breathing, floppiness, low body temperature and convulsions (fits). Take the medicine pack with you, so the doctor knows what was swallowed.

Missed a dose? Mirvaso works on a daily basis, starting with the first day of treatment. If you miss a dose, your redness will not be reduced for that day. Do not use a double dose to make up for a forgotten dose.

Do not stop using Mirvaso without talking to your doctor.

Mirvaso is not suitable for everyone. Do not use this medicine:

• If you are allergic any of the ingredients in this medicine (see section ‘What Mirvaso contains').
• In children below two 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 for depression or Parkinson's disease including socalled monoamine oxidase (MAO) inhibitors (such as 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.

When should this medicine be used with caution?

Talk to your doctor before taking this medicine if:

• The skin of your face is irritated or has open wounds.
• You have problems with your heart or blood circulation.
• 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 system – the immune system – attacks the moistureproducing glands).
• You have, or have had, kidney or liver problems.

If any of the above applies to you, contact to your doctor. Mirvaso may not be suitable for you.

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 while breastfeeding.

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

Other medicines and Mirvaso

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Do not use Mirvaso with selegiline, moclobemide, imipramine, mianserin or maprotiline, which are medicines that can be used for depression and Parkinson's disease, as this could lead in a change in the effectiveness of Mirvaso or could increase the chances for side effects, such as a fall in blood pressure.

Also, tell your doctor if you are taking any of these medicines:

• Medicines used for the treatment of pain, sleep disorders or anxiety disorders.
• Medicines used for the treatment of psychiatric disorders (chlorpromazine) or for hyperactivity (methylphenidate) or high blood pressure (reserpine).
• Medicines which act on the same body mechanism as Mirvaso (other alpha agonists such as clonidine, socalled alpha blockers or alpha antagonists such as prazosin or isoprenaline which are most often used for the treatment of high blood pressure, slow heart rate or asthma).
• Cardiac glycosides (e.g., digoxin), used to treat heart problems.
• Blood pressurelowering medicines such as beta blockers or calcium channel blockers (e.g., propranolol, amlodipine).

If any of the above applies to you, of if you are unsure, talk to your doctor.

Like all medicines, this medicine can cause side effects, although some people may not experience any. If you develop uncommon side effects of severe skin irritation or contact allergy (such an allergic reaction or rash), discontinue the treatment and talk to 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, painful or uncomfortable feeling of the skin, skin irritation or inflammation, dry skin, warm skin, tingling or stinging sensation.
• Acne.
• Swelling of the eyelid.
• Feeling hot.
• Feeling cold in hands and feet.
• Headache.
• Dry mouth.
• Nasal congestion.

If you experience side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

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

Read the package leaflet before use. The official package leaflet of Mirvaso is available for download here.