Brinzolamide genoptim

Package leaflet: Information for the patient

Brinzolamide Genoptim, 10 mg/mL, eye drops, suspension
Brinzolamidum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Brinzolamide Genoptim is and what it is used for

Brinzolamide Genoptim contains brinzolamide, which belongs to a group of medicines called carbonic anhydrase inhibitors. The medicine reduces intraocular pressure.
Brinzolamide Genoptim is used to treat elevated intraocular pressure. Increased pressure may lead to a disease called glaucoma.
If intraocular pressure is too high, it may result in damage to vision.

2. Important information before using Brinzolamide Genoptim

When not to use Brinzolamide Genoptim:

• 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 medicines called sulfonamides. Examples of sulfonamides include medicines used to treat diabetes and infections, as well as diuretics (water tablets). Brinzolamide Genoptim may cause a similar allergic reaction;
• if the patient has excessive acidity of the blood (a condition called hyperchloremic acidosis).

If you have any questions, consult your doctor.
Warnings and precautions
Before starting treatment with Brinzolamide Genoptim, discuss this with your doctor or
pharmacist:

• if the patient has impaired kidney or liver function,
• if the patient has dry eye or corneal disorders,
• if the patient is taking other medicines from the sulfonamide group,
• if the patient has a certain type of glaucoma in which intraocular pressure increases due to blockage of fluid drainage by deposits (pseudoexfoliative or pigmentary glaucoma),

or a certain type of glau游戏副本

3. How to use Brinzolamide Genoptim

This medicine should always be used exactly as your doctor or pharmacist has advised. If in doubt,
please consult your doctor or pharmacist.
Brinzolamide Genoptim is for ophthalmic use only. Do not swallow or inject this medicine.
The recommended dose is one drop into the affected eye(s) twice daily – in the morning and evening.
Use this dose unless your doctor has instructed otherwise. Brinzolamide Genoptim 10 mg/ml, eye drops, suspension may be used in both eyes only if directed by your doctor.
Continue using the medicine for as long as your doctor has advised.

Instructions for use:

1 2 3

• Prepare the Brinzolamide Genoptim bottle and a mirror.
• Wash your hands.
• Shake the bottle and unscrew the cap. If the tamper-evident ring is loose after removing the cap, remove it before using the medicine.
• Turn the bottle upside down, holding it between your thumb and middle finger.
• Tilt your head backwards. With a clean finger, gently pull down the lower eyelid to create a small pocket between the eyeball and the eyelid. This is where the drop should be placed (figure 1).
• Bring the dropper tip close to the eye. You may find it helpful to use a mirror.
• Do not let the dropper touch the eye, eyelid, surrounding area, or any other surface. This could contaminate the drops.
• Gently press the bottom of the bottle to release one drop.
• Do not squeeze the bottle: it is designed so that gentle pressure on the base is sufficient (figure 2).
• After instilling Brinzolamide Genoptim, press your finger against the inner corner of the eye next to the nose (figure 3) for at least 1 minute. This helps prevent the medicine from draining into the rest of the body.
• If using drops in both eyes, repeat the above steps for the second eye.
• Screw the cap back on tightly immediately after use.
• Open a new bottle only after completely using the contents of the previous one.

If the drop misses the eye, try again.
If you are using other eye drops, wait at least 5 minutes between applying Brinzolamide Genoptim 10 mg/ml, eye drops, suspension and any other eye drops. Ointments should be used last.

Overdose of Brinzolamide Genoptim
If too many drops are used, rinse the eye thoroughly with lukewarm water. Do not re-administer the drops until it is time for the next dose.

Missed dose of Brinzolamide Genoptim
If you miss a dose, apply one drop as soon as you remember, then continue with your regular dosing schedule. Do not use a double dose to make up for a missed dose.

Stopping Brinzolamide Genoptim treatment
If you stop using Brinzolamide Genoptim without consulting your doctor, intraocular pressure may no longer be controlled, which could lead to vision loss.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed during the use of brinzolamide.
You should stop using brinzolamide and seek immediate medical help if you notice any of the following symptoms:

• Red, flat, circular rash or resembling a target (bull's eye), occurring on the trunk, often with blisters in the center, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Common adverse reactions (may occur in up to 1 in 10 people)
Eye-related symptoms:
blurred vision, eye irritation, eye pain, eye discharge, eye itching, dry eye, unusual sensations in the eye, eye redness.
General symptoms:
unpleasant taste.

Uncommon adverse reactions (may occur in up to 1 in 100 people)
Eye-related symptoms:
light sensitivity, inflammation or conjunctivitis, eye swelling, eyelid itching, redness or swelling, eye deposits, glare effect, burning sensation, ocular surface nodule, increased eye pigmentation, eye fatigue, crust formation on eyelids, increased tear production.
General symptoms:
slowed or weakened heart function, strong heartbeat which may be fast or irregular, slowed heart rate, breathing difficulties, shortness of breath, cough, decreased number of red blood cells in blood, increased chloride levels in blood, dizziness, memory problems, depression, nervousness, reduced emotional responsiveness, nightmares, general weakness, fatigue, unusual feeling, pain, movement difficulties, decreased libido, reduced sexual performance in men, cold-like symptoms, congestion of mucous membranes in lower respiratory tract, sinus infection, sore throat, throat irritation, unusual or reduced sensation in the mouth, esophageal mucosal inflammation, abdominal pain, nausea, vomiting, indigestion, increased frequency of bowel movements, diarrhea, intestinal gas accumulation, digestive disturbances, kidney pain, muscle pain, muscle cramps, back pain, nosebleeds, runny nose, nasal congestion, sneezing, rash, unusual skin sensations, itching, smooth skin rash or red, raised bumps, skin tightness, headache, dry mouth, eye deposits.

Rare adverse reactions (may occur in up to 1 in 1,000 people)
Eye-related symptoms:
corneal edema, double or restricted vision, abnormal vision, light flashes in the visual field, reduced sensation in the eye, periorbital swelling, increased intraocular pressure, optic nerve damage.
General symptoms:
memory disturbances, drowsiness, chest pain, congestion of mucous membranes in upper respiratory tract, sinus mucosal congestion, nasal mucosal congestion, dry nose, tinnitus, hair loss, generalized itching, feeling of shakiness, irritability, irregular heart rhythm, general malaise, difficulty falling asleep, wheezing, itchy skin rash.

Frequency not known (cannot be estimated from available data)
Eye-related symptoms:
eyelid abnormalities, visual disturbances, corneal disease, ocular allergy, reduced growth or number of eyelashes, eyelid redness.
General symptoms:
severe allergic reactions, reduced sensation, tremor, reduced or loss of taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, limb pain, redness or skin inflammation, itching, abnormal liver function test results, limb swelling, frequent urination, decreased appetite, malaise, red, flat, circular or target-like rashes on the trunk, often with blisters in the center, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs and eyes, which may be preceded by fever and flu-like symptoms. These severe skin rashes may be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Brinzolamide Genoptim

Keep this 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 stated month.
No special storage conditions are required for this medicine.
Discard the bottle 4 weeks after first opening to prevent contamination.
The opening date of each bottle should be recorded in the space provided below and in the designated space on the bottle label and carton. For a pack containing one bottle, enter only one date.
Opening date (1):
Opening date (2):
Opening date (3):
Opening date (4):
Opening date (5):
Opening date (6):
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Brinzolamide Genoptim contains

• The active substance is brinzolamide. Each millilitre of suspension contains 10 mg of brinzolamide.
• The other ingredients are: benzalkonium chloride, solution, carbomer 974P, disodium edetate, mannitol, water for injections, sodium chloride, poloxamer 407, sodium hydroxide 5N.

What Brinzolamide Genoptim looks like and contents of the pack
Brinzolamide Genoptim is a milky liquid (suspension), supplied in boxes containing 1, 3 or 6 plastic bottles with dropper (type "droptainer") and cap, each containing 5 mL of white, homogeneous suspension.
Pack sizes available: cardboard boxes containing 1, 3 or 6 bottles of 5 mL.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Poland

Manufacturer
Pharmathen S.A.
6 Dervenakion
153 51, Pallini Attiki
Greece

Famar S.A.
63 Agiou Dimitriou Street
174 56 Alimos, Athens
Greece

Balkanpharma-Razgrad AD
68 Aprilsko vastanie Blvd.
7200 Razgrad
Bulgaria

Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nuremberg
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Brinzolamide Pharmathen 10 mg/ml oogdruppels, suspensie
Germany: Brinzolamid Heumann 10 mg/ml Augentropfensuspension
Poland: Brinzolamide Genoptim
Lithuania: Brinzolamide ELVIM 10 mg/ml akių lašai (suspensija)
Latvia: Brinzolamide ELVIM 10 mg/ml acu pilieni, suspensija
Estonia: Brinzolamide ELVIM
France: Brinzolamide BIOGARAN 10 mg/ml, collyre en suspension
Italy: BRINZAFLUX
United Kingdom: Brinzolamide 10 mg/ml eye drops, suspension
Greece: Optonium
Czech Republic: Brinzolamid Apotex 10mg/ml oční kapky, suspenze