Brimofree

Package leaflet: Information for the user

Brimofree 2 mg/ml eye drops, solution in single-dose container

Brimonidine tartrate
Please read this leaflet carefully before 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Brimofree is and what it is used for

Brimofree is used to reduce the pressure inside the eye.
It can be used alone, when beta-blocking eye drops are contraindicated, or in combination with another eye drop,
when a single medicine is not sufficient to reduce elevated eye pressure in the treatment of open-angle glaucoma or ocular hypertension.
The active substance in Brimofree is brimonidine tartrate, which works by reducing pressure inside the eyeball.

2. What you need to know before using Brimofree

Do not use Brimofree:

• If you are allergic to brimonidine tartrate or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking monoamine oxidase inhibitors (MAO inhibitors) or certain antidepressants. Please inform your doctor if you are taking any antidepressant medication.
• If you are breastfeeding.
• In infants/children (from birth up to two years of age).

Warnings and precautions
Talk to your doctor before using Brimofree if:

• You suffer or have suffered from depression, reduced mental capacity, reduced blood flow to the brain, heart problems, reduced blood flow to the limbs, or blood pressure disorders.
• You have or have previously had kidney or liver problems.
• You are administering it to a child between 2 and 12 years of age, as the use of Brimofree is not recommended in this age group.

Children and adolescents
Clinical studies have not been conducted in adolescents (from 12 to 17 years of age).
Brimofree is not recommended for use in children under 12 years of age and must not be used in neonates and infants (less than two years of age).

Other medicines and Brimofree
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines:

• Painkillers, sedatives, opioids, barbiturates, or if you regularly consume alcohol.
• Anaesthetics.
• Medicines used to treat heart conditions or to lower blood pressure.
• Medicines that may affect metabolism, such as chlorpromazine, methylphenidate, and reserpine.
• Medicines acting on the same receptor as Brimofree, for example isoprenaline and prazosin.
• Monoamine oxidase inhibitors (MAO inhibitors) and other antidepressants.
• Medicines for any other condition, even if unrelated to your eye condition.
• Or if the dose of any of your current medicines has changed. These may affect your treatment with Brimofree.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Brimofree must not be used if you are breastfeeding.

Driving and using machines

• Brimofree may cause blurred or abnormal vision. This effect may appear worse at night or under conditions of reduced lighting.
• Brimofree may also cause drowsiness or fatigue in some patients.
• If you experience any of these symptoms, do not drive or operate machinery until the symptoms have resolved.

3. How to use Brimofree

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Use in adults
The recommended dose is one drop twice daily in the affected eye(s), approximately 12 hours apart.

Use in children under 12 years of age
Brimofree must not be used in infants under 2 years of age.
Brimofree is not recommended for use in children (from 2 to 12 years of age).

Instructions for use

1. Wash your hands.
2. Open the aluminium pouch and remove the unit-dose container block.
3. Remove one unit-dose container from the strip (Fig. 1).
4. Store the remaining unit-dose containers, close the pouch by folding the end over, and place the pouch back into the carton.
5. Open the unit-dose container by unscrewing the cap. Do not touch the cap after opening the container (Fig. 2).
6. Tilt your head back (Fig. 3).
7. Pull down the lower eyelid with your finger and hold the unit-dose container in the other hand.

Squeeze the container to release one drop into the eye (Fig. 4).

8. Close your eye and press a finger against the inner corner of the eye for about one minute. This will prevent the drop from draining through the tear duct into the throat and will keep most of the drop in the eye (Fig. 5). If necessary, repeat steps 6 to 8 for the other eye.
9. Dispose of the unit-dose container after use.

Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5
If you are using Brimofree with another eye drop, wait 5 to 15 minutes before applying the second eye drop.

If you use more Brimofree than you should
Adults
In adults who have instilled more drops than prescribed, the adverse effects reported are those already known with the use of brimonidine.
Adults who have accidentally swallowed brimonidine eye drops have experienced low blood pressure, which in some patients was followed by a rise in blood pressure.

Children
Serious adverse effects have been reported in children who have accidentally swallowed brimonidine eye drops. Symptoms included drowsiness, floppiness, low body temperature, pallor, and breathing difficulties. If this occurs, contact your doctor immediately.

Adults and children
If Brimofree has been accidentally swallowed or if you have used more than you should, contact your doctor immediately.

If you forget to use Brimofree
If you forget to administer a dose, apply it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule.
Do not use a double dose to make up for a forgotten dose.

If you stop using Brimofree
For Brimofree to work properly, it must be used every day. Do not stop using Brimofree unless your doctor tells you to do so.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur with brimonidine eye drops containing a preservative in multidose containers, and may also occur when using preservative-free brimonidine eye drops in single-dose containers:

Eye-related side effects
Very common (may affect more than 1 in 10 people):

• Eye irritation (red eye, burning, stinging pain, sensation of a foreign body in the eye, itching, follicles or white spots on the transparent layer covering the surface of the eye)
• Blurred vision
• Allergic reaction in the eye

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

• Local irritation (inflammation and swelling of the eyelid, swelling of the transparent layer covering the surface of the eye, sticky eyes, pain and tearing)
• Light sensitivity
• Erosion and spots on the surface of the eye
• Dry eyes
• Blanching of the transparent layer covering the surface of the eye
• Altered vision
• Inflammation of the transparent layer covering the surface of the eye

Very rare (may affect more than 1 in 10,000 people):

• Inflammation inside the eye
• Reduction in pupil size

Side effects for which frequency is not known (frequency cannot be estimated from available data):

• Itching of the eyelids
• Inflammation of the iris (the coloured part of the eye) and ciliary body (the muscles and tissue involved in focusing the eye), known as iridocyclitis. This condition is also called "anterior uveitis".

Body-related side effects
Very common (may affect more than 1 in 10 people):

• Headache
• Dry mouth
• Tiredness/somnolence

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

• Dizziness
• Flu-like symptoms
• Stomach and digestive-related symptoms
• Taste disturbance
• General weakness

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

• Depression
• Palpitations or changes in heart rate
• Dry nose
• General allergic reactions

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

• Shortness of breath

Very rare (may affect up to 1 in 10,000 people):

• Insomnia
• Fainting
• High blood pressure
• Low blood pressure

Side effects for which frequency is not known (frequency cannot be estimated from available data):

• Skin reactions including redness, facial swelling, itching, rash, and blood vessel dilation

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Brimofree

Keep this medicine out of the sight and reach of children.
Store the single-dose container in the aluminium pouch to protect the medicine from light.
Do not use for more than 3 months after opening the aluminium pouch.
Brimofree does not contain a preservative. Once opened, the contents of the single-dose container must
be used immediately. Discard any remaining solution in the single-dose container after
application.
Do not use this medicine after the expiry date stated on the carton, aluminium pouch, and
single-dose container after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Brimofree contains

• The active substance is brimonidine tartrate. One ml of solution contains 2.0 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine. One drop contains 0.06–0.07 mg of brimonidine tartrate.
• The other components are polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, water for injections, and hydrochloric acid or sodium hydroxide (to adjust pH).

Description of the appearance of Brimofree and contents of the pack
Brimofree is a clear, slightly yellowish-green solution. Each single-dose container contains 0.35 ml of solution. Two strips of 5 single-dose containers each are packed in a pouch made of laminated aluminium foil.
Brimofree is available in packs containing 30, 60, or 120 single-dose containers with 0.35 ml of solution each.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milan, Italy

Manufacturer:
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria  Brimonidin sine OmniVision
France   Brimonidine OmniVision
Spain    BRIMVERA
United Kingdom Brimonidine OmniVision