Package Insert: Information for the Patient

Mirvaso 3 mg/g Gel

brimonidine

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this package insert. See section 4.

Mirvaso contains the active ingredient brimonidine, which belongs to a group of medicines commonly known as “alpha agonists”.

It is applied to the skin of the face to treat facial redness caused by rosacea in adult patients.

Facial redness caused by rosacea is due to high levels of blood flow in the skin of the face, which is the result of an increase in size (dilation) of the small blood vessels in the skin.

When applied, Mirvaso acts by constricting these blood vessels, which reduces excessive blood flow and redness.

Do not use Mirvaso:

• If you are allergic to brimonidine or any of the other components of this medication (listed in section 6).
• In children under 2 years of age, as they may have a higher risk of adverse effects from any medication that is absorbed through the skin.
• If you are taking certain medications used for depression or Parkinson's disease, including monoamine oxidase inhibitors (MAOIs) (such as selegiline or moclobemide) or tricyclic antidepressants (such as imipramine) or tetracyclic antidepressants (such as maprotiline, mianserine, or mirtazapine). The use of Mirvaso when taking these medications may cause a drop in blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Mirvaso, especially if:

• Your skin on your face is irritated or has open wounds.
• You have heart problems or circulatory issues.
• You have depression, decreased blood flow to the brain or heart, low blood pressure when standing, decreased blood flow to the hands, feet, or skin, or Sjögren's syndrome (a chronic disease in which the body's natural defenses - the immune system - attack the glands that produce moisture).
• You have kidney or liver problems or have had them in the past.
• You have undergone or plan to undergo any skin laser procedures on your face.

It is essential to start treatment with a small amount of gel, gradually increase the dose, but do not exceed the maximum dose of 1 gram (approximately 5 times the size of a pea). See also the instructions "How to use Mirvaso".

Do not apply Mirvaso more than once a day and do not exceed the maximum daily dose of 1 gram (approximately 5 times the size of a pea). See also the instructions "How to use Mirvaso".

Worsening of skin redness, flushing, or burning sensation:

Up to 1 in 6 patients experience worsening redness. This worsening of redness typically develops within the first 2 weeks of treatment with Mirvaso. It usually resolves spontaneously after discontinuing treatment. The effect should gradually disappear in a few days in most cases. Before reinitiating treatment with Mirvaso gel, test it on a small area of the face on a day when you can stay at home. If you do not experience worsening redness or burning sensation, continue with the usual treatment (see section 3).

In case of unexpected worsening or redness, discontinue treatment and contact your doctor.

If any of the above applies to you, speak with your doctor as this medication may not be suitable for you.

Children and adolescents

Do not administer this medication to children and adolescents under 18 years of age, as its safety and efficacy have not been established in this age group. This is especially important in children under 2 years of age (see Do not use Mirvaso).

Other medications and Mirvaso

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, as these medications may affect your treatment with Mirvaso or Mirvaso may affect your treatment with these medications.

Do not use Mirvaso with selegiline, moclobemide, imipramine, mianserine, or maprotiline, which are medications used for depression or Parkinson's disease, as this may cause a change in Mirvaso's effectiveness or increase the risk of adverse effects such as low blood pressure (see Do not use Mirvaso).

Also, inform your doctor if you are taking any of the following medications:

• Medications used for pain, sleep disorders, or anxiety disorders.

• Medications used for psychiatric disorders (chlorpromazine) or used for hyperactivity (methylphenidate) or, used for high blood pressure (reserpine).
• Medications that work in the same way as Mirvaso (other alpha agonists, e.g., clonidine; alpha blockers or antagonists, e.g., prazosin, isoproterenol, primarily used for high blood pressure, slow heart rate, or asthma).
• Cardiac glycosides (e.g., digoxin), used for heart problems. - Medications to reduce blood pressure, such as beta blockers or calcium channel blockers (e.g., propranolol, amlodipine)

If any of the above applies to you, or if you are unsure, speak with your doctor.

Use of Mirvaso with alcohol

Inform your doctor if you consume alcohol regularly, as this may affect your treatment with this medication.

Pregnancy and breastfeeding

It is not recommended to use Mirvaso during pregnancy, as its effects on the fetus are unknown. Do not use this medication during breastfeeding, as it is unknown whether this medication passes into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

Mirvaso has an insignificant influence on the ability to drive and operate machinery.

Mirvaso contains

• Propylene glycol (E1520),which may cause skin irritation.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Important:Mirvaso is indicated for adults and only for use on the skin of the face. Do not use this medication on any other part of your body, especially on moist body surfaces, for example, the eyes, mouth, nose, or vagina.

Do not ingest.

Keep Mirvaso out of the reach of children.

How to use Mirvaso

It is recommended to apply Mirvaso to the face only once a day.

During the first week, start treatment with a small amount of gel (a quantity the size of a pea) as indicated by your doctor or nurse.

If symptoms remain the same or only slightly improve, you can gradually increase the amount of gel used. Gently and evenly spread a very thin layer as indicated by your doctor or nurse. It is essential not to exceed the maximum daily dose of 1 gram (a quantity 5 times the size of a pea, applied to the entire face).

Wash your hands immediately after applying this medication.

If worsening of symptoms occurs during treatment with Mirvaso (increase in redness or burning sensation on the skin), discontinue treatment and schedule an appointment with your doctor. See also section 2 "Warnings and precautions".

Apply a small amount of gel, the size of a pea, to the front, chin, nose, and both cheeks, and then gently and evenly spread a thin layer on each area. Do not exceed the recommended total daily dose (5 quantities the size of a pea). Avoid the eyes, eyelids, lips, mouth, and nasal passages. If you apply the product to these areas, wash them immediately with plenty of water. If you experience worsening redness or burning sensation on the skin, stop using Mirvaso and contact your doctor if necessary.

Do not apply any other skin medication or cosmetics immediately before the daily application of Mirvaso.

Use these products only after applying Mirvaso, once it has dried.

Pay attention when opening the tube/ pump for the first time, to avoid spilling more gel than necessary. If this occurs, discard the excess gel to avoid applying more than the recommended dose. See the previous paragraph "How to use Mirvaso".

[EU/1/13/904/004-006]

How to open the child-resistant cap tube

Do not squeeze the tube when opening or closing it to avoid spilling.

Press the cap and turn it counterclockwise (turn to the left). Then remove the cap.

How to close the child-resistant cap tube

Press and turn clockwise (turn to the right).

[EU/1/13/904/007]

How to open the child-resistant safety pump

Press the cap and turn counterclockwise (turn to the left).

Note: When the cap is removed, the pump is no longer child-resistant.

Before using it for the first time, prime the pump. To do this, press the pump several times until the medication comes out.

To apply Mirvaso gel to the face, place a quantity of Mirvaso gel the size of a pea on the tip of your finger. Continue pressing down the pump to obtain the quantity the size of a pea that you need according to your doctor's prescription (but not more than 5 times the size of a pea in total).

To close the pump, put the cap back on. Press the cap and turn clockwise (in the direction of the clock hands) until it stops. The pump will become child-resistant again.

If you use more Mirvaso than you should

If you use a quantity greater than the maximum daily dose of 1 gram in a 24-hour period, this could cause skin irritation or other adverse effects at the application site. Repeated doses in the same 24-hour period could cause adverse effects, such as low blood pressure, numbness, or drowsiness.

Contact your doctor, who will advise you on what action to take.

If someone, especially a child, accidentally ingests Mirvaso, they may experience severe adverse effects and require hospital treatment.

Consult your doctor immediately or go to the hospital emergency department if you, a child, or someone else ingests this medication and experiences any of the following symptoms: dizziness due to low blood pressure, vomiting, fatigue, or drowsiness, slow or irregular heartbeats, constricted pupils, difficulty or shallow breathing, weakness, low body temperature, or convulsions. Bring the medication packaging with you so that the doctor can know what was ingested.

If you forget to use Mirvaso

Mirvaso acts daily, starting on the first day of treatment. If you forget a daily dose, the redness will not decrease that day. Do not apply a double dose to compensate for the missed doses and continue your treatment as prescribed.

If you interrupt treatment with Mirvaso

A possible consequence of discontinuing treatment before completing it is that the disease may return to its initial state. Please ask your doctor before discontinuing treatment, so they can advise you on a substitute treatment if necessary.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

If you experience rare adverse effects such as intense irritation or inflammation of the skin, skin rash, skin pain or discomfort, dry skin, sensation of heat on the skin, tingling or pins and needles, facial swelling, or frequent adverse effects such as worsening of rosacea, discontinue treatment and speak with your doctor as this medication may not be suitable for you. In some cases, symptoms may extend beyond the treatment area. See also section 2 “Warnings and Precautions”

If you develop contact allergy (e.g., allergic reaction, rash), or rare angioedema (severe allergic reaction usually accompanied by facial, mouth, or tongue swelling), stop using Mirvaso and seek medical advice promptly.

Mirvaso may also cause the following adverse effects:

Frequent adverse effects (may affect up to 1 in 10 people):

• Redness
• Excessive whitening (pallor) at the site where the gel is applied
• Skin redness, sensation of burning on the skin, or itching

Rare adverse effects (may affect up to 1 in 100 people):

• Acne
• Nasal congestion
• Headache
• Swelling of the eyelids
• Sensation of heat
• Sensation of cold in the hands and feet
• Dry mouth
• Urticaria
• Dizziness

Rare adverse effects (may affect up to 1 in 1,000 people):

• Hypotension (decreased blood pressure)
• Decreased heart rate (slow heart rate, known as bradycardia)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box, tube, and pump after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not freeze.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Mirvaso

• The active ingredient is brimonidine. One gram of gel contains 3.3 mg of brimonidine, equivalent to 5 mg of brimonidine tartrate.
• The other components are carbomer, methyl parahydroxybenzoate (E218), phenoxethanol, glycerol, titanium dioxide, propylene glycol (E1520), sodium hydroxide, purified water. See the end of section 2 for information on methyl parahydroxybenzoate and propylene glycol.

Appearance of the product and contents of the pack

Mirvaso is a translucent gel that is white to light yellow in colour. It is available in tubes containing 2, 10 or 30 grams of gel or in an airless pump system containing 30 g of gel.

Pack with 1 tube or 1 pump.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Galderma International

Tour Europlaza, 20 avenue André Prothin – La Défense 4

La Défense Cedex 92927

France

Responsible Person

Laboratoires Galderma

Z.I. Montdésir

74540 Alby-sur-Chéran

France

Or

Galderma Laboratorium GmbH

Toulouser Allee 19a-23a

D-40211 Düsseldorf

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.