BRINZOLAMIDE 10 mg /Ml Drops

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Brinzolamide Accord, 10 mg/mL, Eye Drops, Suspension
   1. Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.
   2. Table of Contents of the Package Leaflet
3. What is Brinzolamide Accord and What is it Used For
4. Important Information Before Using Brinzolamide Accord
   1. When Not to Use Brinzolamide Accord
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Brinzolamide Accord and Other Medicines
   5. Pregnancy and Breastfeeding
   6. Driving and Using Machines
   7. Brinzolamide Accord Contains Benzalkonium Chloride
5. How to Use Brinzolamide Accord
   1. Recommended Dose
   2. Method of Administration
   3. Using More Brinzolamide Accord Than Prescribed
   4. Missing a Dose of Brinzolamide Accord
   5. Stopping Use of Brinzolamide Accord
6. Possible Side Effects
   1. Eyes:
   2. Eyes:
   3. General:
   4. Eyes:
   5. General:
   6. Eyes:
   7. Reporting Side Effects
7. How to Store Brinzolamide Accord
8. Contents of the Package and Other Information
   1. What Brinzolamide Accord Contains
   2. What Brinzolamide Accord Looks Like and Contents of the Package
   3. Marketing Authorization Holder
   4. Manufacturer
   5. This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:
   6. Date of Last Revision of the Package Leaflet: January 2024

Package Leaflet: Information for the User

Brinzolamide Accord, 10 mg/mL, Eye Drops, Suspension

Brinzolamide

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for the Patient.

• Keep this package 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. 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Brinzolamide Accord and What is it Used For
• 2. Important Information Before Using Brinzolamide Accord
• 3. How to Use Brinzolamide Accord
• 4. Possible Side Effects
• 5. How to Store Brinzolamide Accord
• 6. Contents of the Package and Other Information

1. What is Brinzolamide Accord and What is it Used For

Brinzolamide Accord contains brinzolamide, which belongs to a group of medicines called carbonic anhydrase inhibitors. It lowers the pressure in the eye.
Brinzolamide Accord is used to treat high pressure in the eye. This pressure can lead to the development of a disease called glaucoma.
If the pressure in the patient's eye is too high, it can lead to vision damage.

2. Important Information Before Using Brinzolamide Accord

When Not to Use Brinzolamide Accord

• If the patient has severe kidney disease.
• If the patient is allergic to brinzolamide or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to sulphonamide medicines. Examples of sulphonamides are medicines used to treat diabetes, infections, and diuretics. Brinzolamide Accord may cause the same allergic reactions.
• If the patient has too much acid in the blood (a condition called hyperchloremic acidosis).

If you have any other questions, ask your doctor for advice.

Warnings and Precautions

Before starting to use Brinzolamide Accord, discuss it with your doctor or pharmacist:

• If the patient has kidney or liver disease.
• If the patient has dry eye or corneal disorders.
• If the patient is taking other sulphonamide medicines. If the patient has a certain type of glaucoma, in which the pressure in the eye increases due to

blockage of fluid outflow by deposits (pigmentary and capsular glaucoma) or a certain type of glaucoma, in which the pressure in the eye increases (sometimes suddenly), because the eye becomes deformed forward, thereby blocking the outflow of fluid (narrow-angle glaucoma).

• If the patient has ever had a severe skin rash or skin peeling, blistering, and (or) ulcers in the mouth after using brinzolamide or other related medicines.

Particular caution should be exercised when using brinzolamide:
In connection with brinzolamide treatment, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. Brinzolamide should be discontinued and immediate medical attention should be sought in case of any symptoms related to these severe skin reactions described in section 4.

Children and Adolescents

Brinzolamide Accord should not be used in infants, children, and adolescents under 18 years of age, unless advised by a doctor.

Brinzolamide Accord and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take, including those obtained without a prescription.
Tell your doctor about taking other carbonic anhydrase inhibitors (acetazolamide or dorzolamide, see section 1. What is Brinzolamide Accord and what is it used for).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Women who can become pregnant are advised to use effective contraception during treatment with Brinzolamide Accord. It is not recommended to use Brinzolamide Accord in pregnant or breastfeeding women. Do not use Brinzolamide Accord unless your doctor decides otherwise.
Before using any medicine, ask your doctor or pharmacist for advice.

Driving and Using Machines

Do not drive or operate machinery until your vision has cleared. For some time after using Brinzolamide Accord, vision may be blurred.
Brinzolamide Accord may affect your ability to perform tasks that require increased attention and (or) motor coordination. If such symptoms occur, be cautious when driving or operating machinery.

Brinzolamide Accord Contains Benzalkonium Chloride

Brinzolamide Accord contains a preservative (benzalkonium chloride), which may be absorbed by soft contact lenses and change their color. Remove contact lenses before instillation and wait at least 15 minutes before reinserting. Benzalkonium chloride can also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer on the front of the eye). If you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicine, contact your doctor.

3. How to Use Brinzolamide Accord

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

Recommended Dose

1 drop into the affected eye or eyes, twice a day - in the morning and evening.
Use the dose prescribed by your doctor. Brinzolamide Accord can be used in both eyes only if advised by your doctor. Use the medicine for as long as your doctor tells you.

Method of Administration

• Prepare the Brinzolamide Accord bottle and a mirror.
• Wash your hands.
• Shake the bottle and remove the cap. If the protective collar is loose after removing the cap, remove it before using the medicine.
• Hold the inverted bottle between the thumb and middle finger.
• Tilt your head back. With a clean finger, pull the lower eyelid down to create a "pocket"; the drop should fall into this pocket (Figure 1).
• Bring the tip of the bottle close to the eye. You can use a mirror to help.
• Do not touch the dropper tip to the eye or eyelid, or to any other surface. This could contaminate the drops.
• Squeeze one drop into the pocket (Figure 2).
• After using Brinzolamide Accord, press the corner of your eye near your nose for at least 1 minute. This will help prevent the medicine from draining into your tear duct and being absorbed into your bloodstream.
• If you are using drops in both eyes, repeat the steps for the other eye.
• Tighten the bottle cap immediately after use.
• Open a new bottle only after the previous one is empty.

If the drop does not get into the eye, try again.
If you are using other eye drops, wait at least 5 minutes between using Brinzolamide Accord and other eye drops. Apply eye ointments last.

Using More Brinzolamide Accord Than Prescribed

If you accidentally put too many drops in your eye, flush your eye with warm water. Do not use more medicine until it is time for your next dose.

Missing a Dose of Brinzolamide Accord

Use one drop in the affected eye as soon as you remember, and then continue with your regular schedule. Do not use a double dose to make up for a missed dose.

Stopping Use of Brinzolamide Accord

If you stop using Brinzolamide Accord without consulting your doctor, the pressure in your eye will no longer be controlled, which can lead to vision loss.

4. Possible Side Effects

Like all medicines, Brinzolamide Accord can cause side effects, although not everybody gets them.
Stop using brinzolamide and seek immediate medical attention if you notice any of the following symptoms:

• red, non-raised patches on the body, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

The following side effects have been observed with the use of Brinzolamide Accord.
Common Side Effects(may affect up to 1 in 10 people)

Eyes:

blurred vision; eye irritation, eye pain, eye discharge, eye itching, dry eye, abnormal sensations in the eye, eye redness.
General:unpleasant taste.
Uncommon Side Effects(may affect up to 1 in 100 people)

Eyes:

light sensitivity, inflammation or inflammation of the conjunctiva, eye swelling, eyelid itching, redness or swelling, deposits in the eye, dazzling effect of light, burning sensation, increased eye surface, increased eye pigmentation, eye fatigue, eyelid crust, increased tear production.

General:

slow or weak heart rate, fast or irregular heartbeat, slow heart rate, breathing difficulties, shortness of breath, cough, reduced red blood cell count, increased chloride levels in the blood, dizziness, memory problems, depression, nervousness, decreased emotional involvement, nightmares, general weakness, fatigue, abnormal feeling, pain, movement problems, decreased sex drive, erectile dysfunction, cold symptoms, bronchitis, throat irritation, sore throat, abnormal sensation in the mouth, esophageal inflammation, stomach pain, nausea, vomiting, indigestion, frequent bowel movements, diarrhea, gas, digestive disorders, kidney pain, muscle pain, muscle cramps, back pain, nosebleeds, runny nose, nasal congestion, sneezing, rash, abnormal skin sensation, itching, smooth rash on the skin or red, raised bumps, skin tension, headache, dry mouth, eye deposits.
Rare Side Effects(may affect up to 1 in 1,000 people)

Eyes:

corneal swelling, double vision or limited vision, abnormal vision, flashes of light in the field of vision, decreased sensation in the eye, swelling around the eye, increased eye pressure, optic nerve damage.

General:

memory disorders, drowsiness, chest pain, congestion in the upper respiratory tract, nasal congestion, runny nose, dry nose, ringing in the ears, hair loss, generalized itching, feeling of trembling, irritability, irregular heartbeat, weakness, difficulty sleeping, wheezing, itchy skin rash.
Frequency Not Known(frequency cannot be estimated from the available data)

Eyes:

eyelid abnormalities, vision disorders, corneal disease, eye allergy, decreased eyelash growth or number, eyelid redness.
General:increased allergic symptoms, decreased sensation, tremors, loss or decrease of taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, limb pain, skin redness, inflammation or itching, abnormal liver test results from blood tests, limb swelling, frequent urination, decreased appetite, malaise, red, non-raised patches on the body, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, which may be preceded by fever and flu-like symptoms. These severe skin rashes can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported 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 Brinzolamide Accord

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton, after "EXP".
The expiry date refers to the last day of the month stated.
This medicine does not require any special storage precautions.
To prevent infections, the bottle should be discarded 4 weeks after it is first opened. The date of opening of each bottle should be written in the space provided below and on the label of the bottle and on the carton. For packaging containing one bottle, only one date should be entered.
Date of opening (1):
Date of opening (2):
Date of opening (3):
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 Package and Other Information

What Brinzolamide Accord Contains

• The active substance is brinzolamide. Each milliliter contains 10 mg of brinzolamide.
• The other ingredients are: benzalkonium chloride, mannitol, carbomer 974P, disodium edetate, purified water, sodium chloride. Small amounts of hydrochloric acid or sodium hydroxide are added to adjust the pH.

What Brinzolamide Accord Looks Like and Contents of the Package

Brinzolamide Accord is a white or almost white homogeneous suspension.
The immediate packaging is a sterile 10 mL low-density polyethylene (LDPE) bottle with a sterile dropper made of LDPE and a sterile high-density polyethylene (HDPE) cap with a tamper-evident closure, containing 5 mL of suspension.
Package sizes:
A cardboard box containing 1 or 3 bottles.
Not all package sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer

Lusomedicamenta Sociedade Técnica Farmacêutica, S.A.
Norberto de Oliveira Street, no 1/5
2620-111 Póvoa de Santo Adrião
Portugal

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Date of Last Revision of the Package Leaflet: January 2024