MIRVASO 3 mg /G Żel

Treść ulotki

1. Mirvaso 3 mg/g gel
   1. What is Mirvaso and what is it 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

Mirvaso 3 mg/g gel

brimonidine

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What Mirvaso is and what it is used for
• 2. What you need to know before you use 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 is Mirvaso and what is it used for

Mirvaso contains the active substance brimonidine, which belongs to a group of medicines
generally called “alpha-agonists”.
It is applied to the skin of the face to treat redness due to rosacea in adult patients.
The facial redness due to rosacea is caused by high levels of blood flow in the skin of the
face, which is the result of the enlargement (dilation) of the small blood vessels in the skin.
When applied, Mirvaso works by constricting these blood vessels again, 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 any of the other ingredients of this medicine (listed in section 6).
• In children under 2 years of age, as they may be at greater risk of undesirable effects from any medicine absorbed through the skin.
• If you are taking specific medicines used for depression or Parkinson's disease including so-called monoamine oxidase inhibitors (MAOIs) (e.g. selegiline or moclobemide) or tricyclic antidepressants (such as imipramine) or tetracyclic antidepressants (such as maprotiline, mianserin or mirtazapine). Using Mirvaso while taking these medicines could cause a decrease in blood pressure.

Warnings and precautions
Talk to your doctor or pharmacist before using Mirvaso, particularly if:

• If the skin of your face is irritated or if you have open wounds.
• If you suffer from heart or blood circulation problems.
• If you suffer from depression, reduced blood flow to the brain or heart, low blood pressure when standing up, reduced blood flow to hands, feet or skin, or if you suffer from Sjögren's syndrome (a chronic disease in which the body's natural defenses - the immune system
• attacks the glands that produce fluids).
• If you have kidney or liver problems or have had them in the past.
• If you have undergone or are planning to undergo laser procedures on the skin of your face.

It is important 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 amounts 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 (about 5 amounts the size of a pea). See also the instructions “How to use
Mirvaso”.
Worsening of skin redness, flushing or burning sensation of the skin:
Up to 1 in 6 patients experience a recurrence of redness in a worse form than at the beginning. This
worsening usually occurs within the first 2 weeks of starting treatment with
Mirvaso. Generally, it resolves spontaneously after stopping treatment. In most cases, the effect should disappear gradually within a few days. Before resuming treatment with Mirvaso, perform a test application on a small area of the face on a day in
which you can stay at home. If no worsening of redness or burning sensation occurs,
continue with the usual treatment (see section 3).
If worsening or unexpected redness occurs, stop treatment and see your doctor.
If any of these conditions apply to you, talk to 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 the
safety and efficacy have not been established in this age group. This is particularly
important in children under 2 years (see the section “Do not use Mirvaso”).

Other medicines and Mirvaso
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, as these medicines could affect treatment with Mirvaso
or Mirvaso could affect treatment with these medicines.
Do not take Mirvaso with selegiline, moclobemide, imipramine, mianserine, or maprotiline,
which are medicines that can be used for depression or Parkinson's disease, as
this could lead to a change in the effectiveness of Mirvaso or could increase the
likelihood of side effects such as a drop in blood pressure (see the section “Do not
use Mirvaso”).
Also, tell your doctor if you are taking any of the following medicines:

• medicines used for the treatment of pain, sleep disorders or anxiety
• medicines used for the treatment of psychiatric disorders (chlorpromazine) or used for hyperactivity (methylphenidate) or used for high blood pressure (reserpine)
• medicines that act like Mirvaso on the same body mechanism (other alpha-agonists, for example clonidine; so-called alpha-blockers or alpha-antagonists, for example prazosin, isoprenaline generally used for the treatment of high blood pressure, low heart rate or asthma)
• cardiac glycosides (e.g. digoxin), used for the treatment of heart problems.
• medicines used to lower blood pressure such as beta-blockers or calcium antagonists (e.g. propranolol, amlodipine)

If any of these conditions apply to you or if you have doubts, talk to your doctor.

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

Pregnancy and breastfeeding
The use of Mirvaso is not recommended during pregnancy, as its effects on the
unborn child are not known. Do not use this medicine while breastfeeding, as it is not known whether
this medicine passes into breast milk.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before using this medicine.

Driving and using machines
Mirvaso does not significantly impair the ability to drive and operate machinery.

Mirvaso contains methyl-parahydroxybenzoate (E218), which can cause allergic reactions (including
delayed reactions). This medicine also contains 55 mg of propylene glycol (E1520)in each gram,
which is equivalent to 5.5% w/w, may cause skin irritation .

3. How to use Mirvaso

Use this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.

Important:Mirvaso must only be used in adults and only on the skin of the face. Do not use this
medicine on other parts of the body, especially on moist surfaces of the body, such as the eyes,
mouth, nose or vagina.
Do not ingest.
Keep Mirvaso gel out of the reach of children.

How to use Mirvaso
Mirvaso is recommended to be applied to the face only once a day.
During the first week, start treatment with a small amount of gel (the size of a pea) as explained by the
doctor or nurse.
If the symptoms remain the same or improve only slightly, you can then gradually increase the
amount of gel. Spread well, in a regular and uniform manner, a very thin layer as indicated
by the doctor or nurse. It is important not to exceed the maximum daily dose of 1 g
(5 pea-sized amounts applied to the entire face).
You must wash your hands immediately after applying this medicine.
If during treatment with Mirvaso the symptoms worsen (increased redness or burning),
stop treatment and make an appointment with your doctor; see also Paragraph 2 in
“Warnings and precautions”.
You must avoid eyes, eyelids, lips, mouth and the inside of the nose. If gel does
come into contact with these areas, wash them immediately with plenty of water. If
you experience a worsening of redness or a burning sensation, stop treatment
with Mirvaso and consult your doctor, if necessary.
Do not apply other skin medicines or cosmetics immediately before the daily application
of Mirvaso. These products can only be used when the applied dose of Mirvaso is
dried.
When you open the tube/pump for the first time, be careful not to squeeze out more
gel than necessary. If this happens, remove the excess gel so as not to apply
more than the recommended dose. See above the paragraph “How to use Mirvasoˮ.
[EU/1/13/904/004-006, EU/1/13/904/008-009]

How to open the tube with child-resistant cap
To avoid accidental leakage, do not squeeze the tube while opening or closing.
Press down on the cap and rotate counterclockwise (rotate to the left). Then remove the cap.

How to close the tube with child-resistant cap
Press down and rotate clockwise (rotate to the right).

[EU/1/13/904/007]

How to open the pump with child-resistant cap
Press down on the cap and rotate counterclockwise (rotate to the left) until the cap is removed. Note:
when the cap is removed, the pump is no longer child-resistant.

Before first use, prime the pump by pressing down several times until
the medicine is dispensed onto the fingertip.
To apply Mirvaso gel to the face, dispense onto the fingertip with the pump, an amount of
Mirvaso equal to the size of a pea. Continue to press the pump down to obtain
the required amount of pea-sized quantity, as prescribed by
the doctor (but not more than 5 quantities in total).

To close the pump, screw the cap back on. Press down and rotate the cap to the right (in
clockwise direction) until it stops. The pump is now child-resistant again.

If you use more Mirvaso than you should
If you use an amount greater than the maximum daily dose of 1 gram, within a 24-hour period,
this may cause skin irritation or other undesirable effects at the application site. Repeated doses
within the same 24-hour time frame may cause undesirable effects, such as low blood pressure, fatigue or drowsiness.
Contact your doctor, who will advise you on what actions to take.

If someone, especially a child, accidentally ingests Mirvaso, they may
experience serious side effects and require hospital treatment.
Contact your doctor immediately or go to the emergency room if you, a child or another
person ingests this medicine and experiences any of the following symptoms: dizziness from low blood pressure, vomiting, fatigue or weakness, slow or
irregular heartbeat, small pupils (pupil constriction), difficulty breathing or shortness of breath, weakness,
low body temperature and convulsions (seizures). Bring the medicine packaging with you,
so that the doctor knows what has been ingested .
If you forget to use Mirvaso
Mirvaso works day by day, starting from the first day of treatment. If you forget a daily
dose, the redness will not be reduced for that day. Do not use a double dose to make up for the
missed dose and continue treatment as prescribed.

If you stop using Mirvaso
A potential consequence of stopping treatment, before completing the treatment cycle,
is that the disease returns to its initial state. Contact your doctor before stopping
your treatment, so that they can advise you on a substitute treatment, if necessary.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you develop uncommon side effects of severe skin irritation or inflammation, rash,
skin pain or discomfort, dry skin, skin warming sensation, tingling or
feeling of pins and needles or swelling of the face, or common side effects such as worsening of
rosacea, stop treatment and see your doctor as this medicine may not be
suitable for you. In some cases, symptoms may spread beyond the treatment area. See also the
Paragraph 2 in "Warnings and precautions".
If you develop a contact allergy (e.g. allergic reaction, rash), or a rare
angioedema (a severe allergic reaction that usually causes swelling of the face, mouth or
tongue) stop using Mirvaso and seek immediate medical attention..
Mirvaso may also cause the following additional side effects:
Common side effects (may affect up to 1 in 10 people):

• Hot flushes
• Excessive whitening (paleness) at the application site of the gel
• Skin redness, skin burning sensation or itching

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

• Acne
• Dry mouth
• Cold sensation in hands and feet
• Feeling of warmth
• Headache
• Nasal congestion
• Swelling of the eyelids
• Hives
• Dizziness

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

• Hypotension (low blood pressure)
• Reduced heart rate (slowed heartbeat, known as bradycardia).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Mirvaso

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box, tube and
pump after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Store at a temperature below 30°C and do not freeze.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Mirvaso contains

• The active ingredient 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 (E1520), sodium hydroxide, purified water. For information on methylparahydroxybenzoate and propylene glycol, see the final part of paragraph 2.

Description of the appearance of Mirvaso and contents of the pack
Mirvaso is an opaque gel, ranging in colour from white to light yellow. It is supplied in tubes
containing 2, 10 or 30 grams of gel or in a multi-dose container with an airtight pump system
containing 30 g of gel.
Pack of 1 tube or 1 pump.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Galderma International
Tour Europlaza, 20 avenue André Prothin – La Défense 4
La Défense Cedex 92927
France

Manufacturer
Laboratoires Galderma
Z.I. Montdésir
74540 Alby-sur-Chéran
France
or
Galderma Laboratorium GmbH
Toulouser Allee 19a-23a,
Pempelfort,
Duesseldorf
North Rhine-Westphalia,
40211,Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Österreich
Galderma Austria GmbH
Tel: 0043 732 715 993
e-mail: [email protected]

Italia
Galderma Italia S.p.A.
Tel: + 39 337 1176197
e-mail: [email protected]

België/Belgique/Belgien
Luxembourg/Luxemburg
Galderma Benelux BV
Tél./Tel: +31 183691919
e-mail: [email protected]

Latvija
Tamro SIA, Latvia
Tel. +371 67067800

Lietuva
Tamro UAB, Lithuania
Tel. +37037401099

България
PHOENIX PHARMA EOOD,
Bulgaria
Tel. +359 2 9658 100

Česká republika
Slovenská republika
4 LIFE PHARMA CZ, s.r.o.
Czech
Tel. +420 244 403 003
e-mail: [email protected]

Magyarország
Ewopharma Hungary Kft.
Tel.: +36 1 200 4650
e-mail: [email protected]

Danmark
Norge
Ísland
Suomi/Finland
Sverige
Galderma Nordic AB
Tlf/Sími/Puh/Tel: + 46 18 444 0330
e-mail: [email protected]

Malta
Prohealth Limited
Tel. +356 21461851, +356 21460164
e-mail: [email protected]

Deutschland
Galderma Laboratorium GmbH
Tel: + 49 (0) 800 – 5888850
e-mail: [email protected]

Nederland
Galderma Benelux BV
Tel: + 31 183691919
e-mail: [email protected]

Eesti
Tamro Eesti OÜ, Estonia
Tel. +372 650 3600

Polska
Galderma Polska Sp. z o.o.
Tel.: + 48 22 331 21 80
e-mail: [email protected]

Portugal
Laboratorios Galderma, SA – Sucursal em
Portugal
Tel: + 351 21 315 19 40
e-mail: [email protected]

Ελλάδα
Κύπρος
Pharmassist Ltd
Τηλ: + 30 210 6560700
e-mail: [email protected]

România
Neola Pharma SRL
Tel: + 40 21 233 17 81
e-mail: [email protected]

España
Laboratorios Galderma SA
Tel: + 34 902 02 75 95
e-mail: [email protected]

United Kingdom (Northern Ireland)
Galderma (UK) Ltd.
Tel: +44 (0)300 3035674
e-mail: [email protected]

France
Hrvatska
Ireland
Slovenija
Galderma International
Tél: : +33 08.00.00.99.38
e-mail: [email protected]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.