Azopt

Package leaflet: Information for the user

AZOPT 10 mg/ml eye drops, suspension

brinzolamide
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 using 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 AZOPT is and what it is used for

AZOPT contains brinzolamide, which belongs to a group of medicines called carbonic anhydrase inhibitors. It reduces pressure in the eye.
AZOPT eye drops are used to treat elevated intraocular pressure. This increased pressure may lead to glaucoma.
If the pressure in the eye is too high, it can damage vision.

2. What you should know before using AZOPT

Do not use AZOPT

• if you have severe kidney problems
• if you are allergic to 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 drugs used to treat diabetes, infections, and also diuretics (tablets). AZOPT may cause the same reaction
• if you have too much acid in your blood (a condition called hyperchloremic acidosis)

If you have 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 corneal problems
• if you are taking other sulfonamide medicines
• if you have a specific type of glaucoma in which pressure inside the eye increases due to deposits blocking fluid drainage (pseudoexfoliative or pigmentary glaucoma), or a specific type of glaucoma in which pressure inside the eye increases (sometimes rapidly) because the eye is pushed forward and blocks fluid outflow (narrow-angle glaucoma)
• if you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth ulcers after using AZOPT or other related medicines.

Exercise special caution with AZOPT:
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported during 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 must not be used in newborns, children, or adolescents under 18 years of age, unless specifically advised by a doctor.
Other medicines and AZOPT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
If you are taking another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see section 1 What AZOPT is and what it is used for), consult your doctor.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Women of childbearing potential are advised to use effective contraceptive methods 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 using any medicine.
Driving and using machines
Do not drive or operate machinery until your vision is clear. Your vision may be blurred for a short time after using AZOPT.
AZOPT may reduce your ability to perform tasks requiring mental alertness and/or physical coordination. If you experience such symptoms, be cautious when driving 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) that may be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the outermost transparent layer of the eye). If you experience any unusual sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.

3. How to use AZOPT

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use AZOPT only in your eyes. Do not swallow or inject it.
The recommended dose is
1 drop in the affected eye(s), twice daily – morning and evening.
Use this amount unless your doctor tells you otherwise. Use AZOPT in
both eyes only if your doctor has instructed you to do so. Use the medicine for as long
as 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 has loosened, remove it before using the product.
• Hold the bottle between your thumb and middle finger, with the tip pointing downwards
• Tilt your head back. Pull down the lower eyelid with a clean finger to form a "pocket" between the eyelid and the eye. Instill one drop of the eye drops into the eye (figure 1)
• Hold the tip of the bottle close to the eye. Looking in a mirror may be helpful
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the tip of the bottle. This could contaminate the eye drops
• A gentle pressure at the base of the bottle will release one drop of AZOPT at a time
• Do not squeeze the bottle: it is specifically designed so that gentle pressure at the bottom is sufficient (figure 2)
• After using AZOPT, press with your finger on the inner corner of the eye, near the nose (figure 3), for at least 1 minute. This helps prevent AZOPT from spreading into the rest of the body
• If you need to instill 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 eye ointments, wait at least 5 minutes between applying 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 many drops, rinse the eye immediately with lukewarm water. Do not use the eye drops again until the next scheduled dose.
If you forget to use AZOPT
Use 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 forgotten dose.
If you stop using AZOPT
If you stop using AZOPT without consulting your doctor, your intraocular pressure may not be controlled and could 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 treatment with AZOPT and contact your doctor immediately if you notice any of the following symptoms:

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

Common (may affect up to 1 in 10 people)

• Eye effects: blurred vision; eye irritation, eye pain, eye discharge, eye itching, dry eye, abnormal sensation in the eyes, eye redness.
• General side effects: bad taste.

