AZOPT 10 mg /Ml Eye Drops, Suspension

Зміст інструкції

1. AZOPT 10 mg/ml eye drops, suspension
   1. What is AZOPT and what is it used for
   2. What you need to know before you use AZOPT
   3. How to use AZOPT
   4. Possible side effects
   5. How to store AZOPT
   6. Contents of the pack and other information

AZOPT 10 mg/ml eye drops, suspension

brinzolamide

Read this leaflet carefully before you start 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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is AZOPT and what is it used for

AZOPT contains brinzolamide which belongs to a group of medicines called carbonic anhydrase inhibitors. It decreases the pressure in the eye.
AZOPT eye drops are used for the treatment of high pressure in the eye. This pressure condition
can lead to glaucoma.
If the pressure in the eye is too high, it can damage your vision.

2. What you need to know before you use AZOPT

Do not use AZOPT

• if you have severe kidney problems
• if you are allergic to brinzolamide or 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 (tablets). AZOPT may cause the same reaction
• if you have too much acidity in the blood (a condition called hyperchloremic metabolic acidosis)

If you have any further questions, consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before using AZOPT

• if you have kidney or liver problems.
• if you have dry eyes or problems with your cornea.
• if you are taking other sulfonamide medicines
• if you have a specific form of glaucoma in which the pressure inside the eye increases due to deposits that block the outflow of fluid (pseudoexfoliative or pigmentary glaucoma) or a specific form of glaucoma in which the pressure inside the eye increases (sometimes rapidly) because the eye is pushed forward and blocks the outflow of fluids (narrow-angle glaucoma)
• if you have ever developed a severe skin rash or skin peeling, blisters and/or ulcers in the mouth after using AZOPT or other related medicines.

Take special care with AZOPT:
Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
have been reported in association with treatment with brinzolamide. If you notice any symptoms related to
these severe skin reactions described in section 4, stop treatment with AZOPT and contact
your doctor immediately.

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

Other medicines and AZOPT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see
section 1 What is AZOPT and what is it 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
AZOPT. The use of AZOPT is not recommended during pregnancy or breastfeeding.
Do not use AZOPT unless clearly indicated by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Do not drive or use machinery until your vision is clear. Your vision may be blurred
for a while immediately after using AZOPT.
AZOPT may decrease your ability to perform operations that require mental attention and/or
physical coordination. If you experience such a symptom, be careful when driving vehicles or using
machinery.

AZOPT contains benzalkonium chloride
This medicine contains 3.35 µg of benzalkonium chloride per drop (= 1 dose) which is equivalent to
0.01% or 0.1 mg/ml.
AZOPT contains a preservative (benzalkonium chloride) which can be absorbed by soft contact lenses
and may lead to discoloration of them. Remove contact lenses before using this
medicine and wait 15 minutes before re-applying them. Benzalkonium chloride may also cause irritation
to the eyes, especially if you have dry eyes or corneal disorders (the transparent outermost 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 AZOPT

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Use AZOPT 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 amount unless your doctor tells you to do otherwise. Use AZOPT in
both eyes only if your doctor has told you to do so. Use the medicine for the period of time
that your doctor recommends.

How to use it

1 2 3

• Take AZOPT and a mirror
• Wash your hands
• Shake the bottle and unscrew the cap. After removing the cap, 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. Let a drop of eye drops fall into the eye (figure 1)
• Keep the tip of the bottle close to the eye. It may be helpful to look in the mirror
• Do not touch the eye or eyelid, the surrounding areas or other surfaces with the tip of the bottle. This could infect the eye drops
• A slight pressure on the base of the bottle will produce the release of one drop of AZOPT at a time.
• Do not squeeze the bottle: it has been specially designed so that a slight pressure on the bottom is sufficient (figure 2)
• After using AZOPT, press your finger on the corner of the eye, near the nose (figure 3) for at least 1 minute. This prevents AZOPT from spreading throughout the 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 misses the eye, try again.
If you are using other eye drops or ointments, allow at least 5 minutes to pass between instilling
AZOPT and the other eye drops. Ophthalmic ointments should be administered last.

If you use more AZOPT than you should
If you have instilled too much eye drops, immediately wash the eye with lukewarm water. Do not use the eye drops until the time
of the next dose.

If you forget to use AZOPT
Use a single drop as soon as you remember and then return to your normal instillation times. Do not use a
double dose to make up for a forgotten dose.

If you stop using AZOPT
If you stop using AZOPT without consulting your doctor, your eye pressure will not be 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 AZOPT.
Stop taking AZOPT and contact your doctor immediately if you notice any of the following
symptoms:

• flat, reddish patches on the trunk, resembling a target or circular, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Common(may affect up to 1 in 10 people)

• Effects on the eye:blurred vision; eye irritation, eye pain, eye discharge, itchy eyes, dry eyes, abnormal sensation in the eyes, redness of the eye.
• General side effects: bad taste.

