BRINZOLAMIDE 10 mg /Ml Eye Drops, Solution

Зміст інструкції

1. Brinzolamide Sandoz 10 mg/ml eye drops, suspension
   1. What is Brinzolamide Sandoz and what is it used for
   2. What you need to know before using Brinzolamide Sandoz
   3. How to use Brinzolamide Sandoz
   4. Possible side effects
   5. How to store Brinzolamide Sandoz
   6. Package contents and other information

Brinzolamide Sandoz 10 mg/ml eye drops, suspension

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 their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Brinzolamide Sandozcontains brinzolamidewhich belongs to a group of medicinescalled
carbonic anhydrase inhibitors. It decreases pressure in the eye.

Brinzolamide Sandoz eye drops are used for the treatment of high pressure in the eye.This
pressure condition can lead to a disease called glaucoma.
If the pressure in the eye is too high, it can damage vision.

2. What you need to know before using Brinzolamide Sandoz

Do not use Brinzolamide Sandoz

• if you have severe kidney problems.
• if you are allergicto brinzolamide or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to medicines called sulfonamides. Examples include medicines used for the treatment of diabetes and infections, and also diuretics (water tablets). Brinzolamide Sandoz may cause the same allergic reaction.
• if you have too much acid in your blood(a condition called hyperchloremic acidosis).

If you have any doubts, ask your doctor for advice.

Warnings and precautions
Consult your doctoror pharmacist before using Brinzolamide Sandoz

• if you have kidney or liver problems.
• if you have dry eyes or problems with your cornea.
• if you are taking other sulfonamide medicines.

Children and adolescents
Brinzolamide Sandoz should not be used in newborns, children or adolescents under the age of 18
years unless advised by your doctor.

Other medicines and Brinzolamide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines that can be bought without a prescription
medical.
If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see
section 1 “What is Brinzolamide Sandoz and what it is used for”), consult your doctor.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Women of childbearing potential are advised to use effective contraception during
treatment with Brinzolamide Sandoz. The use of Brinzolamide Sandoz is not recommended during
pregnancy or breastfeeding. Do not use Brinzolamide Sandoz unless specifically indicated
by your doctor.
Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines
Do not drive or use machinesuntil your vision is clear. Your vision may be blurred for
a short time immediately after using Brinzolamide Sandoz.
Brinzolamide Sandoz may decrease your ability to perform tasks that require mental
attention and/or physical coordination. If you experience such symptoms, be careful when driving
vehicles or using machines.

Brinzolamide Sandoz contains benzalkonium chloride
This medicine contains 0.10 mg of benzalkonium chloride in each ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
changes in their colour. Remove your contact lenses before using this medicine and wait 15
minutes before re-applying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the transparent outer layer of the eye). If you experience any abnormal
eye sensation, burning or pain after using this medicine, talk to your doctor.

3. How to use Brinzolamide Sandoz

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, ask your doctor or pharmacist.
Use Brinzolamide Sandoz only for your eyes. Do not swallow it and do not inject it.

The recommended dose is 1 drop in the affected eye(s), twice a day- morning and evening.
Use this dose unless your doctor prescribes a different dose. Use Brinzolamide
Sandoz in both eyes only as prescribed by your doctor. Use the medicine for the period of
time that your doctor recommends.

How to use it

3
Take the bottle of Brinzolamide Sandoz and a mirror.

• Wash your hands.
• Shake the bottle and unscrew the cap. After the cap has been removed, if the safety ring is loose, remove it before using the product.
• Hold the bottle in your hand, between your thumb and middle finger, and hold it with the tip pointing downwards.
• Tilt your head back. Lower the lower eyelid with a clean finger, so as to form a “pocket” between the eyelid and the eye. The drop must fall into this pocket (figure 1).
• Hold the tip of the bottle close to your eye. Use the mirror if it can be helpful.
• Do not touch your eye or eyelid, the surrounding areas or other surfaces with the tip of thebottle. It may infect the eye drops.
• Apply slight pressure on the base of the bottle to release one drop of Brinzolamide Sandoz at a time.
• Do not squeeze the bottle: it has been specially designed so that slight pressure on the bottom is sufficient (figure 2).
• After using Brinzolamide Sandoz, press your finger on the corner of your eye, near your nose (figure 3) for at least 1 minute. This will prevent Brinzolamide Sandoz from spreading throughout your body.
• If you need to put the eye drops in both eyes, repeat the steps for the other eye.
• Replace the cap immediately after use.
• Finish one bottle before opening the next.

If a drop does not enter the eye, try again.

If you are using another eye drop at the same time, allow at least 5 minutes to pass between instilling
Brinzolamide Sandoz and the other eye drop.
Ophthalmic ointments should be used last.

If you use more Brinzolamide Sandoz than you should
If you have instilled too much eye drops, immediately wash your eye with lukewarm water. Do not use the eye drops until it is
time for the next dose.

If you forget to use Brinzolamide Sandoz
Instill one drop as soon as you remember and then return to your normal instillation times. Do notuse
a double dose to make up for a missed dose.

If you stop treatment with Brinzolamide Sandoz
If you stop using Brinzolamide Sandoz without consulting your doctor, your eye pressure is
no longer under control and may lead to vision loss.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed with Brinzolamide Sandoz.

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

Effects on the eye:blurred vision, eye irritation, eye pain, eye discharge, eye itching, dry eye, abnormal sensation in the eyes, redness of the eye.

General side effects: bitter taste in the mouth .
Uncommon side effects(may affect up to 1 in 100 people):

Effects on the eye: sensitivity to light, inflammation or infection of the conjunctiva, eye swelling, itching, redness or swelling of the eyelid, new formation on the surface of the eye, increased eye pigmentation, eye fatigue, crusting on the eyelid margin or increased tearing

General side effects: reduction or decrease in cardiac function, palpitations, reduced heart rate, difficulty breathing, shortness of breath, cough, decreased number of red blood cells in the blood, increased chlorine levels in the blood, dizziness, drowsiness, memory impairment, depression, nervousness, general weakness, fatigue, abnormal sensation, pain, tremor, decreased sexual drive, male sexual dysfunction, cold symptoms, chest congestion, nasal cavity infection, throat irritation, sore throat, increased or decreased sensitivity in the mouth, inflammation of the inside of the esophagus, abdominal pain, nausea, vomiting, stomach pain, frequent bowel movements, diarrhea, intestinal gas, indigestion, kidney pain, muscle pain, muscle spasms, back pain, nosebleeds, runny nose, stuffy nose, sneezing, rash, abnormal skin sensation, itching, headache, dry mouth.

Rare side effects(may affect up to 1 in 1000 people):

Effects on the eye:corneal swelling, double or reduced vision, abnormal vision, decreased eye sensation, swelling around the eye, increased eye pressure, optic nerve damage.

General side effects:memory disturbances, drowsiness, chest pain, upper respiratory congestion, sinus congestion, nasal congestion, dry nose, ringing in the ears, hair loss, generalized itching, feeling nervous, irritability, irregular heartbeat, weakness, sleep disorders.

Not known(frequency cannot be estimated from available data)

Effects on the eye: eyelid abnormality, visual disturbances, corneal disorders, eye allergy, decreased growth or number of eyelashes.

General side effects: increased allergic symptoms, decreased sensitivity, tremor, loss or decrease of taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, pain in the extremities, skin redness, inflammation, or itching, changes in blood tests of liver function values, swelling of the limbs, frequent urination, decreased appetite.

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 at 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 Brinzolamide Sandoz

Keep this medicine out of the sight and reach of children.
Do not use Brinzolamide Sandoz after the expiry date which is stated on the bottle and the package after
“Exp”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
The bottle must be discarded four weeks after first opening, to prevent infections.
Write in the space below and on the space on the label of the bottle and on the package the date of
opening of each bottle. For the pack of 1 bottle write only 1 date.
Opening (1):
Opening (2):
Opening (3):
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Brinzolamide Sandoz contains
The active ingredient is brinzolamide 0.33 mg per drop, corresponding to 10 mg/ml.
The other ingredients are: benzalkonium chloride, disodium edetate, mannitol (E421), carbomer 974P,
tyloxapol, sodium chloride, sodium hydroxide and/or hydrochloric acid (to adjust the pH) and purified
water.

Description of the appearance of Brinzolamide Sandoz and package contents
Brinzolamide Sandoz is a suspension from white to off-white, contained in plastic bottles of 5
ml or 10 ml (LDPE bottles of 5 and 10 ml with LDPE droppers and PP screw cap
with tamper-evident closure (DROPTAINER).
The packs are available in the following sizes: outer carton containing bottles of 1 x 5
ml, 3 x 5 ml and 1 x 10 ml.
Not all pack sizes may be marketed.

Marketing authorisation holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturers
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana
Slovenia
and Alcon-Couvreur nv
Rijksweg 14, B-2870 Puurs
Belgium
Alcon Cusi S.A.
Camil Fabra 58, 08320 El Masnou, Barcelona
Spain
Aeropharm GmbH
Francois-mitterrand-allee 1, 07407 Rudolstadt
Germany
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Netherlands Brinzolamide Sandoz 10 mg/ml, eye drops, suspension
Belgium Brinzolamid Sandoz 10 mg/ml oogdruppels, suspensie
Austria Brinzolamid Sandoz 10 mg/ml - Augentropfensuspension
Germany Brinzolamid HEXAL 10 mg/ml Augentropfensuspension
Denmark Brinzolamide “Sandoz”
Spain Brinzolamida Sandoz 10mg/ml colirio en suspensión
Finland Brinzolamide Sandoz 10 mg/ml silmätipat, suspensio
France BRINZOLAMIDE SANDOZ 10 mg/ml, collyre en suspension
Ireland Brinzolomide Sandoz 10mg/ml eye drops suspension
Italy Brinzolamide Sandoz
Luxembourg Brinzolamid Sandoz 10 mg/ml collyre en suspension
Norway Brinzolamide Sandoz
Poland Brinzolamide Sandoz
Portugal Brinzolamida Sandoz 10 mg/ml, Colirio, suspensao
Sweden Brinzolamide Sandoz 10 mg/ml ögondroppar, suspension
Slovakia Brinzolamid Sandoz 10 mg/ml ocná suspenzná instilácia
Malta Brinzolamide 10 mg/ml eye drops, suspension