AZOPT 10 mg/ml EYE DROPS IN SUSPENSION

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 a group of medicines called sulfonamides. Examples: medicines used to treat diabetes and infections and also diuretics (water pills). AZOPT could cause you the same allergy.
• if you have too much acid in the blood (a disease called hyperchloremic acidosis).

If you are not sure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before you start using AZOPT:

• if you have kidney or liver problems.
• if you have dry eye or cornea problems.
• if you are using other medicines that contain sulfonamides.
• if you have a specific type of glaucoma where the pressure in the eye increases due to deposits that block the drainage of fluid in the eye (pseudoexfoliative glaucoma or pigmentary glaucoma) or a specific type of glaucoma where the pressure in the eye increases (sometimes rapidly) due to a bulge towards the front of the eye that blocks the drainage of fluid (narrow-angle glaucoma).
• if you have ever developed a severe skin rash or skin peeling, blisters and/or sores in the mouth after using AZOPT or other related medicines.

Be careful with AZOPT:

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with brinzolamide treatment. Stop using AZOPT and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children and adolescents

AZOPT should not be used in infants, children, and adolescents under 18 years, unless your doctor recommends it.

Other medicines and AZOPT

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Consult your doctor if you are using another carbonic anhydrase inhibitor (acetazolamide or dorzolamide, see section 1 What is AZOPT 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 may become pregnant 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.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Do not drive or use machines until your vision is clear. Immediately after applying AZOPT, you may notice that your vision becomes blurred.

AZOPT may worsen your ability to perform tasks that require mental alertness and/or physical coordination. If you notice these effects, be careful when driving or using machines.

AZOPT contains benzalkonium chloride

This medicine contains 3.35 µg of benzalkonium chloride per drop (= 1 dose), equivalent to 0.01% or 0.1 mg/ml.

AZOPT contains a preservative (benzalkonium chloride) that can be absorbed by soft contact lenses and may alter the color of the contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before putting them back. Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer of the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

3. How to use AZOPT

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

Use AZOPT only in your eye(s). Do not swallow or inject.

The recommended dose is1 drop in the affected eye(s) twice a day - in the morning and at night.

This is the dosage you should follow unless your doctor has indicated otherwise. You should only apply AZOPT to both eyes if your doctor has recommended it. Continue the treatment for the entire period of time indicated by your doctor.

How to use

1 2 3

• Take the AZOPT bottle and stand in front of a mirror
• Wash your hands
• Shake the bottle and unscrew the cap. After removing the cap, you must remove the security seal ring if it is loose before using this medicine
• Hold the bottle, upside down, between your thumb and index finger
• Tilt your head back. Gently pull the lower eyelid down to form a pocket, where the drop should fall (figure 1)
• Bring the tip of the bottle close to the eye. You can use a mirror to help you
• Do not touch the eye, eyelid, or surrounding areas with the dropper, as the drops could become contaminated
• Gently press the base of the bottle to release one drop of AZOPT at a time
• Do not squeeze the bottle: it is designed to release one drop with a gentle pressure on the base (figure 2)
• After using AZOPT, press the edge of the eye, next to the nose (figure 3) for at least 1 minute. This helps prevent AZOPT from passing into the rest of the body
• If you are applying drops to both eyes, repeat all the previous steps with the other eye
• Screw the cap back on the bottle immediately after use
• Finish the bottle you are using before opening the next one

If a drop falls outside the eye, try again.

If you are using another eye drop, wait at least 5 minutes between applying AZOPT and the other drops. Ophthalmic ointments should be applied last.

If you use more AZOPT than you should

If you have applied too much, you can remove it by rinsing your eyes with warm water. Do not apply more drops until it is time for your next dose.

If you forget to use AZOPT

Apply a drop as soon as you remember and then continue with your usual treatment schedule. Do not apply a double dose to make up for forgotten doses.

If you stop using AZOPT

If you stop using AZOPT without consulting your doctor, the pressure in your eye will not be controlled, which could lead to loss of vision.

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 using AZOPT and seek immediate medical attention if you notice any of the following symptoms:

• red patches, target-like or circular, on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can 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 eye, eye redness.

• Other side effects: bad taste.

Uncommon(may affect up to 1 in 100 people)

• Eye effects:sensitivity to light, conjunctivitis, eye swelling, itching, redness or swelling of the eyelid, deposits in the eye, glare, burning sensation, lump on the surface of the eye, increased pigmentation of the eye, tired eyes, crusts on the eyelid, increased tear production.

• Other side effects:reduced or decreased heart function, strong or irregular heartbeats, decreased heart rate, difficulty breathing, shortness of breath, cough, decreased red blood cell count, increased chloride levels in the blood, dizziness, memory problems, depression, nervousness, decreased emotional interest, nightmares, weakness, fatigue, feeling abnormal, pain, movement problems, decreased sexual behavior, sexual problems in men, cold symptoms, chest congestion, nasal passage infection, throat irritation, sore throat, abnormal or decreased sensation in the mouth, esophageal mucosa inflammation, abdominal pain, nausea, vomiting, stomach pain, frequent bowel movements, diarrhea, gas, digestive disorders, kidney pain, muscle pain, muscle spasms, back pain, nosebleeds, nasal discharge (runny nose), stuffy nose, sneezing, rash, abnormal sensation on the skin, itching, smooth or red skin rash, skin tightness, headache, dry mouth, particles in the eye.

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

• Eye effects:corneal swelling, double or decreased vision, abnormal vision, flashes of light in the field of vision, decreased eye sensitivity, swelling around the eye, increased pressure in the eye, optic nerve damage.

• Other side effects:memory loss, drowsiness, chest pain, upper respiratory tract congestion, sinus congestion, nasal congestion, nasal dryness, ringing in the ears, hair loss, generalized itching, feeling restless, irritability, irregular heartbeat, general weakness, difficulty sleeping, wheezing, skin rash with itching.

Frequency not known(cannot be estimated from the available data)

• Eye effects:eyelid abnormality, vision changes, corneal changes, eye allergy, decreased eyelash growth or number, eyelid redness.

• Other side effects:increased allergy symptoms, decreased sensation, tremor, decreased or lost taste, decreased blood pressure, increased blood pressure, increased heart rate, joint pain, asthma, pain in limbs, itching, skin inflammation or redness, abnormal liver blood test results, swelling of limbs, frequent need to urinate, decreased appetite, general malaise, red patches, target-like or circular, on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes that may be preceded by fever and flu-like symptoms. These severe skin rashes can be potentially life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Reporting of side effects

If you experience 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 carton after “EXP”. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

To avoid infections, you must discard each bottle four weeks after you first open it.Write the date you open each bottle on the space below and on the label of the bottle and carton. For the pack containing only one bottle, write only one date.

Opening date (1):

Opening date (2):

Opening date (3):

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

AZOPT composition

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

Product appearance and container contents

AZOPT is a milky-looking liquid (a suspension) that comes in a box containing a 5-ml or 10-ml plastic bottle with a screw cap, or in a box containing three 5-ml plastic bottles with screw caps. Only certain package sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer responsible

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

Novartis Manufacturing NV

Rijksweg 14

2870 Puurs-Sint-Amands

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

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the last revision of this prospectus

Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu/.