Uncommon(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, deposits in the eye, glare, burning sensation, new tissue formation on the surface of the eye, increased eye pigmentation, eye fatigue, crusting on the eyelid margin, increased tearing.
• General side effects: reduced heart function, strong heartbeat that may be fast or irregular, decreased heart rate, difficulty breathing, shortness of breath, cough, decreased red blood cell count, increased chlorine levels in the blood, dizziness, memory problems, depression, nervousness, decreased emotions, nightmares, general weakness, abnormal sensation, fatigue, feeling unwell, pain, difficulty with movements, decreased sexual drive, erectile dysfunction in men, cold symptoms, chest congestion, nasal cavity infection, throat irritation, sore throat, increased or decreased sensitivity in the mouth, inflammation of the esophagus, abdominal pain, nausea, vomiting, stomach discomfort, frequent bowel movements, diarrhea, intestinal gas, indigestion, kidney pain, muscle pain, muscle spasms, back pain, nosebleeds, runny nose, stuffy nose, sneezing, skin redness, abnormal skin sensation, smooth or reddish skin rashes with raised bumps, skin tension, itching, headache, dry mouth, debris in the eye.

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

• Effects on the eye:corneal swelling, double or reduced vision, abnormal vision, flashes of light in the visual field, decreased eye sensation, swelling around the eyes, increased pressure in the eye, damage to the optic nerve.
• General side effects: impaired memory, drowsiness, chest pain, congestion of the upper respiratory tract, sinus congestion, nasal congestion, dry nose, ringing in the ears, hair loss, generalized itching, feeling of nervousness, irritability, irregular heartbeat, general weakness, difficulty sleeping, dyspnea, itchy rash.

Not known(frequency cannot be estimated from the available data)

• Effects on the eye:eyelid abnormality, visual disturbances, corneal discomfort, eye allergy, decreased growth or number of eyelashes, eyelid redness.
• 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, redness, inflammation or itching of the skin, abnormalities in liver function blood tests, swelling of the extremities, frequent urination, decreased appetite, malaise, flat, reddish patches on the trunk, resembling a target or circular, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers that may be preceded by fever and flu-like symptoms. These serious skin rashes can be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store AZOPT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

The bottle must be discarded four weeks after first opening,to prevent infections.
Write in the space below and in the space on the label of the bottle and the carton 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 waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AZOPT contains

• The active ingredient is brinzolamide. Each millilitre contains 10 mg of brinzolamide.
• The other ingredients are benzalkonium chloride, carbomer 974P, disodium edetate, mannitol (E421), purified water, sodium chloride and tyloxapol. Small amounts of hydrochloric acid or sodium hydroxide are added to maintain normal acidity (pH values).

Description of the appearance of AZOPT and contents of the pack
AZOPT is a milky ophthalmic suspension (in suspension) packaged in a plastic bottle with a
screw cap of 5 ml or 10 ml, or in a pack containing three 5 ml plastic bottles with a screw cap.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer
Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany
S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
Novartis Farmacéutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Siegfried El Masnou, S.A.
Camil Fabra 58
El Masnou
08320 Barcelona
Spain
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Lietuva
SIA Novartis Baltics Lietuvos filialas
Tel: +370 5 269 16 50

България
Novartis Bulgaria EOOD
Тел.: +359 2 489 98 28

Luxembourg/Luxemburg
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11

Česká republika
Novartis s.r.o.
Tel: +420 225 775 111

Magyarország
Novartis Hungária Kft.
Tel.: +36 1 457 65 00

Danmark
Novartis Healthcare A/S
Tlf: +45 39 16 84 00

Malta
Novartis Pharma Services Inc.
Tel: +356 2122 2872

Deutschland
Novartis Pharma GmbH
Tel: +49 911 273 0

Nederland
Novartis Pharma B.V.
Tel: +31 88 04 52 111

Eesti
SIA Novartis Baltics Eesti filiaal
Tel: +372 66 30 810

Norge
Novartis Norge AS
Tlf: +47 23 05 20 00

Ελλάδα
Novartis (Hellas) A.E.B.E.
Τηλ: +30 210 281 17 12

Österreich
Novartis Pharma GmbH
Tel: +43 1 86 6570

España
Novartis Farmacéutica, S.A.
Tel: +34 93 306 42 00

Polska
Novartis Poland Sp. z o.o.
Tel.: +48 22 375 4888

France
Novartis Pharma S.A.S.
Tél: +33 1 55 47 66 00

Portugal
Novartis Farma - Produtos Farmacêuticos, S.A.
Tel: +351 21 000 8600

Hrvatska
Novartis Hrvatska d.o.o.
Tel. +385 1 6274 220

România
Novartis Pharma Services Romania SRL
Tel: +40 21 31299 01

Ireland
Novartis Ireland Limited
Tel: +353 1 260 12 55

Slovenija
Novartis Pharma Services Inc.
Tel: +386 1 300 75 50

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Novartis Slovakia s.r.o.
Tel: + 421 2 5542 5439

Italia
Novartis Farma S.p.A.
Tel: +39 02 96 54 1

Suomi/Finland
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200

Κύπρος
Novartis Pharma Services Inc.
Τηλ: +357 22 690 690

Sverige
Novartis Sverige AB
Tel: +46 8 732 32 00

Latvija
SIA Novartis Baltics
Tel: +371 67 887 070

United Kingdom (Northern Ireland)
Novartis Ireland Limited
Tel: +44 1276 698370

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu