Briglau Free

Package Leaflet: Information for the Patient

Briglau Free, 2 mg/ml, Eye Drops, Solution

Brimonidine Tartrate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Briglau Free and what is it used for
• 2. Important information before using Briglau Free
• 3. How to use Briglau Free
• 4. Possible side effects
• 5. How to store Briglau Free
• 6. Contents of the pack and other information

1. What is Briglau Free and what is it used for

Briglau Free is used to lower the pressure in the eye.
Briglau Free may be used as a single medicine in patients for whom beta-blocker eye drops are contraindicated, or as an adjunctive therapy with other eye drops when intraocular pressure is not sufficiently controlled with single-agent therapy for open-angle glaucoma or ocular hypertension.
The active substance of Briglau Free is brimonidine tartrate, which reduces the pressure in the eye.

2. Important information before using Briglau Free

When not to use Briglau Free

• if you are allergic to brimonidine tartrate or any of the other ingredients of this medicine (listed in section 6),
• if you are using monoamine oxidase inhibitors (MAOIs) (e.g., medicines used in depression or Parkinson's disease) or certain antidepressants. You should tell your doctor about any antidepressants you are taking.
• if you are breastfeeding,
• in children under 2 years of age.

Warnings and precautions

Before starting treatment with Briglau Free, you should discuss this with your doctor or pharmacist:

• if you have or have had depression, your mental ability is impaired, you have had poor circulation of blood in the brain, heart problems, poor circulation in the limbs, or low blood pressure;
• if you have or have had kidney or liver problems;
• if the medicine is used in children between 2 and 12 years of age, as Briglau Free is not recommended in this age group.

Children and adolescents

Briglau Free is not recommended for use in children under 12 years of age.
Briglau Free should not be used in children under 2 years of age.

Briglau Free and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Briglau Free may affect the action of other medicines, and other medicines may affect the action of Briglau Free, including other eye drops used to treat glaucoma.
You should inform your doctor if you are taking or plan to take the following medicines:

• blood pressure-lowering medicines,
• heart medicines, including digoxin,
• pain-relieving medicines, sedatives, opioid pain-relieving medicines, barbiturates,
• medicines that may affect metabolism, such as chlorpromazine, methylphenidate, and reserpine,
• anesthetics,
• medicines that act on the same receptor as Briglau Free, such as isoproterenol and prazosin,
• monoamine oxidase inhibitors (MAOIs) or antidepressants, including amitriptyline, nortriptyline, clomipramine, mianserin, venlafaxine, and duloxetine,
• medicines used for other conditions, even if not related to eye disease, or if the dosage of any medicine you are currently taking has changed.

If you are using other eye drops or ointments,you should keep a minimum of 5 minutes between administrations of different medicines. Eye ointments should be used last.

Briglau Free with alcohol

If you regularly drink alcohol, you should consult your doctor before starting treatment with this medicine. Alcohol may affect the action of Briglau Free.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Briglau Free should not be used during breastfeeding.
You should consult your doctor before using this medicine during pregnancy.

Driving and using machines

After administering Briglau Free, your vision may be blurred or disturbed for a while, especially at night or in low light conditions.
Some patients may also experience dizziness, drowsiness, or fatigue after using Briglau Free.
You should not drive or operate machinery until the symptoms have resolved.

3. How to use Briglau Free

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Briglau Free is for use in the eye only. Do not take it by mouth or inject it.

Adults, adolescents, and children over 12 years of age

Recommended doseis one drop into the affected eye(s) twice a day. You should use the medicine at the same time every day.

Children under 12 years of age

Briglau Free should not be used in children under 2 years of age.
Briglau Free is not recommended for use in children between 2 and 12 years of age.
Briglau Free is a sterile solution that does not contain preservatives. See section 6, What Briglau Free looks like and what the pack contains.

Before administering the eye drops:

• In case of first use, before administering the eye drops, you should test the use of the bottle with the dropper by slowly squeezing it until one drop is released from the bottle. Do this away from the eye.
• If you are sure you can administer a single drop, you should take the most comfortable position for administration (you can sit, lie on your back, or stand in front of a mirror).

Instructions for use:

• 1. Before administering the medicine, wash your hands thoroughly.
• 2. If the packaging or bottle is damaged, do not use the medicine.
• 3. Before first use of the drops, unscrew the cap after making sure the tamper-evident ring on the cap is intact. You will feel a slight resistance when unscrewing, until the ring breaks (Figure 1).
• 4. If the tamper-evident ring is loose, remove it before using the medicine, as it may fall into the eye and cause injury.
• 5. Tilt your head back and gently pull the lower eyelid down to create a "pocket" between the eye and the eyelid (Figure 2). Avoid touching the tip of the dropper with the eye, eyelids, or fingers.
• 6. Administer one drop by slowly squeezing the bottle (Figure 3). Squeeze the bottle gently in the middle, so the drop gets into the eye. Remember that there may be a few seconds' delay between squeezing the bottle and the drop being released. Do not squeeze the bottle too hard. If you have any doubts about using the medicine, you should consult your doctor, pharmacist, or nurse.
• 7. After administering the medicine, press the tear duct (the corner of the eye near the nose) with your finger for at least 1 minute, keeping the eye closed. This will help the medicine penetrate the eye and reduce the amount of medicine that enters the rest of the body.
• 8. If your doctor has prescribed the medicine for both eyes, repeat steps 5, 6, and 7.
• 9. After use, before closing the bottle, shake it downwards without touching the tip of the dropper to remove any remaining liquid from the tip of the dropper. This is necessary to ensure that the next drops can be administered. Immediately after use, screw the cap back on tightly (Figure 4).

If the drop does not get into the eye, try again.

Figure 1.
Figure 2.
Figure 3.
Figure 4.

Using more than the recommended dose of Briglau Free

Adults
If more drops of the medicine are administered than recommended, the side effects reported are the same as those experienced with Briglau Free.
In adults who accidentally ingested Briglau Free, a decrease in blood pressure was reported, followed by an increase in blood pressure in some patients.
Children
Severe side effects have been reported in children who accidentally ingested Briglau Free.
The following symptoms were observed: coma or altered consciousness (usually transient), lethargy, slow heart rate, drowsiness, decreased muscle tone, decreased body temperature, pallor, and breathing difficulties, including apnea. If these symptoms occur, you should contact your doctor immediately.
Adults and children

In case of accidental ingestion or use of a higher dose of Briglau Free, you should contact your doctor immediately.

Missing a dose of Briglau Free

You should take the next dose at the planned time. Do not take a double dose to make up for the missed dose. Never take more than one drop into the affected eye(s) twice a day.

Stopping treatment with Briglau Free

Do not stop using Briglau Free without consulting your doctor. If you stop using Briglau Free, the pressure in the eye will not be controlled, which may lead to loss of vision.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Briglau Free can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop using the medicine and contact your doctor immediately, as they may be signs of an allergic reaction to the medicine.

• Severe skin reactions, including rash or redness or itching of the skin or eyes
• Breathing problems
• Chest pain or irregular heartbeat.

You should contact your doctor immediately if you experience severe fatigue or dizziness.
The following side effects have been observed with Briglau Free and other medicines containing brimonidine.

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

• Eye disorders: eye irritation (redness of the eyes, burning sensation, stinging, itching, feeling of a foreign body in the eye, blisters or white spots on the conjunctiva), blurred vision, allergic reactions of the eye, allergic conjunctivitis and (or) blepharitis.
• General disorders: headache, dry mouth, and feeling of tiredness and (or) drowsiness.

Common side effects (may affect up to 1 in 10 people)

• Eye disorders: local irritation (inflammation and (or) redness of the eyelids, blepharitis, swelling of the conjunctiva, presence of discharge in the conjunctival sac, eye pain, and tearing), sensitivity to light, corneal damage, and spots on the cornea, dry eye, pale conjunctiva, visual disturbance, conjunctivitis.
• General disorders: dizziness, flu-like symptoms, gastrointestinal symptoms, taste disturbances, and general weakness.

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

• General disorders: depression, palpitations or irregular heartbeat, dryness of the nasal mucosa, generalized allergic reactions.

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

• General disorders: shortness of breath.

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

• Eye disorders: uveitis, miosis.
• General disorders: insomnia, fainting, hypertension, hypotension.

Frequency not known (cannot be estimated from the available data)

• Eye disorders: uveitis and iritis (inflammation of the uveal tract and iris), eyelid itching.
• General disorders: skin reactions including redness, facial swelling, itching, rash, and flushing.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Briglau Free

Do not store above 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Shelf life after first opening the bottle: 90 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Briglau Free contains

• The active substance is brimonidine tartrate. Each ml of solution contains 2 mg of brimonidine tartrate, equivalent to 1.3 mg of brimonidine. Each drop of solution contains approximately 0.06 mg of brimonidine tartrate, equivalent to 0.04 mg of brimonidine.
• The other ingredients are: polyvinyl alcohol 40-88, sodium citrate, citric acid monohydrate, sodium chloride, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), water for injections.

What Briglau Free looks like and what the pack contains

Briglau Free is a clear, yellow-green solution.
The medicine is available in a white bottle (LDPE) containing 5 ml of solution (not less than 127 drops), with a multidose dropper (HDPE) that prevents contamination of the solution with bacteria thanks to a system consisting of a silicone membrane and filtered air drawn into the bottle, with a cap made of HDPE with a tamper-evident ring, in a cardboard box.
Pack sizes:
1 bottle of 5 ml.
3 bottles of 5 ml.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Rafarm S.A.
Thesi Pousi Xatzi Agiou Louka
Paiania, 190 02
Greece

Date of last revision of the leaflet: