BRIMONIDINA 2 mg /Ml Eye Drops, Solution

Зміст інструкції

1. Brimonidina Stulln 2 mg/ml eye drops, solution in single-dose container
   1. What is Brimonidina Stulln and what it is used for
   2. What you need to know before using Brimonidina Stulln
   3. How to use Brimonidina Stulln
   4. Possible side effects
   5. How to store Brimonidina Stulln
   6. Contents of the pack and other information

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

Brimonidine tartrate

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Brimonidina Stulln and what it is used for

Brimonidina Stulln is used to reduce the pressure inside the eye.
It can be used alone, when beta-blocker eye drops are contraindicated, or with another eye drop,
when a single medication is not sufficient to reduce the increase in eye pressure in the
treatment of open-angle glaucoma or ocular hypertension.
The active ingredient in Brimonidina Stulln is brimonidine tartrate, which works by reducing the
pressure inside the eyeball.

2. What you need to know before using Brimonidina Stulln

Do not use Brimonidina Stulln:

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

Warnings and precautions
Talk to your doctor before using Brimonidina Stulln

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

Children and adolescents
Clinical studies have not been conducted in adolescents (12 to 17 years of age).
Brimonidina Stulln is not recommended for use in children under 12 years of age and should not
be used in newborns and infants (under two years of age)

Other medicines andBrimonidina Stulln
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Tell your doctor if you are taking any of the following medicines:

• painkillers, sedatives, opioids, barbiturates or are a regular alcohol consumer.
• anaesthetics.
• to treat a heart condition or to lower blood pressure.
• that can act on metabolism such as chlorpromazine, methylphenidate and reserpine.
• that act on the same receptor as Brimonidina Stulln, for example isoprenaline and prazosin.
• monoamine oxidase inhibitors (MAOIs) and other antidepressants.
• medicines for any other condition, even if not related to your eye conditions.
• or if the dose of any of your current medicines has changed.

These can affect the treatment with Brimonidina Stulln.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Brimonidina Stulln must not be used if you are breastfeeding.

Driving and using machines

• Brimonidina Stulln can cause blurred or abnormal vision. This effect may be worse at night or in low light conditions.
• Brimonidina Stulln can also cause drowsiness or fatigue in some patients.
• If you experience any of these symptoms, do not drive vehicles or use machines until the symptoms have disappeared.

3. How to use Brimonidina Stulln

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

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

Use in children under 12 years
Brimonidina Stulln should not be used in infants under 2 years of age.
Brimonidina Stulln is not recommended for use in children (from 2 up to 12 years of age).

Instructions for use

• 1. Wash your hands.
• 2. Open the aluminum pouch and remove the blister pack of single-dose containers.
• 3. Remove one of the single-dose containers from the strip (Fig. 1).

• 4. Replace the remaining single-dose containers and close the bag by folding over the end. Place the bag in the box.
• 5. Open the single-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. Lower your lower eyelid with your finger and hold the single-dose container in your other hand. Squeeze the container to drop one drop into your eye (Fig. 4).
• 8. Close your eyes and press a finger on the inner corner of your eye for about one minute. This will prevent the drop from flowing through the tear duct into your throat and most of the drop will remain in your eyes (Fig. 5). If necessary, repeat steps 6 to 8 with the other eye.
• 9. Dispose of the single-dose container after use.

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

If you use more Brimonidina Stulln than you should

Adults
In adults who have instilled more drops than prescribed, the reported side effects are
those already known with the use of brimonidine.
Adults who have accidentally ingested drops of brimonidine have experienced a
lowering of blood pressure, which in some patients was followed by an increase in
blood pressure.

Children
Serious side effects have been reported in children who have accidentally ingested drops of
brimonidine. Symptoms included drowsiness, floppiness, low body temperature, paleness and
difficulty breathing. If this happens, contact your doctor immediately.

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

If you forget to use Brimonidina Stulln
If you forget to administer a dose, take it as soon as you remember. However, if it is already time
for your next dose, skip the missed dose and continue with your usual dosing schedule.
Do not use a double dose to make up for a missed dose.

If you stop using Brimonidina Stulln
For it to work properly, Brimonidina Stulln must be taken every day. Do not stop using
Brimonidina Stulln until your doctor considers it appropriate.
If you have any doubts about 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.
The following side effects may be observed with brimonidine eye drops with preservative in
multi-dose container and may also occur when using brimonidine eye drops without
preservative in single-dose containers:
Related to the eyes

Very common (may affect more than 1 in 10 people):

• Eye irritation (red eye, burning, stinging pain, feeling of a foreign body in the eye, itching, small lumps or white spots on the clear layer covering the surface of the eye)
• Blurred vision
• An 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 clear layer covering the surface of the eye, sticky eyes, pain and tearing)
• Sensitivity to light
• Erosion and spots on the surface of the eye
• Dry eye
• Whitening of the clear layer covering the surface of the eye
• Altered vision
• Inflammation of the clear 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 with unknown frequency (frequency cannot be estimated from available data):

• Itching of the eyelids
• Inflammation of the iris, that is the colored part of the eye, and the ciliary body, that is the muscles and tissue involved in focusing the eye (iridocyclitis). This condition is also called “anterior uveitis” Related to the body

Very common (may affect more than 1 in 10 people):

• Headache
• Dry mouth
• Fatigue/drowsiness

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

• Dizziness
• Flu-like symptoms
• Symptoms involving the stomach and digestion
• Taste alteration
• General weakness Uncommon (may affect up to 1 in 100 people):
• Depression
• Palpitations or change in heartbeat
• 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 with unknown frequency (frequency cannot be estimated from available data):

• Skin reactions including redness, facial swelling, itching, rash and widening of blood vessels

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system 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 Brimonidina Stulln

Keep this medicine out of the sight and reach of children.
Store the single-dose container in the aluminum pouch to protect the medicine from light.
Do not use for more than 3 months after opening the aluminum pouch.
Brimonidina Stulln 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 which is stated on the carton, on the pouch and on the
single-dose container after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater 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 Brimonidina Stulln contains

• The active ingredient 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 ingredients are polyvinyl alcohol, sodium chloride, sodium citrate, citric acid monohydrate, water for injections and hydrochloric acid or sodium hydroxide (to adjust the pH).

Description of the appearance of Brimonidina Stulln and contents of the pack
Brimonidina Stulln is a clear, slightly yellowish-green solution. Each single-dose container
contains 0.35 ml of solution. Two strips, each containing 5 single-dose containers, are contained
inside a laminated aluminum pouch.
Brimonidina Stulln 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:
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln
Germany
Manufacturer:
Pharma Stulln GmbH
Werksstrasse 3
92551 Stulln
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
Austria Brimonidin Stulln sine 2 mg/ml eye drops, solution in single-dose container
France Brimazed 2 mg/ml eye drops, solution in single-dose container
Germany Brimonidin Stulln sine 2 mg/ml eye drops, solution in single-dose container
Greece Brimofree 2 mg/ml ophthalmic drops, solution in single dose container
Netherlands Brimonidine Stulln 2 mg/ml eye drops, solution in single use packaging
Spain Brimonidina Stulln 2 mg/ml eye drops, solution in single-dose container