Brimonidine Stulln

Package leaflet: Information for the user

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

Brimonidine tartrate
Please read this leaflet carefully before using this medicine because 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 they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including any 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 Brimonidina Stulln is and what it is used for

Brimonidina Stulln is used to reduce pressure within the eye. The active substance in
Brimonidina Stulln is brimonidine tartrate, which belongs to a group of medicines called
alpha-2 adrenergic receptor agonists and works by reducing pressure inside the eyeball.
It can be used alone when beta-blocker 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.

2. What you need to know before using Brimonidine Stulln

Do not use Brimonidine Stulln:

• 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 (MAOIs) or other antidepressant medicines. 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 Brimonidine Stulln if:

• You suffer or have suffered from depression.
• You have reduced mental capacity.
• You have reduced blood flow to the brain.
• You have heart problems.
• You have reduced blood flow to the limbs.
• You have blood pressure disorders.
• You have or have previously had kidney or liver problems.

Children and adolescents
The use of Brimonidine Stulln is not recommended in children aged between 2 and 12 years.
Brimonidine Stulln should generally not be used in adolescents aged between 12 and 17 years, as clinical studies have not been conducted in this age group.

Other medicines and Brimonidine Stulln
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 are a regular consumer of alcoholic beverages.
• 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 Brimonidine 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 health.
• Or if the dose of any of your current medicines has changed.

These medicines may affect your treatment with Brimonidine Stulln.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine. Do not use Brimonidine Stulln during pregnancy unless your doctor considers it necessary.
Brimonidine Stulln must not be used if you are breastfeeding.

Driving and using machines

• Brimonidine Stulln may cause blurred or abnormal vision. This effect may worsen at night or in conditions of reduced lighting.
• Brimonidine Stulln 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 Brimonidina Stulln

Use this medicine exactly as directed by your doctor. If you have any doubts, 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. Do not change the dosage or stop using Brimonidina Stulln without consulting your
doctor.
Use in children under 12 years of age
Brimonidina Stulln must not be used in infants under 2 years of age.
Brimonidina Stulln 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 strip of single-dose containers.
3. Remove one single-dose container from the strip (Fig. 1).
4. Put the remaining single-dose containers back and close the bag by folding over the end. Place the bag inside 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. Pull down the lower eyelid with your finger and hold the single-dose container in the other hand. Squeeze the container so that one drop falls into the eye (Fig. 4).
8. Close your eyes and press a finger against the inner corner of the eye for about one minute. This will prevent the drop from flowing 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. Discard the single-dose container after use.

Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5
If the drop does not enter the eye, repeat the procedure.
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 adverse effects reported are those already known with the use of brimonidine.
Adults who have accidentally ingested brimonidine eye drops have experienced a drop in blood pressure, which in some patients was followed by an increase in blood pressure.
Children
Serious adverse effects have been reported in children who have accidentally ingested 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 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 almost time for your next dose, skip the missed dose completely and continue with your regular dosing schedule.
Do not use a double dose to make up for a forgotten dose.
If you stop using Brimonidina Stulln
To work properly, Brimonidina Stulln must be taken every day. Do not stop using Brimonidina Stulln unless your doctor advises you to do so.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects may occur with brimonidine eye drops containing a preservative in multidose containers and may also occur when using brimonidine eye drops without preservative 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, foreign body sensation in the eye, itching, follicles or white specks 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
• Whitening 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 with unknown frequency (frequency cannot be estimated from available data):

• Eyelid itching
• Inflammation of the iris (the coloured part of the eye) and ciliary body (the muscles and tissue involved in focusing the eye) (iridocyclitis). This condition is also known as "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
• Gastrointestinal and digestive symptoms
• Taste disturbance
• General weakness

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

• Depression
• Palpitations or changes in heart rate
• Dry nose
• Generalised 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 blood vessel dilation

Reporting of side effects

If you experience any side effects, 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 Brimonidine Stulln

Keep this medicine out of 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.
Brimonidine 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 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 Brimonidina Stulln 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 Brimonidina Stulln and package contents
Brimonidina Stulln is a clear, slightly yellowish-green solution. Each single-dose container holds 0.35 ml of solution. Two strips, each containing 5 single-dose containers, are enclosed within an aluminum laminate sachet.
Brimonidina Stulln is available in packages 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 European Economic Area countries under the following names:
Austria Brimonidin Stulln sine 2 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis
France Brimazed 2 mg/ml eye drops, solution in single-dose container
Germany Brimonidin Stulln sine 2 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis
Greece Brimofree 2 mg/ml Οφθαλμικές σταγόνες, διάλυμα σε περιέκτη μίας δόσης
Netherlands Brimonidine Stulln 2 mg/ml oogdruppels, oplossing in verpakking voor éénmalig gebruik
Spain BRIPIO 2 mg/ml colirio en solución en envase unidosis
08/2022