Uncommon (may affect up to 1 in 100 people)

• Eye effects: light sensitivity, conjunctival inflammation or infection, eye swelling, eyelid itching, redness or swelling, deposits in the eye, glare, burning sensation, new growth on the eye surface, increased eye pigmentation, eye fatigue, crusting at the eyelid margin, increased tearing.
• General side effects: reduced heart function, strong heartbeat which may be rapid or irregular, reduced heart rate, breathing difficulty, shortness of breath, cough, decreased blood red cell count, increased blood chloride levels, dizziness, memory problems, depression, nervousness, reduced emotions, nightmares, generalized weakness, abnormal sensation, fatigue, abnormal sensation, pain, movement difficulties, decreased sexual drive, male sexual dysfunction, cold-like symptoms, chest congestion, nasal cavity infection, sore throat, throat irritation, increased or decreased mouth sensitivity, inflammation of the esophagus lining, abdominal pain, nausea, vomiting, stomach discomfort, frequent defecation, diarrhoea, intestinal gas, indigestion, kidney pain, muscle pain, muscle spasms, back pain, nosebleeds, runny nose, nasal congestion, sneezing, skin flushing, abnormal skin sensation, smooth rashes or raised red bumps, skin tightness, itching, headache, dry mouth, eye debris.

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

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

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

• Eye effects: eyelid abnormalities, vision disturbances, corneal discomfort, eye allergy, reduced eyelash growth or number, eyelid redness.
• General side effects: worsening of allergic symptoms, decreased sensitivity, tremor, loss or reduction of taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, pain in extremities, redness, skin inflammation or itching, abnormalities in liver function blood tests, swelling of extremities, frequent urination, decreased appetite, malaise, red, flat patches on the trunk, with a target-like or circular appearance, often with central blisters, skin peeling, mouth, throat, nose, genital, and eye ulcers which may be preceded by fever and flu-like symptoms. These serious skin reactions may be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the bottle and on 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 infection.
Write the opening date in the space below and in the space on the label of the bottle and on the carton for each bottle. For the pack containing 1 bottle, write only one date.
Opening (1):
Opening (2):
Opening (3):
Do not dispose of any medicine 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 AZOPT contains

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

Description of the appearance of AZOPT and contents of the pack
AZOPT is a milky eye drop suspension, supplied in a plastic bottle with a screw cap containing 5 ml or 10 ml, or in a pack containing three 5 ml plastic bottles with screw caps.
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, please contact the local representative of the Marketing Authorisation Holder in your country:

België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SIA Novartis Baltics Lietuvos filialas
Tél/Tel: +32 2 246 16 11 Tel: +370 5 269 16 50

България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел.: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11

Česká republika Magyarország
Novartis s.r.o. Novartis Hungária Kft.
Tel: +420 225 775 111 Tel.: +36 1 457 65 00

Danmark Malta
Novartis Healthcare A/S Novartis Pharma Services Inc.
Tlf: +45 39 16 84 00 Tel: +356 2122 2872

Deutschland Nederland
Novartis Pharma GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111

Eesti Norge
SIA Novartis Baltics Eesti filiaal Novartis Norge AS
Tel: +372 66 30 810 Tlf: +47 23 05 20 00

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Novartis Pharma GmbH
Τηλ: +30 210 281 17 12 Tel: +43 1 86 6570

España Polska
Novartis Farmacéutica, S.A. Novartis Poland Sp. z o.o.
Tel: +34 93 306 42 00 Tel.: +48 22 375 4888

France Portugal
Novartis Pharma S.A.S. Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 66 00 Tel: +351 21 000 8600

Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01

Ireland Slovenija
Novartis Ireland Limited Novartis Pharma Services Inc.
Tel: +353 1 260 12 55 Tel: +386 1 300 75 50

Ísland Slovenská republika
Vistor hf. Novartis Slovakia s.r.o.
Sími: +354 535 7000 Tel: + 421 2 5542 5439

Italia Suomi/Finland
Novartis Farma S.p.A. Novartis Finland Oy
Tel: +39 02 96 54 1 Puh/Tel: +358 (0)10 6133 200

Κύπρος Sverige
Novartis Pharma Services Inc. Novartis Sverige AB
Τηλ: +357 22 690 690 Tel: +46 8 732 32 00

Latvija United Kingdom (Northern Ireland)
SIA Novartis Baltics Novartis Ireland Limited
Tel: +371 67 887 070 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