Mirvaso 3 mg/g gel

Patient Information Leaflet

Introduction

Patient Information Leaflet

Mirvaso 3 mg/g gel

brimonidine

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

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

Leaflet Contents

1. What Mirvaso is and what it is used for
2. What you need to know before using Mirvaso
3. How to use Mirvaso
4. Possible side effects
5. How to store Mirvaso
6. Contents of the pack and other information

1. What Mirvaso is and what it is used for

Mirvaso contains the active substance brimonidine, which belongs to a group of medicines commonly known as "alpha agonists".

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

Facial redness due to rosacea is caused by increased blood flow in the facial skin, resulting from enlargement (dilation) of the small blood vessels in the skin.

When applied, Mirvaso works by narrowing these blood vessels, thereby reducing excess blood flow and redness.

2. What you need to know before using Mirvaso

Do not use Mirvaso:

• if you are allergic to brimonidine or to any of the other ingredients of this medicine (listed in section 6).
• in children under 2 years of age, as they may be at higher risk of adverse effects from any medicine absorbed through the skin.
• if you are taking certain medicines used for depression or Parkinson's disease, including monoamine oxidase inhibitors (MAOIs) (e.g. selegiline or moclobemide), tricyclic antidepressants (such as imipramine), or tetracyclic antidepressants (such as maprotiline, mianserina or mirtazapine). Using Mirvaso while taking these medicines may cause a drop in blood pressure.

Warnings and precautions

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

• the skin on your face is irritated or has open wounds.
• you have heart or blood circulation problems.
• you have depression, reduced blood flow to the brain or heart, low blood pressure upon standing, reduced blood flow to the hands, feet or skin, or Sjögren's syndrome (a chronic condition in which the body's natural defenses – the immune system – attack moisture-producing glands).
• you have or have had kidney or liver problems.
• you have undergone or are planning to undergo any laser procedures on the skin of your face.

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

Worsening of skin redness, erythema, or burning sensation:

Up to 1 in 6 patients may experience worsening redness compared to baseline. This worsening of redness typically develops within the first 2 weeks of treatment with Mirvaso. It usually resolves spontaneously after stopping treatment. The effect should gradually disappear within a few days in most cases. Before resuming treatment with topical 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).

If you experience worsening or unexpected redness, stop treatment and contact your doctor.

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

Children and adolescents

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

Other medicines and Mirvaso

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

Do not use Mirvaso with selegiline, moclobemide, imipramine, mianserina or maprotiline, which are medicines used for depression or Parkinson's disease, as this could lead to a change in the effectiveness of Mirvaso or could increase the risk of adverse effects such as a drop in blood pressure (see “Do not use Mirvaso”).

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

• medicines used to treat pain, sleep disorders, or anxiety disorders.
• medicines used to treat psychiatric disorders (chlorpromazine), hyperactivity (methylphenidate), or high blood pressure (reserpine).
• medicines that work in the same way as Mirvaso (other alpha agonists, e.g., clonidine; alpha-blockers or alpha antagonists, e.g., prazosin, isoprenaline), used mainly for treating high blood pressure, slow heart rate, or asthma.
• cardiac glycosides (e.g., digoxin), used to treat heart problems.
• medicines to lower blood pressure, such as beta-blockers or calcium channel blockers (e.g., propranolol, amlodipine).

If any of the above apply 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 medicine.

Pregnancy and breastfeeding

Mirvaso is not recommended during pregnancy, as its effects on the fetus are unknown. You should not use this medicine during breastfeeding, as it is unknown whether the medicine 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 medicine.

Driving and using machines

The effect of Mirvaso on the ability to drive and use machines is negligible.

Mirvaso contains

• Methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).

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

3. How to use Mirvaso

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Important: Mirvaso is indicated for adults and for use only on the facial skin. Do not use this medicine on other parts of your body, especially on moist body surfaces, e.g., 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 (an amount the size of a pea), as directed by your doctor or nurse.

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

Wash your hands immediately after applying this medicine.

If your symptoms worsen during treatment with Mirvaso (increased redness or burning sensation on the skin), stop treatment and make 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 forehead, chin, nose, and both cheeks, then gently and evenly spread a thin layer over each area. Do not exceed the recommended total daily dose (5 pea-sized amounts). Avoid the eyes, eyelids, lips, mouth, and inside of the nasal passages. If the product is applied to these areas, rinse immediately with plenty of water. If you experience worsening redness or a 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.

You should use these products only after applying Mirvaso, once it has dried.

Take care when opening the tube/pump for the first time to avoid squeezing out more gel than necessary. If this happens, 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 tube with child-resistant cap

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

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

How to close the tube with child-resistant cap

Press down and turn clockwise (turn to the right).

[EU/1/13/904/007]

How to open the pump with child-resistant safety cap

Press down on the cap and turn it counterclockwise (turn to the left).

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

Before first use, prime the pump. To do this, press the pump several times until the medicine comes out.

To apply Mirvaso gel to the face, place a pea-sized amount of Mirvaso gel on the fingertip. Continue pressing down on the pump to obtain the pea-sized amount required according to your doctor’s prescription (but no more than 5 pea-sized amounts in total).

To close the pump, replace the cap. Press down and turn to the right (clockwise) until it stops. The pump will become child-resistant again.

If you use more Mirvaso than you should

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

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

If anyone, especially a child, accidentally ingests Mirvaso, serious adverse effects may occur and hospital treatment may be required.

Contact your doctor immediately or go straight to the hospital emergency department if you, a child, or another person ingest this medicine and experience any of the following symptoms: dizziness due to low blood pressure, vomiting, fatigue or drowsiness, slow or irregular heartbeat, pupil constriction, difficulty breathing or reduced breathing rate, weakness, low body temperature, or seizures. Bring the medicine packaging with you so the doctor knows what has been ingested.

If you forget to use Mirvaso

Mirvaso works daily, starting on the first day of treatment. If you miss a daily dose, redness may not decrease that day. Do not apply a double dose to make up for missed doses; continue your treatment as prescribed.

If you stop using Mirvaso

A possible consequence of stopping treatment before completion is that the condition may return to its original state. Please consult your doctor before stopping treatment, so they can recommend an appropriate alternative treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you experience uncommon adverse effects such as severe irritation or inflammation of the skin, skin rash, pain or discomfort in the skin, dry skin, sensation of heat in the skin, tingling or prickling and itching sensations, swelling of the face, or common adverse effects such as worsening of rosacea, stop treatment and speak with your doctor, as this medicine may not be suitable for you. In some cases, symptoms may extend beyond the treated area. See also section 2 “Warnings and precautions”.

If you develop contact allergy (e.g., allergic reaction, rash) or rare angioedema (a severe allergic reaction usually characterized by swelling of the face, mouth, or tongue), 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):

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

Uncommon 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 (reduced blood pressure)
• Decreased heart rate (slow heart rate, known as bradycardia)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirvaso

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

Do not use this medicine after the expiry date stated on the carton, tube, and pump after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not freeze.

Medicines should not be disposed of via wastewater drains or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirvaso

• The active substance 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), phenoxyethanol, glycerol, titanium dioxide, propylene glycol (E1520), sodium hydroxide, purified water. See the end of section 2 for information regarding methyl parahydroxybenzoate and propylene glycol.

Appearance of the medicinal product and contents of the pack

Mirvaso is an opaque white to pale yellow gel. It is available in tubes containing 2, 10 or 30 grams of gel, or in a non-air-intrusion pump system containing 30 grams of gel.

Pack containing 1 tube or 1 pump.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Galderma International

Tour Europlaza, 20 avenue André Prothin – La Défense 4

La Défense Cedex 92927

France

Manufacturer responsible

Laboratoires Galderma

Z.I. Montdésir

74540 Alby-sur-Chéran

France

Or

Galderma Laboratorium GmbH

Toulouser Allee 19a-23a

D-40211 Düsseldorf

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet

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